Introduction

Pharmacovigilance is the science and practice of monitoring the safety of medicines and vaccines and taking action to reduce risks and increase benefits. The following components are needed for any national pharmacovigilance system:

1. A national pharmacovigilance center with designated staff (at least one full time), stable basic funding, clear mandates, well defined structures and roles, and collaborating with the WHO Programme for International Drug Monitoring.

2. The existence of a national spontaneous reporting system with a national individual case safety report (ICSR) form i.e. an adverse drug report form.

3. A national database or system for collating and managing ADRs.

4. A national ADR or pharmacovigilance advisory committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication.

5. A clear communication strategy for routine and crisis communication.

WHO Global Benchmarking Tool

The WHO Global Benchmarking Tool provides a framework for assessment of country pharmacovigilance readiness, as seen in Table 1.

Table 1: WHO Framework for Assessment of Pharmacovigilance Readiness

Good Pharmacovigilance Practice

Good Pharmacovigilance Practice (GPvP) is defined as a set of guidelines drawn up based on national legislations and regulations to ensure that all medicinal products including vaccines are monitored safely and securely throughout their life cycle. GPvP guidelines provide assurance of the continuous positive benefit-risk profile of medicinal products through

1. The ongoing collection, processing and reporting of safety data,

2. Continuous signal detection and risk management activities,

3. Proactive and timely communication of safety relevant information to all stakeholders including patients, healthcare professionals and the general public, and

4. Quality management of pharmacovigilance procedures.

It is expected that the following core GPvP requirements be met:

• Description of the pharmacovigilance system, a Pharmacovigilance System Master File (PSMF)

• Required procedures on core activities:

  • Collection of safety information (e.g., individual case safety reports ICSRs, literature reports)

  • Processing and analysis of the safety information (individual cases and aggregate safety data review)

  • Individual and aggregate reporting: Regulatory reporting of ICSRs, compiling and regulatory reporting of aggregate reports (i.e. DSURs, PSURs)

  • Signal detection, validation, and evaluation

  • Risk management and risk minimization

  • Benefit-risk assessment

  • Proactive and timely communication of safety relevant information

  • Quality management of pharmacovigilance procedures.

Public Health Emergencies

Safety Data Monitoring is important for any vaccine, but it is even more critical in a Public Health Emergency during which vaccines may be implemented on a large scale quickly in the absence of randomized, controlled efficacy data. Phase 1 clinical trials to evaluate vaccine safety are typically performed on a small number of subjects and may not detect rare adverse events that could be experienced once a vaccine is used in a much larger population. Pharmacovigilance systems in each country should be interconnected to allow for sharing of data and information across countries to aid in development of outbreak responses.

Resources

Good pharmacovigilance practices | European Medicines Agency (europa.eu)

UK Guidance on pharmacovigilance procedures