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Ethical issues related to retrospective drug utilization studies in South Africa
Author(s) -
Truter Ilse
Publication year - 2001
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.647
Subject(s) - medicine , pharmacoepidemiology , retrospective cohort study , drug , intensive care medicine , family medicine , pharmacology , medical prescription
Purpose The purpose of the manuscript is to discuss the ethical issues related to pharmacoepidemiological 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. Copyright © 2001 John Wiley & Sons, Ltd.