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A Pharmacovigilance Perspective on the Coronavirus COVID-19 Impact

Typing a perspective on COVID-19During a recent meeting with UBC’s president, a fellow employee asked how UBC could help during the COVID-19 crisis. As pharmacovigilance physicians and nurses, many of us formerly worked in direct patient care and are struggling a bit with the fact that we aren’t on the frontline efforts.

My “former life” (prior to pharmacovigilance) was as an emergency medicine physician. I’ve often thought about what my role would be like during this pandemic if I were still working in the emergency department. I’m still in contact with a lot of friends working clinically and it’s hard for me to hear about the lack of equipment that places them at risk every day. The question of UBC’s plans to help in the COVID-19 crisis resonated with me.

I feel fortunate to be safe, working from home even when it’s chaotic due to my two boys (under age 5) wanting my attention.  My role within UBC (for a little more than 4 years) is as a medical monitor and as a safety physician performing medical safety reviews of Individual Case Safety Reports (ICSR), signal detection, and medical review of aggregate reports. More than a month into this quarantine, I’ve been able to reflect on my role and participate in DIA-run webinars on “Conducting Clinical Trials During COVID-19”. Although not on the frontlines or even working directly on products pertinent to the pandemic, in our roles providing support services for the biopharmaceutical industry, we’ve all been challenged by this unique situation, and several instances during the COVID-19 quarantine have made me realize how valuable my work and the work of my colleagues with UBC is. As such, I would like to offer a slightly different perspective on COVID-19.

As one such example, I work as a medical monitor for a compassionate use program for an oncology program. This program allows for patients who have either progressed on standard therapy or have no alternative options to receive this medication. This medication can be life-saving for these patients who have exhausted other options. As a medical monitor, we review individual requests from physicians worldwide to see if the risk-benefit is intact for the patient to receive this product, and once the patient is enrolled, we communicate with physicians and their teams to make sure that their patients are having appropriate safety measures and are continuing to benefit from treatment. Getting the medication to patients worldwide and safely monitoring them is challenging when there isn’t a global pandemic and is even harder when borders are locked and when going into hospitals for monitoring can be risky for this already vulnerable patient population. With the client and treating physicians, we’ve had to evaluate these additional unexpected risk-benefit considerations for individual patients and creatively collaborate to pivot and find solutions to get patients treated safely.

I think of the “silent toll” of COVID-19 – patients who will never be diagnosed with COVID-19 who are not able to get (often life-saving) medications as a result of this pandemic. With the work that I do within UBC, I’m not providing direct patient care, but I am challenged by trying to help with solutions in the situations that I’ve already seen and recognize that there will still be more challenges to come.

We’ve also started to see “the silent toll” of COVID-19 in our work in pharmacovigilance. In another oncology program, which has a marketed product, we’ve seen several pharmacovigilance case reports of “holding medication due to risk of COVID-19.” Time will tell, but patients may progress on their already well-controlled disease due to withholding their medications. Additionally, the DIA-run webinar, “Conducting Clinical Trials During COVID-19” highlighted that in mid-March a survey indicated that half of U.S. clinical trial sites were considering holding new enrollment as a result of COVID-19. Further, it was noted that after the pandemic is “over” there will likely be a post-COVID capacity surge for trials. I would assume that when we try to “go back to normal” there will be a strain on all medical resources as even regular office visits have been delayed and may result in diseases being diagnosed at later stages, and unfortunately even missed or serious toxicities from drug products, which could have been avoided.

In the midst of this pandemic, I am thankful to be able to see that the work that I am doing is valuable for patients and their physicians worldwide, both in helping patients to access therapies and also in continuing to ensure the safety of patients through both medical monitoring and medical safety review. I anticipate additional challenges in the upcoming months and look forward to working with the UBC team, sponsors, and treating physicians to come up with viable solutions during this unprecedented time.

To learn more about UBC’s pharmacovigilance capabilities, contact us.