title: Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.
abstract: The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations.
  
  
  
  We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone.
  
  
  
  We conducted interviews with 40 patients and ten physicians recruited from a combination of insurer claims databases and online sources. We evaluated (1) sources of drug safety information; (2) discussions between patients and physicians about the two medications; (3) their knowledge of the DSC; and (4) preferences for learning about future drug safety information. Interviews were transcribed and analyzed thematically.
  
  
  
  Patients cited their physicians, pharmacy inserts, and the Internet as sources of drug safety information. Physicians often referred to medical journals and online medical sources. Most patients reported being aware of information contained in the DSC summaries they were read. Almost all patients and physicians reported discussing side effects during patient-provider conversations, but almost no patients mentioned that physicians had communicated with them key messaging from the DSCs at issue: the risk of next-morning impairment with zolpidem and the lower recommended initial dose for women.
  
  
  
  Some risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients' decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner.
authors.affiliation: Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA. akesselheim@partners.org.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.affiliation: The Hastings Center, Garrison, NY, USA.
authors.forename: Sarah A
authors.initials: SA
authors.lastname: McGraw
authors.affiliation: Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA.
authors.forename: Sara Z
authors.initials: SZ
authors.lastname: Dejene
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
authors.forename: Paula
authors.initials: P
authors.lastname: Rausch
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
authors.forename: Gerald J
authors.initials: GJ
authors.lastname: Dal Pan
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
authors.forename: Brian M
authors.initials: BM
authors.lastname: Lappin
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
authors.forename: Esther H
authors.initials: EH
authors.lastname: Zhou
authors.affiliation: Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA.
authors.forename: Jerry
authors.initials: J
authors.lastname: Avorn
authors.affiliation: Mongan Institute Health Policy Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Campbell
mesh_terms: D000328:Adult; D000368:Aged; D003142:Communication; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D000069582:Eszopiclone / Q000009:adverse effects*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D010820:Physicians; D011725:Pyridines / Q000009:adverse effects*; D036301:Qualitative Research; D000068776:Sleep Aids, Pharmaceutical / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration; D000077334:Zolpidem
chemical_list: D011725:Pyridines; D000068776:Sleep Aids, Pharmaceutical; D000077334:Zolpidem; D000069582:Eszopiclone