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 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. Copyright © 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.

A critical reappraisal of the current data on drug-induced linear immunoglobulin A bullous dermatosis: A real and separate nosological entity?

“…54 Recently, an international Task Force on behalf of the International Society for Pharmacoepidemiology and the International Society of Pharmacovigilance developed guidelines based upon the validated work of Naranjo that includes all the elements ''required'' in constructing an ADR report for publication. 58 Although in the majority of the reviewed cases the suspected offending drug was withdrawn (dechallenge), spontaneous resolution with any additional systemic therapy was reached in fewer than 50% of cases, CDR testing protocol was performed in about 10%, while the Naranjo algorithm was carried out in fewer than 4%. In addition, only very few cases (13 [25%]) did not report any concurrent medications.…”

Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal

“…The analysis of the case reports revealed that the case reports followed most of the criteria mentioned by the ISoP/ ISPE 5. However, in few reports the dosage and the patient disposition were not mentioned properly.…”

“…The Erice Declaration on Communicating Drug Safety Information, published in 1997, provides a vision of vigorous, open, ethical patient-centered communications on drug safety 4. Recently, the International Society of Pharmacovigilance (ISoP) and International Society of Pharmacoepidemiology (ISPE) has developed guidelines for submitting adverse event reports for publication 5. This guideline provides the minimum criteria required in a scientific publication related to individual case reports.…”

A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials

“…1 Common processing strategy used by clinicians when assessing serious adverse events information which reduce the total amount of information processed [19]. Ultimately, if the goal is to produce better quality safety data from clinical trials [20][21][22][23], this is clearly an issue that needs to be addressed.…”