Institutionalizing aDSM standard recording and reporting: Lessons learned

The program focuses on improving access to essential medical products and related services, and on the appropriate use of medicines to ensure better health outcomes for all populations of target countries. The MTaPS approach builds sustainable gains in countries by including all actors in healthcare—government, civil society, the private sector, and academia. The program is implemented by a consortium of global and local partners and led by Management Sciences for Health (MSH), a global health nonprofit. The MTaPS Consortium includes core partners such as Boston University, FHI 360, Overseas Strategic Consulting, Results for Development, International Law Institute-Africa Centre for Legal Excellence, and NEPAD, as well as global expert partners such as Brandeis University, Deloitte USA, Duke-National University of Singapore, and El Instituto de Evaluacion Tecnologica en Salud. In the Philippines, the MTaPS Program has been working with the Department of Health (DOH) to strengthen its pharmacovigilance (PV) systems. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems. The Philippine Food and Drug Administration (FDA) issued Administrative Order (AO) 2011-0009 to establish and implement a National Pharmacovigilance program in the country, which focuses on the spontaneous reporting of adverse events. The World Health Organization (WHO) recommended countries to adopt and implement Active Drug Safety Monitoring (aDSM) Framework, which is an active and systematic, clinical, and laboratory assessment of patients on treatment using new anti-TB drugs, novel Multidrug Resistant TB (MDR-TB) regimens, or Extensive Drug Resistant (XDR-TB) regimens to detect, manage, and report suspected or confirmed adverse drug reactions. In 2015, the DOH's Disease Prevention and Control Bureau-National Tuberculosis Control Program (DPCB-NTP) introduced aDSM through operational research, and the country opted to implement the intermediate package, which includes the reporting of all Serious Adverse Events (SAE) as well as Adverse Events of Special Interest (AESI) to generate standardized aDSM data to inform future policy updates on the use of such medicines. The implementation of aDSM reporting using the Pharmacovigilance information Management System (PViMS) was a key intervention of the MTaPS Program in the Philippines. PViMS is a web-based monitoring tool that enables the implementation of active surveillance activities and standardizes the recording and reporting of aDSM. The DOH-PD, with the support of MTaPS, issued Department Memorandums No. 2022-0087 and 2022-0201 underscoring the reporting of adverse events through PViMS along with the type of adverse events to be reported. A series of training was conducted on the use of PViMS, in conjunction with the Lung Center of the Philippines' (LCP) training for newly hired PMDT nurses and doctors. A total of 44 doctors and nurses were trained in the use of PViMS for aDSM. In addition to PMDT nurses and doctors, a face-to-face refresher training, led by DOH-PD and co-funded by PBSP, for Public Health Pharmacists and National Drug Policy Compliance Officers from each region and all the 199 PMDT facilities was conducted. MTaPS supported the conduct of causality assessment sessions scheduled every quarter and facilitated the determination and generation of reporting of AESI or SAE in collaboration with PD and FDA. Subsequently, MTaPS and PD coordinated in generating reports on the use of PViMS for aDSM reporting, which provided valuable insights into the implementation of aDSM reporting using PViMS in the Philippines. The lessons learned from the implementation of aDSM reporting using PViMS were based on meetings and discussions with various stakeholders, implementing partners, and PMDT facilities who were trained and using the system. Additionally, lessons learned were documented during a site visit and the conduct of causality assessment. The implementation of aDSM reporting using PViMS has been successful in the Philippines, with a decreasing trend in unassessible adverse events reported through PViMS, and a high percentage of facilities trained and using PViMS for TB medicines active safety monitoring. The recommendations from the implementation of aDSM reporting using PViMS include the continued support for the use of PViMS for aDSM reporting, the provision of regular training and refresher training for users, and the generation of reports on the use of PViMS for aDSM reporting to inform future policy updates on the use of such medicines.