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13. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

02.11. bis 03.11.2006, Berlin

Pharmacovigilance between safety of products and safety of use

Meeting Abstract

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  • corresponding author S. Fries - Institute for Health Law and Medical Law, University of Bremen
  • D. Hart - Institute for Health Law and Medical Law, University of Bremen

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 13. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie. Berlin, 02.-03.11.2006. Düsseldorf: German Medical Science GMS Publishing House; 2006. Doc06gaa01

The electronic version of this article is the complete one and can be found online at:

Published: October 30, 2006

© 2006 Fries et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



The Safety of Products and the Safety of Use as two Peculiarities of the Safety of Patients (To this delimitation cf. [1]). When you look at the safety of patients in the context of drugs, you can subdivide this term into the safety of products and the safety of use – or the two correlating branches of law: Pharmaceutical law and medical malpractice law. Pharmacovigilance is in the first place a package of measures to guarantee the safety of the product and thus of the patient. To reach this goal, adverse drug reactions have to be detected and the drugs have– if necessary – to be withdrawn from the market. The knowledge accumulated by measures of pharmacovigilance has subsequently effects on the quality requirements of a medical treatment and thus on the safety of use. So on the one hand one can face an amount of interrelations, but on the other hand it is important to delimit one term selectively to the other.

Example 1: Risk Information (Risikoaufklärung)

The patients’ information in the medical malpractice law is determined by the special circumstances of a drug treatment, which combines questions of product-related safety law and service-related liability law. The product information is the most important source of information to be used by physicians for their risk information. Though, the physician has to participate in education and training and to catch up on the recent news on the risks of drugs. To put it in other words, he has to connect the product-related pharmacovigilance and the service-related treatment with drugs (To this complex cf. [2]).

Example 2: The ADR-term

Both in personal discussions and in viewing recent essays on the topic drug safety, one has to experience a desire for a broader term of adverse drug reactions. A group of physicians want to include adverse reactions arising from intentional and unintentional intoxication, errors in prescription and delivery, therapeutic failure and noncompliance ([3]. For similar enumerations cf. [4], [5]).

The confusion of as different tasks as the safety of products and the safety of use holds many dangers which could be analysed in a deepened presentation.


The examples demonstrate the suspense-packed relationship between the safety of products and the safety of use: In the first example, dealing with risk information, the necessity of interrelation between the two terms is stressed, whereas the second example, envisioning the extent of the ADR-term, emphasizes the importance of a clear differentiation between the two terms of safety.


Hart, MedR 2003, 603 ff.
Hart, Aufklärung bei der Arzneimittelbehandlung, in Rieger (Hrsg.), Lexikon des Arztrechts, 2006 (yet to be published).
Thürmann, Drug Safety 2001, 961 ff., 964
Meier, Unerwünschte Arzneimittelwirkungen (UAW) - Definition und auslösende Faktoren, in Ferber/ Grosdanoff / Kraupp / Lehnert/ Schütz (ed.), Erfassung und Bewertung unerwünschter Wirkungen von Arzneimitteln, Berlin/ New York 1990, S. 3 ff, S. 5
Raschke et al., JAMA 1998, 1317 ff., 1317.