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Pharmacovigilance: The Return on Investment


Previously, I analyzed the history of pharmacovigilance (PV), AEs and clinical therapeutics. This post examines the potential for increased return on investments when pharmacovigilance is implemented.

All AE data holds value; how that value is determined takes an astute scientific approach to surveillance. In 2001, the medical literature began to include the results of a different approach to the treatment of glaucoma and ocular hypertension. The class of drugs was relatively new, and the mechanism of action increased the outflow of aqueous humor and thus decrease intraocular pressure (IOP). For one of the first times, unstable prostaglandin molecules (mediators released from the COX pathway) were mimicked in stable molecular analogs: bimatoprost, travoprost, and latanoprost.

One of the early AEs consistently emerging in these clinical trials was increased eyelash length, thickness, and growth, notable after one to four months of consistent use of the drug, not to mention the effective decrease in IOP. By 2008, Allergan had an approved NDA for (latanoprost) Latisse®, with a second indication for eyelash growth.

By 2013, the drug realized more than $110M in revenue. It’s important to note that this example of return on investment coming from early AE data and astute pharmacovigilance awareness of the data.

There are multiple other examples in medical literature (see table on the following page) demonstrating how adverse event (AE) profiles (including off-label use or misuse) drive new indications for known drugs, which as a result, helps increase ROI and positive patient outcomes. Whether it be a new indication or a contraindication leading to better outcomes, the examples provided below show the value of AE data.

To learn more about the history of pharmacovigilance, current challenges and ROI opportunities, and how to remain proactive in the future, you can download our guide here. Or, you can submit the form below.

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Kari Blaho-Owens

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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