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UNIVERSIDADE FEDERAL DE SERGIPE
PRÓ-REITORIA DE PÓS-GRADUAÇÃO E PESQUISA
DOUTORADO EM CIÊNCIAS DA SAÚDE
GISELLE DE CARVALHO BRITO
SERVIÇOS CLÍNICOS FARMACÊUTICOS EM UNIDADES
DO PROGRAMA FARMÁCIA POPULAR DO BRASIL DO
ESTADO DE SERGIPE: IMPLANTAÇÃO,
IMPLEMENTAÇÃO E CONSOLIDAÇÃO
ARACAJU
2015
GISELLE DE CARVALHO BRITO
SERVIÇOS CLÍNICOS FARMACÊUTICOS EM
UNIDADES DO PROGRAMA FARMÁCIA
POPULAR DO BRASIL DO ESTADO DE SERGIPE:
IMPLANTAÇÃO, IMPLEMENTAÇÃO E
CONSOLIDAÇÃO
Tese apresentada ao Núcleo de Pós-Graduação
em Ciências da Saúde da Universidade Federal
de Sergipe como requisito parcial à obtenção
do grau de Doutora em Ciências da Saúde.
Orientador: Prof. Dr. Divaldo Pereira de Lyra Júnior
ARACAJU
2015
Ficha catalográfica elaborada pela Biblioteca da Saúde/UFS
Brito, Giselle de Carvalho
Serviços clínicos farmacêuticos em unidades do programa Farmácia Popular do
Brasil do estado de Sergipe: implantação, implementação e consolidação.
282f.
Orientador: Prof. Dr. Divaldo Pereira de Lyra Júnior
Tese (Doutorado em Ciências da Saúde) – Universidade Federal de Sergipe, Pró-
Reitoria de Pós-Graduação e Pesquisa, Núcleo de Pós-Graduação em Ciências da
Saúde.
1. Serviços Clínicos Farmacêuticos 2. Farmácia Comunitária 3. Implantação de
Serviços em Saúde
I. Serviços clínicos farmacêuticos em unidades do programa Farmácia Popular do
Brasil do estado de Sergipe: implantação, implementação e consolidação.
CDU
GISELLE DE CARVALHO BRITO
SERVIÇOS CLÍNICOS FARMACÊUTICOS EM UNIDADES
DO PROGRAMA FARMÁCIA POPULAR DO BRASIL DO
ESTADO DE SERGIPE: IMPLANTAÇÃO,
IMPLEMENTAÇÃO E CONSOLIDAÇÃO
Tese apresentada ao Núcleo de Pós-Graduação
em Ciências da Saúde da Universidade Federal
de Sergipe como requisito parcial à obtenção
do grau de Doutora em Ciências da Saúde.
Aprovada em:__/__/__
_________________________________________
Orientador: Prof. Dr. Divaldo Pereira de Lyra Júnior
_________________________________________
Examinador 1: Prof. Dr. Adriano Antunes de Souza Araújo
_________________________________________
Examinador 2: Profa. Dr
a. Mairim Russo Serafini
_________________________________________
Examinador 3: Dra. Karen Sarmento Costa
_________________________________________
Examinador 4: Prof. Dr. Mateus Rodrigues Alves
PARECER
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
Dedico esta tese aos farmacêuticos da
Farmácia Popular do Brasil que construíram
esta história, aos pacientes que são a
verdadeira razão deste trabalho e aos meus
queridos pais que sonharam comigo cada
momento vivido.
AGRADECIMENTOS
Agradeço acima de tudo e de todos a Deus! Como sois bondoso comigo, Senhor!
Ao me dar o dom da vida, me concedestes uma família linda, amigos maravilhosos, o
trabalho que sempre sonhei e, acima de tudo, me destes força para não fraquejar diante
de tantas provações.
Aos meus queridos pais, Juceli e Paulo, vocês são a razão de tudo isso! Como
tenho orgulho de ser filha de vocês. Obrigada por jamais podarem meus sonhos, mesmo
quando eles pareciam impossíveis! Esse título de Doutora é de vocês.
Aos meus amados irmãos Karol e João Paulo, sempre tive a responsabilidade de
irmã mais velha ser exemplo para vocês e é por vocês que me motivo a ser uma pessoa
melhor a cada dia. Nosso amor é imensurável! Ao primo-irmão Thalisson, ver você
seguindo a mesma profissão que escolhi me enche de orgulho! A minha doce Belinha
eu só tenho a agradecer pelo amor gratuito ofertado, não sei o que seria de mim sem o
seu dengo, certamente não seria tão feliz quanto sou hoje!
À minha Família, por compreender a minha louca rotina e vibrar a cada
conquista! Dedico gratidão eterna aos meus queridos avós, João Pedro e Maria do
Carmo, Antônio e Chiquinha, Genilda e João.
Agradeço a confiança de meu Orientador Divaldo, por me aceitar como sua
orientanda desde a iniciação científica. Você me mostrou o quanto é prazeroso aprender
com os pacientes! Serei eternamente grata por cada oportunidade ofertada!
À toda “família” do LEPFS. Vocês tornaram mais prazerosos o meu percurso
acadêmico! Dentro desta “casa” fiz verdadeiros amigos: Daniel, Ana Patrícia, Carina,
Genival, Carla Francisca, Tâmara, Luciana. Agradeço ao professor Wellington pelas
reflexões profissionais, sempre instigando angústias positivas nesta cabeça inquieta.
Aos que partilham esse título comigo: minhas eternas parceiras desbravadoras,
Tatiane e Blície! Lincoln, Thays, Thelma e Chiara obrigada pelas colaborações
valorosas em cada artigo.
À minha querida Aline, essa tese não seria a mesma sem as suas contribuições,
você não foi meu braço direito e esquerdo, você foi toda parte de mim! Hoje temos fruto
esta NOSSA tese e nossa eterna amizade!
À Patrícia, meu exemplo de pesquisadora e amiga fiel, obrigada por me ensinar a
ser disciplinada e confiar de olhos fechados no meu trabalho!
Às amigas que partilho o lema “Nosso compromisso é com a felicidade”:
Alessandra, Izadora, Tatiane, Chiara e Elisdete.
Aos amigos cuja distância só fortalece os laços: Annalu, Jorge, Maísa, Flávio,
Jefferson, Thalys, Jozimário e Ana Paula.
Ao meu grande e melhor amigo, Paulo Victor. Seu companheirismo, paciência e
dedicação ao nosso relacionamento me fazem ter a convicção que quero partilhar todos
os dias da minha vida com você! Agradeço ainda a sua família por ter me acolhido de
forma tão calorosa.
Aos amigos mais parceiros mesmo diante das minhas ausências: Verena, Erica,
Nizy, Geovanna, Simony, Rafael, Luciana, Mônica, Tatiane e Tâmara.
À professora Débora Pimentel por nos aprofundar neste mundo maravilhoso da
pesquisa qualitativa.
A coordenação da Fundação Estadual de Saúde/ SES, especialmente Cristiane
Trindade e Eulália Victor que possibilitaram a execução deste projeto, fazendo com que
a parceria ensino e serviço se consolidasse.
Aos grandes protagonistas desta tese, os Farmacêuticos que fizeram e fazem
parte das Farmácias Populares do Brasil de Estância, Nossa Senhora da Gloria e
Propriá. Agradeço ainda a todos os pacientes que fizeram cada segundo valer a pena!
Agradeço aos companheiros de trabalho do DFAL/UFS e aos meus discentes
queridos que me impulsionam a ser uma docente crítica e comprometida.
Aos meus queridos residentes da SAI e da SF, com os quais partilhei cada
alegria e angústia vivida. Aprendi tanto com vocês!
À Universidade Federal de Sergipe, à Coordenação de Aperfeiçoamento de
Pessoal do Ensino Superior (CAPES) e a FAPITEC pelo apoio concedido a esta
pesquisa.
Aos professores do Núcleo de Pós-Graduação em Ciências da Saúde por serem
instrumentos na construção do conhecimento. Agradeço especialmente à Profa. Amélia
de Jesus e à Isabella, por serem sempre solicitas nos momentos que precisei.
Por fim, agradeço à minha banca de qualificação e defesa, pela disponibilidade e
compreensão nos prazos estabelecidos.
“Quando se sonha sozinho é apenas um sonho. Quando se sonha junto é o começo da
realidade.”.
Miguel de Cervantes
RESUMO
SERVIÇOS CLÍNICOS FARMACÊUTICOS EM UNIDADES DO PROGRAMA
FARMÁCIA POPULAR DO BRASIL DO ESTADO DE SERGIPE:
IMPLANTAÇÃO, IMPLEMENTAÇÃO E CONSOLIDAÇÃO
Giselle de Carvalho Brito, Aracaju, 2015.
Objetivo: Implantar, implementar e consolidar serviços clínicos farmacêuticos em
unidades do programa Farmácia Popular do Brasil do Estado de Sergipe. Métodos:
Inicialmente, foi realizada revisão sistemática da literatura nas bases de dados PubMed,
SCOPUS, EMBASE utilizando os descritores “community pharmacy services”, “quality
assurance health care”, “outcome assessment”. Foi realizado um estudo longitudinal
em três unidades da Farmácia Popular do Brasil do estado de Sergipe sobre a
implantação (2012), implementação (2013) e consolidação dos serviços clínicos
farmacêuticos (2014). Foi avaliada a estrutura das farmácias quanto à estrutura física,
por meio da RDC 44/2009, e aos recursos humanos, pela técnica do paciente simulado.
Em seguida, foram realizados três grupos focais (2012, 2013 e 2014) para obter as
percepções dos farmacêuticos. Por fim, foi utilizada a técnica de coaching para a
implantação, implementação e consolidação dos serviços de: dispensação, aferição da
pressão arterial e glicemia capilar, revisão da farmacoterapia e seguimento da
farmacoterapia. Resultados: Na revisão sistemática 42 artigos preencheram os critérios
de inclusão. Observou-se que os resultados mais avaliados foram hemoglobina
glicosilada (clínico), qualidade de vida (humanístico) e análise da relação custo-eficácia
do serviço (econômico). Na avaliação da estrutura, as intervenções possibilitaram
melhorias em todos os itens que foram considerados inconformes. No entanto, a
impressão geral sobre as competências farmacêuticas para serviços clínicos foi
considerada regular (3) numa escala de 1 a 5. Com relação aos grupos focais, os
farmacêuticos relataram expectativas quanto ter suporte técnico para desenvolver
habilidades, adquirir conhecimentos e ter um acompanhamento constante dos
pesquisadores, além disso, identificaram 13 tipos de barreiras. Por fim, foram destinadas
520 horas de coaching in loco para implantação de fluxos e processos, elaboração de
procedimentos operacionais padrão e elaboração de planos estratégicos situacionais. Na
etapa de treinamento, os farmacêuticos foram submetidos a 176h de treinamento
teórico-prático e os colaboradores a 24h. Após as intervenções do coaching os números
dos serviços foram ampliados: obteve-se 767 atendimentos de dispensação em 2012,
1444 em 2013 e 2537 em 2014; 714 aferições da pressão arterial e glicemia capilar em
2012, 2375 em 2013 e 5039 em 2014; 49 consultas da revisão da farmacoterapia em
2012, 87 em 2013 e 355 em 2014; 15 consultas de seguimento da farmacoterapia em
2012, 33 em 2013 e 271 em 2014. Conclusão:. A partir de um bom diagnóstico
situacional o coaching pode ser considerado uma técnica que auxilia nas etapas de
implantação, implementação e consolidação de serviços clínicos farmacêuticos. Aliado
a um treinanamento profissional, ele permite o acompanhamento individualizado em
etapas como: definição dos serviços e processos, seleção de indicadores para a avaliação
e elaboração de planos estratégicos situacionais. Nesta perspectiva, os resultados
observados poderão embasar a construção de um modelo diferenciado e replicável de
serviços clínicos farmacêuticos em farmácias comunitárias.
Descritores: Serviços clínicos farmacêuticos, Farmácia Comunitária, Pesquisa Baseada
na Prática, Implantação de Serviços de Saúde.
ABSTRACT
CLINICAL PHARMACY SERVICES IN UNITS OF FARMÁCIA POPULAR DO
BRASIL PROGRAM IN STATE OF SERGIPE: ESTABLISHMENT,
IMPLEMENTATION AND CONSOLIDATION
Giselle de Carvalho Brito, Aracaju, 2015.
Objective: To establishing, implement and consolidate clinical pharmacy services in
units of Farmácia Popular do Brasil program in state of Sergipe. Methods: Initially,
systematic review was performed in the databases PubMed, Scopus, EMBASE using
the key words "community pharmacy services", "quality assurance health care",
"outcome assessment". A longitudinal study of three units of the Farmácia Popular do
Brasil in the state of Sergipe on the establishment was carried out (2012),
implementation (2013) and consolidation of clinical pharmacy services (2014). The
structure of pharmacies was evaluated for physical structure, through the RDC 44/2009,
and human resources, the technique of simulated patient. Then three focus groups were
conducted (2012, 2013 and 2014) for the perceptions of pharmacists. Finally, we used
the coaching technique for establishment, implementation and consolidation of
services: dispensing, measurement of blood pressure and blood capillary glucose,
medication review and medication therapy management. Results: In the systematic
review 42 articles met the inclusion criteria. It was observed that the most valued
results were glycosylated hemoglobin (clinical), quality of life (humanistic) and
analysis of the cost-effectiveness of the service relationship (economic). In assessing
the structure, interventions enabled improvements on all items that were considered
non-compliant. However, the overall impression of the pharmaceutical skills for
clinical services was considered regular (3) on a scale from 1 to 5. Regarding the focus
groups, pharmacists reported expectations in technical support to develop skills, gain
knowledge and have a constant monitoring of the researchers, also identified 13 types
of barriers. Finally, was designed 520 hours of coaching in place to implement flows
and processes, development of standard operating procedures and preparation of
strategic plans. In the education training, pharmacists underwent 176 hours of
theoretical and practical training and employees to 24h. After the coaching
interventions the numbers of services were expanded: there was 767 dispensations in
2012, 1444 in 2013 and 2537 in 2014; 714 measurements of blood pressure and blood
capillary glucose in 2012, 2375 in 2013 and 5039 to 2014; 49 consultations of
medication review in 2012, 87 in 2013 and 355 in 2014; 15 consultations of medication
therapy management in 2012, 33 in 2013 and 271 in 2014. Conclusion: From the good
situational diagnosis, the coaching can be considered a technique that assists in
establishment, implementation and consolidation of clinical pharmacy services.
Combined with a professional training, it allows the individual follow-up in steps as:
definition of services and processes, selection of indicators for the assessment and
development of strategic plans. In this perspective, this results may support the
construction of a differentiated and replicable model of clinical services in community
pharmacies.
Keywords: Clinical pharmacy services, Community Pharmacy, Research-Based
Practice, Health services research.
LISTA DE TABELAS
CAPÍTULO I
Table 1: Characterization of the studies (n = 42) included in this systematic review…….. 68
Table 2: Methodological design description of the studies (n = 42) included in this
systematic review…………………………………………………………………………..
74
Table 3: Description of clinical, humanistic and economic results studies (n = 42)
included in this systematic review.………………………………………………..
84
CAPÍTULO II
Table 1 - Items not presented completeness in the evaluations of years 2012 and 2013
according to Brazilian Regulation. ……………………………...........................................
115
Table 2 - Distribution of pharmacotherapeutic recommendations and pharmacists’
communication skills during the interactions with simulated patients in 2012-2013
according to “Assesment of the Counseling Process” instrument………………………….
119
Table 3 - Average performance (±SD) of pharmacotherapeutic recommendations and
pharmacists’ communication skills during the interactions with simulated patients in
2012-2013 according to “Assesment of the Counseling Process” instrument.………….....
122
CAPÍTULO III
Table 1: Pharmacist perceptions during the beginning of establishment (2012),
implementation (2013) and consolidation (2014) of clinical pharmacy services.................
131
CAPÍTULO IV
Table 1 - Pharmacist perceptions about barriers during the beginning of the establishment (2012)
of clinical pharmacy services..............................................................................................................
177
Table 2 - Pharmacist perceptions about barriers during the implementation (2013) of
clinical pharmacy services...…………...……………...…………..…….............................
179
Table 3 - Pharmacist perceptions about barriers during the consolidation (2014) of
clinical pharmacy services…………………...…………………………………………….
180
CAPÍTULO IV
Table 1 – Performande of clinical pharmacy services developed in the “Farmácia
Popular do Brasil” Program in a State in Northeast of Brazil, 2012-2014..........................
208
LISTA DE QUADROS
CAPÍTULO V
Chart 1 - Structure of the training of pharmacist developed in the “Farmácia Popular do
Brasil” Program in a State in Northeast of Brazil, 2012-2014.............................................
192
Chart 2 – Clinical pharmacy services developed in the “Farmácia Popular do Brasil”
Program in a State in Northeast of Brazil, 2012-2014 and their evaluation indicators........
196
LISTA DE FIGURAS
CAPÍTULO I
Figure 1 - Flowchart of the steps of selecting the final sample of the systematic review.... 50
CAPÍTULO II
Figure 1- Registration of Change of structured area of the Dispensation (Before and
After) in 2012………………………………………………………………………………
102
CAPÍTULO V
Figure 1 - Stages of establishment, implementation and consolidation of clinical
pharmacy services in the “Farmácia Popular do Brasil” Program in a State in Northeast
of Brazil, 2012-2014.............................................................................................................
186
Figure 2 – Instruments developed for clinical pharmacy services in the “Farmácia
Popular do Brasil” Program in a State in Northeast of Brazil, 2012-2014..........................
195
SUMÁRIO
1. INTRODUÇÃO..................................................................................................... 17
2. FUNDAMENTAÇÃO TEÓRICA........................................................................ 24
2.1 Histórico da Tese..................................................................................................... 25
2.2 Serviços clínicos farmacêuticos.............................................................................. 27
2.3 Implantação de serviços clínicos e definição de indicadores de
qualidade..................................................................................................................
31
2.4 Estratégias para a implementação de serviços clínicos farmacêuticos.................... 34
2.5 A Farmácia Popular do Brasil e os serviços clínicos farmacêuticos no âmbito do
SUS..........................................................................................................................
36
3. OBJETIVOS.......................................................................................................... 41
3.1 Objetivo geral.......................................................................................................... 42
3.2 Objetivos específicos............................................................................................... 42
4. RESULTADOS...................................................................................................... 43
4.1 CAPÍTULO I – Profile of pharmaceutical services in community pharmacy:
Systematic review...................................................................................................
44
4.2 CAPÍTULO II – Clinical pharmacy services in brazilian public community
pharmacies: A pilot structure’s quality assessment study……...............................
92
4.3 CAPÍTULO III – Establishment, implementation, and consolidation of clinical
pharmacy services in community pharmacies: Perceptions of a group of
pharmacists..............................................................................................................
125
4.4 CAPÍTULO IV – Overcoming barriers to implement clinical pharmacy services
in community pharmacies: A qualitative study …………………………………
149
4.5 CAPÍTULO V – Clinical pharmacy services in the Farmácia Popular do Brasil
program in northeast state of Brazil: Establishiment, implementation and
consolidation............................................................................................................
182
5. CONSIDERAÇÕES FINAIS................................................................................ 210
5.1 Conclusão geral....................................................................................................... 211
5.2 Perspectivas............................................................................................................. 211
6. REFERÊNCIAS.................................................................................................... 212
7. APÊNDICES.......................................................................................................... 218
7.1 Apêndice A – Instrumentos desenvolvidos: 16 passos para boa
dispensação..............................................................................................................
219
7.2 Apêndice B – Instrumentos desenvolvidos: Cartão de acompanhamento dos
parâmetros clínicos..................................................................................................
220
7.3 Apêndice C – Instrumentos desenvolvidos: Controle de entrega e tipo de
serviços....................................................................................................................
221
7.4 Apêndice D – Instrumentos desenvolvidos: Evolução farmacoterapêutica............ 222
7.5 Apêndice E – Instrumentos desenvolvidos: Tabela de horário dos medicamentos 223
7.6 Apêndice F – Instrumentos desenvolvidos: Ficha de registro dos parâmetros
clínicos.....................................................................................................................
224
7.7 Apêndice G – Instrumentos desenvolvidos: Informações básicas para pacientes
na dispensação.........................................................................................................
225
8. ANEXOS................................................................................................................ 226
8.1 ANEXO A – Regras de Publicação......................................................................... 227
17
INTRODUÇÃO
X
X
18
1. INTRODUÇÃO
No final da década de 1990, Holland e Nimmo refletiram sobre a perspectiva
mutável da prática da Farmácia ao longo dos últimos 150 anos e afirmaram que o
processo de mudança de paradigma é contínuo. Deste modo, ressaltam-se os esforços
para reorientar o modelo de processos no ambiente da farmácia, a qual deixa de ser um
posto de distribuição de medicamentos e passa a ser vista como um estabelecimento de
saúde com a prestação de cuidados (HOLLAND; NIMMO, 1999).
No Reino Unido, por exemplo, esta reorientação do ambiente da farmácia
comunitária e reprofissionalização do farmacêutico vêm ocorrendo desde a década de
1970. Tal fato é refletido pelos papéis/funções delineados e apoiados pelas políticas
públicas do país, o que resulta na expansão de serviços clínicos, tais como,
Dispensação, Monitoramento de Parâmetros Clínicos, Revisão da Farmacoterapia e
Seguimento da Farmacoterapia (BUSH; LANGLEY; WILSON, 2009)
Esta mudança da prática farmacêutica se tornou foco de pesquisas e resultaram
em diversos estudos (AGUIAR et al., 2012, 2013; ANDERSON, 1998; BALISA-
ROCHA et al., 2014; NIMMO; HOLLAND, 1999). Revisões Sistemáticas têm
demostrado que a configuração da farmácia comunitária é extremamente favorável para
implantação de cuidados à saúde, visto que é um ambiente que proporciona acesso
facilitado a um profissional de saúde sem a necessidade de procedimentos burocráticos,
como atendimento por hora marcada (BLENKINSOPP; ANDERSON; ARMSTRONG,
2003; MACHADO et al., 2007a, 2007b).
Neste cenário, os avanços em pesquisas sobre serviços clínicos farmacêuticos
em farmácias comunitárias não são acompanhados na mesma velocidade pela
19
consolidação de políticas e pelo estabelecimento de modelos que podem dar subsídio ao
farmacêutico na execução da sua prática (MOSSIALOS; NACI; COURTIN, 2013;
PATWARDHAN; AMIN; CHEWNING, 2014). Tais modelos de serviço devem ser
bem delineados para que possam ser passíveis de avaliação e acompanhamento. A
abordagem conceitual para a avaliação dos serviços de saúde proposta por Donabedian
(1988) é a mais difundida mundialmente e se baseia na tríade estrutura, processo e
resultados, que consiste em um modelo sistêmico e com estreita relação de causa e
efeito (DONABEDIAN, 1988).
Para Mullins e colaboradores (1996) compreender os aspectos da avaliação de
qualidade dos serviços clínicos farmacêuticos, sob a ótica de Donabedian, irá preparar
os farmacêuticos para mudanças no mercado, bem como ajudá-los a mensurar o
impacto dos seus serviços. Para tanto, todas as três medidas de qualidade devem ser
priorizadas. Assim, o melhor atendimento ao paciente virá de profissionais de saúde
que documentam estrutura, processo e resultados e que avaliam estas medidas para
prestar os cuidados adequados (MULLINS; BALDWIN; PERFETTO, 1996).
O farmacêutico não pode fornecer serviços clínicos sem insumos estruturais
importantes como um inventário ou os perfis de pacientes. Do mesmo modo, as ações
do farmacêutico são inviabilizadas caso não haja históricos farmacoterapêuticos, rotinas
estabelecidas para o manejo da farmacoterapia e etapas de orientação ao paciente sobre
o tratamento, visto que todas estas atividades são processos vitais. Os resultados,
produto final da assistência prestada, irão demonstrar o sucesso das ações, como
melhora nos padrões clínicos e na satisfação dos pacientes, redução dos custos ou no
alerta para possíveis adequações das etapas que o antecedem, ou seja, adequações
estruturais e de processos.
20
Uma etapa essencial para o delineamento dos serviços clínicos farmacêuticos,
que subsidia as adequações de estrutura e o desenvolvimento dos processos, é a do
conhecimento de percepção dos profissionais envolvidos. Neste contexto, conhecê-las
pode ajudar a melhorar a qualidade dos estudos sobre os serviços de implementação,
assim como valorizar o papel do farmacêutico na prestação de assistência ao paciente e
antecipar ações para minimizar as barreiras apontadas. Logo, é possível revelar a partir
do olhar das pessoas que trabalham na prática, questões sobre a estruturação dos
serviços, processos de trabalho e as competências profissionais necessárias para o seu
sucesso (EMMERTON et al., 2012; ERDOGAN et al., 2012; SARRIFF et al., 2010).
No panorama nacional, os avanços na prestação de serviços clínicos
farmacêuticos são incipientes, mas nos últimos anos ganharam impulso por meio da
publicação de diversas normativas. Em 2009, por exemplo, foi publicada a RDC
44/2009 que estabelece critérios e condições mínimas para prestação de serviços
farmacêuticos em farmácias e drogarias; em 2013, a Resolução CFF Nº 585 que
regulamenta as atribuições clínicas do farmacêutico e a Resolução CFF Nº 86/2013 que
regula a prescrição Farmacêutica (BRASIL, 2009; CONSELHO FEDERAL DE
FARMÁCIA, 2013a, 2013b).
Nesta perspectiva, no âmbito do Projeto QualiSUS-Rede se desenvolve um
estudo piloto para implementação de serviços clínicos. Um dos produtos do projeto foi
a elaboração dos Cadernos de Cuidado Farmacêutico na Atenção Básica, que possibilita
visitar conceitos e, a partir da experimentação dos serviços, disponibiliza suporte
teórico e metodológico a gestores e profissionais de saúde (BRASIL, 2014a, 2014b,
2014c).
21
Anteriormente a tais resoluções, o programa Farmácia Popular do Brasil foi
criado em 2004 como estratégia de reorientação da Assistência Farmacêutica da
Política Nacional de Medicamentos e Política Nacional de Assistência Farmacêutica
(BRASIL, 2004a, 2004b). As diretrizes deste programa preconizam a promoção do uso
racional de medicamentos por meio do acesso qualificado ao tratamento, o que inclui a
provisão de serviços clínicos farmacêuticos. No entanto, até o momento há registros
escassos da implementação e do impacto de tais serviços, bem como ainda não há
modelos bem definidos de serviços farmacêuticos no Brasil que possibilitem o
atendimento destas políticas públicas (AGUIAR et al., 2013; BRITO, 2012; JUNGES,
2009).
Diante destas lacunas, com o intuito de aprofundar as discussões sobre a
implantação e implementação de serviços clínicos farmacêuticos em farmácias
comunitárias, o grupo de pesquisa do Laboratório de Ensino e Pesquisa em Farmácia
Social (LEPFS) da Universidade Federal de Sergipe - UFS desenvolveu sua primeira
pesquisa nos moldes “practice-based research” para a implantação e implementação de
serviços clínicos em unidades da Farmácia Popular do Brasil no Estado de Sergipe. Tal
estudo teve como foco encontrar referenciais para elucidar o nível de desenvolvimento
destas atividades, assim como descrever os resultados encontrados nas etapas de
implantação, implementação e consolidação dos serviços clínicos farmacêuticos por
meio de indicadores de estrutura, processos e resultados.
22
ESTRUTURA DA TESE
Esta tese foi estruturada seguindo a Instrução normativa Nº 02 do Programa de
Pós-Graduação em Ciências da Saúde / NPGME / UFS. Este formato permite que as
metodologias, resultados e discussões sejam organizados em formato de artigos
científicos. Para tanto ela foi desenvolvida da seguinte forma:
FUNDAMENTAÇÃO TEÓRICA – consistiu em um levantamento da literatura
existente sobre os temas abordados no presente trabalho.
CAPÍTULO I - o capítulo 1 foi desenvolvido em formato de artigo intitulado
como “PROFILE OF PHARMACEUTICAL SERVICES IN COMMUNITY
PHARMACY: SYSTEMATIC REVIEW”, submetido ao periódico científico Research
in Social and Administrative Pharmacy (RSAP). O artigo apresenta dados referentes à
descrição do perfil dos resultados (econômicos, clínicos e humanísticos) de serviços
farmacêuticos em Farmácias Comunitárias.
CAPÍTULO II – este capítulo é composto pelo artigo “CLINICAL PHARMACY
SERVICES IN BRAZILIAN PUBLIC COMMUNITY PHARMACIES: A PILOT
STRUCTURE’S QUALITY ASSESSMENT STUDY”, a ser submetido ao periódico Health
Services Research. Neste capítulo foram apresentados os resultados da avaliação da
estrutura das Farmácias Populares do Brasil geridas pela FUNESA/SE, bem como as
principais intervenções realizadas frente os problemas observados.
CAPÍTULO III – o capítulo 3 também foi desenvolvido em formato de artigo
intitulado como “ESTABLISHMENT, IMPLEMENTATION, AND
CONSOLIDATION OF CLINICAL PHARMACY SERVICES IN COMMUNITY
23
PHARMACIES: PERCEPTIONS OF A GROUP OF PHARMACISTS”, seguindo as
normas do periódico científico Research in Social and Administrative Pharmacy
(RSAP). Este artigo elucidou questões sobre as percepções dos farmacêuticos quanto as
fases de implantação, implementação e consolidação de serviços clínicos farmacêuticos.
.CAPÍTULO IV - o capítulo 4 é composto pelo artigo “OVERCOMING
BARRIERS TO IMPLEMENT CLINICAL PHARMACY SERVICES IN
COMMUNITY PHARMACIES: A QUALITATIVE STUDY”, seguindo as normas do
periódico científico Implementation Science. Neste capítulo foram apresentados os
resultados da identificação das barreiras apontadas pelos farmacêuticos frente a
implantação dos serviços clínicos em suas farmácias e as estratégias delineadas para
superá-las.
CAPÍTULO V - o capítulo 5 também foi desenvolvido em formato de artigo
intitulado como “CLINICAL PHARMACY SERVICES IN THE FARMÁCIA
POPULAR DO BRASIL PROGRAM IN NORTHEAST STATE OF BRAZIL:
ESTABLISHIMENT, IMPLEMENTATION AND CONSOLIDATION”, seguindo as
normas do periódico científico Research in Social and Administrative Pharmacy
(RSAP). Neste capítulo foram apresentados os resultados das etapas de implantação,
implementação e consolidação dos Serviços Clínicos Farmacêuticos nas unidades da
Farmácia Popular do Brasil geridas pela FUNESA/SE.
24
FUNDAMENTAÇÃO TEÓRICA
X
X
25
2. FUNDAMENTAÇÃO TEÓRICA
2.1 HISTÓRICO DA TESE
O Laboratório de Ensino e Pesquisa em Farmácia Social da Universidade
Federal de Sergipe – Brasil (LEPFS/UFS) foi fundado no ano de 2007, focado no
desenvolvimento das atividades relacionadas ao ensino, pesquisa e extensão e formar
profissionais para a execução de estudos na área da Farmácia Social. Este laboratório
tem como missão inovar e formar para o cuidado ao paciente e para promoção do uso
racional dos medicamentos.
Uma das principais características deste laboratório foi direcionar suas pesquisas
para a mensuração do impacto de serviços clínicos farmacêuticos. Desde as primeiras
monografias desenvolvidas no ano de 2007, avaliaram-se os resultados obtidos a partir
da implantação dos serviços clínicos nos mais diversos ambientes (hospital, unidade
básica de saúde, instituição de longa permanência para idosos) (AGUIAR et al., 2008;
ANDRADE; JABBUR-LOPES; OLIVEIRA-FILHO, 2011; BRITO et al., 2009).
Somente em 2009 essas pesquisas foram ampliadas para o ambiente da farmácia
comunitária. As então mestrandas Blície Jennifer Balisa Rocha e Patrícia Melo Aguiar,
nos anos de 2008-2009, e Giselle de Carvalho Brito, nos anos de 2010-2011 realizaram
suas pesquisas de serviços clínicos farmacêuticos. Por meio da parceria com a
Secretaria Municipal de Saúde de Aracaju, as pesquisadoras puderam implantar a
prática do seguimento da Farmacoterapia em idosos portadores de diabetes mellitus,
dislipidemia e hipertensão arterial sistêmica não controlados em uma unidade da
Farmácia Popular do Brasil de Sergipe, com o objetivo de melhorar os resultados
clínicos e a qualidade de vida destes pacientes (AGUIAR et al., 2012; BALISA-
ROCHA et al., 2014; BRITO, 2012).
26
Com a finalização dos estudos, em contrapartida ao apoio fornecido, houve a
apresentação dos resultados obtidos às Secretarias Municipal e Estadual de Saúde de
Sergipe. Diante dos avanços obtidos com as pesquisas, ficou notória a necessidade de
implantar os serviços clínicos para assegurar o maior entendimento do novo paradigma
focado no cuidado ao paciente. Interessada em replicar o sucesso dos estudos no serviço
público do estado, a coordenação da Fundação Estadual de Saúde de Sergipe convidou o
O Laboratório de Ensino e Pesquisa em Farmácia Social para iniciar o atual projeto de
implantação de serviços clínicos farmacêuticos nas três unidades do programa Farmácia
Popular do Brasil geridas por esta fundação que atende grande parte do estado de
Sergipe.
Durante a execução deste projeto, diversos produtos científicos foram gerados,
como: 16 resumos em congressos nacionais e internacionais, um documentário “Somos
parte do SUS que dá certo”. Em consequência, o estudo ficou como finalista do Prêmio
Nacional de Incentivo à Promoção do uso racional de medicamentos “Lenita
Wannmacher” (2013), recebeu o prêmio de melhor trabalho no I Congresso Brasileiro
de farmácia comunitária (2012) e foi agraciado com auxílio financeiro no valor R$
29.000,00 pelo EDITAL FAPITEC/SE/FUNTEC Nº 13/2012 (2013). O projeto é o
pioneiro no país a propor um modelo de serviços clínicos farmacêuticos aplicados ao
programa Farmácia Popular do Brasil. Deste modo, poderá servir como piloto e
referência para otimização da qualidade de serviços farmacêuticos, bem como subsidiar
demais unidades do programa que almejem reproduzir as ações desenvolvidas.
27
2.2 SERVIÇOS CLÍNICOS FARMACÊUTICOS
O conceito atribuído aos serviços clínicos farmacêuticos contempla a variedade
de intervenções desenvolvida pelo farmacêutico para otimizar a farmacoterapia do
paciente. Tal serviço pode ser definido como "qualquer atividade em que os
farmacêuticos usam seus conhecimentos e habilidades profissionais para melhorar
farmacoterapia e gestão da doença, por meio da interação com o paciente ou com outro
profissional de saúde“ (CIPOLLE; STRAND; MORLEY, 1998).
A Federação Internacional Farmacêutica e a Organização Mundial da Saúde em
2011 redefiniram os papéis principais que devem ser praticados pelos farmacêuticos,
com a pretensão de abraçar as emergentes mudanças na profissão farmacêutica
(INTERNATIONAL PHARMACEUTICAL FEDERATION; WORLD HEALTH
ORGANIZATION, 2011). Entretanto, não basta apenas os farmacêuticos conhecerem
seus documentos para que a provisão de serviços clínicos seja bem sucedida, tais
profissionais devem estar cientes dos diferentes componentes do sistema de trabalho na
farmácia comunitária (CHUI; MOTT; MAXWELL, 2011). Além disso, devem conhecer
os componentes que influenciam no fornecimento destes serviços.
A questão da prestação de serviços clínicos centrados no paciente, dentro de uma
filosofia de cuidados farmacêuticos, exige novas competências ao profissional que se
assume como clínico. Neste novo paradigma de atuação do farmacêutico, não basta
conhecer o medicamento desde a sua formulação até à dispensação na farmácia
comunitária. Agora, o farmacêutico se coloca como provedor de serviços ao paciente
com o objetivo de melhorar os seus resultados clínicos, econômicos e humanísticos por
meio da utilização de medicamentos (FIGUEIREDO; CARAMONA, 2014).
28
Apesar de haver diversos estudos que apontem o impacto positivo dos serviços
clínicos farmacêuticos na sociedade, ainda não há consenso sobre sua definição e
nomenclatura (AGUIAR et al., 2014; BALISA-ROCHA et al., 2014; BRITO et al.,
2009; HERNÁNDEZ ARROYO et al., 2013; LENANDER et al., 2014; MARGOLIS et
al., 2013). No Brasil, o Conselho Federal de Farmácia, em 2012, evidenciou grande
divergência na nomenclatura dos termos utilizados na regulação sanitária e profissional,
e em diversas publicações de instituições oficiais. Porém, a descrição das atribuições
clínicas desses diferentes serviços promove maior compreensão sobre os objetivos e
níveis de complexidade de cada um deles (CONSELHO FEDERAL DE FARMÁCIA,
2014).
A criação da Lei nº 13.021/2014 passou a reconhecer a farmácia comunitária,
como unidade de prestação de assistência à saúde, elencando diversas obrigações do
farmacêutico no processo de cuidado, e a Resolução CFF nº 585/2013 regulamentou as
atribuições clínicas do farmacêutico (BRASIL, 2004a; CONSELHO FEDERAL DE
FARMÁCIA, 2013a). Ambas motivaram o Conselho Federal de Farmácia a elaborar um
documento, que propõe o alinhamento dos conceitos relacionados à prática clínica dos
farmacêuticos. Tal documento visa subsidiar os gestores do sistema de saúde brasileiro,
público e privado, bem como os responsáveis pelas políticas educacionais do país,
quanto à necessidade de adequação na formação do farmacêutico e de maior valorização
das potencialidades da sua força de trabalho.
A definição atualizada dos serviços clínicos farmacêuticos organizada pelo
Conselho Federal de Farmácia que se encontra atualmente em consulta pública, definem
os principais serviços clínicos da seguinte forma (CONSELHO FEDERAL DE
FARMÁCIA, 2014):
29
- Dispensação de medicamentos: entrega de medicamentos, geralmente como resposta à
apresentação de uma receita elaborada por um profissional autorizado, com orientação
sobre o seu uso adequado e intervenções educativas.
- Monitoramento de Parâmetros Clínicos ou Monitoring of Clinical Parameters:
monitoramento da pressão arterial, glicemia capilar, peso, circunferência da cintura e
índice de massa corporal, com intervenções educativas.
- Revisão da Farmacoterapia ou Medication Review: avaliação e ajuste da
farmacoterapia (ajuste da dose, horário, frequência) e triagem de pacientes elegíveis a
serviços de seguimento.
- Seguimento Farmacoterapêutico: também conhecido como Medication Therapy
Management, Seguimiento Farmacoterapéutico ou Gestão da Farmacoterapia, este
serviço visa garantir que os objetivos terapêuticos sejam alcançados com identificação,
prevenção e resolução de problemas farmacoterapêuticos (HEPLER; STRAND, 1990).
Diante de tais descrições, percebe-se que o farmacêutico é chamado a assumir a
responsabilidade do uso apropriado do medicamento por parte do paciente. Para tanto, o
farmacêutico tem que identificar as necessidades farmacoterapêuticas do paciente,
tomar decisões que se baseiam tanto em dados objetivos (relacionados com os
problemas de saúde e com os medicamentos) como em subjetivos (relacionados com a
experiência do profissional e com a experiência do doente) (FIGUEIREDO;
CARAMONA, 2014).
No Brasil, historicamente a farmácia comunitária está caracterizada como
estabelecimento comercial e o medicamento é visto como bem de consumo,
30
desvinculado do processo de atenção à saúde. Aliado a isso, há décadas o farmacêutico
sofre uma crise de identidade, que não representa para a sociedade um referencial de
profissional da saúde. A formação clínica do farmacêutico é incipiente. Suas atividades
estão ligadas à área administrativa, estão centradas no medicamento e na maioria das
vezes ainda são exercidas com afastamento do paciente (FREITAS; RAMALHO-DE-
OLIVEIRA; PERINI, 2006).
É importante destacar que este cenário não se restringe ao Brasil. Kelly e
colaboradores (2014), ao avaliarem a compreensão da população canadense quanto às
funções assumidas pelos farmacêuticos e a probabilidade de uso de serviços de
cuidados farmacêuticos, observaram que para a população a provisão destes ainda não é
bem disseminada e conhecida, o que pode gerar resistência inicial (KELLY et al.,
2014).
Na prática, os esforços futuros para garantir a ampliação dos serviços devem
considerar as especificidades do ambiente da farmácia comunitária. O nível de mudança
necessária neste cenário é complexo e exige apoio significativo das associações
profissionais. Ademais, para consolidar tais serviços é necessário incorporar de forma
gradual novas práticas de cuidado ao paciente (FELETTO et al., 2010)
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2.3 IMPLANTAÇÃO DE SERVIÇOS CLÍNICOS E DEFINIÇÃO DE
INDICADORES DE QUALIDADE
Apesar de qualidade ser considerado um termo abstrato e imerso por questões
subjetivas, a qualidade em saúde pode ser entendida como o grau em que os cuidados
ao paciente aumentam a possibilidade de recuperação e reduzem a probabilidade da
ocorrência de eventos indesejados (JOINT COMMISSION ON ACCREDITATION OF
HEALTHCARE, 1989). Nesse contexto, uma das ferramentas destinadas a monitorar a
qualidade de um serviço é o emprego de indicadores, visando o acesso à efetividade,
eficiência, confiabilidade e completude dos processos de trabalho, constituindo-se em
uma prática valiosa para avaliação dos serviços de saúde. Portanto, deve-se elaborar um
conjunto de indicadores para cada componente da tríade estrutura, processo e resultado
(DONABEDIAN, 1992). A estrutura pode ser entendida como o meio pelo qual o
processo se desenvolve; o processo são os cuidados em saúde propriamente ditos; e os
resultados, a consequência dos processos/cuidados recebidos.
A evidência em relação à qualidade dos cuidados de saúde é exigida nos mais
diversos níveis, seja pelos consumidores, pelos provedores e pelas agências
reguladoras, aumentando a demanda por processo de medidas de cuidado. Embora as
medidas de resultados de qualidade representem os resultados finais, a validação dos
seus processos é essencial para embasar as condutas aplicadas à melhoria da saúde.
Esta validação esclarece qual etapa exata deve ser priorizada pelos provedores de saúde
para otimização de resultados tangíveis aos pacientes (RUBIN; PRONOVOST;
DIETTE, 2001).
A construção de um indicador se inicia pelo seu conceito, uma vez que se
tornará uma medida empregada para descrever uma situação, avaliar mudanças ou
32
tendências durante determinado tempo e as ações de saúde a serem executadas. Para
conferir clareza ao que se pretende medir é necessário considerar: o objetivo, a
equação, a população ou amostra, o tipo, a fonte de informação, o método para coletar
dados, a frequência e os fatores avaliativos da variação dessa ferramenta (JOINT
COMMISSION ON ACCREDITATION OF HEALTHCARE, 1989; MAINZ, 2003;
TRONCHIN et al., 2009). A avaliação de indicadores no âmbito da saúde possibilita
rever os processos empregados e o impacto nos resultados, no sentido de atingir
padrões de excelência e no que tange ao ensino e pesquisa, possibilita a
disponibilização de um instrumento válido para a comunidade científica, articulando
interesses e demandas de serviços e de pesquisadores (TRONCHIN et al., 2009).
Quanto aos resultados mensurados, estes podem ser expressos como marcadores
biológicos, indicadores comportamentais e indicadores de medidas de uso do serviço.
Os marcadores biológicos comumente examinados incluem glicose sanguínea, pressões
arteriais, níveis de colesterol, índice de massa corporal e medidas semelhantes. Quanto
aos comportamentos de saúde, que são passíveis de intervenção, incluem, por exemplo,
o uso de tabaco, atividade física, dieta e consumo de álcool. Quanto às medidas de uso
de serviço em saúde podem incluir exames, internações hospitalares, encaminhamento
para especialistas, polifarmácia e adesão aos protocolos. Entretanto, apesar desses
indicadores de resultados serem bem definidos, as pesquisas devem ser impulsionadas,
a fim de identificar potenciais medidas ainda inexploradas (ROHRER, 2014).
A gestão de processos pode ser considerada o cerne da gestão de qualidade,
devido a sua eficiência na busca pela satisfação dos clientes e melhora contínua de suas
tarefas de trabalho, administrando-as de modo a defini-las, descrevê-las, analisá-las,
documentá-las e melhorá-las permanentemente e de maneira interligada. Para se tornar
33
eficiente, as principais atividades e etapas do processo necessitam de constante
avaliação, realizada por meio da utilização dos indicadores que traduzam a qualidade
esperada nas tarefas de cada etapa do processo assistencial. (MENEZES;
D’INNOCENZO, 2013; OLIVEIRA et al., 2006). No ambiente hospitalar esta
avaliação da qualidade dos processos é averiguada pela acreditação hospitalar por meio
de instituições avaliadoras certificadas pela Organização Nacional de Acreditação.
Entretanto, no ambiente da farmácia comunitária ainda não há um modelo de
acreditação que direcione os passos para provisão de tal qualidade.
A fim de compensar esta lacuna, algumas iniciativas foram feitas ao longo das
ultimas décadas (AZZOPARDI et al., 2003; BILLUPS et al., 2000; BOYLE et al.,
2012). Na Holanda, pesquisadores desenvolveram um instrumento, com 42 indicadores
de qualidade para cuidados prestados em farmácias comunitárias que comtemplam os
seguintes domínios: orientação ao paciente (6), manejo do risco clínico (10),
manipulação de medicamentos personalizados (7), distribuição (3), o monitoramento do
uso de medicamentos (11) e de gestão da qualidade (5) (DE BIE et al., 2011).
No Brasil, Silva (2003), desenvolveu de forma pioneira uma proposta de
modelo de acreditação de farmácias comunitárias embasadas na provisão de serviços
clínicos farmacêuticos. O autor propôs um modelo de avaliação de qualidade dos
serviços, que tinha como núcleo temático o desenvolvimento de padrões de qualidade
orientados pelos eixos de estrutura (11 domínios), processos (12 domínios) e resultados
(cinco domínios) (SILVA, 2003). No entanto, tanto as iniciativas nacionais quanto
internacionais, não são amplamente disponibilizadas e/ou difundidas, dificultando
assim o acesso a estas informações e limitando a qualidade dos serviços prestados por
estudos futuros.
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2.4 ESTRATÉGIAS PARA A IMPLEMENTAÇÃO DE SERVIÇOS CLÍNICOS
FARMACÊUTICOS
Apesar das pesquisas em serviços clínicos farmacêuticos terem demonstrado seu
impacto (PATWARDHAN; AMIN; CHEWNING, 2014), a sustentabilidade do
processo de implementação não é investigada (KAAE; CHRISTENSEN, 2012). A
maioria dos estudos limita seus objetos de observação na efetividade das intervenções,
não priorizando a investigação de aspectos que indiquem a consolidação do serviço após
a pesquisa. Em contrapartida, existem modelos de pesquisas que podem atender tal
demanda, como o practice-based research, que seria uma pesquisa inserida/baseada na
prática.
O practice-based research foi definido como um conjunto de práticas na atenção
primária consagrada principalmente para o atendimento de pacientes, cujas questões
investigadas são relacionadas com a prática e com a melhora da qualidade dos cuidados
em saúde (AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, 2011).
Assim, neste modelo de pesquisa, o farmacêutico tem o potencial de construir
conhecimentos no âmbito do uso de medicamentos e na provisão de cuidados
colaborativos (FARLAND et al., 2012).
Nestes moldes de investigação em serviços clínicos farmacêuticos,
pesquisadores com maior expertise, geralmente inseridos na academia, podem oferecer
orientação aos membros menos experientes quanto à resolução das questões de
pesquisa. Este modelo de investigação pode proporcionar um campo fértil de estudo
para estudantes de Farmácia e pós-graduandos, potencialmente plantando as sementes
para a próxima geração de pesquisadores com base na prática (FARLAND et al., 2012;
35
HADI et al., 2014; SCHOMMER et al., 2010). Tais pesquisas podem fornecer
evidências adicionais e resultados para apoiar os serviços de farmácia e lançar avanços
na profissão.
Somado a esse modelo de pesquisa para a implantação de serviços clínicos,
Roberts em 2006, elencou facilitadores potenciais que favorecem a implantação de tais
serviços na farmácia comunitária. Estes foram divididos em duas categorias:
facilitadores individuais e facilitadores organizacionais, os quais podem nortear os
pontos a serem priorizados na implantação dos serviços (ROBERTS et al., 2006).
No que concerne os facilitadores individuais, se destaca: atitudes; autonomia;
competência; motivação; confiança dos farmacêuticos na capacidade de fornecer os
serviços clínicos; educação e formação para os farmacêuticos, com ênfase nos cuidados
ao paciente; habilidades de comunicação e de liderança; satisfação dos profissionais;
educação, formação e atitude dos técnicos da farmácia (ROBERTS et al., 2006).
Os facilitadores organizacionais contemplam os seguintes aspectos: ambiente
físico (espaço adequado / privacidade e fluxo de trabalho); remuneração /incentivos;
recursos humanos (pessoal suficiente e qualificado); a presença de técnicos de
farmácia; a delegação de tarefas; orientação prática inovadora; demanda de pacientes;
relacionamento com os médicos; equipamentos e tecnologia (computadores); acesso às
informações do paciente (registros); sistema de documentação (prontuários).
Com o intuito de apoiar outras iniciativas de implementação de serviços clínicos
no ambiente da farmácia comunitária, assim como minimizar esta carência existente na
literatura, o Laboratório de Ensino e Pesquisa em Farmácia Social se baseou do modelo
36
practice-based research e se embasou nos facilitadores apresentados por Roberts (2006)
para o desenvolvimento de estudos inseridos na prática.
2.5 A FARMÁCIA POPULAR DO BRASIL E OS SERVIÇOS CLÍNICOS
FARMACÊUTICOS NO ÂMBITO DO SUS
O Sistema Único de Saúde no Brasil, o SUS, é referenciado positivamente em
todo mundo. Os seus princípios doutrinários e organizativos, como o atendimento
integral voltado para prevenção, manutenção e promoção de saúde, descentralização
politico-administrativa e participação ativa da população, é garantido por meio de
políticas públicas que vem sendo desenvolvidas desde o início da década de 1990
(BRASIL, 1990). Dentro das ações preconizadas por estas novas políticas tem-se a
implementação de um novo modelo de Assistência Farmacêutica básica, pautado no
atendimento de necessidades e prioridades locais. Este modelo só pode ser concretizado
graças a Política Nacional de Medicamentos, cuja operacionalização teve início no
primeiro semestre de 1999 (BRASIL, 2001).
A Assistência Farmacêutica foi reorientada de modo que o desenvolvimento das
atividades relacionadas à promoção do acesso da população aos medicamentos
essenciais contemplasse as três esferas do Sistema Único de Saúde, deste modo, as
ações deixam de ser centralizadas apenas na aquisição e distribuição de medicamentos
(BRASIL, 2001). O modelo adotado está fundamentado na descentralização da gestão,
na otimização e na eficácia do sistema de abastecimento no setor público, e no
desenvolvimento de iniciativas que possibilitem a redução nos preços dos produtos.
Viabilizando, deste modo, o acesso da população aos produtos no âmbito do setor
37
privado e a promoção do uso racional de medicamentos (BRASIL, 2001; MARIN et al.,
2003).
Como parte essencial da Política Nacional de Saúde, a Política Nacional de
Medicamentos tem como propósito garantir a necessária segurança, eficácia e qualidade
dos medicamentos, assim como a promoção do uso racional e o acesso da população
àqueles considerados essenciais. Esta política exige, para a sua implantação, a definição
ou redefinição de planos, programas e atividades específicas nas esferas federal,
estadual e municipal (BRASIL, 2001). De forma complementar, a Política Nacional de
Assistência Farmacêutica (2004) também é parte integrante da Política Nacional de
Saúde. Esta política define a Assistência Farmacêutica como um conjunto de ações
voltadas à promoção, proteção e recuperação da saúde, tanto individual como coletivo,
tendo o medicamento como insumo essencial e visando o acesso e ao seu uso racional
(BRASIL, 2004b).
A Política Nacional de Medicamentos conceitua o uso racional de medicamentos
como sendo “o processo que compreende a prescrição apropriada; a disponibilidade
oportuna e a preços acessíveis; a dispensação em condições adequadas; e o consumo
nas doses indicadas, nos intervalos definidos e no período de tempo indicado de
medicamentos eficazes, seguros e de qualidade” (BRASIL, 2001). Dados da
Organização Mundial de Saúde indicam que mais de 50% de todos os medicamentos
são prescritos, dispensados ou utilizados de forma inapropriada (WORLD HEALTH
ORGANIZATION, 2010). Esta situação desencadeou ações em nível mundial que
visam aumentar a segurança no uso dos medicamentos e mostra que a promoção do seu
uso racional merece atenção especial por parte dos gestores e responsáveis pelo
gerenciamento da Assistência Farmacêutica. Em consequência, a Política de Assistência
38
Farmacêutica do Sistema Único de Saúde - Sergipe (2010) afirma que os Serviços
Farmacêuticos devem contribuir para a efetividade, segurança e custo-benefício dos
usuários que fazem uso de farmacoterapia no Estado, nos Municípios e Redes
assistenciais (SERGIPE: SECRETARIA DE ESTADO DA SAÚDE, 2010).
Com a finalidade de por em prática estas políticas de saúde, a criação das
fundações de saúde no estado de Sergipe ocorreu na perspectiva de reforma sanitária e
gerencial implementada, sob a ótica de que a administração pública direta sozinha não
consegue dar as respostas que o sistema de saúde precisa. Por isso, foi buscada uma
alternativa dentro do próprio estado para tornar a administração dos serviços de saúde
sob o controle da Secretaria de Estado da Saúde menos burocrática e mais ágil. Assim, a
Fundação Estadual de Saúde teve por finalidade prestar serviços de saúde de atenção
básica, de promoção, prevenção e proteção da saúde coletiva e individual, de formação
profissional e educação permanente na área de saúde pública. Também está incluído
nessa cartela de serviços o gerenciamento dos Centros de Especialidades Odontológicas
e das Farmácias Populares do Brasil (SERGIPE: FUNDAÇÃO ESTADUAL DE
SAÚDE, 2013).
Neste contexto, o programa da Farmácia Popular do Brasil foi criado em 2004,
por meio da Lei no 10.858, atendendo a diretriz de promoção do uso racional de
medicamentos, visto que a mesma tinha como objetivo ampliar o acesso e qualificar o
uso da farmacoterapia (BRASIL, 2004c). Além disso, o programa tem em sua essência
a necessidade de atender as seguintes metas: implementar ações que promovam a
universalização do acesso da população aos medicamentos; assegurar medicamentos
básicos e essenciais a baixo custo, para os cidadãos que são assistidos pela rede privada;
39
proporcionar diminuição do impacto causado pelos gastos com medicamentos no
orçamento familiar, ampliando o acesso aos tratamentos (BRASIL, 2004a).
Atualmente, o programa atua sobre dois eixos de ação: as unidades próprias, que
são mantidas em parceria com municípios e estados e as unidades parceiras, por meio de
convênios com farmácias e drogarias privadas, por meio do programa “Aqui tem
Farmácia Popular¨. No país são mais de 500 unidades próprias difundidas, das quais
nove estão distribuídas no Estado de Sergipe e seis são mantidas por alguns municípios.
Em 2010, foi firmada a parceria entre a Secretaria de Estado da Saúde e a Fundação
Oswaldo Cruz para a criação de três Farmácias Populares gerenciadas no Estado pela
Fundação Estadual de Saúde, nas cidades de Estância, Propriá e Nossa Senhora da
Glória disponível a aproximadamente 125.000 pessoas em suas regiões. Apesar da
Política de Assistência Farmacêutica do estado de Sergipe (2010) ressaltar a
necessidade de se desenvolver o cuidado farmacoterapêutico individualizado e
privativo, não há registro sobre o impacto social das atividades desenvolvidas pelos
farmacêuticos da Farmácia Popular do Brasil no que concerne a promoção do uso
racional de medicamentos. Ao contrário, os registros de atividades, até o ano de 2012,
estão limitados apenas à cobertura da distribuição de medicamentos essenciais a
população (SERGIPE: SECRETARIA DE ESTADO DA SAÚDE, 2010).
Diante deste cenário, a Coordenação da Assistência Farmacêutica da
FUNESA/SE, a Coordenação das Farmácias Populares e ao Laboratório de Ensino e
Pesquisa em Farmácia Social firmaram um convênio no ano de 2012 com o intuito de
reverter este quadro. Desta forma será possível promover mudanças na abordagem de
acesso à farmacoterapia, por meio do fornecimento qualificado de serviços clínicos
farmacêuticos que irão atender as políticas públicas nacionais e regionais, bem como
40
otimizar o uso racional dos medicamentos para parte da população de Sergipe. Ademais,
será possível formular e descrever um modelo de serviço que possa ser incorporado e
reproduzido nas demais unidades da Farmácia Popular do Brasil de todo o país.
41
OBJETIVOS
X
X
42
3. OBJETIVOS
3.1. Objetivo geral
Implantar, implementar e consolidar serviços clínicos farmacêuticos em
unidades do programa Farmácia Popular do Brasil do Estado de Sergipe.
3.2. Objetivos específicos
Analisar a estrutura (recursos materiais e humanos) das Farmácias Populares do
Brasil geridas pela FUNESA/SE para a execução de serviços clínicos
farmacêuticos;
Realizar as intervenções para a melhoria dos indicadores de qualidade de
estrutura nas Farmácias Populares do Brasil geridas pela FUNESA/SE;
Avaliar a percepção dos farmacêuticos comunitários sobre as etapas de
implantação, implementação e consolidação de serviços clínicos em suas
farmácias;
Conhecer as barreiras apontadas pelos farmacêuticos comunitários que passaram
pelas etapas de implantação, implementação e consolidação de serviços clínicos
em suas farmácias;
Delinear as etapas de Implantação, Implementação e Consolidação dos serviços
clínicos farmacêuticos em unidades do programa Farmácia Popular do Brasil
geridas pela FUNESA/SE.
Mensurar a performance dos serviços clínicos farmacêuticos por meio de
indicadores de estrutura, processos e resultados.
43
RESULTADOS
X
X
44
CAPÍTULO I
X
X
45
4. RESULTADOS
4.1 CAPÍTULO I: PROFILE OF PHARMACEUTICAL SERVICES IN COMMUNITY
PHARMACY: SYSTEMATIC REVIEW
Giselle de C. Brito M.Sc. a,b
, Aline S. Dosea, M.Sc. Studant a, Blicie J. Balisa-Rocha,
Ph.D. c , Divaldo P. Lyra Jr., Ph.D.
a
aTeaching and Research Laboratory Social Pharmacy, Federal University of Sergipe,
LEPFS-UFS, s/n, Avenida Marechal Rondon, Jardim Rosa Elze, São Cristóvão, Brazil bFederal University of Sergipe, Lagarto, Brazil
cPharmacy Course, Faculty of Guanambi
Corresponding author: +557991925577
E-mail address: [email protected]
Abstract
Introduction: In recent years pharmaceutical services have gone through a process of
improvement due to the increasing use of drugs and the expansion of the actions of the
clinical pharmacist in direct patient care. However, for their quality be affirmed is
important an assessment of clinical outcomes, humanistic and economic impacts.
Objectives: To describe the profile the results (economic, clinical and humanistic) of
Pharmaceutical Services in Community Pharmacies. Material and Methods: A
systematic review was conducted into the databases EMBASE, MEDLINE, SCOPUS to
track original articles using the following keywords: "community pharmacy services",
"quality assurance health care," "outcome assessment." The resultant articles were
reviewed manually and those who had their titles potentially relevant were reviewed and
selected by the following criteria: articles published from January 1990 to March 2012
in the English language; availability of Abstract and articles which present results in
context of Pharmaceutical Services in Community Pharmacy. We excluded letters to the
editor, publications in congress systematic reviews. Results: The literature search
identified 432 articles, which, 42 met the inclusion criteria. The studies were performed
46
mainly in the United States (n = 13) and time Pharmaceutical most frequent intervention
was 12 months (n = 13). Regarding the type of Pharmaceutical Service, most of the
service was "Pharmaceutical Care" (14).As for methodological design, randomized
controlled intervention study (16) was the most described. Result parameters more
evaluated were glycosylated hemoglobin (clinical), quality of life (humanistic) and
analysis of the cost-effectiveness of the service (economic). About methodological
limitations described in most studies were lack of randomization and sample size
calculation. Conclusion: Few studies showed clinical outcomes, humanistic outcomes
and economic outcomes on the effectiveness of Pharmaceutical Services in Community
Pharmacies simultaneously. Moreover, further research should be conducted to develop
and standardize performance indicators specific to Pharmaceutical Services developed
in Community Pharmacies.
Keywords: Pharmaceutical Services, Community Pharmacy, Clinical Outcomes,
Economic Outcomes, Humanities Outcomes.
47
BACKGROUND
The current changes on the epidemiological profile the world generated new
demands for health and contributed to the World Health Organization (WHO)
recognized the Community Pharmacies as an appropriated places to start patients care.1
In many countries has been occurring the expansion of the list of Pharmaceutical
Services in this practical scenario. In the UK, for example, community pharmacists have
become integrated into public health programs, providing Pharmaceutical Services to
solve problems associated with the irrational drugs use.2
According to Schommer and colleagues (2010) these services has gone through
a process of improvement in recent years, contemplating since the primary health care,
with the service of dispensing drugs, to the management of chronic diseases, with the
Pharmaceutical Care. In these Community Pharmacies, pharmacists inform and
guidance on the drugs correct use, preventing, identifying and solving problems
pharmacotherapeutic through direct contact with the patient.3
As a result of these services, a study of Christensen and colleagues (2004) stated
that the withdrawal of 54% of inappropriate drugs pharmacotherapy of a group of
seniors from North Carolina, generated monthly savings of $ 30 per patient. As Kiel and
McCord (2005), who showed that the percentage of a patientes group to a controlled
clinical parameters increased after service management pharmaceutical.4,5
Meta-analyzes by Machado and colleagues (2007) showed that in recent decades
many countries have developed services and processes directed to Community
Pharmacy aimed to assist the pharmacotherapeutic needs of patients more accessible.6,7
Meanwhile, Holland and colleagues (2007) reported that services Review of
Pharmacotherapy and Dispensing provided in Community Pharmacy reduced the
number of hospitalizations and mortality in patients with heart failure8. Other studies
48
point to the importance of evaluating the Pharmaceutical Services, for only in this way
can be value the quality of it.9,10
According to Donabedian (1966), evaluation of the quality health services,
including those provided by pharmacists, can be performed on three pillars: structure
(physical, human, materials, instrumentals, regulatory, administrative resources, funding
sources), Proceedings (interactions and procedures involving health professionals and
patients) and results (change in health status attributed to the health intervention).11
Complementarily Kozma and colleagues (1993) proposed a model for evaluation of
results, known as ECHO model, subdividing them into economic, clinical and
humanistic.9
Although there are studies that evaluate scientific rigor and quality of the
Pharmaceutical Services in Hospitals results,12,13
there are few studies that perform the
same analysis in Community Pharmacies.14
Therefore, the goal of this review was to
describe the profile the results (economic, clinical and humanistic) of Pharmaceutical
Services in Community Pharmacies.
METHODS
This systematic review was performed in electronic databases - EMBASE,
MEDLINE and SCOPUS - and divided into two stages. In the first step we used the
subject descriptors: “community pharmacy services”, “quality assurance health care”,
“outcome assessment”, with the followingqueries:
1)“community pharmacy services” and “quality assurance health care” and
“outcome assessment”.
49
2) “community pharmacy services” and “outcome assessment”.
3) “community pharmacy services” and “quality assurance health care”
The articles indexed repeatedly in two or more databases included only once.
The second step consisted in manual sorting through titles and abstracts to select
studies specifically on Pharmaceutical Services in Community Pharmacies. Inclusion
criteria were: pharmaceutical intervention studies originals published up to 2012 in the
English language,studies that describing the methodology, the evaluation of
pharmaceutical services and outcome indicators used for the services (economic,
clinical and humanistic).. In the study, as well as systematic reviews were excluded
letters to the editor and publications at conferences, because these models are essentially
short and superficial approach, which could limit the depth of information to be
collected.
The articles were criteriously examined by: (1) Location (Country), (2) patients
number, pharmacists and pharmacies involved, (3) study duration, (4) pharmaceutical
service type, (5) study type; (6) clinical parameters, humanistic and economic results
description and (7) Limitations or bias in the literature evaluated. Articles that met the
inclusion criteria for data extraction were carefully described on the following variables:
(1) Country, (2) Pharmacists number, (3) Patients number, (4) Pharmacies number, (5)
Study duration, (6) Type of Pharmaceutical Service, (7) Design of study, (8) Outcome
indicators of pharmaceutical services,(9) Results, and (10) Limitations declared.
50
RESULTS
The literature search resulted in 432 articles, which 53 (12.26%) were indexed
simultaneously in two or more databases. After the manual sorting step, in the reading
of title and abstracts, 64 articles presented in their contexts results of Pharmaceutical
Services in Community Pharmacy. At the end, 42 articles met the inclusion criteria, thus
forming the final sample.15-56
Figure 1 shows the distribution of articles in the databases
and the steps of selecting the final sample.
Figure 1: Flowchart of the steps of selecting the final sample of the systematic review
432 potentially relevant articles found
in databases:
MEDLINE (117)
EMBASE (345)
SCOPUS (44)
209 excluded because they did not
suggest Pharmaceutical Services
evaluation
53 Articles were Excluded:
indexed in two or more databases
simultaneously
379 Articles selected for analysis
of titles
170 articles were selected by
having their titles in order to read
their abstracts
106 excluded because they did not
suggest Pharmaceutical Services
evaluation and not remitted to the
result indicators
64 Full papers selected to be read
in full
42 Full papers selected
22 papers excluded:
1 Systematic Review
1 Report
10 Articles that have evaluated only service
process
1 Paper was not developed in community
pharmacy
1 Paper worked with simulated patient
8 Papers that were not available
51
The studies were conducted in 14 different countries, mostly in Europe and
North America, and the United States has the highest number of publications (14),15-28
followed by Australia (5).29-33
Only one study was developed in South America.34
Regarding the practice scenarios, the results of this review are grounded on the
analysis of 684 pharmacies, drugstores this number in the study varied from 80.
Furthermore, three studies were described as multicenter. This review evaluated data
8013 patients, the average sample size was 190 patients having a range from 1033
to
73835
patients. Moreover, the average time of study was 24 months, ranging from ten
days to 36 months (Table 1).
INSERT TABLE 1
By analyzing the pharmaceutical services provided, there was fourteen distinct
nomenclatures, (Pharmacy Care Program, Education and Coaching, Follow-up,
Counselling, Medication therapy management, Pharmaceutical Care Pharmacotherapy
review, Patient self-management care, Providing advice on medication, Pharmaceutical
Intervention, Medication Assistance, Monitoring and drug therapy management,
Pharmaceutical Intervention, Therapeutic outcomes monitoring), as can be seen in Table
2. Among the Pharmaceutical Services, the most frequent was "Pharmaceutical Care"
(12), 15-17,36-44
moreover, 2615,20,22-25,27-29,32-34,36-39,42-51
studies gave some definition or
description of the activities.
After critical analysis of the studies, it was observed that a large part was
described as methodologically studies Randomized Controlled Clinical Trial
(11)18,27,29,30,35,41,45,46,47,51,52
and Coorte study (7).15,16,17,22,32,26,53
(Table 2)
INSERT TABLE 2
52
Of the 42 studies included, only seven 15,16,19,21,38,45,54
articles evaluated the
impact of Pharmaceutical Services through indicators of clinical, humanistic and
economic results simultaneously. The authors concluded by statistical analyzes that
pharmaceutical interventions had a statistically significant impact on obtaining clinical
results, humanistic and economic.
In this way it can be observed that the clinical parameters were evaluated –
glycosylated hemoglobin (12),16,17,20,21,26,27,28,34,43,48,49,54
blood pressure
(10),20,21,28,32,34,40,43,44,48,49
respiratory symptoms (9),19,29,36,37,38,42,43,50,55
LDL - cholesterol
(7),15,20,21,26,28,49,54
HDL - cholesterol (3),15,26,28
total cholesterol (5),15,26,28,30,48
triglycerides (2),26,28
body mass index (2),26,34
waist circumference (2),32,34
bodyweight
(1),26
Abstaining from smoking (2),23,47
serum glucose (1),25
fasting glucose (1),43
depression symptoms (1),52
cardiovascular risk factor (1),28
lymphocyte count and
opportunistic infections (2).22,24
Regarding Humanistic aspects can be observed
evaluation quality of life (QOL) (12),15,16,24,33,35,38,39,40,41,46,50,54
patient satisfaction
(10),15,16,25,31,37,39,41,45,50
and perception through the service (3). 18,21,23
All studies
evaluating QOL cited the questionnaire, being the most common being SF-36 (3)41,36,39
and the SF-12 (4).15,16,54,46
As for the evaluation pharmacoeconomic observed that were evaluated the
service cost (13),15,18,19,20,22,28,34,35,38,39,45,53,54
ranging from $ 560 to $ 840 dollars per
year and the economy of the Pharmaceutical Service can provide (1),21
ranging from $ $
155 to $ 918 dollars per year.
Regard to limitations assumed by the authors, only two studies did not described
them.38,48
Among the limitations mentioned, the absence of the calculation to determine
the minimum sample size to perform statistical inferences (13) 15-
53
20,24,27,30,35,40,44,5132,26,13,14,52,16,21,22,15,41 and the lack of randomization of the study groups
(6) 15,22,33,34,50
were the more reported analysis biases. (Table 3)
INSERT TABLE 3
DISCUSSION
Most studies were performed in the United States, which was corroborated by
recent revisions about the investigation of Pharmaceutical Services, which have found
1.894 studies published in this country in the 1990 and 7.975 publications until
2007.57,58
The lack of studies in Latin America about the Pharmaceutical Services can
be justified by the fact that the actions of the pharmacist are more focused on logistical
actions, such as programming, selection, acquisition, storage and distribution of drugs.59
Furthermore, the distribution of countries between studies may have been limited by the
language, because the exclusion of articles in Spanish and Portuguese may have
affected this result.
Although community pharmacies present barriers to achieve positive results,
such as contact dificult with other health professionals, Carter et al. (2003) suggest this
as a promising environment for the development of Pharmaceutical Services, such as
dispensing or patient follow-up. According to the authors, these environments allow
greater interaction between the pharmacist and the population.60,61,62
Another important aspect to be evaluated by the Pharmaceutical Services is a
sample of patients attended. According Touchette et al. (2008), the representativity of
the sample is suggested as a possible limitation of the obteined results in quantitative
studies, whereas small samples may cause systematic errors. This can make unfeasible
the detection of significant results, especially when the instruments used to measure
them are not very sensitive.63
54
With regard to time spent on the practice of Pharmaceutical Services, notes that
some were performed in periods of less than six months. Cooper et al. (2001)
demonstrated by a review composed of 20 meta-analyzes which up to six months
follow-up patients have positive behavior results, but after that period revert to the
behavior and clinical parameters levels previous in an effect called "Hawthorne Effect
".64
Therefore, it is recommended that interventions that require patient follow-up been
developed during more than six months, and it from being re-evaluated in the long term,
even after discharge the patient, ensuring a more effective follow.
Although all authors have termed the type of service provided, were observed
two aggravating the lack of description of the activities inherent to that type of service,
as well as similar services being conceptualized in different ways. The literature points
to the need to conceptualize the practice to distinguish cognitive services offered by the
pharmacist. The standardization of the concepts of Pharmaceutical Services are
important to avoid misunderstanding.65,66
In terms of evidence-based practice, the randomized clinical trial still being
considered the gold standard and has been used as a kind of study of great part of the
present sample revision.67
Thus, most of the research in the field of pharmacy care is
focused quantitative approaches, which leads to a lack of analysis of the perceptions,
attitudes and expectations of patients, health professionals, as well as the pharmacist.68
Regarding the use of ECHO model recommended by Kozma et al. (1993), a
small number of articles of the sample fully implemented its precepts, demonstrating
simultaneously the impact of clinical, economic and humanistic of Pharmaceutical
Services.9 Based on the traditional medical model, which is geared primarily to the
clinical results, the ECHO model adds a multidimensional aspect to incorporate
55
systematic evaluation of humanistic and economic outcomes, as well as clinical
indicators to provide a more comprehensive measure value of the health care.
The notorious use of laboratory tests and clinical results of patients provided
concrete results, factor in strengthening the practice and research in this area. The study
by Machado et al. (2007) demonstrated that programs developed by pharmacists can
significantly reduce HbA1c levels of mellitus diabetes patients (p ≤ 0,05). In contrast,
there have not been found the same results when evaluated the lipid profile, capillary
glycemia and the BP.6,7
Note that as they refer to studies conducted in Community
Pharmacy, these parameters should not be restricted to laboratory tests, whereas demand
higher costs and depend on the cooperation of other health professionals.
In this review we observed the use of three results indicators humanistic, life
quality, satisfaction and perception of patients. Most of the studies did not observed the
significant improvement in life quality, such data may be associated with the sensitivity
of the employed instruments, sample size, the experience of the pharmacist.69,70
Moreover, it can be observed the use of eight distinct instruments to measure it and
none of them was a specific instrument for the disease or the Pharmaceutical Services
offered in Community Pharmacies.
The positive results regarding the satisfaction and perception of patients reflect
not only the care of some patients, needs as well as the degree of involvement of the
pharmacist during the health care practice.71,72
However, there was also a lack of
uniformity in the measurement of these results and the lack of qualitative methods for
evaluation of the patients perception. Thus, it is suggested that upcoming studies
associate quali-quantitative approaches, since those allow an understanding of the
56
perceptions, feelings, expectations and experiences of patients about their
pharmacotherapy and the pharmaceutical service.
Another consistent finding of this review shows the limited number of studies
that evaluated the pharmacoeconomic aspects of pharmaceutical services and lack of
homogeneity of its measurement. It is observed that the methods are not well described
and many of the values are estimations. Furthermore, these data often are not
documented in the pharmacy, but in other health services (hospitals, clinics, etc.), in
which there's not always efficient communication for collecting these data. This type of
evaluation is crucial to provide information to health managers on the cost-benefit of
implementing these services, justify the development of standardized models for the
proper execution of these, preferably with evaluation of direct costs and not
estimated.39,60
The identification of the limitations of the majority of the articles analyzed,
Bond (2006) argues that it is primordial that publishes both the negative and the positive
aspects of the studies. Both are of equal value and serve as learning to other
researchers.67
Among the pointed limitations, three main stand out the lack of specific
instruments to evaluate economic and humanistic outcomes, lack of randomization and
lack of sample size calculation. The lack of uniformity and inexistence of specific
instruments to evaluate humanistic and economic parameters restricts the external
validity of the results evaluated, making difficulty possible analyzes and inferences.
Moreover, the absence of randomization and inadequate sample size may limit the
comparison of the findings with other studies, as well as compromise the methodology
of replication in different environments.63
57
In this systematic review it was identified some limitations: language, time and
database. Due to the fact of this review using keywords only in English language, may
omit important publications in other languages. Another limitation was the restriction of
the time (January 1990 to March 2012) and databases, which may fail to locate previous
studies and relevant papers that are not published in the data source used.
CONCLUSION
In this review, few studies had concomitant clinical, humanistic and economic
results for evidence the effectiveness of pharmaceutical services in community
pharmacies. Given the indicators of clinical outcome, it can be seen that the majority of
studies using laboratory parameters as indicators of improvement. As the humanistic
outcomes, their assessment is still incipient, moreover, there is still a lack of
standardization in specific instruments and methods to measure their impact. Another
important aspect highlighted was the lack of an pharmacoeconomic evaluation , denoted
by the lack of homogeneity in the results, which undermined the finding of a cost-
benefit of pharmaceutical services.
From the gaps found in this review, it is possible make recommendations for
future research. Studies have shown the importance of emphasizing actions to get the
evaluation of humanistic outcomes of pharmaceutical services that best describe the
impact of this aspect of quality of life and patient satisfaction. In addition, it is
recommended evaluation the long-term economic impact of the service in the family
budget, as a strategy to bring improvements to the service and more investment from
managers and public policy. And so it is expected that the standardization of
instruments and evaluations of the impact of pharmaceutical services become more
effective.
58
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Table 1: Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country
Pacients number Pharmacists number Pharmacy number Study duration (months)
Aguwa et al..2008 Niger 24 4 NR 5
Armour et al.,2007 Australia IG:191e CG: 205 57 50 6
Aslani et al.,2011 Australia IG:48 e CG:49 38 38 3
Bauld et al.,2011 United Kingdom (UK) NR NR NR 12
Beaucage et al.,
2006
Canada IG:126 e CG:129 NR 6 14
Bereznicki et al.,
2010
Australia 10 10 NR An interview - focal group
Brook, 2003 Netherlands IG: 69 e CG: 78 19 NR 6
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
69
Table 1: (Continuation) Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country Pacients
number Pharmacists number Pharmacy number Study duration (months)
Correr et al., 2009 Brazil IG:50 e CG:46 NR 4 12
Cranor et al., 2003 United States (US) 85 NR 12 7 - 9
Cranor et al., 2003 (2) United States (US) 85 85 NR 12
Cranor et al., 2003 (3)
United States (US) 85 NR 12 7 - 9
Cranor et al., 2003 (4)
United States (US) 21 16 1 1
Cranor et al., 2006 United States (US) 207 18 12 3
Denneboom et al., 2007 Netherlands 738 28 28 15
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
70
Table 1: (Continuation) Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country
Pacients number Pharmacists number Pharmacy number Study duration (months)
Elliott et al., 2007 England IG: 87 e CG: 118 NR 40 1
Fera et al., 2009 United States (US) 573 102 10 14,8 ± 2,5
Fornos et al., 2006 Spain IG:56 e CG:56 NR 14 13
Garrett et al., 2005 United States (US) 256 NR 80 12
Herborg et al., 2000 Denmark IG: 264 e CG:236 NR IG:16 e CG:15 12
Hirsch et al., 2011 United States (US) Each year ranged from
400 a 600
NR 10 per year 36
Hohmann et al., 2009 Germany IG: 90 e CG: 165 39 NR 12
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
71
Table 1: (Continuation) Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country
Pacients number Pharmacists number Pharmacy number Study duration (months)
Hugtenburg et al., 2009 Netherlands IG:379 e CG:336 NR 37 9
Kennedy et al., 2002 United States (US) 48 15 7 32
Maguire, 2001 Ireland IG:265 e CG: 219 51 24 12
Mangiapane et al., 2005 Germany 183 NR 39 12
March et al., 2007 United States 34 2 1 11
Mclean et al., 2003 Canada IG: 121 e CG: 121 37 9 12
Mcnamara et al., 2012 Australia 67 12 10 6
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
72
Table 1: (Continuation) Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country
Pacients number Pharmacists number Pharmacy number Study duration (months)
Mehuys et al., 2010 Belgium 555 NR 93 5
Mehuys et al., 2011 Belgium IG:153 e CG:135 NR 66 6
Mitchell et al., 2011 United States (US) IG:20 e CG: 32 NR NR 9
Niquille et al., 2010 Switzerland 85 11 14 NR
Oyetayo et al., 2011 United States (US) 126 14 13 12
Planas et al., 2009 United States (US) IG:20 e CG: 32 NR NR 9
Rashed et al., 2010 United States (US) IG:22 e CG:14 NR NR 36
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
73
Table 1: (Continuation) Characterization of the studies (n = 42) included in this systematic review.
Authors, year Country
Pacients number Pharmacists number Pharmacy number Study duration (months)
Schulz et al., 2001 Germany IG: 161 e CG: 81 NR 26 12
Smith et al., 2011 Australia IG:77 e CG:73 NR 20 10 days
Sturgess et al., 2003 Northern Ireland IG:110 e CG: 81 NR 10 18
Stuurman-bieze-part A
et al., 2005
Netherlands 199 27 24 12
Turnacilar, 2009 Turkey 67 NR 8 3
Wermeille, 2003 Scotland 62 NR 4 12
Yuksel, 2010 Canada IG:129 CG:133 NR 15 4
Abbreviations: CG – Control Group; IG – Intervention Group; NR – Not Related; SD- Standard Deviation
74
Table 2: Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of Pharmaceultical
Service
Evaluated indicators (structure,
process and results) Study Type Analyzed Limitations declared
Aguwa et al., 2008
Pharmaceutical care Clinics: BP Humanistics: HQ
Transversal, non-randomized Sample size
High dropout rate
Armour et al., 2007 Follow-up Clinics: Asthma severity Interventional randomized
controlled
Results not generalizable
Results not sustainable in the long run
Results based on self-report
Aslani et al., 2011 Monitoring and drug therapy
management
Clinics: CT Intervencional randomized
controlled
Sample size
High dropout rate
Bauld et al., 2011 Follow-up Economics: Costs per patient Coorte study Being an observacional study
Beaucage et al.,
2006
Telephone follow-up
intervention
Clinics: Symptoms number and
severity
Humanistics: Patient satisfaction.
Economics: Costs per patient
Intervencional randomized
controlled
Low impact on clinical symptoms
Bereznicki et al., 2010 NR Humanistics: Satisfaction and
expectations of patients facing the
pharmaceutical services
Qualitative study of patients
perceptions
The sample already known the service
Results not generalizable
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
75
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of Pharmaceultical
Service
Evaluated indicators (structure,
process and results) Study Type Analyzed Limitations declared
Brook et al.,
2003
Coaching by community
pharmacists
Clinics: Depression levels Intervencional randomized
controlled
Imcomplete data or limited evaluation
Lack of parameters of disease
evaluation (severity degree)
Correr et al.,
2009
Pharmacotherapeutic Follow Clinics: Hb1Ac, BP, WC e BMI
Economics: Costs per patient
Clinical, prospective,
longitudinal, controlled and
non-randomized.
Non-randomized sample
Did not evaluated indirect costs
Cranor et al., 2003 Pharmaceutical care Clinics: HbA1c, TC, HDL e LDL
Humanistics: HQ e patient
satisfaction.
Economics: Costs per patient
Coorte study Data missing
Sample size
Non-randomized
Cranor et al., 2003 (2) Pharmaceutical care Clinics: HbA1c
Humanistics: HQ e patient
satisfaction.
Economics: Costs per patient
Coorte study Sample size
Data missing
Study short time
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
76
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of Pharmaceultical
Service
Evaluated indicators (structure,
process and results) Study Type Analyzed Limitations declared
Cranor et al.,2003 (3)
Pharmaceutical care Clinics: HbA1c and serum lipids
Economics: Costs per patient
Coorte study, quasi-experimental Missing data
Cranor et al.,2003 (4)
Focal groups interview Humanistics: patient satisfaction
Economics: Costs per patient
Intervencional randomized
controlled
Small sample
Cranor et al., 2006 Community-based medication
therapy management
Clinics: Expiratory volume, asthma
severity, frequency of symptoms.
Humanistics: Perception of asthma
Economics: Costs per patient
Longitudinal study, quasi-
experimental
Missing data
Small sample
Denneboom et al., 2007 Pharmacotherapy review Economics: Costs per patient Intervencional randomized
controlled
Incomplete data
Covinient sample choice
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
77
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Elliott et al., 2007 Patient follow up by
phone
Process: Adhesion
Economics: Costs of
Increased Effectiveness
Intervencional randomized
controlled Sample convinience choice
Fera et al., 2009 Patient self-
management
Clinics: HbA1c, LDL e BP
Economics: Costs per
patient
Observacional study, quasi-
experimental Study type limit conclusions
Sample size
The sample was voluntary
Fornos et al., 2006 Follow-up Clinics: HbA1c, LDL e BP
Economics: Costs per
patient.
Observacional study, quasi-
experimental The study wasn’t blinded
Garrett et al.,
2005
Coaching by
community pharmacists
Clinics: HbA1C, LDL,
SBP e DBP.
Humanistics: Patients
satisfaction
Economics: Costs per
patient.
Longitudinal study, quasi-
experimental The analyzes were performed to satisfy the
interests of the financiers
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
78
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Herborg et al.,
2000
Therapeutic
outcomes
monitoring
Clinics: respiratory symptoms
Humanistics: Patients
satisfaction and HQ
Prospective and Controlled Non-randomized
Weak statistics tests
Patients over 45 years had different results of the newest.
Hirsch et al., 2011 Medication
therapy
management
Clinics: Decrease of
opportunistic infections
Economics: Anual cost
estimative
Coorte study Non-randomized
Results based on relations
The viral load and immune status were not evaluated
Hohmann et al.,
2009
Pharmaceutical
care
Humanistics: Patients
satisfaction and HQ.
Intervencional controlled
non-randomized
Non-randomized
Hugtenburg et al.,
2009
Medication
review and patient
counselling
Humanistics: Patients
satisfaction.
Economics: Money spent
with medications during the
intervention
Controlled intervencional The pharmacies choice wasn’t random
The hospital re-admissons, DRP´s and the relation cost-
effectiveness wasn’t documented
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
79
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Kennedy et al.,
2002
Smoke cessation
program
Clinics: Abstaining from
smoking
Humanistics: Patient
perceptions of the service
Estudo de intervenção,
com único grupo e não
cego
Non-significant statistical differences
Non-validated instrument use
Information based on self-report
Maguire et al., 2001 Community
pharmacy-based
smoking cessation
programme
Clinics: Smoking
abstaining time
Intervencional
randomized controlled
Pharmacists have chosen to participate in the service for
convenience
Mangiapane et al.,
2005
Pharmaceutical care Clinics: Severity of
asthma, expiratory peak
flow
Intervencional The evaluation of clinical measures was made by non-validated
process.
March et al., 2007 Pharmacist-managed
drug
Clinics: T CD4
lymphocytes Count
Humanistics: HQ
Intervencional Sample size
Short study time
Use of theSF-8 questionnaire only at the end of the study
Mclean et al., 2003 Enhanced
Pharmaceutical care
Clinics: Respiratory
flow, general symptoms
Humanistics: HQ
Economics: Costs per
patient
NR NR
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
80
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Mcnamara et al.,
2012
Lifestyle and
medicine
management
Clinics: BP e WC Coorte Intervencional Was not controlled
Samples chosen for convenience
Short study time
Mehuys et al.,
2010
pharmacotherapeut
ic management
Clinics: State of COPD,
respiratory flow peak
Transversal study Volunteer patients
Use of prescription renewal amount as an instrument to
evaluate adherence
Mehuys et al.,
2011
Pharmaceutical
care
Clinics: Fasting blood
glucose and HbA1c
Intervencional
randomized controlled
Volunteer patients
A validated measure was not used to evaluate adherence
Not been obtained the Hb1Ac values of all patients
Not been registered the causes of abandonment of some patients
of the study
Have not been evaluated blood pressure and lipid profile
Mitchell et al.,
2011
Diabetes
Medication
Assistance Service
Clinics: Serum glucose
Humanistics: Patient
satisfaction
Intervencional The control group was not included in the analysis of the
results
Auto-selection of pharmacists and patients
Auto-report to capture subjective data
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
81
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Niquille et al.,
2010
Medication
review
Clinics: BP, LDL
cholesterol and HbA1c
Humanistics: HQ
Economics: Daily cost per
patient
Transversal Incomplete or limited evaluation data,
Absence of disease evaluation parameters (degree of severity)
Oyetayo et al.,
2011
Medication
therapy
management
Clinics: HbA1c, LDL, HDL,
TC, triglycerides, BMI e
body weight.
Coorte Longitudinal
pre/post
Without control group
The economic impact of the intervention is unknown
The drop-out rate was high, 60%
Planas et al., 2009 Medication
Therapy
management
Clinics: BP
Intervencional
randomized controlled
Sample size
The randomization of patients was biased
Patients
Rashed et al., 2010 Diabetes
education and
management
Clinics: TC, triglycerides,
HDL, LDL, HbA1C and
cardiovascular risk factor.
Economics: Costs per
patient
Cost-effectiveness
analysis
Sample for convenience
Clinical results were not evaluated during the study time
Schulz et al., 2001 Pharmaceutical
care
Clinics: Expiratory Volume,
severity of asthma
Humanistics: HQ
Intervencional controlled In the control group, pharmacists also intervened on a few DRP´s.
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
82
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Smith et al.,
2011
Goal setting and
counseling
Clinics: Severity of
symptoms
Humanistics: HQ
Intervencional
randomized controlled
Results are not generalizable
Small number of pharmacies
Not randomized sample
Sturgess et al.,
2003
Pharmaceutical
care
Humanistics: HQ
Economics: Cost per patient
Longitudinal,
randomized,
interventional, controlled
The authors reported that the study was too ambitious, and that
this resulted in fatigue on the part of pharmacists and patients
High dropout rate
Stuurman-bieze-
parte A et al., 2005
Pharmaceutical
care
Clinics: Respiratory
symptoms
Humanistics: Patient
satisfaction
Randomized controlled
Interventional
The results were based on reports only
Turnacilar et al.,
2009
Pharmaceutical
care
Clinics: Capillary blood
glucose, blood pressure and
weight
Prospective longitudinal
study
Short study time
Small sample
Results are not generalizable to other pharmacists
Control group missing
HbA1c and lipid profile evaluation missing
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
83
Table 2: (Continuation) Methodological design description of the studies (n = 42) included in this systematic review.
Authors, year
Type of
Pharmaceultical
Service
Evaluated indicators
(structure, process and
results) Study Type Analyzed Limitations declared
Wermeille et al.,
2003
Providing advice
on medication
Clinics: BP, HbAc1 e TC
Prospective pretest-
posttest single group
study
NR
Yuksel et al., 2010 Pharmaceutical
intervention
Clinics: Bone mineral
density test
Humanistics: HQ
Randomized controlled
trial
The drop-out rate was high
Results are not generalizable to other pharmacies
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
84
Table 3: Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Aguwa et al., 2008
Armour et al., 2007
Aslani et al., 2011
↓ BP
↓ Severity of asthma (table of National Asthma
Council's assessment-Australia)
↓TC
NE
NE
NE
↑ HQ ( Brief Questionnaire)
NE
NE
Bauld et al., 2011
NE The cost per participant was £ 79 for pharmacy
customers and £ 368 for customers of the Group
(validated method of cost-effectiveness for
smokers)
NE
Beaucage et al.,
2006
↓ Number and severity of symptoms (5-point
Likert scale)
The cost between $ 5.11 without refund and $
2.65 with reimbursement to pharmacists
(calculated on salary and working time of
pharmacists)
↑ Satisfaction (Larson et al.
Questionnaire)
Bereznicki et al.,
2010
NE NE ↑ Satisfaction (entrevista, relato)
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
85
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Brook et al.,
2003
↓ Depression levels (Symptom Checklist (SCL-
90))
NE NE
Correr et al.,
2009
↓Hb1Ac, ↓BP, ↓CA and ↓BMI
The average cost per patient per year was
estimated at r $ 88,60 (calculated at time of
service)
NE
Cranor et al.,
2003
↓Hb1Ac e HDL ↑ TC and LDL. ↓Costs per patient (consults, prescriptions and
emergencies)
↑HQ (SF-12) ↑Satisfaction (Larson and
MacKeigan instrument).
Cranor et al.,
2003 (2)
↓Hb1Ac ↓Costs per patient (consults, prescriptions and
emergencies)
↑HQ (SF-12) ↑ Satisfaction (Larson and
MacKeigan instrument).
Cranor et al.,
2003 (3)
↓HbA1c ↑ HDL ↓LDL ↓Costs per patient (consults, prescriptions and
emergencies)
NE
Cranor et al.,
2003 (4)
NE ↓Costs per patient (entrevistas, relatos) ↑ Satisfaction (interviews, reports)
Cranor et al.,
2006
Improvements in symptoms ↓Costs per patient (consults, prescriptions and
emergencies)
NR
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
86
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Denneboom et al.,
2007
NE ↓Costs per patient (consults, prescriptions and
emergencies)
NE
Elliott et al., 2007 NE NR NE
Fera et al., 2009 ↓HbA1c ↓LDL ↓BP ↓. Risk of CVD ↓Costs per patient (consults, prescriptions and
emergencies)
NE
Fornos et al., 2006 ↓HbA1c ↓ Fasting glucose ↓TC NE NE
Garrett et al., 2005 ↓ HbA1c ↓ TC↓ BP ↓Costs per patient (consults, prescriptions and
emergencies)
↑ Patient satisfaction (Likert scale -
questionnaire)
Herborg et al.,
2000
↓ Respiratory symptoms
NE ↑HQ (Nottingham Health Profile) ↑
Satisfaction (28-item questtionaire by
Danish College of Pharmacy Practice)
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
87
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Hirsch et al., 2011 ↓ Opportunistic infections NE The difference in costs between the
intervention and control groups was not
significant.
Hohmann et al.,
2009
NE NE ↑HQ (SF-36)
↑ Satisfaction ( 5-point Likert scale -
questionnaire)
Hugtenburg et al.,
2009
NE With reducing the amount of medicines, 19,5 ±
47,9 euros were spent per patient during the
service.
↑ Satisfaction (5-point Likert scale -
questionnaire)
Kennedy et al., 2002 12 patients stopped smoking for more than one
year
Women had five times more success in
stopping
NE
Patient perception-0-10 scale in
satisfaction: 82% scored 10 and 94%
scored 8 or more.
Maguire et al., 2001 14.3% of the intervention group patients kept
smoking abstinence during 12 months.
NE NE
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
88
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Mangiapane et al., 2005 ↓ Symptoms and severity of asthma NE ↑HQ (Living with Asthma Questionnaire)
March et al., 2007 ↑ The count of lymphocytes T CD4 NE ↑HQ (SF-8)
Mclean et al., 2003
↓ Respiratory symptoms ↑ Economics (value of medicines and queries)
↑ HQ (Juniper Questionnaire)
McNamara et al., 2012 ↓ BP ↓ WC NR NR
Mehuys et al., 2010 State of COPD, improves
NR NE
Mehuys et al., 2011 ↓ Fasting glucose ↓ HbA1c NR ↑Patient satisfaction (Diabetes Disease
State Management Questionnaire)
Mitchell et al., 2011 ↓ Serum glucose NR ↑Patient satisfaction (Diabetes Disease
State Management Questionnaire)
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
89
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Niquile et al., 2010 ↓BP ↓LDL ↓HbA1c ↓ Cost per patient (NR) ↑ HQ (SF-12)
Oyetayo et al., 2011 ↓HbA1c, LDL, HDL, TC, triglycerides, BMI
and body weight.
NE NE
Planas et al., 2009 ↑ BP NR NR
Rashed et al., 2010 ↓ TC, triglycerides, HDL, LDL, HbA1C and
cardiovascular risk factor
↓Costs per patient (consults, prescriptions and
emergencies)
NR
Schulz et al., 2011
↑ Expiratory Volume ↓ Severity of asthma NR
↑ HQ (SF-36)
Smith et al., 2011 ↓ Severity of symptoms (gravity questionnaire
of nasal and non-Nasal symptoms); NR
↑ HQ (Mini Rhinoconjunctivitis
Quality of Life Questionnaire)
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
90
Table 3: (Continuation) Description of clinical, humanistic and economic results studies (n = 42) included in this systematic review.
Authors, year Clinical parameters measured:
Positive clinical results
Economic parameters measured:
Positive economic results
Humanistic parameters measured:
Positive humanistic results
Sturgess et al., 2003 ↓ Respiratory symptoms
NE ↑ HQ (SF-36)
Stuurman-bieze-parte A
et al., 2005
↓ Respiratory symptoms NE ↑ Satisfaction (NR)
Turnacilar et al.,
2009
↓ Glycemic Control, BP, weight and BMI NE NE
Wermeille et al., 2003 ↓ BP, HbAc1 and total cholesterol NE NE
Yuksel et al., 2010 ↑ Bone mineral density NE No significant differences: HQ (OPTQoL
e SF-12)
Abbreviations: NR- Not Related; DRP – Drug-related Problem; BP – Blood Pressure; Abbreviations: NR- Not Related; NE- Not Evaluated; BP – Blood Pressure; SBP –
Systolic Blood Pressure; DBP- Diastolic Blood Pressure: HQ – Health Quality; TC - Total Cholesterol; Hb1Ac – glycated hemoglobin, WC – Waist Circumference e BMI –
Body Mass Index
91
CAPÍTULO II
X
X
92
4.2. CAPÍTULO II: CLINICAL PHARMACY SERVICES IN BRAZILIAN PUBLIC
COMMUNITY PHARMACIES: A PILOT STRUCTURE’S QUALITY
ASSESSMENT STUDY
Giselle de C. Brito M.Sc. a,b
, Thelma Onozato, M.Sc.a, Chiara Erminia da Rocha, Ph.D.
b
Aline Santana Dosea a, Divaldo P. Lyra Jr., Ph.D.
a
aTeaching and Research Laboratory Social Pharmacy, Federal University of Sergipe,
LEPFS-UFS, s/n, Avenida Marechal Rondon, Jardim Rosa Elze, São Cristóvão, Brazil bDepartment of Pharmacy, Federal University of Sergipe, Lagarto, Brazil
Corresponding author: +557991925577
E-mail address: [email protected]
Objective. To analyze material and human resources for the implementation of clinical
pharmacy services and describe the interventions performed for quality improvement of
structure indicators.
Study setting. Three public community pharmacies, located in the Northeast region of
Brazil.
Study design. A cross-sectional study.
Data collection. Both material and human resources were evaluated and interventions
occurred from March 2012 until April 2013. The infrastructure of the pharmacies were
assessed using an instrument developed by the researchers according to Brazilian
Health Surveillance Agency and the pharmacist’s competencies for clinical pharmacy
services were assessed by the Simulated Patient Method.
Principal findings. The assessment of resource materials related to trade and dispensing
drugs had appropriated more items and all areas showed improvement in quality after
93
intervention. In contrast, the overall impression about the pharmacist’s competencies
for clinical pharmacy services was considered regular(3) a 1-5 scale.
Conclusions. Initial diagnosis of the structure should be the first step towards the
implementation of clinical pharmacy services with quality, and through it was possible
to identify and resolve nonconformities of the service.Keywords. Community
pharmacy, quality improvement, structure indicator, Health Service Research
94
Introduction
The provision of medicines in Brazil is conducted in a more representative way through
free supply by the government through the Ministry of Health and direct payment by
users. The first initiative of co-payment in the country came up in 2004, through the
“Farmácia Popular do Brasil” Program with the goal of expanding access to medicines,
focusing on the segment of the population that uses the private health care system, but
does not have sufficient income to buy and/ or complete the pharmacological treatment
appropriately(Brasil 2004a; b) . Thus, the program do not establish access barriers to the
population other than the drug prescription, (Santos-Pinto, Costa, and Osorio-de-Castro
2011).
However, studies showed that only access to pharmacotherapy does not guarantee the
improvement of population health, new roles of the pharmacist and the pharmacy are
required (McMillan et al. 2013; You et al. 2011; Saramunee et al. 2014). For World
Health Organization (WHO) the most effective way to improve the use of medicines in
primary care in developing countries is the combination of education and supervision of
healthcare professionals, patient counseling and access to appropriate medications. Any
of these approaches alone, achieves limited impact on the population health (World
Health Organization 2010).
Despite this fact, the standard procedure to deliver medicines at “Farmácia Popular do
Brasil” Program consists in three steps: (1) reception of the user, (2) checking
prescription and (3) distribution/dispensing. This service does not always include
counseling; which is performed only upon request of the user (Brasil 2004c). In face
this reality, the implementation of clinical pharmacy services in the program meets the
WHO recommendations to improve the use of medicines and achieve treatment success.
95
In addition, it meets the program guidelines, which requires specific structure for
clinical pharmacy services.
Notwithstanding the existence of guidelines and recommendations to structure
pharmaceutical services (Brasil 2009a; World Health Organization 2011; Brasil 2009b)
there are few reports about its conduction (Aguiar, Balisa-Rocha, and Lyra Jr 2013;
Rios et al. 2013; Billups et al. 2000). In this context, Donabedian (Donabedian 1966),
proposed the assessment of healthcare quality, using indicators of structure, process and
outcomes. This approach can also be used as a guide for the implementation of
qualified clinical pharmacy services. In the initial phase of the implementation process,
the development of studies about structure are required to identify the existing
conditions and the changes necessary to enable the implementation of this services,
since the organization of structure indicators are essential for subsequent phases that
include the processes and outcomes (Rademakers, Delnoij, and de Boer 2011).
Despite the wide use of Donabedian’s framework, there are few studies that have
evaluated the quality of clinical pharmacy services, in terms of structure indicators, in
Community Pharmacies across the world, including Brazil (Rios et al. 2013; Aguiar,
Balisa-Rocha, and Lyra Jr 2013; De Bie et al. 2011; Schoenmakers et al. 2015).
Therefore, the objective of this paper is to analyze material and human resources for the
implementation of clinical pharmacy services and describe the interventions performed
for quality improvement of structure indicators in three Brazilian public community
pharmacies.
96
Methods
A cross-sectional study was conducted in two phases: in March 2012 and in April 2013
in three public community pharmacies of the “Farmácia Popular do Brasil” program,
located in the Northeast region of Brazil and run by a public healthcare foundation. To
assess the pharmacies quality indicators of structure, both material and human resources
were evaluated in March, 2012. Then, based on the inconsistencies identified in the
Assessment of the Community Pharmacies Structure interventions were outlined. Such
interventions were drawn collaboratively between the researchers and the pharmacists
based on the concepts of structure, process and outcome. Subsequently, in April, 2013 a
second evaluation was taken and new interventions were outlined until 2014.
Context of the study
Through a partnership between Teaching and Research Laboratory in Social Pharmacy,
Federal University of Sergipe, and State Health Foundation was established a
consulting coaching format to deploy (implement) clinical pharmacy services
(Dispensation, Measurement of clinical parameters, Medication review and Medication
Therapy Management) in three public community pharmacies . To achieve this goal,
situational diagnosis training of pharmacists and employees, development and
standardization of work processes as well as evaluation of results were conducted. Also,
as part of the situational diagnosis, the structure of the community pharmacies was
assessed to support the interventions to be drawn in subsequent steps.
Assessment of the Community Pharmacies Structure
Assessment of material resources: the infrastructure of the pharmacies were assessed
using an instrument developed by the researchers according to RDC number 44/2009
97
from “Agência Nacional de Vigilância Sanitária” – ANVISA (Brazilian Health
Surveillance Agency). The evaluation was taken in March, 2012 and April, 2013, by
three different researchers. The instrument contains 48 questions: 19 related to physical
structure (location, architectural project, cleaning, lighting, ventilation, water quality,
presence of bathroom, refectory and private room to pharmacy services), eight related to
human resources (the use of uniforms, presence of individual protection equipment,
educational training, written assignments from each employee, maintenance of
employee’s training records), 14 related to commerce and dispensing of pharmaceutical
products (cleaning and organization of the area, documentation, product’s quality
assurance, presence of standard operating procedures for quality and safety aspects) and
seven regarding to pharmaceutical services (appropriate devices and supplies to measure
biological parameters and records of its calibration and maintenance, an updated list of
public health establishments nearby, use of self-monitoring blood glucose device to
measure capillary blood glucose and appropriate standard operating procedures
describing the device’s operation, techniques, use and discharge of individual protection
equipment and biological reference values).
Simulated Patient Method: the pharmacist’s competencies for clinical pharmacy
services were assessed by the Simulated Patient Method (Santos et al. 2013) in March,
2012 and April, 2013. Two researchers had specific training through a
theoretical/practical workshop on how to act during the simulations and how to assess
the counselling process in a structured way. The standard scripts used a patient (passive
role), who asked for emergency contraceptive pills, and an active patient who asked for
an anthelmintic drug to her 11 year-old daughter. Each procedure was video-recorded
98
and later assessed by three independent researchers according to the instrument
proposed by Berger et al. (Berger, Eickhoff, and Schulz 2005) and translated into
Portuguese and validated by Mesquita et al.(Mesquita, A. R. Santos, E. A. Porto, J. G.
Barros, I. M. Lyra Jr 2012). The instrument is composed of 23 structured items
designed to assess the quality of pharmaceutical counseling, including communication
skills. Questionnaire questions related to the content of information provided, include
items related to self-diagnosis, the medicine selection process, non-pharmacological
recommendations, etc. Each item was evaluated according to the pharmacist’s
performance in the interaction with the simulated patient measured on two types of
scale, a dichotomic scale (yes/no) or a 5-point Likert type scale (1 = very poor, 2 =
poor, 3 = regular, 4 = good, 5 = excellent).
Ethical issues
Approval for this study was granted by the Sergipe Federal University Hospital Ethics
Committee (CAAE: 12639613.0.00000.5546).
Data analyses
Responses were coded and entered into the WHO Word Processing Database and
Statistics Program for Public Health Epi Info, version 3.0, software package and
Biostat, version 5.0 for descriptive statistical analysis. Performance difference estimates
of pharmacists in attendance of simulated patients as ordinal variables were assessed
using the Wilcoxon-Mann-Whitney test. As well as, associations, nominal variables,
were mainly analyzed by Fisher exact tests. All tests were considered to be statistically
significant, if probability (p) was less than 0.05. The results are presented as frequencies
and percentages.
99
Results
Assessment of the Community Pharmacies Structure
Assessment of material resources: From the 19 physical structure items, six (06/19)
were considered inappropriate in all three community pharmacies in 2012. After the
interventions the appropriateness increased, and 16 items (16/19) met the quality
criteria, including location, architectural project, private office to deliver clinical
pharmacy services and cleaning/ sanitization issues. Among the items considered
inadequate, three were associated to individualized clinical pharmacy services (lack of
appropriate furniture and absence of sink in the pharmacist’s office) (see table 1).
Regarding human resources issues, five items (5/8) don´t satisfied the quality criteria in
all pharmacies, in the first evaluation (table 1). After the interventions in 2012, just
three items were not improved, however, there was improvement in employee
identification and use of appropriate uniforms; assignments and responsibilities
described in the Manual of Good Pharmaceutical Practices; and trained personnel. But,
none of the pharmacies keep employees training records, even after the intervention (see
table 1).
Relating to the commerce and dispensing of pharmaceutical products, nine issues
(9/14), satisfied the quality criteria in all pharmacies (cleaning and organization of the
area, documentation, product’s quality assurance and presence of standard operating
procedures for specific commerce and dispensing aspects), and one item was not
applicable to reality pharmacies. After the interventions, four items got improved in at
least one pharmacy, so in the second assessment 12 out of 14 items were in accordance
with the regulation, in all three pharmacies (see table 1).
100
About the clinical pharmacy services, in both evaluations all pharmacies had
appropriate devices and supplies to measure patients biochemical and physiological
parameters, as well as they kept the records of its calibration and maintenance.
However, none pharmacy had an updated list of public healthcare establishments nearby
nor standard operating procedures for use and discharge of individual protection
equipment used to measure biological parameters. The improvement of quality occurred
in two items relating to the use of self-monitoring device to measure capillary blood
glucose and appropriate standard operating procedures describing the device’s
operation, techniques, physiological and biochemical reference values (see table 1).
Interventions related to material resources (2012 – 2014)
After the evaluation visit of infrastructure, reports containing the observed non-
conformities have been prepared. Regarding the physical infrastructure items, issues as
an area for sanitary materials, walls with moisture, delays in sanitation program were
adequated immediately. However, the infrastructure for provision of clinical pharmacy
services could only be completely adequate after the assessment of 2013, as some
materials such as disposable towel and trash and with foot pedal and lid were ordered in
advance, but if an institution of tartar public requests were subject to bidding.
Some inadequacies were observed in items that refer to human resources. Given the
inadequacies of uniforms, both employees of pharmaceutical, was reinforced the
requirement of uniforms and strokes was a professional recognition plan pharmacist.
Within this plan, to broaden the dissemination of services, the pharmaceutical image
was worked, so it was requested that all pharmacists would use different clothes from
other pharmacy staff, as recommended by the standards established in all units of the
program. Thus the patient could relate that professional as team leader and the provider
101
of that environment. Regarding the Good Pharmacy Practice Manual, the pharmacists
were instructed not only to print and leave it in a visible place, but make a presentation
to the staff with the main procedures in this document. Also in relation to operational
procedures, all Standard Operating Procedure were reviewed as well as new Standard
Operating Procedure s were developed for new clinical pharmacy services procedures
(dispensation, medication review, measurement of clinical parameters, medication
therapy management).
With regard to courses and training of employees there was up the habit of writing
them, and the researchers proposed that all training interventions within the pharmacies
must be approved at the meeting of collegiate and one provided in the minutes. In
addition, between the years 2012 and 2014, researchers in partnership with the
coordination of pharmacies institutionalized the annual employee training, an event that
brings together staff from the three pharmacies to share the results with the clinical
pharmacy services and strengthen the standard operating procedures of the activities
carried the units.
Interventions were also performed on the four items that showed irregularities in the
years 2012 and 2013 in Commerce and product’s dispensing field. Humidity on the
walls once again involved in a disagreement. It is noteworthy that the infiltration
problems are always solved immediately. However, it is recurrent because the building
of the three pharmacies is rented, so some issues are under the responsibility of the
owner and so major structural changes are unfeasible.
About the clinical pharmacy services provision, the items required in pharmaceutical
services field could only be fully corrected during the year 2013. Currently, pharmacists
have the contacts of the main health centers in the region. This problem was solved
102
during that the clinical pharmacy services were expanding and increasingly were
brought up with other health professionals, or for referral of patients or to trace the
patient's plan of care in partnership with physicians. In the first evaluation pharmacies
did not have the clinical pharmacy services, but during that year, the service began and
was consolidated in the following years. So, in the face of lack of Standard Operating
Procedure to these services, the pharmacists and the researchers developed two new
Standard Operating Procedure: measurement of blood pressure and capillary blood
glucose. Although there is no specific recommendations in the Brazilian Regulation
about a pharmacist private office or an exclusive area to provide dispensation services,
researchers have adapted the pharmacy layout to improve the dispensation and make it
more private for the patient, as can be shown in Figure 1.
Figure 1. Registration of Change of structured area of the Dispensation (Before and After)
in 2012.
Simulated Patient Method: In March, 2012, five pharmacists were evaluated on their
skills to provide clinical pharmacy services. After the interventions, six participated in
the evaluation, including two new pharmacists hired in January, 2013. The assessments
are described in Tables 2 and 3.
103
Both in 2012 as in 2013, all pharmacists gave information concerning the treatment, and
highlighted aspects of the medication use. But none gave information about what must
be done if the patient forgets to take the medicine in both assessments. In 2012 no
pharmacist provided written information, and after the intervention just one did it.
The difference and association between the pharmacist’s performances were statistically
significant just for two of the items analyzed: in 2012 pharmacists provided more
information about the dosage on the active patient scenario; but in 2013, they gave more
information about therapeutic options to the passive patient.
Although there was no statistically significant difference and association on the other
items, it was observed that in 2012 all pharmacists asked who would use the medication
and advised about non-pharmacological approaches in the active patient scenario, while
with the passive patient only 60% (3/5) did these interventions. On the other hand, only
40% (2/5) of the pharmacists checked if the passive patient had understood the
information given, but none did it with the active patient. Regarding the variable
knowledge and professional skills of the pharmacist, it was considered regular (3.40 ±
0.54) in the passive patient scenario and good (4.00 ± 0.70) to the active one. In 2013,
83% (5/6) of pharmacists questioned the active patient on patient-specific information
(such as age, pregnancy and disease), but only 33% (2/6) of them made it for the
passive patient. Regarding the checking of information given to patients, as occurred in
2012, pharmacists were more careful with the passive patient, all of them verified if she
had understood the information given, but only 50% (3/6) did it with the active one
(table 2).
The passive patient scenario in 2012 revealed that, 3 (3/5) pharmacists asked the patient
if additional information was necessary and only 2 (2/5) of them checked if the patient
104
had understood the information given. In 2013, all pharmacists did both interventions.
But, regarding the variables knowledge and professional skills of the pharmacist and
overall impression of counseling, the results of 2012 were slightly higher (3.40 ± 0.54
for both variables) than those from 2013 (3 ± 1.26 and 3 ± 0.89 respectively). When the
active patient scenario was considered, in 2012 none of the pharmacists checked the
patient’s understanding nor provided written information during the orientation, while
in 2013, 50% (3/6) checked the information given and one provided written
information. As occurred in the passive patient scenario, the results of the variables
knowledge and professional skills of the pharmacist and overall impression of
counseling assessed in 2012 were higher (4.00 ± 0.70 and 3.80 ± 0.44, respectively)
than those from 2013 (3.00 ± 1.26 and 3.00 ± 0.89 respectively) (table 3).
Interventions for improvement in quality of care (2012-2014)
Training: between April and May, 2012, the pharmacists participated in an Educational
Training Program developed by the researchers to improve competencies used in the
delivery of clinical pharmacy services. The topics were chosen according to the results
of the simulated patient activity. The Program offered 60 hours of training divided in 5
modules: (1) communication skills (8h), (2) drug administration (4h), (3) pharmacist
management of minor illness (4h), (4) bases of clinical pharmacy services (16h), (5)
process of clinical pharmacy services (32h). Lectures, workshops, case studies and
simulations were used in the training process. There was the expansion of activities,
being that, Educational Training Program was expanded, totaling 140 hours during
2013 and 2014.
Coaching sessions: from May to September, 2012, five Coaching Sessions (40hours)
were conducted in each pharmacy, for motivation and guidance of the professionals in
105
the clinical pharmacy services implementation. The researchers discussed with the
pharmacists the physical structure adjustments necessary to deliver optimal clinical
pharmacy services, in a way that each pharmacist could figure out the most suitable
solutions to the structural problems observed in their establishments during the
infrastructure assessment. They monitored the development of instruments, workflows,
employee work schedules and educational leaflets, participated in clinical case
discussions and conducted one-to-one sessions to improve pharmacist performances.
They also encouraged pharmacists to participate in scientific events and publicize their
experiences and outcomes with the services delivered. Besides the in loco attendance,
an online discussion group was created to share experiences, to answer questions, give
advices and standardize information and references. In the face of gaps that remained
the coaching Sessions was expanded in 2013 occurred in five visits in each pharmacy
and in 2014 eight visits. Thus, each pharmacy received 152 hours during three years.
Pharmacists recruitment: in January, 2013, the researchers actively participated in the
process of finding and hiring the best-qualified candidates to the post of pharmacist.
The recruitment process included analyzing the requirements for the job, attracting
employees, screening and selecting applicants (using an instrument specially developed
for the selection interview) and integrating the new pharmacist to the team. By the end
of the process, two pharmacists were hired to complete the team of two out of three
pharmaceutical establishments. To implement the services in 2014, two new selections
were made.
106
Discussion:
The physical structure of healthcare may allow appropriate construction of professional-
patient relationship. Similarly, contributes to achieving better patient health outcomes,
whether related to the performance of outpatient procedures, obtaining information or
the purchase of products. Thus, appropriate physical structure alone does not guarantee,
but allows the execution of clinical pharmacy services with quality (Mobach 2009).
The study revealed that aspects related to the commerce and dispensing of
pharmaceutical products were considered more appropriated, followed by infrastructure,
clinical pharmacy services and eventually human resources. In this sense, this could be
a reflection of the orientation of Brazilian sanitary inspection to issues related to trade,
conservation and infrastructure of community pharmacies. of bad orientation of
Brazilian sanitary inspection relating to trade, conservation and infrastructure of
community pharmacies (O’Connell et al. 2007; Moullin et al. 2013) and the obligation
to install the pharmacy in accordance with the requirements of legislation for joining the
program (Brasil 2004c).
The clinical pharmacy services are not yet mandatory for Brazilian community
pharmacies and the non-compliance items related to human resources are not considered
health threats to the population in this country, which could also explain these results
(Bastos, Costa, and Castro 2011). Although WHO guidelines recommend since 1994
that pharmacists must provide consumers with counseling about their health and
medication, to get the best treatment outcomes, in Brazil the actions of the pharmacist
are more focused on logistical actions, such as programming, selection, acquisition,
storage and distribution of drugs. For change this old paradigm, the pharmacist needs to
collect and integrate information on the patient's history, clarify the understanding of the
107
patient on the dose and mode of administration, and advise on possible problems related
to drugs in order to provide quality care (World Health Organization 1994).
Another finding was that all areas showed improvement in quality after intervention.
Nevertheless, none of the areas obtained full compliance, an issue to be resolved
because the basic legislation for the assessment tool of material resources establishes the
criteria and minimum conditions for compliance with Good Practices in pharmacies
(Brasil 2009b).
In the present study, the overall impression about the pharmacist’s competencies for
clinical pharmacy services was considered regular in the likert score, result above those
found in the works of Berger et al. in German (Berger, Eickhoff, and Schulz 2005) and
Mesquita et al. in Brazil (Mesquita et al. 2013). Probably the small sample size and the
fact that pharmacists knew about the evaluation can explain this difference.
In relation to the different scenarios, apparently the patient's attitude influenced the care
of the pharmacist. In active patient scenario more information was provided, on the
other hand, the pharmacists checked with more often the comprehension of information
provided to the passive patient. These data reinforce the need of structured questions to
provide adequate information for the rational use of medicines.
In contrast, the evaluation of human resources showed no statistically significant
difference after intervention. This phenomenon can be attributed to the small sample
size, the rotation of pharmacists (which directly influences the result of the
interventions)and the inexperience of them in the clinical pharmacy services provision,
since the pharmacists were recent graduated (less than five years). In addition, studies
have shown that behavioral changes in relation to new responsibilities and practices are
108
complex and the provision of training and other opportunities to acquire knowledge and
skills do not always translate into positive changes in attitudes (Fjortoft 2006; Squires et
al. 2014).
The initial diagnosis allowed the development of strategies to improve the quality of
items that proved inadequate. The assessment of pharmacists indicated the need for a
structured process of care, knowledge about the drug use process and communication
skills. In this sense, the theoretical and practical training was conducted in an attempt to
fill this gap. But the development of knowledge and skills alone were not enough, study
by Kaae and Christensen (Kaae and Christensen 2012) showed that one of the main
reasons that hinder the implementation of clinical pharmacy services, is not a lack of
knowledge or skills, but low self-esteem of pharmacists who do not believe their skills
are sufficient to provide the service. Thus, individual and motivational monitoring was
necessary, using the coaching methodology to ensure that clinical pharmacy services
were implemented. In the study by Perlstein et al., sustainability in the use of guidelines
was possible because of medical staff training, followed by daily rounds by the clinical
coordinator for strengthening the guidelines and resolution of problems that were
hindering the implementation of the guideline (coaching) (Perlstein et al. 2000).
Therefore, the Coaching Session were expanded during 2013 and 2014.
According to Donabedian, the absence or inadequacy of structural aspects may hinder
the good performance of the processes and the consequent achievement of outcomes.
On the other hand, the existence of a great structure does not guarantee adequate
processes and outcomes, so the relationship between structure and outcomes has
limitations when used for quality assessment. However, this is of great importance
when used for planning, design and implementation of health services with quality
109
(Donabedian 1966; Rademakers, Delnoij, and de Boer 2011). Therefore, it is suggested
that the initial diagnosis of the structure should be the first step towards the
implementation of clinical pharmacy services with quality. From the diagnosis is
possible to analyze the needs for improvement and make proper planning for achieving
optimal results.
Although the results of this pilot study are relevant to show the importance of
evaluating the structure and share the intervention strategies on structural problems, this
has some limitations. Factors such as the turnover of the pharmacists, the pharmacists
were newly graduated and the small sample made it impossible that the data from this
study be generalized. To minimize these limitations, a research with a bigger sample
should be conducted in the future.
Conclusion
It was noted that over the years the non-conformities identified by the instrument
developed to evaluate the physical structure were overcome widely. Therefore, the role
of the researchers was critical, as yet had not instituted to review the structure of
pharmacies on a regular basis. Furthermore, it was possible to consolidate interventions
as reformulation and development of SOPs, definition of infrastructure required for
services and promotion of Educational Training Program.
The study also pointed out deficiencies in communication skills with patients and
conducting treatment guidelines. Given this, the training promotion for three years
andthe coaching sessions, enabled personalized interventions for each pharmacist. Thus,
it is recommended that the implementation of clinical pharmacy services studies do not
underestimate the evaluation of structure before and during the step of consolidation of
110
the services, for this one should have on hand tools and techniques that support a
reliable assessment.
111
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Table 1 - Items not presented completeness in the evaluations of years 2012 and 2013 according to Brazilian Regulation.
QUESTIONS - Adapted from RDC 44/2009
PHYSICAL INFRASTRUCTURE
2012 2013
1 2 3 1 2 3
The pharmacies are located, designed and dimensioned with infrastructure compatible with the activit ies to be developed, having at least
areas for administrative activities, receiving and storage of products, dispensing drugs, storage of cleaning and sanitary materials. N Y Y Y Y Y
The facilities have interior surfaces (floors, walls and ceiling) smooth, impervious, in perfect condition, resistant to sanitizers agents and
easily washable. N Y Y Y N Y
It is kept in the establishment, records from the execution of activities related to sanitation program, including rodent and insect controls. Y Y N Y Y Y
Cleaning materials and germicides in stock are legalized by Anvisa, and are stored in specifically designated and identified area. N Y Y Y Y Y
The area for the provision of pharmaceutical services that require individualized care ensures the privacy and comfort of patients, having
dimensions, furniture and infrastructure compatible with the activities and services offered. N N N Y N N
The area for the provision of pharmaceutical services has sink and running water, offers individual and disposable towel, liquid soap,
antibacterial gel and trash with foot pedal and lid. N N N N N N
1 – Pharmacy 1; 2 – Pharmacy 2; 3 – Pharmacy 3; N- Not, Y – Yes.
116
Table 1 – (continuation) Items not presented completeness in the evaluations of years 2012 and 2013 according to Brazlian Regulation.
QUESTIONS 20-27 - Adapted from RDC 44/2009
HUMAN RESOURCES
2012 2013
1 2 3 1 2 3
Employees are identified, with clean uniforms and in good use condition. Y Y N Y Y Y
The uniform or identification used by the pharmacist distinguishes him / her from other employees so that facilitates their identification
by users of the pharmacy. Y N Y Y Y Y
The tasks and individual responsibilities are described in the Good Pharmacy Practice Manual of the establishment and are
understandable to all employees. Y N N Y N Y
All staff is trained regarding the compliance with current sanitary legislation applicable to pharmacies and drugstores, as well as the
Standard Operating Procedures of the establishment. Y N N Y N Y
Records of courses and training of employees are kept and they contain at least the following information: description of the training
activities carried out; date and hours load; course content; trained workers and their signatures; identification and signature of the
professional, team or company who ran the course or training; and results of the evaluation.
N N N N N N
1 – Pharmacy 1; 2 – Pharmacy 2; 3 – Pharmacy 3; N- Not, Y – Yes.
117
Table 1 – (continuation) Items not presented completeness in the evaluations of years 2012 and 2013 according to Brazilian Regulation.
QUESTIONS 28-41 - Adapted from RDC 44/2009
MARKETING AND PRODUCT’S DISPENSING
2012 2013
1 2 3 1 2 3
The area is kept clean, protected from direct action of sunlight, moisture and heat, in order to preserve the identity and chemical,
physical and microbiological integrity, ensuring quality and safety of the products. N Y Y Y N Y
It is defined in Standard Operating Procedure (SOP) the temperature and humidity measuring methods, specifying time range for
measuring, considering the one in which there is most likely to find the highest temperature and humidity of the day. Y N Y Y Y Y
The standard operating procedures define measures to be taken when inadequate conditions are met for storage, considering the
provisions of RDC 44/2009 Resolution. Y N N Y Y Y
The pharmacy policy for products with close expiry date is clear to all employees and described in the Good Pharmacy Practices
Manual of the establishment. Y N N Y N Y
1 – Pharmacy 1; 2 – Pharmacy 2; 3 – Pharmacy 3; N- Not, Y – Yes.
118
Table 1 – (continuation) Items not presented completeness in the evaluations of years 2012 and 2013 according to Brazilian Regulation.
QUESTIONS 42-49 - Adapted from RDC 44/2009
PHARMACEUTICAL SERVICES
2012 2013
1 2 3 1 2 3
The pharmacy keeps an updated list with the identification of health public facilities nearby, containing the indication of address and
telephone number, available to inform the users. N N N N N N
Measurements of biochemical parameters of capillary blood glucose are carried out through self-test equipment. NA NA NA Y NA Y
The standard operating procedures related to the measurement of physiological and biochemical parameters clearly indicate the
equipment and the techniques or methods used, interpretation of results and bibliographical references. N N N N Y Y
The standard operating procedure includes the personal protective equipment to be used for the measurement of physiological and
biochemical parameters, as well as provides guidance on its use and disposal. N N N N N N
1 – Pharmacy 1; 2 – Pharmacy 2; 3 – Pharmacy 3; N- Not, Y – Yes.
119
Table 2 - Distribution of pharmacotherapeutic recommendations and pharmacists’ communication skills during the interactions with simulated patients in 2012-2013
according to “Assesment of the Counseling Process” instrument.
AP: active patient; PP: passive patient; * = P value < 0.05; P value1 = AP x PP group in 2012, P value
2 = AP x PP group in 2013; P value
3 = into AP group; P value
4
= into PP group; **All tables have zero marginals. The software cannot perform exact calculations.
Content of information provided
2012
(n = 5) P value1
2013
(n = 6) P value1 P value
2 P value
3
AP PP AP PP
The pharmacist provides information only when asked 5 5 ** 6 6 ** ** **
The pharmacist asked to whom the medicine was being dispensed 5 3 0.50 5 5 0.77 0.77 0.50
The pharmacist asked if other drugs were being used 1 1 0.77 0 2 0.23 0.50 0.50
The pharmacist asked specific information about the patient 3 0 0.09 5 2 0.12 0.27 0.23
Information about the following items was provided: - - - -
a) Indication 4 3 0.50 3 4 0.50 0.50 0.50
b) Pharmaceutical dosage form 5 4 0.23 6 5 0.50 ** 0.50
c) Dosage 4 0 0.03* 3 0 0.09 0.50 **
d) Method for drug administration 4 4 0.73 3 4 0.50 0.50 0.73
e) Drug administration times 5 5 0.77 2 3 0.50 0.12 0.27
f) Contraindications 0 0 ** 0 1 0.50 ** 0.50
g) Drug interactions 1 0 0.50 1 0 0.50 0.77 **
120
Table 2 – (continuation) Distribution of pharmacotherapeutic recommendations and pharmacists’ communication skills during the interactions with simulated
patients in 2012-2013 according to “Assesment of the Counseling Process” instrument.
AP: active patient; PP: passive patient; * = P value < 0.05; P value1
= AP x PP group in 2012 and 2013; P value2 = into AP group; P value
3 = into PP group;
**All tables have zero marginals. The software cannot perform exact calculations.
Content of information provided
2012
(n = 5) P value1
2013
(n = 6) P value1 P value
2 P value
3
AP PP AP PP
Information about the following items was provided: - - - - - - --
h) Adverse drug reactions 2 2 0.73 1 2 0.50 0.50 0.73
i) Treatment adherence 0 1 0.50 3 3 0.72 0.09 0.27
j) What must be done if the patient forgets to take the medicine 0 0 ** 0 0 ** ** **
k) Storing medicine safely 0 0 0.50 1 1 0.77 0.50 0.77
l) Therapeutic options 0 3 0.09 0 4 0.03* ** 0.50
The pharmacist asked the patient if additional information was required 2 3 0.50 3 6 0.09 0.72 0.23
Non-drug therapy interventions were mentioned 5 3 0.27 3 3 0.72 0.27 0.72
121
Table 2 – (continuation) Distribution of pharmacotherapeutic recommendations and pharmacists’ communication skills during the interactions with simulated
patients in 2012-2013 according to “Assesment of the Counseling Process” instrument.
AP: active patient; PP: passive patient; * = P value < 0.05; P value1
= AP x PP group in 2012 and 2013; P value2 = into AP group; P value
2 = into PP group; **All tables
have zero marginals. The software cannot perform exact calculations.
Communication skills 2012
(n = 5) P value1
2013
(n = 6) P value2 P value
3 P value
4
AP PP AP PP
The pharmacist spent enough time with the patient 1 1 0.77 4 1 0.12 0.12 0.77
The pharmacist checked the patient’s understanding 0 2 0.27 3 6 0.09 0.27 0.09
Written information was provided during the orientation - - ** - - 0.77 0.50 0.50
a) patient information/brochures 0 0 ** 0 0 ** ** **
b) individual information (computer printout) 0 0 ** 1 1 0.77 0.50 0.50
c) sticker/remark on the package 0 0 ** 0 0 ** ** **
The pharmacist’s indication in case of doubt - - 0.27 - - 0.27 0.77 0.72
a) Visiting physician services 0 0 ** 0 1 0.50 ** 0.50
b) Returning to pharmacy services 4 2 0.12 5 3 0.27 0.77 0.50
c) Looking for the pharmacist (name and phone number) 0 1 0.50 3 1 0.27 0.09 0.77
122
Table 3 - Average performance (±SD) of pharmacotherapeutic recommendations and pharmacists’ communication skills during the interactions with simulated patients in
2012-2013 according to “Assesment of the Counseling Process” instrument.
AP: active patient; PP: passive patient; * = P value < 0.05; P value1 = AP x PP group in 2012, P value
2 = AP x PP group in 2013; P value
3 = into AP group; P value
4 = into PP
group
Questions about content of information provided
and communication skills
2012
(n = 5) P value1
2013
(n = 6) P value2 P value
3 P value
4
AP PP AP PP
Overall impression of knowledge and professional skills
of the pharmacist 4.0±0.70 3.4±0.54 0.07 3.0±1.26 3.0±1.26 0.89 0.92 0.35
Evaluation of the following details of the conversation: - - - -
a) Receptivity 3.4±0.54 3.6±0.54 0.18 3.16±1.47 3.33±1.36 0.83 0.65 0.65
b) Eye contact 3.8±0.83 3.8±0.83 1 4.0±0.89 4.16±0.98 0.79 0.60 0.42
c) Interest (attention) 4.2±0.44 4.4±0.89 1 3.66±1.50 3.66±1.21 0.72 0.59 0.47
d) Involvement 3.6±0.89 4.0±0.70 0.59 4.0±0.89 3.33±1.21 0.35 0.50 0.27
e) Farewell message 3.2±0.83 3.2±0.44 1 4.0±1.26 3.5±1.76 0.58 0.59 0.47
f) Availability 4.0±0.20 4.6±0.54 0.79 4.33±1.21 3.5±1.76 0.47 0.47 0.29
g) Overall impression about the non-verbal
communication
3.2±1.09 3.6±0.54 0.42 3.66±1.03 3.5±1.04 1 1 1
123
Table 3 – (continuation) Average performance (±SD) of pharmacotherapeutic recommendations and pharmacists’ communication skills during the interactions with simulated
patients in 2012-2013 according to “Assesment of the Counseling Process” instrument.
AP: active patient; PP: passive patient; * = P value < 0.05; P value1 = AP x PP group in 2012, P value
2 = AP x PP group in 2013; P value
3 = into AP group; P value
4 =
into PP group
Questions about content of information provided
and communication skills
2012
(n = 5) P value1
2013
(n = 6) P value2 P value
3 P value
4
AP PP AP PP
Evaluation of the comprehensibility of the
counselling: - - - -
a) Logical sequence of the orientation 3.4±0.54 3.8±0.44 0.59 3.16±1.22 2.66±1.36 0.42 0.47 0.11
b) Emphasis on important aspects 3.6±0.54 4.0±0.70 0.36 2.66±1.36 2.66±1.21 1 0.40 0.11
c) Use of terms appropriate to the patient’s
understanding 3.4±0.89 3.6±0.89 0.32 3.5±0.86 3.33±1.03 0.72 0.72 0.59
d) Length of phrases (long phrases may compromise
understanding) 3.6±0.54 3.6±0.89 1 4.33±0.81 4.0±0.63 0.58 0.18 0.18
e) Use of open-ended questions that allow the patient
to speak 2.8±0.83 3.0±1.22 0.86 3.5±1.37 3.16±1.16 0.72 0.42 1
Overall impression of counseling 3.8±0.44 3.4±0.54 0.18 3.33±1.03 3.0±0.89 0.58 0.18 0.50
124
CAPÍTULO III
X
X
125
4.3 CAPÍTULO III: ESTABLISHMENT, IMPLEMENTATION, AND
CONSOLIDATION OF CLINICAL PHARMACY SERVICES IN COMMUNITY
PHARMACIES: PERCEPTIONS OF A GROUP OF PHARMACISTS
Aline S. Dosea, BPharm, M.Sc. Student, a Giselle de C. Brito, BPharm, MSc, Ph.D.
Student, a,b
Lincoln Marques Cavalcante Santos, Pharmacy Studant, a Tatiane C.
Marques, BPharm, MSc, Ph.D. Student,a Blície Balisa-Rocha, BPharm, MSc, Ph.D.,
c
Deborah Pimentel M.D., MSc, Ph.D.,d Denise Bueno BPharm, MSc, Ph.D.,
e Divaldo P.
Lyra Jr., BPharm, MSc, Ph.Da
aTeaching and Research Laboratory, Social Pharmacy, Department of Pharmacy,
Federal University of Sergipe, LEPFS-UFS, s/n, Avenida Marechal Rondon, Jardim
Rosa Elze, São Cristóvão, Brazil
b Department of Pharmacy, Federal University of Sergipe, Health Campus, Lagarto,
Brazil
c Pharmacy Course, Faculty of Guanambi, Guanambi, Brazil.
d Department of Medicine, Federal University of Sergipe, São Cristóvão, Brazil
e Pharmacy Faculty, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
Corresponding author: Divaldo P. Lyra, Jr.
E-mail address: [email protected]
126
Abstract
Background: In community pharmacies, when pharmacists incorporate clinical practice
into their routine there are several barriers and facilitators influencing the
implementation of patient care services. Knowing the perceptions of pharmacists who
promotes the clinical pharmacy services can help improve the quality of implementation
of services as well as valorize the role of the pharmacist in providing patient care.
Objectives: To know and understand the perception of a group of pharmacists who were
working in three units of the Farmácia Popular do Brasil program on the establishment,
implementation, and consolidation of clinical pharmacy services. Material and
Methods: This was a longitudinal and observational qualitative study using focus
groups. Data were analyzed using content analysis. Results: The recording of the focus
groups generated more than 210 minutes of audio that was fully transcribed and
analyzed. The perception of the pharmacists about the Farmácia Popular do Brasil
program was that it facilitates access to healthcare and medication. In addition, the
pharmacists characterized the Farmácia Popular do Brasil program as establishing an
environment with less pressure on pharmacists to make sales. In general, the
pharmacists thought that the Farmácia Popular do Brasil program pharmacies were
better than most pharmacies, and that this model brought the pharmacists using it
greater satisfaction than other approaches. However, several barriers to using the service
emerged. The distance between neighboring cities made it difficult for patients to return
for services. In addition, patients were not accustomed to identifying pharmacies as
healthcare establishments. Lack of training of staff, which created a lack of
communication skills and knowledge, presented another issue. The pharmacists
expressed their expectations to have increased technical support, skills development
opportunities, and monitoring of researchers who assess the progress of the service.
Pharmacists overcame many of their insecurities in 2014 and felt more proactive and
committed to quality service. They began to reach their goals for patients, and they
gained more visibility. Consequently, the pharmacists feel that they have gained further
experience and professional enhancement.Conclusion: The dissemination of positive
experiences in services implementations through perception studies have shown that it
is possible to develop a model of clinical services in community pharmacies.
Keywords: Clinical Pharmacy Services, Community Pharmacy, Pharmacist Perception,
Implementation of healthcare services
127
INTRODUCTION
In recent years, advances in health technologies and new social demands for
specialized services have resulted in changes in pharmacy services.1,2,3
Within this
context, pharmacists have been included into health teams that guide their actions for
the promotion of services focused on the patient. Pharmacists thus have been
encouraged to become co-responsible for health outcomes and improved quality of life
for patients.4,5,6
At the time the pharmacists began incorporating their clinical practices into
community pharmacies, several barriers and facilitators were influencing the
implementation of patient care services.7 Studies showed that barriers to implementation
included low professional remuneration and lack of investment in the infrastructure for
pharmacies.8,9,10
On the other hand, it is possible to observe facilitators as patient
satisfaction with the service and the support of researchers for the improvement and
maintenance of practice.11,12,13
In this context, knowing perceptions of the pharmacists who promote the clinical
pharmacy services can help improve the quality and implementation of services and
valorize the role of the pharmacist in providing patient care. Therefore, it is possible to
reveal from interviews with those working in pharmacy practices what issues there are
about structuring services and the work processes and what professional skills are
necessary for their success.14,15,11
Most studies related to this theme are linked to the perceptions and experiences
of patients using medication and healthcare professionals involved in the services
provided by the pharmacists.16,17,18,19,20,21
However, this practice is still new in Brazil,
and there are few studies on understanding the implementation of clinical pharmacy
services from the perspective of the pharmacists themselves.22,23,24
This study aims to
128
know and understand the perception of a group of pharmacists immersed in experiences
involving the establishment, implementation, and consolidation of clinical pharmacy
services in community pharmacies.
METHODS
This study has a methodology of collecting data on the understanding and
interpretation of the phenomena under investigation without judgment. Since the
collected data would not be measurable nor could hypotheses or causal relationships
between facts be formulated, we chose a qualitative research study approach, which
seeks to explain relationships, values, attitudes, beliefs, and habits.25,26
The setting of this study was composed of three units of the Farmácia Popular do
Brasil program. This program is a pharmacy network created by the government to sell
medications at subsidized prices and to facilitate the population's access to them.27
These units of the Farmácia Popular do Brasil program are located in three cities in the
northeast. They are managed by a health foundation that established a partnership with
researchers who are interested in initiating a project to develop a model of clinical
pharmacy services in community pharmacies. For three years, these researchers have
developed projects to set up and evaluate the establishment, implementation, and
consolidation of pharmacy services.
The pharmacists received advanced training in order to provide quality clinical
services to their new patient load. The study sample consisted of 11 pharmacists who
were working in three units of the Farmácia Popular do Brasil program. The data were
obtained over the course of three focus groups. For this study there are a convenience
sample because the interest is only for person who had a significant relationship with
establishment, implementation and consolidation of clinical pharmacy services.
129
Following the recommendations of the consolidated criteria for reporting
qualitative research (COREQ)28
, focus groups were conducted in a distinct setting of the
workplace in order to minimize possible interference. All pharmacists signed a consent
form that included permission to use video recording and data from the focus groups.
This study was part of the PhD project of researcher Giselle de C. Brito and was
approved by the Ethics Committee of the Federal University of Sergipe, CAAE number:
12639613.0.0000.5546.
Development of scripts
The scripts for the discussion groups were prepared by the researchers involved
in the project. The pharmacists addressed the lived experiences in three stages of the
project: in March 2012, at the beginning of establishing the project; March 2013, during
implementation; and March 2014 during the consolidation of clinical pharmacy
services. Interview questions addressed the perceptions of the pharmacists on the
Farmácia Popular do Brasil program model; the effects on patients because of
receiving services; barriers and facilitators of establishing, implementation and
consolidation of the program; and other factors related to patients, practice, training and
the changes generated during the process.
The interview questions were open and driven by a moderator who had the role
of stimulating an exchange of opinions and maintaining the focus of the discussion.
Groups were conducted for a maximum duration of two hours, and the discussions were
videotaped and later transcribed for analysis.
130
Analysis
Data were analyzed using content analysis29
in which the reports are organized
and systematized into categories and registration units. Two researchers (A.S.D. and
G.C.B.) independently analyzed the focus groups. In cases of disagreement, a third
investigator (D.B.) was also used. This reviewer also suggested improvement in
categorizations that have been accepted by consensus of three reviewers (A.S.D. and
G.C.B. and D.B.). Subsequently, a careful review by a senior evaluator was performed
(D.P.). After the definition of categories was performed a critical analysis of the three
focus groups.
RESULTS AND DISCUSSION
In the present study there was no withdrawal or refusal of any pharmacist invited
to participate in focus groups. The recording of the focus groups generated more than
210 minutes of fully transcribed audio. Subsequently, the material was organized and
analyzed in order to make it functional. This material generated 102 text clippings that
contained references to the topics of discussion. These text clippings were grouped by
similarities, and categories were formed according to the registration units. Table 1
presents the results of the focus groups.
131
Table 1: Pharmacist perceptions during the beginning of establishment (2012), implementation (2013) and consolidation (2014) of clinical pharmacy services.
CATEGORIES REGISTRATION UNITS
Beginning of establishment
in 2012
During implementation
in 2013
Consolidation
in 2014
Facilitating access Access to pharmacist
Access to medication
Lack of pressure for sales
Ideal physical structure of pharmacy
Access to pharmacist
Access to medication
Lack of pressure for sales
Access to clinical service
Not reported
132
Table 1 (continuation): Pharmacist perception during the phases at the beginning of establishment (2012), implementation (2013) and consolidation (2014) of
clinical pharmacy services.
CATEGORIES REGISTRATION UNITS
Beginning of establishment
in 2012
During implementation
in 2013
Consolidation
in 2014
Barriers Distance from neighboring cities
Lack of physicians in the city
Difficulty in recruiting patients/creating demand
Difficulties in the provision of pharmaceutical services, need of
capacitation of pharmacists
Negative influence of paternalistic relationship between physician and
patient
Lack of recognition of the pharmacist by the population
Failures in human resources
Dichotomy between theory and practice
Bureaucracy in services
Professional insecurity for lack of
skills
Consolidation Barriers:
Problems in the structure
Human resources issues
Increased serviced
Overdue barriers:
Practice of clinical services
Communication skills
133
Table 1 (continuation): Pharmacist perception during the phases at the beginning of establishment (2012), during implementation (2013) and consolidation (2014)
of clinical pharmacy services.
CATEGORIES REGISTRATION UNITS
Beginning of establishing
in 2012
During implementation
in 2013
Consolidation
in 2014
Pharmacist
Expectations
Technical support
Partnering with physicians to increase the number of
patients
Ability to generate outcomes for patients
Professional self-confidence
Idealization of service
Enhancement and professional achievement
Doing excellence /reference service
Maintenance of training and technical
support
More professional accomplishments
Expansion of services
Maintenance of technical support
Changes generated in
implementation
Not Reported Improvement of service
Technical support
Overcoming of insecurities
Professional enhancement
Positive results for patients
Technical support
Professional enhancement
Service excellence implemented
Positive results for patients
134
Facilitating access
It was the general opinion of the pharmacists that the Farmácia Popular do
Brasil program greatly facilitated the public’s access to professional help and
medication. They felt that the fact that the government provided drugs at low cost and
that the environment allowed pharmacists to be more available to provide guidance for
patients. The results from this survey emphasize the importance of performing actions
to reduce barriers to medication access to increase adherence to treatment.30,31
Besides promoting greater access to medication, the Farmácia Popular do Brasil
program facilitates the visibility of clinical pharmacy services and pharmaceutical care
that provides comfort and privacy for patients.27,32
This factor has been reported as an
essential factor in building a trust relationship between the pharmacist and patients.
Lack of this type of structure was cited as a recurring problem for community
pharmacies.33-36
In addition, pharmacists saw the program as an environment in which there was
less pressure to make sales; therefore, it was considered a better model for work with
better job satisfaction. This perception corresponds with studies showing that pressures
on the business side of healthcare can cause a lack of patient confidence in the
information provided by the pharmacist and frustration and tension in the pharmacy
professional due to lack of job autonomy.37,38
As one pharmacist noted:
"The pharmacy has a room for pharmaceutical care that allows patient privacy
(...) When you arrive at the service you are seen as a human."
135
Barriers to implementation
Several barriers emerged during the years of implementation of services;
however, over time the majority of problems were overcome. For example, the distance
between cities and the lack of physicians to evaluate clinic conditions presented
difficulties for the development of clinical pharmacy services. Previous researchers
have approached the same problems, in which besides lack of support from physicians
there were also discordances with pharmacist interventions.39,40
This points to the
importance of multidisciplinary monitoring.
Another issue that arose during patient recruitment was that the patients were
not accustomed to identifying pharmacies as healthcare establishments. Faced with
similar problems, several researchers developed strategies for engaging patients, such as
communicating with potential patients about the service benefits.11,35,41
In addition, the
approach of some physicians was exerting a negative influence on patient recruitment to
pharmaceutical services, because patients emphasized that the physician was the only
healthcare provider that should have knowledge and power over clinical decisions.
According to one pharmacist:
"She (the patient) said, 'but the doctor knows more than the pharmacist.’"
Study participants reported service delivery problems due to failures in academic
training and lack of clinical skills. This issue reinforces the need for training and
continuing education for pharmacists.36,42,43
By 2014, many of the barriers to service
were overcome, the performance of clinical pharmacy services had significantly
improved, and pharmacists felt better about the consolidation of services.
136
In Brazil, there is still no law regulating the presence of a qualified pharmacy
staff in community pharmacies.44
Therefore, one factor that also caused problems in the
past was the lack of knowledge and technical training of staff. This failure demanded
time of pharmacists who organized staff training activities and continuing professional
development to avoid problems on the pharmacy.
In 2013, the bureaucracy found in the community health services was considered
to be a barrier that drove away patients and slowed down service delivery. This was due
the necessary documents for the purchase of medicines, however this is a measure of the
program that ensures the control of drug sales. In addition, pharmacists felt insecure
about the provision of clinical services and by the lack of sources of information to
improve care. This brought on feelings of shame, fear, and frustration. One pharmacist
said:
"Sometimes I feel weak. There are some skills that I still could not develop,
especially communication."
Regarding, increased service demand being a barrier:
“If we increase the amount of care service, we have to see how a new routine
(...) is a difficulty, is a new requirement, by the amount of care service that lie ahead."
In 2014, barriers such as lack of clinical skills were overcome and the
performance of clinical pharmacy services improved significantly, what proves that the
support of researchers helped to decrease the dichotomy between theory and practice
and professional insecurity for lack of skills.
137
Expectations and changes generated on implementation
Pharmacist expectations were linked to their idealization of the community
pharmacy service and what would be required for a successful first year of practice.
They expected to have technical support to develop skills and acquire knowledge. They
also wanted to have monitoring by researchers who could assess the progress of the
service. Likewise, in the literature it shows that pharmacists expect more training about
management issues, specific diseases, and approaches to the implementation of services.
Professional pharmacy education at the undergraduate level does not offer that
kind of expertise.45,42,46
For this reason, several studies like ours have advocated
investing in technical support with training, because this strategy will bring about
improvement to the practice of the pharmacist. Furthermore, the pharmacist can become
safer and more self-confident about the provision of clinical services in community
pharmacies and other primary care environments.47-51
In 2012, a pharmacist commented:
"We need to know we have the support of you (researchers) to clarify and
facilitate information for us."
In 2013, another pharmacist said:
"The expectation is to have to be a reference and have professional development,
which is the true pursuit of excellence."
Others commented:
"I think in that year (2014) I need to improve myself, always doing better." and
138
"The coordination support is 100% for me, (it) is very good (...) When I joined, I did not
know how to dispense medications like I dispense today. I did not know how to take
care of patients like I take care of them today."
After the first year of establishing of services, in 2013 the three pharmacies were
able to maintain the same level of evolution of practice, but the pharmacists also hoped
that by partnering with physicians they would increase the number of patient referrals to
clinical pharmacy services. According to studies on the issue, this partnership
sometimes does not happen because of resistance from other healthcare professionals
regarding pharmaceutical interventions or because of fear of approaching physicians on
the part of pharmacists.52,53
Consequently, patient management can become more
difficult and the therapeutic outcomes can become diminished. Therefore, strategies for
fostering good communication, trust, and respect between physicians and pharmacists
are recommended to improve collaboration between these professionals.54,55
During implementation of the program, the pharmacists also had ideas about
improving medication compliance and quality of life for patients who used their
services. These goals, generated increased visibility and recognition by the local
population of the community pharmacy services in the same manner as in Bradley et al.
(2012).
The service received increased appreciation from physicians after the positive
results were achieved by pharmacist intervention regarding drug interactions.56
In this
sense, the improved pharmaceutical services also make patients feel grateful for the
improvement in the understanding they have of their medications.49
The results of the
study showed that clinical pharmacy services bring benefits not only for patients, but
also for the motivation and productivity of pharmacists. As one pharmacist noted:
139
"We're getting to be a reference of healthcare facilities (...) I have seen an
evolution in 2013, and in 2014. I think it worked because (of) patient outcomes." and "If
(we) reduced the quality of services, patients will gonna miss! Because today the
pharmacy has this characteristic, there are people who will go there only for services. "
In 2014, healthcare services were consolidated. Pharmacists had become self-
critical and more independent from technical support. They incorporated practice
routines that gave a sense of professionalism to clinical services. By this time, they had
become different professionals, capable of transforming the reality of their patient
population to being motivated, accomplished, and valued:
"(The service) worked, but lacks the magnification, we need (to) disclose more
(...) want to recruit more patients (...) (and) attain and exceed the target that was
(achieved) last year. "
"I'm performed, I feel that I am important and I can change reality."
"Privilege, transformation, enhancement, experience (...) everyone is beginning
to know our role."
"We feel that we are actually exerting our function to society."
LIMITATIONS
Because of employee turnover, all pharmacists do not have the same level of
training. Although these results may elucidate some of the issues at hand, they are based
only on self-reported data from the participants, so they may not be generalizable to
other pharmacy settings.
140
CONCLUSION
Knowing the perceptions of pharmacists was essential to understanding how it
was possible to consolidate the clinical pharmacy services in community pharmacies
and understanding the barriers and facilitators influencing the process. The perceptions
of pharmacists can point to strengths, such as access to pharmacies and the importance
of technical support received. It is possible to note a gradual change in the pharmacists’
perceptions over the years, as well as the recognition of overcoming obstacles.
Pharmacists were involved with the Farmácia Popular do Brasil program to
improve the application of clinical services. Based on knowledge of the pharmacists’
perceptions, various interventions for improvement were applied, such as mandating
further training and using the guidance of researchers. Therefore, the study has shown
that it is possible to develop a model of clinical services in community pharmacies.
Acknowledgments
To the pharmacists, Maria Cristiane Trindade de Almeida and Eulália Lins
Victor, coordinators of the Farmácia Popular do Brasil program managed by the
Sergipe State Health Foundation and to the 11 pharmacists who participated in the focus
groups. The financial support for this study was obtained from the Coordination for the
Improvement of Higher Education Personnel (CAPES) and the Foundation for Research
Support of the State of Sergipe (FAPITEC).
141
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CAPÍTULO IV
X
X
149
4.4 CAPÍTULO IV: OVERCOMING BARRIERS TO IMPLEMENT CLINICAL
PHARMACY SERVICES IN COMMUNITY PHARMACIES: A QUALITATIVE
STUDY
Giselle de Carvalho Brito 1,2
, Aline Santana Dosea1, Thays Carneiro Boaventura
1,
Lincoln Marques Cavalcante Santos1, Deborah Pimentel
3, Denise Bueno
4, Divaldo
Pereira de Lyra Jr1§
1 Laboratory of Teaching and Research in Social Pharmacy, LEPFS-UFS, Department
of Pharmacy, Federal University of Sergipe, s/n, Avenida Marechal Rondon, Jardim
Rosa Elze, São Cristóvão, Brazil
2 Department of Pharmacy, Federal University of Sergipe, Health Campus, Lagarto,
Brazil
3 Department of Medicine, Federal University of Sergipe, Aracaju, Brazil
4 Pharmacy Faculty, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
§ Corresponding author
Email addresses:
150
Abstract
Background
During the establishment, implementation, and consolidation processes of clinical
pharmacy services, it is important to understand the barriers and factors that influence
the behavior of health professionals. Therefore, this study aims to elucidate the
pharmacist barriers during the process of establishing, implementing, and consolidating
clinical pharmacy services in community pharmacies and to describe the main strategies
developed by researchers to overcoming such barriers.
Methods
First, we conducted a qualitative study using focus groups with pharmacists in three
units of the "Farmácia Popular of Brazil" Program in the State of Sergipe, Brazil. Each
focus group used a structured questionnaire and was conducted during three different
years (2012, 2013, and 2014). The data were interpreted using "content analysis." The
identified barriers to establishing, implementing, and consolidating clinical pharmacy
services were categorized, and strategies to overcome them were subsequently
developed.
Results
Three focus groups were conducted, which generated more than 210 minutes of audio.
Subsequently, the material was organized, analyzed, and categorized as follows: 1)
barriers to begin establishing services (8 barriers, such as failures in human resources
and lack of pharmacist recognition by the population); 2) barriers to implementation, (2
barriers, bureaucracy in services and professionals’ insecurity about skills); 3) barriers
to consolidation (3 barriers, problems in pharmacy structure, human resources issues,
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and increased service demands). Based on these, interventions were devised, such as the
promotion of services, educational training programs, and coaching in loco.
Conclusions
This study examined pharmacists’ perceptions throughout the stages of development.
Results indicated an improvement in service provision following the application of
effective strategies. Therefore, this study might serve as a foundation for future
implementation strategies for clinical pharmacy services in community pharmacies.
Keywords
Barriers, Healthcare service implementation, Pharmaceutical services, Clinical
pharmacy services, Pharmacists, Community pharmacy, Qualitative analysis,
Pharmacist perception
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Background
In several countries, pharmacy services have improved to ensure greater understanding
of patient care, encompassing preventive actions in primary health care to the
management of chronic diseases [1–5]. In the United Kingdom, for example, clinical
pharmacy services began to be integrated into public healthcare programs, solving drug
therapy problems [6]. However, estimates indicate that 60% of all projects to implement
and promote changes in the quality of services fail, and health care is no different [7, 8].
Studies have pointed out some barriers to the successful deployment of clinical
pharmacy services, such as lack of time [9], shortage of specific training and
communication skills [10], absence of qualified support staff [11], lack of economic
incentive [12], and difficulty in interacting with physicians [13]. Understanding of these
barriers and the factors that influence the behavior of healthcare professional in
response to these barriers might ensure the successful implementation of clinical
pharmacy services [14–17].
According to Mousavi and colleagues (2014) [18], the evaluation of these
barriers may contribute to the strategic planning and intervention models to overcome
them by implementing qualified services. Thus, studies describe three stages of
evaluation: needs, process, and impact [19–23]. Each step requires different and specific
interventions to support the later stages in order to achieve the quality of clinical
pharmacy services.
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Although the literature has identified the barriers in the implementation of
clinical pharmacy services, few studies have explored strategies for overcoming such
difficulties, and research with qualitative methods are still rare [24, 25].
A deeper understanding of contexts from the perceptions of pharmacists
involved may facilitate the development and implementation of best solutions, as well
as help identify poorly known barriers. Thus, a qualitative approach to planning for
implementation can offer insight into the elimination of possible barriers [26–28].
Therefore, the aim of this study is to understand the barriers to pharmacists during the
process of establishing, implementing, and consolidating clinical pharmacy services in
community pharmacies, and to describe the main research-based strategies for
overcoming such barriers.
Methods
Methods/Design
Participants of this qualitative study were pharmacists at three community pharmacies
in State in Northeast of Brazil, and were enrolled in the government program,
“Farmácia Popular do Brasil.”
The studied pharmacies had undergone the establishmet, implementation, and
consolidation of clinical pharmacy services process between 2012 and 2014. Therefore,
focus groups were conducted to assess the perceptions and attitudes of pharmacists at
every stage.
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This study was approved by the Ethics Committee of the Federal University of
Sergipe (CAAE number: 12639613.0.0000.5546).
Characterization of the study setting
The “Farmácia Popular do Brasil” program was created in 2004 for the
purpose of increasing access to and use of pharmacotherapy [29]. Specifically, the
program seeks to improve the use of medicine from the clinical service provision to
promote, protect, and restore health [30–34]. There are more than 500 units throughout
the country: nine are in the State of Sergipe, and three of these are managed by the
Sergipe State Department of Healthcare and constituted the sample in this study. These
units are located in the cities of Estância, Propriá, and Nossa Senhora da Glória, and
serve approximately 537,000 people in rural areas. Each pharmacy has 12 employees, of
which two are pharmacists.
Context of the study
Through a partnership between the Laboratory of Teaching and Research in
Social Pharmacy and the Federal University of Sergipe, the Sergipe State Healthcare
Foundation was established to support researchers in the improvement and maintenance
of coaching pharmacy personnel in standard clinical pharmacy services (dispensation,
capillary blood glucose and blood pressure measurement, medication review, and
medication therapy management). The coaching consisted of situational diagnosis,
training of pharmacists and pharmacy technicians, development and standardization of
work processes, and evaluation of results. In addition, as part of the situational
diagnosis, pharmacists’ perceptions regarding service provision were assessed to
determine subsequent interventions.
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Focus Group
Three focus groups were conducted to explore pharmacists’ perceptions at the
following stages: a) stage of establishment (2012), in which pharmacists were not
performing any clinical activities within the pharmacy environment; b) stage of
implementation (2013), whereby clinical pharmacy services had already been
structured, documentation had been prepared, and initial care of patients had
commenced; c) stage of consolidation (2014), whereby most services were fully
implemented, but some service processes still needed to be consolidated. Prior to the
focus groups, the research objectives were explained to participants and written
informed consent was obtained.
The discussion was led by a trained moderator, using a structured questionnaire
and videotaped for later transcription and interpretation of data. Each focus group was
organized according to Bardin's recommendations (2004) [35].
The interview guide encouraged pharmacists to discuss the following topics:
perceptions of the program, such as importance, benefits, and training; perceptions
about the role of pharmacists and clinical pharmacy services; expectations related to
patients; expectations about the establishment, implementation, and consolidation of the
expected services, and barriers at each stage; difficulties overcome after three years of
service expectations for consolidation; the importance of coaching, motivation, and
benefits acquired as a result of service. In this study, we present the barriers discussed
during the focus groups. We plan to present other discussed in future studies.
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Strategies for overcoming barriers
Based on the barriers identified in the focus groups, interventions to overcome
such barriers were devised. These interventions, which were not imposed, were
collaboratively developed by the researchers and the pharmacists. To assist in the
planning and implementation of the interventions, the researchers developed a baseline
conceptual framework for understanding the assessment of health quality based on the
concepts of structure, process, and outcomes [36].
Analysis
Content analysis was used to interpret the focus groups’ reports according to
Bardin's methodology (2004). This methodology is based on understanding
communication reviews by organizing and analyzing message content in a specific way
in order to make logical deductions and explanations regarding it. The technique is
organized into three phases: 1) pre-analysis phase in which the material to be analyzed
is organized to make it functional, systematizing the initial ideas and text cutouts in the
analysis of documents; 2) exploration of the material based on its core aspects; 3)
material is condensed and interpreted, culminating in the interpretations inferential [35].
Two researchers (A.S.D. and G.C.B.) independently analyzed the focus groups.
In cases of disagreement, a third investigator (D.B.) was also used. This reviewer also
made suggestions regarding categorization strategy, which were accepted by all three
reviewers (A.S.D., G.C.B., and D.B.). Subsequently, a careful review by a senior
evaluator was performed (D.P.). After the categories were defined, we performed a
critical analysis of the three focus groups.
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Results
In the three years of study, the focus groups included 11 pharmacist program members,
and encompassed discussions about expectations, perceptions, and experiences
regarding the implementation of clinical pharmacy services. The recording of focus
groups generated more than 210 minutes of audio that were later transcribed.
Subsequently, the material was arranged and examined in order to make it functional.
The ideas were systematized and generated 102 snippets of text containing references to
themes, of which 15 contain allusions to the barriers. To the end, these excerpts were
grouped according to similarity in meaning, and the following categories were created:
1) barriers to the establishment of services, 2) barriers to implementation, and 3)
barriers to consolidation. The following inferences and theoretical interpretations were
made regarding topics 1, 2, and 3 (Tables 1 and 2), with respect to the barriers at each
stage of development.
Focus group 1: perceptions before the establishment of
clinical pharmacy services
In this first stage, pharmacists reported their perceptions at the beginning of the clinical
services establishment process. Thus, eight major barriers were identified as potential
obstacles to establishment (Table 1). The strategies the researchers and pharmacists
developed to overcome or minimize the respective barriers are also described below:
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Overcoming the distance from neighboring cities
To overcome distance from neighboring cities, flow mapping/city movement was
carried out to construct a coherent services agenda commensurate with the flow of
people. The adjustment in patients care prioritized days in which a greater number of
people moved between small towns, such as the fair and market days. Subsequently,
patients recognized the importance of the shift in schedules for the provision of clinical
services.
Overcoming the lack of physicians
Although the lack of physicians in cities has been a focus of researchers, one Brazilian
Federal Government program has aimed to minimize problems associated with this
deficit. The program was introduced in 2013 in order to support the provision of
primary care medical services in poor and deprived areas of Brazil. [37] However, this
problem remains in several small towns.
Overcoming the difficulty in recruiting patients/creating demand
Marketing interventions focusing on the difficulty in recruiting patients/creating
demand were carried out. These strategies consisted of three visits to community radio
stations to advertise services, conducting dozens of educational campaigns, and
conducting 24 visits to healthcare centers to encourage prescribers to identify patients
with drug therapy needs, especially medication non-adherence. Therefore, pharmacists
were trained by the researchers to explain to the public their role as healthcare
professionals and the benefits of the services offered. Furthermore, folders and posters
were disseminated to advertise the clinical services.
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Overcoming difficulties in the provision of pharmaceutical services
The pharmacists participated in an educational training program developed by
researchers to improve their competency in the delivery of pharmacy services. The
program offered 60 hours of training on communication skills, drug administration,
management of minor illnesses, documentation practices, and the basis and processes of
clinical pharmacy services. Lectures, workshops, case studies, and simulations were
used in the training program.
Throughout this study, classroom and online coaching models were developed.
The focus of the coaching is on new skills, knowledge, and individual motivation, with
respect to action monitoring, performance improvement, and professional development
[38]. Therefore, in order to identify the deployment barriers and gaps during process
execution, each pharmacy was visited, and all pharmacists received individualized
assistance.
During the coaching visits, services were offered to the population, and the
coaches (researchers) observed the provision of care without intervening. After each
instance of care service, the pharmacist was invited to analyze the care process and
service compliance with the established procedures, and review the documentation.
Thus, each pharmacist was motivated to identify the strengths and weaknesses of the
service, to be responsible about it, and to propose interventions that could be executed
individually and as a team.
In addition to on-site monitoring, pharmacists received daily monitoring through
an online discussion group ([email protected]). Since this service was offered by the
coaches (researchers), they had available a shared experience environment with other
160
colleagues and the opportunity to receive answers to questions in a short period of time
(i.e., did not have to wait for the next visit to receive necessary guidance).
Overcoming the negative influence of a paternalistic relationship between
physician and patient
Another barrier cited that also was not subject to specific interventions was the negative
influence of a paternalistic relationship between physician and patient. This point was
minimized indirectly in pharmacists’ discussions regarding the development of
therapeutic relationships with patients. Thus, over time, the first patient outcomes were
satisfactory, and physicians began to recognize the value of clinical pharmacy services.
This happened after the relationship between physician and patient became less
hierarchical, and the relationship between doctor and pharmacist became more focused
on benefiting the patient.
Overcoming a lack of pharmacist recognition by the population
In 2012, some strategies were established to publicize services available to the public
internal (institutional) and external, besides the scientific community. The institutional
marketing consisted of promotions within the Sergipe State Department of Healthcare
through the press office, which developed 12 materials about the services. The results
obtained in these services were presented as 16 scientific abstracts in the five best
national and international conferences in the area. Finally, the external marketing
presented the clinical services to increase the number of patients who obtained them.
Therefore, it was necessary to establish a standard marketing intervention within the
three pharmacies, encompassing interviews on regional radio, healthcare professionals,
disclosure on social networks, and healthcare education activities in community
pharmacies.
161
Overcoming failures in human resources
The educational training program, anteriorly quoted, and coaching visits were
also geared toward the prevention and correction of failures in human resources. From
2012 to 2014, pharmacy technicians received 64 h of team training, without accounting
for internal training promoted by pharmacists. Moreover, during the 152 h of coaching
visits in three years to each community pharmacy, the researchers were able to follow
the activities of the team, assist in the implementation of new workflows, and
immediately identify failures in its implementation.
Dichotomy between theory and practice
For pharmacists who had less than five years of professional experience, an
educational training program was also conducted in order to provide greater security to
these professionals, as they not only had minimal work experience, but also minimal
experience with clinical services. Moreover, the coaching was aimed at optimizing the
apprenticeship of pharmacists, emphasizing the fact that theory and practice are
inseparable.
Focus group 2: perceptions during the implementation
stage
At this stage, pharmacists had been through 52 hours of training, the processes of
clinical services had been defined, and clinical practice was underway. Thus, during the
second focus group, participants discussed the barriers faced in the assignment. Two
barriers were identified: bureaucracy in services and professional insecurity regarding
162
lack of skills (Table 2). To overcome these barriers, the following interventions were
developed.
Overcoming bureaucracy in services
The clinical pharmacy service processes were not seen as just another
bureaucratic activity to be performed; rather, the pharmacists and technicians were
sensitized to build work processes. Therefore, in all institutional meetings, they
organized workshops and strengthened standard operating procedures.
Overcoming professional insecurity about lack of skills
Given that certain skills are necessary to meet clinical demands, pharmacists
participated in an educational training program developed by researchers to improve
their clinical competencies. In 2013, the program expanded and began to offer 88 h of
training divided into five modules, and the coaching hours in loco were extended from
120 h in 2012 to 144 h in 2013 and 192 h in 2014.
Focus group 3: perception of consolidation services
Two years after the start of the study, pharmacists reported their perceptions and
experience regarding the consolidation of clinical pharmacy services. Three barriers to
service consolidation were reported (Table 3): 1) structural problems, 2) human
resources issues, and 3) increased services. All barriers were subject to interventions by
the researchers, and the following strategies were devised.
Overcoming structural problems
During the coaching visits, the evaluation of the structure [33] of the Pharmacy
Coordination and the appropriateness of the recommendations were reported. Moreover,
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other strategies, such as changes in service layout, have been employed to facilitate the
comfort and privacy of patients. For example, the dispensation, which was previously
done on foot, is now conducted in a sitting area located in the less busy pharmacy.
Added to this, so that problems with computers (greater structural complaint) did not
affect the provision of clinical pharmacy services, a tablet for each pharmacy was
provided by the researchers.
Overcoming human resources issues
In addition to the educational training program, the selection processes were
restructured, establishing more stringent work criteria for the pharmacies, such as the
requirement of prior experience.
Overcoming increases in service
Given the fear of an increase in pharmacist's duties, we established goals that were
appropriate for workload and the pharmacist's role. The pharmacist manager would
have to be responsible for the provision of 40% of clinical pharmacy services and
responsible for 60% of technical services.
Given the various strategies designed to overcome the barriers, the perception
that this was achieved is observable within the statements of pharmacists, among which
the most important were overcome in two respects:
1) Management of pharmacy practice
"We learn with patients and with the support of researchers how to apply
communication techniques and knowledge about the management of pharmacotherapy.
164
"
2) Communication skills.
"I see how the support of researchers is important. I see the professional growth
of my colleagues (...) before, there was a lack of communication skills; today, there is
this problem"
Discussion
According to the perception of the study participants, barriers may vary according to the
stage of clinical pharmacy service implementation; therefore, different interventions
may be required at different times. In this sense, studies in various areas of health
confirm that a broad understanding of the concerns of all major stakeholder groups is
needed to develop effective strategies and initiatives [39, 40].
In the first focus group held at the beginning of service implementation,
pharmacists had not yet experienced clinical practice and discussed the possible
difficulties that could face in the assignment. In this sense, the patient uptake was
flagged as a possible barrier because the program serves not only the city in which it is
located, but also small surrounding municipalities, which could hinder the movement of
patients from these cities to the pharmaceutical care. The location of pharmacies was
precisely designed for this, so she could meet a region and not just one municipality.
Merks and colleagues (2014) showed that the location is the most frequently
reported factor that may influence the choice of a patient and contribute to frequent
visits to community pharmacies [41]. In this sense, studies in other countries show that
geographical proximity is an important component of access to primary health care and
pharmaceutical services in pharmacies by the community [42–44]. Also, when the
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pharmacy is accessible only by means of transport, may prove to be a barrier to patients
living in more remote areas and low-income families due to the cost of using such
services [45]. So it is important to understand the dynamics of the region so that
services are consistent with the flow of people in the city.
In Brazil, patients are not accustomed to receiving care at the pharmacy and do
not see the pharmacist as a professional who can help in the correct use of medicines
and health [46]. However, this professional has limited the development of
administrative activities, still rooted in product distribution and is underutilized for the
care of patients, which has contributed to their professional isolation and low
recognition of the profession by society [46–48].
Study in Qatar showed that 70% of the public did not expect the community
pharmacist would follow up your health progress or to practice any health screening, as
well as 50% of respondents sought the physician to answer questions related to the drug
[49]. Therefore, in developing countries, patients still have little understanding of the
pharmacist's role in providing services to improve public health in the community
pharmacy [49, 50]. Because of this lack of reference in the pharmaceutical, business
strategies to the physician's office, using letters and phone calls to the prescriber can
create a link for care in co-participation.
Another factor that may also hinder the loyalty of patients to pharmaceutical
care is the lack of physician in Brazilian small towns since patients often need to return
to the doctor for evaluation of your health condition and renewal of prescriptions. As
well as the lack of collaboration with other health professionals make the
interdisciplinary follow-up of the disadvantaged patient because pharmacists reported
166
that they would be as allies in the dissemination of services and referral of patients with
difficulty in the use of medicines [51].
In this sense, this study reinforces similar findings that lack of physicians,
insufficient communication and lack of health professionals collaboration are
considered barriers to the pharmacist's role performance and should provide strategies
for enhancing such cooperation [52, 53]. Moreover, several studies have concluded that
the relationship of cooperation and the incorporation of the pharmacist in the health
team is a viable solution to help improve health care [12, 51, 54, 55].
During the following years, 2013 and 2014, this barrier has been minimized with
a deployment of Brazilian Federal Government program in 2013 [37]. Although not an
overcoming strategy drawn by the researchers but a coincidence, this program allowed
greater coordination for collaborative activities.
Pharmacists have expressed difficulty and uncertainty in the provision of clinical
services before and during deployment. This perception agrees with studies that say that
there are gaps in the pharmacist training in patient care area, because it reflects the lack
of practice on monitoring of pharmacotherapy, the concern of pharmacists in relation to
skills and lack of confidence to provide clinical services [56–59]. Therefore, curriculum
change could stimulate improvements in teaching and research, with the bridge between
education and practice, which would allow more training and safety professionals for
the provision of the clinical pharmacy services [10, 13, 60]. However, to meet this lack
is suggested that the professional classes councils managers of institutions and
entrepreneurs to foster participation and promote knowledge update events.
The lack of knowledge of pharmacies was reported as a barrier aids due to the
need of support for the pharmacist in attracting patients, scheduling appointments and
167
identification of non-conformities in the prescription. Alkhateeb and colleagues (2011)
reported that a pharmacy technician with training and awareness is necessary for the
successful operation of a pharmacy [61]. Therefore, the tecnhician training generates
support for the deployment of services, and reduce bureaucratic of the pharmaceutical
activities, extending the time for the same focus and interact more intensely with
patients in the provision of clinical pharmaceutical services [62, 63].
The training was carried out to order include the techicians in the clinical
pharmacy services flow. It was essential to hear your opinions and suggestions they
could point to make the flow of calls in the most feasible pharmacies. In addition to the
training promoted by researchers, the site visits of coaching allowed the participant
observation of the activities of the auxiliary and the adjustments to the recommended
procedures could be resolved immediately in the workplace.
Pharmacists in this study reported that they could have difficulty in providing
assistance on the use of medicines due to the paternalistic relationship established
between the patient and the physician. Historically, the paternalistic approach to decide
what should be done in medicine, not necessarily contemplates the will and the patient's
wishes, perhaps because there is still the old paternalism of 'doctor knows best' and the
patient accepted the recommendation undoubtedly [64–66]. Another study conducted in
Asia also found that a paternalistic style seems to prevail, regardless of the education of
patients, doctors and patients are not prepared for a participatory style [67]. However,
this relationship is being replaced to a great style that patient empowerment begins with
the information of knowledge, ie, patients are responsible for managing their own
diseases, reflected with autonomy and improvement of treatment results in a significant
way [68–70].
168
In the second focus group, the bureaucratic service processes were also
mentioned as a barrier in the implementation of clinical pharmacy services, due to
complaints from patients. In Brazil, the mandatory monthly presentation of documents
with personal data of the patients takes time and is considered a barrier to access to
pharmacy services. However, some pharmacists have recognized the value of the
bureaucratic nature of actions for the organization and control of the service, as the
documents of verification allows the treatment is not diverted to another patient.
For this negative view related to bureaucratic processes were minimized,
pharmacists and pharmacy assistants during the training sessions were invited to reflect
on the reason for each required process. Based on the understanding of each stage, it
was revealed the real reasons to fulfill each step required in norms, and it was possible
to identify steps and requirements that could be simplified and because it is a national
model, there are points that should be taken the national debate by the governing body
of all own units of “Farmácia Popular do Brasil”.
Linked to this, a structural pharmacy issue was reported, namely that computers
used for the request of the drugs were old and the internet connection often fails, which
generated patient dissatisfaction. Given this barrier, access to services was affected
because patients often seek the pharmacy to ensure low-cost medicines and only after
this step do they receive pharmacist guidelines for drug administration. This was
categorized as a coordination-based barrier and a new strategy was devised whereby
patients were able to receive guidance from the pharmacist without acquiring medicines,
thus making them more likely to visit the pharmacy for health services rather than just
prescription reception.
169
Another barrier to the consolidation of clinical pharmacy services was the new
pharmacy routine, as demand for services has increased considerably. Thus, in addition
to technical responsibilities, pharmacies are now required to offer clinical services.
Okonta and colleagues (2012) stated that lack of time is a barrier to clinical services
implementation frequently mentioned by pharmacists [9]. Therefore, Ibrahim and Scott
(2013) suggest that the increase in the number of qualified pharmacists and pharmacy
technicians is crucial to meet demands for clinical services [11].
It is noteworthy that the temporary lack of pharmacists and pharmacy
technicians also hinders the consolidation of services. Minimal distance between a
given pharmacy and the state capital is an attractive factor for pharmacists and
professionals. A study in Australia reported that for pharmacists and other health
professionals, the distance from large urban centers presents a huge challenge.
However, a number of initiatives in that country have been implemented to promote the
recruitment and retention of pharmacists outside the major urban centers, such as
different salaries [71]. In Brazil, it is necessary to invest more in training and higher pay
for pharmacists and pharmacy technicians, especially in the most remote regions of the
country. Thus, in recognition of the activities carried out and to make this a more
attractive proposition to potential candidates, the salary offered for pharmacists was
reset as higher than the salary paid in the state.
Finally, it can be considered that the various barriers identified were overcome
over the years. Thus, studies report that multiple factors may facilitate initial
implementation, and that the presence or influence of barriers may decrease over time
[72–74]. Therefore, these barriers were overcome after two years of provision of clinical
170
services. This was due to experience with clinical practice and effective coaching
strategies.
Conclusion
This study assessed the perceptions of pharmacists involved the development of clinical
pharmacy services, and clarified the barriers associated with each stage of development.
During the establishment stage, not only were a greater number of obstacles observed,
but there were also feelings of insecurity in professionals about the structure, other
health professionals, and especially the patients. During the implementation, other
barriers appeared and demanded the expansion of interventions. However, in the
consolidation phase, participants indicated that barriers were being overcome and the
interventions were successful.
The present results suggest that clinical service provision improved following
the implementation of effective strategies, such as promoting services, educational
training programs, and coaching in loco. It is noteworthy that the perceptions of
potential barriers need to be considered to increase the likelihood of successful
implementation of pharmaceutical clinical services. Therefore, this study can serve as a
foundation for future implementation strategies to promote clinical pharmacy services in
community pharmacies.
Study limitations
Since this was a qualitative study, generalizations about pharmacists’ perceptions
cannot be made; however, these results serve as a warning to researchers regarding
possible interferences to implementations for clinical pharmacy services.
171
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177
Table 1 - Pharmacist perceptions about barriers during the beginning of the establishment (2012) of clinical pharmacy services.
CATEGORY REGISTRATION UNITS /
QUOTES
OVERCOMING BARRIERS STRATEGIES
BARRIERS TO THE
ESTABLISHMENT
Distance from neighboring cities
“The recruitment of patients from other cities was arduous due to difficulty of
displacement between cities”
- Agenda of services coherent with the influx of people
from other city
Lack of physicians in the city
"The lack of medical professional can influence our work"
- External barrier - Not apply strategies
Difficulty in recruiting patients/creating demand
“We do not know if the patient will take an interest in pharmaceutical care, nor
how it will be the whole process”
- Marketing Interventions (Radio interviews, healthcare
education actions, visits to healthcare centers)
Difficulties in the provision of clinical services; need for competent
pharmacists
“I think the biggest difficulty is to guide on healthy eating and promote quality of
life (...) because we do not feel prepared (...) we do not know how to use
communication skills”
- Educational training program
- Coaching in loco and online
178
Table 1 - (continuation) Pharmacist perceptions about barriers during the beginning of the establishment (2012) of clinical pharmacy
services.
CATEGORY REGISTRATION UNITS /
QUOTES
OVERCOMING BARRIERS STRATEGIES
BARRIERS TO THE
ESTABLISHMENT
Negative influence of the paternalistic relationship between physician and
patient
"The pharmacist explained to the patient about his role, but the patient refused
and said, "the physician knows better than the pharmacist"
- External barrier - Not apply strategies
Lack of recognition of pharmacists by the population
“I realize that the pharmacist is not yet recognized by the population, many
people recognize the physician recognizes the nurse, and pharmacist does not.”
- Marketing interventions (Radio interviews, healthcare
education actions, visits to healthcare centers)
Failures in human resources
“Pharmacy staff are not trained, we have to teach them. They need a knowledge
base to acquire responsibility with drugs”
- Educational training program
- Coaching in loco
Dichotomy between theory and practice
“The pharmacist does not feel well qualified because only the knowledge of the
university are not enough”
- Educational training program
- Coaching in loco
179
Table 2 - Pharmacist perceptions about barriers during the implementation (2013) of clinical pharmacy services.
CATEGORY REGISTRATION UNITS /
QUOTES
OVERCOMING BARRIERS STRATEGIES
BARRIERS TO THE
IMPLEMENTATION
1) Bureaucracy in services
“The pharmacy service flow is bureaucratic, there are several steps between the
sale of medicine and the care of the pharmaceutical”
- Collective construction of standard operating
procedures
- Strengthened standard operating procedures in all
institutional meetings
2) Professional insecurity for lack of skills
“I feel insecure, afraid, and the lack of skills discourages me. I need to practice
support services”
- Expansion of educational training program
- Expansion of coaching in loco
180
Table 3 - Pharmacist perceptions about barriers during the consolidation (2014) of clinical pharmacy services.
CATEGORY REGISTRATION UNITS /
QUOTES
OVERCOMING BARRIERS STRATEGIES
BARRIERS TO THE
CONSOLIDATION
Problems in the pharmacy structure
“The Pharmacy structure has computers and other old equipment, there is often
instability in drug sales system”
- Reporting was made to managers with diagnosis of
structure
- Providing tablets for exclusive use in clinical
pharmacy services
Human resources issues
“There is a high turnover of pharmacy technicians and new hires are difficult”
- Educational training program
- Selection processes were restructured with stringent
criteria
Increases in demand
“We need to organize a new routine work to meet the increase in demand for
clinical pharmacy services”
Establishment of service targets consistent with the
workload and the pharmacist's role (Manager or
technician responsible)
181
CAPÍTULO V
X
X
X
X
182
4.5 CAPÍTULO V: CLINICAL PHARMACY SERVICES IN THE FARMÁCIA
POPULAR DO BRASIL PROGRAM IN NORTHEAST STATE OF BRAZIL:
ESTABLISHIMENT, IMPLEMENTATION AND CONSOLIDATION
Giselle de C. Brito Ph.D Studant. a,b
, Aline S. Dosea, M.Sc. Studant a, Tatiane Cristina
Marquesa Ph.D Studant, Blicie J. Balisa-Rocha, Ph.D.
c , Divaldo P. Lyra Jr., Ph.D.
a
aTeaching and Research Laboratory Social Pharmacy, Federal University of Sergipe,
LEPFS-UFS, s/n, Avenida Marechal Rondon, Jardim Rosa Elze, São Cristóvão, Brazil bFederal University of Sergipe, Lagarto, Brazil
cPharmacy Course, Faculty of Guanambi
Corresponding author: +557991925577
E-mail address: [email protected]
183
Abstract
Objective: To describe the process interventions of establishment, implementation and
consolidation of clinical pharmacy services in pharmacies of “Farmácia Popular do
Brasil” program, the State of Sergipe, Brazil. Material and Methods: from January
2012 to December 2014, we conducted a longitudinal study in three units of Farmácia
Popular do Brasil Program of a rural área in Northeast State in Brazil on the
implementation (2012), implementation (2013) and consolidation of clinical pharmacy
services (2014). The developed services were dispensing , blood pressure and capillary
blood glucose measurement, medication review and medication therapy management,
outlined as follows: 1- Professional training (2012-2014); Definition of services and
processes (2012); Selection for indicators of evaluation (2012); 4- Establishment,
implementation and consolidation of workflow and process (2012-2014); 5- Elaboration
of strategic plans (2013-2014); 6- Marketing of Services (2013-2014); 7- Assessment
the performance of services (2012-2014). Results: were designed 520 hours of on-site
coaching for implementation of six flows and workflow processes, development of six
standard operating procedures and drafting three situational strategic plans. In the
training stage, pharmacists underwent 176 hours of theoretical and practical training on
communication skills techniques, medication administration, identification of signs and symptoms in smaller pharmacy, and process of pharmaceutical care and 24 hours of
training for pharmacy technicians. The disclosure of services was performed in three
lines, the institutional promotion (12 online materials), scientific (16 abstracts, a prize, a
documentary) and external (educational campaigns, visits to health centers and
participation in community radio). After the coaching, the effectiveness of
implementation advanced the number of services: there was 767 dispensing visits in
2012 and 1771 in 2013 and 2537 to 2014; 1481 measurements of blood pressure and
capillary blood glucose measurement in 2012, 3193 in 2013 and 5039 in 2014, 49
consultations of Medication Review in 2012 and 87 in 2013 and 355 in 2014; 15
consultationsof Medication Therapy Management in 2012 and 33 in 2013 and 271 in
2014. Conclusion: The results suggesting the importance of coaching and training in
process interventions to empower pharmacists. Establishment, implementation and
consolidation of clinical pharmacy services require steps such as education training,
definition of services and processes, selection of indicators, development of strategic
plans and marketing services. The results provide the foundation for building a
differentiated and replicable model of clinical pharmacy services in Brazilian
community pharmacies.
Keywords: Clinical Pharmacy Services, Community Pharmacy, Coaching in health
care
184
INTRODUCTION
In recent decades, policies to expand the traditional role of community
pharmacists have been implemented or at least considered in a number of countries, as
advocated by academics, professional organizations, and governments. Such reforms
come on the heel of pressing system-wide challenges 1. Numerous reports on the role of
community pharmacists have concluded that pharmacists could adopt an expanded,
patient-centered role and could contribute to safe, effective and economic use of
medications 2,3
.
Some studies show that community pharmacies are adequate to begin patient
care, which requires the establishment and improvement of Pharmaceutical Services
setting. In several countries have occurred expanding the role of pharmacists in
community pharmacy services 1,4,5
. In the UK, for example, community pharmacists
started to be integrated into public health care programs, providing Pharmaceutical
Services to solve problems associated with irrational use of medicines 6.
According to Schommer and colleagues (2010) these services have undergone a
process of improvement, staring from primary health care, with the service of
dispensing drugs, to the chronic diseases management with pharmaceutical care for
example7. Indeed, community pharmacists have the potential to improve patients’
economic, clinical and humanistic outcomes. Touchette and colleagues noted in their
systematic review that clinical pharmacy services were cost-effective or provided a
good benefit-cost ratios, ranged from 1.05:1 to 25.95:18.
A systematic review and meta-analysis of pharmacist-led fee-for services
medication review showed significant results favouring pharmacists’ intervention were
found for blood pressure (OR 3.50, 95% CI 1.58, 7.75, P = 0.002) and low density
lipoprotein(OR 2.35, 95% CI 1.17, 4.72, P = 0.02) 9. Similarly, humanistic outcomes
185
was significates when assessing the 10 years for MTM service in the patient satisfaction
survey, 95.3% of respondents agreed or strongly agreed that their overall health and
wellbeing had improved because of Medication Therapy Management 10
.
Another recent systematic review, Patwardhan and colleagues asked about what
will it take to help pharmacists deliver more and better clinical services, as well what
type of research can help move this agenda forward?11
. Some studies recommended that
interventions are needed to help pharmacists with their workplaces and systems through
assistance with organizational planning and support 12–14
. Altough the positive impact of
clinical services in community pharmacies is well documented, community pharmacists
have been slow to expand their impact on patient outcomes and health care system
costs, often this subset of studies includes the pharmacist behavior only as a fidelity
measure of the patient intervention 11
.
Accordingly, this paper has the objetive describe the process interventions to
establish and implement clinical pharmacy services, as well as to measure the
performance of each consolidated service.
Methods
Study Design
An intervention study was conducted in three community pharmacies of
Pharmacy of “Farmácia Popular do Brasil” Program in a State in Northeast, Brazil,
through partnership between Federal University of Sergipe and Sergipe State
Department of Healthcare, from January 2012 to December 2014. The research was
divided into three phases: a) establishment (2012); b) implementation (2013); and c)
consolidation (2014). The stages are described in Figure 1.
186
Figure 1- Stages of establishment, implementation and consolidation of clinical pharmacy services in the “Farmácia Popular do Brasil” Program in a State in Northeast of
Brazil, 2012-2014
187
Characterization of “Farmácia Popular do Brasil” Program
The program was established in 2004 by Brazilian regulation, in order to qualify
and increase access of pharmacotherapy, especially in chronic disease 15
. In the country
are more than 500 units diffused, nine are distributed in the State of Sergipe, among
these three of which are managed by the Sergipe State Department of Healthcare and
are the sample of this study.
Local of Study
In Sergipe, in 2010, was signed the partnership between the State Department of
Healthcare and the Oswaldo Cruz Foundation for the creation of three community
pharmacies of the “Farmácia Popular Do Brasil” Program managed by the State
Health Foundation. These pharmacies are located in the small cities of Estância, Propriá
and Nossa Senhora da Glória and serve approximately 125,000 people in rural areas.
Each pharmacy has 12 technicians, of which two are pharmacists.
Process components of the clinical services
The presentation of the results was based on Donabedian 16
. This researcher
developed a baseline conceptual framework for understanding the assessment of quality
of health, based on the concepts of structure, process and outcomes, in this study was
defined as: 1. Educational Training Program (2012, 2013, 2014); 2- Definition of
Services and Processes (2012); 3- Selection for indicators of evaluation (2012); 4-
Implementation of workflow and Process (2012); 5- Elaboration of strategic plans
(2013.2014); 6- Marketing services (2013; 2014); 7- Evaluation of Performance (2012;
2013; 2014).
188
1) Professional training
a) Educational Training Program
After the evaluation stage of human resource structure in the years 2012 and
2013, were offered training to six pharmacist in 2012, six in 2013 and eight in 2014
about content applicable to the reality of clinical services. Due to the turnover of
pharmacists, 14 received this training, and none of them received training during all
three years, Thus, all the training techniques used are active learning methodologies
such:
1- Empowering1718
;
2- Group dynamics19
;
3- Resolution of clinical cases20
;
4- Simulated patients 21
.
b) Training of Pharmacy technicians
The researchers and pharmacists provided training to the pharmacy staff with the
objectives: a) promote harmony and balance the relations of knowledge and power
involved in the work process; b) promote technical update meetings for the care focused
on the patient. These trainings were developed between 2012-2014, with the
participation of the members of the units and used the same methods of pharmacists
training .
2) Definition of Clinical Services and Processes
Pharmacists were encouraged to identify the needs presented by patients to
receive their medications and list the types of services that would meet such demands.
189
Thus, the design of clinical pharmacy services of dispensing, measurement of blood
pressure and capillary blood glucose, medication review and medication therapy
management was part of the Establishment phase. This phase was performed by a
literature review to identify the bettert workflow processes and available validated
instruments.
After defining the clinical services to be developed and the theoretical
fundamentation, pharmacists were challenged to build collectively the standard
operating procedures for each service. In addition, was prioritized the development of
workflows to facilitate the understanding and implementation of standard operating
procedures.
3) Selection for indicators of evaluation
According to a systematic review conducted by this research group in order to
check the overview assessment of the implementation of clinical pharmacy services
effectiveness indicators were established for each service 22
. Although, have been listed
in 2012, some indicators could be evaluated in subsequent years according to the
evolution of services. In this step also aspired identify in the literature validated which
instruments that will give subsidy to the services.
4- Developing f workflows and Processes
After agreement about the workflow processes and instruments applicable to the
reality of pharmacies, in 2012, began the Establishment of services. As individualized
follow-up strategy was used the model of Coaching. In coaching, the focus is on
190
developing new skills, knowledge and individual motivation, regards monitoring of
their actions, aiming performance improvement and professional development 23
.
Therefore, from May to September, 2012, five Coaching Sessions (40hours) were
conducted in each pharmacy, for motivation and guidance of the professionals in the
clinical pharmacy services implementation. Sessions was expanded in 2013 occurred in
five visits in each pharmacy and in 2014 eight visits. Thus, each pharmacy received 152
hours during three years. The researchers discussed with the pharmacists the physical
structure adjustments necessary to deliver optimal clinical pharmacy services, in a way
that each pharmacist could figure out the most suitable solutions to the structural
problems observed in their establishments during the infrastructure assessment. They
monitored the development of instruments, workflows, employee work schedules and
educational leaflets, participated in clinical case discussions and conducted one-to-one
sessions to improve pharmacist performances. They also encouraged pharmacists to
participate in scientific events and publicize their experiences and outcomes with the
services delivered. Besides the in loco attendance, an online discussion group was
created to share experiences, to answer questions, give advices and standardize
information and references.
5) Elaboration of strategic planning
During the years 2013 and 2014 workshops were carried out strategic planning
process. Therefore, the results obtained in previous years were taken up. Firstly, was
performed the presentation and discussion of the mission, vision and values of the
Funesa/SE. Subsequently, was performed a discussion about current situation through
the strengths; opportunities; weaknesses; threats and challenges (SWOT) analysis24
.
191
Finally, the strategic objectives were listed and the action plans were developed. All
plans were contemplated: goals; facilitators and barriers; actions; consequences;
monitoring indicators; necessary resources; staff responsible; deadline; goal or expected
result.
6) Marketing interventions
From the year 2012 was established marketing strategies that were divided into
institutional marketing, scientific marketing and external marketing.
The institutional marketing consisted of promotions within the Sergipe State
Department of Healthcare through the press office. The scientific marketing (2012-
2014) aimed to transform the results obtained in scientific studies to be enjoyed in the
best national and international events in the area. Finally the external Marketing (2013-
2014) aimed to increase the number of patients seen by pharmacists, but before it was
necessary to establish a roadmap to "standardize" the interventions in the three
pharmacies. Therefore, it was necessary to establish a standard marketing intervention
within the three pharmacies, encompassing interviews on regional radio, healthcare
professionals, disclosure on social networks, and healthcare education activities in
community pharmacies.
7) Evaluation of Performance
Based on selection for indicators of evaluation (chart 2), researchers follow the
progress of each clinical pharmacy services. Data were collected by pharmacists under
the supervision of researchers. In case of divergences visits "in loco" were performed
for data conference.
192
RESULTS
1) Educational Training Program
a) Training of pharmacists
During the three years were offered to pharmacists 176h in training about
content about clinical services. Chart 1 illustrates the topics covered in the training, the
methodology used and the hours credited.
Chart 1: Structure of the training of pharmacist developed in the “Farmácia Popular do
Brasil” Program in a State in Northeast of Brazil, 2012-2014
Topics of Trainings Methodology Credit Hours
(176h)
Medication administration
tecniques
Simulated Patient
Resolution of clinical cases
20h
minor signs and symptoms
assessment
Simulated Patient
Resolution of clinical cases
30h
Communication skills Simulated Patient
Group dynamic
30h
Marketing of Services Group dynamic 12h
Documentation of
dispensation, measurement
of blood pressure and
capillary blood glucose,
medication review and
medication therapy
management
Empowering
Simulated Patient
Resolution of clinical cases
30h
Processes of dispensation,
blood pressure and
capillary blood glucose
measurement, medication
review and medication
therapy management
Problematization
Simulated Patient
Rosolution of clinical cases
54h
193
b) Training of Pharmacy technicians
With regard to courses and training of employees there was up the habit of writing
them, and the researchers proposed that all training interventions within the pharmacies
must be approved at the meeting of collegiate and one provided in the minutes. In
addition, between the years 2012 and 2014, researchers in partnership with the
coordination of pharmacies institutionalized the annual employee training, an event that
brings together staff from the three pharmacies to share the results with the Clinical
Pharmacy Services and strengthen the standard operating procedures of the activities
carried the units. Were designed 24h training for pharmacy technicians, which each year
with the participation of 36 employees and included the topics:
1- Definition of services: dispensation, measurement of blood pressure and
capillary blood glucose, medication review and medication therapy
management;
2- Structuring the distribution of medications for the purpose of screening patients
for clinical services;
3- Standardization of patient screening steps for clinical services;
4- Motivational dynamic.
2) Definition of Services and Processes
For the execution of Pharmaceutical Services were established 06 workflows:
1- Medication distribution
2- Medication Dispensing
3- Measurement of blood pressure
4- Measurement of capillary blood glucose
194
5- Medication review
6- Medication therapy management
3) Selection for indicators of evaluation
In this stage were identified validated instruments applicable to the service,
among which were selected: Pharmacy Services Questionnaire for assessment of
humanistic outcomes 25,26
, o Pharmacist Workup Drug Therapy (PWDT) for the
structuring of medication review and medication therapy management27
, to monitor the
process of using of medicines by patients was evaluated adherence to treatment by the
instrument MMAS-828
. Considering the lack of validated instruments for documentation
of interventions made in the dispensation and the need to practice documentation
required the construction of new instruments (Figure 2). Chart 2 demonstrate the
proposed indicators was agreed by pharmacists to facilitate evaluation of the
performance of services.
195
Figure 2 – Instruments developed for clinical pharmacy services in the “Farmácia
Popular do Brasil” Program in a State in Northeast of Brazil, 2012-2014
196
Chart 2 – Clinical pharmacy services developed in the “Farmácia Popular do Brasil”
Program in a State in Northeast of Brazil, 2012-2014 and their evaluation indicators.
SERVICES INDICATORS YEAR OF
EVALUATION
Dispensing Total procedures
Profile of Interventions
Profile of drug therapy problem
2012, 2013,2014
2013, 2014
2013,2014
Measurement
of blood
pressure
Measurement
of capilary
blood glucose
Total procedures
Total procedures uncontroled
Number of patients referred to other healthcare
services
2012, 2013,2014
2013, 2014
2013,2014
Total procedures
Total procedures uncontroled
Number of patients referred to other healthcare
services
2012, 2013,2014
2013, 2014
2013,2014
Medication
Review
Number of patients
Number of consultations
Average number of consultations per patient
Profile of pharmacotherapy problem
Number of letters to the doctor
Number of patients referred to Medication
Therapy Management
2012, 2013,2014
2012, 2013,2014
2012, 2013,2014
2013,2014
2013,2014
2012, 2013,2014
Medication
Therapy
Management
Number of patients
Number of consultations
Average number of consultations per patient
Profile of pharmacotherapy problem
Number of letters to the doctor
2012, 2013,2014
2012, 2013,2014
2012, 2013,2014
2013,2014
2013,2014
197
4- - Workflows and Processes developed
Coaching visits were made in the three years of deployment / implementation /
consolidation, being intended 520h. During these visits, the aspects were covered:
1- Structure diagnostic elaboration;
2- Establishing a marketing plan
3- Discussion of clinical cases
4- Development of health education activities
5- Appropriateness of the structure for provide greater feasibility of the services,
through the organization of workflows;
6- Monitoring the development of the material and instruments of pharmaceutical
services;
7- Monitoring the implementation of workflows established for carrying out the
services;
8- Implementation of the services under the guidance of the coach.
5) Elaboration of strategic plans
During the elaboration of strategic plans the main priorities were: increased
visibility of services, training of pharmacy technicians structural, failures especially in
the computer sector. Therefore, the main strategies were the development and
implementation of marketing plans, change in the selection of new employees and
training of old employees and purchasing new computers, as well request by the system
provider better support technician.
To implement the strategies proposed was identified facilitators and barriers for
each aspect. As facilitators was the continuing education structure established by the
198
institution, have the availability of an acessoria communication and clinical services
offered as well are unique pioneers in the region.However, the bureaucracy involved to
adjust the structure slows down the equipment acquisition process.
6) Marketing Interventions
The marketing of services was performed in three lines, the institutional, the
scientific and the public external. The institutional marketing promoted the
dissemination of 18 reports about clinical services between 2012-2014, it is noteworthy
that until 2011 there was no report that disclose the Farmácia Popular do Brasil
Program in the state of Sergipe. The scientific marketing (2012-2014) resulted 16
abstracts at national and international conferences, a documentary. The strategies used
in external marketing resulted in three participation in radio, 24 visits to health
professionals, 10 health education activities in the pharmacies.and inumerous
disseminations in social networks like facebook.
7) Evaluation of Performance
In this study was numerically calculated the expansion of services since 2012
and the effectiveness of implementation was reflected in advance the number of
services. The table 1 show the main results of the performance of clinical pharmacy
services. In measurement of blood pressure and blood capillary glucose service, in
2014, may be noted that 41.6% (2097) procedures were uncontrolled, (blood pressure>
130x90 mmHg and capillary glucose> 126 mg / dl). It was possible to observe the
progress of clinical services of Medication Review and Medication Therapy
Management .The first service went from 76 patients to 355 between the years 2013 and
199
2014, and the other from 18 patients to 213 in the same period. This stage of data
collection was crucial to verify conformities in documentation of workflow, and the
major non-conformities observed were:
1- Use of non-standardized documentation;
2- Incompleteness in the documentation of services (DRP solved, patients with
uncontrolled parameters, number of patients referred another services)
3- Underreported intervention data (especially during the dispensation)
4- Records with incomplete data (without the time of the consultations, without
the date of birth of patients or without the care plan).
For solved this problem, the last intervention with the pharmacists were
discussed all unconformities and was preconized if in each institucional meeting all
pharmacies will show a resume of the patients records.
200
DISCUSSION
Human resources are one of the pillars of a healthcare system, and this time the
focus of attention to the strengthening of those sistems29
. The planning of human
resources in health aims to ensure that the number and the appropriate type of health
care professionals are available to provide the right kind of services with greater
efficiency possible30
. Within this planning, continued education for these professionals
should be prioritized. In addition, this training must be accompanied by training for
pharmacy technicians. The technicians are directly related to the medication distribution
while not being a clinical services, can be considered an essential phase for patients
screening and recuitment 31,32
. The active-learning techniques are related in literature
with successful. This methodology is particularly suited to interventions where the
objective is to change a subject’s understanding, like in a new services 33,34
.
The step Definition of Services and Processes must be quite planned and take
into account the service deployment facilitators in community pharmacies. It should
prioritize so many individual facilitators, as organizational. Among the individual
facilitators stands out attitudes, autonomy, competence, motivation, confidence of
pharmacistl capacity to provide the clinical services; communication and leadership
skills. As the organizational facilitators should pay attention to the physical
environment (adequate space / privacy and workflow), compensation / incentives,
human resources (sufficient qualified staff), relationship with doctors, equipment and
technology (computers); access to patient information (records) and documentation
system (records)13
.
201
For conducting any kind of scientific study is crucial to identify which search
tools suitable for the development of the work. The data collection technique to get
information and uses the senses in obtaining certain aspects of reality. Is not only to see
and hear, but also to examine facts or phenomena that wish to study. Thus, the use of
validated instruments allows for a greater trust between the data collected and the study
object. However, do not always have available access to validated instruments. So there
needs to be pre-test or pilot test verifying whether it has the elements: reliability - get
the same results, regardless of who applies; validity - to analyze all the data collected,
necessary for research or that no important data has been left out for collection;
operability - verify that the vocabulary presents accessible and is clear about the
meaning of each question35
.
Positives results, similar this research, also was showed for Hetherington and
Henochowicz using the Coaching techniques in implementation services. They argue
that leadership coaching has been an underutilized resource in health care training. The
use of coaching methods has been of great utility for physician and non‐medical
managerial leadership. Health care leaders will need to develop interpersonal and
emotional intelligence competencies in order to successfully run increasingly complex
organizations 23
.
Strategic planning is fundamental to public health, , coating is of particular
importance for the planning of human resources, the assessment of efficiency, service
quality and the search for innovative solutions to health problems and the health care
system29
. The proper use strategic planning is an important tool. It is the process that
determines what an organization wants to be in the future, and how you will do to get
there. It is therefore much more deterministic compared with the strategic thinking that,
in contrast to the planning, involves intuition and creativity36
. A strategic plan should
202
help an organization to deal with contingencies that arise in a dynamic environment
such as health care and help establish a position for long-term success and is
particularly useful for healthcare organizations when dealing with the changes in the
standard of care30
. So this step was crucial to identify the successes and reflect on poor
performance and how to grow with it.
The marketing in pharmacies allowed increase clinical pharmacy services
visibility in some scenarios. Because it is a search based on the strategic practice that
diffuses the information both for the community and for the academy,this may stimulate
other researchers to follow this way and finally fill this gap research. In Greece, Wagner
and colleagues show that marketing has a positive effect on the job satisfaction of
hospital staff 37
. Marketing is essential because the consumers look for services
provided by organizations responsible and market-oriented, customer-friendly.
Furthermore, the consumer is now viewed in a new perspective, as a combination of
traditional patient and modern consumer, having much more knowledge about the
health care system, open to innovation and with an active role in establishment the
diagnosis, treatment and health improvement38
.
The increase in the number of clinical services offered to the community is one of the
main results that demonstrate the success of steps of establishment, implementation and
consolidation. However, the numerical results are not sufficient, the quality of services
evaluation to be provided, as well as its sustainability should be the focus of future
research11
. The assessment of pharmacists for each year indicated the need for a
structured process of care. In this sense, the theoretical and practical training was
conducted in an attempt to fill this gap. But the development of knowledge and skills
alone were not enough, according with Kaae and Christensen of the main reasons that
hinder the implementation of clinical pharmacy services, is not a lack of knowledge or
203
skills, but low self-esteem of pharmacists who do not believe their skills are sufficient to
provide the service39
. Thus, individual and motivational monitoring was developed,
using the coaching methodology to ensure that clinical pharmacy services were
implemented. So,the sustainability in services is potencialized when exist a individual
staff training (coaching) 40
.
CONCLUSION:
It was concluded that establishment, implementation and consolidation of clinical
pharmacy services require steps such : professional training, services and definition of
processes, selection of indicators for evaluation, establishment, implementation and
consolidation of workflow and processes, elaboration of strategic plans and marketing
interventions. The results suggesting the importance of coaching and training in process
interventions to empower pharmacists not only to deal with new roles that were drawn,
but above all make them the protagonists of these changes. The results provide the
foundation for building a differentiated and replicable model of clinical pharmacy
services in Brazilian community pharmacies.
204
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Table 1 – Performande of clinical pharmacy services developed in the “Farmácia Popular do Brasil” Program in a State in Northeast of Brazil,
2012-2014
SERVICES INDICATORS 2012 2013 2014
Dispensing Total procedures 767 1771 2537
Number of Interventions - 5597 19224
Profile of pharmacotherapy problem - DRP 1(116);
DRP 2(5);
DRP 3(56);
DRP 4(220);
DRP 5(48);
DRP 6(17);
DRP 7 (350)
DRP 1(10);
DRP 2(12);
DRP 3(4);
DRP 4(159);
DRP 5(52);
DRP 6(70);
DRP 7 (209)
Measurement of blood pressure
Measurement of blood capillary
glucose
Total procedures 1481 3193 5039
Medication Review Number of consultations 49 87 357
Profile of pharmacotherapy problem
- DRP 1(0);
DRP 2(1);
DRP 3(N);
DRP 4(14);
DRP 5(1);
DRP 6(5);
DRP 7 (21)
DRP 1(7);
DRP 2(56);
DRP 3(36);
DRP 4(43);
DRP 5(24);
DRP 6(39);
DRP 7(127)
209
Table 1 – (continuation) Performande of clinical pharmacy services developed in the “Farmácia Popular do Brasil” Program in a State in
Northeast of Brazil, 2012-2014
SERVICES INDICATORS 2012 2013 2014
Medication Therapy Management Number of consultations 15 33 271
Profile of pharmacotherapy problem DRP 1(N);
DRP 2(N);
DRP 3(N);
DRP 4(3);
DRP 5(1);
DRP 6(1);
DRP 7 (4)
DRP 1(2);
DRP 2(51);
DRP 3(20);
DRP 4(13);
DRP 5(8);
DRP 6(9);
DRP 7(42)
210
CONSIDERAÇÕES FINAIS
211
5.1. CONCLUSÃO GERAL
A revisão sistemática pode dar subsídio quanto aos indicadores mais utilizados
para avaliar os resultados clínicos, econômicos e humanísticos. Deste modo, subsidiou
os pesquisadores no momento de seleção de instrumentos de avaliação dos serviços
clínicos farmacêuticos. A avaliação da percepção dos Farmacêuticos foi essencial para
entender como foi possível consolidar os serviços clínicos e saber quais as barreiras e
facilitadores que influenciaram neste processo. Pode-se observer que a consolidação de
serviços clínicos farmacêuticas exigem várias etapas como: formação profissional,
definição dos serviços e processos, seleção de indicadores, elaboração de planos
estratégicos e intervenções de marketing dos serviços. Nesta perspectiva, os resultados
observados poderão embasar a construção de um modelo diferenciado e replicável de
serviços clínicos farmacêuticos em farmácias comunitárias.
5.2 PERSPECTIVAS
Espera-se que as iniciativas de pesquisa baseada na prática sejam ampliadas e a
parceria Universidade-Serviço possa fomentar o desenvolvimento de indicadores de
qualidade, a fim de atender as demandas oriundas do Sistema Único de Saúde. Deste
modo, futuros estudos poderão ser desenvolvidos, sobretudo no que concerne a
sustentabilidade da implantação dos serviços clínicos farmacêuticos.
Este estudo poderá subsidiar novas pesquisas sobre implantação de serviços
clínicos tanto pelos integrantes do Laboratório de Ensino e Pesquisa em Farmácia
Social da UFS, quanto pelos farmacêuticos que almejem implantar tais serviços em
farmácias comunitárias, sobretudo os profissionais das Farmácias Populares do Brasil.
212
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218
APÊNDICES
X
X
219
7. APÊNDICES
7.1 APÊNDICE A – INSTRUMENTOS DESENVOLVIDOS: 16 PASSOS PARA BOA DISPENSAÇÃO
220
7.2 APÊNDICE B – INSTRUMENTOS DESENVOLVIDOS: CARTÃO DE
ACOMPANHAMENTO DOS PARÂMETROS CLÍNICOS
221
7.3 APÊNDICE C – INSTRUMENTOS DESENVOLVIDOS: CONTROLE DE ENTREGA E TIPO DE SERVIÇOS
222
7.4 APÊNDICE D – INSTRUMENTOS DESENVOLVIDOS: EVOLUÇÃO
FARMACOTERAPÊUTICA
223
7.5 APÊNDICE E – INSTRUMENTOS DESENVOLVIDOS: TABELA DE HORÁRIO DOS MEDICAMENTOS
224
7.6 APÊNDICE F – INSTRUMENTOS DESENVOLVIDOS: FICHA DE REGISTRO DOS PARÂMETROS CLÍNICOS
225
7.7 APÊNDICE G – INSTRUMENTOS DESENVOLVIDOS: INFORMAÇÕES
BÁSICAS PARA PACIENTES NA DISPENSAÇÃO
226
ANEXOS
X
X
227
8. ANEXOS
8.1 ANEXO A: REGRAS DE PUBLICAÇÃO
CAPÍTULO I - “PROFILE OF PHARMACEUTICAL SERVICES IN COMMUNITY
PHARMACY: SYSTEMATIC REVIEW”
CAPÍTULO III – “ESTABLISHMENT, IMPLEMENTATION, AND
CONSOLIDATION OF CLINICAL PHARMACY SERVICES IN COMMUNITY
PHARMACIES: PERCEPTIONS OF A GROUP OF PHARMACISTS”,
CAPÍTULO V - “CLINICAL PHARMACY SERVICES IN THE FARMÁCIA
POPULAR DO BRASIL PROGRAM IN NORTHEAST STATE OF BRAZIL:
ESTABLISHIMENT, IMPLEMENTATION AND CONSOLIDATION”,
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Please write your text in good English (American or British usage is accepted, but not a
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Submit your article
Please submit your article via http://ees.elsevier.com/rsap/.
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For all research manuscripts (including educational research), the author should indicate in the
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review. For research that has undergone such review and approval, a statementto that effect
should be included in the methods section.
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Article Synopsis
With your article submission please include a brief synopsis of the article to appear in the print
editionâ??s table of contents. The synopsis should be approximately 80-100 words in length,
simply stating in summary the studyâ??s purpose and principal findings along with a very brief
mention of the methods employed. The following are example synopses which may be
modeled.
This article describes a qualitative research study using focus groups to explore consumer
views of pharmacogenomics. A number of themes emerged from the focus groups, including
incidence of medication side effects, privacy of genetic information, and costs of tests.
Pharmacogenetic testing was seen as a potential positive contribution, but only if other factors
were considered during the prescribing process. Since participants desired a high level of
information from healthcare professionals, pharmacogenetic education of clinicians and
pharmacists will be essential to satisfy patients' needs.
Pharmacists have an important role in detecting, preventing and solving prescription problems.
In this study, pharmacists contacted prescribers for 1% of all new prescriptions for clarification,
completion, or correction before dispensing. Errors that may compromise patient safety and
medication outcome constituted almost 60% of the identified problems. There was an inverse
correlation between intervention rates and the pharmacy's dispensing volume. Computerized
physician order entry and electronically transmitted prescriptions may reduce the total rate of
prescription problems but may also introduce new clinically important errors.
The theoretical framework of organizational flexibility was used to determine the needs of
pharmacies when delivering services. A 25-item scale was developed to measure the level of
importance and required improvement needed when implementing services in Australian
community pharmacies. The analysis revealed gaps in the capacity of community pharmacy
that could be addressed through management programs. To effectively implement services and
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sustain service delivery, more sophisticated planning and performance monitoring systems are
required, supported by changes to infrastructure and staff mix.
Use of word processing software
It is important that the file be saved in the native format of the word processor used. The text
should be in single-column format. Keep the layout of the text as simple as possible. Most
formatting codes will be removed and replaced on processing the article. In particular, do not
use the word processor's options to justify text or to hyphenate words. However, do use bold
face, italics, subscripts, superscripts etc. When preparing tables, if you are using a table grid,
use only one grid for each individual table and not a grid for each row. If no grid is used, use
tabs, not spaces, to align columns. The electronic text should be prepared in a way very similar
to that of conventional manuscripts (see also the Guide to Publishing with Elsevier:
http://www.elsevier.com/guidepublication). Note that source files of figures, tables and text
graphics will be required whether or not you embed your figures in the text. See also the
section on Electronic artwork.
To avoid unnecessary errors you are strongly advised to use the 'spell-check' and 'grammar-
check' functions of your word processor.
Embedded math equations
If you are submitting an article prepared with Microsoft Word containing embedded math
equations then please read this related support information
(http://support.elsevier.com/app/answers/detail/a_id/302/).
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Article structure
Subdivision - unnumbered sections
Divide your article into clearly defined sections. Each subsection is given a brief heading. Each
heading should appear on its own separate line. Subsections should be used as much as possible
when cross-referencing text: refer to the subsection by heading as opposed to simply 'the text'.
Introduction
State the objectives of the work and provide an adequate background, avoiding a detailed
literature survey or a summary of the results.
Material and methods
Provide sufficient detail to allow the work to be reproduced. Methods already published should
be indicated by a reference: only relevant modifications should be described.
Results
Results should be clear and concise.
Discussion
This should explore the significance of the results of the work, not repeat them. A combined
Results and Discussion section is often appropriate. Avoid extensive citations and discussion of
published literature.
Conclusions
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The main conclusions of the study may be presented in a short Conclusions section, which may
stand alone or form a subsection of a Discussion or Results and Discussion section.
Essential title page information
• Title. Concise and informative. Titles are often used in information-retrieval systems. Avoid
abbreviations and formulae where possible.
• Author names and affiliations. Where the family name may be ambiguous (e.g., a double
name), please indicate this clearly. Present the authors' affiliation addresses (where the actual
work was done) below the names. Indicate all affiliations with a lower-case superscript letter
immediately after the author's name and in front of the appropriate address. Provide the full
postal address of each affiliation, including the country name and, if available, the e-mail
address of each author.
• Corresponding author. Clearly indicate who will handle correspondence at all stages of
refereeing and publication, also post-publication. Ensure that phone numbers (with country and
area code) are provided in addition to the e-mail address and the complete postal address.
Contact details must be kept up to date by the corresponding author.
• Present/permanent address. If an author has moved since the work described in the article was
done, or was visiting at the time, a 'Present address' (or 'Permanent address') may be indicated
as a footnote to that author's name. The address at which the author actually did the work must
be retained as the main, affiliation address. Superscript Arabic numerals are used for such
footnotes.
Structured abstract
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A structured abstract, by means of appropriate headings, should provide the context or
background for the research and should state its purpose, basic procedures (selection of study
subjects or laboratory animals, observational and analytical methods), main findings (giving
specific effect sizes and their statistical significance, if possible), and principal conclusions. It
should emphasize new and important aspects of the study or observations.
Graphical abstract
Although a graphical abstract is optional, its use is encouraged as it draws more attention to the
online article. The graphical abstract should summarize the contents of the article in a concise,
pictorial form designed to capture the attention of a wide readership. Graphical abstracts should
be submitted as a separate file in the online submission system. Image size: Please provide an
image with a minimum of 531 × 1328 pixels (h × w) or proportionally more. The image should
be readable at a size of 5 × 13 cm using a regular screen resolution of 96 dpi. Preferred file
types: TIFF, EPS, PDF or MS Office files. See http://www.elsevier.com/graphicalabstracts for
examples.
Authors can make use of Elsevier's Illustration and Enhancement service to ensure the best
presentation of their images and in accordance with all technical requirements: Illustration
Service.
Keywords
Immediately after the abstract, provide a maximum of 6 keywords, using American spelling
and avoiding general and plural terms and multiple concepts (avoid, for example, 'and', 'of'). Be
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sparing with abbreviations: only abbreviations firmly established in the field may be eligible.
These keywords will be used for indexing purposes.
Abbreviations
Define abbreviations that are not standard in this field in a footnote to be placed on the first
page of the article. Such abbreviations that are unavoidable in the abstract must be defined at
their first mention there, as well as in the footnote. Ensure consistency of abbreviations
throughout the article.
Acknowledgements
Collate acknowledgements in a separate section at the end of the article before the references
and do not, therefore, include them on the title page, as a footnote to the title or otherwise. List
here those individuals who provided help during the research (e.g., providing language help,
writing assistance or proof reading the article, etc.).
Artwork
Electronic artwork
General points
• Make sure you use uniform lettering and sizing of your original artwork.
• Embed the used fonts if the application provides that option.
• Aim to use the following fonts in your illustrations: Arial, Courier, Times New Roman,
Symbol, or use fonts that look similar.
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• Number the illustrations according to their sequence in the text.
• Use a logical naming convention for your artwork files.
• Provide captions to illustrations separately.
• Size the illustrations close to the desired dimensions of the printed version.
• Submit each illustration as a separate file.
A detailed guide on electronic artwork is available on our website:
http://www.elsevier.com/artworkinstructions
You are urged to visit this site; some excerpts from the detailed information are given here.
Formats
If your electronic artwork is created in a Microsoft Office application (Word, PowerPoint,
Excel) then please supply 'as is' in the native document format.
Regardless of the application used other than Microsoft Office, when your electronic artwork is
finalized, please 'Save as' or convert the images to one of the following formats (note the
resolution requirements for line drawings, halftones, and line/halftone combinations given
below):
EPS (or PDF): Vector drawings, embed all used fonts.
TIFF (or JPEG): Color or grayscale photographs (halftones), keep to a minimum of 300 dpi.
TIFF (or JPEG): Bitmapped (pure black & white pixels) line drawings, keep to a minimum of
1000 dpi.
TIFF (or JPEG): Combinations bitmapped line/half-tone (color or grayscale), keep to a
minimum of 500 dpi.
Please do not:
• Supply files that are optimized for screen use (e.g., GIF, BMP, PICT, WPG); these typically
have a low number of pixels and limited set of colors;
• Supply files that are too low in resolution;
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• Submit graphics that are disproportionately large for the content.
Color artwork
Please make sure that artwork files are in an acceptable format (TIFF (or JPEG), EPS (or PDF),
or MS Office files) and with the correct resolution. If, together with your accepted article, you
submit usable color figures then Elsevier will ensure, at no additional charge, that these figures
will appear in color on the Web (e.g., ScienceDirect and other sites) regardless of whether or
not these illustrations are reproduced in color in the printed version. For color reproduction in
print, you will receive information regarding the costs from Elsevier after receipt of your
accepted article. Please indicate your preference for color: in print or on the Web only. For
further information on the preparation of electronic artwork, please see
http://www.elsevier.com/artworkinstructions.
Please note: Because of technical complications that can arise by converting color figures to
'gray scale' (for the printed version should you not opt for color in print) please submit in
addition usable black and white versions of all the color illustrations.
Illustration services
Elsevier's WebShop (http://webshop.elsevier.com/illustrationservices) offers Illustration
Services to authors preparing to submit a manuscript but concerned about the quality of the
images accompanying their article. Elsevier's expert illustrators can produce scientific,
technical and medical-style images, as well as a full range of charts, tables and graphs. Image
'polishing' is also available, where our illustrators take your image(s) and improve them to a
professional standard. Please visit the website to find out more.
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Figure captions
Ensure that each illustration has a caption. Supply captions separately, not attached to the
figure. A caption should comprise a brief title (not on the figure itself) and a description of the
illustration. Keep text in the illustrations themselves to a minimum but explain all symbols and
abbreviations used.
Tables
Number tables consecutively in accordance with their appearance in the text. Place footnotes to
tables below the table body and indicate them with superscript lowercase letters. Avoid vertical
rules. Be sparing in the use of tables and ensure that the data presented in tables do not
duplicate results described elsewhere in the article.
References
Citation in text
Please ensure that every reference cited in the text is also present in the reference list (and vice
versa). Any references cited in the abstract must be given in full. Unpublished results and
personal communications are not recommended in the reference list, but may be mentioned in
the text. If these references are included in the reference list they should follow the standard
reference style of the journal and should include a substitution of the publication date with
either 'Unpublished results' or 'Personal communication'. Citation of a reference as 'in press'
implies that the item has been accepted for publication.
Reference links
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Increased discoverability of research and high quality peer review are ensured by online links
to the sources cited. In order to allow us to create links to abstracting and indexing services,
such as Scopus, CrossRef and PubMed, please ensure that data provided in the references are
correct. Please note that incorrect surnames, journal/book titles, publication year and pagination
may prevent link creation. When copying references, please be careful as they may already
contain errors. Use of the DOI is encouraged.
Web references
As a minimum, the full URL should be given and the date when the reference was last
accessed. Any further information, if known (DOI, author names, dates, reference to a source
publication, etc.), should also be given. Web references can be listed separately (e.g., after the
reference list) under a different heading if desired, or can be included in the reference list.
References in a special issue
Please ensure that the words 'this issue' are added to any references in the list (and any citations
in the text) to other articles in the same Special Issue.
Reference style
Text: Indicate references by (consecutive) superscript arabic numerals in the order in which
they appear in the text. The numerals are to be used outside periods and commas, inside colons
and semicolons. For further detail and examples you are referred to the AMA Manual of Style,
A Guide for Authors and Editors, Tenth Edition, ISBN 0-978-0-19-517633-9 (see
http://www.amanualofstyle.com).
List: Number the references in the list in the order in which they appear in the text.
Examples:
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Reference to a journal publication:
1. Van der Geer J, Hanraads JAJ, Lupton RA. The art of writing a scientific article. J Sci
Commun. 2010;163:51–59.
Reference to a book:
2. Strunk W Jr, White EB. The Elements of Style. 4th ed. New York, NY: Longman; 2000.
Reference to a chapter in an edited book:
3. Mettam GR, Adams LB. How to prepare an electronic version of your article. In: Jones BS,
Smith RZ, eds. Introduction to the Electronic Age. New York, NY: E-Publishing Inc;
2009:281–304.
Journal abbreviations source
Journal names should be abbreviated according to the List of Title Word Abbreviations:
http://www.issn.org/services/online-services/access-to-the-ltwa/.
Video data
Elsevier accepts video material and animation sequences to support and enhance your scientific
research. Authors who have video or animation files that they wish to submit with their article
are strongly encouraged to include links to these within the body of the article. This can be
done in the same way as a figure or table by referring to the video or animation content and
noting in the body text where it should be placed. All submitted files should be properly labeled
so that they directly relate to the video file's content. In order to ensure that your video or
animation material is directly usable, please provide the files in one of our recommended file
formats with a preferred maximum size of 50 MB. Video and animation files supplied will be
published online in the electronic version of your article in Elsevier Web products, including
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ScienceDirect: http://www.sciencedirect.com. Please supply 'stills' with your files: you can
choose any frame from the video or animation or make a separate image. These will be used
instead of standard icons and will personalize the link to your video data. For more detailed
instructions please visit our video instruction pages at
http://www.elsevier.com/artworkinstructions. Note: since video and animation cannot be
embedded in the print version of the journal, please provide text for both the electronic and the
print version for the portions of the article that refer to this content.
AudioSlides
The journal encourages authors to create an AudioSlides presentation with their published
article. AudioSlides are brief, webinar-style presentations that are shown next to the online
article on ScienceDirect. This gives authors the opportunity to summarize their research in their
own words and to help readers understand what the paper is about. More information and
examples are available at http://www.elsevier.com/audioslides. Authors of this journal will
automatically receive an invitation e-mail to create an AudioSlides presentation after
acceptance of their paper.
Supplementary data
Elsevier accepts electronic supplementary material to support and enhance your scientific
research. Supplementary files offer the author additional possibilities to publish supporting
applications, high-resolution images, background datasets, sound clips and more.
Supplementary files supplied will be published online alongside the electronic version of your
article in Elsevier Web products, including ScienceDirect: http://www.sciencedirect.com. In
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order to ensure that your submitted material is directly usable, please provide the data in one of
our recommended file formats. Authors should submit the material in electronic format
together with the article and supply a concise and descriptive caption for each file. For more
detailed instructions please visit our artwork instruction pages at
http://www.elsevier.com/artworkinstructions.
Submission checklist
The following list will be useful during the final checking of an article prior to sending it to the
journal for review. Please consult this Guide for Authors for further details of any item.
Ensure that the following items are present:
One author has been designated as the corresponding author with contact details:
• E-mail address
• Full postal address
• Phone numbers
All necessary files have been uploaded, and contain:
• Keywords
• All figure captions
• All tables (including title, description, footnotes)
Further considerations
• Manuscript has been 'spell-checked' and 'grammar-checked'
• References are in the correct format for this journal
• All references mentioned in the Reference list are cited in the text, and vice versa
• Permission has been obtained for use of copyrighted material from other sources (including
the Web)
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• Color figures are clearly marked as being intended for color reproduction on the Web (free of
charge) and in print, or to be reproduced in color on the Web (free of charge) and in black-and-
white in print
• If only color on the Web is required, black-and-white versions of the figures are also supplied
for printing purposes
For any further information please visit our customer support site at http://support.elsevier.com.
Use of the Digital Object Identifier
The Digital Object Identifier (DOI) may be used to cite and link to electronic documents. The
DOI consists of a unique alpha-numeric character string which is assigned to a document by the
publisher upon the initial electronic publication. The assigned DOI never changes. Therefore, it
is an ideal medium for citing a document, particularly 'Articles in press' because they have not
yet received their full bibliographic information. Example of a correctly given DOI (in URL
format; here an article in the journal Physics Letters B):
http://dx.doi.org/10.1016/j.physletb.2010.09.059
When you use a DOI to create links to documents on the web, the DOIs are guaranteed never to
change.
Proofs
One set of page proofs (as PDF files) will be sent by e-mail to the corresponding author (if we
do not have an e-mail address then paper proofs will be sent by post) or, a link will be provided
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in the e-mail so that authors can download the files themselves. Elsevier now provides authors
with PDF proofs which can be annotated; for this you will need to download Adobe Reader
version 9 (or higher) available free from http://get.adobe.com/reader. Instructions on how to
annotate PDF files will accompany the proofs (also given online). The exact system
requirements are given at the Adobe site: http://www.adobe.com/products/reader/tech-
specs.html.
If you do not wish to use the PDF annotations function, you may list the corrections (including
replies to the Query Form) and return them to Elsevier in an e-mail. Please list your corrections
quoting line number. If, for any reason, this is not possible, then mark the corrections and any
other comments (including replies to the Query Form) on a printout of your proof and return by
fax, or scan the pages and e-mail, or by post. Please use this proof only for checking the
typesetting, editing, completeness and correctness of the text, tables and figures. Significant
changes to the article as accepted for publication will only be considered at this stage with
permission from the Editor. We will do everything possible to get your article published
quickly and accurately. It is important to ensure that all corrections are sent back to us in one
communication: please check carefully before replying, as inclusion of any subsequent
corrections cannot be guaranteed. Proofreading is solely your responsibility.
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CAPÍTULO II – “CLINICAL PHARMACY SERVICES IN BRAZILIAN PUBLIC
COMMUNITY PHARMACIES: A PILOT STRUCTURE’S QUALITY ASSESSMENT STUDY”,
Periódico: Health Services Research.
Section 1: The Vision and Mission of HSR
The primary purpose of Health Services Research is to provide researchers and public and
private policymakers with the latest research findings, methods, and concepts regarding the
financing, organization, delivery, evaluation, and outcomes of health services, and with
analysis of their relationships to clinical practice, management, and policy.
Additionally, HSR provides a mechanism for linking the various disciplines engaged in health
services research and for disseminating the results to those charged with improving the health
of individuals and communities and setting evidence-based policy.
VISION: To be the preferred outlet for:
Dissemination of the findings of original investigations that expand knowledge and
understanding of the broad field of health care and that help to improve the health of
individuals and communities
Analysis and discussion of the implications of these findings for clinical practice,
management, and policy in both U.S. and global contexts
KEY VALUES: ∞ Scientific Integrity ∞Timeliness ∞ Methodological Rigor ∞ Creativity ∞
Policy and Practice Relevance ∞ Clarity of Thought and Expression ∞ Significance ∞
Originality
MISSION: To further our vision and values by publishing thoughtful, timely, rigorously
conducted, state-of-the-art research articles and commentary and that are widely disseminated
and meet the highest standards of scientific peer review.
Section 2: Specific Areas of Research Targeted by HSR
Areas of specific interest for manuscripts include:
252
1. Issues related to the delivery of care—for example, access to and utilization of health
services; cost, cost-effectiveness, quality, and outcomes of care; practice variations,
technology assessment, and health care workforce issues;
2. Assessments of the impact of or changes in specific policies and interventions on
health care delivery—for example, Medicare and Medicaid, state health policies and
regulations, payment policies, personnel licensure and certification, and antitrust
enforcement;
3. Evaluation of national demonstration programs—particularly those focusing on
disease prevention, chronic disease management, and community-based efforts to
integrate services or promote health;
4. Examinations of changes in health services organizations, systems of care, managed
care, and related developments, including comparisons of systems across nations;
and
5. Examinations of the relative importance of biological, behavioral, social, and political
factors, in addition to health care, as determinants of health outcomes.
International Manuscript Submissions: While we welcome manuscripts from outside of the
U.S., HSR has a largely US-based audience and so we want our international articles to 1)
provide enough context about the health care setting in which the research takes place for our
readers to judge its results and implications appropriately and 2) help draw out the implications
of the work for health services research as it can be adapted to the US system.
Section 3: Five Types of Peer-Reviewed Manuscripts in Regular Issues
Authors submitting for a regular issue are asked to indicate which among five types of
manuscripts is best for their manuscript. A manuscript based on an empirical study generally
will include a statement of the problem, objectives of the research, methodology used, and
discussion of the analysis and findings. In addition, the manuscript should include a thoughtful
discussion of the relevance of the findings to clinical practice, health services management, or
health care policy development.
HSR publishes five basic types of manuscripts in its regular issues. Most issues include full-
length research articles, research briefs, and methods articles:
253
1. Full-length research articles deal with important empirical issues involving health and
health services.
2. Research briefs involve incremental contributions to the literature such as validation or
extensions of previous work, single-setting studies, or case studies. A research brief is
also appropriate for articles in which the essential message can be communicated in
fewer pages.
3. Methods articles and briefs focus on contributions involving the development of new
methods and tools, the application of current methods in novel ways, and examination
of the pros and cons of using different methods and tools in particular study situations
and empirical settings. Health Services Research is interested in studies that
appropriately apply the full range of research methods, from quantitative to qualitative
and from primary data to analytic reviews of the literature. These articles may also
serve to introduce methodological approaches understood by one discipline to readers in
other disciplines.
From time to time, issues will include policy/managerial impact articles or
debates/commentaries. These are typically invited by the editors:
4. Policy impact articles are thoughtful essays on the impact of health services research
on policy and managerial decision makers, the overall relationship between health
services research and the users of research, or articles that examine the impact of
specific health services research initiatives on an overall body of work in the field.
These include the Chair’s Address and selected Roundtable panel discussions from the
AcademyHealth Annual Research Meetings.
5. Debates/Commentaries feature pro and con views on important, controversial health
services or policy issues or commentary on an article in the issue.
Section 4: Publication in Print and Electronically
HSR publishes in print six issues and two special or theme issues annually. All manuscripts
published in print are also published electronically. Electronic versions may include color and
are accompanied by any electronic-only appendices and disclosures. HSR now publishes
manuscripts OnLine Early usually within less than six months of acceptance. These are fully
citable as being published. Articles subsequently appear in a regular printed issue, within a few
months of publication Online Early.
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Section 5: Special Issues and Theme Issues
1. Special issues (usually bound separately) or special sections in regular issues.
Up to twice a year, HSR publishes special issues or special sections, usually based on
papers presented at conferences. These papers are subject to the same external peer
review process as other papers submitted to the journal. Thus, there is no guarantee that
a paper presented at a conference and subsequently submitted to HSR will be published.
All special issues and sections are supported by outside funds, and proposals require
editorial approval.
Sponsors or guest editors for a special issue should contact the editors
[email protected] and click here for recent special issues and a link to an editorial
on the process. A manual for guest editors is available via the business manager
for HSR at HRET.
2. Theme issues are bound separately but are based on a call for papers on a particular
theme developed and issued by the editors of HSR and the publisher. These
manuscripts undergo the usual peer review process but are published as a set or series.
See our Web for an editorial about the theme issue series (see "from the editors" section
of www.hsr.org). For current calls for theme issues, see the home page at www.hsr.org.
Back to Top
Section 6: External Peer Review Process
Manuscripts submitted to HSR are subject to review by the editorial staff and, if they clear the
initial review, by external peer review from at least two reviewers. Authors are encouraged to
suggest reviewers for their manuscript who have appropriate expertise but no apparent or real
conflicts of interest; we prefer 2 to 4 suggestions but up to 10 (all with e-mail addresses) can be
named. However, there is no guarantee that suggested individuals will be used. Authors may
also request that specific reviewers not be used.
HSR's electronic peer review system permits each author to monitor the progress of the
manuscript through the peer review process via our Web site on Manuscript Central. We
generally make an initial decision to reject or send out for external review within two weeks of
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submission. For more information about our peer review process and times associated with
each step, see our “From the Editors” editorials at www.HSR.org.
Back to Top
Section 7: Requirement of Original Manuscripts and Disclosure of Prior Dissemination
Only original manuscripts will be considered for publication. Articles published, accepted, or
submitted for publication elsewhere will not be considered. Articles previously distributed
publicly via the Internet or via national meetings may be accepted, subject to the approval of
the editors. Prior dissemination of findings does not automatically preclude review and
acceptance of an article, but raises the bar with respect to how publication in HSR will benefit
the field. Prior dissemination or concurrent submission must be disclosed at the time of
submission. For further detail, see "Policy on Prior Dissemination" located at www.hsr.org.
Back to Top
Section 8: Additional Material Published in HSR
Additional types of material may be published in HSR, either in print or exclusively in
electronic form:
1. Updates from AcademyHealth and other organizations. HSR publishes a regular
update of activities and key news from AcademyHealth, the official sponsor of HSR.
The journal will also publish selected 500-word abstracts of key reports from
governmental agencies such as the Agency for Healthcare Research and Quality,
Centers for Disease Control and Prevention, Congressional Budget Office, Food and
Drug Administration, Department of Health and Human Services, and the Office of
Management and Budget, as well as reports from private foundations.
2. Electronic-only appendices and use of color in electronic versions. HSR will publish,
at the co-editors’ discretion, electronic-only supplemental materials and color
figures that will appear only in the Web-based version of the published journal. These
materials should be referenced in the printed article and will be maintained permanently
by Blackwell Publications. We will also publish the author and contributor grid as an
electronic appendix.
3. Other electronic-only published material. In addition, HSR will occasionally create
electronic-only features designed to improve the peer review process or enhance the
256
field, for example, by illustrating the evolution of an article through the peer review
process; encouraging reactions and comments on innovations in the field; providing
databases or supplemental appendices for readers to perform additional analyses or
examine details of instruments used or analyses performed that are not available in the
print version of HSR. We welcome suggestions and nominations for such features.
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Section 9: Preparation of Manuscript to Submit to HSR
1. General order of presentation of material. In the manuscript as submitted, please use
this preferred order: the title and structured abstract (with keywords) are first, followed
by the text, generally without embedded tables and figures. After the text, place notes
(if any) and references; place tables and figures at the end of the article, following the
references. We prefer that all text and notes, references, tables, and figures be included
in the same electronic file or in as few separate electronic files as possible.
2. Text style and manuscript length "word counts and tables/figure
maximums." ALL MANUSCRIPTS MUST BE SUBMITTED IN ELECTRONIC
FORM via the Web-based peer review system located
at http://mc.manuscriptcentral.com/hsr. Authors’ identifying information should appear
only in a cover letter or notes to the editors and appropriate author fields, not in the
manuscript file, its headers or footers, or in the file name. Manuscripts should
preferably be submitted in a single document, including tables and figures, using Word
or WordPerfect and double-spaced. Please use U.S. English spellings and be sure to
number all pages for easy reference. Only if necessary, include tables or figures in a
separate file; PowerPoint or Excel are acceptable. Provide a brief structured abstract
(defined below) and up to five key words that reflect the content of the manuscript.
Full-length research manuscripts and methods articles, including text and any notes,
should be no longer than 4800 words (abstract, references, tables and figures are not
included in this count). The abstract should be no longer than 200 words. The number
of tables and figures should not exceed five.
Research and methods briefs and commentaries should not exceed 2500 words (text and
any notes) with an abstract limited to 125 words.
257
Longer manuscripts or manuscripts with more than five tables/figures may be published
if there is a compelling justification. Requests to waive the maximums will be handled
on a case-by-case basis through discussions between the corresponding author and
editors assigned to the manuscript. The editors may ask that certain text and
tables/figures be posted on the Web as supplementary material; authors are encouraged
to avail themselves of this opportunity whenever appropriate.
3. Structured abstract. Manuscripts that are submitted as a research article, research
brief, or methods article or brief are required to have a structured abstract prepared
according to the format described herein. (Manuscripts submitted as a policy impact or
commentary/debate may have a more flexible structure for their abstracts that conveys
at least the objectives of the piece, the principal findings, and conclusions.) Manuscripts
without appropriate abstracts will not be accepted. Each abstract should not exceed the
word count and should include information under each of the following headings:
Objective (or study question). Provide a single partial sentence, beginning with the
word ‘‘To,’’ indicating the principal reason for conducting the study. For example: ‘‘To
test’’ a specific hypothesis or theory.
Data sources/study setting. Provide a single partial sentence indicating whether
primary or secondary data were collected and the time frame of the data collection.
Descriptions of the study setting, with regard to both primary and secondary analyses
"in complete sentence(s)", will help to establish the generalizability of the findings.
Study design. Describe succinctly (with complete sentences) the general structure of
the study approach, indicating whether the study involved an intervention,
randomization of subjects, or particular diagnostic or therapeutic procedures, and
whether measures were taken at multiple points in time. Identify the key variables in the
analysis.
Data collection/extraction methods. Indicate in complete sentence(s) the procedures
used in assembling the data for the analyses.
Principal findings. Using complete sentences, focus on the most important
observations from the data pertinent to the questions or issues identified.
258
Conclusions. Using complete sentences, mention only those conclusions directly
supported by the data from this particular study. Avoid speculative observations but
indicate the extent to which additional research may be required to address the central
issues raised in the article.
Key words (part of abstract). At the end of the abstract, provide no more than five
terms or concepts that reflect the essential content and message of the article. These
keywords can differ from those required in the pull-down menu on the Web-based
system for submitting articles. Please note that the author should also select key words
from the pull-down menu of choices on the Web page. The latter are used to categorize
the manuscripts and select reviewers; therefore it is very important to select all
appropriate pre-determined keywords, in addition to any included in the manuscript.
4. Mathematics/formulas. Only if absolutely necessary should mathematical equations or
expressions be included. Keep mathematical notation as simple as possible. Avoid
barred, dotted, or otherwise-accented symbols; use only one superior and one inferior
level of superscript and subscript; and use ‘‘slash’’ rather than ‘‘stacked’’ fraction
forms in equations, especially where complex terms appear in the fraction.
5. Endnotes. Endnotes are additional explanatory statements outside the "flow of the
text." If used, they should be kept to a minimum. Cite endnotes in the text with a
superscript number and list them, double-spaced, at the end of the text and before the
references. Do not list notes at the bottom of the page. A note is not a reference but may
refer to one.
Sample endnote:
1. Superscript numbers are standard procedure for notes in scholarly papers (Turabian
1963).
6. References. All references listed must be cited in the text, and all text citations must
have a reference listed. The in-text citation (usually in parentheses) should appear with
authors’ last names and the publication date.
Sample in-text citation for
• Up to three authors, use (Smith, Jones, and Reynolds 2006)
• Four or more authors, use (Smith et al. 2006)
List references separately at the end of the text (following notes), in alphabetical order.
259
Double-space each reference. Journal references must include names and initials of all
authors, title of article, name of journal spelled out, volume number, issue number (if
given), date or month/season (if given), first and last page number, and year of
publication. See examples below or in past issues of HSR.
We recommend using a tool such as EndNote or Reference Manager for reference
management and formatting. EndNote reference styles can be searched for
here:http://www.endnote.com/support/enstyles.asp
Reference Manager reference styles can be searched for
here:http://www.refman.com/support/rmstyles.asp
Please note: When EndNote (or, beginning in the fall of 2007, Reference Manager) is
used in the writing process, the article HTML proof within our Manuscript Central peer
review system will have its references linked directly into Web of Science. This features
allow authors to check accuracy of references. Link creation occurs during the file
upload part of the submission process, and currently takes approximately one second
per reference. We expect to see this time decrease over the next few months as new
resources come online.
Sample journal reference:
Florence, C.S., A. Atherly, and K.E. Thorpe. 2006. "Will Choice-Based Reform Work
for Medicare? Evidence from the Federal Employees Health Benefits Program." Health
Services Research 41(5): 1741-1761.
References to proceedings and other collections of papers should include the
specific pages referred to:
Francisco, E. 1970. ‘‘Analysis of Cost Variations Among Short-Term General
Hospitals.’’ In Empirical Studies on Health Economics: Proceedings of the Second
Conference on Economics of Health, edited by H. Klarman, pp. 321–32. Baltimore,
MD: Johns Hopkins Press.
References to unified books should be treated as illustrated:
Aday, L. A., C. E. Begley, D. R. Lairson, and C. H. Slater. 1993. Evaluating the
260
Medical Care System: Effectiveness, Efficiency, and Equity. Chicago: Health
Administration Press.
References to articles published in HSR’s Online Early, prior to being in a print
issue.
Zinn, J.S., V. Mor, Z. Feng, and O. Intrator. 2006. "Doing Better to Do Good: The
Impact of Strategic Adaptation on Nursing Home Performance." Health Services
Research, doi: 10.1111/j.1475-6773.2006.00649.x
[Note: to search online at Blackwell for an HSR article if you know its doi, append
the doi number to this address: http://dx.doi.org/. It will find the article whether it
is still in Online Early or assigned to a printed issue.]
Sample Web site and software references: Note: It is important that authors check
on the current availability of the Web site and in general refer only to those sites
that are expected to be available permanently.
Centers for Medicaid and Medicare Services. 2000. “State Children’s Health Insurance
Program (SCHIP) Aggregate Enrollment Statistics for the 50 States and the District of
Columbia for Federal Fiscal Year 2000” [accessed on August 8, 2003]. Available
at:http://www.cms.hhs.gov/schip/fy2000.pdf
Research Triangle Institute. 1997. SUDAAN (release 7.5) statistical software. Research
Triangle Park, NC: Research Triangle Institute.
7. Tables/figures. Each table and figure should be on a separate page in the file and must
be specifically cited within the text. In preparing tables and figures, please keep in mind
the image area of the printed journal: 4.5 inches by 7.0 inches. Keep titles brief but clear
and descriptive of the contents. Key the table footnotes to the body of the table with
symbols rather than numerals or letters. All illustrative artwork (all figures) must be
original and of camera-ready quality resolution. Color may be used, but note that the
printed version will appear in black and white only. We encourage authors to avoid
excess tabular data. Include no more than five tables or figures unless reasons for
additional tabular material are specified in the cover letter accompanying the
manuscript.
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8. English as a Second Language. Blackwell Publishing has introduced a service for
authors who speak English as a second language, providing some linkages to
nonaffiliated services that provide such services. Contacts and any fees should be
arranged directly with these services. Blackwell’s Web site with links to the suppliers’
Web pages can be found
atwww.blackwellpublishing.com/bauthor/english_language.asp
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Section 10. Disclosures and Criteria for Determining Authors and Other Contributors
1. Definitions. Health services research is increasingly a team effort, but not everyone on
the team has necessarily contributed enough and knows enough about the manuscript to
take responsibility for it, in exchange for receiving credit as an author.
To be considered an author, HSR requires that one make a substantial intellectual
contribution:
(1) in
(a) conception and design,
(b) acquisition of the data, or
(c) analysis and interpretation of the data
and
(2) in
(a) drafting the manuscript or
(b) critical revision of the manuscript for important intellectual content
All authors meeting the criteria for authorship must approve the final manuscript (including
revisions) and take public responsibility for it.
1. Contributorship matrix. Although we use the above explicit criteria for who should
receive the credit for (and accept the responsibility of) authorship, we also want to
facilitate the formal recognition of those playing other critical roles in the research
process. e.g., providing statistical analysis, programming, administrative, technical or
material support (including data), supervision, obtaining funding, initiating the study or
262
through other means. Thus, we will publish electronically a contributorship
matrix identifying who did what in the research—listing both the authors and other
contributors. On the behalf of all the authors, the corresponding author will certify that
all who have contributed to the study are appropriately identified in an
acknowledgement of contributorship and that all agree to such listing. Over time,
analysis of such information may lead to more formal recognition of the “idea people,”
“statisticians,” “commentators,” or “graphics experts” who helped create many great
manuscripts, yet were listed as the authors of none. A sample contributorship
matrix and disclosure form is available at www.hsr.org and
at http://mc.manuscriptcentral.com/hsr.
For a more complete discussion of the rationale for our approach to authorship, see New Policy
on Disclosures at Health Services Research.
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Section 11. Disclosures about Potential Conflicts of Interest and Funding
Authors will be asked to disclose all financial and material support (including the provision of
or access to data) for the research and to disclose to the editors all affiliations and financial
involvements with organizations with a financial or policy interest in the subject matter
discussed in the manuscript. Authors are also requested to disclose public stands they have
taken (in print, media, testimony, or other venues) that are identified with a particular advocacy
position relevant to the manuscript and whether their current (or at the time of writing)
organization is identified with such an advocacy position.
We also ask whether sponsors and/or supporters of the research (including employers and
providers of data) have contractual rights to (a) review and approve or (b) review and comment
on the manuscript within a reasonable number of days.
For a more complete discussion of the rationale for our approach to disclosures, see New Policy
on Disclosures at Health Services Research in the "From The Editors" section of www.hsr.org.
Disclosure process. At HSR we emphasize disclosure of sponsors and relationships to related
advocacy groups to the editors and reasonable publication of such information. With the
exception of “review and approve” clauses that raise the possibility of censorship, such
263
information will not enter into our decisions to accept or reject a manuscript. To minimize the
burden on both authors on editors, we do not require such disclosure statements until a
manuscript has cleared the initial hurdle of external review and revisions are requested. Before
submitting a manuscript to HSR, however, all authors should be aware of our
requirements for disclosure.
For accepted manuscripts, we will publish electronically and in print a one to three paragraph
acknowledgement/disclosure statement recognizing the various forms of support that made the
project possible and summarizing all real or potential financial and other conflicts about which
readers may be concerned. This statement reflects disclosures with respect to the project
supporting the work and the authors, and will be submitted by the corresponding author, with
the concurrence of all the authors.
Each author is expected to submit his or her own disclosure statement to the corresponding
author, and the corresponding author will be responsible for submitting the disclosure
statements and for working with the editors to create a combined disclosure statement for
publication. We expect that individual disclosures may go into more detail than needed for
publication and anticipate a few “rounds” of revisions to make sure the statements are
necessary and sufficient, but not overdone. To prevent manuscript publication from being
delayed during this process, we encourage all authors to submit drafts of their disclosures to the
corresponding author and encourage the corresponding author to submit a draft of the joint
statement as early in the peer review process as possible. We generally expect to see an initial
draft submitted with the first invitation to revise and resubmit. Please add it to the manuscript
record in our electronic peer review system (http://mc.manuscriptcentral.com/hsr ) in the area
‘for the editors only’ as supplemental files not for review. The editors will review the draft and
individual disclosures for consistency and completeness in parallel to the manuscript moving
through our normal process.
The disclosure form is available at www.hsr.org and at the authors instructions area when
submitting manuscripts at http://mc.manuscriptcentral.com/hsr.
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Section 12: Supplementary Materials
264
1. Required materials. Our Manuscript Central process requires authors, at submission,
to indicate any prior publication and conflicts of interest. Authors should explain
affirmative answers in the section for author’s notes or in an accompanying cover letter.
[See Sections 7 and 11 respectively for details.]
Copyright permission (required if relevant). If an article contains material
reproduced from other sources, written permission from the author and publisher to use
such material must be received prior to our sending the manuscript for review.
2. Optional materials. Three types of optional supplementary materials may be
submitted:
1. For the editors’ use only (example: disclosures; suggested reviewers who can
give an unbiased review; requests for people who should not be asked to review
this manuscript)
2. For the editors’ and reviewers’ use only (example: a paper that describes the
sample in more detail)
3. For an electronic-only appendix intended for all readers (example:
appendices with details on the questions used in a survey or a database)
Upload separate files to the windows clearly indicated for the type of supplementary
material, and describe briefly in the note area.
3. Acknowledgements and disclosure statements to be published if the manuscript is
accepted will not be sent to reviewers; please submit any files related to these in the
area indicated for supplementary material that is NOT intended for reviewers. These
files will be required only at the time of submitting a revised manuscript. Note: While
potential conflicts need to be addressed during the editorial review process, and prior
publication may influence the value of a manuscript as submitted, they will usually not
jeopardize publication. Failure to disclose these issues initially is a far more serious
problem and may rise to the level of being considered scientific misconduct.
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REGARDING MATERIALS ACCEPTED OR PUBLISHED IN HSR
265
Section 13: Copyediting and Publication
Once a manuscript is accepted for publication in HSR, the author will be asked to provide the
accepted version in both a document format (preferably using Microsoft Office Word or Excel)
and a PDF. Most modern word processing software can be accommodated; any PowerPoint
slides or figures must use high resolution. Edited page proofs are returned electronically to the
corresponding author for review. The author-approved copyedited manuscript should be
returned (with all additions, changes, and clarifications) within 48 hours of receipt. In the event
that the corresponding author does not respond, attempts to communicate with coauthors will
be made. Delays may result in postponement of the article or deletion from special issues.
Accompanying appendices and databases may be accepted for electronic publication and
mounted on the journal’s Web page. See here for the form. Be sure to add title and number and
authors’ information as well as signatures. Note that a signed hardcopy of the copyright transfer
form should be signed by the corresponding author on behalf of all authors and sent by mail to
the managing editor. The Certification and Disclosure form should be completed by the
corresponding author and uploaded onto our submission site if and when your manuscript is
asked to be revised.
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Section 14: Offprints and Reprints
After publication, each author will be furnished with one free print copy of the issue containing
his or her article. Corresponding authors will be sent a PDF of their article to use under
specified circumstances. NOTE: The contents of Health Services Research are protected by
copyright and may not be reproduced without permission. The note beneath the table of
contents indicates that the copyright owner consents to copy reproduction of the article for
personal or internal use by individuals or specific clients. For copying beyond that permitted in
Sections 107 and 108 of the U.S. Copyright Law (e.g., for copying for general distribution,
large-scale copying for internal distribution, copying for resale), the copier must pay the stated
per-copy fee through the Copyright Clearance Center, Inc. (P.O. Box 765, Schenectady, NY
12301).
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266
Section 15: Permissions to Reprint Articles from HSR in New Collective Work.
Please contact the Journals Rights & Permissions Coordinator, Blackwell Publishing, Osney
Mead, Oxford OX2 0EL, UK
Email: [email protected]
267
CAPÍTULO IV - “OVERCOMING BARRIERS TO IMPLEMENT CLINICAL
PHARMACY SERVICES IN COMMUNITY PHARMACIES: A QUALITATIVE STUDY”,
Periódico: Implementation Science.
Instructions for authors
Research articles
Submission process | Preparing main manuscript text | Preparing illustrations and
figures |Preparing tables | Preparing additional files | Style and language
See 'About this journal' for descriptions of different article types and information about policies
and the refereeing process.
Submission process
Manuscripts must be submitted by one of the authors of the manuscript, and should not be
submitted by anyone on their behalf. The submitting author takes responsibility for the article
during submission and peer review.
Please note that Implementation Science levies an article-processing charge on all accepted
Research articles; if the submitting author's institution is a BioMed Central member the cost of
the article-processing charge may be covered by the membership (see About page for detail).
Please note that the membership is only automatically recognised on submission if the
submitting author is based at the member institution.
To facilitate rapid publication and to minimize administrative costs, Implementation
Science prefersonline submission.
Files can be submitted as a batch, or one by one. The submission process can be interrupted at
any time; when users return to the site, they can carry on where they left off.
See below for examples of word processor and graphics file formats that can be accepted for
the main manuscript document by the online submission system. Additional files of any type,
such asmovies, animations, or original data files, can also be submitted as part of the
manuscript.
268
During submission you will be asked to provide a cover letter. Use this to explain why your
manuscript should be published in the journal, to elaborate on any issues relating to our
editorial policies in the 'About Implementation Science' page, and to declare any potential
competing interests. You will be also asked to provide the contact details (including email
addresses) of potential peer reviewers for your manuscript. These should be experts in their
field, who will be able to provide an objective assessment of the manuscript. Any suggested
peer reviewers should not have published with any of the authors of the manuscript within the
past five years, should not be current collaborators, and should not be members of the same
research institution. Suggested reviewers will be considered alongside potential reviewers
recommended by the Editor-in-Chief and/or Editorial Board members.
Assistance with the process of manuscript preparation and submission is available
from BioMed Central customer support team.
We also provide a collection of links to useful tools and resources for scientific authors on
our Useful Tools page.
File formats
The following word processor file formats are acceptable for the main manuscript document:
Microsoft word (DOC, DOCX)
Rich text format (RTF)
Portable document format (PDF)
TeX/LaTeX (use BioMed Central's TeX template)
DeVice Independent format (DVI)
TeX/LaTeX users: Please use BioMed Central's TeX template and BibTeX stylefile if you use
TeX format. During the TeX submission process, please submit your TeX file as the main
manuscript file and your bib/bbl file as a dependent file. Please also convert your TeX file into
a PDF and submit this PDF as an additional file with the name 'Reference PDF'. This PDF will
be used by internal staff as a reference point to check the layout of the article as the author
intended. Please also note that all figures must be coded at the end of the TeX file and not
inline.
If you have used another template for your manuscript, or if you do not wish to use BibTeX,
then please submit your manuscript as a DVI file. We do not recommend converting to RTF.
269
For all TeX submissions, all relevant editable source must be submitted during the submission
process. Failing to submit these source files will cause unnecessary delays in the publication
procedures.
Preparing main manuscript text
General guidelines of the journal's style and language are given below.
Overview of manuscript sections for Research articles
Manuscripts for Research articles submitted to Implementation Science should be divided into
the following sections (in this order):
Title page
Abstract
Keywords
Background
Methods
Results and discussion
Conclusions
Availability of supporting data
List of abbreviations used (if any)
Competing interests
Authors' contributions
Authors' information
Acknowledgements
Endnotes
References
Illustrations and figures (if any)
Tables and captions
Preparing additional files
The Accession Numbers of any nucleic acid sequences, protein sequences or atomic
coordinates cited in the manuscript should be provided, in square brackets and include the
corresponding database name; for example, [EMBL:AB026295, EMBL:AC137000,
DDBJ:AE000812, GenBank:U49845, PDB:1BFM, Swiss-Prot:Q96KQ7, PIR:S66116].
270
The databases for which we can provide direct links are: EMBL Nucleotide Sequence Database
(EMBL), DNA Data Bank of Japan (DDBJ), GenBank at the NCBI (GenBank), Protein Data
Bank (PDB), Protein Information Resource (PIR) and the Swiss-Prot Protein Database (Swiss-
Prot).
You can download a template (Mac and Windows compatible; Microsoft Word 98/2000) for
your article.
For reporting standards please see the information in the About section.
Title page
The title page should:
provide the title of the article
list the full names, institutional addresses and email addresses for all authors
indicate the corresponding author
Please note:
the title should include the study design, for example "A versus B in the treatment of
C: a randomized controlled trial X is a risk factor for Y: a case control study"
abbreviations within the title should be avoided
Abstract
The Abstract of the manuscript should not exceed 350 words and must be structured into
separate sections: Background, the context and purpose of the study; Methods, how the study
was performed and statistical tests used; Results, the main findings; Conclusions, brief
summary and potential implications. Please minimize the use of abbreviations and do not cite
references in the abstract. Trial registration, if your research reports the results of a controlled
health care intervention, please list your trial registry, along with the unique identifying number
(e.g. Trial registration: Current Controlled Trials ISRCTN73824458). Please note that there
should be no space between the letters and numbers of your trial registration number. We
recommend manuscripts that report randomized controlled trials follow the CONSORT
extension for abstracts.
Keywords
Three to ten keywords representing the main content of the article.
271
Background
The Background section should be written in a way that is accessible to researchers without
specialist knowledge in that area and must clearly state - and, if helpful, illustrate - the
background to the research and its aims. Reports of clinical research should, where appropriate,
include a summary of a search of the literature to indicate why this study was necessary and
what it aimed to contribute to the field. The section should end with a brief statement of what is
being reported in the article.
Methods
The methods section should include the design of the study, the setting, the type of participants
or materials involved, a clear description of all interventions and comparisons, and the type of
analysis used, including a power calculation if appropriate. Generic drug names should
generally be used. When proprietary brands are used in research, include the brand names in
parentheses in the Methods section.
For studies involving human participants a statement detailing ethical approval and consent
should be included in the methods section. For further details of the journal's editorial policies
and ethical guidelines see 'About this journal'.
For further details of the journal's data-release policy, see the policy section in 'About this
journal'.
Results and discussion
The Results and discussion may be combined into a single section or presented separately.
Results of statistical analysis should include, where appropriate, relative and absolute risks or
risk reductions, and confidence intervals. The Results and discussion sections may also be
broken into subsections with short, informative headings.
Conclusions
This should state clearly the main conclusions of the research and give a clear explanation of
their importance and relevance. Summary illustrations may be included.
List of abbreviations
If abbreviations are used in the text they should be defined in the text at first use, and a list of
abbreviations can be provided, which should precede the competing interests and authors'
contributions.
272
Competing interests
A competing interest exists when your interpretation of data or presentation of information may
be influenced by your personal or financial relationship with other people or organizations.
Authors must disclose any financial competing interests; they should also reveal any non-
financial competing interests that may cause them embarrassment were they to become public
after the publication of the manuscript.
Authors are required to complete a declaration of competing interests. All competing interests
that are declared will be listed at the end of published articles. Where an author gives no
competing interests, the listing will read 'The author(s) declare that they have no competing
interests'.
When completing your declaration, please consider the following questions:
Financial competing interests
In the past three years have you received reimbursements, fees, funding, or salary
from an organization that may in any way gain or lose financially from the publication of
this manuscript, either now or in the future? Is such an organization financing this
manuscript (including the article-processing charge)? If so, please specify.
Do you hold any stocks or shares in an organization that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future? If so,
please specify.
Do you hold or are you currently applying for any patents relating to the content of
the manuscript? Have you received reimbursements, fees, funding, or salary from an
organization that holds or has applied for patents relating to the content of the manuscript?
If so, please specify.
Do you have any other financial competing interests? If so, please specify.
Non-financial competing interests
Are there any non-financial competing interests (political, personal, religious, ideological,
academic, intellectual, commercial or any other) to declare in relation to this manuscript? If so,
please specify.
If you are unsure as to whether you, or one your co-authors, has a competing interest please
discuss it with the editorial office.
273
Authors' contributions
In order to give appropriate credit to each author of a paper, the individual contributions of
authors to the manuscript should be specified in this section.
According to ICMJE guidelines, An 'author' is generally considered to be someone who has
made substantive intellectual contributions to a published study. To qualify as an author one
should 1) have made substantial contributions to conception and design, or acquisition of data,
or analysis and interpretation of data; 2) have been involved in drafting the manuscript or
revising it critically for important intellectual content; 3) have given final approval of the
version to be published; and 4) agree to be accountable for all aspects of the work in ensuring
that questions related to the accuracy or integrity of any part of the work are appropriately
investigated and resolved. Each author should have participated sufficiently in the work to take
public responsibility for appropriate portions of the content. Acquisition of funding, collection
of data, or general supervision of the research group, alone, does not justify authorship.
We suggest the following kind of format (please use initials to refer to each author's
contribution): AB carried out the molecular genetic studies, participated in the sequence
alignment and drafted the manuscript. JY carried out the immunoassays. MT participated in the
sequence alignment. ES participated in the design of the study and performed the statistical
analysis. FG conceived of the study, and participated in its design and coordination and helped
to draft the manuscript. All authors read and approved the final manuscript.
All contributors who do not meet the criteria for authorship should be listed in an
acknowledgements section. Examples of those who might be acknowledged include a person
who provided purely technical help, writing assistance, or a department chair who provided
only general support.
Authors' information
You may choose to use this section to include any relevant information about the author(s) that
may aid the reader's interpretation of the article, and understand the standpoint of the author(s).
This may include details about the authors' qualifications, current positions they hold at
institutions or societies, or any other relevant background information. Please refer to authors
using their initials. Note this section should not be used to describe any competing interests.
274
Acknowledgements
Please acknowledge anyone who contributed towards the article by making substantial
contributions to conception, design, acquisition of data, or analysis and interpretation of data,
or who was involved in drafting the manuscript or revising it critically for important intellectual
content, but who does not meet the criteria for authorship. Please also include the source(s) of
funding for each author, and for the manuscript preparation. Authors must describe the role of
the funding body, if any, in design, in the collection, analysis, and interpretation of data; in the
writing of the manuscript; and in the decision to submit the manuscript for publication. Please
also acknowledge anyone who contributed materials essential for the study. If a language editor
has made significant revision of the manuscript, we recommend that you acknowledge the
editor by name, where possible.
The role of a scientific (medical) writer must be included in the acknowledgements section,
including their source(s) of funding. We suggest wording such as 'We thank Jane Doe who
provided medical writing services on behalf of XYZ Pharmaceuticals Ltd.'
Authors should obtain permission to acknowledge from all those mentioned in the
Acknowledgements section.
Endnotes
Endnotes should be designated within the text using a superscript lowercase letter and all notes
(along with their corresponding letter) should be included in the Endnotes section. Please
format this section in a paragraph rather than a list.
References
All references, including URLs, must be numbered consecutively, in square brackets, in the
order in which they are cited in the text, followed by any in tables or legends. Each reference
must have an individual reference number. Please avoid excessive referencing. If automatic
numbering systems are used, the reference numbers must be finalized and the bibliography
must be fully formatted before submission.
Only articles, datasets, clinical trial registration records and abstracts that have been published
or are in press, or are available through public e-print/preprint servers, may be cited;
unpublished abstracts, unpublished data and personal communications should not be included
in the reference list, but may be included in the text and referred to as "unpublished
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observations" or "personal communications" giving the names of the involved researchers.
Obtaining permission to quote personal communications and unpublished data from the cited
colleagues is the responsibility of the author. Footnotes are not allowed, but endnotes are
permitted. Journal abbreviations follow Index Medicus/MEDLINE. Citations in the reference
list should include all named authors, up to the first 30 before adding 'et al.'..
Any in press articles cited within the references and necessary for the reviewers' assessment of
the manuscript should be made available if requested by the editorial office.
Style files are available for use with popular bibliographic management software:
BibTeX
EndNote style file
Reference Manager
Zotero
Examples of the Implementation Science reference style are shown below. Please ensure that
the reference style is followed precisely; if the references are not in the correct style they may
have to be retyped and carefully proofread.
All web links and URLs, including links to the authors' own websites, should be given a
reference number and included in the reference list rather than within the text of the
manuscript. They should be provided in full, including both the title of the site and the URL, in
the following format: The Mouse Tumor Biology
Database [http://tumor.informatics.jax.org/mtbwi/index.do]. If an author or group of authors
can clearly be associated with a web link, such as for weblogs, then they should be included in
the reference.
Examples of the Implementation Science reference style
Article within a journal
Koonin EV, Altschul SF, Bork P: BRCA1 protein products: functional motifs. Nat
Genet 1996,13:266-267.
Article within a journal supplement
Orengo CA, Bray JE, Hubbard T, LoConte L, Sillitoe I: Analysis and assessment of ab initio
three-dimensional prediction, secondary structure, and contacts
prediction. Proteins 1999, 43(Suppl 3):149-170.
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In press article
Kharitonov SA, Barnes PJ: Clinical aspects of exhaled nitric oxide. Eur Respir J, in press.
Published abstract
Zvaifler NJ, Burger JA, Marinova-Mutafchieva L, Taylor P, Maini RN: Mesenchymal cells,
stromal derived factor-1 and rheumatoid arthritis [abstract]. Arthritis
Rheum 1999, 42:s250.
Article within conference proceedings
Jones X: Zeolites and synthetic mechanisms. In Proceedings of the First National
Conference on Porous Sieves: 27-30 June 1996; Baltimore. Edited by Smith Y. Stoneham:
Butterworth-Heinemann; 1996:16-27.
Book chapter, or article within a book
Schnepf E: From prey via endosymbiont to plastids: comparative studies in
dinoflagellates.In Origins of Plastids. Volume 2. 2nd edition. Edited by Lewin RA. New
York: Chapman and Hall; 1993:53-76.
Whole issue of journal
Ponder B, Johnston S, Chodosh L (Eds): Innovative oncology. In Breast Cancer
Res 1998, 10:1-72.
Whole conference proceedings
Smith Y (Ed): Proceedings of the First National Conference on Porous Sieves: 27-30 June
1996; Baltimore. Stoneham: Butterworth-Heinemann; 1996.
Complete book
Margulis L: Origin of Eukaryotic Cells. New Haven: Yale University Press; 1970.
Monograph or book in a series
Hunninghake GW, Gadek JE: The alveolar macrophage. In Cultured Human Cells and
Tissues.Edited by Harris TJR. New York: Academic Press; 1995:54-56. [Stoner G (Series
Editor): Methods and Perspectives in Cell Biology, vol 1.]
Book with institutional author
Advisory Committee on Genetic Modification: Annual Report. London; 1999.
PhD thesis
Kohavi R: Wrappers for performance enhancement and oblivious decision graphs. PhD
thesis.Stanford University, Computer Science Department; 1995.
Link / URL
The Mouse Tumor Biology Database [http://tumor.informatics.jax.org/mtbwi/index.do]
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Link / URL with author(s)
Corpas M: The Crowdfunding Genome Project: a personal genomics community with
open source values [http://blogs.biomedcentral.com/bmcblog/2012/07/16/the-crowdfunding-
genome-project-a-personal-genomics-community-with-open-source-values/]
Dataset with persistent identifier
Zheng, L-Y; Guo, X-S; He, B; Sun, L-J; Peng, Y; Dong, S-S; Liu, T-F; Jiang, S;
Ramachandran, S; Liu, C-M; Jing, H-C (2011): Genome data from sweet and grain sorghum
(Sorghum bicolor).GigaScience Database. http://dx.doi.org/10.5524/100012.
Clinical trial registration record with persistent identifier
Mendelow, AD (2006): Surgical Trial in Lobar Intracerebral Haemorrhage. Current
Controlled Trials. http://dx.doi.org/10.1186/ISRCTN22153967
Preparing illustrations and figures
Illustrations should be provided as separate files, not embedded in the text file. Each figure
should include a single illustration and should fit on a single page in portrait format. If a figure
consists of separate parts, it is important that a single composite illustration file be submitted
which contains all parts of the figure. There is no charge for the use of color figures.
Please read our figure preparation guidelines for detailed instructions on maximising the quality
of your figures.
Formats
The following file formats can be accepted:
PDF (preferred format for diagrams)
DOCX/DOC (single page only)
PPTX/PPT (single slide only)
EPS
PNG (preferred format for photos or images)
TIFF
JPEG
BMP
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Figure legends
The legends should be included in the main manuscript text file at the end of the document,
rather than being a part of the figure file. For each figure, the following information should be
provided: Figure number (in sequence, using Arabic numerals - i.e. Figure 1, 2, 3 etc); short
title of figure (maximum 15 words); detailed legend, up to 300 words.
Please note that it is the responsibility of the author(s) to obtain permission from the
copyright holder to reproduce figures or tables that have previously been published
elsewhere.
Preparing a personal cover page
If you wish to do so, you may submit an image which, in the event of publication, will be used
to create a cover page for the PDF version of your article. The cover page will also display the
journal logo, article title and citation details. The image may either be a figure from your
manuscript or another relevant image. You must have permission from the copyright to
reproduce the image. Images that do not meet our requirements will not be used.
Images must be 300dpi and 155mm square (1831 x 1831 pixels for a raster image).
Allowable formats - EPS, PDF (for line drawings), PNG, TIFF (for photographs and screen
dumps), JPEG, BMP, DOC, PPT, CDX, TGF (ISIS/Draw).
Preparing tables
Each table should be numbered and cited in sequence using Arabic numerals (i.e. Table 1, 2, 3
etc.). Tables should also have a title (above the table) that summarizes the whole table; it
should be no longer than 15 words. Detailed legends may then follow, but they should be
concise. Tables should always be cited in text in consecutive numerical order.
Smaller tables considered to be integral to the manuscript can be pasted into the end of the
document text file, in A4 portrait or landscape format. These will be typeset and displayed in
the final published form of the article. Such tables should be formatted using the 'Table object'
in a word processing program to ensure that columns of data are kept aligned when the file is
sent electronically for review; this will not always be the case if columns are generated by
simply using tabs to separate text. Columns and rows of data should be made visibly distinct by
ensuring that the borders of each cell display as black lines. Commas should not be used to
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indicate numerical values. Color and shading may not be used; parts of the table can be
highlighted using symbols or bold text, the meaning of which should be explained in a table
legend. Tables should not be embedded as figures or spreadsheet files.
Larger datasets or tables too wide for a landscape page can be uploaded separately as additional
files. Additional files will not be displayed in the final, laid-out PDF of the article, but a link
will be provided to the files as supplied by the author.
Tabular data provided as additional files can be uploaded as an Excel spreadsheet (.xls ) or
comma separated values (.csv). As with all files, please use the standard file extensions.
Preparing additional files
Although Implementation Science does not restrict the length and quantity of data included in
an article, we encourage authors to provide datasets, tables, movies, or other information as
additional files.
Please note: All Additional files will be published along with the article. Do not include files
such as patient consent forms, certificates of language editing, or revised versions of the main
manuscript document with tracked changes. Such files should be sent by email
to [email protected], quoting the Manuscript ID number.
Results that would otherwise be indicated as "data not shown" can and should be included as
additional files. Since many weblinks and URLs rapidly become broken, Implementation
Sciencerequires that supporting data are included as additional files, or deposited in a
recognized repository. Please do not link to data on a personal/departmental website. The
maximum file size for additional files is 20 MB each, and files will be virus-scanned on
submission.
Additional files can be in any format, and will be downloadable from the final published article
as supplied by the author. We recommend CSV rather than PDF for tabular data.
Certain supported files formats are recognized and can be displayed to the user in the browser.
These include most movie formats (for users with the Quicktime plugin), mini-websites
prepared according to our guidelines, chemical structure files (MOL, PDB), geographic data
files (KML).
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If additional material is provided, please list the following information in a separate section of
the manuscript text:
File name (e.g. Additional file 1)
File format including the correct file extension for example .pdf, .xls, .txt, .pptx
(including name and a URL of an appropriate viewer if format is unusual)
Title of data
Description of data
Additional files should be named "Additional file 1" and so on and should be referenced
explicitly by file name within the body of the article, e.g. 'An additional movie file shows this
in more detail [see Additional file 1]'.
Additional file formats
Ideally, file formats for additional files should not be platform-specific, and should be viewable
using free or widely available tools. The following are examples of suitable formats.
Additional documentation
o PDF (Adode Acrobat)
Animations
o SWF (Shockwave Flash)
Movies
o MP4 (MPEG 4)
o MOV (Quicktime)
Tabular data
o XLS, XLSX (Excel Spreadsheet)
o CSV (Comma separated values)
As with figure files, files should be given the standard file extensions.
Mini-websites
Small self-contained websites can be submitted as additional files, in such a way that they will
be browsable from within the full text HTML version of the article. In order to do this, please
follow these instructions:
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1. Create a folder containing a starting file called index.html (or index.htm) in the root.
2. Put all files necessary for viewing the mini-website within the folder, or sub-folders.
3. Ensure that all links are relative (ie "images/picture.jpg" rather than
"/images/picture.jpg" or "http://yourdomain.net/images/picture.jpg" or "C:\Documents
and Settings\username\My Documents\mini-website\images\picture.jpg") and no link
is longer than 255 characters.
4. Access the index.html file and browse around the mini-website, to ensure that the most
commonly used browsers (Internet Explorer and Firefox) are able to view all parts of
the mini-website without problems, it is ideal to check this on a different machine.
5. Compress the folder into a ZIP, check the file size is under 20 MB, ensure that
index.html is in the root of the ZIP, and that the file has .zip extension, then submit as
an additional file with your article.
Style and language
General
Currently, Implementation Science can only accept manuscripts written in English. Spelling
should be US English or British English, but not a mixture.
There is no explicit limit on the length of articles submitted, but authors are encouraged to be
concise.
Help and advice on scientific writing
The abstract is one of the most important parts of a manuscript. For guidance, please visit our
page on Writing titles and abstracts for scientific articles.
Tim Albert has produced for BioMed Central a list of tips for writing a scientific
manuscript. American Scientist also provides a list of resources for science writing. For more
detailed guidance on preparing a manuscript and writing in English, please visit the BioMed
Central author academy.
Abbreviations
Abbreviations should be used as sparingly as possible. They should be defined when first used
and a list of abbreviations can be provided following the main manuscript text.
Typography
Please use double line spacing.
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Type the text unjustified, without hyphenating words at line breaks.
Use hard returns only to end headings and paragraphs, not to rearrange lines.
Capitalize only the first word, and proper nouns, in the title.
All pages should be numbered.
Use the Implementation Science reference format.
Footnotes are not allowed, but endnotes are permitted.
Please do not format the text in multiple columns.
Greek and other special characters may be included. If you are unable to reproduce a
particular special character, please type out the name of the symbol in full. Please ensure
that all special characters used are embedded in the text, otherwise they will be lost
during conversion to PDF.
Units
SI units should be used throughout (liter and molar are permitted, however).