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

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)635-639
Number of pages5
JournalPharmacoepidemiology and Drug Safety
Volume10
Issue number7
DOIs
Publication statusPublished - 2001

Fingerprint

Postmarketing Product Surveillance
Hungary
Ethics
Population Surveillance
Computer Security
Publication Bias
Drug Evaluation
Population Control
Down Syndrome
Informed Consent
Autopsy

Keywords

  • Confidential handling of data and informed consent
  • Drug teratogenicity
  • Personal data protection
  • Postmarketing surveillance

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

The ethical issues of the postmarketing surveillance of drug teratogenicity in Hungary. / Czeizel, E.

In: Pharmacoepidemiology and Drug Safety, Vol. 10, No. 7, 2001, p. 635-639.

Research output: Contribution to journalArticle

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