The ethical issues of the postmarketing surveillance of drug teratogenicity in Hungary.

PURPOSE

To discuss some ethical issues of the postmarketing surveillance of drug teratogenicity.

METHODS

To describe the three study groups of the Hungarian Case-Control Surveillance of Congenital Abnormalities with the three sources of data collection.

RESULTS

This large population-based surveillance system comprised 22,843 cases with congenital abnormalities, 38,151 population controls without congenital abnormalities and 834 patient controls with Down syndrome between 1980 and 1996. The major ethical issue is connected with personal data protection (confidential handling of data and informed consent). However, the Hungarian experiences displayed the ethical dilemma between the balance of individual and community rights and interest (mandatory notification, mandatory autopsy of infant deaths, personal identification number). Finally the medical consequences of publication bias at the evaluation of drug teratogenicity are presented as these also have some ethical aspects.

CONCLUSION

The ethical issues of postmarketing surveillance of drug teratogenicity show similarities with general epidemiological research but this public health system also has some special aspects.