By Dr. Seema Jaitly, Essjay Solutions

With the advent of the new PV legislation within the EU, there is an increasing need to focus on documented benefit:risk of medicinal products. It could be argued that actually this is what we should have been doing all along and the changes are really cementing best practices regarding pharmacovigilance. Looking at the PSUR; this document was always a review of the safety data at certain points in time, and the review was always meant to take cumulative data into context to see what had changed from the safety perspective. The issue was that many companies did not do this as it was not explicitly stated and this has now led to the issuing of clear guidance around this subject and the purpose of the document. The result being a more formal comparative benefit:risk assessment that has led to a lot of discussion around applicability of indication, especially for the very old drugs with minimal studies to support efficacy.

Regarding the QPPV role, it is clear that the Marketing Authorisation Holder (MAH) has responsibility for supporting the QPPV and ensuring they have the right tools to perform their duties, but is it still explicit enough or is there still room for interpretation? We have now got a lot more experience with the QPPV role and there is a clearer understanding of the requirements, but this can still lead to conflict with management and sometimes within the pharmacovigilance department itself. It is not clear how this will be resolved, however what is clear is that two roles are evolving; the head of safety and the QPPV, and they are not the same, although have many common goals!

Risk management and minimisation have also been a key aspect of pharmacovigilance in recent years, however the focus has now shifted to the evaluation of what is being implemented. Again this is something that should always have been considered. What also needs considering is the main objective of the risk minimisation activity, however all too often a tool will be implemented without real consideration to the behaviour change required. Both MAH and the regulators are to blame for this, often requiring something to be implemented but not thinking about overall objectives of the activity and the feasibility.

Signal detection has also taken centre stage. Although this has been carried out for a very long time, with sophisticated systems to identify disproportionality, there has been a lack of transparency with regards to decisions taken within organisations. This needed to be addressed as there was limited transparency around the decisions made throughout a signals lifecycle. It is very clear now that key decisions in the process need to be tracked from initial identification, validation through to decision, with justification stated. This has proved to be difficult in some organisations where it is felt that predefined timeframes and clarity is a set up for failure at audit. This needs to be addressed with a pragmatic approach that does not compromise patient safety.

Overall the PV legislative changes have brought drug safety into the 21st century, however there are significant challenges associated with implementing the requirements and also understanding the bigger picture and where your product is positioned overall. There is a need to be more proactive and accountable for decisions which brings about a sense of anxiety to some. Surely it’s not a bad thing to be accountable? Maybe the issue is that when things do go wrong, there is the inevitable looking for someone to blame and no one wants to be that scapegoat. Companies and regulators need to ensure that this is not the case and that only incompetence is punished, not issues that could not be identified much before they occurred. Let us see what happens in the future, there are increasing pressures on the regulators too and in a way these changes have impacted the regulatory authorities significantly, both in terms of skills and resources. Mindset changes are needed in both the industry and within the regulatory authority, it is a steep learning curve, but will lead to better protection for patients.