Ensuring Compliance in Pharmacovigilance: Adherence and Monitoring in the PV Landscape

Compliance in the context of pharmacovigilance (PV) is not explicitly defined in the Guidelines on Good Pharmacovigilance Practices (GVP) Annex I, but it resembles 'adherence to rules'. It involves following legal and regulatory guidance such as the GVP in the EU, as well as internal and external policies like standard operating procedures and industry codes.

The focus of compliance is not on the purpose of the measures or processes; instead, it emphasizes continuous monitoring of adherence to measure against expectations and proper documentation.

Five Key Performance Indicators (KPIs) are crucial in PV compliance and require constant monitoring, as outlined in GVP II.B.4.6:

1. Timeliness of 15-day and 90-day reporting
2. Quality of submitted reports to competent authorities
3. Timeliness of Periodic Safety Update Reports (PSURs)
4. Timeliness of safety variation submissions
5. Adherence to risk management plan (RMP) commitments

Other parameters might be considered, such as how well distributors or affiliates fulfill their obligations, but it’s important to keep the number of parameters manageable.

Each parameter must be well-defined, specifying what is measured, the timeframe, methods used, targets, and results. If the results fall short of the targets (e.g., achieving only 88% of timely case submissions instead of the intended >98%), this should be clearly indicated, possibly using a 'traffic light system'. Given the significance of the indicators, appropriate actions should be taken, documented, and monitored.

The subsequent compliance report will reflect whether the implemented measures have achieved the desired outcome. Audits are crucial tools for monitoring compliance, but they warrant a separate discussion.

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