Pharmacovigilance KPIs: How They Can Assist You

How important are pharmacovigilance KPIs in the effective management of a PV system?  We look at the issue and look at how to generate an effective evaluation of your pharmacovigilance system.  This article is an update to an article first written in 2017.

We consider issues such as the criteria that you should be using to determine your KPI’s and we look at the different types of indicators that you need to be aware of.

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 System

In 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

Key Performance Indicators

Structural Indicators measure systems and physical infrastructures. These indicators provide an assessment of current PV documentation and resource compliance with regulatory PV expectations and requirements e.g. Existence of Company PV SOPs that reflect current practice, current GVP requirements, and as documented in the PSMF Process Indicators measure how the system works. These provide insight into what extent the PV System is being implemented as planned e.g. SOP/SDEA/PSMF compliance.

Implementation metrics are identified in advance and tracked over time as this helps to support and correct implementation where necessary e.g. by re-Training, updating SDEAs, reviewing procedures e.g. Existence of an audited system for coordination and collation of pharmacovigilance data from all sources in the country ( e.g., literature, MAH’s, EMA, CA’s, medical enquiries, complaints).

Outcome Indicators measure the final product of the inputs made into PV activities. These provide an overall measure of the level of risk control (patient safety) that has been achieved with the PV system in place. Examples of these indicators would be; a number of audit findings, a number of PRAC requests for safety updates to patient information, percentage compliance with safety data reporting timelines.

Key performance indicators should be re-evaluated to assess their relevance as indicators, and targets can be re-set when deemed appropriate.  As a consequence of the monitoring of the PV System performance, corrective and preventive measures can be implemented where deemed necessary, resulting in continuous improvements to the PV System.

Our expert team provides pharmacovigilance support to companies around the world.  If you would like to talk to us about how we might be able to support your company in its PV activities then call us today on 00353 52 61 76 706 or complete your details below and we will get back to you.

Gemma Robinson PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved in client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance, and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects.
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Yvonne McCormack
Pharmacovigilance Manager
Yvonne is the Pharmacovigilance Manager at Acorn Regulatory. In addition to PV qualifications, Yvonne is a qualified QP and brings that same high level of quality to the PV system at Acorn. In her current role she manages a diverse PV team (which includes QPPV, Medical Assessor and UK National Contact Person) conducting Routine Pharmacovigilance, Contract Management, PSMF management, Signal Detection, Aggregate Reporting, RMP preparation and PV Auditing. A recent project has seen the Acorn Regulatory Pharmacovigilance Team open a UK based office to offer UK Pharmacovigilance services to our clients with UK MA’s, including UK PSMF, preparation, maintenance and submission, and National Contact Person services.
Eileen Shortiss
Senior Regulatory Affairs Advisor -Pharmacovigilance
Eileen Shortiss joined Acorn Regulatory in 2006. During her time with Acorn Regulatory, Eileen has worked on a vast array of projects for clients all over the world. Eileen is extensively involved with pharmacovigilance KPIs and driving continuous improvement measures across the department. Furthermore, she has considerable expertise and experience in the area of patient information leaflets.
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Avril Keane
Regulatory Affairs Advisor - Pharmacovigilance
Avril is a qualified Pharmacist with experience in clinical, community and regulatory settings. Avril’s role encompasses all aspects of the PV function at Acorn Regulatory with specialty in scientific report writing. Avril works closely with the Medical Assessor and QPPV in her preparation and critical assessment of ICSR’s for expedited reporting, signal detection reports and PSUR’s. Avril also prepares RMP’s for Clients to support their submissions to the Regulatory Authorities. Avril has built a strong collaborative relationship with our global Clients and their 3rd Parties though her interactions with them on routine PV and reconciliation.