Evidence for under-reporting of adverse drug events by health care providers

A doctor and patient discuss medicines

Clinical question

In type 2 diabetes on oral antidiabetic drug treatment, do patients report more side-effects than health care providers?

This systematic review set out to compare patient-reported adverse drug events (such as abdominal pain, dyspepsia or constipation) with provider-reported adverse drug events to see if they are consistent.

The evidence

The reviewers searched Medline and EMBASE and found nine studies that reported rates of adverse drug events.  They pooled the data from these studies, then compared the rates for different methods of reporting these events.

They concluded that patients reported more adverse events than health care providers, and that the patient-reported events were more in line with the patterns reported in pharmaceutical drug information.  This suggests that health care providers may under-report the events.

Appraisal hints

Users of this research should consider:

  • Whether it makes sense to combine the results of the different studies
  • Whether other factors may have accounted for the observed differences between patient-reported and provider-reported adverse events.
  • Were the outcomes measured consistently?
  • Were the studies carried out on different populations?
  • Were the methods of event reporting carried out on different populations?
  • Whether the observed differences are clinically important.


Hakobyan L, Haaijer-Ruskamp FM, et al. Comparing Adverse Event Rates of Oral Blood Glucose-Lowering Drugs Reported by Patients and Healthcare Providers: A Post-Hoc Analysis of Observational Studies Published between 1999 and 2011. Drug Saf. 2011 Dec 1;34(12):1191-202.


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I am an information scientist with an interest in making knowledge from systematic research more accessible to people who need it. This means you. I've been attempting this in the area of Evidence-Based Health Care since 1995. So far the results have been mixed. For some reason we expected busy clinicians to search databases and appraise papers instead of seeing patients. We also expected publishers to make the research freely available to the people who paid for it.. Ha! Hence The National Elf service.

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