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Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.
This chapter discusses the broad categories of clinical investigations used in post-market drug safety assessment. It presents the three main methods of clinical post-marketing safety assessment: case reports and case series; observational epidemiological studies; and clinical trials. Active surveillance systems are also being explored to identify and examine drug safety issues. Drug safety active surveillance systems, which take advantage of large repositories of automated healthcare data, are now being developed and tested by multiple organizations. The two most common observational epidemiological study designs are the case-control design and the cohort design. The majority of clinical trials are performed primarily to assess the efficacy of a product. The design of a post-marketing clinical trial testing a safety hypothesis is often an active-controlled trial that uses a non-inferiority study design. Relative to observational epidemiological studies, clinical trials designed to answer drug safety questions are usually more costly and more time-consuming.
Human immunodeficiency virus (HIV) infection has expanded to become a global pandemic which threatens health in most areas of the world, and is now the leading cause of death among some segments of the population. Infection with HIV-1, a member of the lentivirus subfamily of retroviruses, produces a wide spectrum of clinical manifestations, ranging from asymptomatic infection to severe, life-threatening opportunistic infections. The prevalence of HIV dementia is only 0.4% during the asymptomatic phase of infection. In patients with AIDS, dementia develops in 15-20%. The diagnosis of HIV dementia is established by a history of a progressive cognitive or behavioral decline with apathy, memory loss, or slowed mental processing and by appropriate ancillary studies. HIV-1 associated vacuolar myelopathy (HIV myelopathy) is characterized by a vacuolar degeneration affecting predominantly the thoracic spinal cord. Patients may have multiple concurrent opportunistic processes, or opportunistic processes may coexist with HIV-related neurological disorders.
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