What Are PV KPI’s?Pharmacovigilance key performance indicators (PV KPI’s) are a set of quantifiable measures that a company uses to gauge its performance over time. These quantifiable measures can be used to indicate how well a pharmacovigilance system is performing and whether the system is continually improving. The demands on a PV system vary depending on the number of products concerned, the nature of the products and the life cycle, and regulatory demands placed on the products. Module I of the GVP Guidance (I.B.12.)– Pharmacovigilance systems and their quality systems require the “Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system”. Guidance on compliance monitoring for each pharmacovigilance process is provided in each Module of GVP as appropriate, however, measuring compliance with requirements is not the only way to measure the performance of a PV System. Too many MAH’s limit the reporting of KPIs to the system’s compliance with reporting timelines (e.g. expedited reporting of ICSRs, PSUR submissions and PRAC Variations).
Generate An Effective Evaluation of Your PV SystemIn order to generate an effective evaluation of the PV system that will be of value, the following criteria should be considered:
- Assessments/evaluations should be timely – accounting for the time required for the implementation of e.g. a new procedure/intervention/RMP/Variation
- Evaluation should address all (relevant) aspects of the PV system
- The evaluation strategy should include outcomes that can be realistically measured that will not generate inaccurate or misleading data