// April 21, 2021

USP Volunteer Profile: Developing the COVID-19 Vaccine Handling Toolkit

USP Volunteer Profile: Developing the COVID-19 Vaccine Handling Toolkit

USP’s success in its mission to improve global public health through creation of standards and related programs depends in large part on the work of volunteers. Independent experts serve as essential pillars supporting USP’s work by donating their time and expertise to work on our Council of Experts, Expert Committees and Panels. Through this combination of expertise from a variety of scientific fields, USP develops standards and other resources that help ensure the quality, safety and benefit of medicines and vaccines people can trust.

As part of USP’s response to the coronavirus pandemic, we advanced our public health mission through development of the USP COVID-19 Vaccine Handling Toolkit, led by over 30 expert volunteers. Simply put, the toolkit is designed to help address critical operational efficiency gaps at practice settings, maximize shots, and increase confidence that procedures are consistent wherever vaccinations are performed.

I recently sat down with Melody Ryan*, who led development of the Toolkit as chair of USP’s Healthcare Safety and Quality Expert Committee, to highlight the value of the Toolkit to the global vaccination effort, as well as the role of expert volunteers in supporting USP’s work to improve global health.

Q: Tell us about the work of USP’s Healthcare Safety and Quality (HSQ) Expert Committee?

A: We deal with safety and quality in healthcare, mainly to help ensure access to needed medications. This has included addressing medication packaging and prescription labeling issues, for example, to help ensure clear and understandable labeling for opioid-containing medications. More recently, we developed USP’s COVID-19 Vaccine Handling Toolkit.

Q: How did the COVID-19 Vaccine Handling Toolkit effort get going and why did you get involved?

A: When USP leadership asked about my committee serving as the host for this effort, I jumped at the opportunity. Anything I can do to help end this pandemic is a chance I would not miss. USP was rapidly engaging diverse stakeholders to identify and address operational efficiency gaps at vaccination sites to increase vaccinations. There was information from manufacturers, but not about pre-drawing and labeling syringes, or transportation of the vaccines, for example. The U.S. Centers for Disease Control and Prevention (CDC) had a Vaccine Storage and Handling Toolkit, but it did not contain information specific to COVID-19 vaccines. There were reports of being able to get more COVID-19 vaccine doses out of vials due to manufacturer overfill, but it was not clear how to maximize these amounts. It was clear we needed a way to assemble related, useful information in one place to help minimize waste, maximize shots in arms, and increase confidence in consistent procedures across vaccination sites.

Q: Can you share other aspects of your USP volunteerism, and how it contributes to your broader work as a healthcare practitioner?

A: I’ve also been involved with USP efforts to address healthcare inequity in our society. Ultimately, our plan is to advance health security, health literacy, and health data. As a pharmacist and neurology clinician, I’ve seen for myself the difficulties some patients have in accessing needed medications. Being a part of ensuring Medicare patients have reasonable access to the medications they need is an important piece of advocacy for me. More broadly, I love that USP is committed to advancing global health. A big part of that – helping ensure quality and safety of medications – is perfectly aligned to the work of healthcare practitioners everywhere. Many work with patients on an individual level, but work with USP addresses systemic issues for all patients and improves public health. I’m proud to have been selected to serve as a USP volunteer and continue to be a part of that mission.

Q: Drilling down on the Toolkit, you brought your leadership and expertise as a pharmacist and neurology clinician to this effort. What other expertise contributed to its development?

A: The Toolkit was developed by over 30 independent expert volunteers, led by my committee, but with representation from USP’s Packaging and Distribution Expert Committee, Nomenclature and Labeling Expert Committee, Health Information and Technology Expert Committee, and Compounding Expert Committee, as well as from the CDC, FDA, and the American Society of Health-System Pharmacists. The effort was also informed by existing USP public quality standards. Having all this expertise directed toward one goal made it incredibly powerful and efficient.

Q: What were the biggest challenges?

A: Logistically, getting the committee together was tough. Beyond just the need to work remotely and maintain social distancing during the pandemic, we had to move quickly and incorporate a lot of emerging information. We had a number of virtual meetings in a short period of time. The design team at USP also deserves a lot of credit for making the Toolkit visually appealing and easy to access.

Q: Who are the biggest beneficiaries?

A: One of my other volunteer roles as a pharmacist – apart from my work at USP – is helping to provide vaccinations, and I believe the biggest beneficiaries of the Toolkit are those setting up new vaccination clinics or trying to increase efficiency at established sites. The Toolkit provides critical information to pharmacists, physicians, nurses, physician assistants, health profession students and others for COVID-19 vaccine handling and administration.

Q: What’s next?

A: Keeping the Toolkit updated as additional COVID-19 vaccines receive FDA emergency use authorization (EUA), and as other information becomes available, is an ongoing challenge, with multiple versions issued to date. We also anticipate a version specifically addressing COVID-19 vaccines available in other countries, leveraging further input from international experts.

Q: What are the benefits of volunteering at USP and the best ways to get involved?

A: Being a USP volunteer is rewarding and meaningful. Volunteers utilize their personal, professional, and scientific judgment to benefit global public health. I think it is fair to say that being selected to serve as a USP volunteer can also add prestige and distinction to a career. Every five years USP invites qualified candidates — scientists, academicians, regulatory professionals, healthcare practitioners, and others who work with medicines and foods — to apply to serve as decision makers on its Council of Experts and Expert Committees. Qualified candidates may also be invited to serve as advisors on Expert Panels that make recommendations to Expert Committees. For more information, readers should see the USP Volunteers web page, or email USPVolunteers@usp.org.

Thank you, Dr. Ryan.

For more information about becoming a USP expert volunteer, please click here. To download the COVID-19 Vaccine Handling Toolkit, go to www.usp.org/covid-vaccine-handling. For readers with questions about the Toolkit, please email us at HealthcareQuality@usp.org.


Melody Ryan, Pharm.D., MPH, is director, International Professional Student Education, at the University of Kentucky College of Pharmacy. Dr. Ryan also holds appointments at the University of Kentucky as a professor at the College of Pharmacy, Department of Pharmacy Practice and Science, as well as the College of Medicine Department of Neurology, and is the university’s assistant provost for global health.