Determinants of Adverse Drug Reactions Reporting In Retail Chemists In Nairobi County, Kenya

Abstract

Access to safe essential medicines is a key success indicator of a functional health system of which the private sector such as retail chemists plays a critical role. Despite their obvious benefits, medicines have the potential to cause harm in form of Adverse Drug Reactions that may not be determined in the drug development process. Reporting of Adverse Drug Reactions leads to regulatory action that improve the safety profiles of medicines. However, reporting of adverse drug reactions has not been extensively reviewed in retail chemists. The purpose of this study was to assess the factors that affect reporting of Adverse Drug Reactions in retail chemists. The objectives of this study were to determine the role played by the regulatory body, The Pharmacy and Poisons Board, in reporting Adverse Drug Reactions in the retail chemists; establish the operationalization of pharmacovigilance implementation strategies on Adverse Drug Reactions reporting in the retail chemists; determine the effect of the retail chemist personnel capacity on Adverse Drug Reactions and establish the effect of underlying motivation factors of the personnel on reporting of Adverse Drug Reactions. The research adopted a descriptive cross-sectional study design using structured questionnaires for the staff in the retail chemists and interview schedules. Nairobi County was selected as the study area due to its high concentration of retail chemists. The target population was the personnel in 895 registered chemists according the Pharmacy and Poisons Board database. Using the Yamane sample size calculation formula a study sample size of 276 respondents was elicited as one personnel was considered adequate for each retail chemist which were sampled purposively. The study also targeted key informants at the Department of Medicine Information and Pharmacovigilance at the Pharmacy and Poisons Board. The data collection tools used were the Retail Chemist Personnel Questionnaire and the Key Informant Interview Guide. The data were analyzed using Statistical Package for Social Scientists Version 23. Results shows that there was a positive relationship between the Regulatory body, Pharmacy and Poisons Board factors (r=0.275, p<0.001), Pharmacovigilance implementation strategies in the retail chemists (r=0.374, p<0.001), Retail chemist personnel capacity (r=0.466, p<0.001), Underlying motivation factors (r=0.466, p<0.001) and Adverse Drug Reactions reporting. Multiple regression analysis showed that in a combined relationship, Pharmacovigilance implementation strategies (P<0.05), retail chemist personnel capacity (P<0.05) and underlying motivation factors (P<0.05), all had a significant influence on adverse drug reporting among Chemist in Nairobi County. In conclusion therefore, this study established that the Pharmacy and Poisons Board did not influence reporting of adverse drug reactions in retail chemists, pharmacovigilance implementation strategies were not fully operationalized to facilitate reporting of adverse drug reactions, retail chemist personnel did not have adequate capacity and knowledge to optimally report adverse drug reactions and while their underlying motivation factors influenced reporting of adverse drug reactions, they were not adequately motivated to report. This study therefore recommends that there should be improved engagement between Pharmacy and Poisons Board and the retail chemists on pharmacovigilance, continuous in-service pharmacovigilance training for retail chemist personnel, review of the adaptability of the implementation strategies in place and provision of consistent feedback on reported adverse drug reaction by pharmacy and poisons board as a strategy to motivate retail chemist personnel to report adverse drug reactions.