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Brent I. Fox, Pharm.D., Ph.D and Joshua C. Hollingsworth, Pharm.D., Ph.D.

THE COVID-19 PANDEMIC CONTINUES to prompt change in our daily lives. This change occurs rapidly as we learn more about the disease and how to emerge from it. While the ComputerTalk staff are able to quickly get our columns into print, it is possible that new information has come to light in the time from submitting our thoughts and those thoughts being published for you to read. However, we believe recent news is worth bringing to your attention, even though new information continues to become available. In mid-October, the Department of Health & Human Services (HHS) authorized “qualified pharmacy technicians and state-authorized pharmacy interns” to administer vaccines — including the pending COVID-19 vaccine — and COVID-19 tests. This news follows a September authorization granting state-licensed pharmacists the ability to order and administer the COVID-19 vaccine, when available. In even more recent news, early data indicates two vaccines with effectiveness great than 90%.

While we know pharmacies and other institutions will first need to address the storage requirements for the vaccine, we are encouraged to see pharmacies being recognized as sites to address this public health crisis. In fact, we previously discussed the need to incorporate pharmacists in the mass vaccination efforts that are coming. In that column from July/August 2020, we highlighted the importance of an accurate and up-to-date immunization record, especially as it relates to COVID-19. Unfortunately, the reality is that reporting rates to immunization registries by community pharmacies are low. Immunization registries are similar to prescription drug monitoring programs (PDMPs) in that they are managed by the states. However, while pharmacists in most states are able to query other states’ PDMPs, there is not a national immunization registry.

So we have a challenge on the horizon: Millions of Americans will likely receive COVID-19 vaccines in their community pharmacy, but will these immunizations be reported to registries? We have not seen this question posed in the medical literature or lay press. What have we seen? We have observed a political climate unlike any in our lifetimes in terms of acrimony and open hostility between the two primary political parties. One of the current points of contention is the trust that should be placed in the safety and efficacy of the pending COVID-19 vaccine. While unprecedented efforts are underway to rapidly bring a vaccine to the public, many are questioning the process and the likelihood the vaccine will lack efficacy or, worse, cause harm at greater rates than vaccines developed under customary circumstances. This harm falls in the adverse drug reaction (ADR) category, which is defined as harm to a patient that occurs under situations of appropriate use and is not due to a mistake or error.

THE RISKS


As pharmacists, we know there are inherent risks in vaccines, which are statutorily classified as both drugs and biologics. Does the average American understand that adverse drug reactions can occur with any drug (or vaccine), and can — by definition — occur under situations of appropriate medical use? Probably not. If we look specifically at the question of harm, we know that some people will experience ADRs to the COVID-19 vaccine. The question is whether this harm is disproportionately more frequent, or severe, than harm customarily found in the administration of other vaccines. How can we answer this question? We need data — specifically, we need pharmacovigilance data, which informs us about drug safety issues in populations. The CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration) maintain the Vaccine Adverse Event Reporting System, known as VAERS, which as the name suggests, is the United States’ database containing reports of adverse events due to vaccines. The goal of VAERS is not to attribute health problems to vaccines. Rather, some of the primary objectives, as stated on the VAERS website, are to:

  • Detect new, unusual, or rare vaccine adverse events.
  • Identify potential patient risk factors for particular types of adverse events.
  • Assess the safety of newly licensed vaccines.
  • Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.


While these objectives were developed prior to 2020, one could argue that they are tailored to the current COVID-19 vaccine.

As we dig into this topic, it seems that VAERS offers promise to address concerns with the vaccine’s safety profile. Like other reporting systems, the quality of the data for analysis is dependent upon the accuracy of the data being submitted. In fact, VAERS is open to anyone who wants to report a safety issue. Other relevant limitations include: (1) Causality cannot be definitively attributed, (2) Reporting rates may be influenced by external factors, such as media attention, and (3) The level of detail for any single report may be insufficient to provide a complete picture of the adverse event. Still, VAERS is our best source of vaccine safety monitoring data.

Reports indicate that current plans for initial safety monitoring include multiple federal agencies and private organizations. For example, the CDC’s Vaccine Safety Datalink partners with nine integrated health systems to provide safety data for more than 10 million people, ranging from adolescents to those over 65 years of age. The VA’s (Department of Veterans Affairs’) and Department of Defense’s electronic health records will also provide data for safety monitoring for millions of Americans. Other data sources include the Indian Health Service. In all of these scenarios, VAERS appears to be the common denominator, serving as the recipient of vaccine safety monitoring data.

Considering the accessibility and geographic location of community pharmacies across the country, we believe that community pharmacies should also be included as a source of COVID-19 vaccine safety data. However, VAERS does not currently offer an interoperable method for report submission by pharmacies. In fact, healthcare providers wanting to submit a report have the same options as a patient: (1) an online form directly on the VAERS website, and (2) a writable PDF form available for download from the VAERS website. These options do not scream efficiency and workflow integration. If VAERS is able to electronically exchange data with the partners listed above, one is inclined to expect similar functionality for pharmacy management systems.

COVID-19 has caused considerable change in many aspects of our lives. It has been (and continues to be) the great disruptor. It has driven the relaxation of regulations to allow cross-state practice by healthcare professionals, a decade worth of telemedicine advancements in six months, and pharma’s new perception as a critical player in public health. Now, might the impending COVID-19 vaccine drive the development of systems that allow pharmacies to submit adverse event data related to the vaccine — in an efficient manner that integrates with existing workflow? Stranger things have happened… in just the past year. We welcome your comments. CT

Brent I. Fox, Pharm.D., Ph.D., is an associate professor in the Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, and Joshua C. Hollingsworth, Pharm.D., Ph.D., is an assistant professor, Pharmacology and Biomedical Sciences, Edward Via College of Osteopathic Medicine, Auburn Campus, Auburn University. The authors can be reached at foxbren@auburn.edu and jch0010@auburn.edu.

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