Abstract
Background
Spontaneous reporting of adverse drug reactions (ADRs) is one approach to increasing our knowledge on the risks of drugs in clinical practice. Under-reporting is a shortcoming of this system.
Objectives
To evaluate if repeated e-mails with attachments on ADR information can affect (1) the reporting of ADRs and (2) the quality of the ADR reports.
Methods
All 117 heads of primary health care units in the region of Västra Götaland in Sweden were randomly allocated (1:1) to an intervention group or a control group. The intervention consisted of e-mails with attachments sent out to each of the 117 heads in January, May and September 2007. These e-mails included (1) the heading “Every ADR report is important”, (2) a current case report of an ADR and (3) instructions on how to report. The number of reports from each primary health care unit run by the same head was registered, as was the quality of the report. The quality was defined as high if the ADR was (1) serious, (2) unexpected or (3) related to the use of new drugs and not labeled as common in the summary of product characteristics. All other reports were regarded as low-quality reports.
Results
The total number of reports increased from 89 in 2006 to 111 in 2007 (P = 0.037). No difference in the number of reports between intervention (n = 56) and control (n = 55) units could be detected. The proportion of high-quality reports before and after the intervention was 36 and 48%, respectively (intervention, P = 0.11) and 40 and 36%, respectively (control, P = 0.55).
Conclusions
No apparent effect of repeated ADR e-mails on the reporting of ADRs could be detected, although an increase in the reporting rate in general was noted.
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Acknowledgments
The authors are grateful to John Karlsson, Department of Clinical Pharmacology, for the randomization procedure. The study was supported by the Swedish Foundation for Strategic Research and The Swedish Society of Medicine.
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Johansson, ML., Brunlöf, G., Edward, C. et al. Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports. Eur J Clin Pharmacol 65, 511–514 (2009). https://doi.org/10.1007/s00228-008-0603-6
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DOI: https://doi.org/10.1007/s00228-008-0603-6