Numéro Thérapie Volume 64, Numéro 4, Juillet-Août 2009 Page(s) 289 - 294 Section Pharmacovigilance/Pharmacovigilance DOI http://dx.doi.org/10.2515/therapie/2009041 Publié en ligne 07 Octobre 2009

Thérapie 2009 Juillet-Août; 64 (4): 289-294
DOI: 10.2515/therapie/2009041

Guidelines for Submitting Adverse Event Reports for Publication

Recommandations pour la publication des événements indésirables

William Kelly¹, Felix Arellano², Joanne Barnes³, Ulf Bergman⁴, Ralph Edwards⁵, Alina Fernandez⁶, Stephen Freedman⁷, David Goldsmith⁸, Kui Huang⁹, Judith Jones¹⁰, Rachel McLeay¹¹, Nicholas Moore¹², Rosie Stather¹¹, Thierry Trenque¹³, William Troutman¹⁴, Eugène van Puijenbroek¹⁵, Frank Williams¹⁶ and Robert Wise<sup>17

1</sup>  William N. Kelly Consulting Inc., Oldsmar, Florida, USA
²  Risk Management Resources, Dip Pharm Med, Bridgewater, NJ, USA & Zaragoza, Spain
³  University of Auckland, Auckland, New Zealand
⁴  Karolinska Insitute, Stockholm, Sweden
⁵  Uppsala Monitoring Centre, Uppsala, Sweden
⁶  TAP Pharmaceutical Products, Inc., Lake Forest, Illinois, USA
⁷  The Hospital for Sick Children, Toronto, Canada
⁸  Goldsmith Pharmacovigilance and Systems, New York, USA
⁹  Pfizer Pharmaceuticals, New York, USA
¹⁰  The Dedge Group, Ltd., Arlington, VA, USA
¹¹  Wolters Kluwer Health, Auckland, New Zealand
¹²  Université Victor Segalen, Bordeaux, France
¹³  Centre Hospitalier Universitaire, Reims, France
¹⁴  University of New Mexico, Albuquerque, New Mexico, USA
¹⁵  Netherlands Pharmacovigilance Centre, Hertogenbosch, The Netherlands
¹⁶  United States Navy, Bethesda, USA
¹⁷  United States Food and Drug Aministration, Rockeville, USA

Text received 11 june 2009; accepted 30 june 2009; published online 7 October 2009

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' 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.

Key words: guidelines -- adverse -- event -- report


© Société Française de Pharmacologie et de Thérapeutique 2009

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