The Role of ISoP in the Advancement of Pharmacovigilance in Low‑and Middle‑Income Countries (LMICs)

Abstract

The slow development of pharmacovigilance (PV) in low- and middle-income countries (LMICs) calls for an analysis of the challenges and opportunities for enhancing its growth in these countries. In the aftermath of the thalidomide tragedy in the early 1960s, and pockets of medicine-related harm still occurring to this day, it is evident that many countries in LMIC continue to give little priority to the field [1, 2]. Although many of the national pharmacovigilance centers in these countries joined the World Health Organization (WHO) Program for International Drug Monitoring (PIDM) in the 1990s and early 2000, the practice of PV remains at a rudimentary phase compared to the more mature systems in many developed countries [3, 4].

The global PV landscape and societal context have shifted swiftly in the last few decades and are still changing. PV has expanded in scope and increased its focus to all health products, and to all circumstances where adverse events may occur such as medication error, abuse, misuse, and drug addiction. PV has shifted from using a reactive approach that relies on spontaneous reporting to a more proactive approach with the introduction of active surveillance, benefit-risk assessment, risk-management planning, risk communication, and minimization strategies.

In many LMICs, the rapid growth in the population as well as the increased purchasing power of the middle class have resulted in a higher demand for high-quality, safe, and efficacious medicines and healthcare products. Supply inequities may increase the risk for adverse outcomes as they increase the chances for the circulation of substandard and falsified medicinal products assumed to be pharmacologically equivalent and off-label use of approved products [5]. The safety monitoring of medicines must meet up with this changing demand for safer medicines, both in speed and in rigor.