Masterarbeit

Current drug safety measures for thalidomide and their national implementation in Germany and the UK ***

Britta Weingarten (2014)

Summary
Language: English
The historical experience with thalidomide and its known high-risk profile, especially its teratogenic potential, required the imposition of exceptional safety obligations when the substance gained EU-wide approval in 2008. Additional risk minimisation measures (RMMs) – among others a controlled distribution system, a pregnancy prevention programme and the provision of extensive educational material - were therefore mandatory elements that were imposed on MAH and member states with the approval decision. The implementation of these additional risk minimisation measures had to take place on national level. This thesis explains how the implementation was realised in Germany and the United Kingdom. In Germany, the prescribing and dispensing of thalidomide was laid down by changes in national law, providing for the introduction of a specific prescription form for teratogenic substances (T-Rezept) and the registration of the prescribing physicians with the authority. In the UK, the handling of thalidomide is not regulated by national law; however, the country has implemented a document called Prescription Authorisation Form that must accompany every prescription, and pharmacies need to register with the MAH prior to the first dispensing of the drug. To see the bigger picture, the scope of this thesis allows a further short peek to another EU country, France, where the prescribing and dispensing of thalidomide takes place in hospitals only.
This illustrates that the national implementation of the additional risk minimisation measures imposed on EU level differs considerably in outcome and leads to quite divergent pictures in the member states. This concerns not only the national system of prescribing and dispensing, but also the content of the educational material and the role of the respective national regulatory authority in monitoring and data collection. The different ways of implementation take into account the different national healthcare and legal systems and allow customised solutions for the single member states. However, based on the observations of the present thesis, it is concluded that it will be necessary to study the national ways of implementation, their effectiveness and outcomes on patient safety. This is even more urgent since generics will enter the market and a coordinate action and a harmonised approach will then be required for products with the same substance in the same market. Future exchange on EU level would enhance the mutual knowledge about the differences in the member states. This and adequate measures to assess the effectiveness of additional risk minimisation measures (which the new pharmacovigilance legislation provides), as well as more detailed guidance on the implementation of single RMMs like pregnancy prevention programmes, could enhance patient safety for thalidomide products on a common European level.
Pages: 56, Annexes: 4 (21 pages)