Empowering Public Health Pharmacy Practice—Moving from Collaborative Practice Agreements to Provider Status in the U.S.

1 Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, 301 S. Perimeter Park Dr., Suite 220, Nashville, TN 37211, USA; ude.cshtu@esanreca (A.C.); ude.cshtu@46letapk (K.P.)

Meghana Aruru

2 Health Analytics Network, LLC, Pittsburgh, PA 15237, USA

Suzanne Clark

3 Center for Teaching and Learning, California Northstate University College of Pharmacy, 9700 West Taron Drive, Elk Grove, CA 95757, USA; ude.usnc@kralc.ennazus

Komal Patel

1 Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, 301 S. Perimeter Park Dr., Suite 220, Nashville, TN 37211, USA; ude.cshtu@esanreca (A.C.); ude.cshtu@46letapk (K.P.)

Natalie DiPietro Mager

4 Department of Pharmacy Practice, Ohio Northern University College of Pharmacy, 525 S Main St, Ada, OH 45810, USA; ude.uno@orteipid-n

Vaiyapuri Subramaniam

5 Washington Metropolitan Society of Health-System Pharmacists, 11160 Veirs Mill Road Suite LLH-18, Box 332, Silver Spring, MD 20902, USA; moc.liamg@sirupv

Hoai-An Truong

1 Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, 301 S. Perimeter Park Dr., Suite 220, Nashville, TN 37211, USA; ude.cshtu@esanreca (A.C.); ude.cshtu@46letapk (K.P.)

3 Center for Teaching and Learning, California Northstate University College of Pharmacy, 9700 West Taron Drive, Elk Grove, CA 95757, USA; ude.usnc@kralc.ennazus

4 Department of Pharmacy Practice, Ohio Northern University College of Pharmacy, 525 S Main St, Ada, OH 45810, USA; ude.uno@orteipid-n

5 Washington Metropolitan Society of Health-System Pharmacists, 11160 Veirs Mill Road Suite LLH-18, Box 332, Silver Spring, MD 20902, USA; moc.liamg@sirupv

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

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Abstract

This article describes the history and evolution of pharmacist-physician collaborative practice agreements (CPAs) in the United States with future directions to support pharmacists’ provider status as the profession continues to evolve from product-oriented to patient-centered care and population health. The pharmacy profession has a long history of dispensing and compounding, with the addition of clinical roles in the late 20th century. These clinical roles have continued to expand into diverse arenas such as communicable and non-communicable diseases, antimicrobial stewardship, emergency preparedness and response, public health education and health promotion, and critical and emergency care. Pharmacists continue to serve as integral members of interprofessional and interdisciplinary healthcare teams. In this context, CPAs allow pharmacists to expand their roles in patient care and may be considered as a step towards securing provider status. Moving beyond CPAs to a provider status would enable pharmacists to be reimbursed for cognitive services and promote integrated public health delivery models.

1. History and Development of Collaborative Practice Agreements (CPAs)

The profession of pharmacy has a long history of dispensing and compounding with an increasing emphasis on clinical services in the late 20th century. Pharmacy as a clinical profession expanded its role in public health through regulatory, licensure, and cultural changes, including the development of collaborative practice agreements (CPAs) in the late 20th and early 21st centuries.

In the past, pharmacists in the United States (US) often provided a range of compounding, medicinal advice, and other services, based on their knowledge of pharmacognosy and use of natural products to compound medicinal products. Also, during the 19th and early 20th centuries, some physicians were selling medicines directly to patients, which put physicians in competition with apothecaries, druggists, chemists, and pharmacists. With the development of the pharmaceutical industry and the production of drugs, a narrower vision of the profession arose after the Second World War [1]. This led to a post-war phase of constriction of professional roles more limited to “count and pour” services. The Durham-Humphrey Amendment of 1951 and the Federal Food, Drug, and Cosmetic (FDC) Act of 1983 led to the legal separation of prescribing (physicians) and dispensing (pharmacists). Prescription drugs were differentiated from non-prescription or over-the-counter drugs; it also became illegal for pharmacists to refill medications without authorization by a physician [2,3].

During this same time, the American Pharmaceutical Association (now the American Pharmacists Association or APhA) developed a Code of Ethics in 1952 that stated pharmacists were not allowed to discuss the therapeutic effects or composition of a prescription with a patient—that role was reserved for the prescriber (physician or dentist) [1,2]. This resulted in a period of time during which a customer could leave a pharmacy with a prescription bottle, but the label may not have included the name of the drug, nor would the pharmacist be allowed to discuss with the patient the contents or intended use of the prescription. Instead, the patient would be referred back to the physician or other prescriber for answers to their questions. Similarly, during this time, pharmacists were employed in hospitals, but their duties were narrowly focused on products—dispensing, compounding, and formulary development.

Soon after this period, pharmacists’ roles were expanding in selected areas. In the 1960s, pharmacists in the Indian Health Service (IHS) began assuming an active role in drug therapy management. The IHS is the part of the United States Public Health Service (USPHS) that focuses on service in Native American and tribal populations throughout the contiguous US and its owned territories [4]. The first Collaborative Practice Agreement (CPA) was developed by the IHS under a grant from the National Center for Health Services Research in 1973. Specially trained pharmacists provided drug therapy management services in collaboration with physicians. A 1-year evaluation found that physicians judged the quality of care of this program to be satisfactory and patient acceptance was excellent [5]. Since the 1970s, many CPAs have been initiated in the US and a recent review evaluated the characteristics of CPAs across the US [6]. As of 2016, there were 50 states with active CPAs. CPAs vary by state with respect to pharmacist-initiated prescribing activities; there is little uniformity between states regarding pharmacists’ ability to commence, modify, monitor, and discontinue medication therapies, along with heterogeneity in their ability to order laboratory tests [6].

Also in the mid-1950s, US pharmacists embraced patient care roles that provided opportunities in subsequent decades for the profession to shift from dispensing to a more clinically driven practice [7]. The term ‘clinical pharmacy’ reflects the notion that the duties of a ‘regular’ pharmacist were restricted to “count and pour”. In other words, the pharmacist was viewed as a profession that existed outside the healthcare system and as a provider of medications prescribed and communicated by physicians. However, this limited view of the profession was never the norm, and pharmacists have provided clinical services such as patient education, communication, and therapeutic guidance throughout the history of the profession. Higby, (2002) traced the evolution of the modern concept of clinical pharmacy to the 1960s, during which both pharmacists and various institutions were instrumental in moving the profession towards clinical practice [1].

Subsequent regulations, including the federal Omnibus Budget Reconciliation Act of 1990 (OBRA-90), addressed pharmacy services in federally funded and state-managed Medicaid programs [8]. In the US, Medicaid is a joint federal and state program for low-income individuals and families. Most Medicaid enrollees lack access to other affordable forms of health insurance. The program is governed by Title XIX of the Social Security Act and a large body of federal regulations, which define federal Medicaid requirements, state options, and authorities. The Centers for Medicare and Medicaid Services (CMS) within the Department of Health and Human Services (HHS) is responsible for implementing laws governing Medicaid. The CMS recognized that proper drug use was in the best interest of Medicaid recipients, and that pharmacists could play a role in improving drug use through review of medications and prescription counseling. Thus, the OBRA-90, which took effect in 1993, required pharmacists to conduct prospective drug use review (PDUR) of Medicaid prescriptions, and to ‘offer’ to discuss medications with patients at the point-of-sale. This Act helped codify pharmacy services in integral federal health programs.

Pharmacists’ foray into clinical roles led to an urgent need to enhance the training of future pharmacists. As a result, the Doctor of Pharmacy (Pharm.D.) degree was created and designed to parallel to the Doctor of Medicine and other clinical Doctoral degrees [9]. The first Pharm.D. programs were initiated in the 1950s; more programs were developed over recent decades [10]. In the US, Pharm.D. programs are accredited by the Accreditation Council for Pharmacy Education (ACPE).

By the 2000s, all US pharmacy schools and colleges had adopted the Pharm.D. as the universal standard for pharmacy education. Accordingly, the Bachelor of Pharmacy (PharmBS) degree as the professional degree for pharmacy in the US was phased out. In addition, accelerated Pharm.D. programs were developed to allow students to graduate with three years of professional training, following completion of undergraduate prerequisite courses. PharmBS graduates prior to the advent of Pharm.D. degrees were grandfathered in as licensed (registered) pharmacists and use Registered Pharmacist or RPh to denote their status. Pharm.D. and PharmBS pharmacists must comply fully with US Federal and State pharmacy laws. For example, continuing education training (CE hours) is a requirement for maintaining licensure for both PharmBS and Pharm.D. pharmacists [11]. Expansion of clinical roles brought further regulatory and practice opportunities, as exemplified by the development of Pharmaceutical Care and the Medicare Modernization Act of 2005.

In the early 2000s, the US Senate and House of Representatives passed legislation that recognized pharmacists as healthcare providers for Medicare patients at the national level [12]. This has helped advance the pharmacy profession towards greater integration into healthcare teams. Healthcare costs continue to rise in the US and in 2019, healthcare spending grew by 4.6%, reaching $3.8 trillion or $11,582 per person [13]. There is an urgent need to mitigate costly care and simultaneously improve the quality of care.

Pharmacists are well-positioned to provide cost-effective care and effect medication adherence that has a direct impact on patient outcomes. As an example, the Asheville Project, a quasi-experimental, longitudinal pre-post cohort study launched in 1997 in 12 community pharmacies in Asheville, North Carolina led to improved adherence, reduced adverse events, and ultimately decreased overall healthcare costs) [14,15].

2. Pharmaceutical Care and Medication Therapy Management (MTM)

During the 1990s, the emergence of “pharmaceutical care” provided the terminology to capture complex concepts of clinical care provision by pharmacists and is highly relevant even today. Pharmaceutical care was defined by Hepler and Strand as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life” [16]. The core tenet of pharmaceutical care is to maximize a patient’s therapeutic outcomes by utilizing pharmacists’ skills and knowledge [17,18]. In the past three decades, this concept has gained acceptance and has been implemented in many countries [19,20].

Pharmaceutical care has been presented in the last two decades as a model for pharmacists to develop a therapeutic plan that yields enhanced patient outcomes [17]. To ensure that pharmaceutical care goals are achieved, and mitigate medication-related issues, pharmacists collaborate closely with the healthcare team. To date, the pharmaceutical care model used in different US healthcare systems is composed of a range of pharmacists’ services that contribute directly to patient outcomes [21]. Further, the scope of pharmacy practice is increasingly integrated into team-based care and is responsible for medication management [12].

With the advent of the Medicare Modernization Act (MMA) of 2003, prescription medications for the Medicare program (care for the elderly and disabled) which were previously not covered would now be reimbursed under Medicare Part D. (Parts A, B and C covered hospital, inpatient, and managed care services). This change was largely brought about due to the changing US demographics, with an increase in the senior population and the need to ensure that this population had coverage through the federal Medicare program to access needed prescription medications.

In recognition of the fact that medication monitoring in this population was crucial to avoid therapeutic duplications, minimize adverse events, and improve medication adherence, the term Medication Therapy Management (MTM) was coined. MTM is defined as “…distinct service or group of services that optimize therapeutic outcomes for individual patients.” MTM can be provided by pharmacists, or another qualified healthcare provider’s scope of practice, independently or together with a medication product [22]. In addition to the MTM consensus definition by 11 professional pharmacy organizations in 2005, the APhA and the National Association of Chain Drug Stores (NACDS) collaborated to develop a MTM Core Elements Service Model that include five core elements: