Key messages
- Healthcare professionals have a responsibility to report unexpected and harmful responses to medicines. These responses are known as 'adverse drug events', a term that includes both adverse drug reactions (ADRs) and medication errors (MEs).
- An education session (outreach, in-person workshops or via telephone), along with providing a reminder card and ADR report form, may substantially increase the number of ADR reports submitted.
- Using a standardised discharge form with additional ADR items that is designed to make it easier to report ADRs may slightly increase the number of ADR reports submitted.
- Future studies need to assess the benefit (increase in the number of adverse drug event reports submitted) and harm (increase in the number of false adverse drug event reports submitted) of any intervention designed to improve healthcase professionals' reporting of adverse drug events.
- Interventions suitable for use in low- and middle-income countries need to be developed and rigorously evaluated.
What did we want to find out?
This Cochrane review investigated whether interventions for healthcare professionals are effective for improving at their reporting of adverse drug events. Adverse drug events include any adverse drug reaction (ADR) and any medication error (ME).
What did we do?
We looked at evidence from a range of different types of studies to find out if interventions aimed at healthcare professionals could increase the number of adverse drug event reports they make. We compared the total number of adverse drug event reports (which included both ADR and ME reports) submitted by healthcare professionals. We were also interested in the number of false adverse drug event reports they made. As well as the total number of reports, we looked separately at the number of reports submitted for adverse drug events that were categorised as serious, high-causality (i.e. very likely to be caused by the drug), unexpected (i.e. previously unknown) or related to recent drugs (i.e. only used in the last five years).
What did we find?
This review included 15 studies (62,389 participants) that compared the effect of various interventions aimed at healthcare professionals to increase the number of adverse drug event reports they make. All the studies were carried out in high-income countries. None of the studies looked at whether these interventions led to more false adverse drug event reports.
Compared to usual practice (spontaneous reporting and some training from regional units that monitor the safety of medicines), an education session about why and how to report adverse events, plus reminder of the session content and provision of an ADR report form, may increase the number of ADR reports made by healthcare professionals.
Compared to usual practice (spontaneous reporting), using a standardised discharge form with additional ADR items about when the ADR occurred and how it developed may also slightly improve the number of ADR reports made. The standardised form tested was based on the ‘Diagnosis Related Groups’ system for recording patient diagnoses and the medical and surgical procedures patients receive during their hospital stay.
We are very uncertain about the effectiveness of other interventions that were tested in the studies, including:
- sending informational letters or emails to GPs and nurses;
- interventions with multiple aspects, including financial and non-financial incentives, fines, education and reminder cards;
- implementing government regulations together with financial incentives;
- including ADR report forms in quarterly bulletins and prescription pads;
- providing a hyperlink to the reporting form in hospitals' electronic patient records;
- improving the reporting method by re-engineering the web-based electronic error reporting system;
- the presence of a clinical pharmacist in hospital who actively identifies adverse drug events and encourages the identification and reporting of adverse drug events.
How up to date is this review?
The evidence in this review is based on searches up to October 2022.