A clinical research site pharmacy for the division of AIDS sponsored clinical trials in a low middle income country

Abstract

This review article provides information on the role of clinical research site (CRS) Pharmacies in supporting the division of AIDS (DAIDS)-sponsored clinical trials at the CRS, their legislative framework, and how they differ from community pharmacies. These pharmacies are relatively few, and little information is available about their operation, setup, and requirements in low-and middle-income countries (LMICs). The information in this article is pertinent to pharmacy associations and regulators who formulate policies and guidelines and to pharmacy professionals eager to enhance their skills and competencies through knowledge sharing to improve the quality of healthcare services. Moreover, this information is relevant in establishing a CRS pharmacy and understanding its interaction with various administrative and financial institutions. This article provides information on how CRS pharmacies achieve uninterrupted power supply for investigational medicinal products (IMP) throughout the year, the sponsor and regulatory requirements for the CRS pharmacy and the processes for IMP shipment, from its dispensation to the study participants. The article also provides information on quality control and assurance processes for maintaining a CRS pharmacy. CRS pharmacies in LMICs have unique requirements, operations, services, and setups, and regulatory authorities must develop policies and guidelines that align with these distinct features. More so, leveraging the existing CRS pharmacies to disseminate skills and knowledge to trainees, community pharmacies, and other medicine outlets can significantly enhance the quality of health services delivered to the community.