Yurt Dışı İlaçlar Hakkında Hastaya Yeterli ve Güvenilir Bilgi Sağlanmamasının İlaç Güvenliği ve Etik Sorunlar Açısından Analizi: Nitel Araştırma

Abstract

Objective: The Imported Medicine List was published for the first time on October 11, 2013 by the Ministry of Health of the Republic of Türkiye. The purpose of importing drugs from abroad is to supply the human medicinal products that are not licensed in our country and/or that are not available in the market for various reasons despite being licensed, on prescription for use in the diagnosis and treatment of diseases in emergencies. The aim of this qualitative research is to examine the information presented about these medicines on the imported medicine list and to evaluate the possible ethical problems that may be caused by insufficient information presentation. Material and Methods: The medicines on the 25/02/2022 Turkish Medicines and Medical Devices Agency imported medicine list were included in the analysis. First, between the dates 07-27 February 2022, it was determined whether these medicines had short product information and instructions for use on the Turkish Medicines and Medical Devices Agency website by searching for active substances. Then, all medicines were searched in the RxMediaPharma database by the active substance name, and those not found by this method were searched by the ATC code. Finally, the ethical implications of the issue were discussed and suggestions were presented. Results: The change in the number of active substances in the imported medicine list by years and the presence of generic and medicine-specific information in different Informed Consent Forms have been determined. The ambiguity of the criteria for keeping the unlicensed essential drugs used to meet the priority health needs of the population in the foreign-dependent list has been determined. Conclusion: The risks to patients' right to autonomy have been determined as the result of the lack of sufficient, adequate, and accurate information in the Informed Consent Forms carries risks for patients' rights to autonomy.