How to implement a "standard of care" regulatory model for pharmacists.

National pharmacy associations have increasingly explored regulation according to a "standard of care." In such a model, pharmacists can provide a wide range of clinical services aligned with their education and training. Based on Idaho's experience implementing this model, there are five critical steps states must take to enact a standard of care: 1) Adopt a broad definition of "practice of pharmacy;" 2) Allow elasticity for practice innovation over time; 3) Decide which limited instances still necessitate prescriptive regulation; 4) Eliminate all unnecessary regulations; and 5) Strengthen accountability for deviations from the standard of care. States wishing to adopt a standard of care approach can follow this five-step process to enhance patient care and mitigate the lag that is otherwise constant between laws and practice.

Creation and maintenance of a table for assessment of evolving evidence for COVID-19-related treatments.

PURPOSE: This report describes the development and maintenance of a table to present an assessment of evidence for treatments used in patients with coronavirus disease 2019 (COVID-19). SUMMARY: AHFS Drug Information (AHFS DI) (American Society of Health-System Pharmacists, Bethesda, MD) is ASHP's evidence-based drug compendium that contains drug monographs written for pharmacists and other healthcare professionals. The professional editorial and analytical staff of pharmacists critically evaluate published evidence to develop drug monographs for AHFS DI. In response to the global COVID-19 pandemic, these skills were applied to assess emerging evidence for COVID-19-related treatments, and the information was compiled into a new resource for pharmacists and other healthcare professionals to use at the point of care. A list of therapies was developed and prioritized based on review of scientific and public discussions on the use of these therapies in patients with COVID-19; certain therapies used for supportive care and therapies that might theoretically be harmful to patients with COVID-19 also were considered for inclusion. Potential treatments were identified, and the evidence for use in patients with COVID-19 was assessed and summarized in a table format. Information presented for each therapy included the rationale for use, summaries of clinical trials or experience, trial registry numbers, and dosage regimens. Comments on safety and efficacy, including limitations of available data, were presented along with recommendations from recognized authorities. The editorial team continued to add new therapies to the table and update existing entries as new evidence emerged. CONCLUSION: A comprehensive table that summarized available evidence for potential treatments for patients with COVID-19 was developed. The table format enabled the drug information editorial staff to provide ongoing updates as new information emerged during the pandemic.

Evolution of the AMCP Format for Formulary Submissions.

DISCLOSURES: No funding was required for this project. The authors are or have been members of the Format Executive Committee.

Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.

BACKGROUND: Improved knowledge of the molecular pathophysiology and immunopathogenesis of cholestatic liver diseases in recent years has led to an increased interest in developing novel therapies. Patients with cholestatic liver disease often require different approaches to assessment and management of suspected drug-induced liver injury (DILI) compared to those with healthy livers and those with parenchymal liver diseases. At present, there are no regulatory guidelines or society position papers, that systematically address best practices pertaining to detection of DILI in these patients. AIMS: To outline best practices for detection, assessment and management of suspected acute DILI during clinical trials in adults with the cholestatic liver diseases - Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). METHODS: This is one of the several papers developed by the IQ DILI Initiative, which is comprised of members from 16 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. The contents are the result of an extensive literature review, as well as in-depth discussions among industry, regulatory and academic DILI experts, to achieve consensus recommendations on DILI-related issues occurring during clinical trials for cholestatic liver diseases. RESULTS: Recommended best practices are outlined pertaining to hepatic eligibility criteria, monitoring of liver tests, approach to a suspected DILI signal, and hepatic discontinuation rules. CONCLUSIONS: This paper provides a framework for the approach to detection, assessment and management of suspected acute DILI occurring during clinical trials in adults with cholestatic liver disease.

ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing-2016.

PURPOSE: The results of the 2016 ASHP national survey of pharmacy practice in hospital settings are presented. METHODS: A stratified random sample of pharmacy directors at 1,315 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method offering a choice of completing a paper survey or an online survey. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. RESULTS: The survey response rate was 29.8%. Drug policy development by pharmacy and therapeutics committees continues to be an important strategy for improving prescribing. Strict formulary systems are maintained in 63.0% of hospitals, and 89.7% of hospitals use clinical practice guidelines that include medications. Pharmacists have the authority to order laboratory tests in 89.9% of hospitals and order medications in 86.8% of hospitals. Therapeutic interchange policies are used in 89.2% of hospitals. Electronic health records (EHRs) have been implemented partially or completely in most hospitals (99.1%). Computerized prescriber-order-entry systems with clinical decision support are used in 95.6% of hospitals, and 92.6% of hospitals have barcode-assisted medication administration systems. Transitions-of-care programs are increasing in number, with 34.6% of hospitals now offering discharge prescription services. Pharmacists practice in 39.5% of hospital ambulatory or primary care clinics. The most common service offered by pharmacists to outpatients is anticoagulation management (26.0%). When pharmacists practice in ambulatory care clinics, 64.5% have prescribing authority through collaborative practice agreements. CONCLUSION: Pharmacists continue to expand their role in improving the prescribing of medications in both hospital and outpatient settings. The adoption of EHRs and medication-use technologies has contributed to this growth.

The future of the pharmaceutical sciences and graduate education: recommendations from the AACP Graduate Education Special Interest Group.

Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master's and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining excellent basic skills in research. However, recommendations to date have not taken into account the future trends in the pharmaceutical industry. The AACP Graduate Education Special Interest Group has completed a literature survey of the trends in the pharmaceutical industry and graduate education in order to determine whether our graduate programs are strategically positioned to prepare our graduates for successful careers in the next few decades. We recommend that our pharmaceutical sciences graduate programs take a proactive leadership role in meeting the needs of our future graduates and employers. Our graduate programs should bring to education the innovation and collaboration that our industry also requires to be successful and relevant in this century.

[Educational standards of the Polish Pharmacoeconomic Society]. / Standardy Edukacyjne Polskiego Towarzystwa Farmakoekonomicznego.

The objective of creating Educational Standards of the Polish Pharmacoeconomic Society (Polish Chapter of the International Society for Pharmacoeconomics and Outcomes Research) was to define and establish a scope of knowledge and skills needed for people conducting and interpreting pharmacoeconomic analyses as well as health technology assessments. A Working Group of the Society identified target groups and divided the requirements into 3 groups: basic, intermediate and advanced. The document reflects conditions of the Polish healthcare and educational systems and is harmonized with international regulations in the field of pharmacoeconomics, outcomes research and health technology assessment. The standards may also serve as guidelines for educators in this area.

[PICS: pharmaceutical inspection cooperation scheme]. / PICS : un système de coopération en matière d'inspection des produits pharmaceutiques.

The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

Guidelines for pharmacoeconomic and outcomes research fellowship training programs: joint guidelines from the american college of clinical pharmacy and the international society of pharmacoeconomics and outcomes research.

Abstract Pharmacoeconomics and outcomes research (PEOR) demonstrates the added value of health services and treatments and is used by a variety of individuals in numerous settings to optimize patient care. Currently, 51 PEOR fellowship programs are publicized on Web sites from organizations such as the American College of Clinical Pharmacy (ACCP), the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and the Academy of Managed Care Pharmacy. These programs demonstrate the diversity of PEOR fellowships, as they are offered by sponsors in a variety of environments (e.g., academia, industry, consulting services, United States managed care, and government). Although the program sponsors vary, all fellowships should have the common goal of providing directed, highly individualized postgraduate training designed to prepare participants to become independent PEOR researchers. Like any health discipline, advancements in knowledge and technology along with changes in health care systems require refinement of existing training programs, including PEOR fellowships. Members of ACCP and ISPOR developed a survey instrument to assess structure, educational objectives, and outcome measures of PEOR fellowship programs. The survey objectives were to determine PEOR researchers' beliefs regarding qualifications of the training site, program, and preceptors(s) as well as fellowship applicant requirements, research commitment, didactic coursework and evaluation of fellows' research skills; and to develop PEOR fellowship guidelines based on data obtained from the survey. Pharmacoeconomics and outcomes research fellowship guidelines were originally published in 1999; this document outlines the revised PEOR fellowship guidelines based on recent literature and results of the ACCP-ISPOR survey described above. These guidelines are intended to assist PEOR researchers design, refine, and self-assess their fellowship program and to serve as a tool for prospective PEOR fellowship candidates to evaluate programs.