• Top
• Background
• Methods
• Results
• Discussion
• References

Background

The term pharmacovigilance is defined as watchfulness in guarding against danger from drugs or providing for safety of drugs (Royer and Ollagnier, ESOP Conference 1998). In most countries pharmacovigilance is practised primarily as a spontaneous ADR reporting system. All doctors should be aware that ADR reporting is part of overall patient care.

In Germany, general practitioners and clinicians are bound by law to report serious and unexpected adverse drug reactions (ADR) to the Federal Institute for Drugs and Medical Devices (BfArM). However, there is a considerable degree of under-reporting in the spontaneous ADR reporting scheme.

In 1997 a multicentre network was established whose primary objective is to monitor, evaluate and report ADRs which occur in general practice and lead to hospital admission. As part of this network, a regional Pharmacovigilance Centre was begun at the Department of Clinical Pharmacology of University Rostock. There are two hospitals; effective co-operation could be established with both. The number of patients of these two hospitals is representative for approximately 300,000 inhabitants in the region.

Methods

Twice a week, specially trained physicians at the Pharmacovigilance Centre prospectively screen all patients with high-risk diagnostic groups on all wards of the Departments of Medicine at the two hospitals. Patients considered to be at risk are asked in an interview for details of drug consumption, including the use of over-the-counter drugs. In rare cases, the data are collected by the hospital physicians or obtained from hospital records. In Germany the level of data security is so high that it is impossible to obtain this information from data banks. Whether or not the hospital admission is due to a suspected ADR is assessed using the rating scale developed by Bégaud et al.[1] for each drug taken. ADRs are reported to the BfArM.

Results

Underreporting of ADRs was drastically reduced by the monitoring of ADRs. The monthly detected number of ADRs increased from about 5, at the beginning, to about 30 to 40 at present. Until the end of December 2001, about 1700 cases of ADR in Rostock were registered. On the basis of this increasing tendency, it will be possible to obtain information on ADR incidences in the investigated region.

Many ADRs are also suspected to be associated with prescription perils (errors increasing the risk for the patient) in the period preceding hospital admission: dangerous drug combinations, wrong dosages and prescription of a drug despite existing contraindications. Sometimes recommended control investigations are neglected. Using the example of NSAID or ASA associated gastrointestinal bleeding, it is possible to demonstrate that in the Rostock region additional administration of prophylactic drugs (PPI) was not taken into account, even in patients with three or more risk factors, in which PPIs are highly recommended in order to reduce the risk of gastrointestinal ADRs.

Discussion

The significance of prescription perils is often underestimated, especially in the public view. Fatal consequences of therapeutic use of a drug were often only associated with the drug alone, regardless of whether or not associated with a prescription error. In Germany the avoidance of such prescription errors is merely regarded as a matter for every medical doctor to deal with on his own. It is therefore very difficult to find the financial resources necessary for contributing to more overall security in the field of drug prescription. It is, however, very important to do everything possible to avoid prescription errors and in this way to avoid many ADRs. The German pharmacovigilance network could be a suitable screening tool for detecting prescription perils as an important first step towards eliminating them.

References

1. Begaud B, Evreux JC, Jouglard J, Lagier G: Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France.

   Therapie 1985, 40:111-118. PubMed Abstract

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