Poor Awareness and Confusion Hamper Patient Reporting of Adverse Drug Reactions


Patients fail to report adverse drug reactions due to poor awareness, but when they do speak up, it’s to prevent others from suffering.

The main reason that patients fail to report adverse drug reactions is poor awareness of available reporting systems. When patients do report adverse drug reactions, the most common motive is an altruistic wish that others avoid suffering the same adverse drug reactions, according to an analysis of 21 studies conducted under Rania AL Dweik, Ph.D., of the University of Ottawa in Canada.

Although it is recognized that adverse drug reactions cause significant morbidity and mortality worldwide, only about 5-10 percent are reported, and only 5 percent of health care professionals report them.

To identify barriers and motives influencing the reporting of adverse drug reactions by patients, leading ultimately to strategies for improving voluntary patient reporting, researchers writing in the Nov. 25 issue of the British Journal of Clinical Pharmacology, conducted a systematic review guided by the Cochrane Handbook in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Included studies addressed patient perceptions of adverse drug reactions and focused on factors influencing their reporting. The studies, with publication dates spanning 2008 to 2014, were conducted in 12 countries (UK [n=5], the Netherlands [n=4] and Australia [n=3] most common), but none were conducted in North America.

Among 14 studies reporting barriers to patient reporting, all cited poor awareness of the need to report, eight cited confusion as to who reports and to whom reporting should be directed, five studies cited patients who believed that their adverse drug reactions would resolve, and four studies named difficulty with adverse drug reactions procedures and forms.

Two studies cited patients who stated they were concerned about the lack of feedback to previously submitted reports on adverse events. In other studies, patients failed to mail their reports and in one, patients feared that reporting adverse events would disappoint their primary healthcare provider.

Among 10 studies addressing motives for patient reporting, seven cited prevention of similar adverse drug reactions in others, and five stated that improving drug safety, the seriousness of their adverse drug reactions and a desire for personal feedback as reasons for sharing adverse events.

In three studies, patients reported that “informing regulators, drug manufacturers, healthcare providers and the public about adverse events was the only way to create awareness of such incidents.” In three other studies, patients felt that reporting adverse events would inform and educate healthcare providers.

In two studies, patients (in the UK) emphasized that health care professionals had not taken their concerns seriously which, in turn, motivated their self-reports. In two other studies, physicians specifically asked patients to report adverse events.

Al Dweik, et al. concluded, “Patient reporting of adverse drug reactions should be actively supported by increasing patient familiarity with available ADR reporting systems, health care professionals encouraging them to report, providing clear guidance on using the reporting system, as well as providing feedback. Initiating strategies that are informed by these factors has the potential to improve spontaneous patient adverse drug reactions reporting.”

They suggested further that increasing adverse drug reactions reporting could also provide opportunities to promote educational interventions, for example, directing patients to websites that offer high-quality drug information materials.



Rania Al Dweik, Dadwn Stacey, Dafna Kohen and Sanni Yaya. "Factors affecting patient reporting of adverse drug reactions: a systematic review," British Journal of Clinical Pharmacology. First published: 25 November 2016. DOI: 10.1111/bcp.13159

David W. Bates, MD, MSc; David J. Cullen, MD; Nan Laird, PhD; et al. "Incidence of Adverse Drug Events and Potential Adverse Drug Events Implications for Prevention," JAMA. July 5, 1995. DOI: 10.1001/jama.1995.03530010043033

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