[Safety of medicinal products and reporting of adverse drug reactions].
The authors present the role of reports of adverse drug reactions (ADR) in pharmacotherapy. Worldwide monitoring of ADRs together with the European and Polish pharmacovigilance systems are discussed. Some practical information concerning the report form is described i.e. types of reactions, definition of a serious adverse drug reaction, minimum information for the report validation, handling of reports.
Skibicka
Izabela
I
Wydział Monitorowania Niepozadanych Działań Produktów Leczniczych Urzedu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Warsaw. izabela.skibicka@urpl.gov.pl
Maciejczyk
Agata
A
D016907:Adverse Drug Reaction Reporting Systems; D016903:Drug Monitoring / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D011044:Poland; D011358:Product Surveillance, Postmarketing / Q000379:methods*