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.

Early clinical trial data and real-world assessment of COVID-19 vaccines: Insights from the Society of Infectious Diseases Pharmacists.

As of August 2021, there were three COVID-19 vaccines available in the United States for the prevention of coronavirus 2019 (COVID-19). The purpose of this narrative review is to examine the early experience from the Emergency Use Authorization (EUA) of BNT162b2 (Pfizer, Inc./BioNTech), mRNA-1273 (Moderna, Inc.), and Ad26.COV2.S (Johnson and Johnson/Janssen Global Services, LLC) through July 2021. The EUA data from the clinical trials have largely been corroborated by real-world effectiveness investigations post-authorization. These studies indicate that immunity is obtained within 2 weeks post-vaccination and may endure for 6 months. The immunity conferred by the vaccines may also be effective against SARS-CoV-2 variants of concern. Additionally, populations not included in the emergency use authorization studies may also benefit from vaccination. This look back at the initial clinical experience can be used by the global community to inform and develop COVID-19 vaccine programs.

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.

Report of the 2019-2020 AACP Academic Affairs Committee: Developing the Pharmacist Workforce for Society's Medication Use Needs in 2030.

The 2019-2020 Academic Affairs Committee was charged with identifying promising practices in academic-practice partnerships and professional pharmacy organization initiatives that are accelerating the transformation of a workforce prepared to assume responsibility for society's medication use needs in 2030 and determining the role AACP can plan in supporting these partnerships and initiatives. The committee identified a set of ideal principles, characteristics, and design elements of a high-quality, large-scale workforce development program. The committee also categorized current mechanisms for professional workforce development, in addition to identifying their strengths and weaknesses, with the realization that novel approaches are needed to accomplish the goal of large-scale workforce transformation. This report also highlights two existing initiatives aligned with accelerating the transformation of the workforce (ie, the Community Pharmacy Enhanced Services Network (CPESN) ACT (Academia-CPESN Transformation) Pharmacy Collaborative and the American Pharmacists Association ADVANCE platform) and is proposing a policy statement affirming AACP's support. Furthermore, the committee is proposing another policy statement supporting colleges and schools of pharmacy taking an active role in implementing innovative and novel approaches for the development of the current workforce. In order to truly understand the many factors influencing large-scale workforce transformation, the committee is also proposing a stakeholder conference with a wide range of participants and a targeted set of questions focused on current and future needs.

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.

Executive Summary: Therapeutic Monitoring of Vancomycin for Serious Methicillin-Resistant Staphylococcus aureus Infections: A Revised Consensus Guideline and Review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists.

BACKGROUND: Recent vancomycin PK/PD and toxicodynamic studies enable a reassessment of the current dosing and monitoring guideline in an attempt to further optimize the efficacy and safety of vancomycin therapy. The area-under-the-curve to minimum inhibitory concentration (AUC/MIC) has been identified as the most appropriate pharmacokinetic/pharmacodynamic (PK/PD) target for vancomycin. The 2009 vancomycin consenus guidelines recommended specific trough concentrations as a surrogate marker for AUC/MIC. However, more recent toxicodynamic studies have reported an increase in nephrotoxicity associated with trough monitoring. METHODS AND RESULTS: This is the executive summary of the new vancomycin consensus guidelines for dosing and monitoring vancomycin therapy and was developed by the American Society of Health-Systems Pharmacists, Infectious Diseases Society of America, Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists vancomycin consensus guidelines committee. CONCLUSIONS: The recommendations provided in this document are intended to assist the clinician in optimizing vancomycin for the treatment of invasive MRSA infections in adult and pediatric patients. An AUC/MIC by broth microdilution (BMD) ratio of 400 to 600 (assuming MICBMD of 1 mg/L) should be advocated as the target to achieve clinical efficacy while improving patient safety for patients with serious MRSA infections. In such cases, AUC-guided dosing and monitoring is the most accurate and optimal way to manage vancomycin therapy.

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.

Association between student characteristics and rankings when applying for a residency in health-system pharmacy administration.

PURPOSE: Results of a study to identify characteristics associated with pharmacy residency applicant success in obtaining an invitation to interview and a top candidate ranking are reported. Subsequent development and initial validation of a predictive model based on those characteristics are described. METHODS: Bivariable analyses were performed for planned stratifications of applicants to a health-system pharmacy administration residency program according to whether they were offered an on-site interview or were among the 8 top candidates by final candidate ranking. A Random Forest algorithm was created to identify predictors of the likelihood of an applicant being offered an on-site interview. RESULTS: Applicants who were offered interviews had a higher median pharmacy school grade point average (GPA) than those not invited to interview: 3.63 (interquartile range [IQR], 3.46-3.79) versus 3.35 (IQR, 3.2-3.49); p < 0.001. Invited applicants also received more scholarships during pharmacy school (median, 2 [IQR, 1-3) versus 1 [IQR, 0-2]; p = 0.002). Applicants with prior work experience as a hospital pharmacy intern were also more likely than those without such experience to be offered an interview (70.0% versus 37.8% were invited, p = 0.001), as were applicants who presented a poster at a national meeting during pharmacy school (80% versus 60%, p = 0.02) or who served in a national pharmacy organization leadership position (41.4% versus 20%, p = 0.03). Pharmacy school GPA was associated with final candidate ranking; top-ranked candidates had a significantly higher median GPA than lower-ranked applicants (3.68 [IQR, 3.51-3.8] versus 3.48 [IQR, 3.23-3.7]; p = 0.003). CONCLUSION: Objective criteria within the realms of academic performance and prior work experience may be used to streamline the applicant screening process when determining candidates to invite for an on-site interview. Pharmacy school GPA was the only characteristic found to be associated with applicant final ranking.

ASHP national survey of pharmacy practice in hospital settings: Monitoring and patient education-2018.

PURPOSE: The results of the 2018 ASHP national survey of pharmacy practice in hospital settings are presented. METHODS: Pharmacy directors at 4,897 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method of contact by mail and email. Survey completion was online using Qualtrics. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. RESULTS: The response rate was 16.6%. The percentage of hospitals that routinely have pharmacists assigned to provide drug therapy management has increased. Transitions-of-care processes have generally increased over the last 6 years. The percentage of hospitals with pharmacists in a wide variety of clinic types and clinical practice areas has increased over the last 2 years. Opioid stewardship programs are emerging in many U.S. hospitals, with pharmacists participating or taking the lead in program implementation. Outsourcing of compounded sterile product preparation is common. The proportion of hospitals not using any technology when compounding sterile preparations has declined. Pharmacy departments commonly track and monitor trends for administrative, operational, quality, and outcome metrics. CONCLUSION: Pharmacists continue to improve drug therapy monitoring for patients in U.S. hospitals. They are also responding to public health issues related to medication use. These advancements include taking an active role in opioid stewardship programs, safe compounding of sterile medications for patients, and reducing the need for hospital-based care.

The West coast regional safety pharmacology society meeting update: Filling translational gaps in safety assessment.

The Safety Pharmacology Society (SPS) held a West Coast Regional Meeting in Foster City, CA on November 14, 2018 at the Gilead Sciences Inc. site. The meeting was attended by scientists from the pharmaceutical and biotechnology industry, contract research organizations (CROs) and academia. A variety of scientific topics were presented by speakers, covering a broad variety of topics in the fields of safety risk assessment; from pro-arrhythmia and contractility risk evaluation, to models of heart failure and seizure in-a-dish; and discovery sciences; from stem cells and precision medicine, to models of inherited cardiomyopathy and precision cut tissue slices. The present review summarizes the highlights of the presentations and provides an overview of the high level of innovation currently underlying many frontiers in safety pharmacology.