SERVICES

Pharmacovigilance Services in South Africa

Pharmacovigilance is quintessential to monitor the safety of health products and reporting of the adverse drug events plays a central role in this. The South African Health Products Regulatory Authority (SAHPRA) of the Department of Health is responsible for overseeing pharmacovigilance activities in South Africa. It monitors the safety of health products for a comprehensive understanding of possible adverse drug events and their association with the suspect drugs. Adverse events (AE) can be reported by the general public, physicians, other health professionals, medical device suppliers and pharmaceutical manufacturers via phone, fax, or email. Alternatively, adverse drug event forms can be filled which are available at National Adverse Drug Event Monitoring Centre (NADEMC) or the manufacturer ADR/ADR Report Form. Recently, a mobile application Med Safety App is developed for reporting adverse drug events related to medicines. It can be used by both public and health care professionals. The app is user-friendly and covers all the basic information required for reporting. An adverse event can be reported even if not sure about the suspicious drug. It is the responsibility of SAHPRA to assess the causality through scientific analysis and clinical to ensure that the benefits associated with the use of the suspect drug or medical device outweigh the risks for its safe use. However, the under-reporting of adverse drug events is a possible challenge faced by SAHPRA.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in South Africa that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, Literature Monitoring, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Monthly reconciliation
  • Medical review of Signal detection ; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review Audit and Compliance to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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