Life Sciences

Questions Regarding Pharmacovigilance Reporting During COVID-19

Pharmacovigilance

With the shift to working from home, changing daily priorities, and resources during the COVD-19 pandemic, regulators have or are making transitions to ease the stress without losing valuable data that may contribute to the treatment of COVID-19 or interrupting clinical trials.

The pace at which the information on COVID-19 itself appears is so fast; it can be overwhelming and hard to digest. Earlier this week, we shared our picks of the sites, providing real-time updates for clinical therapeutics and the rapidly evolving COVID-19 pandemic. Remember that while we are disrupted, the regulatory authorities are probably impacted by a two-for-one. They are working to evaluate and approve clinical trials for COVID-19 in record time and they are working with what we all face: physical/social distancing and possibly a reduced staff.

In order for us to keep patient safety at the forefront, it is now more critical than ever for us to work together as a team with our partners, regulators. We are in a marathon, not a sprint; we will need positivity, open communication, and encouragement to sustain our businesses. This crisis will abate and we will have many valuable learnings. Each sector is rising to the occasion, so being open and trying to be succinct is the fastest way to ensure that your pharmacovigilance (PV) reporting and practices during a pandemic remain compliant. That said, where can we find some relief?

For clinical trial reporting and spontaneous individual case safety reports ICSRs, where is the guidance? Secondly, searching for them is not always easy, but hopefully this takes off some of the workload and gives you easier access.

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Below, you’ll see the links to critical processes when operating in a stressful (global pandemic) time when not all information may be readily available and our holistic pharmacovigilance system (from intake to reporting) is disrupted. We have focused only on FDA, EMA, and Health Canada, for now.

Health Canada has issued specific guidance for the COVID-19 Pandemic. It is a short, easy-to-understand read:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-industry-mandatory-reporting-requirement-covid-19-pandemic.html

FDA issued a comprehensive guide that covers all of its regulatory areas (human drugs, devices, combination products, nutraceuticals, animal health and tobacco products):

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic

EMA has valuable information for managing clinical trials, as well as information on their initiatives for COVID-19, published at the link below. There are also links to guidances on reporting:

https://www.ema.europa.eu/en/news/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic

 

About the Author

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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