Scope of Pharmacist Practice J Am Pharm Assoc 2010
Scope of Pharmacist Practice J Am Pharm Assoc 2010
Scope of Pharmacist Practice J Am Pharm Assoc 2010
Scope of contemporary pharmacy practice: Roles, responsibilities, and functions of pharmacists and pharmacy technicians
Council on Credentialing in Pharmacy
Approved for distribution by the Council on Credentialing in Pharmacy Board of Directors on February 25, 2009. Coauthored by Nicole Paolini Albanese, PharmD, Clinical Assistant Professor, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences; and Michael J. Rouse, BPharm(Hons), MPS, Assistant Executive Director, International and Professional Affairs, Accreditation Council for Pharmacy Education. Correspondence: Marissa Schlaifer, BPharm, MS, Secretary/Treasurer, Council on Credentialing in Pharmacy, c/o Academy of Managed Care Pharmacy, 100 North Pitt St., Suite 400, Alexandria, VA 22314. Acknowledgments: To Melissa Murer Corrigan, BPharm, Executive Director/CEO, Pharmacy Technician Certifcation Board; Susan Meyer, PhD, Associate Dean for Education, University of Pittsburgh School of Pharmacy; Mitchel C. Rothholz, BPharm, MBA, Chief of Staff, American Pharmacists Association; Marissa Schlaifer, MS, BPharm, Director of Pharmacy Affairs, Academy of Managed Care Pharmacy; Janet A. Silvester, BPharm, MBA, FASHP, Immediate Past President, American Society of Health-System Pharmacists; Janet Teeters, BPharm, MS, Director of Accreditation Services Division, American Society of Health-System Pharmacists; Peter H. Vlasses, PharmD, BCPS, FCCP, Executive Director, Accreditation Council for Pharmacy Education; C. Edwin Webb, PharmD, MPH, Director, Government and Professional Affairs, American College of Clinical Pharmacy; and David R. Witmer, PharmD, Vice President, Member Relations, 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 Buffalo School of Pharmacy and Pharmaceutical Sciences is acknowledged later in the document.
Abstract
Objective: To provide an overview of the current context and scope of pharmacy practice, the range of professional services offered by pharmacists, and the supporting role of pharmacy technicians. Data synthesis: A synopsis of the current state of pharmacy practice as it relates to the spectrum of professional roles and responsibilities, the diversity of patient populations served, the complexities of patient services provided, and various aspects of emerging pharmacy practice is provided. The current work focuses on patient care services provided by pharmacists; it does not address all possible activities of pharmacists, such as administration and general management. This is a descriptive analysis. It does not take a position regarding future changes but is intended to serve as a foundation for understanding the relationship and alignment between the professions various mandatory and voluntary credentials and the scope of practice continuum. The key educational and credentialing standards for pharmacists and pharmacy technicians are summarized and referenced. Conclusion: The evolutions in health care and pharmacy practice are presenting many new opportunities for pharmacists to perform functions and provide services not considered as traditional roles. The profession of pharmacy is working to achieve a pervasive model and standard of care determined only by the needs of patients and populations. The Council on Credentialing in Pharmacy hopes that the material presented herein, including the framework for credentialing in pharmacy practice, will allow audiences to gain a better understanding of where pharmacy is today and what future pharmacy practice will look like. Keywords: Credentialing, licensure (pharmacists), pharmacy technicians, practice standards. J Am Pharm Assoc. 2010;50:e35e69. doi: 10.1331/JAPhA.2010.10510
www.japha.org
3/17/10 9:41 AM
Purpose
This paper, commissioned by the Council on Credentialing in Pharmacy (CCP; see Appendix for member organizations of CCP), provides an overview of the current context and scope of pharmacy practice, the range of professional services offered by pharmacists, and the supporting role of pharmacy technicians. The paper has been developed as a companion piece to CCPs resource paper, Credentialing in Pharmacy.1 To provide a link between credentialing and scope of practice, the paper also describes how credentials commonly held by pharmacists correlate with their professional scope of practice. Intended readers of this paper include members of the pharmacy profession, colleagues in other healthcare professions, students, healthcare administrators, regulators, insurers, and the general public. This paper provides a synopsis of the current state of pharmacy practice as it relates to the spectrum of professional roles and responsibilities, the diversity of patient populations served, the complexities of patient services provided, and various aspects of emerging pharmacy practice. The paper focuses on the patient care services provided by pharmacists; it does not address all possible activities of pharmacists, such as administration and general management. The paper is a descriptive analysis. It does not take a position regarding future changes, but is intended to serve as a foundation for understanding the relationship and alignment between the professions various mandatory and voluntary credentials and the scope of practice continuum. The key educational and credentialing standards for pharmacists and pharmacy technicians are summarized and referenced.
Introduction
The mission of the profession of pharmacy is to improve public health through ensuring safe, effective, and appropriate use of medications. Contemporary pharmacy practice refects an evolving paradigm from one in which the pharmacist primarily supervises medication distribution and counsels patients, to a more expanded and team-based clinical role providing patient-centered medication therapy management, health improvement, and disease prevention services2. The Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (NABP) defnes the practice of pharmacy as follows: The Practice of Pharmacy means the interpretation, evaluation, and implementation of Medical Orders; the Dispensing of Prescription Drug Orders; participation in Drug and Device selection; Drug Administration; Drug Regimen Review; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling; the provision of those acts or services necessary to provide Pharmacist Care in all areas of patient care, including Primary Care and Collaborative Pharmacy Practice; and the responsibility for Compounding and Labeling of Drugs and Devices (except Labeling by a ManufacJournal of the American Pharmacists Association
turer, Repackager, or Distributor of Non-Prescription Drugs and commercially packaged Legend Drugs and Devices), proper and safe storage of Drugs and Devices, and maintenance of required records. The practice of pharmacy also includes continually optimizing patient safety and quality of services through effective use of emerging technologies and competency-based training.3 An overview of the regulatory history and changing role of pharmacists is presented in Manasse and Speedies 2006 paper.4 By describing the full range of professional services currently provided, this paper seeks to clarify the contribution of pharmacists to healthcare delivery and the resulting benefts to society. A vision for pharmacy practice has been articulated in the Joint Commission of Pharmacy Practitioners (JCPP; see Appendix A for member organizations of JCPP) Future Vision for Pharmacy Practice 2015, which states that Pharmacists will be the healthcare professionals responsible for providing patient care that ensures optimal medication therapy outcomes.5 (Appendix B) The concept of optimal medication therapy implies that the use of medicines occurs within a system that assures the highest likelihood of achieving desired clinical, humanistic, and economic outcomes. The JCPP Vision further states that pharmacists will beneft society and be essential to the provision of effective health care by ensuring that: (a) medication therapy management is readily available to all patients; (b) desired patient outcomes are more frequently achieved; (c) overuse, underuse, and misuse of medications are minimized; (d) medication-related public health goals are more effectively achieved; and (e) cost effectiveness of medication therapy is optimized. Existing pharmacy practice settings and their associated professional services and activities vary. The spectrum of patient care needs is broad, as patients medication use involves self care, acute care, and long-term or chronic care. These different needs transcend all practice settings and add complexity to care delivery. The majority of pharmacists practice in community pharmacies, ambulatory care clinics, hospitals and health systems, long-term care facilities, home-care agencies, and managed-care organizations. Other practice settings or roles include the pharmaceutical industry, research, federal agencies such as the Food and Drug Administration (FDA), academia, associations, and a number of unique healthcare practices such as drug and poison information centers. JCPP organizations recognize also that pharmacy technicians are a critical part of the pharmacy workforce to implement the 2015 Vision. In many practice settings, pharmacy technicians are used to support pharmacists to manage the medication-use process (see section on Pharmacy Technicians below). Along with robotic dispensing technology, such support enables pharmacists to play a more proactive and expanded role in patient care. Pharmacy technicians are accountable to the supervising pharmacist, who is legally responsible (by virtue of state licensure) for the care and safety of patients served by the
www.japha.org M a r /a p r 2010 50:2
JAPhA e36
3/17/10 9:41 AM
FEATURE
pharmacy. Regardless of practice setting, professional pharmacy services and activities emphasize communication, education, and information exchange with patients and their caregivers, prescribers, and other healthcare professionals. Pharmacist management of medication use provides patient-centered medication therapy and is integrated with the additional responsibilities of medication distribution, supervision of pharmacy technicians, adaptation of new pharmaceutical technologies, effcient management of systems and resources, and integration of information systems and applications, all in a rapidly changing healthcare environment. This broad scope of professional practice and the complexity of the medications managed within each of these individual practices require a pharmacy workforce that is diverse in knowledge and skills, competently trained, and adequately credentialed. The workforce must demonstrate professional judgment, ethics, attitudes, and values.
Globally, as people are generally healthier and living longer, the worlds healthcare focus is shifting from treatment of patients with acute diseases to management of patients with chronic medical conditions. Chronic illness affects a high percentage of the US population; many patients present with co-morbidities and require complex, multi-drug therapies. Community-based treatment in the communityboth acute and chronichas escalated medication use. Higher prescription volumes attributable to a growing elderly population with multiple medications, an increased number of prescription and over-the-counter medications, direct-toconsumer advertising, increased consumer reliance on selfcare, and increased outpatient surgeries have all placed the pharmacist in a more prominent position to provide more information and services to the public. Advances in therapeutics Advances in medical research, pharmaceutical and biomedical technologies have contributed to the development of therapies for an expanding range of medical conditions. Many therapies are complex, have high risk profles, and require intensive monitoring. Some therapies are highly individualized or must be subject to limited distribution. Medication therapy is an essential element of healthcare delivery but the complexities of the medication use process are becoming increasingly clear. Multiple factors can have a direct impact on a patients ability to access and adhere to medication therapy and to achieve the desired therapeutic outcomes. These factors are accentuated in chronic medication therapy. Interprofessional collaboration is crucial when developing and implementing complex therapeutic plans. The genetic composition of a patient can infuence his/her response to medications and appropriate dosing. Patients from different ethnic, cultural, or social backgrounds may have different perceptions, beliefs, behaviors, or practices relevant to disease states or medication therapy, which can impact the success or failure of patient outcomes. Cultural issues may also impact pharmacist-patient or pharmacistcaregiver communication. Beyond basic language barriers, pharmacists must be able to accurately assess the ability of the patient and/or caregiver to obtain, interpret, and understand basic health information and services (their health literacy) to ensure that all communications are appropriate and understood. A patient must be able to use available information and be aware of how to access and use services to enhance their health. However, an individuals health literacy can impact the achievement of desired patient outcomes. Such situations are faced daily by pharmacists, and necessitate the growing area of education and training in cultural competency. Pharmacists are being trained to deliver culturally competent care as part of their efforts to optimize patient outcomes and eliminate disparities that exist in the healthcare delivery system.9 Patients on a reduced budget, those without any income, and those who are homeless are increasing in number and often have limited access to the healthcare system. Such patients often need help to access
Journal of the American Pharmacists Association
3/17/10 9:41 AM
indigent-care medication programs or pharmaceutical manufacturers medication programs. Medication therapy management Patients may require a combination of information, education, guidance, and coaching about their medications. Pharmacists have a broad knowledge base to appropriately assess and respond to a patients medication therapy needs, thereby contributing to the interprofessional management of patients and optimal patient care. Medication therapy management (MTM) is a partnership of the pharmacist, the patient or their caregiver, and other health professionals that promotes the safe and effective use of medications and helps patients achieve the targeted outcomes from medication therapy. In 2004, eleven national pharmacy organizations developed a consensus defnition for medication therapy management services (MTMS) as follows: Medication therapy management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services are independent of, but can occur 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 qualifed healthcare providers, scope of practice. Examples of medication management therapy services are provided in Appendix C. A more comprehensive framework for the development of MTM programs is provided in Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Version 2.0 released in March 2008 by the American Pharmacists Association (APhA) and the National Association of Chain Drug Stores (NACDS) Foundation.12 The introduction of a prescription drug beneft under Medicare Part D increased the recognition that pharmacists play an active role in the prevention and resolution of medication-related problems and medication management, thereby contributing to the optimization of patient therapeutic outcomes.13 Other organizations committed to improved healthcare delivery have recognized the contribution of pharmacists in this regard.14 While Medicare Part D provides an excellent example of an MTM beneft, such services are often provided by pharmacists to patients other than those covered by Medicare. MTM service capability is supported by the recent revisions to the accreditation standards for professional degree programs in pharmacy. To ensure that pharmacists have this essential clinical management expertise, these standards emphasize the achievement by graduates of competency in the development and maintenance of individual patient-care plans.15 Implicit in the ability of a pharmacist to obtain accurate disease and medication history is a thorough understanding of the primary medical problem, co-morbidities, and pharmacologic effects of the individual patient medication regimen. In cases where patients are receiving multiple medications, an in-depth understanding of drug interactions is also required. In the area of medication-related problems, pharmacists have developed expertise in monitoring the pharJournal of the American Pharmacists Association
macologic effects of medications for certain disease states including, but not limited to, diabetes, asthma, hypertension, seizures, hyperlipidemia, anticoagulation, and infectious diseases. These initiatives provide an early warning system that identifes patients with sub-optimal treatment responses and those patients who may experience excessive drug effects, drug interactions, adverse drug effects, and/ or drug toxicity. Studies have demonstrated the clinical and economic benefts of MTM services provided by pharmacists.16 Pharmacists have assumed an expanded role in medication safety, prevention of medication-related problems, disease prevention, and wellness programs. In the area of disease prevention and health promotion, pharmacists have developed practices such as those that reduce morbidity from obesity, osteoporosis, heart failure, hypertension, diabetes, and other chronic medical conditions, as well as patient habits and behaviors that impact health, such as smoking. The rapid, dramatic advances in medication therapy over recent decades have also created a niche for pharmacy practitioners who specialize in specifc kinds of treatment and aspects of care. Practice-based research projects Community-based initiatives, such as the Asheville Project, have demonstrated that, by providing intensive education and ensuring that patients are using their medications correctly, pharmacists can contribute to improved patient outcomes, lowered total healthcare costs, a reduction in number of sick days taken, and increased satisfaction with pharmacist services. With the support of a pharmacist coach, patients can become effective at self-managing a chronic disease. The Asheville Project began in 1996 as an effort by a self-insured employer to provide education and personal oversight for employees with chronic health problems such as diabetes, asthma, hypertension, and high cholesterol. During a six-year period, cardiovascular and cerebrovascular (CV collectively) medication use increased nearly threefold, but CV-related medical costs decreased by 46.5 percent. CV-related medical costs decreased from 30.6 percent of total healthcare costs to 19 percent. A 53 percent decrease in risk of a CV event and greater than 50 percent decrease in risk of a CV-related emergency department/hospital visit were also observed17. Using a similar approach to the Ashville Project, the Diabetes Ten City Challenge was launched in 2005, involving employers in ten distinct geographic locations. Using incentives, employers encouraged people to manage their diabetes with the help of pharmacist coaches, physicians, and community health resources. Results to date indicate that this collaborative approach results in (a) savings of approximately $918 per employee in total healthcare costs for the initial year, with even greater savings in subsequent years, (b) return on investment of at least 4:1 beginning in the second year, (c) a 50 percent reduction in absenteeism and fewer workers compensation claims, (d) high employee satisfaction (95 percent approval for pharmacist care) and
www.japha.org M a r /a p r 2010 50:2
JAPhA e38
3/17/10 9:41 AM
FEATURE
improved quality of life, and (e) employees saving an average of $400600 per year with incentives such as waived co-pays.18 Numerous studies of pharmacist-provided patient care services show that increased access to and adherence with prescription drug therapies, reduced medication errors and other harms, improved outcomes, and reduced costs all result from the pharmacists intervention.19 Launched in 2007, Project Destinya joint effort of the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA)seeks to validate community pharmacys future role in the delivery of health care as a valuable and integral component, accepted and recognized by patients, payers, and policymakers for the patient care services delivered. The initiative aims to position the pharmacist as the medication expert and the key provider of MTM services to patients, thereby reinforcing the role of the pharmacist as a key contributor to a patients overall health and to substantial reductions of overall healthcare costs.
determine the scope of pharmacy practice, differ somewhat between states. This ultimately determines how progressive pharmacy practice can be from state to state. NABPs Model State Pharmacy Act and Model Rules provides state boards of pharmacy with model language that may be used when developing state laws or board rules for regulating the practice of pharmacy and the distribution of drugs and related devices. NABP also revises and publishes annually the NABP Survey of Pharmacy Law, which provides summary data about topical issues in pharmacy, including prescribing and dispensing authority, pharmacy technicians, the facsimile and electronic transmission of prescriptions, and patient counseling requirements. Competency-based education The mission of pharmacy education is to prepare graduates who provide patient-centered care that ensures optimal medication therapy outcomes and provides a foundation for specialization in specifc areas of pharmacy practice; to participate in the education of patients, other healthcare providers, and future pharmacists; to conduct research and scholarly activity; and to provide service and leadership to the community.29 For pharmacist education, the American Association of Colleges of Pharmacy (AACP) Center for the Advancement of Pharmaceutical Education (CAPE) Educational Outcomes provide a framework that integrates professionalism, interprofessional practice, ethical attitudes and behaviors, and basic science across three expected educational outcomes: Pharmaceutical Careb, Systems Management, and Public Health to meet this mission mandate.30 (bThe term Patient Care is used hereafter.) The Educational Outcomes are the competencies that should be achieved by a graduate of a professional degree program in pharmacy prior to entering the work force. A pharmacist is able to provide Patient Care (Outcome 1) in cooperation with patients, prescribers, and other healthcare practitioners by utilizing sound therapeutic principles and evidence-based data, while always emphasizing legal, ethical, social, economic, and professional issues surrounding technology and evolving clinical sciences. Also, upon graduation, a pharmacist is expected to be competent in Systems Management (Outcome 2). Systems management includes managing resources in cooperation with patients, prescribers, and other healthcare providers, as well as administrative and supportive personnel (eg, pharmacy technicians) to promote health and provide, assess, and coordinate medication distribution. Finally, a pharmacist must also be able to promote Public Health (Outcome 3) by improving health, wellness, and disease prevention in cooperation with patients, communities, at-risk populations, and other interprofessional teams of healthcare providers. The recently revised Accreditation Council for Pharmacy Education (ACPE) Standards for accreditation of the professional degree in pharmacythe Doctor of Pharmacy (PharmD)adopted the CAPE Educational Outcomes with minor modifcations. (Table 1) The North American PharJournal of the American Pharmacists Association
3/17/10 9:41 AM
Table 1. Alignment of competency and credentialing frameworks: ACPE Standards, AACPs CAPE Outcomes, and NABPs NAPLEX Blueprint
ACPE Standard 12: Professional Competencies and Outcome Expectations Professional pharmacist competencies that must be achieved by graduates through the professional degree program curriculum are the ability to: Provide patient care in cooperation with patients, prescrib1. ers, and other members of an interprofessional health care team based upon sound therapeutic principles and evidence-based data, taking into account professional issues, emerging technologies, and evolving biomedical, pharmaceutical, social/behavioral/administrative, and clinical sciences that may impact therapeutic outcomes. Manage and use resources of the health care system, in 2. cooperation with patients, prescribers, other healthcare providers, and administrative and supportive personnel, to promote health; to provide, assess, and coordinate safe, accurate, and time-sensitive medication distribution; and to improve therapeutic outcomes of medication use.
AACP CAPE Educational Outcomes 2004 Outcome Provide patient-centered care 1: PharProvide populationmaceutibased care cal Care
Area 1
3.
Promote health improvement, wellness, and disease prevention in cooperation with patients, communities, at-risk populations, and other members of an interprofessional team of health care providers.
Manage human, physical, medical, informational, and technologi- Area 2 cal resources Manage medication use systems Assure the availability of effective, quality health and disease Area 3 prevention services Develop public health policy
These professional competencies must be used to guide the development of stated student learning outcome expectations for the curriculum. To anticipate future professional competencies, outcome statements must incorporate the development of the skills necessary to become self-directed lifelong learners.
macist Licensure Examination (NAPLEX) is the principal licensure examination that all students who graduate from an accredited professional degree program in pharmacy must pass to obtain licensure and practice as a pharmacist. The NAPLEX Blueprint, developed from regularly updated practice analyses, comprises detailed competency statements in three main areas: (1) Assure Safe and Effective Pharmacotherapy and Optimize Therapeutic Outcomes; (2) Assure Safe and Accurate Preparation and Dispensing of Medications; and (3) Provide Healthcare Information and Promote Public Health31. The blueprint refects the knowledge, judgment, and skills expected to be demonstrated by an entrylevel pharmacist to protect the health and welfare of their patients. Table 1 illustrates how the ACPE Standards, CAPE Educational Outcomes, and the NAPLEX Blueprint mirror each other. The close alignment of the competency frameworks of AACP, ACPE, and NABP serves the professions and patients needs well by addressing both current and evolving practice activities. Effective in 2000, all students enrolled in a professional Doctor of Pharmacy degree program are required to complete a minimum of six years of post-secondary education, up from the minimum of fve years required by previous accreditation standards, which expired in 2004. The curricular change to the Doctor of Pharmacy degree provided for inJournal of the American Pharmacists Association
creased clinical training. One of the primary reasons for this additional clinical training was to ensure that pharmacists could work more effectively with physicians, nurses and other healthcare professionals. The ongoing accreditation review of the degree programs of colleges and schools of pharmacy, providers of continuing education, and residency training programs, and the expansion of post-licensure education and training opportunities encourage a continued focus on the emerging roles and practice competencies that pharmacists require as new pharmacy practices are established. Tasks and functions of pharmacists On a regular basis, there have been collaborative initiatives within the profession to analyze and document the professional activities of pharmacists. The last of these was the Scope of Pharmacy Practice Project (19921994).32 Following the third JCPP Pharmacy in the 21st Century Conference in 1994, a collaborative effort of ten national pharmacy organizationsc led to the development of the Pharmacist Practice Activity Classifcation (PPAC), a hierarchical categorization of pharmacist activities.33 (Table 2) The PPAC also includes activities that are either delegated by pharmacists to technicians or are carried out by automated systems. (cAcademy of Managed Care Pharmacy, American Associawww.japha.org M a r /a p r 2010 50:2
JAPhA e40
3/17/10 9:41 AM
FEATURE
Table 3. Required and elective educational outcomes for postgraduate year one (PGY1) pharmacy residency programs
Required Outcomes: Outcome R1 Outcome R2 Manage and improve the medicationuse process Provide evidence-based, patient-centered medication therapy management with interdisciplinary teams Exercise leadership and practice management skills Demonstrate project management skills Provide medication and practice-related education/training Utilize medical informatics
Conduct pharmacy practice research Exercise added leadership and practice management skills Demonstrate knowledge and skills particular to generalist practice in the home care practice environment Demonstrate knowledge and skills particular to generalist practice in the managed care practice environment Participate in the management of medical emergencies Provide drug information to healthcare professionals and/or the public Demonstrate additional competencies that contribute to working successfully in the healthcare environment
Outcome E4 tion 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-System Pharmacists, National Association of Boards of Pharmacy, National Association of Chain Drug Stores, National Community Pharmacists Association) The three competency frameworks and the PPAC also align closely with the fve core competencies applicable to all healthcare professionals and which are identifed by the IOM, namely: (1) delivering patient-centered care, (2) working as a part of interprofessional teams, (3) practicing evidence-based medicine, (4) focusing on quality improvement, and (5) using information technology.7 The three broad competency areasPatient Care, Systems Management, and Public Healthalso refect a framework that is used in this document to describe the areas of practice of pharmacists. The primary focus of this paper is, however, Patient Care, ie, professional services provided directly to patients. Services provided by pharmacists in the other two areas (Systems Management and Public Health) will be described in lesser detail. Credentialing in pharmacy As described in CCPs resource paper, Credentialing in Pharmacy, post-licensure education and training opportunities for
e41 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
pharmacists have expanded dramatically in the past few decades. This trend refects the enhanced and expanded roles of pharmacists in response to the changing societal needs outlined earlier. A parallel development has been the emergence of more formal and structured education and training programs for pharmacy technicians, accreditation of such training programs, and nationally recognized certifcation. Underpinned by state board-mandated continuing education activities that aim to ensure that all practitioners remain competent to practice, additional offerings support the professional development and enhanced competency of pharmacists in a variety of ways. Some are specifc to pharmacists, while others are offered to multiple health professionals. (Appendix E, Figure 7) The recognition of pharmacy specialty practices in specifc disease states led to agreement
Journal of the American Pharmacists Association
3/17/10 9:41 AM
Table 4. Pharmacy practice areas for postgraduate year two (PGY2) residencies
Educational Goals and Objectives have been developed for the following areas of pharmacy practice: Ambulatory Care Critical Care Drug Information Geriatrics Health-System Pharmacy Administration Infectious Diseases Informatics Internal Medicine Medication-Use Safety Nuclear Medicine Nutrition Support Oncology Pediatrics Pharmaco-therapy Psychiatry Solid Organ Transplant
rity, and validity.1 As examples, brief overviews of pharmacy practice residencies and specialty certifcation are provided below. (dNISPC Certifed Disease Manager Certifcation program expired on December 31, 2008. eWith effect from January 1, 2009, ACPE implemented new accreditation standards for providers of continuing pharmacy education and no longer maintains separate accreditation standards for providers of Certifcate Programs.) Residency training Residency training programs are one year in length and provide an environment and structure for accelerating growth and experience beyond entry-level professional competence through supervised practice under the guidance of model practitioners (preceptors) in real-world settings. Residents are exposed to a wide range of patients with multiple disease states and work with a variety of health professionals, thereby advancing their clinical, interpersonal, and leadership skills. The frst postgraduate year of pharmacy residency training focuses on managing the medication use process and providing optimum medication therapy outcomes for patients with a broad range of disease states. The second year of postgraduate residency training focuses on a specialized area of practice and more in-depth training and experience. Established in 1962 and maintained by the American Society of Health-System Pharmacists (ASHP), accreditation standards for Post-Graduate Year One (PGY1) pharmacy residencies (previously referred to as pharmacy practice residencies) and Post-Graduate Year Two (PGY2) pharmacy residencies (previously referred to as specialized residency training) incorporate required and elective educational out-
that standard competencies should be demonstrated on a national basis with regard to best practices.34 Disease-specifc and specialized training and certifcation were initiated through the National Institute for Standards for Pharmacist Credentialing (NISPC),d the Board of Pharmaceutical Specialties (BPS), and individual ACPE-accredited Certifcate Programs (eg, in HIV/AIDS, immunization, and diabetes).e Full details of these programs are provided in Credentialing in Pharmacy. Post-licensure training programs and credentials are (1) competency-based, (2) developed on the basis of a comprehensive practice analysis in the relevant areas, and (3) offered or accredited by organizations that adhere to accepted principles and practices to assure quality, integ-
Domain 1
Domain 2
Domain 3
Guidelines, Policies, and Standards (15%) Public Health and Advocacy (5%)
www.japha.org
Domain 4
M a r /a p r 2010 50:2
JAPhA e42
3/17/10 9:41 AM
FEATURE
Narrow
Broad
Narrow
Entry-Level
Broad
Generalist practitioner Wide variety oQ patients and diseases; minor ailments to more complex conditions
Focused practitioner Wide variety oQ diseases in a unique setting or population, or a narrow disease Qocus
Entry-Level
Do m
Advanced
Pr a
ct
ic
Advanced generalist practitioner Wide variety oQ patients and diseases; complex healthcare issues
Advanced focused practitioner Focused patient populations; medically complex patients, therapies, and/or technology
ai
t Pa ie nt ed us oc -F
e
Sy st em oc -F us ed
Advanced
3/17/10 9:41 AM
Focused Practitioners. (Figures 1 and 2) This differentiation,based on breadth of practice/patient focus and level of knowledge, skills, and experienceis expanded upon in the next section where the roles, responsibilities and functions of practicing pharmacists are described.
Generalist practitioners Generalist practitioners (Figure 2, Quadrant A) care for patients with a wide variety of medical conditions and diseases, ranging from minor ailments to complex acute and chronic conditions. They may also provide consultation regarding the healthcare issues and needs of individuals seeking advice and those for whom an intervention is warranted to promote good health, prevent the development of disease, or avoid the consequences of lifestyles and behaviors that pose health risks. The practice settings for these pharmacists are primarily community pharmacies, ambulatory clinics, hospitals, and health systems. It is envisioned that the pharmacy services for the large majority of patients and individuals can be provided by generalist practitioners; hence, this is where there is the shortest supply and greatest need for pharmacists. Community-based care The fow of activities that is typically associated with medication management in a community pharmacy or ambulatory clinic practice is shown in Figure 3; it depicts a pharmacists responsibilities for the provision of direct patient care. New prescriptions for acute illness and reflls of medications for chronic conditions are accompanied by a full medication (prescription and nonprescription) and allergy history. Pharmacists should conduct a health-literacy assessment and then provide individualized counseling, education, and coaching to ensure that the patient and/or the patients caregiver is aware of the identity of the product, the indications and directions for use, storage requirements, side effects, long-term toxicity, drug interactions, food interactions, and medication adherence factors. Community pharmacy is the practice setting that the public primarily envisions when pharmacy practice is discussed. The provision of medication for ambulatory patients is the primary responsibility of community pharmacy practitioners and the volume will increase as a result of an aging population and the trend toward managing more acute conditions and acute exacerbations of chronic conditions in the ambulatory environment. The complexity and sophistication of the medications used in the ambulatory setting, coupled with the increasing number of ambulatory patients, suggests that pharmacists in community pharmacies will become an even more essential access point for acquisition of healthcare services. This trend will continue despite the fact that an increasing number of patients receive their medications and medication information from an institutional or health system-affliated pharmacy or a pharmacy that is located within an organized primary care medical practice.
Journal of the American Pharmacists Association
Institution-based care The policies and procedures in the acute care or long-term care institutional settings are analogous to but slightly different from those depicted for ambulatory settings. In these settings there is often active participation by pharmacists in the medication selection decision as part of the medical care team. This collaboration precedes the generation of the medication orders, which are interpreted and processed by other pharmacists to ensure accurate medication selection and the development of monitoring plans to assure that optimal outcomesincluding patient safetyare achieved (Figure 4). Pharmacists in the medication distribution process have a responsibility for the training and supervision of pharmacy technicians, effcient use of information technology, and application of management skills that allow for patient priorities to be set in daily practice activities. In addition to collaborating with other health professionals in the medication selection process and monitoring drug distribution, pharmacists have responsibilities to assure that patients receive the safest and best therapy possible, are educated about their medications, and are provided strategies to enhance their compliance with medication regimens. Pharmacists provide consultation and recommendations to physicians, nurses, physician assistants, and other healthcare professionals regarding approved and off-label indications, dosing and administration guidelines, drug interactions, chemical incompatibilities, therapeutic drug-monitoring approaches to avoid toxicity and maximize effectiveness, adverse-effect monitoring and prevention, and avoidance of therapeutic duplication as the result of poly pharmacy. Dosing might have to be adjusted according to the patients age, disease, renal function, or hepatic function. In a hospital a variety of routes of administration may be available including intravenous, intramuscular, subcutaneous, irrigation, nasogastric tube, oral, or targeted therapies. When this scope of pharmacy services is present, the pharmacist becomes a critical contributor to direct patient care through interactions with providers on decision-making processes for drug regimens, formulary issues, and optimal drug therapies to meet the needs of the individual patient. Many factors infuence the type of activities for the pharmacist in a hospital setting. Some of these factors include: the size of the hospital, the services provided by the hospital (eg, pediatrics, oncology, transplant, trauma center), academic affliations with the hospital, the presence of pharmacy residency programs, geographic location, affliated health insurance programs, related ambulatory clinics, the level of deployment of pharmacy technicians and the extent of integration of information systems and technology such as robotics, automated dispensing, and computerized physician order entry (CPOE). The nature of acute care requires that pharmacists in this setting have a broad knowledge base in parenteral medications, intravenous fuid and nutritional therapy, chemistry, physiology, and pathophysiology. Pharmacists are involved in determining chemical compatibilities, infuwww.japha.org M a r /a p r 2010 50:2
JAPhA e44
3/17/10 9:41 AM
FEATURE
Pharmacist makes recommendations for optimization of therapy and discusses with prescriber
Collaboration
Pharmacist discusses medication with patient Prescriber makes diagnosis/ assessment and issues prescription
If indicated, patient schedules follow-up visit with pharmacist to manage medication therapy
No problem identifed
Problem Solving
Figure 3. Flow diagram depicting steps to optimize medication therapy for ambulatory patients
sion rates, and sequencing of multiple medications that may need to be infused intravenously into a patient. Additionally, pharmacists interpret a wide array of laboratory and imaging tests to monitoring drug therapy. Patients in hospitals receive a high number of medications, and have frequently changing medical conditions that increase the opportunity for drug interactions and adverse side effects. The pharmacists must always be reviewing medications to help assure the best outcomes for the patient. Recent advances in infore45 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
matics facilitate more effcient access to drug information, lab information, and patient data so that all pharmacists provide drug information to a variety of healthcare practitioners. Population-based care Pharmacists also participate in medication management through involvement in the pharmacy and therapeutics (P&T) committees of hospitals, health systems, and manJournal of the American Pharmacists Association
3/17/10 9:41 AM
As needed, pharmacist interviews patient Pharmacist reviews patients chart and evaliates patientspecifc information to assess therapy
Collaboration
Pharmacist makes recommendation for optimization of therapy and discisses with prescriber/medical team
Pharmacist/ technician flls order and sends order to nirse for administration
No problem identifed
Problem is addressed
Problem Solving
Pharmacist ises an evidence-based approach, relying on patient-specifc information, cirrent giidelines, and other evidence to address problems
Figure 4. Flow diagram depicting steps to optimize medication therapy for hospitalized patients
Journal of the American Pharmacists Association www.japha.org M a r /a p r 2010 50:2
JAPhA e46
3/17/10 9:41 AM
FEATURE
aged-care organizations. A key aspect of this role for pharmacists is involvement in the development of protocols, guidelines, and formularies for directing safe and effective use of medications while in the hospital. While patient safety and improved healthcare outcomes are the primary focus, pharmaco-economic aspects of drug therapy decision making and contract pricinggenerally coordinated by pharmacistsare also integral to the pharmacy and therapeutics committee process; these in turn facilitate cost containment within the health system. Recent regulatory requirements have expanded the role of the pharmacist in risk management and regulatory compliance.14 Furthermore, the importance of continuity of care has led to an increased need to have a pharmacist in the emergency department, and to evaluate medication histories upon admission to hospital and provide medication counseling prior to discharge. In this role, pharmacists address acute-care needs and help to transition patients into and out of the hospital. Other roles for pharmacists in hospital and health-system practice include managing pain, coordinating reimbursement for indigent-care programs, preparing for bioterrorism, supervising investigational drug distribution, and participating in clinical research. A pharmacist practicing in a medical clinic or ambulatory clinic setting is often an active participant in an interprofessional team that may include physicians, mid-level providers, medical residents, students, nurses, social workers, and others. In many ambulatory settings, pharmacists directly collaborate with members of the healthcare team while, in others, written consultations or patient progress notations may be the predominant means of communication. Generalist practitioners in ambulatory settings assist patients by reviewing their prescription, nonprescription, and herbal medications, as well as nutritional therapies. They may also provide disease state specifc management education to patients, train them in the use of devices and tools to monitor their disease state(s), and regularly follow-up with patients and/or their caregivers to verify adherence to the medication regimen. Providing such comprehensive services to selected communities has been associated with more effcient patient care and positive clinical, humanistic, and economic outcomes.36 Pharmacists in over 45 states and territories can now serve as providers and directly interact with patients during their clinic visit or after, participate in medical chart review and documentation, and serve an essential role in the structured prescriber-directed medical team review of patients.37 In this type of pharmacy practice, patient evaluation, monitoring, medication recommendation, medication modifcation, and formulary management with follow-up are facilitated with a collaborative drug therapy management (CDTM) agreement. The objectives of CDTM are to better coordinate drug prescribing, dispensing, administration, monitoring, and dosage adjustment and avoid drug-related problems that contribute to less than optimal patient outcomes and increased healthcare costs.38 CDTM agreements
e47 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
typically specify what pharmacists are authorized to do (generally by physicians), such as selection of medications for identifed medical conditions, adjustment of dosage regimens based on patients response to therapy, monitoring of key vital signs, authorizing prescription reflls, providing drug information, assessing patient compliance, drug policy development, and development and evaluation of therapeutic management policies. Collaborative practice agreements have covered a variety of patient service areas, most commonly anticoagulation, monitoring and dosage adjustment, pain management, emergency contraception, and diseasestate management of asthma, diabetes, and hyperlipidemia.39 The benefts of physicians and pharmacists working collaboratively to improve patients quality of life and reduce medication-related adverse effects have been acknowledged by several physician and medical organizations.40,41 The Veterans Affairs (VA) Health System and several other regional healthcare organizations have developed models that maximize the contribution of a pharmacists interaction with ambulatory patients and also emphasize the clinical integration of pharmacotherapy expertise.42 An example of CDTM activities undertaken by pharmacists practicing in an ambulatory care setting is provided in Appendix D. The VA approach has allowed the VA care delivery system to function effciently and economically while enhancing patient care. Within the VA system, the pharmacist acts as an extension of the physician and is able to implement medication and dosage changes as well as ensure continuity of care by prescribing medication and directing medication dispensing. This model has been replicated in many states that have adopted collaborative practice initiatives and has been shown to improve patient safety, quality of life, and economic markers.42 Many generalist practitioners in any practice setting even while spending the majority of their practice dealing with a broad range of patients and medical conditionsmay have developed expertise in a specifc area. This may be refected in the provision of more specialized services at their practice site. These specialized services may be focused on one disease state (such as asthma) or on public health initiatives (such as smoking cessation or the provision of immunizations). Currently, 49 states have adopted regulations that allow pharmacists to administer immunizations. The laws vary in depth and breadth since some states (eg, Virginia) allow pharmacists to administer all immunizations including travel specifc vaccines, whereas other states (eg, Delaware) only allow pharmacists to deliver infuenza and pneumococcal vaccines. In states where pharmacists are permitted to immunize, the percentage of people immunized is increasing toward the goals of Healthy People 2010.43 Mail-service pharmacy Some patients receive their medicationsespecially reflls for medications used for chronic medical conditionsfrom mail-service pharmacies, which are used by some health plans, prescription beneft management companies (PBMs),
Journal of the American Pharmacists Association
3/17/10 9:41 AM
American Association of Poison Control Centers Board of Pharmaceutical Specialties (BPS) American Board of Applied Toxicology
Certifed Specialist in Poison Information (CSPI) Board Certifed Psychiatric Pharmacist (BCPP) Diplomat of the American Board of Applied Toxicology (DABAT)
* The NISPC Certifed Disease Manager Certifcation program expired on December 31, 2008
large pharmacy chains, and Internet pharmacy providers to reduce costs associated with the supply of medications and provide the convenience of home delivery of medications. Patients typically order their medications via telephone,
Journal of the American Pharmacists Association
fax, e-mail, or the Internet. Once a prescription order is transmitted to the mail-service pharmacy, patients usually receive their prescription within a week to ten days. Large numbers of pharmacists and pharmacy technicians are
www.japha.org M a r /a p r 2010 50:2
JAPhA e48
3/17/10 9:41 AM
FEATURE
employed at mail-service pharmacies, but many of the processes use high-volume automated dispensing technologies. Some mail-service pharmacies provide medication management services for individual or population-based patients. Focused practitioners Focused practitioners are those pharmacists who either see a wide variety of diseases in a specifc setting or patient population such as pediatrics, or who treat a relatively narrow spectrum of diseases such as thrombotic disease. Pharmacists practicing as focused practitioners (Figure 2, Quadrant B) have the knowledge, skills, attitudes, and valuesachieved through appropriate post-graduate education, training, and/or experienceto provide the level of care needed for patients in these settings. Specifc competencies are usually needed to address these patients unique medical and pharmacotherapy-related issues along with their associated socio-behavioral and cultural issues. Pediatric pharmacy practice The pediatric patient population spans the years from birth through adolescence, presenting a unique challenge with regard to drug therapy administration and monitoring. Unlike adults, dosing is most commonly based on body weight, and pharmacokinetic variables are standardized relative to weight and/or body surface area. Since physical growth and organ system maturation are dynamic processes throughout the aging continuum, frequent individual dosing calculations and adjustments are necessary, particularly in infants. Pediatric disease states, such as cystic fbrosis can further impact pharmacotherapy due to differences in pharmacokinetics seen in this particular subset of patients. Pediatric patients are under-represented in clinical trials, resulting in an inadequate evidence base on which to make individualized therapeutic decisions. Most commerciallyavailable drugs are not formulated for use in infants and children. In addition, the pediatric patient population poses a higher risk for medication errors. Pediatric patients are three times more likely to suffer from a medication error; and a relatively small magnitude of error, as compared to adults, may result in more serious consequences, especially in the youngest, most vulnerable patients.44 Pediatric patients frequently experience adverse drug reactions similar to adults, but adverse reactions in the pediatric population may be harder to recognize or be of greater or lesser intensity.45 Adverse drug events occurred in 11 percent of admissions to 12 childrens hospitals.46 Pediatric pharmacists have specialized knowledge of the age-related differences that impact on medication regimens, are able to recognize the need of the individual patient, and then make the needed adjustments to ensure safe and effective medication use in infants, children and adolescents. Pediatric pharmacists possess a broad knowledge of treatment of the various diseases that are common in childhood, such as otitis media, as well as those diseases that are relatively rare, but more serious, such as cystic fbrosis. These pharmacists, who have often completed one or more years of post-graduate
e49 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
residency training, have been shown to be effective in decreasing preventable adverse drug events.47,48 Geriatric pharmacy practice Elderly 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, decreased protein binding, reduced liver function, and reduced physiologic reserveall of which lead to unique medication selection and dosing requirements compared to younger adults.49 As a result of concomitant disease states, multiple medications are often prescribed for elderly patients by a variety of providers. They also often require additional assistance to understand how to take their medications to avoid possible adverse drug effects. Lack of mobility, vision/hearing diffculties, and possible altered mental status may further hamper proper use of medications by the elderly. There is a shortage of healthcare professionals trained in geriatric pharmacotherapy and seniors older than 75 years of age are under-represented in clinical trials, resulting in a poor evidence base on which to make individualized therapeutic decisions.50 As the number of elderly patients continues to increase, the contribution of the pharmacist to quality, long-term medication management will require dramatic expansion. Some state boards of pharmacy (eg, Florida) instituted a requirement for pharmacists to complete special certifcate programs in the area of geriatrics/long-term care consulting. Since the area of geriatric pharmacotherapy is highly specialized, in 1997 the American Society of Consultant Pharmacists (ASCP) founded the Commission for Certifcation in Geriatric Pharmacy (CCGP), which now awards the Certifed Geriatric Pharmacist (CGP) credential. (Table 6 and Appendix E Figure 7) The content outline for the certifcation examination is published on the CCGP Website http://www.ccgp.org/pharmacist/certifcation/content.htm. As the proportion of elderly patients in society has increased, so has the demand for long-term care. The term long-term care (LTC) encompasses pharmacy practice in skilled nursing facilities, intermediate-care facilities, assisted-living facilities, psychiatric centers, rehabilitation centers, and sub-acute care settings. Pharmacists practice in these areas as consultants, preparers, dispensers, and/ or in-house reviewers of patients medication regimens. Consultant pharmacists play a crucial role in LTC settings as a result of federal mandates in 1974 requiring pharmacist-conducted drug regimen reviews at least monthly for all residents of skilled nursing facilities.51 This requirement was extended to intermediate care facilities in 1987. Beginning with statutory requirements in 1990, pharmacists have an expanded essential role in ensuring the proper use of psychoactive medications and ensuring residents drug regimens are optimized (ie, eliminating excessive dose and duration, duplicate therapy, inadequate monitoring, unsubstantiated indications for use, and continued use in the presence of adverse consequences indicating the dose
Journal of the American Pharmacists Association
3/17/10 9:41 AM
should be reduced or discontinued). In 1999, the Beers Criteria was added to the drug therapy guidelines for nursing facility residents to ensure avoidance of certain medications that are inappropriate or potentially inappropriate for use in seniors.52,53 Pharmacists have also expanded the provision of clinical services to patients in Adult Congregate Living Facilities. Certifed diabetes educators Diabetes is costly to manage and its prevalence has been increasing at an epidemic rate. Managing diabetic patients presents an enormous challenge (clinical and economic) to healthcare providers and the healthcare system. The CDC has reported that the availability of preventive care is insuffcient to meet the need, and compliance with national health recommendations is suboptimal.54 Patient education and behavioral interventions play an important role in improving the management of diabetic patients. Pharmacists focusing their practice on diabetic patients commonly complete certifcate training programs on diabetes and can continue building their credentials in this area. Pharmacists who have been certifed as diabetes educators (CDEs) focus much of their practice on the provision of education
and other professional services to diabetic patients to improve blood glucose control, thereby preventing diabetesrelated complications and positively impacting patient outcomes. This process involves assessment of the patients education needs, identifcation of self-management goals, education and behavioral interventions, and evaluation of achievement of goals. In addition to educational activities, professional services provided by pharmacists in the management of diabetic patients include dispensing, drug and device information (to patient, caregiver and other healthcare professionals), modifcation of therapy and ordering of laboratory tests under protocol, nutritional and physical assessments, point-of-care testing, and referrals to other specialty providers. Pharmacist CDEs typically practice in ambulatory care clinics and community pharmacies, but may also be found in hospitals. Apart from improved clinical outcomes for patients, pharmacist-based diabetes programs have demonstrated signifcant cost savings. Some pharmacist CDEs have also achieved the Board Certifed Advanced Diabetes Management (BCADM) credentialan advanced multidisciplinary certifcation in diabetes care that emphasizes clinical assessment and disease-state management.
Collaboration
Pharmacist provides written and/or verbal communication to referring prescriber with recommendation and/ or protocol is followed for intervention
Pharmacist reviews medical chart and sees patient to obtain pertinent history and other information
Problem Solving
Pharmacist determines best therapeutic options using an evidence-based approach Pharmacist assesses patientspecifc information (eg, lab/test results, other disease-specifc parameters), and medications
Figure 5. Flow diagram of prescriberpharmacotherapy specialist interactions intended to optimize medication therapy
Journal of the American Pharmacists Association www.japha.org M a r /a p r 2010 50:2
JAPhA e50
3/17/10 9:41 AM
FEATURE
Compounding pharmacists Because every patient has different needs, customized, compounded medications are a vital part of quality medical care. The basis of the profession of pharmacy has always been the patientphysicianpharmacist relationship. Through this relationship, patient needs are determined by a physician, who chooses a treatment regimen that may include a compounded medication. Physicians prescribe compounded medications for many reasons including the following situations: When needed medications are discontinued by or generally unavailable from pharmaceutical companies, often because the medications are no longer proftable to manufacture, When the patient is allergic to certain preservatives, dyes, or binders in off-the-shelf medications, When treatment requires tailored dosage strengths for patients with unique needs (eg, infants), When a pharmacist can combine several medications the patient is taking to increase compliance, When the patient cannot ingest the medication in its commercially available form and a pharmacist can prepare the medication in cream, liquid, or other, more easily used form, When medications require favor additives to make them more palatable for some patients, most often children. For those people with unique health needs that cannot be met by commercially available manufactured prescription medicines, compounded medications prescribed or ordered by physicians can be prepared safely by trained compounding pharmacists. Compounding is in even greater demand for treating animals because of their greater diversity in size and therapeutic needs and the relatively narrow selection, favors, and dosages of medicines that are manufactured by pharmaceutical companies. Many pharmacists have unique knowledge and skills in pharmaceutical compounding, having studied chemical compatibilities and been trained to prepare alternate dosage forms. Accreditation standards for professional degree programs in pharmacy require instruction in compounding pharmaceutical ingredients and so all pharmacists have foundational knowledge and skills in this area. Some pharmacists, however, have elected to focus their practice in this area and have additional experience, education, and training. In 2004, the Pharmacy Compounding Accreditation Board (PCAB) was established by eight national pharmacy organizations. This was an important development impacting the practice of pharmacy compounding because it established a national standard of best practices for compounding pharmacies. PCAB accreditation is a voluntary process focused on maximizing the quality of pharmacy compounding and reducing risk of patient harm. PCAB accreditation has been recognized by the American Medical Association and the American Pharmacists Association as a way to identify compounding pharmacies that meet high quality standards.55,56
e51 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
Advanced generalist practitioners Pharmacists practicing as advanced generalist practitioners (Figure 2, Quadrant C) provide services to a wide variety of patients with complex healthcare issues covering a broad range of diseases. Many such pharmacists are board certifed in a defned specialty such as pharmacotherapy. Their advanced knowledge, skills, and experience are developed in a broad, varied population. An advanced generalist practitioner must be competent in assessing the status of complex patients, developing individualized therapeutic regimens to achieve the desired outcomes, and implement and monitor the patients response to optimize their therapeutic outcome. Such pharmacists may work in a variety of settings, including direct patient care settings (community pharmacies, clinics, and hospitals) where the pharmacist usually interacts face-to-face with the patient, or in an alternative care delivery setting such as a call center of a managed care organization or health plan for patients with complex healthcare needs requiring MTM services such as anticoagulation. For these pharmacists, collaboration with other healthcare professionals is an integral part of their practicenot only for the management of individual patients but for the collaborative development of treatment protocols for management of groups of patients, based on best practice and evidence. Pharmacotherapy specialists Figure 5 summarizes the functioning of an advanced generalist practitioner working as a pharmacotherapy specialist. Pharmacotherapy, as defned by BPS, is that area of pharmacy practice that is responsible for ensuring the safe, appropriate, and economical use of drugs in patient care. The pharmacotherapy specialist (BCPS) has responsibility for direct patient care, often functions as a member of a multidisciplinary team, and is frequently the primary source of drug information for other healthcare professionals. Advanced focused practitioners Pharmacists practicing as advanced focused practitioners (Figure 2, Quadrant D) have sophisticated knowledge, skills, and experience to draw from when dealing with a narrow and focused patient population or practice site. Within each area the specifc professional responsibilities of the pharmacist may be different. A pharmacist specializing in drug therapy for cardiovascular disease might be responsible for both patient education and adherence while also individualizing medication regimens and maintaining a specialized practice such as an anticoagulation clinic. By contrast, an HIV/AIDS specialist has an extensive knowledge base regarding antiretroviral medications and infectious disease as they pertain to the treatment of an HIV/AIDS patient, but less advanced knowledge in the treatment of sepsis in a trauma patient. In addition to serving medically complex patients, advanced focused practitioners often manage complex therapies, diagnostic agents, and technologies. Because of the advanced knowledge, skills, and experience, and narrow focus of an advanced focused practitioner, they are considered experts
Journal of the American Pharmacists Association
3/17/10 9:41 AM
Patient Safety
Business Management
in their specialized felds. Many board-certifed specialists would, therefore, be placed in this practice quadrant, including pharmacotherapy specialists with the two added qualifcations currently recognized by BPSCardiology and Infectious Diseases. Many of these individuals may also have completed a postgraduate year two (PGY2) pharmacy residency in a focused area of training. The practice of pharmacists in the four more focused BPS specialty areas is summarized below. Additional detail can be found on the BPS Website www.bpsweb.org or in Appendix D of CCPs resource document Credentialing in Pharmacy. Nuclear pharmacy was the frst recognized area of specialty practice within pharmacy. Nuclear pharmacists seek to improve and promote the public health through the safe and effective use of radioactive drugs for diagnosis and therapy.
Journal of the American Pharmacists Association
JAPhA e52
3/17/10 9:41 AM
FEATURE
(who acquire the images), occasionally chemists, physicists, nurses, pharmacists, and physicians. Nutrition support pharmacy addresses the care of patients who receive specialized nutrition support, including parenteral and enteral nutrition. Nutrition support pharmacists have responsibility for promoting maintenance and/or restoration of optimal nutritional status and designing and modifying treatment according to the needs of the individual patient. Nutrition support pharmacists have responsibility for direct patient care and often function as members of an interprofessional nutrition support team. Oncology pharmacists provide specialized care to patients with cancer. Specialists recommend, design, implement, monitor and modify pharmacotherapeutic plans to optimize outcomes in patients with malignant diseases. This includes the supportive care needed to minimize side effects from the oncology treatments and the disease. Oncology agents require specialized handling and preparation, and the patients require frequent monitoring to achieve the desired outcome. Pharmacists play a key role in assuring the safety and optimum care of these patients. Oncology pharmacists may practice in hospitals or ambulatory oncology clinics, or a combination of both. Many oncology agents are now infused in ambulatory infusion centers. Psychiatric pharmacy addresses the care of patients with psychiatric-related illnesses. As a member of an interprofessional treatment team, the psychiatric pharmacy specialist is often responsible for optimizing drug treatment and patient care by conducting such activities as monitoring patient response, patient assessment, recognizing drug-induced problems, and recommending appropriate treatment plans.
decisions for a population of patients. Pharmacists practicing in managed care organizations, including health plans and PBMs, are responsible for a broad range of clinical, quality-oriented drug management services.58 The role of a pharmacist in a managed care organization is often stratifed into seven different areas of activity: (1) drug distribution and dispensing; (2) patient safety; (3) clinical program development; (4) communication with patients, prescribers and pharmacists; (5) drug beneft 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 are encouraged to collaborate in the provision of health care through an interprofessional approach. Patient management is based on provider group interactions that address all aspects of individualized patient care. This interprofessional team includes but is not limited to the physician, nurse, physicians assistant, nurse practitioner, pharmacist, nutritionist, medical assistant, and benefts manager. A pharmacist in this environment has the beneft of direct and immediate contact with not only the primary healthcare provider, but also the rest of the healthcare team. This kind of one-on-one contact among health professionals often leads to more patient-centered health care and effcient MTM services. Also, within this type of environment, the pharmacist has access to pharmacy claims data, which allows for large numbers of patients to be reviewed. Since many of these models have an integrated dispensing pharmacy program, the patient-care team can monitor medication adherence and utilization. Patient care call eenters Call center pharmacists provide patient and prescriber education, patient counseling, drug information, and customer service, as well as drug utilization review, health management and formulary management. Pharmacists in call centers interact with patients telephonically to promote effective drug therapy. Call center pharmacists are primarily employed in health maintenance organizations (HMOs), PBMs, and health plans, but may also be found in other environments. These pharmacists make calls to and receive calls from patients to optimize medication therapy. Some calls focus on medication adherence reminders; others are to obtain information about adverse medication events; and some calls focus on patients questions about treatment. Some call center pharmacists focus on specifc disease states, such as anticoagulation, hypertension, or diabetes. In the disease-specifc model, pharmacists manage the medication therapy for one disease. Another model places a patients total medication therapy under the direction of one call center pharmacist. In this model, pharmacists manage full patients drug regimens and are able to suggest changes and make referrals to other healthcare professionals to ensure positive patient outcomes. Call centers may provide services for specifc member populations, for example, MTM services for Medicare Part D benefciaries.
Journal of the American Pharmacists Association
3/17/10 9:41 AM
Resolve conficts through negotiation. Understand the principles for managing change. Appreciate the need to adapt direct patient care to meet the needs of diversity. Appreciate the benefts of active involvement in local, state, and national technician and other pharmacy organizations. Appreciate the value of obtaining technician certifcation. Understand the importance of and resources for staying current with changes in pharmacy practice. Communicate clearly when speaking or writing.
Goal 8:
Goal 26:
Maximize work effciency through the use of technology. Effciently solve problems commonly encountered in ones own work. Display a caring attitude toward patients in all aspects of job responsibilities. Maintain confdentiality of patient and proprietary business information. Understand direct patient care delivery systems in multiple practice settings. Effciently manage ones work whether performed alone or as part of a team. Function effectively as a member of the health care team. Balance obligations to ones self, relationships, and work in a way that minimizes stress. Understand the use and side effects of prescription and nonprescription medications used to treat common disease states. Assist the pharmacist in assuring the quality of all pharmaceutical services.
Goal 12: Goal 13: Goal 14: Goal 15: Goal 16:
Goal 30: Goal 31: Goal 32: Goal 33: Goal 34:
Goal 35:
Hospice Hospices range from small rural organizations to very large hospices. Regardless of the organizations structure, a large part of the care they provide, and a signifcant cost, is medication-centered. Pharmacists practicing in this setting help to ensure that medications are appropriately seJournal of the American Pharmacists Association
JAPhA e54
3/17/10 9:41 AM
FEATURE
symptom control; (ii) counseling and educating the hospice team about medication therapy; (iii) ensuring that patients and caregivers understand and follow the directions provided with medications; (iv) providing effcient mechanisms for extemporaneous compounding of nonstandard dosage forms; (v) addressing fnancial concerns; (vi) ensuring safe and legal disposal of all medications after death; and (vii) establishing and maintaining effective communication with regulatory and licensing agencies.59 Hospice programs are varied in their structure and hospice pharmacy practice models have evolved to complement these programs. Models include: (a) hospice-employed pharmacist; (b) contracted consultant pharmacist or pharmacist group; (c) pharmacy benefts manager (PBM) with or without in-house or contracted clinical pharmacist services; (d) central dispensing pharmacy with PBM and clinical support that services hospices regionally or nationally; (e) selected pharmacies that generally dispense on a contract basis to a local hospice; and (f) community pharmacies that dispense to hospice patients usually on contract with the hospice. Compounded medications often constitute a signifcant element of the pharmacy services provided because of the need to individualize dosages and/or dosage forms for terminally ill patients. Drug and poison information services Drug and poison information services have had a longstanding role in the emergence of clinical roles for pharmacists that were built on drug expert contributions. Pharmacy drug information services have expanded in recent years to include many practice areas from the hospital drug information service to community practice-based pharmacies. Easier access to information via the Internet, CD or DVD-based drug information databases, and electronic journals has contributed to this development. Pharmacists access these databases to assist medication prescribers, the healthcare community, and the general public (as appropriate) with information on drug indication and dosing, interactions such as drugdrug, drugfood, drugdisease, and drugdiagnostic test, adverse drug reactions, drug use for specialized populations (eg, elderly, pediatric, immunosuppressed, diabetic), parenteral nutrition calculations, chemotherapeutic dosing regimens, toxicology and poisoning, and evidence-based medical literature review. While the work of these pharmacists is typically not delivered directly to the patient, its impact on patient care is signifcant. On meeting the certifcation requirements, pharmacists working in centers certifed by the American Association of Poison Control Centers can become Certifed Specialists in Poison Information (CSPI). Pharmacist information technology specialist The rapid development of technology and the impact technology can have on patient care have led to the emergence of the pharmacist information technology specialist or pharmacy informatics specialist. These individuals are in high demand especially in large health systems. Initiatives such as CPOE, bar coding, dispensing software development,
e55 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
automated medication dispensing machines, programmed infusion devices, and systems maintenance require both a clinical and technical knowledge to be implemented effectively and to reduce errors.
Pharmacists in academia, health organization management, regulatory oversight, pharmacy organizations, and industry
Many pharmacists pursue a career that allows them to help facilitate the attainment of the goals of the profession through academic, organizational, and government initiatives that are focused on advancing the full scope of pharmacy practice. Pharmacists who choose to combine practice with academia have a responsibility to develop practice, research, and teaching role models in evolving healthcare settings. These innovative areas of practice become integrated into the experiential component of the pharmacy curriculum, thus contributing to sustained practice advancement.60 As university faculty members, pharmacists have multiple paths from which to choose. Faculty positions vary greatly but, in general, they include an integration of practice activities with clinical programs, research, teaching, mentoring, consulting, scholarship, community and campus-based service, and collaboration with other health science programs. Others may focus primarily on research, establishing novel research programs that bridge practice with basic and/or clinical science. Preparation for academic positions may include additional work through postgraduate education or training programs, either academic degree programs (eg, Masters or PhD) or professional programs (ie, residencies, fellowships) and/or specialty certifcation depending on the faculty role expectation. Regardless of practice sitefrom generalist to the most specialized practicespharmacists have the opportunity to serve as preceptors for colleges and schools of pharmacy to help prepare future pharmacists. Professional pharmacy organization management is another area that pharmacists utilize their expertise to organize and administer initiatives that have a regional, national, or even international impact on pharmacy practice. Leaders in professional pharmacy organizations assist the profession as a whole by representing pharmacists with regard to education, practice, credentialing, reimbursement, health policy, and future planning for practitioners and graduating students. Pharmacists also hold positions within government agencies and nongovernmental organizations, such as the US Public Health Service (PHS) Commissioned Service (Food and Drug Administration (FDA) Indian Health Service (IHS) and Bureau of Prisons), the National Institutes of Health (NIH), the CDC, the Armed Services, state boards of pharmacy, and the World Health Organization (WHO) or Pan American Health Organization (PAHO). They serve in a multitude of capacities relying on their pharmacy degree as a foundation for the particular area in which they are working.
Journal of the American Pharmacists Association
3/17/10 9:41 AM
The pharmaceutical industry has become an environment that offers many types of positions for pharmacists. Opportunities in industry include drug development research, post-approval drug marketing, pharmaceutical sales, drug information, quality control, administration, consulting, and advisory roles. Curricular changes addressing advances in clinical pharmacotherapeutics and pharmacoeconomics have allowed for expanded job opportunities for PharmD graduates in this sector. As a result, positions are available to new graduates and those with professional practice experience.
Pharmacy technicians
A pharmacy technician is an individual working in a pharmacy who, under the supervision of the licensed pharmacist, assists in pharmacy activities that do not require the professional judgment of a pharmacist. A certifed pharmacy technician (CPhT) is a pharmacy technician who has passed a certifcation examination and is maintaining his/her certifcation. A 2002 white paper on pharmacy technicians provided a comprehensive analysis of historical developments, drivers for change, work-force issues, and the education, training, certifcation, and regulation of pharmacy technicians.61 The paper called for a profession-wide vision for pharmacy technicians, identifed the key issues that needed to be addressed, and described the needed action.
An increasing number of state boards of pharmacy, recognizing the integral role of pharmacy technicians, have revised practice regulations to allow a broadening of their responsibilities and regulation of pharmacy technicians has increased signifcantly over the past 15 years. In 1993, only 12 states regulated pharmacy technicians. At present, 39 states regulate pharmacy technicians through licensure, certifcation, or registration. It is estimated that there are over 280,000 technicians regulated by state boards of pharmacy. The majority of states require some level of training or education that must be completed by a pharmacy technician; 29 of the 39 states that regulate pharmacy technicians have mandated training requirements. The majority of these training programs must be reviewed, or approved by the state board of pharmacy. As a part of their regulation of technicians, 14 boards of pharmacy have examination requirements that must be completed, such as the Pharmacy Technician Certifcation Examination (PTCE) (see below). An overview of the state regulation of pharmacy technicians is provided in NABPs annual Survey of Pharmacy Law.62 The following synopsis of the practice and credentialing of pharmacy technicians is provided to give readers an understanding of the vital role that they play in the delivery of pharmacy services. Pharmacy technicians work in a wide variety of practice settings, including community pharmacies, hospitals,
JAPhA e56
3/17/10 9:41 AM
FEATURE
perform such functions as assisting in the dispensing process; processing of medical coverage claims; stocking of medications; cashiering but excluding drug regimen review; clinical confict resolution; prescriber contact concerning prescription drug order clarifcation or therapy modifcation; patient counseling; dispensing process validation; prescription transfer; and receipt of new prescription drug orders.63 There have been recurring collaborative initiatives to analyze and document the work activities of pharmacy technicians. Some of these studies have been accomplished at the same time as an evaluation of professional activities of pharmacists, eg, the Scope of Pharmacy Practice Project (19921994) mentioned above.32, 64 The most recent practice analysis for pharmacy technicians was completed in 2005. It identifed new responsibilities performed by CPhTs, including the handling and processing of restricted, investigational, and chemotherapy drugs; working in mail-order pharmacy settings; and increased involvement in third-party payment. New knowledge areas identifed in the practice analysis included knowledge of error prevention strategies for data entry, cultural diversity, third-party payment, and
Journal of the American Pharmacists Association
3/17/10 9:41 AM
pharmacy beneft management companies. The practice analysis indicated that CPhTs spend about 66 percent of their time assisting the pharmacist in serving patients, 22 percent maintaining medication and inventory control systems, and 12 percent participating in pharmacy practice management and administration. This distribution of the workday is similar across community, health-system, and other work settings. Community-based CPhTs are most frequently involved in assisting with outpatient prescription dispensing, purchasing and inventory control, and billing. For health-system CPhTs, assisting in inpatient medication dispensing, preparing intravenous admixtures, and prepackaging and repackaging are the primary responsibilities. CPhTs are taking on additional, more advanced responsibilities, including those more traditionally performed by a pharmacist. In community settings, there has been growth in the extent to which pharmacy technicians are contacting prescribers for clarifcation of prescriptions and participating in quality assurance activities. Skilled technicians are now playing an important role in improving patient safety and medication-error strategies. Technician roles include medication order entry, multiple-point checking, screening medication orders for dangerous medical abbreviations, physically separating look-alike medications and soundalike medication names, and assisting the pharmacist in monitoring patient outcomes by collecting patient-specifc data. Many CPhTs now have expanded supervisory responsibilities, including order-entry verifcation, preparation and packaging of medications produced by other technicians, and preparing prescription and medication orders for fnal approval by a pharmacist, as allowed by law. Additional practice management tasks include collecting productivity information, performing billing and accounting functions, performing or contributing to employee evaluations, and participating in the establishment, implementation, and monitoring of policies and procedures. There have been a number of signifcant positive developments affecting pharmacy technicians in the past ten to ffteen years including the establishment of certifcation boards, the development of the Model Curriculum for pharmacy technician training65, an expansion in the number of accredited training programs, and greater regulatory recognition of pharmacy technicians in state pharmacy practice acts. Pharmacy technician education and training requirements vary among states and employers; there is, however, a trend toward more formalized technician training, either through an academic training program or on the job. The Model Curriculum provides a starting point for identifying core competencies for pharmacy technicians and a framework for training pharmacy technicians for all practice settings and geographic locations. The goal statements of the Model Curriculum are listed in Table 8. Several national pharmacy organizations have adopted policies calling for nationally standardized education and training for pharmacy technicians.6668 The development of guidelines and standards to regulate the qualifcations of individuals who work
Journal of the American Pharmacists Association
as pharmacy technicians will ultimately reduce the variation in pharmacy technician qualifcations and deployment across the country. Accreditation of pharmacy technician training programs In an attempt to standardize pharmacy technician training programs, in 1982 ASHP established a process of programmatic accreditation for pharmacy technician training programs. The accreditation standards require all accredited programs to educate and train pharmacy technicians on core outcomes that relate to the knowledge required and activities most frequently performed by pharmacy technicians. These outcomes encompass activities that occur in both community and hospital settings. The program must include didactic and experiential training. ASHP utilizes the Pharmacy Technician Certifcation Boards scope of practice analysis data to determine the required outcomes for programs. Accredited programs include employers own programs (eg, chain drug stores, military) and programs in hospitals, community colleges, vocational/technical colleges, and universities. All programs are held to the same accreditation standard. Some states require that pharmacy technicians complete an accredited training program to become registered or licensed. Not all institutions offering training programs for pharmacy technicians have programmatic accreditation, however, many have institutional accreditation. Only ASHP programmatic accreditation reviews the actual technician curriculum and experiential training component directly related to actually training a pharmacy technician.61,69 Certifcation of pharmacy technicians Certifcation of pharmacy technicians commenced nationally in 1995 with voluntary certifcation by the Pharmacy Technician Certifcation Board (PTCB), which administers the PTCE. A second certifying bodythe Institute for the Certifcation of Pharmacy Technicians (ICPT)was established in October 2005; ICPT administers the Exam for Certifcation of Pharmacy Technicians (ExCPT). The validity and defensibility of the certifcation examinations are maintained by conducting periodic practice analyses and through external evaluation of the certifcation program; both certifcation programs are accredited by the National Commission for Certifying Agencies (NCCA)f.70,71 From 1995 to March 2008, PTCB has certifed over 300,000 pharmacy technicians through examination or transfer process.72 As at July 2008, ICPT has certifed over 2,400 pharmacy technicians. PTCB completed its latest practice analysis in 2005 and developed the Content Outline for the PTCE based on the results.73 ICPT completed a similar practice analysis in 2005. The certifcation examinations are designed to assess the candidates knowledge and skill base for activities that are most commonly performed by a pharmacy technician, as determined by national task analyses. The PTCE Content Outline is divided into three domains: (1) assisting the pharmacist in serving patients; (2)
www.japha.org M a r /a p r 2010 50:2
JAPhA e58
3/17/10 9:41 AM
FEATURE
maintaining medication and inventory control systems; and (3) participating in the administration and management of pharmacy practice. The ExCPT Content Outline is similarly divided: (1) regulation and technician duties; (2) drugs and drug products; and (3) the dispensing process. Table 9 provides a summary of the examination blueprints that defne the roles, responsibilities, functions, and competencies of a pharmacy technician upon successful completion of the certifcation exam.74,75 Full details of the content outlines can be found on the respective Websites www.ptcb.org and www.nationaltechexam.org. CPhTs are required to complete approved continuing education activities to maintain their certifcation, and a growing number of states require continuing education for maintenance of licensure or registration. (fThe NCCA is the accrediting body of the National Organization for Competency Assurance [NOCA].)
3.
Model State Pharmacy Act and Model Rules of the National Boards of Pharmacy; National Association of Boards of Pharmacy; http://www.nabp.net; August 2008; Accessed: December 30, 2008. Manasse HR and Speedie MK. Pharmacists, Pharmaceuticals, and Policy Issues Sharing the Work Force in Pharmacy. Am J Health-System Pharm. 2007; 64:e30-48. Future Vision of Pharmacy Practice; Joint Commission of Pharmacy Practitioners; http://www.ascp.com; August 2004; Accessed: December 30, 2008. Dussault G, Dubois C-A. Human Resources for Health Policies: A Critical Component to Health Policies. Human Resources for Health. 2003; http://www.human-resources-health.com/content/1/1/1; Accessed: December 30, 2008. Greiner AC, Knebel E, eds. Health Professions Education: A Bridge to Quality. Washington, D.C.: The National Academies Press. 2003:45-74. Prescription Drug Trends; Kaiser Family Foundation; http:// www.kff.org/rxdrugs/upload/3057_06.pdf; May 2007; Accessed February 19, 2008. Cumulative Policies of the American Association of Colleges of Pharmacy House of Delegates; AACP Argus Commission; www.aacp.org; 2005; Accessed October 23, 2007.
4.
5.
6.
7.
Summary
The evolutions in health care and pharmacy practice are presenting many new opportunities for pharmacists to perform functions and provide services not considered as traditional roles.76 A clear vision for pharmacy practice has been articulated. New roles and responsibilities for pharmacy technicians will assist pharmacists to achieve this vision. As pharmacists evolve their practice to meet the healthcare needs of society related to medication use and pharmacotherapy, individual practitioners seek to expand the scope of services they offer to provide high quality, relevant care to patients.76 Education, training, and licensing processes to underpin practice are competency-based. New professional services have been introduced and an expanded range of post-licensure credentials, education, and training have been created to assure the contemporary competence of all practitioners and to support their continuing professional development and career progression. Accreditation and psychometrically sound examinations have been developed to provide consistency and quality assurance in the education, training, and credentialing of both pharmacists and pharmacy technicians. The profession of pharmacy is working to achieve a pervasive model and standard of care determined only by the needs of patients and populations. The Council on Credentialing in Pharmacy hopes that the material presented herein, including the framework for credentialing in pharmacy practice, will allow audiences to gain a better understanding of where pharmacy is today and what future pharmacy practice will look like.
References
1. Council on Credentialing in Pharmacy. White Paper. Credentialing in Pharmacy. 2006. Council on Credentialing in Pharmacy; http://www.pharmacycredentialing.org/ccp/Files/CCPWhitePaper2006.pdf; Accessed December 30, 2008. Webb E. Prescribing medications: Changing the Paradigm for a Changing Health Care System. Am J Health-Syst Pharm. 1995;52:1693-5.
8.
9.
10. Medication Therapy Management Services Defnition and Program Criteria; American Pharmacists Association; http://www. pharmacist.com/AM/Template.cfm?Section=Pharmacist_ Practitioners&TEMPlATE=/CM/ContentDisplay. cfm&CONTENTID=4577. Accessed July 6, 2008. 11. Bluml BM. Defnition of Medication Therapy Management: Development of Profession Wide Consensus. J Am Pharm Assoc. 2005;45:56672. 12. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model, Version 2.0; National Association of Chain Drug Stores; http://www.nacds.org/userassets/pdfs/MTM/FinalMTMServiceModel_WEB.pdf; March 2008; Accessed December 30, 2008. 13. The Offcial U.S. Government Site for People with Medicare. http://www.medicare.gov; Accessed July 2006. 14. The Joint Commission Sentinel Event Alert Issue 35; Patient Medication Safety Goals Number 8: Reconcile medications; http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_35.htm; January 25, 2006; Accessed February 11, 2009. 15. Accreditation Council for Pharmacy Education. Accreditation Standards and Guidelines for the Professional Program in Pharmacy leading to the Doctor in Pharmacy Degree. Standards for Curriculum, Standard 12: Professional Competencies and Outcome Expectations. http://www.acpe-accredit.org/pdf/ ACPE_Revised_PharmD_Standards_Adopted_Jan152006.pdf; January 2006; Accessed February 11, 2009. 16. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and Economic Outcomes of Medication Therapy Management Services: The Minnesota experience. J Am Pharm Assoc. 2008 MarApr; 48(2):203211. 17. Bunting BA, Smith BH, Sutherland SE. The Asheville Project: Clinical and Economic Outcomes of a Community-Based longTerm Medication Therapy Management Program for Hypertension and Dyslipidemia. J Am Pharm Assoc. 2008;48(1):23-31.
Journal of the American Pharmacists Association
2.
www.japha.org
3/17/10 9:41 AM
18. American Pharmacists Association Foundation Diabetes Ten City Challenge; American Pharmacists Association: http:// www.aphafoundation.org/Programs/Diabetes_Ten_City_ Challenge/; Accessed December 30, 2008. 19. Behind-the-Counter Availability of Certain Drugs; Comments of the American Pharmacists Association submitted to the Food and Drug Administration; Docket No. 2007N-0356; http://www.pharmacist.com/AM/Template. cfm?Section=Government_Affairs&TEMPlATE=/CM/ContentDisplay.cfm&CONTENTID=15052; December 17, 2007; Accessed July 5, 2008. 20. Bureau of labor Statistics: Occupational Employment Statistics, 29-1051 Pharmacists. http://www.bls.gov/oes/2007/may/ oes291051.htm; Accessed December 30, 2008. 21. Bureau of labor Statistics, U.S. Department of labor: Occupational Outlook Handbook; http://www.bls.gov/oco/ocos079. htm; 2008-09 edition. Accessed January 22, 2008. 22. Jones JM; lobbyists Debut at Bottom of Honesty and Ethics list; Gallup; http://www.gallup.com/poll/103123/lobbyistsDebut-Bottom-Honesty-ethics-list.aspx; December 10, 2007; Accessed December 30, 2008. 23. Carter Bl, Elliott WJ. The Role of Pharmacists in the Detection, Management, and Control of Hypertension: A National Call to Action. Pharmacotherapy. 2000;20(2):119-122. 24. National Center for Health Statistics. Health, United States, 2004 With Chartbook on Trends in the Health of Americans. Hyattsville, Maryland: 2004. 25. Stagnitti MN. Statistical brief #21Trends in Outpatient Prescription Drug Utilization and Expenditures: 19972000; Medical Expenditure Panel Survey. 26. levit K, Smith C, Cowan C, et al. Health Spending Rebound Continues in 2002. Health Affairs. 2004;23:147-59. 27. Hoffman JM, Shah ND, Vermeulen lC, et al. Projecting Future Drug Expenditures2005. Am J Health-Syst Pharm. 2004;61:145-58. 28. IMS Health. IMS Annual U.S. Pharmaceutical Market PerformanceTM http://www.imshealth.com/portal/site/imshealth/ menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid= 280c1d3be7a29110VgnVCM10000071812ca2RCRD&cpsextcu rrchannel=1; Accessed February 11, 2009. 29. Bradberry JC, Droege M, Evans Rl, et al. Curricula Then and Now: An Environmental Scan and Recommendations Since the Commission to Implement Change in Pharmaceutical Education: Report of the 2006-2007 Academic Affairs Committee. AACP; http://www.aacp.org/governance/COMMITTEES/ academicaffairs/Documents/2006-07_AcadAffairs_Final%20 Report.pdf; Accessed December 30, 2008. 30. American Association of Colleges of Pharmacy. Educational Outcomes 2004. Alexandria, VA: Center for the Advancement of Pharmaceutical Education Outcomes; 2004. http://www. aacp.org/resources/education/Documents/CAPE2004.pdf; 2004; Accessed February 11, 2009. 31. National Association of Board of Pharmacy North American Pharmacist licensure Examination (NAPlEX) Blueprint http:// www.nabp.net/ftpfles/NABP01/updatednaplexblueprint.pdf; Accessed February 11, 2009. 32. Summary of the Final Report of the Scope of Pharmacy Practice Project. Am J Hosp Pharm. 1994;51:2179-82.
Journal of the American Pharmacists Association
33. Maine ll. Pharmacy Practice Activity Classifcation. J Am Pharm Assoc. 1998;38(2):139-48. http://www.pharmacist.com/ AM/Template.cfm?Section=Home&TEMPlATE=/CM/HTMlDisplay.cfm&CONTENTID=2908; Accessed December 30, 2008. 34. Pradel FG, Palumbo FB, Flowers l, Mullins CD, Haines ST, Roffman DS. White paper: Value of Specialty Certifcation in Pharmacy. J Am Pharm Assoc. 2004 Sep-Oct;44(5):612-20. 35. The American Society of Health-System Pharmacists; PGy2 Residencies. http://www.ashp.org/Import/ACCREDITATION/ ResidentInfo/NextStep.aspx; Accessed February 13, 2009. 36. Cranor CW, Buntin BA, Christensen DB. The Asheville Project: long-Term Clinical and Economic Outcomes of a Community Pharmacy Diabetes Care Program. J Am Pharm Assoc. 2003;43:173-84. 37. Centers for Medicare & Medicaid Services. http://www.cms. hhs.gov; Accessed July 2006. 38. Hammond RW, Schwartz AH, Campbell MJ, et al. Collaborative Drug Therapy Management by Pharmacists. Pharmacotherapy. 2003;23(9):1210-25. 39. Health Resources and Services Administration. SHIP Grantee Hospitals may be Eligible for the 340B Drug Pricing Program. http://ruralhealth.hrsa.gov/news/340B.htm; Accessed February 13, 2009. 40. Keely Jl. American College of Physicians (ACP) American Society of Internal Medicine (ASIM) Position Statement. Pharmacist Scope of Practice. Ann Intern Med. 2002;136:79-85. 41. Woods TM. An Essential Ingredient. Am J Health-System Pharm. 2007;64:1911. 42. Cheung A, Sleight SM, Sisson NM. Pharmacy Practice in the Veterans Administration. Am J Hosp Pharm. 1987;44(4):74754. 43. American Pharmacists Association Immunization Resources; http://www.pharmacist.com/AM/Template. cfm?Section=Search1&template=/CM/HTMlDisplay. cfm&ContentID=15432; American Pharmacists Association; Accessed February 13, 2009. 44. Kaushal R, Bates DW, landrigan C, et al. Medication Errors and Adverse Drug events in Pediatric Inpatients. JAMA. 2001;285:2114 2120. 45. American Society of Hospital Pharmacists. ASHP Guidelines for Providing Pediatric Pharmaceutical Services in Organized Health Care Systems. Am J Hosp Pharm. 1994;51:16902. 46. Takata GS, Mason W, Taketomo C, logsdon T, Sharek PJ. Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in US Childrens Hospitals. Pediatrics. 2008;121;e927-935. 47. Fortescue EB, Kaushal R, landrigan CP, et al. Prioritizing Strategies for Preventing Medication Errors and Adverse Drug Events in Pediatric Inpatients. Pediatrics. 2003;111:722-729. 48. Kaushal R, Bates DW, Abramson El, et al. Unit-Based Clinical Pharmacists Prevention of Serious Medication Errors in Pediatric Patients. Am J Health-Syst Pharm. 2008;65:1254-1260. 49. Burton ME, Shaw lM, Schentag JJ, Evans WE, eds. Applied Pharmacokinetics and Pharmacodynamics: Principles of Therapeutic Drug Monitoring. 4th ed. lippincott Williams & Wilkins, 2005.
www.japha.org
M a r /a p r 2010 50:2
JAPhA e60
3/17/10 9:41 AM
FEATURE
50. Institute of Medicine of the National Academies. Retooling for an Aging America: Building the Health Care Workforce. http:// www.nap.edu/catalog/12089.html; Washington, DC; April 14, 2008; Accessed December 30, 2008. 51. Delafuente JC. Refections on Geriatric Pharmacy: The Times They are Changin. The Annals of Pharmacotherapy. 2006;40:950-1. 52. Beers MH. Explicit Criteria for Determining Potentially Inappropriate Medication Use by the Elderly. Arch Intern Med. 1997;157(14):1531-36. 53. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Results of a US Consensus Panel of Experts. Arch Intern Med. 2003;163:2716-2724. 54. Department of Health and Human Services Centers for Disease Control and Prevention. Rates of Preventive Care Practices per 100 Adults with Diabetes, United States, 2005; http:// www.cdc.gov/diabetes/statistics/preventive/fAllPractices. htm; March 26, 2007; Accessed December 30, 2008. 55. American Medical Association. Health and Ethic Policies of the Policies of the American Association of Colleges of Pharmacy House of Delegates 1980-2008; AACP Academic Affairs Committee, 1987. http://www.aacp.org/governance/HOD/Documents/Cumulative%20Policies,%201980-2008.pdf; Accessed February 13, 2009. 61. White Paper on Pharmacy Technicians 2002: Needed Changes Can no longer Wait. Am J Health-Syst Pharm. 2003;60:37-51; http://www.ashp.org/s_ashp/docs/fles/Tech_WhitePaper.pdf; Accessed February 13, 2009. 62. Survey of Pharmacy law; National Association of Boards of Pharmacy; http://www.nabp.net; Accessed December 30, 2008. 63. National Association of Boards of Pharmacy. The Model State Pharmacy Act and Model Rules (Model Act); http://www.nabp. net; Accessed February 13, 2009. 64. Zellmer WA. Role of Pharmacy Organizations in Transforming the Profession: The Case of Pharmaceutical Care. Am J Health-System Pharm. 2001;58(21):2041-2049. 65. American Society of Health-System Pharmacists. Model Curriculum for Pharmacy Technician Training. 2nd Edition. American Society of Health-System Pharmacists; http://www.ashp. org/Import/MEMBERCENTER/Technicians/Training/ModelCurriculum.aspx. Bethesda, MD. 2001; Accessed February 13, 2009. 66. Position Statement: Pharmacy Technician Education, Training, and Certifcation. Adopted by the Board of Regents, August 10, 2007; American College of Clinical Pharmacy; http:// www.accp.com/docs/positions/positionStatements/Technician_Position_Statement.pdf; Accessed February 13, 2009. 67. 2008 Actions of the APhA House of Delegates; San Diego, CA; March 14-17, 2008. Pharmacy Technician Education and Training; American Pharmacists Association; http://www.pharmacist.com/Content/NavigationMenu3/AboutAPha/HouseofDelegates/APhA_House_of_Delega.htm; Accessed February 13, 2009. 68. ASHP Policy Positions: Education and Training. American Society of Health-System Pharmacists; http://www.ashp.org/Import/PRACTICEANDPOlICy/PolicyPositionsGuidelinesBestPractices/BrowsebyTopic/Education/PolicyPositions.aspx;
AMA. H-120.945; AMA Action on Non FDA-Approved Compounded Medications; www.ama-assn.org/ad-com/polfnd/ Hlth-Ethics.doc; Accessed February 13, 2009. 56. 2008 Actions of the APhA House of Delegates; San Diego, CA; Pharmacy Compounding Accreditation; American Pharmacists Association; http://www.pharmacist.com/Content/NavigationMenu3/AboutAPha/HouseofDelegates/APhA_House_ of_Delega.htm; March 14-17, 2008; Accessed February 13, 2009. 57. United States Nuclear Regulatory Commission; http://www. nrc.gov. Accessed December 30, 2008. 58. Academy of Managed Care Pharmacy. The Role of Pharmacists in Managed Health Care Organizations. http://www.amcp.org/amcp.ark?p=AA8CD7EC; Accessed February 13, 2009. 59. American Society of Health-System Pharmacists. ASHP Statement on the Pharmacists Role in Hospice and Palliative Care. Am J Health-Syst Pharm. 2002;59:17703. http://www. ashp.org/Doclibrary/BestPractices/Hospice.aspx. Accessed 02/13/09. 60. American Association of Colleges of Pharmacy. Cumulative Accessed February 13, 2009. 69. Pharmacy Technician Accreditation Regulations and Standards; American Society of Health-System Pharmacists; http://www.ashp.org/Import/ACCREDITATION/TechnicianAccreditation/RegulationsStandards.aspx; Accessed February 13, 2009. 70. Pharmacy Technician Certifcation Board. PTCBs National Pharmacy Technician Certifcation Program is accredited by the NCCA; https://www.ptcb.org/AM/Template. cfm?Section=Press_Releases1&TEMPlATE=/CM/ContentDisplay.cfm&CONTENTID=2366; Accessed February 13, 2009. 71. Institute for the Certifcation of Pharmacy Technicians. Exam for Certifcation of Pharmacy Technicians Receives Distinguished NCCA Accreditation. http://www.nationaltechexam. org/AnnouncementRetrieve.aspx?ID=10247; Accessed February 13, 2009. 72. Pharmacy Technician Certifcation Board. https:// www.ptcb.org/AM/Template.cfm?Section=Press_ Releases1&TEMPlATE=/CM/ContentDisplay. cfm&CONTENTID=2975; Accessed February 13, 2009. 73. Muenzen PM, Corrigan MM, Mobley Smith MA, Rodrigue PG. Updating the Pharmacy Technician Certifcation Examination: A Practice Analysis Study. Am J Health-System Pharm. 2005;62:2542-6. 74. Pharmacy Technician Certifcation Board. Updated PTCE Blueprint and New Passing Standard Study. https://www.ptcb.org/ AM/Template.cfm?Section=Press_Releases1&TEMPlATE=/ CM/ContentDisplay.cfm&CONTENTID=2174; Accessed February 13, 2009. 75. Institute for the Certifcation of Pharmacy Technicians. Exam for Certifcation of Pharmacy Technicians. Exam content; http://www.nationaltechexam.org/excptinfo.html#6; Accessed February 13, 2009. 76. Webb CE. Key Questions in Credentialing in Pharmacy. [unpublished]
www.japha.org
3/17/10 9:41 AM
Glossary
For the purpose of this paper, the following are the defnitions, interpretations, and intent of the terms utilized throughout the paper: Accreditation: The process whereby an association or agency grants public recognition to an organization, site, or program that meets certain established qualifcations or standards, as determined through initial and periodic evaluations. Adherence: A patients correct following of professional advice or directions. Ambulatory care: Health services delivered on an outpatient basis. Blueprint [as in examination blueprint]: An indication of the proposed structure and defnition of the exam; the content or topic areas that will be included on the exam; any required levels of cognitive demand or processing level for each topic area; the number of items that should be included by topic and cognitive level; and any relevant item specifcations by topic and cognitive level. Certifcate Program: A structured, systematic, postgraduate education and continuing education experience for pharmacists that is generally smaller in magnitude and shorter in duration than a degree program or residency training program. Certifcate programs are designed to instill, expand, or enhance practice competencies through the systematic acquisition of specifc knowledge, skills, attitudes, and performance behaviors. Certifcation: The voluntary process by which a nongovernmental agency or an association grants recognition to an individual who has met certain predetermined qualifcations specifed by that organization. This formal recognition is granted to designate to the public that this individual has attained the requisite level of knowledge, skill, and/or experience in a well-defned, often specialized, area of the total discipline. Certifcation usually requires initial assessment and periodic reassessments of the individuals knowledge, skills, and/or experience. Certifed: Adjective that is used to describe an individual who holds certifcation and that is incorporated into the name of the credential awarded that individual. For example, someone who has earned BPS certifcation in oncology is a Board-Certifed Oncology Pharmacist. Clinical privileges: Authorization to provide a specifc range of patient-care services. (See also Privileging) Collaborative Drug Therapy Management: Collaborative drug therapy management (CDTM) is a team approach to healthcare delivery whereby a pharmacist and prescriber establish written guidelines or protocols authorizing the pharmacist to initiate, modify, or continue drug therapy for designated patients. (Alliance for Pharmaceutical Care) Competence: The ability to perform ones duties accurately, make correct judgments, and interact appropriately with patients and colleagues. Professional competence is characterized by good problem-solving and decision-making abilities, a strong knowledge base, and the ability to apply
Journal of the American Pharmacists Association
knowledge and experience to diverse patient-care situations. Competency: A distinct knowledge, skill, attitude or value that is essential to the practice of a profession. A pharmacist must master a variety of competencies to gain competence in his or her profession. Compounding: Traditional pharmacy practice which includes the preparation, mixing, assembling, packaging, or labeling of a completed compounded preparation or administration device by compounding personnel: (1) as the result of a practitioners prescription order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; (2) for the purpose of, or as an incident to, research, teaching, or chemical analysis, and shall not be dispensed for resale by a third party; (3) preparation of drugs or devices in anticipation of prescription orders to be received by the compounding pharmacist based on routine, regularly observed prescribing patterns; (4) preparation of completed compounded preparations for practitioner administration, pursuant to state and federal regulations; (5) preparation of Non-Legend completed compounded preparations, pursuant to state requirements; and (6) preparing completed compounded preparations for both human and non-food-producing animal patients. (Pharmacy Compounding Accreditation Board) Continuing education: Continuing education for the profession of pharmacy is a structured educational activity designed or intended to support the continuing development of pharmacists and/or pharmacy technicians to maintain and enhance their competence. Continuing pharmacy education should promote problem-solving and critical thinking and be applicable to the practice of pharmacy. Continuing professional development: The lifelong process of active participation in learning activities that assists individuals in developing and maintaining continuing competence, enhancing their professional practice, and supporting achievement of their career goals. Credential: Documented evidence of professional qualifcations. For pharmacists, academic degrees, state licensure, residencies, and Board certifcation are examples of credentials. Credentialing: (1) The process of granting a credential (a designation that indicates qualifcations in a subject or an area). (2) The process by which an organization or institution obtains, verifes, and assesses qualifcations to provide patient-care services. (See also Privileging) Direct patient care: Direct patient care practice involves the pharmacists direct observation of the patient and his/her contributions to the selection, modifcation, and monitoring of patient-specifc drug therapy. This is often accomplished within an interprofessional team or through collaborative practice with another healthcare provider. (American College of Clinical Pharmacy. Vision of the Future: Postgraduate Pharmacy Residency Training as a Prerequisite for Direct Patient Care Practice. Pharmacotherapy. 2006;26(5):722-733.)
www.japha.org M a r /a p r 2010 50:2
JAPhA e62
3/17/10 9:41 AM
FEATURE
Enteral administration: Administration that involves any part of the alimentary canal. (See also Parenteral) Fellowship: A directed, highly individualized postgraduate program designed to prepare a pharmacist to become an independent researcher. Formulary: A continually updated list of medications, related products, and information representing the clinical judgment of physicians, pharmacists, and other experts in the diagnosis and/or treatment of disease and promotion of health. Also referred to as a Preferred Drug List. Formulary management: An integrated process of medication selection that enables physicians, pharmacists, and other healthcare professionals to work together to promote clinically sound, effcacious, safe, and cost-effective patient care. Formulary management provides the healthcare system with a rational, evidence-based process for evaluating and selecting from available medications those considered most useful in patient care. Generalist: A practitioner who provides continuing, comprehensive, and coordinated care to a population regardless of age, gender, disease state, drug treatment category, or organ system. (Adapted from Schwinghammer TL. Defning the Generalist Pharmacy Practitioner. AJPE. 2004;68(3) Article 76.) Health Management Organization (HMO): A form of health insurance in which its members prepay a premium for the HMOs health services, which generally include inpatient and ambulatory care. For the patient, it means reduced out-of-pocket costs (eg, no deductible), reduced paperwork (eg, insurance forms), and only a small co-payment for each offce visit. (Adapted from Academy of Managed Care Pharmacy Glossary of Managed Care Terms available at www. amcp.org.) Health Plan: A form of health insurance in which its members prepay a premium for health services, which generally include inpatient and ambulatory care. Interdisciplinary: An interdisciplinary team includes members from different professions and occupations that work together closely and communicate frequently to optimize care for the patient. In addition to the term interdisciplinary, the literature refers to multidisciplinary and interprofessional. Multidisciplinary education and practice often is described as disciplines working in parallel, frequently with diverse goals. While the term interdisciplinary is arguably the most common in the literature, the term interprofessional is gaining currency, perhaps because medicine often uses interdisciplinary to describe collaboration between medical specialties. (Greiner A. Educating Professionals in Teams: Current Reality, Barriers, and Related Actions. Presentation. Institute of Medicine. http://www.iom. edu/?id=10487; Accessed November 5, 2008.) Interprofessional: Involving members of different healthcare professions. (See also Interdisciplinary.) License: A credential issued by a state or federal body that indicates that the holder is in compliance with minimum mandatory governmental requirements necessary to prace63 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
tice in a particular profession or occupation. Licensure: The process of granting a license. Managed Health Care: The sector of health insurance in which administrative health care organizations, or managed care organizations, manage the allocation of health care benefts. In contrast with conventional indemnity insurers, which do not govern the provision of medical services and simply pay for them, managed care organizations have a signifcant role in how the services are administered so that they may better control health care costs. Health maintenance organizations (HMOs) and preferred provider organizations (PPOs) are examples of managed care organizations. (Adapted from Academy of Managed Care Pharmacy Glossary of Managed Care Terms available at www.amcp. org.) Managed Care Organization (MCO): A generic term applied to a managed care plan; includes a health maintenance organization (HMO), preferred provider organization (PPO), exclusive provider organization (EPO), health plan, or prescription beneft management company (PBM), although the MCO may not conform exactly to any of these formats. (Adapted from Academy of Managed Care Pharmacy Glossary of Managed Care Terms available at www.amcp. org.) Medication therapy management: Medication therapy management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services are independent of, but can occur in conjunction with, the provision of a medication product. Parenteral: Administration by injection, eg, intravenous, intramuscular, or subcutaneous. (See also Enteral). Pharmacist: A person licensed to engage in the practice of pharmacy. Pharmacy [Practice of]: The interpretation, evaluation, and implementation of medical orders; the dispensing of prescription drug orders; participation in drug and device selection; drug administration; drug regimen review; the practice of telepharmacy within and across state lines; drug or drug-related research; the provision of patient counseling; the provision of those acts or services necessary to provide pharmacist care in all areas of patient care, including primary care and collaborative pharmacy practice; and the responsibility for compounding and labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and devices), proper and safe storage of drugs and devices, and maintenance of required records. The practice of pharmacy also includes continually optimizing patient safety and quality of services through effective use of emerging technologies and competency-based training. (NABP Model Act and Model Rules) Pharmacy Beneft Management Company (PBM): An organization that manages pharmaceutical benefts for managed care organizations, other medical providers, or employers.
Journal of the American Pharmacists Association
3/17/10 9:41 AM
Pharmacy Technician: An individual who, under the supervision of a licensed pharmacist, assists in pharmacy activities not requiring the professional judgment of the pharmacist. Preceptor: A practitioner who gives personal instruction, training, and supervision to a student or trainee in his or her practice or other places of work. Privileging: The process by which a healthcare organization, having reviewed an individual healthcare providers credentials and performance and found them satisfactory, authorizes that individual to perform a specifc scope of patient-care services within that organization. Registered: Adjective used to describe a pharmacist or pharmacy technician who has met state requirements for licensure or registration and whose name has been entered on a state registry of practitioners who are licensed or registered to practice in that jurisdiction. Residency: An organized, directed, postgraduate training program in a defned area of pharmacy practice. PGY1 Residency: Postgraduate year one of pharmacy residency training is an organized, directed, accredited program that builds upon knowledge, skills, attitudes, and abilities gained from an accredited professional pharmacy degree program. The frst-year residency program enhances general competencies in managing medication-use systems and supports optimal medication therapy outcomes for patients with a broad range of disease states. PGY2 Residency: Postgraduate year two of pharmacy residency training is an organized, directed, accredited program that builds upon the competencies established in postgraduate year one of residency training. The secondyear residency program is focused in a specifc area of practice. The PGY2 program increases the residents depth of knowledge, skills, attitudes, and abilities to raise the residents level of expertise in medication therapy management and clinical leadership in the area of focus. In those practice areas where board certifcation exists, graduates are prepared to pursue such certifcation. Scope of Practice: The boundaries within which a health professional may practice. For pharmacists, the scope of practice is generally established by the board or agency that regulates the profession in a given state or organization. Specialist: (1) A practitioner whose practice is limited to a particular class of patients (eg, children) or diseases (eg, infectious diseases, oncology, cardiology). (2) A practitioner who is qualifed by advanced training and certifcation by a specialty examining board to so limit his or her practice. Specialty: A recognized branch of a profession in which one specializes. Statement of Continuing Education Credit: A document issued to an individual upon completion of a continuing education program provided by an organization accredited by the Accreditation Council for Pharmacy Education. Traineeship: A short, intensive, clinical and didactic
Journal of the American Pharmacists Association
postgraduate educational program intended to provide the pharmacist with knowledge and skills needed to provide a high level of care to patients with specifc diseases or conditions. Acknowledgments This resource paper draws extensively from a document commissioned by CCP and prepared by the University at Buffalo, School of Pharmacy and Pharmaceutical Sciences. Recognition for early iterations of the commissioned document is given to: Edward Bednarczyk, PharmD Tammie Lee Demler, PharmD Karl D. Fiebelkorn, RPh, MBA Lee Klevens, PharmD Susan Ksiazek, BS, RPh Robert Wahler, PharmD Recognition for conceptualization of Figures 3, 4, and 5 for the commissioned document is given to: Cindy J. Amabile, PharmD Marc A. Luxemburg, PharmD Recognition for later iterations of the commissioned document is given to: Gene D. Morse, PharmD Nicole Paolini Albanese, PharmD
Council on Credentialing in Pharmacy Founded in 1999, the Council on Credentialing in Pharmacy (CCP) is a coalition of 13 national pharmacy organizations committed to providing leadership, guidance, public information, and coordination for credentialing programs in or relevant to pharmacy. The following organizations are members of CCP: Academy of Managed Care Pharmacy (AMCP) Accreditation Council for Pharmacy Education (ACPE) Commission for Certifcation in Geriatric Pharmacy (CCGP) American Association of Colleges of Pharmacy (AACP) American College of Apothecaries (ACA) American College of Clinical Pharmacy (ACCP) American Pharmacists Association (APhA) American Society of Consultant Pharmacists (ASCP) American Society of Health-System Pharmacists (ASHP) Board of Pharmaceutical Specialties (BPS) Institute for the Certifcation of Pharmacy Technicians (ICPT) National Alliance of State Pharmacy Associations (NASPA) Pharmacy Technician Certifcation Board (PTCB) Pharmacy Technician Educators Council (PTEC) Joint Commission of Pharmacy Practitioners Founded in 1977, the Joint Commission of Pharmacy Practitioners (JCPP) serves as a forum on matters of common interest and concern to national organizations of pharmacy
www.japha.org M a r /a p r 2010 50:2
JAPhA e64
3/17/10 9:41 AM
FEATURE
practitioners and invited liaison members. JCPP also provides a platform to create consensus in the pharmacy profession at the national level. The following organizations are members of JCPP: Academy of Managed Care Pharmacy (AMCP) American College of Apothecaries (ACA) American College of Clinical Pharmacy (ACCP) American Pharmacists Association (APhA) American Society of Consultant Pharmacists (ASCP) American Society of Health-System Pharmacists (ASHP) National Community Pharmacists Association (NCPA) Liaison members Accreditation Council for Pharmacy Education (ACPE) American Association of Colleges of Pharmacy (AACP) National Alliance of State Pharmacy Associations (NASPA) National Association of Boards of Pharmacy (NABP)
cation therapy outcomes. Pharmacy practice in 2015 The Foundations of Pharmacy Practice. Pharmacy education will prepare pharmacists to provide patient-centered and population-based care that optimizes medication therapy; to manage healthcare system resources to improve therapeutic outcomes; and to promote health improvement, wellness, and disease prevention. Pharmacists will develop and maintain: A commitment to care for, and care about, patients An in-depth knowledge of medications and the biomedical, sociobehavioral, and clinical sciences The ability to apply evidence-based therapeutic principles and guidelines, evolving sciences and emerging technologies, and relevant legal, ethical, social, cultural, economic, and professional issues to contemporary pharmacy practice How pharmacists will practice Pharmacists will have the authority and autonomy to manage medication therapy and will be accountable for patients therapeutic outcomes. In doing so, they will communicate and collaborate with patients, care givers, healthcare professionals, and qualifed support personnel. As experts regarding medication use, pharmacists will be responsible for: rational use of medications, including the measurement and assurance of medication therapy outcomes promotion of wellness, health improvement, and disease prevention design and oversight of safe, accurate, and timely medication distribution systems Working cooperatively with practitioners of other disciplines to care for patients, pharmacists will be: The most trusted and accessible source of medications and related devices and supplies The primary resource for unbiased information and advice regarding the safe, appropriate, and cost-effective use of medications Valued patient care providers whom healthcare systems and payers recognize as having responsibility for assuring the desired outcomes of medication use How pharmacy practice will beneft society Pharmacists will achieve public recognition that they are essential to the provision of effective health care by ensuring that: Medication therapy management is readily available to all patients Desired patient outcomes are more frequently achieved Overuse, underuse, and misuse of medications are minimized Medication-related public health goals are more effectively achieved Cost-effectiveness of medication therapy is optimized
Appendix B. Joint Commission of Pharmacy Practitioners: Future Vision of Pharmacy Practice 2015
The organizations of the Joint Commission of Pharmacy Practitioners (JCPP), including seven member pharmacy practitioner groups (Academy of Managed Care Pharmacy, American College of Apothecaries, American College of Clinical Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, National Community Pharmacists Association) and four liaison members (Accreditation Council for Pharmacy Education, American Association of Colleges of Pharmacy, National Association of Boards of Pharmacy, National Council of State Pharmacy Association Executives) have all endorsed the following common vision of the preferred future for pharmacy by the year 2015. The JCPP Future Vision of Pharmacy Practice is a consensus document that articulates a vision for pharmacy and how it will be practiced. Equally important, the document describes how pharmacy practice will beneft society. The document was offcially adopted by the JCPP members executive offcers following the November 2004 JCPP meeting and has subsequently been endorsed by each JCPP members board of directors. The stakeholders group identifed and prioritized the top groups and organizations pharmacy must engage in efforts to work toward the vision of optimized medication use. While pharmacy intends to take leadership roles in improving the use of medications in health and wellness it cannot do so in isolation from the many others involved in the medication use process. Future Vision of Pharmacy Practice Vision Statement Pharmacists will be the healthcare professionals responsible for providing patient care that ensures optimal medie65 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
3/17/10 9:41 AM
Defnition and program criteria Medication Therapy Management is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication Therapy Management Services are independent of, but can occur in conjunction with, the provision of a medication product. Medication Therapy Management encompasses a broad range of professional activities and responsibilities within the licensed pharmacistsor other qualifed healthcare providersscope of practice. These services include but are not limited to the following, according to the individual needs of the patient: Performing or obtaining necessary assessments of the patients health status; Formulating a medication treatment plan; Selecting, initiating, modifying, or administering medication therapy; Monitoring and evaluating the patients response to therapy, including safety and effectiveness; Performing a comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events; Documenting the care delivered and communicating essential information to the patients other primary care providers; Providing verbal education and training designed to enhance patient understanding and appropriate use of his/ her medications; Providing information, support services and resources designed to enhance patient adherence with his/her therapeutic regimens; Coordinating and integrating medication therapy management services within the broader healthcare-management services being provided to the patient. A program that provides coverage for Medication Therapy Management Services shall include: Patient-specifc and individualized services or sets of services provided directly by a pharmacist to the patient*. These services are distinct from formulary development and use, generalized patient education and information activities, and other population-focused quality assurance measures for medication use. Face-to-face interaction between the patient* and the pharmacist as the preferred method of delivery. When patient-specifc barriers to face-to-face communication exist, patients shall have equal access to appropriate alternative delivery methods. Medication Therapy Management programs shall include structures supporting the establishment and maintenance of the patient*pharmacist relationship. Opportunities for pharmacists and other qualifed healthcare providers to identify patients who should receive medication therapy management services. Payment for Medication Therapy Management Services
Journal of the American Pharmacists Association
consistent with contemporary provider payment rates that are based on the time, clinical intensity, and resources required to provide services (eg, Medicare Part A and/or Part B for CPT & RBRVS). Processes to improve continuity of care, outcomes, and outcome measures. Approved July 27, 2004 by the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American College of Apothecaries, the American College of Clinical Pharmacy, the American Society of Consultant Pharmacists, the American Pharmacists Association, the American Society of Health-System Pharmacists, the National Association of Boards of Pharmacy**, the National Association of Chain Drug Stores, the National Community Pharmacists Association and the National Council of State Pharmacy Association Executives.
Narrow Broad
Entry-Level
ai
t Pa ie nt oc -F
Do
C
us
ed
Advanced
Pr a
ct
ic
Sy st em oc -F us ed
Narrow
Figure 1 (top). Scope of pharmacy practice and professional competencies in the U.S. Figure 2 (bottom). Practitioners in direct patient care.
www.japha.org M a r /a p r 2010 50:2
Broad
Generalist practitioner Wide variety oQ patients and diseases; minor ailments to more complex conditions
Focused practitioner Wide variety oQ diseases in a unique setting or population, or a narrow disease Qocus
Entry-Level
Advanced generalist practitioner Wide variety oQ patients and diseases; complex healthcare issues
Advanced focused practitioner Focused patient populations; medically complex patients, therapies, and/or technology
Advanced
JAPhA e66
3/17/10 9:41 AM
FEATURE
*In some situations, Medication Therapy Management Services may be provided to the caregiver or other persons involved in the care of the patient. **Organization policy does not allow NABP to take a position on payment issues.
Appendix D. Authorized activities for clinical pharmacists under a collaborative drug therapy management agreement*
to their practice setting. 2. Incorporate this information in collaborative practice of evidence-based medicine. 3. Provide education to physicians, mid-level providers, nurses and other practitioners in the ambulatory-care setting regarding best prescribing patterns. Participate in developing and evaluating therapeutic management policies in the ambulatory care clinic setting
Direct patient care Conduct direct patient-care activities using a consistent approach that refects the philosophy of primary care and pharmaceutical care. These activities include patient visits to establish therapeutic goals, drug-related physical assessment (eg, blood pressure checks), laboratory assessments, and follow up telephone calls. Design, recommend, monitor, and evaluate patientspecifc therapeutic regimens for primary care patients incorporating the principles of evidence-based medicine. Prescribing and drug-tailoring activities will be at the discretion of the Clinic Medical Director in collaboration with the Pharmacist. 1. Appropriately refer ambulatory-care patients to other healthcare practitioners including nutritionists, nurses, social workers, etc. 2. Provide education for patient self-management of their own health care to primary care patients and their caregivers. 3. Ensure continuity of pharmaceutical care between primary care and other healthcare settings. 4. Document pharmaceutical care activities appropriately in the medical record. 5. Integrate disease prevention and wellness promotion strategies into ones practice. Prescription refll authorization The pharmacist is authorized to manage refll-authorization requests from clinic patients and community pharmacies. In rendering refll-authorization decisions, the pharmacist will review the patient chart to assure that the decision and directions given to the requesting pharmacy is consistent with the treatment plan and therapeutic intent of the prescriber as documented in the chart. The pharmacist will also assess the appropriateness of the refll based on time since last clinic visit or time since specifc procedure or test completed (INR, TSH, blood pressure, serum potassium, etc.). If specifc information is absent (absence of data in the progress notes or lab sheet), a decision based upon professional judgment will be made and/or the physician will be consulted. Chart documentation will accompany these decisions. Depending upon the clinical circumstances, the pharmacist may elect to authorize the refll, deny the refll, or authorize only a limited quantity pending a clinic visit. Participate in drug information and drug policy development 1. Maintain a working knowledge of literature as it applies
e67 JAPhA 50 : 2 M a r /a p r 2010
www.japha.org
Narrow
Legend: PGY1 = Post Graduate Year One (Residency), PGY2 = Post Graduate Year Two (Residency)
Legend: BCADM = Board CertifedAdvanced Diabetes Management, BCNP = Board Certifed Nuclear Pharmacist, BCNSP = Board Certifed Nutrition Support Pharmacist, BCOP = Board Certifed Oncology Pharmacist, BCPP = Board Certifed Psychiatric Pharmacist, BCPS = Board Certifed Pharmacotherapy Specialist, CDE = Certifed Diabetes Educator, CDM = Certifed Disease Manager, CGP = Certifed Geriatric Pharmacist Journal of the American Pharmacists Association
Broad
A
Continuing education activities
B
PGY1
Certifcate training programs Continuing education activities
Entry-Level
Traineeships
PGY2
Advanced
Narrow
Broad
CDM
B
CDE BCADM
Entry-Level
CGP
BCPS
Advanced
3/17/10 9:41 AM
1. Development or modifcation of policies for the therapeutic management of patients in the ambulatory-care setting. 2. Participate in interdisciplinary performance improvement programs in the ambulatory-care environment. 3. Provide instruction to pharmacy technicians, pharmacy students, pharmacy residents, and other pharmacists. 4. Perform prospective and retrospective fnancial and clinical outcomes analyses and report these to the Board of Pharmacy on a quarterly basis. (*Harborview Medical Center, Seattle, WA; August 2007; used with permission)
the terms used to describe pharmacists in each of the quadrants are more descriptors than terms used in practice. A brief description of the patient population typically served by such pharmacists in each of the quadrants is provided. Figure 2 illustrates where and how a pharmacist after graduating from a professional degree program and obtaining a license enters the workforce and how he/she initially fts into the overall framework of professional practice in the direct patient care domain. After graduation, a majority of pharmacists practice as a Generalist Practitioner (Quadrant A). Generalist practitioners initially have entry-level knowledge, skills, and experiences while at the same time their breadth of patient focus is broad, refecting their comprehensive professional education. With further practice experience and exposure to a larger cohort of patients and medical conditions, a pharmacists breadth of patient or practice focus may expand, but certainly his/her level of knowledge and skills will advance, supported (at a minimum) by continuing education activities. Quadrant A describes the patient population as a wide variety of patients and diseases; minor ailments to more complex conditions. In society, this represents the most populous patient group and this is where most pharmacists are neededand chooseto practice. This quadrant refects the practice of most community and hospital pharmacists. Pharmacists, who make a conscious decision to develop their professional careers in a specifc way, will move into one of the other quadrantsB, C, or D. Such a conscious decision usually involves additional education, training, or credentialing, although specifc practice experience and on-the-job training can achieve a comparable practice focus and level of knowledge and skills. Pharmacists who elect to narrow their patient or practice focus (eg, in diabetes or geriatrics) will move into Quadrant B; they are described in the framework as Focused Practitioners. Their practice could be summarized as wide variety of diseases in unique setting or population, or narrow disease focus. An example of a pharmacist in this quadrant would be a pharmacist who focuses on geriatric care. Pharmacists who elect to maintain a broad base of patients and diseases but who wish to substantially advance their level of knowledge, skills, and experience will move into Quadrant C. They can be described as Advanced Generalist Practitioners and the framework summarizes their practice as wide variety of patients and diseases; complex healthcare issues. An example of a pharmacist in this quadrant would be a pharmacotherapy specialist. Pharmacists in Quadrant D have both narrowed their patient/practice focus and substantially advanced their knowledge and skills. An example of an Advanced Focused Practitioner would be a Board Certifed Oncology Pharmacist (BCOP), one of the recognized specialty credentials in the pharmacy profession. Figure 6 depicts the range of post-licensure education and training activities pharmacists engage in to maintain their professional competencies and to support their conwww.japha.org M a r /a p r 2010 50:2
JAPhA e68
3/17/10 9:41 AM
FEATURE
tinuing professional development. The most pervasive are continuing education (CE) activities which, in the majority of cases, are offered by ACPE-accredited providers of continuing pharmacy education. CE activities, appropriate to their practice, are offered to pharmacists in all four quadrants. Certifcate Programs, which focus on the development of professional skills and their application in practice, would typically be undertaken by pharmacists in Quadrants A and B. From a patient/practice perspective, such programs may be broad or more focused. Traineeships, on the other hand, are more focused and would typically be undertaken by pharmacists with a narrower patient/practice focus (Quadrant B). Post-Graduate Year One (PGY1) pharmacy residencies provide training for generalists in hospitals, health systems, managed care, or community settings, hence their depiction in Quadrant A in Figure 6. PGY1 residencies provide pharmacists with the opportunity to advance their knowledge, skills, and experience in an accelerated timeframe through
a structured, practice-based training program. Most pharmacists who undertake a PGY1 residency do so in their frst year after graduating. Post-Graduate Year Two (PGY2) residencies provide advanced training in a focused area of patient care. Residencies are typically one to two years in length and a PGY1 residency must be completed before going on to a PGY2 residency. Figure 7 depicts post-licensure certifcations and where they would typically apply to pharmacists in narrowly focused and/or advanced areas of practice. Detailed descriptions of these credentials have already been provided in CCPs resource document Credentialing in Pharmacy. As noted earlier, many pharmacists in the areas of practice represented by Quadrants B, C and D would have one or more of the certifcations shown in Figure 7, but other pharmacists in these areas of practice would have comparable focus, knowledge, skills, and experience, and may have other credentials not included here.
www.japha.org
3/17/10 9:41 AM