南非回顾性药物利用研究相关的伦理问题。

Ethical issues related to retrospective drug utilization studies in South Africa.

作者信息

Truter I

机构信息

Department of Pharmacy, University of Port Elizabeth, PO Box 1600, Port Elizabeth, 6000, South Africa.

出版信息

Pharmacoepidemiol Drug Saf. 2001 Dec;10(7):679-83. doi: 10.1002/pds.647.

DOI:10.1002/pds.647

PMID:11980261

Abstract

PURPOSE

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.

摘要

目的

本文的目的是讨论与南非药物流行病学研究相关的伦理问题，特别强调三项近期开展的回顾性药物利用研究。

方法

讨论了与三项关于高脂血症、糖尿病和三环类抗抑郁药的回顾性药物利用研究相关的伦理考量。

结果

在提交正式提案后，从三个不同组织获取了计算机化的用药记录。数据集中包含的信息各不相同，在某些情况下，必须进行大量人工编码才能使数据可用于研究目的。该研究并非由私营制药行业赞助，这最大限度地减少了研究中出现任何偏差的可能性。数据隐私和保密性在任何时候都得到了维护。无法追踪到任何患者，也无法确定哪些医生参与了这些药物的处方开具。