title: Guidelines for submitting adverse event reports for publication.
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.
authors.affiliation: William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA. wnkelly@earthlink.net
authors.forename: William N
authors.initials: WN
authors.lastname: Kelly
authors.forename: Felix M
authors.initials: FM
authors.lastname: Arellano
authors.forename: Joanne
authors.initials: J
authors.lastname: Barnes
authors.forename: Ulf
authors.initials: U
authors.lastname: Bergman
authors.forename: Ralph I
authors.initials: RI
authors.lastname: Edwards
authors.forename: Alina M
authors.initials: AM
authors.lastname: Fernandez
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Freedman
authors.forename: David I
authors.initials: DI
authors.lastname: Goldsmith
authors.forename: Kui A
authors.initials: KA
authors.lastname: Huang
authors.forename: Judith K
authors.initials: JK
authors.lastname: Jones
authors.forename: Rachel
authors.initials: R
authors.lastname: McLeay
authors.forename: Nicholas
authors.initials: N
authors.lastname: Moore
authors.forename: Rosie H
authors.initials: RH
authors.lastname: Stather
authors.forename: Thierry
authors.initials: T
authors.lastname: Trenque
authors.forename: William G
authors.initials: WG
authors.lastname: Troutman
authors.forename: Eugene
authors.initials: E
authors.lastname: van Puijenbroek
authors.forename: Frank
authors.initials: F
authors.lastname: Williams
authors.forename: Robert P
authors.initials: RP
authors.lastname: Wise
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D003625:Data Collection / Q000706:statistics & numerical data*; D004812:Epidemiologic Methods; D006801:Humans; D016247:Information Storage and Retrieval / Q000706:statistics & numerical data; D010506:Periodicals as Topic / Q000592:standards*; D011358:Product Surveillance, Postmarketing