contemporary pharmacy practice

7/31/2019 Contemporary Pharmacy Practice

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A Resource Paper of the

Council on Credentialing in Pharmacy

Scope of Contemporary Pharmacy Practice:Roles, Responsibilities, and Functions of Pharmacists and Pharmacy Technicians

Approved for distribution by CCP Board of Directors on February 25, 2009

Copyright 2009, Council on Credentialing in PharmacyThe Council on Credentialing in Pharmacy

Washington, DC, February 2009


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2 A Resource Paper of the Council on Credentialing in Pharmacy (2009)

Scope o Contemporary Pharmacy Practice: Roles, Responsibilities, and Functions o Pharmacists and Pharmacy Technicians

This document was co-authored by Nicole Paolini Alba-nese, PharmD, Clinical Assistant Professor at the Universityat Buffalo, School of Pharmacy and Pharmaceutical Scienc-es and Michael J. Rouse, BPharm (Hons), MPS, AssistantExecutive Director, International and Professional Affairs,Accreditation Council for Pharmacy Education.

Special recognition is given to the following persons for their contributions to this document: Melissa Murer Corri-gan, RPh, Executive Director/CEO, Pharmacy Technician

Certi cation Board; Michael S. Maddux, PharmD, FCCP,Executive Director, American College of Clinical Phar-macy; Susan Meyer, PhD, Associate Dean for Education,University of Pittsburgh School of Pharmacy; Mitchel C.Rothholz, RPh, MBA, Chief of Staff, American PharmacistsAssociation; Marissa Schlaifer, MS, RPh, Director of Phar -macy Affairs, Academy of Managed Care Pharmacy; JanetA. Silvester, RPh, MBA, FASHP, Immediate Past President,American Society of Health-System Pharmacists; Janet

Teeters, RPh, MS, Director of Accreditation Services Divi-sion, American Society of Health-System Pharmacists; Pe -ter H. Vlasses, PharmD, BCPS, FCCP, Executive Director,Accreditation Council for Pharmacy Education; C. EdwinWebb, PharmD, MPH, Director, Government and Profes-sional Affairs, American College of Clinical Pharmacy; andDavid R. Witmer, PharmD, Vice President, Member Rela-tions, American Society of Health-System Pharmacists.

Thanks are extended to the many other individuals who

assisted with the development and review of the document.The work of faculty members from the University at Buf-falo School of Pharmacy and Pharmaceutical Sciences is ac-knowledged later in the document.Address correspondence to:Marissa Schlaifer, RPh, MS, Secretary/Treasurer, Councilon Credentialing in Pharmacy, c/o Academy of ManagedCare Pharmacy, 100 North Pitt Street, Suite 400, Alexan-dria, VA 22314

Major changes continue to occur in the delivery of health care in the United States, driv-en in part by changes in payment policies intended to rein in rising costs and by advances

in technology that have allowed more complex treatments to be performed on an outpatient basis. Hospital inpatient utilization has been stable in recent years. The ratio of physicians per population continues to increase slowly, but supply is not equally distributed across thecountry. The supply of other practitioners, including pharmacists and nurses, may not beincreasing as rapidly as needed to keep pace with our aging population.

National Center for Health Statistics Health, United States, 2007

[Pharmacists are] dedicated to the preservation and advancement of public health. Their efforts enhance the quality of our lives by helping us to live as free as possible from dis-ease, pain, and suffering.

Pharmacists: Unsung HeroesWLIW New York 2005


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Purpose

This paper, commissioned by the Councilon Credentialing in Pharmacy (CCP), a pro-vides an overview of the current contextand scope of pharmacy practice, the rangeof professional services offered by pharma-cists, and the supporting role of pharmacytechnicians. The paper has been developedas a companion piece to CCPs resource

paper, Credentialing in Pharmacy .1 To provide a link between credentialing andscope of practice, the paper also describeshow credentials commonly held by phar-macists correlate with their professionalscope of practice. Intended readers of this

paper include members of the pharmacy profession, colleagues in other healthcare professions, students, healthcare adminis-trators, regulators, insurers, and the general

public.This paper provides a synopsis of the

current state of pharmacy practice as it re-lates to the spectrum of professional roles

and responsibilities, the diversity of patient populations served, the complexities of pa-tient services provided, and various aspectsof emerging pharmacy practice. The paper focuses on the patient care services provid-ed by pharmacists; it does not address all

possible activities of pharmacists, such asadministration and general management.The paper is a descriptive analysis. It doesnot take a position regarding future chang-a The member organizations of the Council on Credentialingin Pharmacy are listed in Appendix A

seling; the provision of those acts or services necessary to provide Pharma-cist Care in all areas of patient care, in-cluding Primary Care and CollaborativePharmacy Practice; and the responsibil -ity for Compounding and Labeling of Drugs and Devices (except Labeling by aManufacturer, Repackager, or Distributor of Non-Prescription Drugs and commer-cially packaged Legend Drugs and De-vices), proper and safe storage of Drugsand Devices, and maintenance of requiredrecords. The practice of pharmacy alsoincludes continually optimizing patientsafety and quality of services through ef-fective use of emerging technologies andcompetency-based training. 3

An overview of the regulatory historyand changing role of pharmacists is pre-sented in Manasse and Speedies 2006 pa-

per. 4 By describing the full range of pro-fessional services currently provided, this

paper seeks to clarify the contribution of pharmacists to healthcare delivery and theresulting bene ts to society.

A vision for pharmacy practice has been articulated in the Joint Commissionof Pharmacy Practitioners (JCPP) b FutureVision for Pharmacy Practice 2015, whichstates that Pharmacists will be the health-care professionals responsible for provid-ing patient care that ensures optimal medi-cation therapy outcomes. 5 (Appendix B)

b The member organizations of the Joint Commission of Pharmacy Practitioners are listed in Appendix A

es, but is intended to serve as a founda-tion for understanding the relationship andalignment between the professions variousmandatory and voluntary credentials andthe scope of practice continuum. The keyeducational and credentialing standards for

pharmacists and pharmacy technicians aresummarized and referenced..

IntroductionThe mission of the profession of phar-

macy is to improve public health throughensuring safe, effective, and appropriateuse of medications. Contemporary pharma-cy practice re ects an evolving paradigmfrom one in which the pharmacist primar-ily supervises medication distribution andcounsels patients, to a more expanded andteam-based clinical role providing patient-centered medication therapy management,health improvement, and disease preven-tion services 2.

The Model State Pharmacy Act andModel Rules of the National Associationof Boards of Pharmacy (NABP) de nes the

practice of pharmacy as follows:The Practice of Pharmacy means theinterpretation, evaluation, and implemen-tation of Medical Orders; the Dispensingof Prescription Drug Orders; participa -tion in Drug and Device selection; DrugAdministration; Drug Regimen Review;the Practice of Telepharmacy within andacross state lines; Drug or Drug-relatedresearch; the provision of Patient Coun -

A Resource Paper of theCouncil on Credentialing in Pharmacy

Scope of Contemporary Pharmacy Practice:

Roles, Responsibilities, and Functions of Pharmacists and Pharmacy TechniciansApproved for distribution by CCP Board of Directors on February 25, 2009

Copyright 2009, Council on Credentialing in Pharmacy

The Council on Credentialing in Pharmacy

Washington, DC, February 2009


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A Resource Paper of the Council on Credentialing in Pharmacy (2009) 5


The concept of optimal medication ther-apy implies that the use of medicines oc-curs within a system that assures the high-est likelihood of achieving desired clinical,humanistic, and economic outcomes. TheJCPP Vision further states that pharmacistswill bene t society and be essential to the

provision of effective health care by ensur-ing that: (a) medication therapy manage-ment is readily available to all patients;(b) desired patient outcomes are more fre-quently achieved; (c) overuse, underuse,and misuse of medications are minimized;(d) medication-related public health goalsare more effectively achieved; and (e) costeffectiveness of medication therapy is op-timized.

Existing pharmacy practice settings andtheir associated professional services and

activities vary. The spectrum of patientcare needs is broad, as patients medica-tion use involves self care, acute care, andlong-term or chronic care. These differentneeds transcend all practice settings andadd complexity to care delivery. The ma-

jority of pharmacists practice in commu-nity pharmacies, ambulatory care clinics,hospitals and health systems, long-termcare facilities, home-care agencies, andmanaged-care organizations. Other prac-tice settings or roles include the pharma-ceutical industry, research, federal agen-cies such as the Food and Drug Admin-istration (FDA), academia, associations,and a number of unique healthcare prac-tices such as drug and poison informationcenters. JCPP organizations recognizealso that pharmacy technicians are a criti-cal part of the pharmacy workforce to im-

plement the 2015 Vision. In many practicesettings, pharmacy technicians are used tosupport pharmacists to manage the med-ication-use process (see section on Phar-macy Technicians below). Along with ro-

botic dispensing technology, such supportenables pharmacists to play a more pro-active and expanded role in patient care.Pharmacy technicians are accountable tothe supervising pharmacist, who is legallyresponsible (by virtue of state licensure)for the care and safety of patients served

by the pharmacy.Regardless of practice setting, profes-

sional pharmacy services and activitiesemphasize communication, education,

Medication Use StatisticsPharmaceutical preparationsinclud-

ing prescription and nonprescription med-icationsplay a vital role in improving

patients quality of life. They are used todiagnose, cure, treat, or control medicalconditions, prevent disease and ill-health,

and eliminate or reduce symptoms. Thenumber of prescriptions purchased from1994 to 2005 increased 71 percent (from2.1 billion to 3.6 billion), while the US

population only grew by 9 percent. Theaverage number of retail prescriptions per capita increased from 7.9 in 1994 to 12.4in 2006. The population aged 65 years andover is increasing at a faster rate than the to-tal population and 92 percent of this grouphave some prescription drug expenditure.Globally, as people are generally healthier

and living longer, the worlds healthcarefocus is shifting from treatment of patientswith acute diseases to management of pa-tients with chronic medical conditions.Chronic illness affects a high percentage of the US population; many patients presentwith co-morbidities and require complex,multi-drug therapies. Community-basedtreatment in the communityboth acuteand chronichas escalated medicationuse. Higher prescription volumes attribut-able to a growing elderly population withmultiple medications, an increased number of prescription and over-the-counter medi-cations, direct-to-consumer advertising,increased consumer reliance on self-care,and increased outpatient surgeries have all

placed the pharmacist in a more prominent position to provide more information andservices to the public.

Advances in TherapeuticsAdvances in medical research, phar-

maceutical and biomedical technologieshave contributed to the development of therapies for an expanding range of medi-cal conditions. Many therapies are com-

plex, have high risk pro les, and requireintensive monitoring. Some therapies arehighly individualized or must be subject tolimited distribution. Medication therapy isan essential element of healthcare delivery

but the complexities of the medication use process are becoming increasingly clear.Multiple factors can have a direct impacton a patients ability to access and adhere

and information exchange with patientsand their caregivers, prescribers, and oth-er healthcare professionals. Pharmacistmanagement of medication use provides

patient-centered medication therapy and isintegrated with the additional responsibili-ties of medication distribution, supervision

of pharmacy technicians, adaptation of new pharmaceutical technologies, ef cientmanagement of systems and resources, andintegration of information systems and ap-

plications, all in a rapidly changing health-care environment. This broad scope of pro-fessional practice and the complexity of themedications managed within each of theseindividual practices require a pharmacyworkforce that is diverse in knowledge andskills, competently trained, and adequatelycredentialed. The workforce must demon-

strate professional judgment, ethics, atti-tudes, and values.

Healthcare Delivery in the United States

The healthcare system in the United Statesis complex and faces many challenges. Anumber of recent reports have identi edthat human and economic resources with-in the system are stretched and, overall,not ef ciently utilized. 6 As patients movethrough the health system, they encoun-ter multiple providers and multiple levelsof care. Traversing the healthcare systemrequires continuity of a patients medica-tion therapy and medical history to avoiderrors and maximize outcomes. There is,however, an unacceptable level of error (including medication errors) in the sys-tem. The Institute of Medicine (IOM) iden-ti ed ve core competencies required for all health professionals to optimize patientoutcomes; namely: (1) deliver patient-cen -tered care; (2) work as part of an interdisci -

plinary c team; (3) practice evidence-basedmedicine; (4) apply quality improvementapproaches; and (5) use information tech -nology. The IOM stresses the need to fullyutilize the knowledge and skills of eachteam member. 7

c The term interprofessional is preferred by CCP and is usedhereinafter when describing a collaborative working relation-ship between members of different healthcare professions,such as pharmacists, physicians, and nurses.


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to medication therapy and to achieve thedesired therapeutic outcomes. These fac-tors are accentuated in chronic medicationtherapy. Interprofessional collaboration iscrucial when developing and implement-ing complex therapeutic plans. The geneticcomposition of a patient can in uence his/

her response to medications and appropri-ate dosing. Patients from different ethnic,cultural, or social backgrounds may havedifferent perceptions, beliefs, behaviors, or

practices relevant to disease states or medi-cation therapy, which can impact the suc-cess or failure of patient outcomes. Culturalissues may also impact pharmacist-patientor pharmacist-caregiver communication.Beyond basic language barriers, pharma-cists must be able to accurately assess theability of the patient and/or caregiver to ob-

tain, interpret, and understand basic healthinformation and services (their health lit-eracy) to ensure that all communicationsare appropriate and understood. A patientmust be able to use available informationand be aware of how to access and use ser-vices to enhance their health. However, anindividuals health literacy can impact theachievement of desired patient outcomes.Such situations are faced daily by pharma-cists, and necessitate the growing area of education and training in cultural compe-tency. Pharmacists are being trained to de-liver culturally competent care as part of their efforts to optimize patient outcomesand eliminate disparities that exist in thehealthcare delivery system. 9 Patients on areduced budget, those without any income,and those who are homeless are increasingin number and often have limited access tothe healthcare system. Such patients oftenneed help to access indigent-care medica-tion programs or pharmaceutical manufac-turers medication programs.

Medication TherapyManagement

Patients may require a combinationof information, education, guidance, andcoaching about their medications. Phar-macists have a broad knowledge base toappropriately assess and respond to a pa-tients medication therapy needs, therebycontributing to the interprofessional man-agement of patients and optimal patientcare. Medication therapy management

Implicit in the ability of a pharmacistto obtain accurate disease and medicationhistory is a thorough understanding of the

primary medical problem, co-morbidities,and pharmacologic effects of the individ-ual patient medication regimen. In caseswhere patients are receiving multiple med-

ications, an in-depth understanding of druginteractions is also required. In the area of medication-related problems, pharmacistshave developed expertise in monitoringthe pharmacologic effects of medicationsfor certain disease states including, but notlimited to, diabetes, asthma, hypertension,seizures, hyperlipidemia, anticoagulation,and infectious diseases. These initiatives

provide an early warning system thatidenti es patients with sub-optimal treatment responses and those patients who may

experience excessive drug effects, druginteractions, adverse drug effects, and/or drug toxicity. Studies have demonstratedthe clinical and economic bene ts of MTMservices provided by pharmacists. 16

Pharmacists have assumed an expand-ed role in medication safety, prevention of medication-related problems, disease pre-vention, and wellness programs. In the areaof disease prevention and health promo-tion, pharmacists have developed practicessuch as those that reduce morbidity fromobesity, osteoporosis, heart failure, hyper-tension, diabetes, and other chronic medi-cal conditions, as well as patient habits and

behaviors that impact health, such as smok-ing. The rapid, dramatic advances in medi-cation therapy over recent decades havealso created a niche for pharmacy practi-tioners who specialize in speci c kinds of treatment and aspects of care.

Practice-based Research ProjectsCommunity-based initiatives, such as

the Asheville Project, have demonstratedthat, by providing intensive education andensuring that patients are using their medi-cations correctly, pharmacists can contrib-ute to improved patient outcomes, loweredtotal healthcare costs, a reduction in num-

ber of sick days taken, and increased satis-faction with pharmacist services. With thesupport of a pharmacist coach, patientscan become effective at self-managing achronic disease. The Asheville Project be-gan in 1996 as an effort by a self-insured

(MTM) is a partnership of the pharmacist,the patient or their caregiver, and other health professionals that promotes the safeand effective use of medications and helps

patients achieve the targeted outcomesfrom medication therapy. In 2004, elevennational pharmacy organizations devel-

oped a consensus de nition for medicationtherapy management services (MTMS) asfollows:

Medication therapy management is adistinct service or group of services thatoptimize therapeutic outcomes for individ-ual patients. Medication therapy manage-ment services are independent of, but canoccur in conjunction with, the provision of a medication product. 10,11

MTM encompasses a broad range of professional activities and responsibilities

within the licensed pharmacists, or other quali ed healthcare providers, scope of practice. Examples of medication manage-ment therapy services are provided in Ap-

pendix C. A more comprehensive frame-work for the development of MTM pro-grams is provided in Medication TherapyManagement in Pharmacy Practice: CoreElements of an MTM Service Version 2.0released in March 2008 by the AmericanPharmacists Association (APhA) and the

National Association of Chain Drug Stores(NACDS) Foundation. 12 The introductionof a prescription drug bene t under Medi -care Part D increased the recognition that

pharmacists play an active role in the pre-vention and resolution of medication-relat-ed problems and medication management,thereby contributing to the optimization of

patient therapeutic outcomes. 13 Other orga-nizations committed to improved health-care delivery have recognized the contribu-tion of pharmacists in this regard. 14 WhileMedicare Part D provides an excellent ex-ample of an MTM bene t, such servicesare often provided by pharmacists to pa-tients other than those covered by Medi-care. MTM service capability is supported

by the recent revisions to the accreditationstandards for professional degree programsin pharmacy. To ensure that pharmacistshave this essential clinical managementexpertise, these standards emphasize theachievement by graduates of competencyin the development and maintenance of in-dividual patient-care plans. 15


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sciences. Also, upon graduation, a pharma-cist is expected to be competent in SystemsManagement (Outcome 2). Systems man-agement includes managing resources incooperation with patients, prescribers, andother healthcare providers, as well as ad-ministrative and supportive personnel (eg,

pharmacy technicians) to promote healthand provide, assess, and coordinate medi-cation distribution. Finally, a pharmacistmust also be able to promote Public Health

modi cations. (Table 1) The North American Pharmacist Licensure Examination

(NAPLEX ) is the principal licensure ex-amination that all students who graduatefrom an accredited professional degree

program in pharmacy must pass to obtainlicensure and practice as a pharmacist.

The NAPLEX Blueprint, developed fromregularly updated practice analyses, com-

prises detailed competency statements inthree main areas: (1) Assure Safe and Ef-

Table 1: Alignment o Competency and Credentialing Frameworks: ACPE Standards, AACPs CAPE Outcomes, andNABPs NAPLEX Blueprint

ACPE Standard 12: Professional Competencies andOutcome Expectations

AACP CAPE EducationalOutcomes 2004

NABP NAPLEX Blueprint

Pro essional pharmacist competencies that must be achievedby graduates through the pro essional degree program cur-riculum are the ability to:

1. Provide patient care in cooperation with patients,prescribers, and other members o an interpro essionalhealth care team based upon sound therapeutic prin-ciples and evidence-based data, taking into accountpro essional issues, emerging technologies, and evolvingbiomedical, pharmaceutical, social/behavioral/adminis-trative, and clinical sciences that may impact therapeuticoutcomes.

O u

t c o m e

1 :

P h a r m a c e u

t i c a

l

C a r e

Provide patient-centered care

A r e a

1

Assure Sa eand E ectivePharmaco-therapy and

OptimizeTherapeuticOutcomes

Provide popula-tion-based care

2. Manage and use resources o the health care system, incooperation with patients, prescribers, other healthcareproviders, and administrative and supportive personnel,to promote health; to provide, assess, and coordinatesa e, accurate, and time-sensitive medication distribu-tion; and to improve therapeutic outcomes o medicationuse.

O u

t c o m e

2 :

S y s

t e m s

M a n a g e m e n

tManage human,physical, medi-

cal, in ormational,and technological

resources A r e a

2

Assure Sa eand AccuratePreparation

and Dispens-ing o Medica-

tionsManage medica-tion use systems

3. Promote health improvement, wellness, and diseaseprevention in cooperation with patients, communities,at-risk populations, and other members o an interpro-

essional team o health care providers.

O u

t c o m e

3 :

P u

b l i c H e a

l t h

Assure the avail-ability o e ective,quality health and

disease preventionservices A r e a

3Provide Health

Care In or-

mation andPromote Public

HealthDevelop publichealth policy

These pro essional competencies must be used to guide thedevelopment o stated student learning outcome expectationsor the curriculum. To anticipate uture pro essional compe-tencies, outcome statements must incorporate the develop-ment o the skills necessary to become sel -directed li elonglearners.

(Outcome 3) by improving health, well-ness, and disease prevention in cooperationwith patients, communities, at-risk popula-tions, and other interprofessional teams of healthcare providers.

The recently revised AccreditationCouncil for Pharmacy Education (ACPE)

Standards for accreditation of the pro-fessional degree in pharmacythe Doc-tor of Pharmacy (PharmD)adopted theCAPE Educational Outcomes with minor


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fective Pharmacotherapy and OptimizeTherapeutic Outcomes; (2) Assure Safeand Accurate Preparation and Dispensingof Medications; and (3) Provide HealthcareInformation and Promote Public Health 31.

The blueprint re ects the knowledge, judg -ment, and skills expected to be demonstrat-

ed by an entry-level pharmacist to protectthe health and welfare of their patients. Ta-

ble 1 illustrates how the ACPE Standards,CAPE Educational Outcomes, and the NA-PLEX Blueprint mirror each other. Theclose alignment of the competency frame-works of AACP, ACPE, and NABP servesthe professions and patients needs well byaddressing both current and evolving prac-tice activities.

Effective in 2000, all students enrolledin a professional Doctor of Pharmacy de-

gree program are required to complete aminimum of six years of post-secondaryeducation, up from the minimum of veyears required by previous accreditationstandards, which expired in 2004. The cur-ricular change to the Doctor of Pharmacydegree provided for increased clinical train-ing. One of the primary reasons for this ad-ditional clinical training was to ensure that

pharmacists could work more effectivelywith physicians, nurses and other health-care professionals. The ongoing accredi-tation review of the degree programs of colleges and schools of pharmacy, provid-ers of continuing education, and residencytraining programs, and the expansion of

post-licensure education and training opportunities encourage a continued focus onthe emerging roles and practice competen-cies that pharmacists require as new phar-macy practices are established.

Tasks and Functionsof Pharmacists

On a regular basis, there have been col-laborative initiatives within the professionto analyze and document the professionalactivities of pharmacists. The last of thesewas the Scope of Pharmacy Practice Proj-ect (19921994). 32 Following the thirdJCPP Pharmacy in the 21st Century Con-ference in 1994, a collaborative effort of ten national pharmacy organizations e led toe Academy of Managed Care Pharmacy, American As-sociation of Colleges of Pharmacy, American College of Apothecaries, American College of Clinical Pharmacy,American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-

the development of the Pharmacist Prac-tice Activity Classi cation (PPAC), a hi -erarchical categorization of pharmacist ac-tivities. 33 (Table 2) The PPAC also includesactivities that are either delegated by phar-macists to technicians or are carried out byautomated systems.

The three competency frameworks andthe PPAC also align closely with the vecore competencies applicable to all health-care professionals and which are identi ed

by the IOM, namely: (1) delivering patient-centered care, (2) working as a part of in-terprofessional teams, (3) practicing evi-dence-based medicine, (4) focusing on qual-ity improvement, and (5) using informationtechnology. 7 The three broad competencyareasPatient Care, Systems Management,and Public Healthalso re ect a frame -work that is used in this document to de-scribe the areas of practice of pharmacists.The primary focus of this paper is, however,Patient Care, ie, professional services pro-vided directly to patients. Services provided

by pharmacists in the other two areas (Sys-System Pharmacists, National Association of Boards of Pharmacy, National Association of Chain Drug Stores,

National Commun ity Pharmacists Association

Table 2: Pharmacist Practice Activity Classifcation (PPAC) Domains andClasses

Domain: Class:

A. EnsuringAppropriateTherapy andOutcomes

A.1. Ensuring appropriate pharmacotherapyA.2. Ensuring patients understanding/adherence tohis or her treatment planA.3. Monitoring and reporting outcomes

B. DispensingMedicationsand Devices

B.1. Processing the prescription or drug order B.2. Preparing the pharmaceutical productB.3. Delivering the medication or device

C. HealthPromotionand DiseasePrevention

C.1. Delivering clinical preventive servicesC.2. Surveillance and reporting o public health issuesC.3. Promoting sa e medication use in society

D. Health Sys-tems Man-agement

D.1. Managing the practiceD.2. Managing medications throughout the health systemD.3. Managing the use o medications within the healthsystemD.4. Participating in research activitiesD.5. Engaging in interdisciplinary collaboration

tems Management and Public Health) will be described in lesser detail.

Credentialing in PharmacyAs described in CCPs resource paper,

Credentialing in Pharmacy , post-licensureeducation and training opportunities for

pharmacists have expanded dramatically inthe past few decades. This trend re ects theenhanced and expanded roles of pharma-cists in response to the changing societalneeds outlined earlier. A parallel develop-ment has been the emergence of more for-mal and structured education and training

programs for pharmacy technicians, ac-creditation of such training programs, andnationally recognized certi cation. Under

pinned by state board-mandated continu-ing education activities that aim to ensurethat all practitioners remain competent to

practice, additional offerings support the professional development and enhancedcompetency of pharmacists in a variety of ways. Some are speci c to pharmacists,while others are offered to multiple health

professionals. (Appendix E, Figure 7) Therecognition of pharmacy specialty practices


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sure training programs and credentials are(1) competency-based, (2) developed onthe basis of a comprehensive practice anal-ysis in the relevant areas, and (3) offeredor accredited by organizations that adhereto accepted principles and practices to as-sure quality, integrity, and validity. 1 As ex-amples, brief overviews of pharmacy prac-tice residencies and specialty certi cationare provided below.

Residency TrainingResidency training programs are one

year in length and provide an environmentand structure for accelerating growth andexperience beyond entry-level professionalcompetence through supervised practiceunder the guidance of model practitio-

Table 3: Required and Elective Educational Outcomes or Postgraduate Year One (PGY1) Pharmacy Residency Programs

RequiredOutcomes:

Outcome R1 Manage and improve the medication-use process

Outcome R2 Provide evidence-based, patient-centered medication therapymanagement with interdisciplinary teams

Outcome R3 Exercise leadership and practice management skills

Outcome R4 Demonstrate project management skills

Outcome R5 Provide medication and practice-related education/training

Outcome R6 Utilize medical in ormatics

PotentialElectives:

Outcome E1 Conduct pharmacy practice research

Outcome E2 Exercise added leadership and practice management skills

Outcome E3 Demonstrate knowledge and skills particular to generalistpractice in the home care practice environment

Outcome E4 Demonstrate knowledge and skills particular to generalistpractice in the managed care practice environment

Outcome E5 Participate in the management o medical emergencies

Outcome E6 Provide drug in ormation to healthcare pro essionals and/or the public

Outcome E7 Demonstrate additional competencies that contribute to work-ing success ully in the healthcare environment

Table 4: Pharmacy Practice Areasor Postgraduate Year Two (PGY2)Residencies

Educational Goals and Objectiveshave been developed for thefollowing areas of pharmacypractice:

AmbulatoryCare

Medication-UseSa ety

Critical CareNuclear

Medicine

DrugIn ormation

Nutrition Support

Geriatrics Oncology

Health-SystemPharmacy

AdministrationPediatrics

In ectiousDiseases

Pharmaco-therapy

In ormatics Psychiatry

InternalMedicine

Solid OrganTransplant

in speci c disease states led to agreementthat standard competencies should be dem-onstrated on a national basis with regardto best practices. 34 Disease-speci c andspecialized training and certi cation wereinitiated through the National Institute for Standards for Pharmacist Credentialing(NISPC) f , the Board of PharmaceuticalSpecialties (BPS), and individual ACPE-accredited Certi cate Programs (eg, inHIV/AIDS, immunization, and diabetes) g.Full details of these programs are providedin Credentialing in Pharmacy . Post-licen-

f The NISPC Certi ed Disease Manager Certi cation pro -gram expired on December 31, 2008.g With effect from January 1, 2009, ACPE implemented newaccreditation standards for providers of continuing pharmacyeducation and no longer maintains separate accreditationstandards for providers of Certi cate Programs.

ners (preceptors) in real-world settings.Residents are exposed to a wide range of

patients with multiple disease states andwork with a variety of health professionals,thereby advancing their clinical, interper-sonal, and leadership skills. The rst postgraduate year of pharmacy residency train-ing focuses on managing the medicationuse process and providing optimum medi-cation therapy outcomes for patients with a

broad range of disease states. The secondyear of postgraduate residency training fo-cuses on a specialized area of practice andmore in-depth training and experience.

Established in 1962 and maintained bythe American Society of Health-SystemPharmacists (ASHP), accreditation stan-dards for Post-Graduate Year One (PGY1)

pharmacy residencies (previously referredto as pharmacy practice residencies) andPost-Graduate Year Two (PGY2) pharma-cy residencies (previously referred to as


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specialized residency training) incorpo-rate required and elective educational out-comes, goals, and objectives. These out-comes build upon the PharmD competen-cies and augment the IOM competencies.A PGY1 pharmacy residency must be com-

pleted before going on to a PGY2 phar-

macy residency. The educational outcomesfor PGY1 residencies are listed in Table 3.PGY2 educational outcomes are more ex-tensive and each specialized area of train-ing has its own speci c outcomes. Table4 lists the practice areas for which PGY2educational goals and objectives have beendeveloped. 35

Specialty Certi cationIn pharmacyas in all healthcare prac-

ticesspecialization has become essen-

tial to optimal patient care. The evolutionof specialists in pharmacy is much shorter than in medicine and other healthcare pro-fessions. Established in 1976 by the Ameri-can Pharmacists Association, the Board of Pharmaceutical Specialties (BPS) currentlycerti es pharmacists in ve specialties: nu -clear pharmacy, nutrition support pharma-cy, oncology pharmacy, pharmacotherapy,and psychiatric pharmacy. The recognition

Table 5: Domains and Content Outlines or BPS Specialty Examinations

NuclearNutritionSupport Oncology

Pharmaco- Therapy Psychiatric

Domain 1 Drug Order Provi-sion (66% o theexamination)

Clinical Practice/Provision o Indi-vidualizedNutrition Supportto Patients (68%)

Clinical Skills andTherapeutic Man-agement (60%)

Patient-Speci cPharmacotherapy(55%)

Clinical Skills andTherapeutic Man-agement(65%)

Domain 2 Health and Sa ety(24%)

Management o Nutrition SupportOperations (20%)

Generation, In-terpretation, andDissemination o

In ormation (20%)

Retrieval, Genera-tion, Interpretationand

Disseminationo Knowledge inPharmacotherapy(30%)

Education andDissemination o In ormation (25%)

Domain 3 Drug In ormationProvision (10%)

Advancement o Nutrition SupportPractice (12%)

Guidelines, Poli-cies, and Stan-dards (15%)

Health System-Related Pharmaco-therapy (15%)

Clinical Adminis-tration (10%)

Domain 4 Public Health andAdvocacy (5%)

Figure 1: Scope o Pharmacy Practice and Pro essional Competencies in the U.S.

Breadth of Patient / Practice FocusB r o a d

N ar r ow

L e v e l

of K n

owl e

d g e , S k i l l s ,

a n

d E x p

e r i e n

c e

Entry-Level

Advanced

A

C

B

DCAPE #1 Patient Care

CAPE #2 Systems Management

CAPE #3 Public Health P r

a c t i c

e D o m

a i n

P a t i e n t - F o c u s e d

S y s t e m - F o c u s e d


13/40



of each specialty is the result of collabora-tion between BPS and one or more pharma-cy organizations. Each specialty examina-tion has a separate Content Outline validat-ed through a national survey of pharmacistspecialists. The Content Outlines providedetail on the major areas (domains) of responsibility for a specialist, the tasks thatare required to ful ll these responsibilities,and the knowledge that underlies the per-formance of these tasks. For example, theContent Outline for the PharmacotherapySpecialty is divided into three domains: (1)

patient-speci c pharmacotherapy; (2) re -trieval, generation, interpretation and dis-semination of knowledge in pharmacother-apy; and (3) health system-related pharma -cotherapy.

Table 5 provides the domains for theve specialties. Each certi cation examina -tion question is linked to a speci c domain,task, and knowledge statement. Certi ca -tion examinations are developed to be psy-chometrically sound and legally defensible.In 1997, BPS introduced the designation of Added Quali cations to denote that anindividual has demonstrated an enhancedlevel of training and experience in one seg-

of professional education, licensure, andentry to practice; (2) the post-graduate education and training activities in which theymay participate; (3) the credentials/certications they may earn; and (4) the relationship between credentialing, broad compe-tency areas, scope of practice, and patient

populations served.The Patient Care domain of the frame-

work depicts pharmacists as falling intoone of four quadrants in the model: (A)Generalist Practitioners; (B) FocusedPractitioners; (C) Advanced Generalist Practitioners; and (D) Advanced Focused Practitioners. (Figures 1 and 2) Thisdifferentiation,based on breadth of

practice/patient focus and level of knowl-edge, skills, and experienceis expandedupon in the next section where the roles,

responsibilities and functions of practicing pharmacists are described.

Pharmacists InPatient-Care Roles

Generalist PractitionersGeneralist practitioners (Figure 2,

Quadrant A) care for patients with a widevariety of medical conditions and diseases,ranging from minor ailments to complexacute and chronic conditions. They mayalso provide consultation regarding thehealthcare issues and needs of individu-als seeking advice and those for whom anintervention is warranted to promote goodhealth, prevent the development of disease,or avoid the consequences of lifestyles and

behaviors that pose health risks. The prac-tice settings for these pharmacists are pri-marily community pharmacies, ambula-tory clinics, hospitals, and health systems.It is envisioned that the pharmacy servicesfor the large majority of patients and indi-viduals can be provided by generalist prac-titioners; hence, this is where there is theshortest supply and greatest need for phar-macists.

Community-based CareThe ow of activities that is typically as

sociated with medication management in acommunity pharmacy or ambulatory clinic

practice is shown in Figure 3; it depicts a pharmacists responsibilities for the provi-

Figure 2: Practitioners in Direct Patient Care

ment of a BPS-recognized specialty. Infec-tious Diseases and Cardiology are the twoadded quali cations for the pharmacother -apy specialty currently recognized by BPS.BPS believes that a new specialty, focusedin the area of ambulatory or primary care

pharmacy practice, might be an appropriateaddition to the ve specialty certi cationsoffered and introduction of such a specialtyis under active consideration. Further de-tails regarding specialty certi cation can

be found on the BPS Website http://www. bpsweb.org/08_Resources.html.

A Framework for Credentialingin Pharmacy Practice

The CCP has embraced a conceptualframework that articulates the relationship

between the scope of a pharmacists prac-tice and his/her credentials and post-licen-sure education and training. The framework is described in detail in Appendix E. Usinga three-dimensional model to encompassthe three major domains of pharmacy prac-tice described earlierPatient Care, Sys-tems Management, and Public Healththeframework illustrates: (1) how pharma-cists careers may evolve after completion

Breadth of Patient / Practice FocusB r o a d

N ar r ow

L e v

e l of K n

owl e

d g e , S k i l l s ,

a n

d E x p

e r i e n

c e

Entry-Level

Advanced

A

C

B

D

Generalistpractitioner

Wide variety of patients and diseases;

minor ailmentsto more complex

conditions

Focusedpractitioner

Wide variety of diseases in a uniquesetting or population,or a narrow diseasefocus

Advancedgeneralist

practitionerWide variety of

patients and diseases;

complex healthcareissues

Advanced focusedpractitionerFocused patientpopulations; medicallycomplex patients,

therapies, and/or technology


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sion of direct patient care. New prescrip-tions for acute illness and re lls of medi -cations for chronic conditions are accom-

panied by a full medication (prescriptionand nonprescription) and allergy history.Pharmacists should conduct a health-liter-acy assessment and then provide individu-

alized counseling, education, and coach-ing to ensure that the patient and/or the

patients caregiver is aware of the identityof the product, the indications and direc-tions for use, storage requirements, side ef-fects, long-term toxicity, drug interactions,food interactions, and medication adher-ence factors.

Community pharmacy is the practicesetting that the public primarily envisionswhen pharmacy practice is discussed. The

provision of medication for ambulatory pa-

tients is the primary responsibility of com-munity pharmacy practitioners and the vol-ume will increase as a result of an aging

population and the trend toward managingmore acute conditions and acute exacerba-tions of chronic conditions in the ambu-latory environment. The complexity andsophistication of the medications used inthe ambulatory setting, coupled with theincreasing number of ambulatory patients,suggests that pharmacists in communi-ty pharmacies will become an even more

essential access point for acquisition of healthcare services. This trend will contin-ue despite the fact that an increasing num-

ber of patients receive their medicationsand medication information from an insti-tutional or health system-af liated pharma -cy or a pharmacy that is located within anorganized primary care medical practice.

Institution-based CareThe policies and procedures in the

acute care or long-term care institutionalsettings are analogous to but slightly dif-ferent from those depicted for ambulatorysettings. In these settings there is oftenactive participation by pharmacists in themedication selection decision as part of themedical care team. This collaboration pre-cedes the generation of the medication or-ders, which are interpreted and processed

by other pharmacists to ensure accuratemedication selection and the developmentof monitoring plans to assure that optimaloutcomesincluding patient safetyare

achieved (Figure 4). Pharmacists in themedication distribution process have a re-sponsibility for the training and supervi-sion of pharmacy technicians, ef cient useof information technology, and applicationof management skills that allow for patient

priorities to be set in daily practice activi-ties. In addition to collaborating with other health professionals in the medication se-lection process and monitoring drug distri-

bution, pharmacists have responsibilities toassure that patients receive the safest and

best therapy possible, are educated abouttheir medications, and are provided strat-egies to enhance their compliance withmedication regimens. Pharmacists provideconsultation and recommendations to phy-sicians, nurses, physician assistants, andother healthcare professionals regarding

approved and off-label indications, dos-ing and administration guidelines, druginteractions, chemical incompatibilities,therapeutic drug-monitoring approaches toavoid toxicity and maximize effectiveness,adverse-effect monitoring and preven-tion, and avoidance of therapeutic duplica-tion as the result of poly pharmacy. Dos-ing might have to be adjusted according tothe patients age, disease, renal function,or hepatic function. In a hospital a varietyof routes of administration may be avail-able including intravenous, intramuscular,subcutaneous, irrigation, nasogastric tube,oral, or targeted therapies. When this scopeof pharmacy services is present, the phar-macist becomes a critical contributor to di-rect patient care through interactions with

providers on decision-making processes

Figure 3: Flow diagram depicting steps to optimize medication therapy orambulatory patients.

Pharmacistmakes

recommendationsfor optimizationof therapy anddiscusses with

prescriber

If indicated,

patient schedulesfollow-up visit

with pharmacist tomanage medication

therapy

Pharmacistcontacts

prescriber or follows collaborative

drug therapymanagement

protocol

Pharmacistuses an

evidence-basedapproach, relying

on patient-specicinformation, current

guidelines, and other evidence to address

problems

Pharmacistevaluates

patient-specicinformation to

assess medicationtherapy

Problemis

addressed ProblemSolving

Collaboration

Pharmacistdiscusses

medication withpatient

Patientpresents toprescriber

Prescriber examinespatient

Prescriber makes

diagnosis/assessmentand issues

prescription

Prescriptionreceived bypharmacy

Pharmacistevaluates

appropriatenessof prescription for

this patient

Pharmacist/technicianprepares

medication for patient

Potentialproblem

identied

No problemidentied


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for drug regimens, formulary issues, andoptimal drug therapies to meet the needs of the individual patient.

Many factors in uence the type of ac -tivities for the pharmacist in a hospital set-ting. Some of these factors include: the sizeof the hospital, the services provided by the

hospital (eg, pediatrics, oncology, trans- plant, trauma center), academic af liationswith the hospital, the presence of pharmacyresidency programs, geographic location,af liated health insurance programs, relat -ed ambulatory clinics, the level of deploy-ment of pharmacy technicians and the ex-tent of integration of information systemsand technology such as robotics, automat-ed dispensing, and computerized physicianorder entry (CPOE).

The nature of acute care requires that

pharmacists in this setting have a broadknowledge base in parenteral medications,intravenous uid and nutritional therapy,chemistry, physiology, and pathophysiol-ogy. Pharmacists are involved in determin-ing chemical compatibilities, infusion rates,and sequencing of multiple medicationsthat may need to be infused intravenouslyinto a patient. Additionally, pharmacistsinterpret a wide array of laboratory andimaging tests to monitoring drug therapy.Patients in hospitals receive a high num-

ber of medications, and have frequentlychanging medical conditions that increasethe opportunity for drug interactions andadverse side effects. The pharmacists mustalways be reviewing medications to helpassure the best outcomes for the patient.Recent advances in informatics facilitatemore ef cient access to drug information,lab information, and patient data so that all

pharmacists provide drug information to avariety of healthcare practitioners.

Population-based CarePharmacists also participate in medica-

tion management through involvement inthe pharmacy and therapeutics (P&T) com-mittees of hospitals, health systems, andmanaged-care organizations. A key aspectof this role for pharmacists is involvementin the development of protocols, guidelines,and formularies for directing safe and ef-fective use of medications while in the hos-

pital. While patient safety and improvedhealthcare outcomes are the primary focus,

pharmaco-economic aspects of drug therapy decision making and contract pricing generally coordinated by pharmacistsarealso integral to the pharmacy and therapeu-tics committee process; these in turn facili -tate cost containment within the health sys-

Figure 4: Flow diagram depicting steps to optimize medication therapy orhospitalized patients.

tem. Recent regulatory requirements haveexpanded the role of the pharmacist in risk management and regulatory compliance. 1

Furthermore, the importance of continuityof care has led to an increased need to havea pharmacist in the emergency department,

Prescriber/medical team

makes diagnosis/assessment and

issues order

Problem

Solving

Collaboration

Pharmacistmay round

with prescriber/medical team

Prescriptionorder is

sent to thepharmacy to

ll

Pharmacistevaluates

appropriatenessof order for this patient

Pharmacist/technician lls

order and sendsorder to nurse for

administration

Pharmacistuses an

evidence-basedapproach, relying

on patient-specicinformation, current

guidelines, and other evidence to address

problems

Pharmacistcontacts

prescriber or follows

institutionalprotocol

Problemis

addressed

Pharmacistreviews

patients chart and

evaluates patient-specic information

to assesstherapy

Asneeded,

pharmacistinterviews

patient

Physician/medical team

examinespatient

Pharmacistmakes

recommendation for optimization of therapy

and discusses withprescriber/medical

team

Noproblem

identied

Potentialproblem

identied


16/40



and to evaluate medication histories uponadmission to hospital and provide medica-tion counseling prior to discharge. In thisrole, pharmacists address acute-care needsand help to transition patients into and outof the hospital. Other roles for pharmacistsin hospital and health-system practice in-

clude managing pain, coordinating reim- bursement for indigent-care programs, preparing for bioterrorism, supervising in-vestigational drug distribution, and partici-

pating in clinical research.A pharmacist practicing in a medical

clinic or ambulatory clinic setting is oftenan active participant in an interprofessionalteam that may include physicians, mid-lev-el providers, medical residents, students,nurses, social workers, and others. In manyambulatory settings, pharmacists directly

collaborate with members of the health-care team while, in others, written consul-tations or patient progress notations may

be the predominant means of communica-tion. Generalist practitioners in ambulatorysettings assist patients by reviewing their

prescription, nonprescription, and herbalmedications, as well as nutritional thera-

pies. They may also provide disease statespeci c management education to patients,train them in the use of devices and tools tomonitor their disease state(s), and regularlyfollow-up with patients and/or their care-givers to verify adherence to the medica-tion regimen. Providing such comprehen-sive services to selected communities has

been associated with more ef cient patientcare and positive clinical, humanistic, andeconomic outcomes. 36

Pharmacists in over 45 states and ter-ritories can now serve as providers anddirectly interact with patients during their clinic visit or after, participate in medicalchart review and documentation, and servean essential role in the structured prescrib-er-directed medical team review of pa-tients. 37 In this type of pharmacy practice,

patient evaluation, monitoring, medicationrecommendation, medication modi cation,and formulary management with follow-up are facilitated with a collaborative drugtherapy management (CDTM) agreement.The objectives of CDTM are to better co-ordinate drug prescribing, dispensing, ad-ministration, monitoring, and dosage ad-

justment and avoid drug-related problems

their practice site. These specialized ser-vices may be focused on one disease state(such as asthma) or on public health ini-tiatives (such as smoking cessation or the

provision of immunizations). Currently, 49states have adopted regulations that allow

pharmacists to administer immunizations.

The laws vary in depth and breadth sincesome states (eg, Virginia) allow pharma-cists to administer all immunizations in-cluding travel speci c vaccines, whereasother states (eg, Delaware) only allow

pharmacists to deliver in uenza and pneumococcal vaccines. In states where phar-macists are permitted to immunize, the per-centage of people immunized is increasingtoward the goals of Healthy People 2010. 4

Mail-service Pharmacy

Some patients receive their medica-tionsespecially re lls for medicationsused for chronic medical conditions from mail-service pharmacies, which areused by some health plans, prescription

bene t management companies (PBMs),large pharmacy chains, and Internet phar-macy providers to reduce costs associatedwith the supply of medications and pro-vide the convenience of home delivery of medications. Patients typically order their medications via telephone, fax, e-mail, or the Internet. Once a prescription order istransmitted to the mail-service pharmacy,

patients usually receive their prescriptionwithin a week to ten days. Large numbersof pharmacists and pharmacy techniciansare employed at mail-service pharmacies,

but many of the processes use high-volumeautomated dispensing technologies. Somemail-service pharmacies provide medica-tion management services for individual or

population-based patients.

Focused PractitionersFocused practitioners are those phar-

macists who either see a wide variety of diseases in a speci c setting or patient population such as pediatrics, or who treat arelatively narrow spectrum of diseases suchas thrombotic disease. Pharmacists practic-ing as focused practitioners (Figure 2,Quadrant B) have the knowledge, skills, at-titudes, and valuesachieved through ap-

propriate post-graduate education, training,and/or experienceto provide the level of

that contribute to less than optimal patientoutcomes and increased healthcare costs. 38 CDTM agreements typically specify what

pharmacists are authorized to do (generally by physicians), such as selection of medi-cations for identi ed medical conditions,adjustment of dosage regimens based on

patients response to therapy, monitoringof key vital signs, authorizing prescriptionre lls, providing drug information, assess -ing patient compliance, drug policy devel-opment, and development and evaluationof therapeutic management policies. Col-laborative practice agreements have cov-ered a variety of patient service areas, mostcommonly anticoagulation, monitoringand dosage adjustment, pain management,emergency contraception, and disease-statemanagement of asthma, diabetes, and hy-

perlipidemia.39

The bene ts of physiciansand pharmacists working collaboratively toimprove patients quality of life and reducemedication-related adverse effects have

been acknowledged by several physicianand medical organizations. 40,41

The Veterans Affairs (VA) Health Sys-tem and several other regional healthcareorganizations have developed models thatmaximize the contribution of a pharma-cists interaction with ambulatory patientsand also emphasize the clinical integra-tion of pharmacotherapy expertise. 42 Anexample of CDTM activities undertaken

by pharmacists practicing in an ambula-tory care setting is provided in AppendixD. The VA approach has allowed the VAcare delivery system to function ef cientlyand economically while enhancing patientcare. Within the VA system, the pharmacistacts as an extension of the physician andis able to implement medication and dos-age changes as well as ensure continuity of care by prescribing medication and direct-ing medication dispensing. This model has

been replicated in many states that have ad-opted collaborative practice initiatives andhas been shown to improve patient safety,quality of life, and economic markers. 42

Many generalist practitioners in any practice settingeven while spending themajority of their practice dealing with a

broad range of patients and medical con-ditionsmay have developed expertise ina speci c area. This may be re ected in the

provision of more specialized services at


17/40



Table 6: Credentialing Programs or Pharmacists

Program Credentialing Agency Credentials Earned

Anticoagulation National Institute or Standards or PharmacistCredentialing (NISPC)*

Certi ed Disease Manager (CDM)

National Certi cation Board or AnticoagulationProviders (NCBAP)

Certi ed Anticoagulation Care Provider (CACP)

Asthma National Institute or Standards or PharmacistCredentialing (NISPC)*


National Asthma Educator Certi cation Board(NAECB)

Certi ed Asthma Educator (AE-C)

Diabetes National Institute or Standards or PharmacistCredentialing (NISPC)*


National Certi cation Board or Diabetes Educators(NCBDE)

Certi ed Diabetes Educator (CDE)

American Nurses Credentialing Center (ANCC) Board Certi ed-Advanced DiabetesManagement (BC-ADM)

Dyslipidemia National Institute or Standards or PharmacistCredentialing (NISPC)*


Geriatrics Commission or Certi cation in Geriatric Pharmacy(CCGP)

Certi ed Geriatric Pharmacist (CGP)

Li e Support American Heart Association Advanced Cardiovascular Li e SupportCerti cation (ACLS)

American Heart Association Pediatric Cardiovascular Li e SupportCerti cation (PALS)

Lipids National Institute or Standards or PharmacistCredentialing (NISPC)*


Accreditation Council or Clinical Lipidology Clinical Lipid Specialist

Nuclear Board o Pharmaceutical Specialties (BPS) Board Certi ed Nuclear Pharmacist (BCNP)Nutrition Support Board o Pharmaceutical Specialties (BPS) Board Certi ed Nutrition Support Pharmacist

(BCNSP)

Oncology Board o Pharmaceutical Specialties (BPS) Board Certi ed Oncology Pharmacist (BCOP)

Pain Management American Academy o Pain Management (AAPM) Credentialed Pain Practitioner (CPP)

Pharmacotherapy Board o Pharmaceutical Specialties (BPS) Board Certi ed Pharmacotherapy Specialist(BCPS)

Pharmacotherapy withAdditional Quali cations inCardiology

Board o Pharmaceutical Specialties (BPS) Board Certi ed Pharmacotherapy Specialist(BCPS)

Pharmacotherapy withAdditional Quali cations inIn ectious Diseases

Board o Pharmaceutical Specialties (BPS) Board Certi ed Pharmacotherapy Specialist(BCPS)

Poison In ormation American Association o Poison Control Centers Certi ed Specialist in Poison In ormation (CSPI)

PsychiatryBoard o Pharmaceutical Specialties (BPS) Board Certi ed Psychiatric Pharmacist (BCPP)

Toxicology American Board o Applied Toxicology Diplomat o the American Board o AppliedToxicology (DABAT)

* The NISPC Certifed Disease Manager Certifcation program expired on December 31, 2008


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care needed for patients in these settings.Speci c competencies are usually neededto address these patients unique medicaland pharmacotherapy-related issues alongwith their associated socio-behavioral andcultural issues.

Pediatric Pharmacy PracticeThe pediatric patient population spansthe years from birth through adolescence,

presenting a unique challenge with regardto drug therapy administration and moni-toring. Unlike adults, dosing is most com-monly based on body weight, and phar-macokinetic variables are standardizedrelative to weight and/or body surface area.Since physical growth and organ systemmaturation are dynamic processes through-out the aging continuum, frequent indi-

vidual dosing calculations and adjustmentsare necessary, particularly in infants. Pedi-atric disease states, such as cystic brosiscan further impact pharmacotherapy dueto differences in pharmacokinetics seen inthis particular subset of patients. Pediatric

patients are under-represented in clinicaltrials, resulting in an inadequate evidence

base on which to make individualizedtherapeutic decisions. Most commercially-available drugs are not formulated for usein infants and children. In addition, the pe-diatric patient population poses a higher risk for medication errors. Pediatric pa-tients are three times more likely to suffer from a medication error; and a relativelysmall magnitude of error, as compared toadults, may result in more serious conse-quences, especially in the youngest, mostvulnerable patients. 44 Pediatric patients fre-quently experience adverse drug reactionssimilar to adults, but adverse reactions inthe pediatric population may be harder torecognize or be of greater or lesser inten-sity. 45 Adverse drug events occurred in 11

percent of admissions to 12 childrens hospitals. 46 Pediatric pharmacists have special-ized knowledge of the age-related differ-ences that impact on medication regimens,are able to recognize the need of the indi-vidual patient, and then make the neededadjustments to ensure safe and effectivemedication use in infants, children and ad-olescents. Pediatric pharmacists possess a

broad knowledge of treatment of the vari-ous diseases that are common in childhood,

society has increased, so has the demandfor long-term care. The term long-term care(LTC) encompasses pharmacy practice inskilled nursing facilities, intermediate-carefacilities, assisted-living facilities, psychi-atric centers, rehabilitation centers, andsub-acute care settings. Pharmacists prac-

tice in these areas as consultants, prepar-ers, dispensers, and/or in-house reviewersof patients medication regimens. Consul-tant pharmacists play a crucial role in LTCsettings as a result of federal mandates in1974 requiring pharmacist-conducted drugregimen reviews at least monthly for allresidents of skilled nursing facilities. 51 Thisrequirement was extended to intermediatecare facilities in 1987. Beginning with stat-utory requirements in 1990, pharmacistshave an expanded essential role in ensuring

the proper use of psychoactive medicationsand ensuring residents drug regimens areoptimized (ie, eliminating excessive doseand duration, duplicate therapy, inadequatemonitoring, unsubstantiated indicationsfor use, and continued use in the presenceof adverse consequences indicating thedose should be reduced or discontinued).In 1999, the Beers Criteria was addedto the drug therapy guidelines for nursingfacility residents to ensure avoidance of certain medications that are inappropriateor potentially inappropriate for use in se-niors. 52,53 Pharmacists have also expandedthe provision of clinical services to patientsin Adult Congregate Living Facilities.

Certi ed Diabetes EducatorsDiabetes is costly to manage and its

prevalence has been increasing at an epi-demic rate. Managing diabetic patients

presents an enormous challenge (clinicaland economic) to healthcare providers andthe healthcare system. The CDC has report-ed that the availability of preventive careis insuf cient to meet the need, and com

pliance with national health recommenda-tions is suboptimal. 54 Patient education and

behavioral interventions play an importantrole in improving the management of dia-

betic patients. Pharmacists focusing their practice on diabetic patients commonlycomplete certi cate training programs ondiabetes and can continue building their credentials in this area. Pharmacists whohave been certi ed as diabetes educators

such as otitis media, as well as those diseas-es that are relatively rare, but more serious,such as cystic brosis. These pharmacists,who have often completed one or moreyears of post-graduate residency training,have been shown to be effective in decreas-ing preventable adverse drug events. 47,48

Geriatric Pharmacy PracticeElderly patients are unique in that they

possess an altered metabolic capacity for medications due to, for example, increased

body fat and water, decreased muscle mass,decreased cardiac output and perfusion, de-creased protein binding, reduced liver func-tion, and reduced physiologic reserveallof which lead to unique medication selec-tion and dosing requirements compared toyounger adults. 49 As a result of concomi-

tant disease states, multiple medicationsare often prescribed for elderly patients bya variety of providers. They also often re-quire additional assistance to understandhow to take their medications to avoid pos-sible adverse drug effects. Lack of mobil-ity, vision/hearing dif culties, and possiblealtered mental status may further hamper

proper use of medications by the elderly.There is a shortage of healthcare profes-sionals trained in geriatric pharmacothera-

py and seniors older than 75 years of ageare under-represented in clinical trials, re-sulting in a poor evidence base on whichto make individualized therapeutic deci-sions. 50 As the number of elderly patientscontinues to increase, the contribution of the pharmacist to quality, long-term medi-cation management will require dramaticexpansion. Some state boards of pharma-cy (eg, Florida) instituted a requirementfor pharmacists to complete special cer-ti cate programs in the area of geriatrics/long-term care consulting. Since the areaof geriatric pharmacotherapy is highly spe-cialized, in 1997 the American Society of Consultant Pharmacists (ASCP) foundedthe Commission for Certi cation in Geriat -ric Pharmacy (CCGP), which now awardsthe Certi ed Geriatric Pharmacist (CGP)credential. (Table 6 and Appendix E Fig-ure 7) The content outline for the certi ca -tion examination is published on the CCGPWebsite http://www.ccgp.org/pharmacist/certi cation/content.htm.

As the proportion of elderly patients in


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lished by eight national pharmacy organi-zations. This was an important develop-ment impacting the practice of pharmacycompounding because it established a na-tional standard of best practices for com-

pounding pharmacies. PCAB accreditationis a voluntary process focused on maximiz-

ing the quality of pharmacy compoundingand reducing risk of patient harm. PCABaccreditation has been recognized by theAmerican Medical Association and theAmerican Pharmacists Association as away to identify compounding pharmaciesthat meet high quality standards. 55,56

Advanced GeneralistPractitioners

Pharmacists practicing as advancedgeneralist practitioners (Figure 2, Quad-

rant C) provide services to a wide varietyof patients with complex healthcare issuescovering a broad range of diseases. Manysuch pharmacists are board certi ed in ade ned specialty such as pharmacother -apy. Their advanced knowledge, skills,and experience are developed in a broad,varied population. An advanced general-ist practitioner must be competent in as-sessing the status of complex patients,developing individualized therapeuticregimens to achieve the desired outcomes,and implement and monitor the patientsresponse to optimize their therapeutic out-come. Such pharmacists may work in avariety of settings, including direct patientcare settings (community pharmacies,clinics, and hospitals) where the pharma-cist usually interacts face-to-face with the

patient, or in an alternative care deliverysetting such as a call center of a managedcare organization or health plan for pa-tients with complex healthcare needs re-quiring MTM services such as anticoagu-lation. For these pharmacists, collabora-tion with other healthcare professionals isan integral part of their practicenot onlyfor the management of individual patients

but for the collaborative development of treatment protocols for management of groups of patients, based on best practiceand evidence.

Pharmacotherapy SpecialistsFigure 5 summarizes the functioning

of an advanced generalist practitioner

working as a pharmacotherapy special-ist. Pharmacotherapy, as de ned by BPS,is that area of pharmacy practice that isresponsible for ensuring the safe, appro-

priate, and economical use of drugs in pa-tient care. The pharmacotherapy specialist(BCPS) has responsibility for direct pa-

tient care, often functions as a member of a multidisciplinary team, and is frequentlythe primary source of drug information for other healthcare professionals.

Advanced Focused PractitionersPharmacists practicing as advanced

focused practitioners (Figure 2, QuadrantD) have sophisticated knowledge, skills,and experience to draw from when dealingwith a narrow and focused patient popula-tion or practice site. Within each area the

speci c professional responsibilities of the pharmacist may be different. A pharmacistspecializing in drug therapy for cardiovas-cular disease might be responsible for both

patient education and adherence while alsoindividualizing medication regimens andmaintaining a specialized practice suchas an anticoagulation clinic. By contrast,an HIV/AIDS specialist has an extensiveknowledge base regarding antiretroviralmedications and infectious disease as they

pertain to the treatment of an HIV/AIDS patient, but less advanced knowledge in thetreatment of sepsis in a trauma patient. Inaddition to serving medically complex pa-tients, advanced focused practitioners of-ten manage complex therapies, diagnosticagents, and technologies. Because of theadvanced knowledge, skills, and experi-ence, and narrow focus of an advancedfocused practitioner, they are consideredexperts in their specialized elds. Many

board-certi ed specialists would, there -fore, be placed in this practice quadrant,including pharmacotherapy specialists withthe two added quali cations currentlyrecognized by BPSCardiology and In-fectious Diseases. Many of these individu-als may also have completed a postgradu-ate year two (PGY2) pharmacy residencyin a focused area of training. The practiceof pharmacists in the four more focusedBPS specialty areas is summarized below.Additional detail can be found on the BPSWebsite www.bpsweb.org or in AppendixD of CCPs resource document Credential-

ing in Pharmacy .Nuclear pharmacy was the rst recog

nized area of specialty practice within phar-macy. Nuclear pharmacists seek to improveand promote the public health through thesafe and effective use of radioactive drugsfor diagnosis and therapy. A nuclear phar-

macist, as a member of the nuclear medi-cine team, specializes in the procurement,compounding, quality-control testing, dis-

pensing, distribution, and monitoring of radiopharmaceuticals. In addition, the nu-clear pharmacist provides consultation re-garding health and safety issues, as well asthe use of nonradioactive drugs and patientcare. Working with radioactive isotopes as

part of a compounding process demandsspecialized training, with requirements setin part by the Nuclear Regulatory Commis-

sion.57

This product-focused training hastended to link this area of practice with thecompounded product rather than a clinicalservice. Nuclear pharmacy practice largelyoccurs in two areaswithin free standingradiopharmacies or within hospital set-tings. Nuclear pharmacy and nuclear medi-cine practice are interprofessional areas of

practice involving technologists (who ac-quire the images), occasionally chemists,

physicists, nurses, pharmacists, and physi-cians.

Nutrition support pharmacy addressesthe care of patients who receive specializednutrition support, including parenteral andenteral nutrition. Nutrition support phar-macists have responsibility for promotingmaintenance and/or restoration of optimalnutritional status and designing and modi-fying treatment according to the needs of the individual patient. Nutrition support

pharmacists have responsibility for direct patient care and often function as membersof an interprofessional nutrition supportteam.

Oncology pharmacists provide special-ized care to patients with cancer. Special-ists recommend, design, implement, moni-tor and modify pharmacotherapeutic plansto optimize outcomes in patients with ma-lignant diseases. This includes the support-ive care needed to minimize side effectsfrom the oncology treatments and the dis-ease. Oncology agents require specializedhandling and preparation, and the patientsrequire frequent monitoring to achieve the


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Table 7: Pharmacist Roles in Managed Health Care Organizations

Role Description o Activity

Drug Distribution andDispensing

Through their own pharmacies: pharmacists provide enhanced pharmaceutical services, beyondtraditional dispensing, because they are members o a ully integrated patient care system

Through community pharmacies: broad-based networks o contracting pharmacies inter ace withmanaged care pharmacists to provide online eligibility and claims processing

Through mail order: pharmacists assess legitimacy o prescriptions, eligibility or coverage,appropriateness and sa ety o the medication or the patient

Patient Sa ety

Drug Utilization Review (DUR) is a process that identi es potential prescription-related problemssuch as drug-drug interactions, duplication o drugs, known allergies, under or overdosing or inappropriate therapy

Prior Authorization (PA) is an approval process that encourages proper use o medications anddiscourages inappropriate prescribing

Monitoring Programs or certain drugs that require lab-based monitoring or dosage adjustment

Quality Assurance (QA) programs that enhance patient sa ety and improve patient drug use

Clinical Program

Development

Use evidence-based clinical and research data to create disease management programs

Evaluate scienti c evidence in order to select appropriate drugs or a patient population througha Pharmacy and Therapeutics (P&T) Committee

Design and conduct outcomes based research in order to help patients achieve the desiredresults rom their drug therapy

Communication withPatients, Prescribers andPharmacists

Helps prescribers choose drugs that will meet patients needs and quali y or coverage

Provide and educate patients about their individual prescription history

Provide a dispensing pharmacist with a patients drug pro le in order to identi y potential adversedrug reactions or duplicate therapies

Drug Bene t Design

Determining i a ormulary (approved list o medications that the plan will cover) should be used,and whether it should be restricted or open; and the use o patient cost-sharing structure or generic, covered brand-name drugs and non- ormulary drugs

Determine i a participating pharmacy network should be established and what the criteria or QA would be

Determine criteria and procedures or drug utilization

Business Management

Negotiate with manu acturers or discounts on drug prices or clients in exchange or movingmarket share

Provide clients with customized clinical reporting that meet their population needs

Cost Management

Encourage prescribers to make cost e ective drug choices

Identi y compliance and noncompliance with prescribing guidelines; assess physicianper ormance; identi y prescribing patterns that require improvement

desired outcome. Pharmacists play a keyrole in assuring the safety and optimumcare of these patients. Oncology pharma-cists may practice in hospitals or ambula-tory oncology clinics, or a combination of

both. Many oncology agents are now in-

fused in ambulatory infusion centers.Psychiatric pharmacy addresses the

care of patients with psychiatric-relatedillnesses. As a member of an interprofes-sional treatment team, the psychiatric phar-macy specialist is often responsible for op-

timizing drug treatment and patient care byconducting such activities as monitoring

patient response, patient assessment, rec-ognizing drug-induced problems, and rec-ommending appropriate treatment plans.


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Pharmacy Practicein NontraditionalHealthcare Settings

A growing number of pharmacists are practicing in what could be referred to asnontraditional practice roles or settings.Pharmacists in such roles contribute direct-ly to patient care (at the individual patientand population levels) and may have directinteractions with patients and healthcare

professionals, but not necessarily face-to-face. Pharmacists are also involved in pro-viding care to animals. Veterinary pharma-cists receive special training in veterinary

pharmacology and therapeutics and must be pro cient at compounding, which is akey service for animal patients. The com-

plete spectrum of nontraditional pharma-cist roles cannot be provided in this paper,

but a few examples are given below:

Managed Care OrganizationsA pharmacist in a managed care practice

provides a markedly different type of pro-fessional activity, and as a result, additionalcompetencies are required. For a pharma-cist working in this environment, patientsare monitored as a population database and

pharmacist care is directed through database review and querying. Economic andclinical outcomes are weighed against,and with each other, to make appropriatedecisions for a population of patients.Pharmacists practicing in managed careorganizations, including health plans andPBMs, are responsible for a broad rangeof clinical, quality-oriented drug manage-ment services. 58 The role of a pharmacist ina managed care organization is often strati-ed into seven different areas of activity:(1) drug distribution and dispensing; (2)

patient safety; (3) clinical program devel -opment; (4) communication with patients,

prescribers and pharmacists; (5) drug ben -e t design; (6) business management; and(7) cost management. Additional detail is

provided in Table 7.Drug distribution within a managed care

model has embraced many pharmacy roles.Service providers in this type of setting areencouraged to collaborate in the provisionof health care through an interprofessionalapproach. Patient management is based on

provider group interactions that address all

aspects of individualized patient care. Thisinterprofessional team includes but is notlimited to the physician, nurse, physiciansassistant, nurse practitioner, pharmacist,nutritionist, medical assistant, and bene tsmanager. A pharmacist in this environmenthas the bene t of direct and immediate con -

tact with not only the primary healthcare provider, but also the rest of the health-care team. This kind of one-on-one contactamong health professionals often leads tomore patient-centered health care and ef -cient MTM services. Also, within this typeof environment, the pharmacist has accessto pharmacy claims data, which allows for large numbers of patients to be reviewed.Since many of these models have an inte-grated dispensing pharmacy program, the

patient-care team can monitor medication

adherence and utilization.

Patient Care Call CentersCall center pharmacists provide patient

and prescriber education, patient counsel-ing, drug information, and customer service,as well as drug utilization review, healthmanagement and formulary management.Pharmacists in call centers interact with pa-tients telephonically to promote effectivedrug therapy. Call center pharmacists are

primarily employed in health maintenanceorganizations (HMOs), PBMs, and health

plans, but may also be found in other envi-ronments. These pharmacists make calls toand receive calls from patients to optimizemedication therapy. Some calls focus onmedication adherence reminders; others areto obtain information about adverse medi-cation events; and some calls focus on pa -tients questions about treatment. Some callcenter pharmacists focus on speci c dis -ease states, such as anticoagulation, hyper-tension, or diabetes. In the disease-speci cmodel, pharmacists manage the medica-tion therapy for one disease. Another model

places a patients total medication therapyunder the direction of one call center phar-macist. In this model, pharmacists managefull patients drug regimens and are able tosuggest changes and make referrals to other healthcare professionals to ensure positive

patient outcomes. Call centers may provideservices for speci c member populations,for example, MTM services for MedicarePart D bene ciaries.

HospiceHospices range from small rural organi-

zations to very large hospices. Regardlessof the organizations structure, a large partof the care they provide, and a signi cantcost, is medication-centered. Pharmacists

practicing in this setting help to ensure

that medications are appropriately select-ed and that management of symptoms is

balanced with costeffectiveness. ASHPhas published a statement on the Pharma-cists Role in Hospice and Palliative Care,which outlines service issues that should

be addressed, including: (i) assessing theappropriateness of medication orders andensuring the timely provision of effec-tive medications for symptom control; (ii)counseling and educating the hospice teamabout medication therapy; (iii) ensuring

that patients and caregivers understand andfollow the directions provided with medi-cations; (iv) providing ef cient mechanisms for extemporaneous compoundingof nonstandard dosage forms; (v) addressing nancial concerns; (vi) ensuring safeand legal disposal of all medications after death; and (vii) establishing and maintaining effective communication with regu-latory and licensing agencies. 59 Hospice

programs are varied in their structure andhospice pharmacy practice models haveevolved to complement these programs.Models include: (a) hospice-employed

pharmacist; (b) contracted consultant phar macist or pharmacist group; (c) pharmacy

bene ts manager (PBM) with or withoutin-house or contracted clinical pharmacistservices; (d) central dispensing pharmacywith PBM and cl

contemporary pharmacy practice

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