ABSTRACT
Background: Recognized in 1994 as a global emergency by the World Health Organization, tuberculosis (TB) remains an ongoing health threat. In Cameroon, the mortality rate is estimated at 2.9%. Treatment of multidrug-resistant TB (MDR-TB) defined as the resistance to the two most effective antiTB drugs, and requires therapy of more than 7 drugs taken on a daily basis during 9-12 months. This study aimed to evaluate the safety profile of treatment regimens used for MDR-TB at Jamot Hospital of Yaounde (JHY). Methods: This was a retrospective cohort study of patients treated for MDR-TB at HJY from January 1, 2017, to December 31, 2019. Patients characteristics of the cohort, drugs regimen were collected and described. All possible adverse drug reactions (ADR) were described clinically and by severity grade. Results: During the study period, 107 patients were included, and 96 (89.7%) experienced at least one ADR. Most parts of the patients (90) experienced mild or moderate ADR. Hearing loss was the most frequent ADR, and led mostly in aminoglycosides dose reduction (n = 30, 96.7%). Gastrointestinal events were commonly observed during the study period. Conclusion: Our findings suggested that ototoxicity was a prominent safety issue during the study period. The implementation of the new short treatment regimen could be effective in reducing the burden of ototoxicity among MDR-TB patients. Nevertheless, new safety issues could emerge.
Subject(s)
Antitubercular Agents , Tuberculosis, Multidrug-Resistant , Humans , Antitubercular Agents/administration & dosage , Antitubercular Agents/adverse effects , Cameroon , Ototoxicity/etiology , Ototoxicity/prevention & control , Retrospective Studies , Tuberculosis, Multidrug-Resistant/drug therapy , Male , Female , Adult , Middle Aged , Cohort Studies , Hearing Loss/chemically induced , Hearing Loss/prevention & control , Time FactorsABSTRACT
Background: Data are needed to serve as evidence in planning the strengthening of pharmacovigilance in health programs administering drugs to populations. The present study was proposed to map the distribution of pharmacovigilance units in health programs, assess the availability of key resources, the implementation of key pharmacovigilance activities and identify needs of involved actors. Methods: It was a cross sectional descriptive study targeting all health programs of the Cameroon Ministry of Public Health administering drugs/vaccines to the population. Data were collected using semi structured questionnaire administered face to face to key persons in charge of drug safety monitoring or drug management in health programs. Results: Out of the 09 health programs involved in drug distribution, 07 consented to participate. Five out of them (71.4%) claimed to have existing pharmacovigilance units. Office space, computers, operating budget, data analysis software and a trained staff were available in 28.6%, 42.9%, 42.9%, 14.3%, 00.0%, and 42.9% of the health programs respectively. One of the 7 health programs (14.3%) declared conducting detection/notification of adverse events following exposure drugs, 2 (28.6%) conduct causality assessment and 3 (42.8%) conduct analysis of pharmacovigilance data. All health programs proposed to prioritize the allocation of budget and qualified personnel and the training of existing personnel as key interventions to improve drugs/vaccines safety monitoring in health programs. Conclusion: The study reports limited coverage of Cameroon health programs with activities leading to drugs and vaccine safety monitoring. Suggested actions have to be taken into account when attempting to improve the situation.