Literature DB >> 31152320

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature.

Jessica T DeFrank1, Lauren McCormack2, Suzanne L West2, Craig Lefebvre2, Olivia Burrus2.   

Abstract

Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety. The types of communications included in these studies were news reports, direct-to-consumer advertisements, and those released by government agencies. Among the 26 studies identified, the most commonly reported unintended effects were decreased drug use or discontinuation. Other unintended effects included spillover to populations not targeted by the communications (e.g., discontinuation of antidepressants among adults following communications concerning use among youth), shifts in clinical diagnoses (e.g., fewer diagnoses of depression), increased use of alternative therapies, and other undesirable behaviors (e.g., possible increased suicide attempts because antidepressants were discontinued). Limitations to the literature include the inability to establish causation or to isolate the effects of multiple communication sources and messages. Further, because the intended effect of many communications was not known, our study was limited by challenges in defining some effects as unintended. Most studies used health insurer claims data to identify unintended effects of communications, which provide an incomplete picture; few used self-reported or other methodologies that could help illuminate the reasons underlying the effects observed in the claims data. Best practices for communicating about the potential benefits and harms of drugs in a manner that minimizes negative unintended effects are needed to protect and improve public health.

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Year:  2019        PMID: 31152320     DOI: 10.1007/s40264-019-00840-3

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  34 in total

Review 1.  Impact of safety-related regulatory action on clinical practice: a systematic review.

Authors:  Sigrid Piening; Flora M Haaijer-Ruskamp; Jonie T N de Vries; Menno E van der Elst; Pieter A de Graeff; Sabine M J M Straus; Peter G M Mol
Journal:  Drug Saf       Date:  2012-05-01       Impact factor: 5.606

Review 2.  Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.

Authors:  Anjan Kumar Banerjee; Inge M Zomerdijk; Stella Wooder; Simon Ingate; Stephen J Mayall
Journal:  Drug Saf       Date:  2014-01       Impact factor: 5.606

Review 3.  Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review.

Authors:  Stacie B Dusetzina; Ashley S Higashi; E Ray Dorsey; Rena Conti; Haiden A Huskamp; Shu Zhu; Craig F Garfield; G Caleb Alexander
Journal:  Med Care       Date:  2012-06       Impact factor: 2.983

4.  Methodological approaches to evaluate the impact of FDA drug safety communications.

Authors:  Aaron S Kesselheim; Eric G Campbell; Sebastian Schneeweiss; Paula Rausch; Brian M Lappin; Esther H Zhou; John D Seeger; John S Brownstein; Steven Woloshin; Lisa M Schwartz; Timothy Toomey; Gerald J Dal Pan; Jerry Avorn
Journal:  Drug Saf       Date:  2015-06       Impact factor: 5.606

5.  Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools.

Authors:  Rachel E Sobel; Andrew Bate; James Marshall; Kevin Haynes; Nandini Selvam; Vinit Nair; Gregory Daniel; Jeffrey S Brown; Robert F Reynolds
Journal:  Pharmacoepidemiol Drug Saf       Date:  2018-02-02       Impact factor: 2.890

6.  News coverage of FDA warnings on pediatric antidepressant use and suicidality.

Authors:  Colleen L Barry; Susan H Busch
Journal:  Pediatrics       Date:  2009-12-07       Impact factor: 7.124

7.  Antidepressant prescribing practices for the treatment of children and adolescents.

Authors:  Supriya K Bhatia; Amy J Rezac; Benedetto Vitiello; Michael A Sitorius; Bruce A Buehler; Christopher J Kratochvil
Journal:  J Child Adolesc Psychopharmacol       Date:  2008-02       Impact factor: 2.576

8.  Early evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents.

Authors:  Robert D Gibbons; C Hendricks Brown; Kwan Hur; Sue M Marcus; Dulal K Bhaumik; Joëlle A Erkens; Ron M C Herings; J John Mann
Journal:  Am J Psychiatry       Date:  2007-09       Impact factor: 18.112

9.  Antidepressants and suicide risk: how did specific information in FDA safety warnings affect treatment patterns?

Authors:  Susan H Busch; Richard G Frank; Douglas L Leslie; Andrés Martin; Robert A Rosenheck; Erika G Martin; Colleen L Barry
Journal:  Psychiatr Serv       Date:  2010-01       Impact factor: 3.084

Review 10.  A critical review of methods to evaluate the impact of FDA regulatory actions.

Authors:  Becky A Briesacher; Stephen B Soumerai; Fang Zhang; Sengwee Toh; Susan E Andrade; Joann L Wagner; Azadeh Shoaibi; Jerry H Gurwitz
Journal:  Pharmacoepidemiol Drug Saf       Date:  2013-07-12       Impact factor: 2.890

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