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 feld
[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, beneft-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 efcacious medicines and healthcare products.
Supply inequities may increase the risk for adverse
outcomes as they increase the chances for the circulation of
substandard and falsifed medicinal products assumed to be
pharmacologically equivalent and of-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.
