Ethical issues arising in pharmacoepidemiologic research in a community hospital in Crete, Greece.

This paper presents the various issues encountered in planning, designing, performing, and reporting pharmacoepidemiologic research. Five hundred and fifty-one indigent patients insured by Social Care visited the Hospital Pharmacy of Chania General Hospital, and were compared with 551 patients insured under Social Security funds who visited three community pharmacies. The study had no external funding. Before we started the study, we officially sought approval from the Scientific Committee of our Hospital and from the local Pharmaceutical Association. We asked also for approval from the Medical School of the University of Crete. Patient privacy was of great concern in the design and performance of the study. The law in Greece, according to the directives of European Union, affects the way we use records in hospitals and protect patient rights. After these studies were completed, we made proposals to the authorities concerning continuous health education for both patients and health workers. Pharmacoepidemiologic research is difficult in hospitals outside universities or institutions, because of the lack of adequate funding and grants to support research staff.