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Compliance Metrics for Pharmacovigilance Activities
Posted on August 19th, 2016 by J.-P. Clement MD in Pharmacovigilance
Measuring the compliance of a defined set of variables is key for functions like pharmacovigilance, where there is intense reporting to different regulatory and non-regulatory entities with strict regulations and high inspection risk. The real objective of monitoring compliance is indeed not only checking how close the department is to the ideal goal of 100% compliance (which is rarely met in real life), but, more importantly, measuring the performance of the system in its ability to detect and prevent future non-compliance situations.
A 100% compliance rate objective will often be elusive because of breakages in the reporting chain due to situations such as:
- Legal cases arriving in boxes, with hundreds or more pages to scan, read and interpret. If the legal department has not been trained properly, this information will arrive late in the PV department;
- A letter from a customer, sent directly to the CEO, that complains of a negative drug experience, and that languishes too many days on someone’s desk in the C suite;
- Cases arriving late from partners in spite of a well-defined Safety Data Exchange Agreement;
- An overnight data dump from a regulatory authority containing thousands of AE reports, which need to be translated, triaged, captured, coded, reviewed and sent to partners and health authorities with impossible timelines.
Beyond compliance to reporting timelines, other quantitative or qualitative elements are extremely relevant to verify the performance and compliance of a PV system, and to implement corrections and improvements wherever needed. Here are some examples of additional quantitative metrics:
- Compliance from partners or other functions: capturing all deviations from established timelines to receive cases from partners or other departments will be key to identifying the usual culprits. Or to finding where there are weak points in the data collection system, and determining how to act before it is too late.
- Cases in danger of being late: PV databases should generate a daily listing showing where the cases are in the workflow and which cases are reaching the threshold where the company will not have enough time or resources to distribute the cases on time to partners, health authorities, investigators or IRBs.
- Compliance to follow-up: not adhering to the agreed follow-up process, which should be proportionate to the nature and seriousness of the cases, would demonstrate a lack of focus for getting documented reports and having a robust basis for signal detection activities. This would be a critical observation during an inspection.
- Compliance to agreed timelines for the interim steps of an aggregate reports preparation. Even if these internal timelines are unlikely to be a focus during an inspection, they are key indicators of the probability that a final report will be delivered late, and with potential quality issues, as there may be less focus on quality in the rush to compensate for other delays.
- Compliance to PV training: it should be easy to demonstrate a constant 100% compliance for the PV team and all relevant stakeholders, with a robust process for regular review and update of the training curriculum.
Other quantitative and qualitative elements are good indicators of how much the organization and its systems are actually geared to maximizing compliance. The following continuous improvement items should also be part of the compliance dashboard:
- Too many review and correction loops to complete an activity, or redoing someone else’s job (such as outsourced activities) will end in low compliance situations. It shows sub par allocation of resources and talent to get the job done right the first time with minimal quality controls and corrections.
- Complicated or unclear processes will likely impact the overall compliance and performance. The PV SOPs or WINs should be clear and simple, and easy to follow and comply with.
- Always looking at how to simplify and make processes easier will have a major impact on compliance-related performance, not to mention increased job satisfaction and talent retention.
Compliance and continuous improvement reviews deserve a specific forum in a PV organization. A standing PV Compliance and Continuous Improvement committee, meeting on a regular and ad-hoc basis, and driven by a Charter or SOP, is a guarantee that the focus on compliance is there and will positively influence the compliance numbers. All key PV functions should contribute; a participation from QA is also recommended. A robust Corrective and Preventative Action Plan system and project management tools will be critical. Visualization tools will help manage and communicate clearly with regard to the performance of the group. Good documentation practices are a must.
Overall, a healthy and compliant PV organization will be the result of a continuous drive for optimal compliance, the use of the right dashboards, a solid CAPA system and a continuous effort to improve the performance of the activities. Reaching this state will minimize the risk of critical observations during an inspection. It will also be a powerful tool to communicate internally about best practices and further increase the recognition of the strategic role of pharmacovigilance.
For more information on current and emerging literature monitoring and review requirements, read the white paper Pharmacovigilance: Rethinking literature monitoring and review.
All opinions shared in this post are the author’s own.
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J.-P. Clement MD
Executive Pharmacovigilance Consulting
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