Life Sciences

Pharmacovigilance During COVID-19: Finding the Best Information

Pharmacovigilance

There is no question that the pandemic COVID-19 has transformed life as we know it today. We are now operating in a different pharmacovigilance (PV) paradigm, adapting as we move daily. While patient safety remains the first priority, AEs will continue to come in for processing, and daily PV activities will continue. New therapeutic information for the treatment of COVID-19 and potential COVID-19drug interactions to consider are part of the influx of clinical and PV data.

How can we use the PV data, and how are scientists, clinicians, and FDA pivoting so quickly to push drugs into clinical trials for the treatment of COVID-19? Where can you find the best sources for trials and clinical data regarding evolving COVID-19 story? How can we help in our daily PV roles?

President Trump, on Friday, March 13, 2020, declared a national state of emergency. With that move, and with previous forward-thinking actions such as “right to try,” he untangled the regulatory burden so that healthcare providers, patients, regulatory agencies, and scientists could have all tools available to help patients. President Trump has also strategically met with manufacturers of critical medical supplies to ramp up production and, in partnership with the FDA, ensure that supply chains remain steady. FDA with an unprecedented Twitter feed asking for supply chain information:

When it comes to speeding up the identification of potential treatment options for COVID-19 and finding a way to slow or decrease the morbidity and mortality, pharmacovigilance data plays an important role. It’s critical to understand what a drug can and cannot do.

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For COVID-19, the most successful early information on effective treatment is with known drugs. As of March 21, 2020, the combination of hydroxychloroquine (known for anti-malarial and used since the 1940s) with azithromycin looks very promising. “Look” and “anectdotal” are not scientific evidence, but is it enough in a global pandemic?

In a global pandemic, we need visibility and reliable sources of disease progression and the impact of any early trials.

Where can you find accurate data, and how can those performing pharmacovigilance activities help? We know most have made the transition to working remotely, so in order to best collaborate, the information must be readily available.

Here is what we have found to be of value for PV for COVID-19 data:

  1. PubMed (Dedicated website for COVID-19 clinical data that is available for tracking publications and information in real time)
    1. https://www.ncbi.nlm.nih.gov/research/coronavirus/
  2. Johns Hopkins University (Tracks coronavirus COVID-19 global cases)
    1. https://www.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
  3. National Institutes of Health (NIH)
    1. https://www.nih.gov/coronavirus
  4. Centers for Disease Control (CDC)
    1. https://www.coronavirus.gov
  5. World Health Organization
    1. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
  6. Medscape (For healthcare providers; great up to date information and links)
    1. medscape.com
  7. Your own PV data
    1. If there are drugs with similar mechanisms of action, take a look. We have often spoken of the value of data. Hydroxychloroquine and azithromycin are not new drugs; your own pharmacovigilance data may hold valuable information as well.

Here are some examples of ongoing clinical trials that are repurposing existing therapies. More can be found at www.fda.gov or www.clinicaltrials.gov.

Repurposing existing therapies:

Remdesivir: FDA approves Phase III trials with remdesivir, an anti-viral as a potential treatment for COVID-19 patients under emergency use, and expanded access to the drug under the new IND requirements and patient access. As of March 19, 2020, 250 patients have received the drug.

Chloroquine/Hydroxychloroquine:  March 19, 2020: FDA approves chloroquine for use in COVID-19 patients. A long staple of prevention and treatment of malaria (a parasitic infection), as well as having immunosuppressant activities that may help decrease viral replication, is now available. The combination of hydroxychloroquine and azithromycin was quickly added.

Sarilumab – An IL-6 receptor antibody to decrease the pulmonary inflammation seen in COVID-19 patients hospitalized with severe COVID-19 infection. On March 16, 2020, a trial began to determine if the attenuation of pulmonary inflammation in COVID-19 patients was clinically beneficial.

Our pharmacovigilance and safety team is dedicated to real-time surveillance and technology support. We also understand the pharmacology behind your products. During this challenging time, if you need additional support, please reach out. We are ready to spool up quickly and help if additional PV resources are required. Please contact Kari Blaho-Owens, Ph.D., Director PV and Safety, at kari.owens@perficient.com for more information.

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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