Multiple marketing withdrawals due to proarrhythmic concerns occurred in the United States, Canada, and the United Kingdom in the late 1980s to early 2000s. This primer reviews the clinical implications of a drug's identified proarrhythmic liability, the issues associated with these safety-related withdrawals, and the actions taken by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and by regulatory agencies in terms of changing drug development practices and introducing new nonclinical and clinical tests to asses proarrhythmic liability. ICH Guidelines S7B and E14 were released in 2005. Since then, they have been adopted by many regional regulatory authorities and have guided nonclinical and clinical proarrhythmic cardiac safety assessments during drug development. While this regulatory paradigm has been successful in preventing drugs with unanticipated potential for inducing the rare but potentially fatal polymorphic ventricular arrhythmia torsade de pointes from entering the market, it has led to the termination of drug development programs for other potentially useful medicines because of isolated results from studies with limited predictive value. Research efforts are now exploring alternative approaches to better predict potential proarrhythmic liabilities. For example, in the domain of human electrocardiographic assessments, concentration-response modeling conducted during phase 1 clinical development has recently become an accepted alternate primary methodology to the ICH E14 "thorough QT/QTc" study for defining a drug's corrected QT interval prolongation liability under certain conditions. When a drug's therapeutic benefit is considered important at a public health level but there is also an identified proarrhythmic liability that may result from administration of the single drug in certain individuals and/or drug-drug interactions, marketing approval will be accompanied by appropriate directions in the drug's prescribing information. Health-care professionals in the fields of medicine and pharmacy need to consider the prescribing information in conjunction with individual patients' clinical characteristics and concomitant medications when prescribing and dispensing such drugs.
Background: Disparities in health care among lesbian, gay, bisexual, or transgender (LGBT) communities have been researched in primary care, but few have examined these phenomena among LGBT inpatients. Methods: Descriptive correlational study. A questionnaire was emailed to an LGBT population for a total of 508 participants. Questionnaires addressed level of satisfaction with hospital employees and whether this was related to their sexual orientation or gender identity (SOGI). Descriptive statistics describe participants and hospitals. χ2 was used to examine satisfaction and belief based on SOGI, recommendation to LGBT friends, and the relationship between location and likelihood of recommendation. Results: Those reporting dissatisfaction were likely to indicate it was related to their SOGI. They were less likely to recommend the hospital to LGBT friends or family. Analysis between location and recommendation identified rural hospitals as less likely to be recommended. Discussion: Lesbian, gay, bisexual, or transgender patients perceived lack of courtesy by hospital employees to be related to their SOGI.
Context in which sensitive questions are asked may affect the accuracy of demographic data. Lack of information regarding patients' sexual orientation or gender identity may impact perceived need for culturally competent care. Results suggest the need for efforts to provide training for mental health specialists in rural areas to provide sensitive care.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.