Actors in Spontaneous Reporting

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Chapter: Pharmacovigilance: Spontaneous Reporting in Germany

Spontaneous adverse drug reaction (ADR) reporting began in Germany in the first half of the 1960s.



In Germany, two national agencies are responsible for licensing and pharmacovigilance activities for human medicinal products: the Federal Institute for Drugs and Medical Devices (BfArM), dealing with all chemically defined medicinal products, herbal drugs and drugs used in complementary medicine, and the Paul-Ehrlich-Institute (PEI), dealing with medic-inal products containing active ingredients derived from blood, vaccines, drugs containing antibodies, devitalised tissue implants and innovative gene ther-apy products. In pharmacovigilance issues, they act on a nearly identical legal basis and have similar instruments for pharmacovigilance measures at their disposal.


Spontaneous adverse drug reaction (ADR) reporting began in Germany in the first half of the 1960s. At that time, no national drug safety agency had been established in the Federal Republic of Germany (West Germany) with an official mandate and sufficient expertise and resources to systematically collect and evaluate ADR reports. Since 1978, the responsibilities for collecting ADR reports have been clarified, and the actors now play different roles within the system.

A three-way reporting system is in place. Health-care professionals can report suspected cases of ADRs (1) directly to one of the two national agencies for human medicinal products, (2) to the Drug Commis-sion of the German Medical Association, mainly used by physicians and not by other healthcare profession-als, and (3) to the MAH of the medicinal product suspected to have caused the ADR. However, both national drug agencies are the final and only institu-tion where the ADR reports are collected in unique databases. Legal reporting requirements for the MAH and contractual rules between the national agencies and the Drug Commission of the Medical Association assure that all single case reports are stored in central databases, whichever reporting route is chosen by the individual reporter.


Historically, the Drug Commission of the German Medical Association began in 1963 with collecting spontaneous ADR reports. This was a consequence of the thalidomide disaster. The Drug Commission of the German Medical Association exclusively receives reports directly from physicians. They give quick confirmation of the receipt of the report and, if appro-priate, provide additional information to the reporter. The total number of reports received in this manner amounts to about 2000 per year.

The Drug Commission of the German Medical Asso-ciation of today is also an expert panel of experi-enced clinicians with a smaller core group handling the incoming reports and making preliminary case assess-ments with regard to seriousness, causality and report-ing quality. The Drug Commission of the German Medical Association is a close and regular partner of BfArM and PEI. Both national agencies consult the Drug Commission of the German Medical Associa-tion with regard to new or ongoing safety issues and ask for scientific advice. On the contrary, the Drug Commission of the German Medical Association has access to BfArM’s national ADR database and may publish statements based on data evaluation from this database in their own responsibility. There are contrac-tual and legal rules in place that regulate co-operation between the competent authorities and the Drug Commission of the German Medical Association.


To improve the national pharmacovigilance system, i.e. to broaden the tools on how to get early and proper information on new or serious ADRs that may require regulatory actions, BfArM and PEI will establish a network of regional pharmacovigilance centres. Pharmacovigilance centres will not substi-tute the spontaneous reporting system (SRS) but will add an additional instrument for detecting ADRs not recognised so far, including frequency estimates. BfArM had in mind the French pharmacovigilance system established in the early 1980s. Because there was a need to investigate whether the French system could be transferred to Germany in parts or entirely, BfArM financed a pilot project to test and evaluate the feasibility under the specific conditions of the healthcare system in Germany that is different from the system in France. This project ran for 8 years (from 1996 to 2004) and comprised the following main tasks:

·     To register all patients with pre-defined trigger diagnoses hospitalised e.g. blood dyscrasias, seri-ous allergic reactions, renal and liver dysfunctions, central nervous system (CNS) effects, etc., but excluding elective hospital stays.

·     To select patients with regard to whether the reason for hospitalisation could be an ADR, which would be serious per definition, and then to completely document, follow-up and assess the case.

·     To increase and ensure high quality of these reports by a separate quality assurance unit and to report these cases to the national competent authorities, i.e. BfArM or PEI.

·     To make estimates on the frequencies of these ADRs on the basis of exact prescription data received from the regional health insurance and pharmacy reimbursement systems, covering the population within a circumscribed region of the respective hospital.

Four university hospitals in East Germany with the support from an information technology (IT) unit in Munich and the quality assurance unit in Wuppertal took part in this project. Important experiences have been gathered during this pilot phase and will now be implemented in a tailored system in Germany. There will be about six to seven regional pharmacovigi-lance centres of this type covering a population of at least 1.5 million inhabitants. Another five centres of a different type will join the network within the next few years. They will have specific tasks and structures, and two of them are already working: (1) a case– control surveillance system looking in a quantita-tively defined population for cases of rare or very rare diseases (presently blood dyscrasias) that are predom-inantly caused by exogenous agents including drugs, comparing these with a control group from the same population, and (2) a register of non-systematically reported drug exposure during pregnancy with follow-up and pregnancy outcome surveillance. Additional pharmacovigilance centres are planned. They will be concerned with the collection of ADR reports in paediatric and psychiatric hospital units. The pharma-covigilance centres’ network will also include a unit for statistical analyses and another for developing new methods for the quantification of drug risks.

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