The new article provides further clarifications regarding the reporting requirements to be followed in order to ensure that critical information is communicated without undue delay.
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 scope of the guidance covers, inter alia, the aspects related to reporting requirements and the way they should be followed.
Who Can Report?
In accordance with the applicable regulatory requirements, spontaneous reports can be submitted directly to the National Pharmacovigilance Centre (NPC) by the following stakeholders:
- Healthcare Professionals (HCPs): Physicians, dentists, pharmacists, and nurses.
- Patients and Consumers: Including their relatives.
In addition, other stakeholders of the pharmacovigilance programme collect reports from HCPs and patients and forward them to NPC:
- Registration holders.
- Provincial Pharmacovigilance Centres (PPCs).
- Public Health Programmes (PHPs).
- Hospitals and therapeutic goods sale points (e.g., distributors, wholesalers, retailers) report suspected ADRs to PPCs, which assess and forward the reports to NPC.
What to Report?
The NPC accepts the following types of reports:
- Serious or non-serious ADRs/AEs with therapeutic goods (known or unknown).
- Adverse Events Following Immunization (AEFIs): Both serious and non-serious.
- Lack of therapeutic efficacy for vaccines, contraceptives, antibiotics, or life-critical medicines.
- AEs linked to quality issues (e.g., substandard or falsified products).
- Reports related to adverse outcomes due to overdose, abuse, misuse, off-label use, occupational exposure, or medication errors.
Reports must include all required fields in the adverse event reporting forms. Mandatory information is the minimum criterion for a report to be accepted. Reports lacking mandatory information will not be processed.
When submitting a report, stakeholders should provide detailed information, including:
- Patient details (e.g., age, gender, weight).
- Description of the AE or AEFI (e.g., onset, symptoms).
- Therapeutic goods details (e.g., brand name, batch number, dose).
- Concurrent drugs or therapeutic goods.
- Past medical history, allergies, or conditions.
Reporting Forms
The document also describes in detail the applicable reporting forms to be used, explaining the approach to be followed.
- Yellow Form for Healthcare Professionals
- Designed for ADR or AE reporting by HCPs
- Available in hard format and on the DRAP website.
- Reports can be sent via email or postal service to NPC.
- Med Vigilance E-Reporting System
- WHO-based electronic reporting system accessible via the DRAP website.
- Supports reports in Urdu for user-friendliness.
- Enables reporting by HCPs, patients, and their relatives.
- VigiMobile App
- Developed by Uppsala Monitoring Centre (UMC) for NPC.
- Available on Android and iOS via QR codes on the DRAP website.
- Med Safety Mobile Application
- Created by WEB-RADR, MHRA, and UMC.
- Used in low- and middle-income countries for AE reporting.
- Downloadable from app stores; usage guidelines are available on the DRAP website.
- Industry E-Reporting
- Designed for registration holders to report ADRs/ICSRs using manual data entry or E2B upload modules.
- Accessible through secure login credentials provided by DRAP.
- CIOMS Form
- Manual reporting for registration holders without electronic reporting facilities.
- Hard copies can be mailed to NPC in exceptional circumstances.
- E2B XML Reporting
- For submission of E2B XML files directly through the Industry E-Reporting system.
- Reporting via VigiFlow
- Used by PPCs, PHPs, and hospitals as a uniform ADR reporting tool.
- Integrated into the national pharmacovigilance database for seamless reporting.
When to Report?
Under the existing legislation, HCPs and patients should report serious AEs or AEFIs immediately to minimize potential harm to others. Non-serious AEs should also be reported promptly. Reporting timelines are outlined in the Pharmacovigilance Rules, 2022.
What Happens to Reports?
- Hospitals
- Pharmacovigilance officers (POs) document and assess ADRs/AEs for mandatory data quality.
- Initial causality assessments are reviewed by hospital pharmacovigilance committees.
- Reports are forwarded to PPCs or directly entered into VigiFlow for integration with the national database.
- Provincial Pharmacovigilance Centres (PPCs)
- POs document, assess, and review reports for completeness.
- Provincial committees review causality assessments before submission to NPC or VigiFlow.
- Public Health Programmes (PHPs)
- POs collect reports at treatment sites, assess them at provincial levels, and forward them to the federal PHP.
- Expert Safety Review Panels (ESRP) perform causality assessments and signal detection for programme-specific drugs.
- National Pharmacovigilance Centre (NPC)
- NPC collects, validates, and assesses reports from all stakeholders.
- Reports are entered into VigiFlow, and causality assessments are conducted.
- NPC identifies signals, validates them, and transfers Individual Case Safety Reports (ICSRs) to WHO’s VigiBase.
Assessment of Individual Case Safety Reports (ICSRs)
As further explained by the authority, the subsequent assessment process involves:
- Documentation Quality: Completeness, diagnosis integrity, and follow-up.
- Coding: Using WHO Drug Dictionary for drugs and MedDRA for adverse events.
- Relevance: Identifying new, unknown, or serious reactions.
- Duplicate Identification: Avoiding redundancy in reporting.
- Causality Assessment: Evaluating potential links between the drug and the AE.
Use of Pharmacovigilance Data
The document also outlines the ways data reported could be used in the future.
- Signal Detection and Strengthening
- Early detection of new ADR signals is prioritized.
- International collaboration through WHO’s VigiBase strengthens signal detection.
- Risk Management
- Identifying and prioritizing risks to minimize harm and ensure patient safety.
- Drug Regulation
- Pharmacovigilance data informs updates to prescribing information, product recalls, and regulatory actions.
- Risk Communication
- Disseminating safety alerts, newsletters, and DHPCs to healthcare professionals.
- Education and Feedback
- Updating healthcare professionals on pharmacovigilance practices to improve medication use.
Conclusion
In summary, the guidelines for reporting pharmacovigilance data ensure robust monitoring of therapeutic goods. According to the document, a streamlined process involving all stakeholders, effective reporting tools, and international collaboration is vitally important for safeguarding public health by detecting, assessing, and mitigating risks associated with therapeutic goods.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
