Supportive Supervision was conducted on general pharmacovigilance and Active TB-Drugs Safety Monitoring and Management (aDSM)
Ethiopia has implemented different regimens for treatment of Multi Drug Resistant Tuberculosis (MDR-TB) and introduced new anti TB drugs (bedaquiline (Bdq) and delamanid (Dlm) and repurposed drugs (clofazimine and linezolid) for treatment of MDR-TB. Ethiopia has introduced active TB-drugs safety monitoring and management (aDSM) as part of the introduction of new TB drugs and novel MDRTB regimens. A supportive supervision was conducted on the implementation of aDSM as well as the general Pharmacovigilance practice in selected 10 MDR TB treatment initiating centers (TICs) by EFDA-pharmacovigilance and clinical trials team in collaboration with the national TB Program (NTP), Armaeur Hanson Research Inistitute (AHRI), the Pharmacovigilance Africa (PAVIA), the USAID /ETBE and the USAID Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) projects. It was conducted from February 23-March 5, 2021.
The objective of the supportive supervision was to assess the general pharmacovigilance practices (detecting, managing and reporting of Adverse Drug Events) and the implementation of aDSM at the MDR TB TICs so that identified gaps to be filled and share experiences/lessons learned with in these health facilities.
aDSM was integrated in the TB pharmaceuticals supply management and General Pharmacovigilance Training
The Ethiopian Food and Drug Administration (EFDA) has been leading the efforts to strengthen the national pharmacovigilance system. As part of these efforts, the development of training material to build the capacity of healthcare professionals on pharmacovigilance was determined to be necessary.
Thus, the development of a training manual is an important step to address knowledge, skill and attitude gaps identified to enhance the national monitoring and reporting of ADE thereby improving patient safety. The training material was further enriched by appropriate experts from FMOH, EFDA, universities, hospitals, and development partners.
Besides, since an effective management of Tuberculosis (TB) depends on availability and rational use of pharmaceuticals and hence, the role played by pharmacy professionals and TB focals are of paramount importance. Recent assessments have indicated that, the lack of capacity building initiatives for pharmacy professionals and TB focals have resulted in poor supply chain management of required pharmaceuticals and absence of standardized drug safety monitoring for both ambulatory and hospitalized patients.
Thus, the Ethiopian Pharmaceuticals supply Agency and FMOH in collaboration with EFDA and GHSC-PSM developed a training material on TB Pharmaceuticals Management (TB-PSM) where EFDA played main role in integrating issues of Active TB drug safety monitoring and management (aDSM). The TB-PSM manual mainly targets pharmacy and other health personnel working in public health facilities and involved in TBL pharmaceuticals management while the PV manual targets every health care professional. Pilot trainings have been provided to the target audience where totally Twenty-Five (25) health professionals receive the training on pharmacovigilance. Besides, seventy-two (72) professionals (pharmacy and DR TB focals) received the training on the TBL pharmaceuticals management, where both of the trainings covered aDSM as a separate chapter.
The EFDA has established a national aDSM committee
Ethiopian Food and Drug Administration (EFDA) has established aDSM committee which involves different experts who have the knowledge and experience on TB especially on DR TB.
The general objective of these committee is to assist the national pharmacovigilance center on aDSM related activities mainly on investigation of SAEs related to the use of TB drugs and causality assessment of investigated cases thereby provide advice to the EFDA on such SAEs to inform future policy updates on the use of new and repurposed anti TB drugs. This committee is expected to collaboratively work with the main national safety advisory committee during causality assessment of TB drugs.