Pharmacovigilance Services in Kenya

The National Pharmacovigilance Centre (NPC) based at the Pharmacy and Poison Board, under the Ministry of Health, oversees pharmacovigilance activities including adverse drug reactions (ADRs) and poor-quality medicine reporting in Kenya. Under the NPC, the Pharmacovigilance Risk Assessment and Advisory Committee (PRAAC) is responsible for assisting in the technical aspects such as the causal relationship between the suspected ADR and the suspected drug. In Kenya, it is the responsibility of the general public, the National Medicines Regulatory Authorities (NMRAs), healthcare providers across all levels of the healthcare system as well as public health programs (PHPs), and the pharmaceutical industry, including marketing authorization holders (MAHs) to report all ADRs. All except MAH can submit adverse drug reactions reports through the various forms developed by NPC: Adverse Event Following Immunization (AEFI), Suspected Adverse Drug Reaction Reporting Form (SADR), medical devices incident reporting form, medication error reporting form, Poor Quality Medical Products and Health Technologies (PQMP), and adverse transfusion reaction form. MAHs can submit an ADR report using the international CIOMS form. In addition to this, it is a must to have a QPPV person who will be the single point of contact on behalf of the MAH regarding the pharmacovigilance of the marketed products. Also, Kenya has a county investigation team with a county Vigilance focal person who receives ADR reports from local hospitals, physicians, and the public and reports them to NPC.

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 Kenya 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 Processing & 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)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, pharmacovigilance aggregate reporting as well as regulatory agency website monitoring
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

QPPV Services

  • Authoring & Review of PSMF, PV SOPs etc.
  • 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 compliance audit 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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