scholarly journals Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool

2022 ◽  
Vol 12 ◽  
Author(s):  
Muhammad Akhtar Abbas Khan ◽  
Saima Hamid ◽  
Tofeeq Ur-Rehman ◽  
Zaheer-Ud-Din Babar

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.

Public Health ◽  
2020 ◽  
Author(s):  
Ellen Whitney ◽  
Katherine Seib ◽  
Jessica Blackburn ◽  
Jacob Clemente ◽  
Courtenay M. Dusenbury ◽  
...  

More than one hundred countries around the world have established national public health institutes (NPHIs) to coordinate and lead their public health systems. Some NPHIs, such as the US Centers for Disease Control and Prevention (CDC), South African National Institute for Communicable Diseases (NICD), Brazilian Oswaldo Cruz Foundation (FIOCRUZ), and Chinese Center for Disease Control and Prevention, have developed over time. Others, such as the Public Health Agency of Canada (PHAC), emanated in response to more recent global public health threats like severe acute respiratory syndrome (SARS). NPHI functionalities range from combatting primarily infectious diseases to comprehensive mandates to lead national efforts for prevention and control of both infectious and noncommunicable disease threats. The International Association of National Public Health Institutes (IANPHI), envisioned in 2001 and chartered in 2006, serves to link and catalyze the capacity of NPHIs around the world through a robust international professional and scientific network. IANPHI works closely with the World Health Organization (WHO) through a formal partnership agreement. The Bill & Melinda Gates Foundation, the Rockefeller Foundation, member dues and peer assistance, bilateral cooperative agreements, and private-sector partnerships support its activities. IANPHI’s members encompass more than five billion people across six continents. IANPHI is the only organization whose mission is to strengthen national public health institutes. To do this, IANPHI’s work focuses on (a) supporting a robust scientific community of NPHI directors through an annual meeting, a listserv, and collaborative activities; (b) developing and distributing guidelines and tools that strengthen NPHIs’ abilities to conduct and evaluate public health programs and efforts, including the IANPHI NPHI development framework, the Staged Development Tool, NPHI-to-NPHI evaluation guidance, and a best practices series; and (c) investing in projects designed to create NPHIs and strengthen public health systems in low-resource countries. IANPHI helps NPHIs by advocating for strong and well-supported NPHIs and providing timely information and insights for public health programs and actions.


2019 ◽  
Vol 8 (1) ◽  
pp. 127
Author(s):  
Laurent Cleenewerck ◽  
Devender Bhalla ◽  
Kabiru Abubakar Gulma

<p>This research aimed to evaluate the performance of six ongoing public health programs through core performance indicators in Katsina State, Nigeria. The healthcare delivery in Africa is mostly program-based. This requires that such programs need to be evaluated which may in turn help to identify any existing gaps towards the improvement of patients' access and coverage to their given service. We identified all active health facilities where our programs on malaria, Routine Immunization (RI), Family Planning (FP), Tuberculosis and Leprosy (TBL), HIV/AIDS, and Free Medicare (FMC) were being carried out. After that, a representative sample was derived to obtain data regarding five key performance indicators by using a Logistics Indicators Assessment Tool. Of 1,718 facilities, a total of 983 (57.22%) were visited, In other words, by assuming a normal distribution; each facility expectedly covers only 3,371 individuals. All programs provided different and diverse results on each indicator; however, the most obvious challenge was in the stock-out and demand vs. receipt of required medications. These are particularly for malaria, FMC, FP, and HIV. For instance, the stock-out lasted 222 days for malaria and 135 days for FP. Despite this, none of the programs had a lower than gold-standard near-term availability of required products. Program-based healthcare delivery is inadequate and ineffective unless the local system gets simultaneously developed. If required medications are not becoming available, optimal access, coverage, and benefits cannot be expected to be obtained. Clearly, Nigeria experiences a push system of meeting term supplies. Nigeria needs to strengthen its pharmaceutical system.</p>


2017 ◽  
Vol 9 (1) ◽  
pp. 47-54
Author(s):  
Siva Prasada Reddy Maddirala Venkata ◽  
Peter Kielgast ◽  
Ubaidulla Udhumansha ◽  
Marja Airaksinen

2019 ◽  
Vol 10 ◽  
pp. 204209861986485 ◽  
Author(s):  
Didier Nzolo ◽  
Andrea Kuemmerle ◽  
Yves Lula ◽  
Nsengi Ntamabyaliro ◽  
Aline Engo ◽  
...  

Implementation of pharmacovigilance (PV) systems in resource-limited countries is a real endeavor. Despite country- and continent-specific challenges, the Democratic Republic of the Congo (DRC) has been able to develop one of the most active PV systems in the sub-Saharan Africa. The World Health Organization (WHO) regional Office identified the DRC experience to set up a PV system for antimalarial drugs safety monitoring as a ‘best practice’ that needed to be documented in order to help DRC improve its PV system and to be scaled up in other African countries. In response to the WHO request, a best practices and bottlenecks analysis was conducted in 2015. This analysis was updated in 2018 in the light of the minimum requirements of the WHO to set up a PV system taking into account other guidance for PV systems. The following themes were retained for analysis: (1) creation of the national PV center; (2) implementation of PV in the health system; (3) data collection and analysis; (4) collaboration with public health programs; (5) collaboration with the National Regulatory Authority. Lessons learnt from the DRC experience show that it is possible to implement PV systems in order to promote patients’ safety in resource limited sub-Saharan African countries with no guaranteed funding. The ability of national PV centers to collaborate with Public health stakeholders, including public health authorities at all levels as well as public health programs, and to use existing health information systems are considered the main key to success and may substantially reduce the cost of PV activities.


2014 ◽  
Vol 11 ◽  
Author(s):  
Douglas A. Luke ◽  
Annaliese Calhoun ◽  
Christopher B. Robichaux ◽  
Michael B. Elliott ◽  
Sarah Moreland-Russell

2005 ◽  
Vol 10 (1) ◽  
pp. 25-38 ◽  
Author(s):  
Hilde Iversen ◽  
Torbjørn Rundmo ◽  
Hroar Klempe

Abstract. The core aim of the present study is to compare the effects of a safety campaign and a behavior modification program on traffic safety. As is the case in community-based health promotion, the present study's approach of the attitude campaign was based on active participation of the group of recipients. One of the reasons why many attitude campaigns conducted previously have failed may be that they have been society-based public health programs. Both the interventions were carried out simultaneously among students aged 18-19 years in two Norwegian high schools (n = 342). At the first high school the intervention was behavior modification, at the second school a community-based attitude campaign was carried out. Baseline and posttest data on attitudes toward traffic safety and self-reported risk behavior were collected. The results showed that there was a significant total effect of the interventions although the effect depended on the type of intervention. There were significant differences in attitude and behavior only in the sample where the attitude campaign was carried out and no significant changes were found in the group of recipients of behavior modification.


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