Ethical issues in pharmacoepidemiologic research using Saskatchewan administrative health care utilization data.

PURPOSE: To describe the process of obtaining access to the administrative health care utilization data of the Canadian province of Saskatchewan and the ethical issues involved.

METHODS

The report focuses on the process of obtaining data for two recent studies. In the first, associations between aplastic anemia and agranulocytosis and prior drug use were evaluated, while the second is an examination of anti-arrhythmia drug utilization. In these studies, data from files containing computerized information on prescription drug use, hospitalizations, physician services and cancer registrations were linked together and also with information from hospital charts, physician records and death registrations.

RESULTS

Data on individual patients are available from the Saskatchewan data-files after the removal of identifying variables, and access to external information from hospitals, physicians, death registrations and the patients themselves is possible. However, researchers must accept that data considered to be only indirectly relevant to the objectives of the study or which, due to small numbers, may potentially identify either patients or physicians will only be released in aggregate form.

CONCLUSIONS

Access to the Saskatchewan data-files and to external information from hospitals, physicians and death registrations is normally straightforward. Restrictions that are applied are discussed.