Educational Interventions Improve Adverse Drug Reaction Reporting

Do educational interventions improve the likelihood that health care professionals will report adverse drug reactions?

When combined with adverse drug reaction reporting forms and reminder cards, educational interventions improve the overall reporting rate by health care professionals compared with standard spontaneous reporting (risk ratio [RR] = 3.00; 95% CI, 1.53–5.90; five studies; n = 21,655).¹ (Strength of Recommendation [SOR]: C, based on disease-oriented evidence.) Improving hospital-based health care professionals' access to standardized adverse drug reaction reporting forms at the time of patient discharge improves the number of reports submitted (RR = 2.06; 95% CI, 1.11–3.83). (SOR: C, based on disease-oriented evidence.) Most educational interventions in isolation, such as sending informational letters or emails to health care professionals, do not affect the number of reports submitted.

Adverse drug events, including adverse drug reactions and drug errors, are estimated to be among the most common causes of death worldwide.^1,2 Although some adverse drug reactions are detected during clinical trials, many remain unknown and require strong pharmacovigilance by health care professionals to identify and report adverse reactions to prevent or minimize further potential harm.^3,4 Spontaneous or voluntary reporting of adverse drug reactions by health care professionals is considered standard practice, yet adverse drug reactions remain underreported.^3,4 Depending on the type and severity of adverse drug reaction, estimates suggest that up to 94% of events are not reported.^3,4 Reports to the US Food and Drug Administration (FDA) must at minimum include the drug name, description of the event, and name of the reporter. Various educational and promotional activities have been implemented to improve adverse drug reaction reporting rates, including informational initiatives, financial incentives, governmental regulations, and process improvement efforts enhancing access to report forms or increasing reporting options.¹

This review included 15 studies (eight randomized controlled trials, six interrupted time series studies, and one nonrandomized crossover study) with more than 60,000 participants.¹ Included studies were performed in large tertiary care hospitals in high-income countries. The primary outcome measure was the total number of adverse drug reaction reports submitted by health care professionals (eg, general practitioners, other specialists, pharmacists, nurses). An adverse drug reaction was defined as “a harmful effect suspected to be caused by a drug at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”

An educational session with adverse drug reaction report form training and reminder cards compared with usual practices without standardized education increased the number of adverse drug reaction reports submitted (RR = 3.00; 95% CI, 1.53–5.90; five studies; n = 21,655; low-certainty evidence).¹ In addition, a standardized hospital discharge form made it easier for health care professionals to report adverse drug reactions (RR = 2.06; 95% CI, 1.11–3.83; one study; n = 5,967; low-certainty evidence).

All studies included in this review recruited hospital-based health care professionals.¹ Most studies were performed outside the United States. Nonetheless, the identified barriers to adverse drug reaction reporting (ie, lack of awareness about reporting systems, lack of time, ambiguity regarding the responsible reporter, and lack of information by patients) are likely generalizable to US primary care settings.