Ethical issues related to retrospective drug utilization studies in South Africa.
OBJECTIVE
The purpose of the manuscript is to discuss the ethical issues related to pharamacoepidemiological research in South Africa, with specific emphasis on three recently performed retrospective drug utilization studies.


METHODS
Ethical considerations relating to three retrospective drug utilization studies on hyperlipidaemia, diabetes and tricyclic antidepressants are discussed.


RESULTS
Computerized medication records were obtained from three different organizations after formal proposals had been submitted. The information contained in the data sets varied, and in some instances, a fair amount of manual coding had to be performed to make the data useable for research purposes. The research was not sponsored by the private pharmaceutical sector and this minimized the potential for any bias in the studies. Data privacy and confidentiality were maintained at all times. No patient could be traced, and it was also not possible to determine which medical practitioners were involved in the prescribing of the drugs.


CONCLUSIONS
Retrospective drug utilization studies are a relatively easy, inexpensive and uncomplicated method to comment on the prescribing of drugs in large patient populations provided that ethical principles related to confidentiality and data privacy are adhered to.
Truter
I
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Department of Pharmacy, University of Port Elizabeth, PO Box 1600, Port Elizabeth, 6000, South Africa. pmaiit@upe.ac.za
D001675:Bioethics; D003219:Confidentiality; D016208:Databases, Factual; D004363:Drug Utilization; D006801:Humans; D017891:Pharmacoepidemiology / Q000592:standards*; D012106:Research / Q000592:standards; D012189:Retrospective Studies; D013019:South Africa