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