Elizabeth Hall-Lipsy

Pharmacotherapeutic disparities: racial, ethnic, and sex variations in medication treatment.

PURPOSE Variations in the medication treatment received by racial and ethnic minorities and women and the negative health outcomes associated with these differences were examined. METHODS Studies published between January 1990 and June 2008 were identified via electronic searches of MEDLINE, PsychINFO, International Pharmaceutical Abstracts, PubMed, and CINAHL using search terms related to race, ethnicity, sex, drug treatment, and disparity or variation. Articles were excluded if they addressed only medical or surgical care or did not include a statistical analysis of differences in drug treatment based on race, ethnicity, or sex. Data regarding the frequency of reported race, ethnic, and sex differences in medication treatment, the types of treatment differences observed, and associated health outcomes were extracted. RESULTS A total of 311 research articles were identified that investigated whether race, ethnicity, or sex was associated with disparities in medication treatment. Seventy- seven percent (n = 240) of included articles revealed significant disparities in drug treatment across race, ethnicity, and sex (p < 0.05). The most frequent disparity, found in 73% of the articles studied, was differences in the receipt of prescription drugs; however, documented disparities occurred related to differences in the drugs prescribed, drug dosing or administration, and wait time to receipt of a drug. Documented outcomes associated with pharmacotherapeutic disparities included increased rates of hospitalization, decreased rates of therapeutic goal attainment (e.g., low- density-lipoprotein cholesterol, blood pressure goals), and decreased rates of survival. CONCLUSION A literature review revealed significant disparities in the medication treatment received by racial and ethnic minorities and women.

Systematic review of professional liability when prescribing β-lactams for patients with a known penicillin allergy

OBJECTIVE To describe medical negligence and malpractice cases in which a patient with a known penicillin allergy received a β-lactam and experienced an adverse reaction related to the β-lactam. DATA SOURCES Lexis-Nexus, Westlaw, and Google Scholar were searched. STUDY SELECTIONS Medical negligence and malpractice cases were eligible for inclusion if they met the following criteria: the plaintiff had a known penicillin allergy, received a β-lactam, and experienced an adverse event. All United States federal and state cases were eligible. RESULTS Twenty-seven unique cases met the inclusion criteria. Eighteen cases involved the receipt of a penicillin-based antibiotic; of these cases with a known legal outcome, the plaintiff (patient or representative) prevailed or settled in 3 cases and defendants (providers) prevailed in 7 cases. Seven cases involved the receipt of a cephalosporin; of these cases with a known legal outcome, the plaintiff settled with physicians before trial in 1 case and defendants prevailed in 3 cases. Two cases involved the receipt of a carbapenem. Defendants prevailed in one case and the legal outcome of the other case is unknown. In cases in which the defense successfully moved for summary judgment, judges cited a lack of scientific evidence demonstrating a cephalosporin or carbapenem was contraindicated for a patient with a penicillin allergy. CONCLUSION The cases with published legal outcomes found limited professional liability for clinicians who prescribed cephalosporins or carbapenems to a patient with a known penicillin allergy. These results may decrease the litigation fears of practitioners and risk managers within health care systems.

Practice-Based Research Networks and the Mandate for Real-World Evidence

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

Defamation lawsuits: academic sword or shield?

Scientists and academics are used to defending their theories, methods, and results in the classroom, at conferences, and in peer‐reviewed publications. But Pieter Cohen, an assistant professor at Harvard Medical School, learned that he had to defend his research in a defamation suit while reading a supplement industry trade publication (Robins, ). Cohen is known as a “dogged detective” for scrutinizing dietary supplements and for advocating for their stricter oversight by the US Food and Drug Administration (FDA).