The Legislative Declaration of the Pharmacist's Societal Role
Pharmacists' roles within health care have evolved significantly over the past hundred years. In the earliest decades of the 20th century, the pharmacist's primary responsibilities were to prepare reliable medications and distribute them to patients. Pharmacists during that time period also often maintained neighborhood pharmacies and served as a trusted source of health care advice for the residents of those communities. During the middle of the 20th century, pharmaceutical preparation largely shifted from local retail stores' compounding operations to large-scale industrial production facilities. Consequently, the pharmacist did less compounding and more distribution of prepared medications.
When hospital pharmacy practice began to evolve during the first quarter of the 20th century, pharmacists were involved in distributing drugs within the hospital, but they did not participate significantly in direct patient care. Beginning in the 1960s, some pharmacists moved into clinical roles, especially in hospital settings, and began to interact with physicians, nurses, and patients. They provided drug information, monitored drug therapy for specific patients, and, in some cases, adjusted doses based on pharmacokinetic data.[29] The 1970s and the decades since have seen the focus of the hospital pharmacist move away from the safe keeping and distribution of drugs toward counseling patients about their prescription drugs and how to best use them.
Over the past 15 years, the practice in community settings has also evolved toward a more direct patient care model; but at this writing, this shift of focus is far from complete. In 1990, Hepler and Strand[30] defined pharmaceutical care as assuming responsibility for the prevention, identification, and resolution of drug therapy problems and recommended its adoption as the basic definition of the practice of pharmacy. While pharmacists have maintained responsibility for the safe preparation and distribution of medications, the pharmaceutical care definition of pharmacy practice has moved the pharmacist's role into the domain of collaborative direct patient care, with that domain's incumbent responsibilities for assessing patients' status, developing and implementing a therapeutic plan, documentation and follow-up of outcomes, and assuming responsibility for those outcomes.
The adoption of this definition of pharmacy practice by professional pharmacy membership associations and the American Council for Pharmaceutical Education (the accrediting body for colleges and schools of pharmacy, now called the Accreditation Council for Pharmaceutical Education [ACPE]) and the American Association of Colleges of Pharmacy (AACP), dramatically changed the education of pharmacists, culminating in the affirmation by ACPE in 2000 of the doctor of pharmacy as the sole entry-level degree for pharmacists.
As the practice has evolved, the legislative declaration of the scope of practice of pharmacy has also evolved through a combination of federal and state legislative actions. A survey of 51 state pharmacy practice acts was conducted in 1988[31] and followed up in 1992[32] and 1998.[33]
In 1988, 20% of state statutes contained no definition of pharmacy practice.[31] In the remaining 41 states, dispensing was legally defined in 97.5% of states, compounding in 92.5%, interpretation and evaluation of prescriptions in 68.2%, and consultation in 73%. Pharmacokinetic consultation, drug administration, pharmacist prescribing, and pharmaceutical research were defined in one, seven, four, and one state(s), respectively. During the following decade, state pharmacy practice acts increased the codification of pharmaceutical care services as integral pharmacy functions. However, a number of states had not yet incorporated definitions of pharmaceutical care functions into their statutes, and four states still provided no statutory definition of the practice of pharmacy.
By 1998, states had codified the various pharmaceutical services as follows: interpreting and evaluating prescriptions appeared in 39 of 47 practice acts; compounding, in all 47; dispensing, in all 47; consultation, in 41; drug administration, in 24; drug product selection, in 45; drug-use review, in 35; patient assessment, in 6; pharmacokinetic services, in 3; pharmacist prescribing under protocol, in 15; and participation in drug research, in 10.[33]
On the federal level, the passage of the Omnibus Reconciliation Act of 1990 required pharmacist review of patients' prescriptions and counseling of the patient as an integral component of the role of a pharmacist. Prospective drug-use review was mandated as a condition of participation in the federally cofunded, but state-administered, Medicaid programs. Prospective drug-use review requires that the Medicaid state plan establish a point-of-sale review of each prescription before it is dispensed and that potential problems such as therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dosage or duration of treatment, and drug-allergy interactions should be discovered, resolved, and communicated to the patient. Unfortunately, this mandate was unfunded except in a few states, and implementation varied from state to state and site to site.
In the meantime, National Association of Boards of Pharmacy (NABP) developed (and continues to update) a Model State Pharmacy Act and Model Rules to guide states that desire to expand their pharmacy practice acts to keep up with the evolution of the practice of pharmacy. The current Model State Pharmacy Act defines the practice of pharmacy as follows[34]:
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 Reviews; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling and the provision of those acts or services necessary to provide Pharmaceutical 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 Non- Prescription Drugs and commercially packaged Legend Drugs and Devices), proper and safe storage of Drugs and Devices, and maintenance of proper records for them.
The greatest strides during recent years in expanding the role of the pharmacist in state statutes have been in the area of collaborative pharmacy practice. As of October 2005, 41 states have granted pharmacists the authority to enter into voluntary collaborative practice agreements with physicians, and in some cases with other providers, to perform a variety of patient care functions under certain specified conditions and limitations. The increasing willingness of states to authorize collaborative practice agreements has been bolstered by studies that have demonstrated the value of such relationships in the care of patients. For example, the city of Asheville, North Carolina, contracted pharmacists to provide diabetes management for city employees, resulting in significant improvement in the quality of life and ability to function and decreased total health care costs by $2000 per enrollee.[35]
Collaborative practice agreements have covered a variety of patient service areas. The services most used include anticoagulation monitoring and dosage adjustment, pain management, emergency contraception, and disease-state management of asthma, diabetes, and hyperlipidemia.[36] In some cases, the agreements have centered on pharmaceutical care that provides review and management of all of the patients' medications, especially for patients with multiple diseases and multiple medications.[37] In any case, with collaborative drug therapy management, the pharmacist shifts from simply dispensing what physicians prescribe to working with them to design and carry out patient care related to medications.
Reimbursement for services provided under collaborative practice arrangements has been limited in the past. Some states (e.g., Mississippi, Wisconsin, Iowa) have provided for payment under their Medicaid reimbursement schemes, but, in other states, pharmacy practitioners depend on Medicare-regulated "incident to" reimbursement rules. "Incident to" billing is issued for pharmacist interventions that occur "incident to" (i.e., in relation to, as a consequence of) a visit to a physician. It requires that the pharmacist be on-site with the physician. Under this system, pharmacist services are reimbursed at a much lower rate than for an independent physician visit.
The recent passage of the MMA should help ease some of the difficulties with reimbursement and is expected to further expand the patient care role of pharmacists. Part D of the MMA provides for reimbursement of MTM, including direct patient care provided by a pharmacist, to be included in the prescription drug plans that will be purchased by patients as they access the prescription drug benefit of the MMA, starting in January 2006. It is widely expected that the anticipated improved outcomes of drug therapy for Medicare patients through the provision of MTM will influence other payers to follow suit and begin reimbursing for MTM services. In preparation for MTM reimbursement, CMS recently approved a set of Current Procedural Terminology billing codes for a variety of pharmaceutical services.[38]
Despite the federal legislative advance of the MMA, Part D, pharmacists are not yet recognized as providers under Part B of the act. In an effort to secure such recognition, a group of pharmacy professional organizations organized the Pharmacist Provider Coalition in 2002, with the stated goal of achieving recognition and payment for pharmacist services under Part B of the Medicare program. While bills have been introduced into Congress to accomplish this objective (e.g., the Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2004 [H.R. 4724], sponsored by Representative Richard Burr of North Carolina), none have been passed, and this remains an elusive goal. With the enactment of a provider bill, CMS would set payment mechanisms so that pharmacists are less affected by the potential narrow scope of coverage provided by prescription drug benefit plans.
The specific roles fulfilled by a particular pharmacist will vary widely across health care settings and geographic locales. In some hospital settings and some community pharmacy settings, especially busy chain outlets, pharmacists are pre-dominantly engaged in distributive functions, having minimal direct engagement with patients. They do ensure the accuracy of order fulfillment, review prescriptions for drug interactions and blatant errors in drug selection and dosage, solve problems related to payment for the medications, and provide answers to patients' and other health care providers' questions; but very little of this work involves direct contact between pharmacist and patient, nor is it reimbursed beyond the markup on any product cost or a small dispensing fee.
At the other extreme are pharmacists in clinics and many hospital settings, who play very little, if any, role in dispensing but spend their time providing medication management in direct interaction with patients and other health care providers. Many progressive health care organizations have some combination of these activities, with some pharmacists performing disease-state management, MTM, and drug dispensing functions. Some pharmacists have pursued board certification for their particular practice specialties.
Geography can significantly affect the nature of a pharmacist's work. The breadth of a pharmacist's services, and his or her visibility and stature in the community, sometimes seem to correlate inversely to the availability of other health providers in or near that community. Particularly in rural settings, a single pharmacist may provide pharmaceutical services in a community pharmacy, to the town's long-term-care facility, and to a colocated small rural hospital. Patients and providers are likely to turn to the local pharmacist as an alternative to driving long distances to neighboring communities for the products and services they need.
Communities have a strong desire to retain their pharmacists, because these individuals provide well- regarded health advice, triage health problems, and make available prescription drugs and nonprescription items. They may also serve either formally or informally as health educators, thereby improving the community's public health. Rural pharmacists are often also key professional leaders and economic contributors in the community. However, decreasing reimbursement for dispensing services, combined with competition from mail prescription pharmacies, increasingly threatens the economic survival of many rural pharmacies. In response, states and individuals have looked to implement creative models of practice that will make the retention of the pharmacist in the community economically feasible.[39] Similar situations are also seen in underserved urban neighborhoods, and the Health Resources and Services Administration has been working on programs to help expand pharmacy services to these communities.[40]
Not all pharmacists are engaged in direct patient care roles. The profession has encountered a significant demand for doctor of pharmacy graduates outside of traditional hospital or community pharmacy settings. Pharmacists are found in a wide variety of health-related disciplines, including pharmacy benefit management companies, the pharmaceutical industry, state and federal government regulatory agencies, and educational institutions.
About 20% of pharmacy graduates nationally seek additional postgraduate education in a variety of fields (e.g., residencies and fellowships, master of business administration, doctor of law, master of public health, doctor of philosophy), the majority of them seeking one-year residency training positions. Residency-trained practitioners are the ones most likely to advance the direct patient care roles of pharmacists, although residency training is not required for the provision of direct patient care in generalist roles. Several reports have recommended that policymakers should facilitate the wider implementation of residency programs.[41,42] With the exception of residency graduates, most of the individuals who complete advanced education do not end up in direct patient care roles.
State and federal legislation and regulations have made important strides in articulating and affirming the expanding responsibilities of pharmacists, particularly in the area of collaborative therapy management. However, the expansion of pharmacy-related policy has been inconsistent from state to state. Pharmacists have improved patient outcomes and reduced costs in states that have allowed them to closely manage patients' treatment. The attainment of provider status for pharmacists under Medicare is an essential enabler for health organizations that employ them and for payers to reap the therapeutic and economic benefits of engaging pharmacists more directly in patient care.
Am J Health Syst Pharm. 2007;64(12):e30-e48. © 2007 American Society of Health-System Pharmacists
Cite this: Pharmacists, Pharmaceuticals, and Policy Issues Shaping the Work Force in Pharmacy - Medscape - Jun 01, 2007.
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