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Patient Safety Reporting Considerations for COVID-19 Research

David Varner

Post By David Varner

April 1, 2020

As market insights professionals, many of us are seeking to understand the impact of COVID-19 on the life science market through primary market research. As we explore these critical questions, we need to recognize the nature of this work and its vulnerability to compliance-related considerations.

When conducting COVID-19 research, it’s important to remember that doing so could solicit adverse events, product complaints, and special situations unintentionally. Vital primary market research around the disease must continue; however, we all must do so with proper pharmacovigilance reporting requirements in mind.  

Below are just a few examples of reporting situations that may be sparked by COVID-19 research:  

  • Death—If a patient is on a pharmaceutical product regulated by the FDA (pharmaceutical product) and dies, this must be reported.
  • Hospitalization—If a patient is on a pharmaceutical product and is hospitalized, this must be reported.  
  • Off-label use—In most cases, if a pharmaceutical product is used off-label, for treatment of COVID-19 or suspected COVID-19, this must be reported.
  • Treatment non-compliance—In some cases, if a pharmaceutical product is not taken as prescribed, either voluntarily or involuntarily, this must be reported. For example, a drug that makes someone immunocompromised is not taken as prescribed due to concern that the patient may contract the coronavirus (i.e., taking less medication, stopping medication, or delaying the next dose of medication), may need to be reported.
  • Any symptom, disease, or change in underlying disease—If a patient is taking a pharmaceutical product and reports symptoms thought to be associated with COVID-19 or mentions having been diagnosed with COVID-19, this must be reported. 

Remember we must report regardless of causality or perceived severity and seriousness of the event. For example, we may suspect that a fever was caused by COVID-19, not caused by the pharmaceutical product, but we do not know. It is not our job to determine causality. Rather, it is our job as market insights professionals to report the event to the pharmaceutical company’s pharmacovigilance team. Additionally, for many pharmaceutical companies, if multiple, non-identifiable patients are mentioned as experiencing a COVID-19-like symptom while on a company’s pharmaceutical product, this must be reported.

Finally, open-ended questions are “open books” for healthcare professionals and patients to provide feedback and thoughts about the current pandemic. We may not think that our question will trigger a patient safety report. However, the open text box gives respondents an open forum to write and communicate what they are experiencing. If any of these answers are about a pharmaceutical product and a safety event that can be tied to a patient, it must be reported per the pharmaceutical company’s pharmacovigilance procedures.

A good rule of thumb is that we must report known changes in a patient’s medical status if that patient is known to currently be taking or has discontinued a pharmaceutical company’s product whether related to the underlying condition or any other cause. When in doubt, always report and always contact the pharmaceutical company’s pharmacovigilance team for any clarification as needed.

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