Pathway to pharmacist medical provider status in Washington State.

OBJECTIVES: To describe Washington State's successful legal and legislative efforts to gain pharmacist medical provider status and major medical compensation and to compare those efforts with similar efforts in other states to identify key lessons learned. SUMMARY: Washington State Engrossed Substitute Senate Bill 5557 was enacted in 2015, securing pharmacists as medical providers and requiring compensation under major medical insurance for pharmacists providing health services (Revised Code of Washington 48.43.715). Other states have passed, or attempted to pass, pharmacist provider status bills, but none have achieved both pharmacist medical provider status and mandatory major medical compensation. CONCLUSION: Pharmacist medical provider status ideally should include recognition as a medical provider and compensation through major medical health insurance as a clinical decision maker rather than an "incident-to" provider. Both elements should be sought as part of a complete legislative package to ensure sustainable patient access to needed health care services.

Pharmacist provider status legislation: Projections and prospects.

OBJECTIVE: To compare legislation at the federal level that would recognize pharmacists as health care providers under Medicare Part B with similar state-level efforts in an attempt to identify the strengths and weaknesses of these options and forecast outcomes. SUMMARY: The current primary care provider shortage poses a significant threat to public health in the United States. The effort to achieve federal provider status for pharmacists, currently in the form of identical bills introduced in January 2015 into the U.S. House of Representatives and the U.S. Senate as the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592 and S. 314), would amend the Social Security Act to recognize pharmacists as health care providers in sections of Medicare Part B that specify coverage and reimbursement. This action has budgetary implications owing to the compensation that would accrue to pharmacists caring for Medicare beneficiaries. Passage of these bills into law could improve public health by sustainably increasing access to pharmacists' patient care services in medically underserved areas. In this article, the legislation's strengths and weaknesses are analyzed. The resulting information may be used to forecast the bills' fate as well as plan strategies to help support their success. Comparison of the bills with existing, state-level efforts is used as a framework for such policy analysis. CONCLUSION: While the current political climate benefits the bills in the U.S. Congress, established legislative precedents suggest that parts of H.R. 592/S. 314, specifically those regarding compensation mechanisms, may require negotiated amendment to improve their chances of success.

Pharmacy waste, fraud, and abuse in health care reform.

OBJECTIVE: To describe the new Medicare and Medicaid waste, fraud, and abuse provisions of the Affordable Care Act (H. R. 3590) and Health Care and Education Affordability Reconciliation Act of 2010 (H. R. 4872), the preexisting law modified by H. R. 3590 and H. R. 4872, and applicable existing and proposed regulations. SUMMARY: Waste, fraud, and abuse are substantial threats to the efficiency of the health care system. To combat these activities, the Department of Health and Human Services and Centers for Medicare & Medicaid Services promulgate and enforce guidelines governing the proper assessment and billing for Medicare and Medicaid services. These guidelines have a number of provisions that can catch even well-intentioned providers off guard, resulting in substantial fines. H. R. 3590 and H. R. 4872 augment preexisting waste, fraud, and abuse laws and regulations. This article reviews the new waste, fraud, and abuse laws and regulations to apprise pharmacists of the substantial changes affecting their practice. CONCLUSION: H. R. 3590 and H. R. 4872 modify screening requirements for providers; modify liability and penalties for the antikickback statute, federal False Claims Act, remuneration, and Stark Law; and create or extend auditing and management programs. Properly navigating these changes will be important in keeping pharmacies in compliance.

Fit to practise? Processes for dealing with misconduct among pharmacists in Australia, Canada, the UK and US.

In many countries with legal systems based on English common law, pharmacy regulators have a responsibility to protect, promote and maintain the health and safety of patients. Where there is a potential risk to patient safety, or where the public's confidence in pharmacy could be adversely affected by the actions of a pharmacist, these regulators have a statutory duty to investigate concerns. The legal provisions underpinning each jurisdiction's disciplinary processes depict distinctive outlooks from the different authorities, as each works towards the same goal. Legal statues, regulations, rules, and guidance affecting the disciplinary process in Great Britain, Australia, New York and New Brunswick were collated, and the processes they describe were attached to a common process flow diagram for step-by-step evaluation of their respective legal provisions. The initial stages of the respective investigation process are broadly similar in all the jurisdictions examined; however, each process has subtle differences that afford some level of advantage or disadvantage over its comparators. Factors including: how matters of discipline are framed; the existence of a separate process for minor and uncontested violations; the ability to effect an interim suspension of a practitioner's license; threshold criteria for escalation of complaints; the membership of disciplinary panels; and the perceived independence of these panels all philosophically affect the public safety remit of each regulator. This work constitutes the first comparison of international regulatory frameworks for the profession of pharmacy. Of the four jurisdictions examined, Great Britain most clearly acts in the interest of the public and the profession - rather than the respondent pharmacist - at every step of its process.

Transitioning pharmacy to "standard of care" regulation: Analyzing how pharmacy regulates relative to medicine and nursing.

BACKGROUND: The National Association of Boards of Pharmacy (NABP) recently established a task force to help states develop regulations based on "standards of care" rather than "prescriptive rule-based regulation." The NABP resolution signals a paradigm shift as the pharmacy profession has historically been governed by prescriptive rules at both the federal and state levels. OBJECTIVE: To identify opportunities to make the transition to a "standard of care" regulatory model in pharmacy law as NABP has advanced, this manuscript attempts to quantify the regulatory burden for the medical, nursing, and pharmacy professions in the state of Idaho to facilitate a comparison. METHOD: The relevant statutes and regulations were gathered, and key measures were extracted, including word count and restrictions (e.g., the use of specific terms like "shall"), the composition and age of each profession's laws, how frequently the respective laws have been amended, and how the composition has changed from 1996 to 2017. RESULTS: When compared to medicine and nursing, pharmacy laws have a larger overall word count, more restrictions, a younger overall age, and have been amended more frequently. In particular, pharmacy has 97.5% more words than nursing and 105.8% more words than medicine with respect to the regulation of professional practice standards. From 1996 to 2017 nursing and pharmacy took two diverging paths to professional practice standard regulation. Nursing decreased the net word count in this area (-3006 words; -28.7%), whereas pharmacy (5208 words; 36.6%) experienced gains. CONCLUSIONS: For pharmacy to continue to evolve, replicating the medical and nursing approach to the regulation of professional practice standards will be necessary to fully achieve patient and public health goals.

Canadian prescription drug importation programs contain risks for Oklahoma physicians.

In response to high prescription drug prices in the United States, several services have attempted to make prescription drugs available directly from Canadian pharmacies, which often can sell the drugs at a significantly cheaper price. Normally, a patient must have his physician become directly involved in this process in order to import the drugs from Canada. Although it is understandable for a physician to want to help a patient in this manner, there are several potential risks for an Oklahoma physician participating in these programs. In addition, there is significant risk the patient may not be getting the drugs prescribed.

The argument for pharmaceutical policy.

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Pharmacists' liability into the year 2000.

OBJECTIVE: To educate the pharmacy community regarding areas of potential liability arising from the pharmacist's role in the changing health care delivery system. DATA SOURCES: Published cases (LEXIS and Westlaw), literature (NEXIS and Westlaw), and abstracts available through July 1998. CASE SELECTION AND DATA ABSTRACTION: Selected on the basis of the authors' objectives and the usefulness of the information for practicing pharmacists. DATA SYNTHESIS: As the pharmacist's role in the health care delivery system continues to change, so too does the pharmacist's exposure to liability. Although historically a pharmacist had no common law "duty to warn," new laws requiring a pharmacist to counsel patients, along with increased scrutiny by the media, have increased the pharmacist's potential for liability. An evaluation of recent case law indicates that state courts are increasingly willing to extend a pharmacist's duty to warn where the pharmacist has special knowledge of the patient or the patient's condition, contraindicated drug usage, where a prescription substantially exceeds the maximum safe dosage, or where a pharmacist fills or refills a prescription without physician authorization. A recent issue that may add to the list of potential liability concerns is the substitution of generically equivalent narrow therapeutic index drug products. CONCLUSION: The pharmacist's role in the ever changing health care delivery system, along with the public's increased scrutiny of pharmacists' dispensing practices, may inevitably extend a pharmacist's duty to warn a patient of potential problems related to prescription drug products. This trend is expected to continue into the new millennium.

Pharmacy practice acts: a decade of progress.

OBJECTIVE: This 10-year follow-up study of previously published surveys of pharmacy practice acts examines 50 state and the District of Columbia pharmacy practice acts to assess the range of statutory definitions and determine the direction and magnitude of statutory changes since 1988. DATA SOURCES: State codes for 50 states and the District of Columbia, with attention focused on the pharmacy practice acts; Puerto Rico and the Virgin Islands were excluded. DATA EXTRACTION: The focus on each statute was the statutory definition of the "practice of pharmacy." DATA SYNTHESIS: Comparing 1998 with 1988, codification of interpreting and evaluating prescriptions increased 22% (1998; 39/47, four states contain no definition of the practice of pharmacy), compounding 8% (47/47), consultation 19% (41/47), dispensing 2.5% (47/47), drug administration threefold (24/47), drug product selection twofold (45/47), drug utilization review 70% (35/47), patient assessment 6.5-fold (6/47), pharmacokinetic services threefold (3/47), pharmacist prescribing 4.6-fold (15/47), and participation in drug research 10.5-fold (10/47). CONCLUSIONS: Since 1988, state pharmacy practice acts have increased the codification of pharmaceutical care services as integral pharmacy functions. Although substantial progress has been made over the past decade, a number of states have not incorporated definitions of pharmaceutical care functions into their state statutes. Enactment of the National Association Boards of Pharmacy Model State Pharmacy Act is one way for pharmacists' practice to expand with the evolution of the practice of pharmacy.

O processo decisório judicial e a assessoria técnica: a argumentação jurídica e médico-sanitária na garantia do direito à assistência terapêutica no Sistema Único de Saúde / The judicial decision making and technical assistance: the legal and medical and health argument in ensuring the right to health assistance in the Health System

A alta intensidade de demandas judiciais relacionadas à assistência terapêutica, contra entes públicos, tem trazido preocupações sanitárias, e representam um desafio para o sistema público de saúde. A principal crítica à atuação judicial refere-se às ordens judiciais de entrega de medicamentos respaldadas exclusivamente na prescrição médica. A problemática tem exigido esforços interdisciplinares na busca de concordância prática das dimensões jurídica e médica-sanitária do direito à saúde, estimulando-se a oferta de assessoria técnica aos magistrados. O estudo analisou a utilização dos elementos médico-sanitários na argumentação judicial, nos processos judiciais contra entes públicos, em tramitação, no período de setembro de 2009 a outubro de 2010, no Tribunal de Justiça do Estado do Rio de Janeiro (TJ-RJ), que possui o Núcleo de Assessoria Técnica em Ações de Saúde (NAT), da Secretaria de Saúde do Estado do Rio de Janeiro, para apoio aos magistrados, por meio de convênio. Foi examinada uma amostra de 347 processos judiciais. Os magistrados solicitaram Parecer do NAT em 128 processos, na maioria das vezes, antes da apreciação da decisão de tutela antecipada e processos com pedidos de medicamentos. O Parecer NAT continham informações clínicas e sanitárias sobre o diagnóstico declarado, a terapêutica requerida, a regulamentação sanitária e programas de saúde vigentes...

The high intensity of litigation on therapeutic care against public entities represented a challenge for the public health system. This challenge has required interdisciplinary efforts attempting to reach the concordance in juridical and medical sanitary dimensions to ensure the right to the health, encouraging the provision of technical advice to the judges. The main criticism to the judicial action refers to granting injunctions for individual requests based only on the medical prescription. The study examined the use of medical sanitary information on the legal reasoning in a sample of lawsuits against public entities, in process, from September 2009 to October 2010, at the Court of the State of Rio de Janeiro (TJ -RJ). The TJ-RJ, through an agreement, provides the Technical Assistance Center on Health Action (NAT) of the State Health Secretariat of Rio de Janeiro (SES-RJ) to support magistrates. 347 lawsuits were examined in the sample. NAT analyzed the applications and medical documents in 128 cases, and in the most of the cases, before the injunctive relief. The technical advice of NAT contained on the diagnosis stated, required therapy, health regulations and existing health programs. (...) Most cases had performance of the Prosecutor (MP), and favorable opinions to the requests; in only 04 cases the MP recommended the holding of expertise and / or new medical report...