title: [Pharmacovigiance: The spontaneous reporting system in Switzerland].
abstract: The aim of pharmacovigilance is to continuously update and enhance our knowledge about the safety of medicines in order to improve patient care. The most important method of postmarketing drug surveillance is the spontaneous reporting system. As a rapid alert system it is able to detect unknown and rare as well as insufficiently described reactions and risks. A broad population, including all potential high-risk groups, can be surveilled over a long period of time. The attentiveness of health care professionals as well as the quality and quantity of the information provided are crucial for the success of this system. As no detailed data concerning the number of patients taking a particular medication are available and only a small percentage of adverse drug reactions is reported, it is impossible to draw conclusions about the incidence of adverse drug reactions or the relative risk, which is a big disadvantage. Since 2002 healthcare professionals and pharmaceutical companies are obliged to report adverse drug reactions in accordance with the Swiss Therapeutic Products Act. Six Regional Pharmacovigilance-Centres collect health care professionals' reports, analyze them, enter the data into the national database and forward the anonymized reports to the National Pharmacovigiance-Centre at Swissmedic. There, all reports are screened for signals and, if necessary, appropriate measures are initiated. All reports received by Swissmedic are forwarded to the WHO Collaborating Centre for International Drug Monitoring (Uppsala, Sweden} for inclusion in the international database.
authors.affiliation: 1 Swissmedic, Schweizerisches Heilmittelinstitut, Bern.
authors.forename: Martina
authors.initials: M
authors.lastname: Schäublin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D016903:Drug Monitoring / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000517:prevention & control; D005858:Germany; D006801:Humans; D019221:Mandatory Reporting; D008508:Medication Errors / Q000517:prevention & control / Q000706:statistics & numerical data*; D017891:Pharmacoepidemiology / Q000379:methods; D060735:Pharmacovigilance