Assessment of conformity with regulatory requirements of cold chain storage of medicines in private pharmacies in Kampala, Uganda
Abstract
Background:
Pharmaceutical products are required to be stored under predetermined conditions of temperature and relative humidity in order to preserve their integrity, quality, safety and efficacy. Cold chain products are those whose safe handling is recommended within low temperature range usually between 2°C to 8°C. Evidence from studies conducted in different countries indicates inadequacies in adherence to regulatory requirements during the management of cold chain pharmaceutical products. Little is documented about adherence of Private-for-profit Pharmacies in Uganda to standard guidelines in provision of quality cold chain products. This study was therefore aimed at assessing medicines cold chain storage conformity with the regulatory requirements in private-for-profit pharmacies of Kampala city.
Methods:
A facility based cross-sectional study design was employed in Private-for-profit Pharmacies that handle cold chain medicines in Kampala city between June and July 2022. Face to face interviews using semi-structured questionnaires were used to collect quantitative data while key Informant interviews were used to collect qualitative data using a Key informant guide in the same time period. Quantitative data was analysed using STATA version14. Content analysis of qualitative data was transcribed in Microsoft word and organized in a meaningful and systematic way and analysed manually.
Results:
Out of the 60 pharmacies that were analysed, only 20 pharmacies had good adherence to WHO or NDA cold chain management guidelines for supplying temperature sensitive medicines. The adherence rate was therefore 33.33%. After adjusting for confounders and other factors, adherence rate was 4.4 higher among the pharmacies where the profession of the staff was pharmaceutical scientist (Pharmacist, pharmacy tech, Drug dispenser) as compared to those where the staff was medical attendant (APR=4.4, 95% CI: 1.9-6.8, P=0.016). The adherence was 5.6 times among the pharmacies with staff who had experience of over 3 years as compared to those with less than one year (APR=5.6, 95% CI: 2.2-7.5, P=0.011). Pharmacies whose staff had attended a training on storage, distribution and handling procedures of cold chain medicines had adherence rate that was 5.5 times higher compared to those whose staff were not trained (APR=5.5, 95% CI: 2.5-8.9, P=0.0001). Pharmacies that were using pharmaceutical grade had adherence rate that was 4.1 times higher compared to those using domestic grade (APR=4.1, 95% CI: 1.9-6.8, P=0.012). Private pharmacy players were knowledgeable about the cold chain management and when asked to comment about the current adherence of pharmacies to cold chain management, the private pharmacy players acknowledged that adherence was low. The factors that affect adherence to cold chain management guidelines as expressed by the private players included inadequate equipment, lack of training as well as power blackouts for long time. The main challenges that affected pharmacies’ adherence to cold chain management included multi-tasking of staff working in pharmacy dispensing and monitoring at the same time and lack of training.
Conclusion:
From the findings of this study, it can be concluded that medicines cold chain storage conformity with the regulatory requirements in private pharmacies in Kampala, Uganda was low, 33.3%. The main factors associated with low adherence included absence of appropriately qualified professionals, inadequate experience and lack of training of technical persons, inappropriate equipment and accessories used. Although there were inadequate number of staff in pharmacies, the health workers in the pharmacies were found to be knowledgeable about good cold chain management practices and agreed that guidelines in place were sufficient.