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Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study

Author

Listed:
  • Aaron S. Kesselheim

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Sarah A. McGraw

    (The Hastings Center)

  • Sara Z. Dejene

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Paula Rausch

    (Center for Drug Evaluation and Research)

  • Gerald J. Dal Pan

    (Center for Drug Evaluation and Research)

  • Brian M. Lappin

    (Center for Drug Evaluation and Research)

  • Esther H. Zhou

    (Center for Drug Evaluation and Research)

  • Jerry Avorn

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Eric G. Campbell

    (Massachusetts General Hospital and Harvard Medical School)

Abstract

Introduction 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. Objective 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. Methods 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. Results 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. Conclusions 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.

Suggested Citation

  • Aaron S. Kesselheim & Sarah A. McGraw & Sara Z. Dejene & Paula Rausch & Gerald J. Dal Pan & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Eric G. Campbell, 2017. "Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study," Drug Safety, Springer, vol. 40(6), pages 531-542, June.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:6:d:10.1007_s40264-017-0516-3
    DOI: 10.1007/s40264-017-0516-3
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    Cited by:

    1. Aaron S. Kesselheim & Michael S. Sinha & Eric G. Campbell & Sebastian Schneeweiss & Paula Rausch & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Gerald J. Dal Pan, 2019. "Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem," Drug Safety, Springer, vol. 42(11), pages 1287-1295, November.
    2. Bo-Ram Yang & Kyu-Nam Heo & Yun Mi Yu & Ga-Bin Yeom & Hye Duck Choi & Ju-Yeun Lee & Young-Mi Ah, 2021. "Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts," IJERPH, MDPI, vol. 18(10), pages 1-12, May.

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