Document Detail

Guidelines for submitting adverse event reports for publication.
MedLine Citation:
PMID:  17471601     Owner:  NLM     Status:  MEDLINE    
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 sufficient 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' web sites. 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.
William N Kelly; Felix M Arellano; Joanne Barnes; Ulf Bergman; I Ralph Edwards; Alina M Fernandez; Stephen B Freedman; David I Goldsmith; Kui Huang; Judith K Jones; Rachel McLeay; Nicholas Moore; Rosie H Stather; Thierry Trenque; William G Troutman; Eugene van Puijenbroek; Frank Williams; Robert P Wise; ;
Publication Detail:
Type:  Journal Article; Practice Guideline    
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  16     ISSN:  1053-8569     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-05-07     Completed Date:  2007-09-11     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  581-7     Citation Subset:  IM    
Copyright Information:
Copyright 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.
William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems / standards*
Diagnosis, Differential
Drug Toxicity / chemically induced,  diagnosis*
Drug-Induced Liver Injury
Liver Diseases / diagnosis
Pharmaceutical Preparations / administration & dosage,  adverse effects
Publishing / standards*
Reg. No./Substance:
0/Pharmaceutical Preparations

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