Evidence map›Paper›PMID 28247279›Full record

ArticleDrug safety2017

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

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

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Physicians' use of and preferences for FDA-approved prescribing information.Research in social & administrative pharmacy : RSAP · 2022
    Article
  5. Article
  6. Article
  7. Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts.International journal of environmental research and public health · 2021
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Aaron S KesselheimProgram 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.
Sarah A McGrawThe Hastings Center, Garrison, NY, USA.
Sara Z DejeneProgram 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.
Paula RauschUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Gerald J Dal PanUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Brian M LappinUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Esther H ZhouUS Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Jerry AvornProgram 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.
Eric G CampbellMongan Institute Health Policy Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

objectiveWe 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.

methodsWe 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.

resultsPatients 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.

conclusionsSome 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.

Indexed as

AdultAgedCommunicationDrug-Related Side Effects and Adverse ReactionsEszopicloneFemaleHumansInternetMaleMiddle AgedPhysiciansPyridinesQualitative ResearchSleep Aids, PharmaceuticalUnited StatesUnited States Food and Drug AdministrationEszopiclonePyridinesSleep Aids, PharmaceuticalZolpidem

Identifiers

PMID28247279

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.