Improving reporting of adverse drug reactions: Systematic review

Abstract

Background:

Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, with many being identified post-marketing. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health.

Objectives:

To evaluate methods to improve ADR reporting via a systematic literature review.

Methods:

Data sources were Medline, Embase, Cochrane Library and National Library for health searches on ADR reporting (January 1997 to August 2007) including cross-referenced articles. Twenty-four out of 260 eligible studies were identified and critically assessed. Studies were grouped as follows: i) spontaneous reporting (11); ii) medical chart/note review (2); iii) patient interviews/questionnaires (3); and iv) combination methods including computer-assisted methods (8).

Results:

Using computerized monitoring systems (CMS) to generate signals associated with changes in laboratory results with other methods can improve ADR reporting. Educational interventions combined with reminders and/or prescription card reports can improve hospital-based ADR reporting, and showed short to medium term improvement.

Conclusions:

The use of electronic health data combined with other methods for ADR reporting can improve efficiency and accuracy for detecting ADRs and can be extended to other health care settings. Although methods with educational intervention appear to be effective, few studies have reviewed long-term effects to assess if the improvements can be sustained.

Keywords:

• adverse drug reaction
• reporting
• ADR

Acknowledgements

MM is funded by a post-doctoral fellowship from the National Coordinating Centre for Research Capacity Development, and is an investigator for the FP7 EU-ADR project (http://www.euadr-project.org/). The Department of Primary Care and Social Medicine at Imperial College and Department of Acute Medicine, Division of Medicine is grateful for support from the NIHR Biomedical Research Centre scheme and the NIHR Collaboration for Leadership in Applied Health Research and Care for Northwest London. ST and MM undertook review design and data collection. All authors contributed to critical revisions and writing of the manuscript and approved the final version for publication.