The Internet and drug safety - What are the implications for pharmacovigilance?

Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Gove rnments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Eva luation of Medicinal Products (EMEA) and other agencies have developed site s containing enormous amounts of information both on pharmacovigilance in g eneral and on specific drugs in particular. Under the US 'Freedom of Inform ation Act' the FDA has put major parts of its adverse event database on lin e. Regulatory documents are also available from the FDA site or from hyperl inks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announceme nt service of these updates. Similarly, the EMEA updates its site frequentl y and publishes extensive material including regulatory documents, guidelin es, European Public Assessment Reports on newly approved medications and ot her useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance y et. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial a nd investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning t o use the Internet. The electronic transmission of safety information, using the standards deve loped by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accep t adverse events from healthcare providers and consumers directly on line u sing an electronic version of its MedWatch form. It is expected that these developments will change the nature of the way pharmacovigilance is carried out. Significant issues will arise from this including privacy concerns. The Eu ropean Union's 1995 directive on 'the protection of individuals with regard to the processing of personal data and on the free movement of such data ( 95/46/EC)' went into effect in October 1998. The enabling legislation now b eing passed by the member states will produce significant changes in the wa y companies and governments handle individual patient data in order to assu re the privacy and protection of individuals.