Ethical challenges in pharmacoepidemiological research in Colombia.

PURPOSE: To illustrate and to discuss some ethical challenges encountered during pharmacoepidemiological research in a developing country (Colombia), as well as the decisions made to solve them. METHODS: The authors in Bogotá describe three recent studies. The first one collected data from clinical records to evaluate the prescriptions patterns in recently graduated physicians. The second used an interrupted time series design, with a set of observations prior and after a combined intervention, to assess whether it improved the quality of intravenous antibiotic prescribing practices in a university-based hospital. The third evaluated pharmacists' advice in childhood acute respiratory infection and acute diarrhea through a community survey, followed by focus groups and in-depth interviews of key informers. RESULTS: The ethical issues raised by these studies include the need for obtaining informed consent from participants (physicians in Study 1 and drug sellers in Study 3), deciding when to intervene in case of gross prescription mistakes detected during the collection of data as part of the time series assessment (Study 2), the use of simulated clients to collect data in the community survey, and the use of study resources to buy, in some cases, useless medications (Study 3). CONCLUSION: Although ethical challenges in pharmacoepidemiology in non-industrialized countries like Colombia may be different from those in developed nations, ethical principles that guide research remain the same. The processes to safeguard these principles in Colombia for virtually all research are also universal in nature, and include the ethical review committee, subject privacy, informed consent, and disclosure of funding sources.