title: The reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.
abstract: Despite the fact that adverse effects are vastly under-reported, spontaneous reporting remains the foundation of pharmacovigilance. A small series of properly documented cases, when very specific, can suffice to constitute a signal. In France, reporting adverse effects to Regional Pharmacovigilance Centres (CRPVs) permits high-quality analysis of pharmacovigilance signals, so that they can be brought to the attention of the national agency responsible for making decisions about drugs, the French Health Products Agency (ANSM). The ANSM can use this information to protect patients by implementing the measures within its power or by initiating a European referral. When a decision taken at the national level concerns a drug marketed in several Member States of the European Union, a "harmonisation" procedure results in a decision taken at community level, applicable in all Member States. This means that a safety issue raised by a single Member State sometimes leads to a decision that protects the population of the entire European Union. But it also means that other European decisions can compel national agencies to allow back onto the market a drug that they sought to withdraw in order to protect their citizens. Negotiations with other Member States, the European Medicines Agency (EMA) and the European Commission must be supported by robust data: this is yet another reason for each country to have its own effective national pharmacovigilance database, the contents of which should be publicly accessible. This is unfortunately not yet the case in France in 2014. It also provides another good reason for healthcare professionals and patients to report adverse effects, so that the details can be recorded in national and European databases.
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D003299:Cooperative Behavior; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000517:prevention & control*; D005060:Europe; D006291:Health Policy / Q000331:legislation & jurisprudence; D006801:Humans; D007391:International Cooperation; D009936:Organizational Innovation; D009937:Organizational Objectives; D016134:Organizational Policy; D061214:Patient Safety / Q000331:legislation & jurisprudence; D060735:Pharmacovigilance; D011050:Policy Making; D011634:Public Health / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D012307:Risk Factors