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Why Proactive Pharmacovigilance Can Work


My last two blogs compared a hypothetical example of reactive and proactive pharmacovigilance (PV). My next installment in this series outlines how PV can work.

Rather than reacting to the data, in the second hypothetical scenario, Company A pivoted with ready-planned interventional pharmacovigilance practices at the level of the intake system and took a patient-centric approach using smart technology and dedicated patient advocates.

In the weeks following the implementation of patient adherence and patient support programs (e.g., reminding patients of their next dose, answering any questions or concerns), the rate of lack of drug effect and the rate of disease progression decreased to a level comparable with that reported in the pre-marketing clinical trials.

The patient assistance and adherence program is so successful that Company A suffers no financial impact, and payers and providers are now willing to cover the drug under their benefits. The novel treatment is so successful that Company A begins to look at other immune-mediated diseases in which its biologic could be as successful or other products where PSP or PAP are beneficial. The data from the patient disease journals was used as real-world data to change the device post-marketing to a smaller needle and less buffer to decrease patient injection site reactions.

The second scenario is an example of proactive PV. It is only successful if the data is digested and provided in real time. Are there technologies available that allow such views of the PV data? Unequivocally, yes!

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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