Guidelines for submitting adverse event reports for publication.
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' 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 Consulting Inc., Oldsmar, Florida, USA.
William
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Kelly
Felix
F
Arellano
Joanne
J
Barnes
Ulf
U
Bergman
Ralph
R
Edwards
Alina
A
Fernandez
Stephen
S
Freedman
David
D
Goldsmith
Kui
K
Huang
Judith
J
Jones
Rachel
R
McLeay
Nicholas
N
Moore
Rosie
R
Stather
Thierry
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Trenque
William
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Troutman
Eugène
E
van Puijenbroek
Frank
F
Williams
Robert
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Wise
D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D000529:Complementary Therapies / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008297:Male; D028321:Plant Preparations / Q000009:adverse effects; D011643:Publishing / Q000592:standards*
D028321:Plant Preparations