Pharmakon 2003ESCP, Valencia

Implementing standards of practice

Hanne Herborg

Director R&D, Pharmakon

Danish College of Pharmacy Practice (DCPP)

Pharmakon 2003

Task given by chairperson

Provide your vision about implementation and evaluation of pharmaceutical services in the context of standards of practice

Please include:– How we can turn clinical evidence into standards of care – in

particular pharmaceutical care– The need for research to design and evaluate services, which

should achieve expected patient outcomes– Organisation and the process of delivery of care from a practical

perspective– Education and training needs– Experience form your own work on these issues

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My plan: - Case study approach: The DCPP experience

1. Introduction – my platform

2. Research types relevant for implementation of practice standards

3. Case story: A research programme for implementation of dyspepsia standards in community pharmacy

4. Taking research into practice

5. Conclusion and vision

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DCPP R&D: - Strategy and profile

DCPP: An educational centre owned by the Danish Pharmaceutical Association (DPA)

R&D objective – to contribute to quality development and documentation of

pharmacy services and of the role of the pharmacy in the health care system.

Profile– Research in pharmacy practice– Development of cognitive pharmacy services– Training & consultancy on implementation

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DCPP: Major research activities 1993-2003

PCNE collaboration Asthma-Therapeutic Outcomes Monitoring (TOM) Pharmaceutical care for elderly polypharmacy patients (OMA) Self-medication and self-care Implementation and dissemination of cognitive pharmacy services

DCPP/DPA collaboration Sustainable implementation (The Counselling Pharmacy) Nursing home services Pharmacy Practice Documentation Database Prescription interventions

Partnership with Danish universities Ph.d. projects: Change management; Drug related problems,

Implementation and dissemination Pharmacy-university project Evaluations of: Weight reduction service; Smoking cessation

service;Triptan over-use service HTA : Automated dose-dispensing

Partnership with regional health administrations Primary care clinical pharmacist Dose-dispensing services

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DCPP – pharmacy service development

Cognitive community pharmacy services offered to Danish pharmacies by DPA

Clinical pharmacy at individual level Basic services: Medication review, advice-giving, ‘patient safety

alert services’, ‘pharmaceutical care at the counter’ Disease specific pharmaceutical care: Asthma, Diabetes,

Rheumatic diseases, Angina Generic pharmaceutical care: Pharmacist consultation Automated dose dispensing & counselling

Clinical pharmacy at institutional level Nursing home services: education, quality assurance, medication

review, dose dispensing Health promotion and disease prevention

Smoking cessation, weight reduction Screening and health counselling: BP, BS, cholesterol, health risk

profiles Customer & patient health information materials

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The role of research in implementation of standards

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DCPP research: Implementation involves several essentially different research types/purposes

1. Descriptive studies: – Drug Related Problems (DRPs), risk, consumer needs

2. Collate evidence: “Pharmacy practice documentation database”– www.pharmakon.dk

3. Randomised controlled trials (RCTs)

4. Development projects: Formative evaluation, action research, pilot studies

5. Implementation research: Document activity, study implementation process

6. Comparative research: Health Technology Assessment (HTA), comparison of alternative models of care

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British Medical Research Council, april 2000: Framework for trials of complex interventions- a similar strategy

Health services research following phases of drug development Pre-clinical Theory

Phase 1 Modelling

Phase 2 Exploratory trial

Phase 3 Definitive RCT

Phase 4 Long-term implementation

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Case: Heartburn and dyspepsia

- a research programme on Improved Self-medication and Self-care

A development and pilot study with 4 pharmacies and 110 patients, 1999-2000

A qualitative master’s project on dyspepsia patient perceptions 1999

A controlled study with 25 pharmacies, 648 hay fever patients and 573 dyspepsia patients, 2001-03

An long-term implementation research project, “The Counselling Pharmacy” in 2 of 8 pharmacies, 2001-02

A masters’ project with qualitative studies of 15 patient pathways, 2003

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Why have a standard based community pharmacy care model for dyspepsia?

Most dyspepsia drugs are OTC

Many patients do not get evaluated by physicians or do not get systematic follow-up

Result: Heartburn and dyspepsia is “a self-care condition”,and pharmacies may have better opportunity to catch problems of poor outcomes than GP’s.

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Potential problems with self-care outcomes

Wrong “self-diagnose”Self-treatment not appropriate

Risk of serious illness not diagnosedRx treatment needed, not givenRisk of long-term expensive health care

Self-medication with no effectNo self-medicationNo prevention, life-style problems

Symptoms remain unsolvedPreventable problem developsUnnecessary GP contacts

Self-care inducing harm–Drugs, herbal medicines, non-drug solutions

New medical problems added

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Patient case

Woman 75 year

Asks for specific medication (Cimetidine) Reflux symptoms every day, problems with pain Daily activity inhibited all days, no days of illness Has had contact with GP Medicines:

Cimetidine 300 mg, 1 daily Antacid 1 x 1-2 Other: Sertraline, Ibuprofen

Alarm symptoms: Daily symptoms >3 weeks, swallowing problems, NSAID DRP’s: Inappropriate drug? Interaction? Adverse effect? Self-care: Knows advice; Does not prevent; Dissatisfied with drugs and GP Intervention: GP referral, Counselling on condition, drugs and prevention

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Phase 0 and 1: Theory and modelling

How do we turn standards into a patient care model?

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Defining the care model- not just reviewing literature

Theory input– Clinical guidelines– B. Marklund: Referral criteria for pharmacies and GP telephone

visitation functions– Response to symptoms – Drug related problems, pharmaceutical care – Self-care theory– New consumer theory, User perspectives – Concordance/compliance– Communication

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Self-care as the key concept

Definition:

”Actions people do themselves to solve or prevent health problems and maintain health”

Lunde 1990

”The fundamental health resource”WHO 1987

The core: The patient is the decision maker!

A main strategy in Good Pharmacy Practice

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The intervention: An extended counselling service

A systematic counselling on self-care and self-medication in community pharmacies, aimed at empowering customers by enabling them to make self-care decisions and solve problems in order to obtain better health and well-being.

Individual problem assessment and counselling in relation to 4 key elements:

– Response to symptoms – Self-medication and drug related problems– Life-style problems– Patient perceived problems

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Pharmacy Counselling about Self CareThe Two-Legged Platform

The Scientific LegKeywords: Evidence based, quality controlled practice Medical starting point Expert role Objective (value neutral) Focus on symptoms, drug problems, and

life style problems

Identify risks, errors and problems Give correct advice and treatment Network gives interference and errors The professional is in charge

The Humanistic LegKeywords: User competence, empowerment

Starting point in every day life Discussion partner Personal, subjective (with values) Focus on the user’s experiences, wants,

comprehension, habits, and terms Identify resources Help to tailor solutions Network are important resources The user is in charge

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Phase 1-2: Explorative research

How do we know that the care model is feasible?

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The development and pilot project - The key to everything else!

Formative objectives – to learn

Design: Action research in 4 pharmacies, 111 customers testing

1. Implementation model: service, processes, tools, training 2. Project management model: registrations, diaries,

experience exchange groups, and telephone interviews, audits, pseudo-customers

3. Evaluation model: test of design and measurement instruments - face validity, reliability, and data collection procedures

4. Effects on process, and outcomes: registrations and questionnaires at start and 4 weeks

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Tools:- The means to fix the process and integrate the clinical standard

Instruction and flowchart Interview guide (WWHAM) Registration form

– Problem identification: Algorithms for alarm symptom and DRP’s Lifestyle problem categories Patient problem?

– Interventions: Referral, Counselling categories

Checklist– Concentrated knowledge base: clinical guideline and counselling support

Written patient information

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Yes

The customer’s descriptionof the problem and

registration of data

Alarm signals of illness

Drug related problems

Choice of drug

Product informationgeneral advice

Counselling in relationto identified problems

Collection phase:

Counselling phase

Analysis phase Referralto doctor

PharmacistYes

Possibly

identified No problems

Problems identified

User perception

Lifestyle problems

Documentationand follow up

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Tools example 1- the interview

Who? Customer identity,age, gender

What symptoms? Why do you use this medicine?

How will you describe your symptoms?

How long? How long have you had the symptoms?

Action? What have you tried in order to get rid of your discomforts?

Medicines? What other medicine do you take for the symptoms?

Personal ideas? How do you cope with your symptoms in daily life?

Wants and needs for counselling?

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Tools example 2- Referral criteria Dyspepsia alarm symptom algorithm

1. Black stool, vomit, strong stomach pain

2. Increased problems with physical effort

3. Shortness of breath and coughing at night

4. Swallowing difficulties

5. Symptoms almost daily > 3 weeks

6. Painkillers (NSAID)

7. Patient > 45 years without previous symptom history

8. Unexplained weight loss

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Ja

Yes

Heavy stomach pain, repeatedvomiting, black bowel or

vomit

Increased discomfort under strain

Nightly coughdyspnoea problems

Daily discomfort for more than3 weeks

Taking painkillers

New symptoms -patient over 40 years

Refer to doctor

Refer to doctor

Refer to doctor

Refer to doctor

Refer to doctor

Refer to doctor

Self medication / self care

No

No

No

No

No

Yes

Yes

Yes

Yes

Refer to doctor

Yes

Yes

No

No

Problems in swallowing

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Tools example 3- drug related problems Lack of effect

1. Untreated indication

2. Inappropriate drug

3. Too low dosage used

4. Inappropriate use, patient not receiving drug

Risk of adverse effect5. Too high dosage taken

6. Adverse reactions

7. Interactions

8. Drug not indicated

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Evaluation conclusions

The service was of value for the customers. Improvements were seen on final outcomes: Dyspepsia score, self reported symptoms, days of symptoms, and satisfaction with new service.

It was feasible to get sufficient and reliable data

A controlled study is recommended

Implementation was feasible, however a differentiation is necessary in order to define customers who will benefit from the service

Minor adjustments on tools, training, evaluation instruments and design are necessary.

There is no basis for undertaking an economic evaluation of the service in a four week study.

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Have you had it before?

“The traffic light model”- Customer differentiation

No

No

Information according to

customer wish

Asks for a product

Presents a symptom

Small non-problematic useQ. How often do you take it?Q. How is the effect?

Information wantsQ. Do you have additional questions?Q. May I give you a brochure?

Assesment of treatment Information and counselling

Yes

Yes

Response to symptomsAssessment/choice of drug treatmentAssesment of life-style problems/customer demandInformation and counselling

Service

No

Yes

Light service

Attendance concluded

Sufficiently assessed by pharmacy/GPQ. Have you discussed the symptoms with the GP?Q. Has the pharmacy assessed your symptoms?Q. Are the symptoms still the same?

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Phase 3: RCT

How do we know that the care model can produce the expected outcomes?

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Objectives of the controlled study

To evaluate if systematic counselling on self-medication and self-care in the pharmacy leads to improved treatment outcomes and more rational use of resources for society and patients

Effects measured on: – Quality of counselling and referral

– Drug use

– Patient knowledge and behaviour

– Patient satisfaction

– Patient health outcomes

– Use of economic resources: Drugs and health care contacts

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A randomised, controlled multi-centre study

25 pharmacies randomly assigned to an intervention and a control group aimed at inviting all customers presenting relevant symptoms or drug requests and recruiting 30 patients each.

Two intervention periods, cross-over design

1. Hay fever: Spring 2002 ; 343 intervention/305 control patients

2. Dyspepsia: Autumn 2002; 262 intervention/311 control patients

Evaluation after 2 respectively 4 weeks

6 month follow up in dyspepsia group; April 2003

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Summary of results

At 4 or 2 weeks health status improved significantly in both groups in both dyspepsia and hay fever programs. The difference between intervention and control group was significant for dyspepsia. For hay fever no difference was seen.

Symptoms improved significantly in both hay fever and dyspepsia programs. The difference between intervention and control group was significant for dyspepsia. For hay fever only satisfaction with symptoms showed significant difference.

Satisfaction was significantly higher in the intervention group for both programs

Willingness to pay was significantly higher for the dyspepsia intervention group, no difference was seen for hay fever

At 6 months dyspepsia patients had significantly improved health outcomes. The difference between intervention and control patients did not persist.

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Reflections on the role of the RCT in implementation of standards Quality problems = weak results

Stronger interventions, study designs, indicators, …… Practice research has to compromise, cannot work without

implementation Political actors and biomedical research focus on RCT as “The golden

standard” is overvalued– Reality?

• RCT is a strong political strategy• RCT is still the stronger answer to efficacy questions• RCT is a research strategy with limitations

RCT limitations in pharmaceutical care as a soft health technology– Not technical hardware like a pill. “It could be otherwise”– Software: a social construction/interaction that can be implemented

differently and is continuously modified. – RCT is made for controllable technical systems. In social systems it

has limitations, and other evaluation strategies are equally valuable– RCT cannot alone provide the knowledge we need– Triangulation: validate with other data

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After the RCT?- What we need to know - examples

The realistic implementation process Study effectiveness and negative consequences in

full scale , “post marketing” How to account for differences and relate to

outcomes Implementation barriers and facilitators

Optimisation research – not well developed Identify target groups with more benefit Improve and focus processes and technology Reduce resources Optimise total health care model and role of

pharmacy in the team (integrated care)

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Future: Comparative research

Health Technology Assessments (HTA)- Comparing benefits for alternative solutions to health care problems

in relation to: - technology/interventions

- organisation,

- economy

- patient preferences Examples

Compare pharmacy services to other modelsCompare brief and comprehensive pharmacy modelsCompare across health systems, between regions and

between countriesCompare models of integrated care

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Phase 4: Realistic practice research

How do we know that it still works in routine practice?

Cost-effectiveness and risk in routine practiceImplementation process studiesOptimisation Comparing models of care

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Implementation research- “The counselling pharmacy”Why?

Research projects have shown that pharmaceutical care services contribute to positive patient outcomes

Implementation in daily routines is still lacking behind Objective

To develop and test a programme supporting pharmacies in implementing defined cognitive pharmacy services on a permanent basis.

Services

1. Basic drug-information

2. Self-medication and self-care

3. Pharmaceutical care at the counter

4. Health promotion services

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Implementation support programme

Training and coaching

Brief training courses Process consultants/coaches Individual feedback/ role models Additional needs based training

sessions Distance learning packages Experience exchange groups Manager consultations Project management support

Documentation and feedback

Quality manuals and tools Basic interview Analysis of barriers Process and outcomes

documentation Quality audits Pseudo-customer feedback Customer satisfaction surveys    

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Pharmacy care process

Documentationand feedback

Implementation

Establish corporation• Role of the pharmacy• Role of the coach• Resource use

Data collection

Goal-setting and establishment of success criteria

Identification and analysis of problems

Follow up and intervention in case of

new problems

Choice of plan

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Programme intensity

Pharmacy

Coaches

Pharmacy care

Permanent implementation implies that the pharmacy must take charge of the process

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Methods of evaluation

Action research design with continuous documentation and data triangulation

Basic interview (goals, success criteria, organisation, competence)

Barrier analysis (internal and external barriers)

Evaluation of implementation (continuous data collection, structured meetings with coach, log book, experience exchange groups)

Process control (audit, pseudo customers, status report)

Customer and staff satisfaction questionnaires

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Success criteria

1. Implementation on a permanent basis

2. Relevant and feasible services

3. Reasonable cost/benefit balance

4. Continuing development of services

5. Customer satisfaction with services

6. Competence development in the pharmacies

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Results: Organisational issues

Services and processes that the pharmacies had not implemented before were delivered now

Motivation for new roles had not grasped everyone Services were not always offered when relevant due to capacity problems, time

problems, organisation of workflow, and physical premises Pharmacies chose to tailor the instructions and documentation systems to what

they found practical to ensure their usage. Ownership and simplification were a must. Protocols should provide both structure and flexibility.

Lack of relevant technology was a barrier to documentation and decision making Pharmacy premises are designed for shop-keeping, not as patient care setting

with flexible levels of privacy Getting the support from other professionals takes time and remains a challenge

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Leavitt’s model of an organisation

Environment

Impact

Technology

Task/goalActors

Structure

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Competence issues: - pseudo customer analyses

Process elements that were in place in case simulations were not always implemented in real life.

Instruction techniques on drug use were quite impressing: correct and yet short and simple; however sometimes too technical.

Open-ended questioning in relation to symptoms, life styles and patient concerns was weaker; often counselling would start before needs were fully assessed.

Making agreements on follow-up was a weak spot Some problems due to lack of knowledge lead to incorrect advice-giving were

seen Clinical problem analysis and -judgement of the individual patient case were

performed, but were still major challenges Business competencies were a challenge: Promoting consumer paid services

actively to customers, reacting on need signals, getting started, demanding a price ….

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PROFESSIONAL COMPETENCE EQUATION- R.Holland & C.Nimmo

Skills

Psychomotor

Problem Solving

- Strategic Content (WHAT)

- Procedural Knowledge (HOW)

ProfessionalSocialization Attitudes

Values

+ + =ProfessionalCompetence

ClinicalJudgment

Practicewith feedback

Reflectionon practice

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Today’s work with DPA

How do we take research into practice?

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Implementation of standard based services

DPA: Remuneration and dissemination– Negotiation with payers– Marketing to pharmacies, public and payers – theme years– Collaboration with health care professions– Collaboration with patient and consumer organisations– Operating an ISO quality certificate, quality bench-marks– Collaboration with educators, researchers and pharmacy networks– Access to up-to-date technology

DCPP: Development, dissemination, implementation support– Standards, quality manuals, – Tools and technology support– Patient information resources– Training, learning resources– Consultancy, coaching– Optimisation and rationalisation of services

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The Quality Manual- a ‘sensitive’ document

Requirements: – Comply with standards, evidence, product descriptions

– Pharmacy accept and adoption

– Implementation feasible

– Documentation of quality feasible

– Sustainability in the pharmacy setting

Structure: – Description of the service on 3 levels:

“The brief overview” “The case-story” “The detailed technical description”

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Competence development- CPD trends in Danish pharmacies

Internal pharmacy training Learning resources: “Morning meeting materials”, service manuals, web-

resources, video demonstrations etc. Patient information materials, marketing materials Individual distance learning, WBT Pharmacist networking groups

Short targeted courses Diseases, pharmacotherapy Services: Implementation process, case training, test Staff training workshops

Quality audit Pseudo-customer audit Individual performance evaluation and coaching

Certified education Long courses, practice and problem based learning Collaboration with external partners Counsellor educations, Smoking cessation, Internal audit

General CE & Master programme in Quality Assured Drug Use

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Conclusion and vision

Research &

Implementation in practice

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Research - conclusion

Well-designed evaluations of outcomes in controlled studies are of primary importance.

Equally important, is research in the design of services. Controlled studies of care models that are not carefully designed and

demonstrated as implementable may fail to produce the expected outcomes. Formative evaluation studies in action research designs can help develop and

test models and provide opportunities for studying organisational learning.

Research of services in routine practice needs further development. Comparative research needs development.

Acknowledgement, publication and funding of these studies Stronger dialogue between pharmacy practice researchers, practitioners,

politicians, and other partners in health care

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Implementation barriers - conclusion Some do not share the vision of the pharmacy as a patient care facility.

– Reasons are e.g. No belief in it as sustainable business, they can live from Not their view of their professional identity Want to keep the pharmacy as a shop No confidence in own competence

New remuneration structure based on activity is essential to those who are committed to patient care.

Some important barriers are manageable– Competence, particularly clinical judgement and intervention– Organisational change and development

Condition: Danish pharmacies do not accept authoritative protocols. They pick and choose what they like, if sanctions/awards are not very strong (post-modern behaviour).

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Vision: - A system approach – not just guidelines

The Practice Change System

PracticeEnvironment

Learning Resources

MotivationalStrategies

Holland-Nimmo Practice Change System, ASHP 1998

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Vision: Involve all levels in the chain:

- remuneration, dissemination, implementation

PRACTICE ENVIRONMENT

Society

Pharmacy Owners

PracticeSite

Holland-Nimmo Practice Change System, ASHP 1998

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Metamorphosis to patient care- a change of culture

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Thank you for your attention!