Pharmacovigilance: Good News and Bad News

BPM
  • September 27, 2018
  • Larry
  • 0 Comments
DNA in blue

Editor’s note: This guest post is the third 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.]

 

If you are a pharmacovigilance (PV) professional, we have good news and bad news.

The good news is, your job is secure. The bad news is that you are about to get slammed with exponentially more adverse events (AEs) and potential signal data than you have ever had to process before.

Hopefully, neither is a surprise to you.

Just take a look at Chart 1. Over the past 10 years, the numbers of AEs reported have grown by more than 500% to a total number in 2018 likely to exceed 2 million. This exponential increase in the numbers of adverse events is what pharmacovigilance professionals are ALREADY dealing with. Even these numbers will be dwarfed by what is coming!

Chart 1. Source: FDA Adverse Event Reporting System (FAERS) Public Dashboard

Before we go on, if you are a consumer or patient reading this, REST EASY! These adverse event numbers do not mean that there is a rampant increase in bad stuff caused by pharmaceutical or devices. The increase this last decade is largely the result of the internet reporting tools, more formalized reporting, and greater awareness by consumers to report directly. In fact, over the past 10 years, the percentage of serious adverse events have fallen significantly. See Chart 2.

Chart 2. Source: FDA Adverse Event Reporting System (FAERS) Public Dashboard

The truth is, pharmaceuticals are more patient-specific, more heavily studied, and more rigorously assessed for efficacy and safety than ever before. Click here for a short overview. Biopharmaceutical Development: The Process Behind the Scenes

Consumers also need to know that the entire medical field of pharmacovigilance is designed to help healthcare providers, manufacturers, and regulators assure the safety of patients and improve the knowledge of scientists and medical professionals.

Achieving the ultimate goal that no patients experience adverse medical events requires more reporting of possible issues, not less. Ironically, use of the FDA’s adverse event reporting system is largely voluntary — only drug companies, not doctors or patients, are required to report problems.

According to Government Accountability Office estimates, the FDA Adverse Reporting System only captures 1% to 10% of all adverse reactions. So, it is conceivable that the numbers of adverse events could exceed 10 million, which is in line with the current trajectory shown in Chart 1.

If you are a PV executive, you already know that adding more people to your team is too costly. You also know that pharmacovigilance is one of your core business processes and that regulators the world over are expecting companies to act more quickly and know their product’s risk-benefit data better. This means that further outsourcing of work may not be an option.

What you may not know is how you can use business process redesign and digital operations to solve current and future capacity challenges. In fact, the pharmacovigilance process is perfectly suited to end-to-end digital process automation and the application of high-end computing such as natural language processing and artificial intelligence for signal detection and surveillance.

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 up.

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