Guidelines for Submitting Adverse Event Reports for Publication
- 1 January 2007
- journal article
- guideline
- Published by Springer Science and Business Media LLC in Drug Safety
- Vol. 30 (5), 367-373
- https://doi.org/10.2165/00002018-200730050-00001
Abstract
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies’ websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.Keywords
This publication has 20 references indexed in Scilit:
- Case reports of suspected adverse drug reactions—systematic literature survey of follow-upBMJ, 2006
- Guidelines for anecdotes might include more informationBMJ, 2003
- Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuriesJournal of Clinical Epidemiology, 1993
- Criteria of drug-induced liver disorders: Report of an International Consensus MeetingJournal of Hepatology, 1990
- Quality criteria for early signals of possible adverse drug reactionsThe Lancet, 1990
- Drug points: Addendum to guidelines for reporting adverse drug reactionsBMJ, 1988
- ROLE OF MEDICAL JOURNALS IN ADVERSE REACTION ALERTSThe Lancet, 1985
- Standards for reporting adverse drug reactions.BMJ, 1983
- The case report. I. Guidelines for preparationInternational Journal of Cardiology, 1983
- How good are articles on adverse drug reactions?BMJ, 1982