RxLegal: Emergency Use Authorizations.

Emergency use authorizations (EUAs) are a mechanism to allow for the availability and use of medical products during a public health emergency. During the COVID-19 pandemic, hundreds of products have been authorized for use under an EUA. This has led to legal issues-most prominently, the legality of vaccine mandates. Language within the statute that created the EUA pathway has been subject to varying interpretations that could refuse or allow the implementation of EUA vaccine mandates and suits have been filed against organizations that have established vaccine mandates as a term of continued employment.

Transdermal Patch Administration and Magnetic Resonance Imaging (MRI)-2020.

This is an update to the 2010 article published in Hospital Pharmacy on safety concerns involving transdermal patches and magnetic resonance imaging (MRI). Since publication of the original article, new brand and generic transdermal medications have become available and notable changes regarding the presence or absence of metallic content among existing transdermal formulations occurred. To update the tables within the article, Food and Drug Administration (FDA)-approved transdermal medications through October 2020 were researched in order to determine metallic content and procedures for reapplication after MRI, if applicable. Readers should consult the prescribing information or manufacturer for the most current information on use of transdermal medications in the MRI setting. Of note, manufacturers have not evaluated the use of transdermal products while patients undergo a MRI scan.

RxLegal: The Evolving Legal Landscape of Telehealth.

The provision of telehealth services has increased dramatically during the COVID-19 pandemic with the introduction of various temporary waivers and rules designed to increase flexibility in the pandemic response. This expansion of telehealth has not only increased patient access, but protected essential healthcare workers from potential virus exposure. The advantages of increased telehealth services has prompted the introduction of a bipartisan bill in Congress, which seeks to make some of the temporary measures undertaken during the pandemic permanent. Pharmacists have been able to expand telehealth services further with the implementation of these regulatory changes.

Trends in gender composition on editorial boards in leading medicine, nursing, and pharmacy journals.

OBJECTIVE: To investigate the proportions and trends in gender ratios of journal editorial boards in medicine, nursing, and pharmacy from 1995 to 2016. DESIGN: This was a pooled cross-sectional evaluation of 21 high-impact medical, nursing, and pharmacy journals. SETTING AND PARTICIPANTS: The gender composition of editorial boards for each discipline was obtained. Gender expression was based on the person's name or other information available on the Internet. OUTCOME MEASURES: The proportion of all editorial board member positions, including editorial leadership positions, occupied by the underrepresented gender, and trends over time were measured. RESULTS: A total of 5309 editorial board members and 312 editorial leadership positions were identified. From 1995 to 2016, women remained underrepresented across medicine and pharmacy journal editorial boards, whereas men remained underrepresented across nursing journal editorial boards. However, there were statistically significant increases in the representation of the underrepresented gender on editorial boards across all disciplines. Medicine was the only discipline to experience a statistically significant increase in the underrepresented gender of the editorial board being appointed to a leadership position; the proportion of women increased from 3% in 1995 to 35% in 2016. CONCLUSION: The gender gap in medicine and pharmacy journals appears to be narrowing. Although men continue to lag behind women in nursing journals, they are and have been overrepresented when considering the proportion of men practicing in the field. Overall, continued efforts are needed to resolve gender inequities in academic health sciences.

The Orphan Drug Act: An Appropriate Approval Pathway for Treatments of Rare Diseases?

The Orphan Drug Act provides financial incentives to pharmaceutical manufacturers to develop treatments for rare diseases affecting limited patient populations. Since passage of the Act in 1983, the U.S. Food and Drug Administration (FDA) has approved more than 600 orphan drug indications from greater than 450 distinct drug products. The annual number of orphan drug designation approvals has increased significantly in the recent past with much of this increase driven by approval of secondary indications for previously approved treatments. This recent increase has led to concerns regarding the Act as some pharmaceutical manufacturers have reaped outsized financial benefits while avoiding the regulatory requirements and costs associated with nonorphan drug development.

RxLegal: Pharmacist Gag Clauses.

Much publicity has surrounded the use of gag clauses in contracts between insurance companies or their pharmacy benefit managers (PBMs) and pharmacies. These clauses prohibit pharmacists from voluntarily informing patients that their prescription medication may cost less if paid for directly by them instead of through their insurance. By concealing the least expensive way to purchase a medication, critics state that gag clauses reduce transparency and medication affordability for patients and appear to be counterintuitive to one of the major activities of a PBM-negotiation of drug pricing. Due to the uproar surrounding these clauses, the bipartisan Patient Right to Know Drug Prices Act was recently introduced in Congress to effectively ban the practice.

RxLegal: A Rapid Review of Right-To-Try.

Right-to-try legislation is intended to allow patients with life-threatening illnesses access to investigational medical treatments without formal Food and Drug Administration (FDA) involvement. Currently, right-to-try laws have been enacted in 40 states. Despite the increased passage of right-to-try legislation at the state level, individuals have detailed arguments both for and against these laws. Proponents state that right-to-try removes regulatory burdens and improves timely access to potentially lifesaving medications for terminally ill patients, reduces inequalities regarding access, and improves patient-provider communication and decision making. Opponents argue that right-to-try does not really guarantee access, reinforces preexisting health care inequalities, prioritizes rapid access over safety and the interests of the individual over the public, and produces concerns regarding informed consent. Despite these issues, right-to-try has recently gained traction on the federal level with both Congressional chambers passing separate bills.

The Prescription Drug User Fee Act: Cause for Concern?

The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992. PDUFA provides the Food and Drug Administration (FDA) with needed revenue in the form of various fees paid by drug and biologic manufacturers. The FDA utilizes this revenue to streamline the review and approval process for medications. Since the enactment of PDUFA, the median approval time for priority new drug applications and biologics license applications has reduced significantly. The FDA views PDUFA as a successful program that provides a consistent revenue stream to the agency, improves access to medications for patients, and allows industry to have a more predictable product review timeline. However, critics of PDUFA cite concerns including the potential for a lack of FDA independence and medication safety issues involving drugs approved after the existence of PDUFA.

Intravenous Push Administration of Antibiotics: Literature and Considerations.

Intravenous (IV) push administration can provide clinical and practical advantages over longer IV infusions in multiple clinical scenarios, including in the emergency department, in fluid-restricted patients, and when supplies of diluents are limited. In these settings, conversion to IV push administration may provide a solution. This review compiles available data on IV push administration of antibiotics in adults, including preparation, stability, and administration instructions. Prescribing information, multiple tertiary drug resources, and primary literature were consulted to compile relevant data. Several antibiotics are Food and Drug Administration-approved for IV push administration, including many beta-lactams. In addition, cefepime, ceftriaxone, ertapenem, gentamicin, and tobramycin have primary literature data to support IV push administration. While amikacin, ciprofloxacin, imipenem/cilastatin, and metronidazole have limited primary literature data on IV push administration, available data do not support that route. In addition, a discussion on practical considerations, such as IV push best practices and pharmacodynamic considerations, is provided.

Direct and Indirect Remuneration Fees: The Controversy Continues.

The Centers for Medicare and Medicaid Services (CMS) initially created direct and indirect remuneration (DIR) fees with the enactment of Medicare Part D in order to track rebates and other price adjustments made to pharmacy benefit managers (PBMs). PBMs have expanded the use of these fees to "claw back" money from pharmacies on already dispensed medications. Community and specialty pharmacies claim these fees are not transparent, hurt patients and taxpayers, and negatively impact their fiscal bottom line, while PBMs assert that these fees actually reduce premiums for patients. Congress has stepped into the dispute by introducing legislation that would halt retroactive DIR fees.

Analyzing temozolomide medication errors: potentially fatal.

The EORTC-NCIC regimen for glioblastoma requires different dosing of temozolomide (TMZ) during radiation and maintenance therapy. This complexity is exacerbated by the availability of multiple TMZ capsule strengths. TMZ is an alkylating agent and the major toxicity of this class is dose-related myelosuppression. Inadvertent overdose can be fatal. The websites of the Institute for Safe Medication Practices (ISMP), and the Food and Drug Administration (FDA) MedWatch database were reviewed. We searched the MedWatch database for adverse events associated with TMZ and obtained all reports including hematologic toxicity submitted from 1st November 1997 to 30th May 2012. The ISMP describes errors with TMZ resulting from the positioning of information on the label of the commercial product. The strength and quantity of capsules on the label were in close proximity to each other, and this has been changed by the manufacturer. MedWatch identified 45 medication errors. Patient errors were the most common, accounting for 21 or 47% of errors, followed by dispensing errors, which accounted for 13 or 29%. Seven reports or 16% were errors in the prescribing of TMZ. Reported outcomes ranged from reversible hematological adverse events (13%), to hospitalization for other adverse events (13%) or death (18%). Four error reports lacked detail and could not be categorized. Although the FDA issued a warning in 2003 regarding fatal medication errors and the product label warns of overdosing, errors in TMZ dosing occur for various reasons and involve both healthcare professionals and patients. Overdosing errors can be fatal.

Curriculum and instructional methods for drug information, literature evaluation, and biostatistics: survey of US pharmacy schools.

BACKGROUND: The drug information curriculum in US colleges of pharmacy continues to evolve. The American College of Clinical Pharmacy (ACCP) Drug Information Practice and Research Network (DI PRN) published an opinion paper with specific recommendations regarding drug information education in 2009. Adoption of these recommendations has not been evaluated. OBJECTIVE: To assess which recommendations made in the ACCP DI PRN opinion paper are included in US pharmacy school curricula and characterize faculty qualifications, educational methods, and recent changes in drug information education. METHODS: An electronic survey was designed using the ACCP DI PRN opinion paper and the Accreditation Council for Pharmacy Education standards and guidelines for accreditation of PharmD programs in the US. Survey questions addressed curricular content within the following categories: drug information, literature evaluation, and biostatistics. A letter including the online survey link was sent via email to the dean of each US college/school of pharmacy (N = 128). Recipients were instructed to forward the email to the individual at their institution who was the most knowledgeable about the content and methodology used for didactic drug information education. RESULTS: Sixty-four responses were included in the final analysis. Of the 19 ACCP DI PRN minimum core concepts, 9 (47%) were included in curricula of all responding institutions; 14 of 19 (74%) were included in curricula for all but 1 institution. In contrast, 5 of 16 concepts (31%) were not formally taught by a number of institutions. Many respondents noted an increased focus on evidence-based medicine, medication safety, and informatics. CONCLUSIONS: Although a survey of drug information curricula documented substantial inclusion of the essential concepts presented in the ACCP DI PRN opinion paper, room for improvement remains in drug information curricula in US colleges of pharmacy.

Report on 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination.

PURPOSE: The 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination was convened in order to gather subject matter experts in the field of hazardous drug (HD) handling to develop consensus statements regarding surface contamination monitoring for adoption by stakeholders in the drug supply chain, policy, and healthcare arenas. SUMMARY: The Safe to Touch conference convened virtually on September 22, 24, and 26, 2020. An expert panel of healthcare providers with experience in HD handling, monitoring, and research; pharmacy and nursing operations; and medication safety led the conference. An experienced audience of approximately 25 reaction panel members provided feedback to the panel via a preconference survey, during the conference, and at a postconference virtual town hall. Additionally, expert speakers presented on a range of issues, including the impact of HD surface contamination on health, current regulations and standards, surface contamination monitoring technologies, and variables impacting surface contamination testing. CONCLUSION: At the end of the conference, the expert panel developed 11 consensus statements and corresponding recommendations that should be widely disseminated in order to educate individuals regarding the impact of HD surface contamination and increase the scope of HD surface contamination monitoring. Institutions involved in the handling of HDs should set short- and long-term goals for implementation of applicable consensus statements.

Peramivir: an intravenous neuraminidase inhibitor for the treatment of 2009 H1N1 influenza.

OBJECTIVE: To review the efficacy and safety of peramivir, an unapproved neuraminidase inhibitor recently granted an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of 2009 H1N1 influenza in select patients. DATA SOURCES: Literature was accessed via MEDLINE (1950-April 2010) using the search terms peramivir, BCX-1812, RWJ 270201, influenza H1N1, swine influenza, and neuraminidase inhibitors. The manufacturer of peramivir, BioCryst Pharmaceuticals, was contacted for unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and FDA Web sites. The mandatory requirements for the EUA for peramivir were also consulted. STUDY SELECTION AND DATA EXTRACTION: Available English-language literature was reviewed and selected based on relevance, as was information from the CDC, FDA, and the drug manufacturer. DATA SYNTHESIS: The 2009 H1N1 influenza pandemic has necessitated the selective use of intravenous peramivir, an unapproved neuraminidase inhibitor. Intravenous peramivir has been studied in 4 clinical trials, 2 of which compared the drug to oseltamivir. Dose adjustments are required in pediatric patients and in those with impaired renal function. Clinicians wishing to use peramivir must request authorization from the CDC to confirm patient characteristics warranting its use and to verify the prescriber's understanding of dosing considerations and unapproved status. CONCLUSIONS: Peramivir has shown efficacy for the treatment of 2009 H1N1 influenza; however, it has yet to receive FDA approval. Peramivir is used in hospitalized adult and pediatric patients with suspected or laboratory-confirmed 2009 H1N1 influenza meeting specific criteria, including those unable to receive inhaled or oral neuraminidase inhibitors, those who have not responded to other neuraminidase inhibitors, or when drug delivery by a route other than intravenous is not feasible.