Abstract
Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan. Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations. Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps. Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.
Highlights
While medicines have benefits, they are considered to have harmful effects
This study aims to assess Pakistan’s PV system
Drug Regulatory Authority of Pakistan (DRAP) achieved an aggregate score of 75% (Table 1) with breakup into four categories: (1) “policy, law, and regulation” (66.6%), (2) “Structures, systems, and stakeholder’s coordination” (76%), (3) “Signal generation and data management” (100%), (4) “Risk assessment and evaluation” (41.66%), and (5) “Risk management and communication” (84.61%), (Figure 2)
Summary
Adverse drug reactions (ADRs) are among the major reasons for death (WHO, 2004). Pharmacovigilance (PV) is a wider discipline and 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” (WHO, 2002). Several issues emerged in the incident including the hesitant approach of regulatory authorities, poor regulations, and weak review processes. This incident highlighted the significance of a thorough evaluation process and many countries introduced new regulations and strengthened existing drug safety systems and legislation (WHO, 2002; Rice, 2007; Lembit and Santoso, 2010; Beninger and Ibara, 2016)
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