German health ministry launches plan to improve drug safety

The German Health Ministry has announced plans for improving drug safety (Arzneimittel-therapie-sicherheit, AMTS) in conjunction with the German medical association's drug commission (Arzneimittelkommission der Deutschen arzteschaft, Akda).

The plan aims to improve awareness of drug safety issues among medical professionals and patients, improve drug safety information and promote drug safety research.

The initiative was sparked in part by expert commission reports in 2003 and 2007 urging greater attention be paid to drug safety in Germany, particularly in terms of adverse effects.

The Akda document addresses not only patients failing to take their medication as directed, but also systemic problems with the way medicines are prescribed and administered - including doctors intentionally prescribing drugs beyond the scope of the label if risk-benefit considerations merit it.

Starting in 2008, the German Health Ministry will hold a workshop for healthcare professionals, pharmacists and others, on ways to best to inform patients about using medicines safely.

The measures in the plan include identifying high-risk medications, reassessing dosage recommendations, and approaches that should be taken with new drugs.

In the second half of 2008, the German Institute for Pharmaceuticals and Medical Products (Bundesinstitut fuer Arzneimittel und Medizinprodukte, BfArM) and the Paul Erlich Institute (PEI) will submit a position paper on the labelling and packaging of medicines containing new active ingredients.

In early 2009, the Health Ministry will hold workshops for health care professionals, pharmaceuticals' industry representatives and patients about the pros and cons of specific labelling for new medicines.

The Association of German pharmacists (Allgemeiner Bund Deutscher Apothekerverbaende, ABDA), the Association of hospital pharmacists (Allgemeiner Bund Deutscher Krankenhausapotheken, ADKA) and the Akda are expected in the first half of 2008 to identify "sound-alike" and "look-alike" drugs and present proposals to prevent confusion between these products in the first half of 2009.

Next year BfArM will assess legibility of pack inserts and make recommendations based on its evaluation.

A number of authorities are to be involved in continuing to improve the access to information about drug safety by patients and health care professionals alike. The German Institute for Information and Documentation in Medicine (Deutsches Institut fuer medizinische Dokumentation und Information, DIMDI) is expected to play a key role in implementing these measures in 2008.

In the coming two years, a series of measures will also be implemented to require additional training for doctors and pharmacists and to ensure that such training is included in educational programmes. The German Health Ministry, Germany's Federal Chamber of Doctors (Bundesaerztekammer, BaK) and Federal Chamber of Pharmacists (Bundesapothekerkammer, BAK), the Adka and the ABDA will share responsibility for implementing these plans.

In the first half of 2008, the German Research Ministry is also expected to consider including drug safety in its health research programmes.