Questionnaire Survey Among Hospital Pharmacists On The Effects Of The Change In The Legislation Regulating Clinical Trials In Bulgaria

Abstract

The participation of hospital pharmacists in the conduction of clinical trials is important in order to have quality and traceability of storage, dispensing and accountability for the investigational medicinal product (IMP). A mandatory section regulating this process became a part of the local Bulgarian pharmaceutical legislation in 2015. During the last years, many changes in regard to this regulation can be followed in the conduct of clinical research. Hospital pharmacists have become the responsible ones for IMP management as defined in the Good Clinical Practice. They have a vital role in relation to clinical research, which is to safeguard participants, healthcare professionals and trust by ensuring investigational medicinal products are appropriate for use and are procured, handled, stored and used safely and correctly. The following conclusions can be drawn from the analysis of the data from the survey conducted with master pharmacists who are managers of hospital pharmacies: 1.    There is an increase in the number of clinical trials involving master pharmacist teams. 2.    The necessary conditions have been created by the medical establishments to store the tested medicinal products in the hospital pharmacy and to carry out clinical trials. 3.    Master pharmacists and hospital pharmacy managers feel confident and well prepared to participate actively in clinical trials.