With the inevitable (eventual) implementation of IDMP across industry, it’s essential that business units embrace the need to cooperate and become accountable for their share of the workload.
The mandatory introduction of xEVMPD in 2012 highlighted that many business units outside of Pharmacovigilance (PV) could be affected by it, either through owning/holding related information or through being part of the process that supports change. However, also evident was a broad consensus that xEVMPD was solely a PV initiative and so the responsibility lay firmly at that department’s door.
But is that the case? The short answer is NO, as there are potentially many other business units involved in the change management process when there is a need to update the xEVMPD.
Clearly it can be claimed that PV is the primary trigger for change, depending on outcomes following causality assessments of case reports, e.g. any subsequent corrective actions, such as revision to a formulation, packaging or labelling, etc. This then potentially causes an effect where other business units become intrinsically involved by default. For example, a SUSAR may create grounds for change of product use, which triggers a new MAA or a variation to be submitted, or a in other instances an outcome may mean a simple revision to the PIL is required. When a change to a licence is required a variation may be submitted to the agency by the regulatory department and once approved, the xEVMPD is updated within the required timelines. There are many potential scenarios.
In a broader sense, as we look down the road to IDMP, the change management process could (at one time or another) involve clinical, manufacturing, packaging and labelling, marketing, legal, regulatory affairs, quality and business units such as IT and finance for the necessary investment in and implementation of new (or upgrading of existing) IT systems to support IDMP. Any change generally requires some form of approval, testing or validation, and so whether it’s related to budget, IT, legal, quality, regulatory or safety, etc., IDMP affects multiple business units.
As we move forward then, it is prudent to take a holistic view of the entire product lifecycle process and identify how stakeholders can work effectively together to guarantee compliance without compromising each department’s efficiency, effectiveness or indeed morale. Such a need is highly evident in creating and maintaining the PSMF, which is ultimately the ‘bible’ for PV within any organisation; but as IDMP finally kicks in, the frequency of involvement in the process will undoubtedly increase and so, looking at these issues now is imperative in being prepared for what is coming.
Like xEVMPD, IDMP really isn’t simply a PV initiative then, and working collaboratively as a TEAM benefits everyone concerned. Indeed, together everyone achieves more and so perhaps each stakeholder should be committed to that concept – I’ll Do My Part (IDMP).