The new article elaborates further on the existing types of surveillance, highlighting 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 different types of surveillance introduced in order to ensure the safety and proper performance of healthcare products allowed for marketing and use in Pakistan.
Types of Surveillance in Pakistan
According to the guidance, pharmacovigilance surveillance in Pakistan involves both passive and active systems, supplemented by observational studies, clinical trials, and drug utilization studies. Each type plays a distinct role in monitoring the safety of therapeutic goods.
Passive Surveillance
Passive surveillance relies on healthcare professionals (HCPs) and patients voluntarily reporting adverse drug reactions (ADRs) or events (AEs) after the administration of therapeutic goods. It does not actively seek reports but encourages voluntary submission.
Key Features:
- Covers the entire population and real-world practices.
- Least expensive and easiest to implement.
- Generates signals for further evaluation through active surveillance.
Weaknesses:
- Heavy reliance on voluntary reporting.
- Issues with under-reporting and data quality.
Spontaneous Reporting
Unsolicited communication by an HCP or patient to a regulatory body, describing ADRs or AEs not derived from organized data collection.
- Benefits: Easy to establish, low-cost, and covers all medicines throughout their lifecycle. Effective for detecting new, rare, or serious ADRs.
- Drawbacks: Limited by under-reporting, difficulty detecting delayed ADRs, and reliance on suspected ADR data.
Spontaneous reporting is the primary method of pharmacovigilance in Pakistan, generating signals for further investigation.
Active Surveillance
Active surveillance involves targeted and systematic monitoring to ascertain the number of ADRs or AEs through a pre-planned process.
Key Methods:
- Intensive Monitoring Schemes (Sentinel Sites):
– Focus on data collection in designated areas like hospital units.
Utilizes ward rounds, medical record reviews, and patient interviews.Monitors specific conditions such as hepatic disorders, renal failure, or hematological issues.
Offers insights unavailable in passive systems.
- Prescription/Drug Event Monitoring (PEM):
- Identifies patients via prescription data or insurance claims.
- Uses follow-up questionnaires for details on demographics, treatment duration, and clinical events.
- Particularly useful after product launches.
- Registries:
- Disease Registries: Collect data on diseases like blood dyscrasias or congenital malformations.
- Exposure (Drug) Registries: Focus on specific populations exposed to a drug (e.g., pregnant women, rheumatoid arthritis patients).
- Provide standardized, prospective data for targeted studies.
Observational Studies
Observational studies validate signals from passive and active surveillance or case series using traditional epidemiological methods.
Major Types:
- Cross-Sectional Studies:
- Capture data at a single time point.
- Useful for examining disease prevalence or trends over time.
- Best for static exposures.
- Case-Control Studies:
- Compare exposed and non-exposed groups to investigate associations between drugs and rare ADRs.
- Efficient for assessing multiple risk factors and rare outcomes.
- Cohort Studies:
- Follow populations at risk over time to calculate incidence rates and relative risks of ADRs.
- Useful for studying multiple adverse outcomes within the same group.
Clinical Trials
Clinical trials, especially post-authorization studies (e.g., Phase IV), are conducted to evaluate risks identified during pre-approval trials.
These studies may involve:
- Pharmacokinetics/Dynamics: To identify dosing regimens that reduce ADR risks.
- Genetic Testing: To understand patient-specific risks.
- Special Populations: Older adults, children, pregnant women, and patients with co-morbidities often excluded from initial trials.
Drug Utilization Studies (DUS)
DUS analyzes how medicines are prescribed and used in real-world settings, focusing on populations often excluded from clinical trials (e.g., children, pregnant women).
Applications:
- Assess the impact of regulatory actions on prescribing habits.
- Identify medication errors and off-label use.
- Guide post-authorization safety studies (PASS) by providing user population characteristics.
Surveillance Structure in Pakistan
In Pakistan, spontaneous reporting is the routine method for data collection, facilitated by HCPs voluntarily reporting ADRs, AEs, or AEFIs to NPC, PPCs, or PHPs.
Other approaches include:
- Active Surveillance: Conducted by hospital-based Clinical Pharmacy & Pharmacovigilance Officers (CPPOs) for high-alert medications.
- Pharmacoepidemiological Studies: Conducted by PHPs for program-specific drugs (e.g., for HIV, tuberculosis).
- Post-Authorization Safety Studies (PASS): Conducted voluntarily or imposed by NPC or the Registration Board.
Criteria for Initiating Active Surveillance
Active surveillance is initiated based on the following:
- Nature of the Medicine:
- New vaccines or biologicals.
- New drugs for HIV, tuberculosis, or rare diseases.
- Emergency Use Authorization (EUA) products.
- Adverse Events of Special Interest (AESIs):
- Serious hepatic, renal, or hematological events.
- Rare or population-specific events (e.g., in children or pregnant women).
Stakeholders for Active Surveillance in Pakistan
Key stakeholders involved in active surveillance include:
- NPC-DRAP: Directs initiatives and integrates data from stakeholders.
- Sentinel Hospitals: Provide focused monitoring.
- Medical Universities: Use teaching hospitals for data collection.
- Provincial Pharmacovigilance Centres: Coordinate active surveillance in hospitals.
- Public Health Programmes: Conduct programme-specific surveillance.
- Registration Holders: Conduct voluntary or mandated PASS.
Conclusion
In summary, Pakistan employs a comprehensive pharmacovigilance framework that integrates passive and active surveillance, supported by observational studies, clinical trials, and DUS. These methods ensure the detection, assessment, and mitigation of risks associated with therapeutic goods, safeguarding public health through collaborative stakeholder engagement.
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