JMIR Public Health Surveill. 2018 Feb 27;4(1):e21. doi: 10.2196/publichealth.9282.
Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.
JMIR public health and surveillance
Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka
Affiliations
Affiliations
- Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
- Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.
- Vancouver General Hospital Emergency Department, Vancouver, BC, Canada.
- School of Communication, Simon Fraser University, Burnaby, BC, Canada.
- Department of Pharmaceutical Sciences, Vancouver General Hospital, Vancouver, BC, Canada.
PMID: 29487041
PMCID: PMC5849794 DOI: 10.2196/publichealth.9282
Abstract
BACKGROUND: Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported.
OBJECTIVE: Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.
METHODS: This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice.
RESULTS: We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation.
CONCLUSIONS: Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.
©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 27.02.2018.
Keywords: adverse drug event; adverse drug reaction; adverse events; drug safety; electronic health records; information and technology; medication reconciliation; pharmacovigilance; qualitative research
References
- Springerplus. 2016 Oct 11;5(1):1764 - PubMed
- J Wound Ostomy Continence Nurs. 2005 Nov-Dec;32(6):413-20 - PubMed
- Can J Clin Pharmacol. 2007 Winter;14(1):e45-57 - PubMed
- Br J Clin Pharmacol. 2011 Jul;72(1):143-52 - PubMed
- J Am Med Inform Assoc. 2014 May-Jun;21(3):547-57 - PubMed
- Br J Clin Pharmacol. 1996 May;41(5):434-5 - PubMed
- BMJ Qual Saf. 2017 May;26(5):350-353 - PubMed
- JAMA. 2003 Mar 5;289(9):1107-16 - PubMed
- CMAJ. 2015 Aug 11;187(11):789-90 - PubMed
- Drug Saf. 2009;32(1):19-31 - PubMed
- Drug Saf. 2006;29(5):385-96 - PubMed
- Br J Clin Pharmacol. 2016 Oct;82(4):1048-57 - PubMed
- Drug Saf. 2010 Jul 1;33(7):535-8 - PubMed
- CMAJ. 2008 Jun 3;178(12):1563-9 - PubMed
- Clin Epidemiol. 2009 Aug 09;1:75-92 - PubMed
- Acad Emerg Med. 2012 Jun;19(6):640-9 - PubMed
- Ther Adv Drug Saf. 2013 Apr;4(2):73-90 - PubMed
- Ann Emerg Med. 2001 Dec;38(6):666-71 - PubMed
- Drug Saf. 2000 Aug;23 (2):165-72 - PubMed
- JAMA. 1998 Apr 15;279(15):1200-5 - PubMed
- JMIR Res Protoc. 2016 Aug 18;5(3):e169 - PubMed
- Ann Intern Med. 2004 May 18;140(10):795-801 - PubMed
- JAMA. 1997 Jan 22-29;277(4):301-6 - PubMed
- Rev Esc Enferm USP. 2014 Aug;48(4):739-47 - PubMed
- Res Nurs Health. 2000 Aug;23(4):334-40 - PubMed
- Pharmacoepidemiol Drug Saf. 2011 Dec;20(12):1295-302 - PubMed
- N Engl J Med. 2011 Nov 24;365(21):2002-12 - PubMed
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