20th ISoP Annual Meeting “Integrated pharmacovigilance for safer patients” 8–10 November 2021 Muscat, Oman (Hybrid meeting)
Valdiserra, G., Ferraro, S., Fornili, M., Convertino, I., Cappello, E., Lucenteforte, E., Tuccori, M.
Abstract
Background/Introduction: The implementation of the active drug safety monitoring and management scheme (aDSM) instituted by the World Health Organization (WHO) [1][2][3] has witnessed different levels of progress in different countries world-wide [4]. Broad based collaboration among stakeholders is critical for the success of the scheme. The primary stakeholders in Nigeria are the national drug regulatory body, NAFDAC (National Agency for Food and Drug Administration and Control) and the NTBLCP (National Tuberculosis and Leprosy Control Program). The PAVIA project (funded by EDCTP) strengthened collaboration between these stakeholders in Nigeria [5], which has a yearly estimate of 21,000 incidence of multidrug/rifampicin-resistant tuberculosis [6]. Objective/Aim: To ascertain the implementation of the aDSM scheme in an era of enhanced support from external collaborators, such as the PAVIA project by describing: (a) the total number of adverse drug reactions (ADRs) reported (b) proportions of ADRs associated with the new antituberculosis and repurposed drugs (c) characteristics of the ADRs and (d) the collaboration among the primary stakeholders. Methods: Individual case safety reports (ICSR) submitted to the NAFDAC database by the NTLCP from 2017 to 2021 were extracted and analyzed. The new antituberculosis drugs requiring aDSM were bedaquiline and delamanid, combined with the repurposed drugs (capreomycin, clofazimine, cycloserine, ethambutol, kanamycin, levofloxacin, linezolid, moxifloxacin, and pyrazinamide). The ADRs submitted to the NAFDAC database by the NTBLCP and the characteristics of the ADRs were the basis for assessing the collaboration. Summary statistics was applied for the analysis. Results: The NTBLCP submitted a total of 284 reports to the NAFDAC database: 251/284 (88%) were from the repurposed drugs and 33/284 (12%) from bedaquiline [29/33 (88%)] and delamanid [4/ 33 (12%)]. ADRs were most frequently reported for men [285/499 (57%)] and the age range, 18-44 years [353/510 (69.2%)]. Vomiting, hypokalemia, and arthralgia [69 (13.2%) vs 55 (10.5%) vs 47 (9.1%)] had the highest reporting frequency and gastrointestinal, ear and labyrinth and nervous system disorders were the frequently reported system organs affected by the ADRs [108 (20.6%) vs 102 (19.5%) vs 93 (17.7%)]. Prolonged hospitalization (18/3.4%) was the frequently reported indicator for classifying ADRs as serious. Overall, there were 10 (1.9%) fatalities.