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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.  

QPPV? ……Check! 
SOPs? …….Check! 
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…

  • Pharmacovigilance is dedicated to preventing harm and reducing the risks associated with the use of any medicinal product;
  • Pharmacovigilance ensures the benefits of the product are maximised and any new, or previously unknown benefits are explored;
  • Pharmacovigilance aims to reduce the financial burden to the health authorities by monitoring adverse reactions to its medicinal compounds;
  • Pharmacovigilance focuses on providing clear, legible and easy to follow instructions on the correct use of a medicinal product;
  • Pharmacovigilance collects data, that would otherwise not be available, on use the of drugs in pregnancy and monitors foetal outcome;
  • Pharmacovigilance takes a special interest in vulnerable population groups often excluded from clinical trials, such as children, the elderly and immuno-compromised;
  • Pharmacovigilance monitors the quality and integrity of the product through product complaint analysis and advises on improvements to the product or any of its labelling and packaging components;
  • Pharmacovigilance monitors the use of its products off-licence to establish market trends and to fill that gap in product knowledge;
  • Pharmacovigilance is a valuable source of information for all company departments and takes a collaborative approach to product development;
  • Pharmacovigilance staff are experts on drug safety, enthusiastic about their science and their skills should be tapped;
  • Pharmacovigilance know the legislation and regulatory framework and provide advice on various issues relating to risk management;
  • Pharmacovigilance is an important contributor when communicating risk to healthcare professionals.

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.

Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
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