The new article describes in detail the current structure of the pharmacovigilance programme implemented in Pakistan.
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.
Legal Basis for Pharmacovigilance in Pakistan
Pharmacovigilance activities in Pakistan are governed by the DRAP Act, 2012 (XXI of 2012). Under this legislation:
- The Division of Pharmacy Services is mandated to develop, promote, and regulate pharmacovigilance activities, as outlined in Section 2 (xxvi) and Section 4 (1)(g).
- To implement these activities, the Pharmacovigilance Rules, 2022 were officially notified through S.R.O 540 (I)/2022 on April 22, 2022. These rules define the responsibilities of various stakeholders, including the National Pharmacovigilance Centre (NPC), Provincial Pharmacovigilance Centres (PPCs), Public Health Programmes (PHPs), hospitals, and registration holders.
Further details on these rules can be accessed on the DRAP website.
Vision
According to the document, the vision of the pharmacovigilance programme is to safeguard the health of the population by ensuring that the benefits of therapeutic goods outweigh the associated risks. Aligned with Pakistan’s National Health Vision 2016-2025, the programme envisions establishing robust pharmacovigilance centres at the national level, supported by provincial collection points.
Mission
The mission of the pharmacovigilance programme is to enhance patient safety and public welfare by monitoring the safety of therapeutic goods and mitigating associated risks. This ensures the effective use of therapeutic goods across the country.
Scope of the Pharmacovigilance Programme
The pharmacovigilance programme oversees the post-marketing safety of therapeutic goods and collects reports on:
- Serious and non-serious spontaneous ADRs or AEs associated with therapeutic goods.
- Adverse events following immunization (AEFIs) related to vaccines.
- Reports of lack of therapeutic efficacy, particularly for vaccines, contraceptives, antibiotics, and life-critical medicines.
- AEs arising from quality issues, such as substandard or falsified products.
- Reports involving overdose, abuse, misuse, off-label use, occupational exposure, and medication errors.
Covered Therapeutic Goods
The programme includes a wide range of products as defined under the DRAP Act, 2012, such as:
- Allopathic medicines.
- Alternative medicines (e.g., Ayurvedic, Chinese, Unani, homeopathic, and biochemic systems).
- Over-the-counter (OTC) products (nutraceuticals and health products).
- Biologicals, vaccines, and blood products.
- Medical devices and related products.
Goals of the Programme
The document further describes in detail the most important goals of the programme, addressing the key points associated.
Short-Term Goals:
- Strengthen the National Pharmacovigilance Centre (NPC) at DRAP.
- Coordinate with provincial health departments to establish Provincial Pharmacovigilance Centres (PPCs).
- Appoint pharmacovigilance officers at the NPC.
- Facilitate the nomination of focal persons at provincial centres.
- Establish the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) at the national level.
- Encourage healthcare professionals to report AEs, ADRs, and AEFIs.
- Integrate provincial centres into the national pharmacovigilance programme.
Medium-Term Goals:
- Develop sub-regional pharmacovigilance centres at hospitals.
- Coordinate with PHPs for site-level pharmacovigilance centres.
- Facilitate the nomination of focal persons at hospitals and public health programmes.
- Support the formation of hospital-based Pharmacovigilance Committees.
- Establish Expert Safety Review Panels (ESRP) at PHPs for data evaluation.
- Ensure data collection, causality assessment, and integration into the national database.
Long-Term Goals
- Detect signals within the national pharmacovigilance database.
- Initiate regulatory decisions to ensure therapeutic safety.
- Promote active reporting of ADRs and AEs by HCPs.
- Conduct post-authorization safety studies and active surveillance.
- Implement Good Pharmacovigilance Practices (GVP) inspections for registration holders.
Overview of the Pharmacovigilance System
In order to assist the key stakeholders, the document provides an extensive overview of the current pharmacovigilance system, explaining its main elements and components.
National Pharmacovigilance Centre (NPC)
The NPC operates under DRAP’s Division of Pharmacy Services, headquartered in Islamabad.
It is tasked with:
- Collecting data from healthcare professionals (HCPs), patients, PPCs, PHPs, and registration holders.
- Signal detection, risk management, and education for HCPs.
- Recommending regulatory actions and integrating provincial, hospital, and public health programme data into a unified system.
- Issuing safety communications and newsletters.
Provincial Pharmacovigilance Centres (PPCs)
Established by provincial health departments, PPCs:
- Collect data from hospitals, sale points, and HCPs.
- Evaluate provincial pharmacovigilance data through committees.
- Supervise pharmacovigilance officers at public hospitals.
Public Health Programmes (PHPs)
PHPs nominate focal persons to coordinate with NPC and manage pharmacovigilance officers. Their responsibilities include:
- Establishing Expert Safety Review Panels (ESRP).
- Conducting pharmacoepidemiological and active surveillance studies.
Hospitals
Both public and private hospitals are required to establish pharmacovigilance centres. Responsibilities include:
- Nominating focal persons for data submission to PPCs.
- Evaluating pharmacovigilance data through hospital committees.
Registration Holders
Registration holders must:
- Maintain a Pharmacovigilance System Master File (PSMF).
- Nominate a Qualified Person for Pharmacovigilance (QPPV).
- Regularly report data to NPC.
Comprehensive guidelines for these responsibilities are provided in the Good Pharmacovigilance Practices document available on the DRAP website.
Role of PRAEC
The Pharmacovigilance Risk Assessment Expert Committee (PRAEC) advises the NPC on:
- Signal detection and management.
- Risk minimization and communication.
- Evaluating periodic safety reports and risk management plans (RMPs).
Collaboration and Coordination
The pharmacovigilance programme promotes collaboration between federal and provincial entities, including DRAP, PPCs, PHPs, and hospitals. DRAP ensures effective coordination under the Drugs Act, 1976, enabling safe access to therapeutic goods while maintaining harmony in inter-provincial trade.
Conclusion
In summary, the pharmacovigilance programme in Pakistan, under the leadership of DRAP, ensures the post-marketing safety of therapeutic goods through active monitoring, robust reporting systems, and stakeholder collaboration. With clearly defined goals and structured systems, the programme aims to safeguard public health and improve patient safety. For further details, stakeholders are encouraged to refer to the Pharmacovigilance Rules, 2022, and other resources available on the DRAP website.
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