Pharmacovigilance(PV) is not a cost center its a cost saving centre

                                Pharmacovigilance(PV) is not a cost center its a cost saving center

 

If you have worked in mid to senior roles in PV, you may have come across this dilemma where we need to continuously convince, communicate and influence other non-pharmacovigilance departments regarding the importance of pharmacovigilance. And the more difficult task for someone in leadership is to also break the myth that "PV is a cost center" meaning PV does not bring any money, and on the contrary, we have to invest the money in running the pharmacovigilance department. 

 

And the basis of this argument, is actually coming from the fact that, pharmacovigilance requires setting up the call center (toll free number, telephony and employees working 24/7 to handle the calls), then collection of adverse event via other sources, safety database (very costly licenses), and other application supporting safety database, costly aggregate reporting applications, signal detection applications, so on and so forth. All these applications need to be validated and upgraded every time, hence this is never ending payments to the application owners. Also its a niche area, so the human resource has to be highly trained and experts (pharmacists, doctors), so this also adds to the cost. Moreover, the inspection and audits add to the cost. So, what people perceive does have a basis?  Owing to all of these factors, there is always an ongoing struggle to get more budget and investment for pharmacovigilance-related assignments in the PV department.

 

How do we change this perception? No definite or one-size-fits-all answer. But one thing we can do is to convert the data that we analyse and the outcomes we generate from this data into meaningful and relevant, easy-to-understand impact and value we create for patients.

 

These are thinking points for each person working in pharmacovigilance and not for the department heads, because as working professionals, even when we work as data entry, we need to know the value, impact and importance of our own PV work we do. Additionally, we need to be prepared to also spread the awareness and message to others whenever needed.

 

 

 

 

 

Key components that can be used for building our case

 

1. Regulatory expectations: 

 

Understanding and complying with the regulatory guidance is not an easy task. While the regulatory affairs department is the one leading the dialogue and ensuring compliance, pharmacovigilance is the one who is implementing and ensuring we have documented evidence to showcase our compliance to regulatory authorities. 

Markets the drug is being marketed are covered by that country's pharmacovigilance regulation from national health authorities. Although at a high level the PV requirements remain consistent, they are changing, evolving and differing at the country level. This needs to showcase how we meet those specific country requirements.

 

Having a core data available that can be presented regarding the most complex health authorities' requirements and how PV meet them with ongoing addition of examples on changes adapted to meet this HA compliance will make it easy for non-PV leadership to also understand the importance. E.G. Instead of showcasing we met FDA requirements, add an example of FDA requirements and give an example of how they were met and what the outcome.

 

 

 2. All is well until its not /Inspections

 

Build and maintain a database on pharmacovigilance inspections done by various regulatory authorities in terms of the name of the health authority, type of inspection, duration, inspectors, findings, category of each finding, outcome of inspection, and what corrective and preventive actions were implemented. Talk about the outcome, especially the positive, how it saved money in terms of not having non-compliance.

 

3. Outsourcing vs inhouse 

The age-old dilemma of having a pharmacovigilance department in a pharma company or outsourcing the PV to CRO/KPO/BPO (Vendors). Both has its own merits. Clear, Definite and Ongoing continuous evolving PHARMA-Vendor model of partnership serves as the best solution. For a pharma company, due diligence on the vendor is a must i.e. are the processes set, is it a working model, what would be the cost of implementation, how much oversight will be needed. Ultimately, having an actionable plan that can be referenced in terms of the business value the vendor is bringing is a must.

 

4. Data points that can be used

 

While showcasing the impact and value pharmacovigilance creates, the easiest data points is volumes i.e. how adverse events are received and processes (ICSR volumes), submission compliance ( timelines met to submit to each health authority) how many aggregate reports processed ( PSUR, DSUR, PADERs), how many articles reviews, how many data sources screened for signals, number of signals identified and validated.

 

The tricky data points that are difficult to put in a coherent and relatable manner are what this means for business and patients. For this, we need to build stories, if a signal is validated, how was it addressed, and how it helps patients, if there was a health authority request, how was it managed. If there was no requirement asked by the health authority and we could say no, and it was accepted, e.g. conducting a phase IV study, how much money was saved, etc.?

 

Written by:

Dr.Shraddha Bhange.

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References :

ICH E2E – Pharmacovigilance Planning

EMA Good Pharmacovigilance Practices (GVP), Module I & IX