Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Information in the Internet about Medicinal Products Provided by Governmental Institutions in Germany, Great Britain and the United States

Dr. Jan Dütemeyer (Abschlußjahr: 2001)

The aim of this master thesis is to investigate the public information from governmental institutions, i.e. state owned or state related institutions, which professionals and non-professionals can search out. They should be able to obtain the information at Internet sites with or without passwords which should be gratuitous. The information should be sought and evaluated in three countries: Germany, Great Britain and the United States of America.

Comparing the information about medicinal products presented by the national authorities for regulatory affairs in Germany (BfArM), Great Britain (MCA) and the United States (FDA) reveals some differences between the three countries. The BfArM and the MCA give regulatory guidance, i.e. providing legislation like laws and guidelines. They also offer safety related information, for example knowledge about side effects and the consequential actions of the authorities like recalls, withdrawals or changing of Patient information leaflets (PIL). In addition the MCA presents "Dear Doctor" letters and a "Safety Bulletin" which is sent quarterly to the health professionals. For very few well-known products complete PIL's can be found at the BfArM ("Mustertexte"), but not at the MCA. On the other hand the MCA enumerates all approved drugs in two lists (prescription and non-prescription), while the BfArM does not offer such an overview. In Germany only the PEI presents an approval list for medicinal products regulated by the PEI (immuno-)biological and hematobiological drugs).

In contrast to the BfArM and MCA, nearly every kind of medicinal information can be found at the FDA web site, which is regulated by the American authority. For example, this site informs about assessment reports, approval letters, approval lists, warning letters sent to the companies, packaging information (labelling) and meeting protocols, which are presented by the MCA as well. Although time-consuming, a very detailed picture about the characteristics of a drug can be obtained, which is difficult to get at the sites of the MCA or of the BfArM. But the FDA page is not structured highly systematically, which can be explained by the extreme quantity of facts offered. The systematically approach seems to be easier at the MCA and particular at the BfArM.

On the other hand the FDA and MCA have installed search engines which explore their web sites. Due to this service special information is quickly found. An exception are the officially approved PIL's and SmPC's (Summary of product characteristics). The PIL's cannot be found by the search engines, although in the US they are available as in pdf-files of FDA assessment reports. Self edited summaries of PIL's can be obtained by other institutions than the regulatory authorities, that is in Germany for certain indications by RKI (concerning HIV), in the United Kingdom by NICE for some medicinal products and in the United States by the NLM.

A feature which is not provided by the MCA and the BfArM but by the FDA is particular health and drug information for non-professionals as well as comments from consumers and patients. Similar drug information is also given by numerous other governmental institutions in the United States.

Nevertheless, scientific information is also presented beside the regulatory authorities in all of the countries. Each country provides access to online libraries (DIMDI, NLM, NeLH), but often showing abstracts and not the complete publications. In addition for certain medicinal products in Great Britain NICE presents particularised data, even cost assessments, which is done partially by the MCA, too. Also the Department of Health in the UK publishes (scientific) recommendations for medicinal products, which is given predominantly by the FDA in the US. In Germany such publications are hardly found by governmental institutions.

In all countries there are no differences in obtaining information about drugs provided by state owned or related institutions, no matter whether professionals or nonprofessionals, prescription or non-prescription drugs are concerned. Passwords do not exist to separate information for health professional from that for consumers and patients. If institutions differentiate access for various groups, the accesses are not protected by passwords. This should be seen as a service, so that professionals and others can find their information more easily.

Generally, it is obvious that in the United States much more information about medicinal products is available than in Germany and Great Britain. One possible explanation are the different advertising laws in the US and in Europe.

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