Alex J. Adams

The Mandatory Residency Dilemma: Parallels to Historical Transitions in Pharmacy Education

Objective: To review recent literature regarding mandatory residencies in the perspective of the historical entry-level degree debate. Data Sources: Articles were identified through searches of MEDLINE/PubMed, national pharmacy association Web sites, and a review of the references of related literature. Study Selection and Data Extraction: Several studies, commentaries, and reviews are examined to discuss viewpoints from both the entry-level degree and mandatory residency debates. Similarities were observed between the 2 debates in regard to objectives and rationale for change, educational issues, pharmaceutical care issues, and economic issues. Data Synthesis: Fewer than 10 years ago, after many years of debate, colleges of pharmacy made the transition to offering the PharmD degree as the sole entry-level degree for licensure as a pharmacist. Similar debates have taken place over the past several years and continue to take place regarding the necessity for residency training. One key 2006 document by the American College of Clinical Pharmacy calls for mandatory residency training for entry into pharmacy practice by 2020. Conclusions: In parallel with the entry-level degree debate, consensus has yet to be reached among pharmacists and pharmacy organizations, but several have shown support for mandatory residency training for all pharmacists involved in direct patient care. Many questions have yet to be answered regarding the timeline, economics, and feasibility of such a mandate.

U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing

BACKGROUND The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Community pharmacies are among the most accessible health professionals, and they are increasingly offering CLIA-waived tests. This manuscript aims to determine: 1) the current number of pharmacies in the United States with CLIA-waivers; 2) the uptake of CLIA-waivers by different pharmacy store types; and 3) the state-by-state differences in the percentage of pharmacies with a CLIA-waiver. METHODS Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015. The website allows for exportation of demographic data on all CLIA-waived facilities by state. RESULTS Pharmacies are currently the fourth highest-ranking facility of CLIA-waived laboratories with 10,838 locations. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver (43.16%). States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a median percentage of 19.56% (0%-60.00% range). CONCLUSIONS Community pharmacies are currently a leading facility for CLIA-waived laboratories. Substantial state-level variation is observed in the percentage of pharmacies with CLIA-waivers, and these differences may be driven by restrictions in state law or regulations.

The Continuum of Pharmacist Prescriptive Authority.

Recently momentum has been building behind pharmacist prescriptive authority for certain products such as oral contraceptives or naloxone. To some, prescriptive authority by pharmacists represents a departure from the traditional role of pharmacists in dispensing medications. Nearly all states, however, currently enable pharmacist prescriptive authority in some form or fashion. The variety of different state approaches makes it difficult for pharmacists to ascertain the pros and cons of different models. We leverage data available from the National Alliance of State Pharmacy Associations (NASPA), a trade association that tracks pharmacy legislation and regulations across all states, to characterize models of pharmacist prescriptive authority along a continuum from most restrictive to least restrictive. We identify 2 primary categories of current pharmacist prescriptive authority: (1) collaborative prescribing and (2) autonomous prescribing. Collaborative prescribing models provide a broad framework for the treatment of acute or chronic disease. Current autonomous prescribing models have focused on a limited range of medications for which a specific diagnosis is not needed. Approaches to pharmacist prescriptive authority are not mutually exclusive. We anticipate that more states will pursue the less-restrictive approaches in the years ahead.

Toward permissionless innovation in health care.

1So too has the technology and resources available to support pharmacist clinical services. These advancements have not been met with concomitant advancements in state-level “scope of practice” laws. As a result, the gap between the clinical ability of pharmacists and their legal authority, as permitted by state law, has widened substantially. To foster innovation and entrepreneurship within the profession of pharmacy, we must embrace and advocate for “permissionless innovation” in health care.

Use of CLIA-waived point-of-care tests for infectious diseases in community pharmacies in the United States

Review of point-of-care (POC) testing in community pharmacies, availability and specifications of CLIA-waived infectious disease POC tests, and provide recommendations for future community pharmacy POC models in an effort to improve patient outcomes while reducing antibiotic resistance. PubMed and Medscape were searched for the following keywords: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests. All studies utilizing POC tests in community pharmacies for infectious disease were included. Studies, articles, recommendations, and posters were reviewed and information categorized into general implementation of POC testing in community pharmacies, CLIA-waived tests available, Influenza, Group A Streptococcus pharyngitis, Helicobacter pylori, HIV and Hepatitis C. POC testing provides a unique opportunity for community pharmacists to implement collaborative disease management programmes for infectious diseases and reduce over-prescribing of antibiotics and improve patient outcomes through early detection, treatment and/or referral to a specialist.

Historical Development and Emerging Trends of Community Pharmacy Residencies

Clinical pharmacy services necessitate appropriately trained pharmacists. Postgraduate year one (PGY1) community pharmacy residency programs (CPRPs) provide advanced training for pharmacists to provide multiple patient care services in the community setting. These programs provide an avenue to translate innovative ideas and services into clinical practice. In this paper, we describe the history and current status of PGY1 community pharmacy residency programs, including an analysis of the typical settings and services offered. Specific information on the trends of community programs compared with other PGY1 pharmacy residencies is also discussed. The information presented in this paper is intended to encourage discussion regarding the need for increasing the capacity of PGY1 community pharmacy residency programs.

Report of the 2010-2011 Professional Affairs Committee: Effective partnerships to implement pharmacists' services in team-based, patient-centered healthcare.

According to the Bylaws of the AACP, the Professional Affairs Committee is to study: issues associated with the professional practice as they relate to pharmaceutical education, and to establish and improve working relationships with all other organizations in the field of health affairs. The Committee is also encouraged to address related agenda items relevant to its Bylaws charge and to identify issues for consideration by subsequent committees, task forces, commission, or other groups. COMMITTEE CHARGE President Rodney A. Carter charged the 2010-2011 American Association of Colleges of Pharmacy (AACP) Professional Affairs Committee with: Examining how AACP and its members can most effectively partner with a variety of key stakeholders to accelerate the implementation of pharmacist services (e.g., MTM, primary care) as the standard for team-based, patient-centered care. Members of the 2010-2011 Professional Affairs Committee include faculty from various colleges and schools of pharmacy as well as pharmacy practice association representatives from the American Pharmacists Association (APhA), the American Society of Health-System Pharmacists (ASHP), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA). In order to fulfill the Committee charge, the Committee members met for a day and a half in Arlington, Virginia in October 2010 to discuss the committee charge and develop a plan of action to address the charge. Following this meeting, the Committee communicated via a series of conference calls as well as personal exchanges via telephone and email. The result is the following report which is positioned to discuss various models of care, challenges and opportunities pertaining to the charge, successful practices of AACP members and multiple pharmacy practice organizations, and recommendations to AACP in response to the Committee charge. BACKGROUND The pharmacy profession has been intransition from a product-based to a patient-centered care model since the introduction of the pharmaceutical care philosophy in the 1990s. (1) This transition has been accomplished to varying degrees in different pharmacy practice settings and has been influenced by a variety of factors including the transition to the clinically-focused Doctor of Pharmacy (Pharm.D.) degree as the entry level degree and the increasing recognition that medication-related problems pose a significant threat to public health. (2) The Centers for Medicare and Medicaid Services (CMS) recognized the importance of medication therapy management (MTM) services by requiring all Medicare Part D plans to provide MTM as part of their programs. Recent healthcare reform (HCR) legislation includes provisions for MTM and pharmacist-provided services as part of integrated team-based care models designed to improve the quality of healthcare delivered in the United States. (4) Pharmacists are well-positioned to serve as the medication therapy expert on the healthcare team. (5) Currently, MTM services are not offered to all patients in all settings. This creates a situation of inequality and fragmentation of pharmacy services. It is imperative that the profession and the Academy accelerate the implementation of patient-centered, team-based care as the standard of pharmacy practice with the availability of MTM services to all patients. This vision has been clearly articulated in the Joint Commission of Pharmacy Practitioners (JCPP) vision for pharmacy practice. (6) Identification of the factors that are impeding the realization of this vision and the development of strategies to accelerate its adoption as the standard of pharmacy practice in 2015 are the focus of this report. With the current HCR legislation, increasing the momentum for implementation of medication management services and chronic disease management services provided by pharmacists is a critical issue for pharmacy practice and education. …

Advancing technician practice: Deliberations of a regulatory board

In 2016, the Idaho State Board of Pharmacy (U.S.) undertook a major rulemaking initiative to advance pharmacy practice by broadening the ability of pharmacists to delegate tasks to pharmacy technicians. The new rules of the Board thus moved the locus of control in technician scope of practice from law to pharmacist delegation. Pharmacist delegation is individualistic and takes into account the individual technicians capabilities, the pharmacists comfort level, facility policies, and the risk mitigation strategies present at the facility, among other factors. State law limits, by contrast, are rigid and can mean that pharmacists are unable to delegate tasks that are or could otherwise be within the abilities of their technicians. The expanded technician duties are in two domains: 1) medication dispensing support (e.g., tech-check-tech, accepting verbal prescriptions, transferring prescriptions, and performing remote data entry); and 2) technical support for pharmacist clinical services (e.g., administering immunizations). This commentary reviews the evidence behind these expanded duties, as well as the key regulatory decision points for each task. The Boards rules and approach may prove useful to other states and even other governing bodies outside the U.S. as they consider similar issues.

Tech-Check-Tech in Community Pharmacy Practice Settings:

Objective: The benefit of a tech-check-tech (TCT) practice model in institutional settings has been well documented. To date, few studies have explored TCT beyond institutional settings. This article summarizes the existing evidence in community pharmacy–based TCT research with respect to dispensing accuracy and pharmacist time devoted to direct patient care. Data Sources: A literature review was conducted using MEDLINE (January 1990 to August 2016), Google Scholar (January 1990 to August 2016), and EMBASE (January 1990 to August 2016) using the terms “tech* and check,” “tech-check-tech,” “checking technician,” and “accuracy checking tech*”. Bibliographies were reviewed to identify additional relevant literature. Study Selection and Data Extraction: Studies were included if they analyzed TCT and were conducted in a community pharmacy practice site, inclusive of chain, independent, mass merchant, supermarket, and mail order pharmacies. Studies were excluded if the TCT practice model was conducted in an institutional or long-term care setting. Survey data on theoretical models of TCT in community pharmacy practice settings were also excluded. Data Synthesis: Over the past 14 years, 4 studies were identified indicating TCT has been performed safely and effectively in community settings. The studies demonstrate that trained community technicians perform as accurately as pharmacists and that TCT increased the amount of pharmacist time devoted to clinical activities. In the 2 studies that reported accuracy rates, pharmacy technicians performed at least as accurately as pharmacists (99.445 vs 99.73%, P = .484; 99.95 vs 99.74, P < .05). Furthermore, 3 of the studies reported gains in pharmacist time, with increases between 9.1% and 19.18% of pharmacist time for consultative services. Conclusions: The present studies demonstrate that TCT can be safe and effective in community pharmacy practice settings, with results similar to those found in institutional settings. It is anticipated more states will explore TCT in community settings in the years ahead as a strategy to improve patient care.

Defining and Measuring Primary Medication Nonadherence: Development of a Quality Measure.

UNLABELLED Poor medication adherence has been increasingly recognized as a major public health issue and a priority for health care reform. Primary medication nonadherence (PMN) is a subset of this broader subject and occurs when a new medication is prescribed for a patient, but the patient does not obtain the medication, or an appropriate alternative, within an acceptable period of time after it was prescribed. It is increasingly evident that the public health problem of PMN is widespread. However, the lack of standardized definitions and measures inhibits the ability to establish the true incidence of this problem or to track changes in PMN rates over time. Given the limitations of current measures, the Pharmacy Quality Alliance (PQA) convened an expert working group to set parameters for a new industry measure. That new measure, which links electronic prescribing and pharmacy dispensing databases and was developed and approved by the PQA, is described here. PMN literature from 1990 to June 2015 is also reviewed, and existing PMN measures are summarized. DISCLOSURES No funding was received for this article, and the authors declare no conflicts of interest. The views expressed in this article are those of the authors alone and do not necessarily reflect those of their respective employers. Adams has received grant support from Pfizer for adherence research. Adams and Stolpe were equally involved in all aspects of study design, data collection and interpretation, and manuscript preparation.