Abstract

Objective: Iran Food and Drug Administration (IFDA) has the mission to regulate all aspects of pharmaceutical market including registration of the new medicines. Iran Drug Selection Committee has the responsibility to maintain and revise Iran Medicine List (IML). The National law has banned production, importation, distribution, and prescription of medicines not included in IML. Although, IFDA policy makers have created a mechanism to provide medicines not included in the list but might be essential for the treatment of specific patients. Methods: A cross-sectional study was carried out on prescription of out of IML medicines during the year 2015. This study was conducted on a total of 1375 application forms received by Secretariat of Iran Drug Selection Committee for prescription of out of IML medicines. Findings: It has been shown that among 402 specialist physicians, the most out of IML medicine were prescribed by oncologist/hematologist. Antineoplastic and immunomodulating agents were the most frequently prescribed medicines both in terms of number and diversity. According to the collected data, more than 76 of all medicines were supplied by only 4 out of 25 pharmaceutical companies in 1 year. Conclusion: Results of this study show that despite its early intention this mechanism is easily abused by some pharmaceutical companies as an unethical way of induced demand and marketing of their products. Therefore, IFDA decision makers should revise this mechanism and decide based on its real benefits and harms both to the patients and Iran national health system.