Pharmacovigilance Made Simple

  • September 13, 2018
  • Larry
  • 0 Comments

[Editor’s note: This guest post is the first in a series from Larry Taber, BP3’s Digital Strategy Officer for Life Sciences and Pharma. Larry has over 32 years of deep pharmaceutical and biotech expertise ranging from discovery research to business development. He has over 17 years of leadership of international teams successfully partnering with over 100 companies. Larry is a proven business process problem-solving professional and trainer. He has completed Master Black Belt, Black Belt, and Malcolm Baldrige National Quality Award /Performance Excellence Examiner certifications. He is passionate about the incredible advances in medical science and the enablement that is being made possible for patients through digital technologies. He holds a M.S. in Medical Biochemistry from Indiana University Medical School and a B.S. in Chemistry (Magna Cum Laude) from Purdue University.]

 

Pharmacovigilance (PV or PhV)(as defined by Wikipedia), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

It is a suitably fancy word for an important and complex process that is simply about our safety.

I would like to tell you a bit about it from a personal perspective and then point you to some other materials you might find interesting.

My Experience with PV Inside Pharma
Years ago, I remember my quality assurance reps assisting the corporate pharmacovigilance (PV) team with adverse event investigations.  Reading reports of something unexpected that frightened or harmed someone lifted us out of daily ops and put us in the shoes of patient. and put us into super-sleuth mode. Once in super-sleuth mode, we obsessed on trying to crack the case.  What were we missing?  Are we sure there is nothing wrong with product?  Go back and look.  Can we tell whether the patient took their dose properly?  Is this something we have seen before?

Often there was scant detail in the complaint, making it impossible to even know what to look for.  So, we double-checked digital and paper records beginning-to-end, scouring everything for any evidence of anything unusual about the manufacture of the lot.   It was always a search for a needle in the haystack

Ruling out the drug itself is always the first step in the process putting our reports at the front of the line of the multiple investigative steps taking as part of the overall PV process.  With our job complete, the medical team pushed on in high gear with the prescribers and doctors to piece together more information about what had happened.

Normally, we would never hear about the final outcomes for the patients, but we always wondered.

Every adverse event involves hundreds of hours work behind the scenes at pharmaceutical companies.  They receive several thousand complaints every year across the millions of doses of product sold; and, they take every reported event seriously.  I know, because I was there.

For more on Pharmacovigilance register for our upcoming webinar: Next Generation Pharmacovigilance, happening Wednesday, October 3 at 10 AM (CST). We will present a variety of quick wins that can immediately improve quality, speed, accuracy, risk management and more. Click here to sign pup.

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