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.

With multiple waves and variants, the coronavirus disease 2019 (COVID-19) pandemic has affected routine vaccination programs globally. Its impact is also visible in Pakistan as routine health services continue to be disrupted. Consequently, thousands of children have emerged as vulnerable in the face of vaccine-preventable diseases (VPDs), which have already started causing outbreaks in the country. Infections with polio and measles have been significantly reported, especially during the last few years. This reemergence of both diseases is posing great challenges for the country at local, national, and global levels. These impacts are being multiplied by the 2022 flooding – called “super floods” – in the country. Hence, relevant stakeholders, such as the Pakistani government and the World Health Organization (WHO), need to revisit the entire vaccination program to address and resolve issues occurring at the management or local levels. It is highly important to pay attention to the context that provides a fertile ground to negatively affect vaccine uptake.

The world bank has classified 80 economies based on their Gross National Income (GNI) per capita as High-Income. European Medicines Agency (EMA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA) are the major regulatory stakeholders driving global pharmacovigilance regulations. The purpose of this article is to describe pharmacovigilance systems and processes in high-income countries, particularly those that are also members of the International Conference on Harmonization (ICH). All high-income countries are members of the WHO PIDM. The income level of a country has a direct relationship with medicine safety measures. All ten pioneering members of the Uppsala monitoring centre are from high-income countries and were the first responders after the thalidomide tragedy by making drug evaluation committees, introducing the ADR reporting forms and taking safety measures. Despite access to the VigiBase, some countries have separate databases for managing and analyzing data like Canada Vigilance online database, FDA Adverse Event Reporting System, the French pharmacovigilance database and European Union’s system Eudravigilance. All high-income countries have robust pharmacovigilance systems. USFDA and EMA are the world leaders in the field of pharmacovigilance. Most high-income countries follow EMA guidelines. Medicine safety is directly influenced by a country’s income level.

Objectives:Due to the absence of necessary rules, poor coordination, and various challenges, the pharmacovigilance system of Pakistan is not optimally functional at all levels of the health system. The objective of the study was to assess the stakeholders’ perceptions of the current ADR reporting system and to identify the pharmacovigilance policy issues and problems of effective coordination.Methodology:Stakeholders from a broad range of disciplines, academia, regulatory authorities, the pharmaceutical industry, international health organizations, as well as pharmacovigilance experts, and healthcare professionals were included in the study. A total of 25 stakeholders throughout Pakistan were interviewed during exploratory semi-structured interviews. The interviews were recorded digitally, transcribed, coded, compared, and grouped according to their similarity of themes. Participants provided insights into gaps, limitations, and challenges of Pakistan’s current ADR reporting system, issues with proposed pharmacovigilance rules, and coordination difficulties.Results:The majority of the participants considered the ADR reporting system in Pakistan to be improving but in a nascent phase. The identified gaps, challenges, limitations of the system, and barriers to reporting were labeled as reasons for limited functioning. Almost all stakeholders were aware of the existence of draft pharmacovigilance rules; however, participants in the industry were familiar with the contents and context of draft pharmacovigilance rules. Bureaucratic red tape and lack of political will appeared to be the top reasons for delaying the approval of the pharmacovigilance rules. Wider consultation, advocacy, and awareness sessions of policymakers and HCPs were suggested for early approval of rules. Participants unanimously agreed that the approval of rules shall improve the quality of life and reduce the economic burden along with morbidity and mortality rates. The need for greater and collaborative coordination among the stakeholders in promoting medicines’ safety was highlighted. All participants suggested the use of media and celebrities to disseminate the safety information.Conclusion:Participants showed partial satisfaction with the way pharmacovigilance in Pakistan is moving forward. However, stakeholders believed that engagement of multi-stakeholders, approval of pharmacovigilance rules, and the establishment of pharmacovigilance centers in provinces, hospitals, and public health programs (PHPs) shall support in achieving the desired results.