Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings.
drug safety
pharmacovigilance
prescriber attitudes
qualitative methods
risk communication
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
revised:
03
07
2021
received:
05
03
2021
accepted:
09
07
2021
pubmed:
3
8
2021
medline:
12
4
2022
entrez:
2
8
2021
Statut:
ppublish
Résumé
Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. Semi-structured qualitative interviews were carried out with 40 primary care physicians, endocrinologists and other generalist specialists in Boston (USA) and Australia. Coding and analysis were performed inductively and iteratively to identify and examine key factors. Analysis centred around four areas: physicians' awareness of drug safety information, preferred information sources, opinion-forming and sharing of information with patients. Uncertainty, trust and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the "clinical grapevine" for awareness, and on clinical colleagues, specialists and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs. Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance and accessibility, and address physicians' needs in communicating risk to patients.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
713-722Subventions
Organisme : CIHR
ID : ID#153275
Pays : Canada
Informations de copyright
© 2021 British Pharmacological Society.
Références
Alexander SPH, Kelly E, Mathie A, et al. The Concise Guide to Pharmacology 2019/20: Transporters. Br J Pharmacol. 2019;176(S1):S397-S493.
Pharmaceutical Society of Australia. Medicine Safety: Take Care. Canberra: PSA; 2019. https://www.psa.org.au/wp-content/uploads/2019/01/PSA-Medicine-Safety-Report.pdf
Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US emergency department visits for outpatient adverse drug events, 2013-2014. JAMA. 2016;316(20):2115-2125.
Dusetzina SB, Higashi AS, Dorsey ER, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care. 2012;50(6):466-478.
Piening S, Haaijer-Ruskamp FM, de Vries JT, et al. Impact of safety-related regulatory action on clinical practice: a systematic review. Drug Saf. 2012;35(5):373-385.
Kesselheim AS, Sinha MS, Rausch P, et al. Patients' knowledge of key messaging in drug safety communications for Zolpidem and Eszopiclone: a national survey. J Law Med Ethics. 2019;47(3):430-441.
Kesselheim AS, McGraw SA, Dejene SZ, et al. Patient and physician perceptions of drug safety information for sleep aids: a qualitative study. Drug Saf. 2017;40(6):531-542.
Kesselheim AS, Sinha MS, Campbell EG, et al. Multimodal analysis of FDA drug safety communications: lessons from Zolpidem. Drug Saf. 2019;42(11):1287-1295.
Simis MJ, Madden H, Cacciatore MA, Yeo SK. The lure of rationality: why does the deficit model persist in science communication? Public Underst Sci. 2016;25(4):400-414.
Mollebaek M, Kaae S, De Bruin ML, Callreus T, Jossan S, Hallgreen CE. The effectiveness of direct to healthcare professional communication-a systematic review of communication factor studies. Res Social Adm Pharm. 2019;15(5):475-482. https://doi.org/10.1016/j.sapharm.2018.06.015
Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010;33(12):1065-1079.
De Vries ST, Van Der Sar MJM, Cupelli A, et al. Communication on safety of medicines in Europe: current practices and general practitioners' awareness and preferences. Drug Saf. 2017;40(8):729-742.
Piening S, Haaijer-Ruskamp FM, de Graeff PA, Straus SM, Mol PG. Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in The Netherlands. Drug Saf. 2012;35(11):1061-1072.
Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth. 2008;20(1):35-39.
Singh T, Prakash A, Rais T, Kumari N. Decreased use of antidepressants in youth after US Food and Drug Administration black box warning. Psychiatry. 2009;6(10):30-34.
Richardson LP, Lewis CW, Casey-Goldstein M, McCauley E, Katon W. Pediatric primary care providers and adolescent depression: a qualitative study of barriers to treatment and the effect of the black box warning. J Adolesc Health. 2007;40(5):433-439.
Perry LT, Bhasale A, Fabbri A, et al. Comparative analysis of medicines safety advisories released by Australia, Canada, the United States, and the United Kingdom. JAMA Intern Med. 2019;179(7):982-984.
Kesselheim AS, Franklin JM, Avorn J, Duke JD. Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs. BMJ Qual Saf. 2013;22(9):727-734.
Shimazawa R, Ikeda M. Safety information in drug labeling: a comparison of the USA, the UK, and Japan. Pharmacoepidemiol Drug Saf. 2013;22(3):306-318.
Bjerre LM, Parlow S, De Launay D, et al. Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK. BMJ Open. 2018;8:e020150. https://doi.org/10.1136/bmjopen-2017-020150
Perry LT, Bhasale A, Fabbri A, et al. A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States-2007 to 2016. Pharmacoepidemiol Drug Saf. 2020;29(9):1054-1063.
Hooimeyer A, Bhasale A, Perry L, et al. Regulatory post-market drug safety advisories on cardiac harm: a comparison of four national regulatory agencies. Pharmacol Res Perspect. 2020;8:e00680. https://doi.org/10.1002/prp2.680
Bhasale A, Mintzes B, Sarpatwari A. Communicating emerging risks of SGLT2 inhibitors-timeliness and transparency of medicine regulators. BMJ. 2020;368:m1107.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117.
Ritchie J, Lewis J, McNaughton Nicholls C, Ormston R (Eds). Qualitative Research Practice: a guide for social science students and researchers. 3rd ed. Los Angeles, CA: Sage; 2014.
Bazeley P, Jackson K (Eds). Qualitative Data Analysis with NVivo. 2nd ed. London: Sage; 2013.
NVivo [computer program]. Melbourne: QSR International; 2020.
Fabbri A, O'Keeffe M, Moynihan R, et al. Media coverage of drug regulatory agencies' safety advisories: a case study of citalopram and denosumab. Br J Clin Pharmacol. 2020;86(7):1416-1429.
de Vries E, Denig P, de Vries ST, Monster TBM, Hugtenburg JG, Mol PGM. Drug safety issues covered by lay media: a cohort study of direct healthcare provider communications sent between 2001 and 2015 in The Netherlands. Drug Saf. 2020;43(7):677-690.