Review article
History of Adverse Drug Reaction Reporting in Croatia
Igor Francetić
; Medicinski fakultet Sveučilišta u Zagrebu
Abstract
WHO Program for spontaneous adverse drug reactions (ADR) monitoring started in 1970. WHO Program followed a Pilot program for ADR monitoring organized in the USA and initiated by the well known talidomide catastrophy. In 1974, we joined the WHO Program as the 18th participating country. At the very beginning our main task was to disseminate and spread the knowledge and unbiased information on ADR in order to stimulate both physicians and pharmacists to start reporting ADRs to the National Center. The National Center for ADR collected reports from the entire country during the first few years. For that purpose, a simple reporting form was printed and distributed throughout the country. Each report was checked for completeness and any causality relationship between the drug and ADR was estimated using the Karch and Lasagna method. Every report was translated, a WHO form was filled out and sent to Uppsala WHO Center. It is important to note that each reporting physician or pharmacist received a personal letter with relevant data on the drug that caused ADR and advice on alternative drugs that may be used by that particular patient.
Keywords
ADR monitoring; National Center for ADR monitoring; ADR report form; personal letter
Hrčak ID:
185262
URI
Publication date:
26.7.2017.
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