A Systematic Evaluation of Regulations for Radiopharmacy Practice in Kenya in Comparison to International Guidelines

Abstract

Introduction: Radiopharmacy is a branch of nuclear medicine that involves the preparation and dispensing of radiopharmaceuticals for diagnostic, therapeutic or research applications. It combines the skills involved in pharmaceutical preparation and handling of radioactive substances. Radiopharmaceuticals find importance in the identification of a disease in its most basic stages and can precisely locate diseased tissue in a patient often before the disease becomes symptomatic or leads to abnormalities that can be detected with other diagnostic tests. Radiopharmacy is well established and practiced in several sites in the country such as at the Aga Khan University Hospital Nairobi, and with new sites emerging such as at the Kenyatta University Teaching, Referral and Research Hospital, however growth of the sector has been slow. One of the reasons for the slow growth is the lack of local regulations for the field. As medicinal products, the production and handling of radiopharmaceuticals should comply with the rules for manufacturing sterile products intended for human medicinal use, however their radioactivity poses challenges in their management and requires further guidance. The local drug regulatory authority, Pharmacy and Poisons Board has published several guidelines for good practices in the pharmaceutical industry, referred to as GXP guidelines, on the manufacture, storage, distribution, dispensing and waste disposal of pharmaceutical products. However, these do not consider the unique requirements of radiopharmaceuticals. This study aimed to explore the creation of GXP guidelines specific to radiopharmacy practice in Kenya by comparing current local guidelines with international ones, to assess the alignment of these to the emerging radiopharmacy practice in the country, and to understand the challenges faced by stakeholders involved in the sector. Study objectives: To analyse local and international drug regulatory authorities’ guidelines on radiopharmaceuticals to identify gaps in local regulations, and explore how these could be addressed by adapting international regulations as guidance materials for regulation for radiopharmaceuticals in Kenya. Methods: A desktop review of reference regulations and guidelines was performed using the regulatory or guidance bodies’ official websites. In addition, a local radiopharmacy practicing site was audited for evaluation of adherence of IAEA requirements, and challenges in current practice were captured using key informant interviews. 2 Results: Differences in local guidelines and international radiopharmacy practice guidelines were noted that affect various aspects of the field by analysing local GXP guidelines against international radiopharmacy practice guidelines. These covered facets related to production, handling, distribution, and recall of the radiopharmaceuticals. The radiopharmacy unit at selected site of the Aga Khan University Hospital largely complied to the IAEA requirements, however the unit at the Kenyatta National Hospital could not be audited as it was inactive at the time of data collection. Key informant interviews shed light on the challenges faced in the sector and emphasized the need for local guidelines. Study significance: The purpose of the study being to propose GXP guidelines specific to radiopharmacy practice in Kenya with the hope to create informed policies which lead to improvement and enhancement of the sector in Kenya thus ultimately benefit local and regional patients.