The new article outlines the main stakeholders of the pharmacovigilance system and highlights the key points associated thereto.
Table of content
The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of healthcare products, has published a new revision of the guidelines on the national pharmacovigilance system. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. The document describes the main stakeholders, paying special attention to their roles and functions.
Ministry of National Health Services Regulations and Coordination (NHSR&C)
The Ministry of NHSR&C serves as the primary administrative body for health in Pakistan, with the following key roles:
- Formulating health and drug policies.
- Overseeing the implementation of laws and rules related to therapeutic goods.
- Coordinating national and international health activities.
- Supervising the Drug Regulatory Authority of Pakistan (DRAP).
- Striving to maintain and improve public health in Pakistan.
Drug Regulatory Authority of Pakistan (DRAP)
DRAP plays a central role in the pharmacovigilance system by ensuring the safety, efficacy, and quality of therapeutic goods.
Its responsibilities include:
- Supervising the National Pharmacovigilance Centre (NPC) and its activities.
- Allocating budgets and hiring personnel for the NPC.
- Implementing regulatory actions and risk minimization measures across Pakistan, including:
- Coordinating with Provincial Health Departments.
- Enforcing decisions made by DRAP’s other divisions or registration holders.
- Approving pharmacovigilance guidelines, procedures, and reporting forms.
- Supporting capacity building and professional development of pharmacovigilance officers.
- Coordinating pharmacovigilance efforts with provincial health authorities.
National Pharmacovigilance Centre (NPC)
The NPC, under DRAP, develops and manages Pakistan’s pharmacovigilance system.
Its key activities include:
Coordination:
- Collaborating with national and international stakeholders, including the World Health Organization (WHO) and Uppsala Monitoring Centre (UMC).
- Coordinating with Provincial Pharmacovigilance Centres (PPCs), Registration Holders, and Public Health Programmes (PHPs).
- Engaging hospitals and academic institutions.
Monitoring and Data Management:
- Developing adverse event reporting forms for stakeholders.
- Supervising the VigiFlow database, integrating data from provinces, hospitals, and PHPs.
- Monitoring and analyzing pharmacovigilance data to assess risks and benefits.
Risk Management and Regulatory Actions:
- Performing signal detection, causality assessment, and risk communication.
- Evaluating safety protocols, including PBRERs, RMPs, and PASS studies.
- Recommending regulatory actions, such as product variations, withdrawals, or safety specification updates.
Communication and Training:
- Issuing safety alerts and press releases to inform stakeholders of risks.
- Training pharmacovigilance officers at all levels (NPC, PPCs, PHPs).
- Promoting ADR reporting through awareness campaigns for healthcare professionals and patients.
Additional Functions:
- Acting as the secretariat for the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
- Sharing pharmacovigilance data with international bodies like WHO-UMC.
- Publishing newsletters and conducting outreach campaigns.
Provincial Pharmacovigilance Centres (PPCs)
PPCs are established under the Pharmacovigilance Rules, 2022, and are responsible for:
- Collecting reports from hospitals, pharmacies, and therapeutic goods’ sale points via the VigiFlow database.
- Conducting causality assessments of AE and ADR reports.
- Coordinating with hospitals, academia, and sub-provincial pharmacovigilance centres.
- Monitoring and training pharmacovigilance officers at public hospitals.
- Implementing regulatory and risk minimization measures in provinces.
- Conducting awareness campaigns for healthcare professionals.
- Submitting provincial pharmacovigilance data to the NPC.
Public Health Programmes (PHPs)
PHPs, such as those for tuberculosis, HIV/AIDS, malaria, and immunization, perform the following roles:
- Establishing pharmacovigilance centres at the national and provincial levels.
- Collecting pharmacovigilance data from treatment sites and submitting it to the NPC via VigiFlow.
- Establishing Expert Safety Review Panels (ESRP) for signal detection and causality assessment.
- Conducting active surveillance and pharmacoepidemiological studies for high-risk or new drugs.
- Raising awareness among healthcare professionals and patients.
Registration Holders
In accordance with the applicable legislation, registration holders, including manufacturers and importers, are responsible for:
- Establishing pharmacovigilance systems and nominating a Qualified Person for Pharmacovigilance (QPPV).
- Maintaining a Pharmacovigilance System Master File (PSMF) and submitting it to the NPC.
- Reporting ADRs, AEs, and other safety concerns to the NPC via the Industry E-Reporting System.
- Conducting non-interventional PASS studies when required.
- Submitting PBRERs and RMPs to the NPC as per timelines.
- Implementing risk minimization measures and reporting product risks identified during self-assessments.
Academia
Academic institutions contribute to pharmacovigilance through:
- Integrating pharmacovigilance into healthcare curricula.
- Conducting training sessions, conferences, and symposiums.
- Collaborating with PPCs and NPC to promote education and research.
Hospitals
Hospitals, both public and private, play a critical role in pharmacovigilance:
- Establishing hospital-level pharmacovigilance centres.
- Nominating focal persons for coordination with PPCs.
- Conducting initial causality assessments and submitting data to PPCs via VigiFlow.
- Implementing NPC and PPC risk minimization measures.
Therapeutic Goods’ Sale Points (TGSPs)
Distributors, wholesalers, and retailers of therapeutic goods are expected to:
- Report suspected ADRs or AEs to PPCs.
- Counsel patients on consulting healthcare professionals if adverse events occur.
Healthcare Professionals (HCPs)
HCPs are central to pharmacovigilance efforts and are responsible for:
- Detecting, managing, and documenting ADRs and AEs, including serious, non-serious, and unexpected reactions.
- Performing initial causality assessments.
- Reporting suspected ADRs or AEs to the NPC, PPCs, or registration holders.
Patients and Consumers
Patients and consumers are encouraged to:
- Report adverse events to healthcare professionals, NPC, PPCs, or registration holders.
- Avoid duplication by reporting through a single channel.
Media
As explained by the authority, the media can support pharmacovigilance by:
- Raising public awareness through press releases and news coverage.
- Reporting adverse events for follow-up by NPC and PPCs.
- Ensuring accuracy in reporting, with DRAP’s public relations officer or NPC head as the authorized spokesperson.
Conclusion
In summary, the pharmacovigilance system in Pakistan relies on the active participation of various stakeholders, including government bodies, healthcare providers, registration holders, academia, and patients. Their coordinated efforts ensure the monitoring, assessment, and management of risks associated with therapeutic goods, thereby enhancing public health and safety.
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