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Positive Perspectives on Pharmacovigilance
Red Line subscribes to a number of scientific journals, one of my favourites of which is the Drug Safety journal. As a QPPV with a background in pharmacy, it is really inspiring to see the on-going research and debates around the science of drug safety, efficacy and ultimately risk management.
It can however, be quite demoralising when new staff in our drug safety team realise they are viewed by their colleagues, or clients, as prohibitive and obstructive to the medicinal product. There is an out-dated perception that pharmacovigilance is just a legislative ‘box-ticking’ exercise.
Eudravigilance registration? ……Check!
PV training certificate? ……………Check!
This is often the perception of departments with a commercially driven directive. The PV department is viewed as ‘Those folks from the ‘dark-side’, who embrace the adverse event report and feed each one into that monstrous database. Only to spit it all out later with more restrictions and more changes to the reference safety information.’ It is no surprise then that adverse event reporting rates are low and feedback to follow up investigation is laborious and slow. After all, if we can’t convert our own colleagues then what chance do we have with everyone else?
Admittedly, the past culture of pharmacovigilance training would provide a rather negative slant to the science. Hiding behind burdensome legislation and strict, uncompromising regulatory frameworks, pharmacovigilance becomes an abstract, almost mysterious being. A creature. ‘He-Who-Must-Not-Be-Named’. I think this tactic was used to dodge the mud slinging and eye rolling from the commercial guys and to allow the drug safety geeks to shield themselves safely behind their paperwork.
It is time we took a more promotional attitude towards the reputation and importance of pharmacovigilance. After all, ‘If you can’t beat ‘em, join ‘em.’
Pharmacovigilance training should include positive affirmations about this science, such as case studies proven to be beneficial to both patient safety, and the company, and should include examples of how a collaborative inter-departmental approach can be used to maximise the potential of a medicinal product. If its sales they want, let’s give it to them. Sell them pharmacovigilance.
So, it was with that in mind that I thought I would run through a few of my training slides and put a more positive spin on my angle. So, here goes…
There you have it, a positive perspective on pharmacovigilance. It wasn’t as difficult as I thought it would be. If you think about it, all these statements show that pharmacovigilance is an important part of the pharmaceutical business arena. Together, with sales, manufacturing, marketing and medical information they can play an integral part in the medicinal product life cycle, both pre-and post-marketing.
It’s always good to show that although pharmacovigilance can be a serious issue and deals with serious cases, a light hearted approach can go a long way to building better and more transparent corporate collaboration.
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