How does a 200-year-old standards-setting institution remain an essential part of ensuring access to trusted, quality-assured medicines and foods? At the U.S. Pharmacopeia (USP), the most important way is through the work of dedicated volunteers who answer the call to commit their expertise, time, and talents to advancing USP’s mission to improve global health. As we close out this year’s observance of National Volunteer Week, USP is proud to celebrate and honor the commitment and achievements of over 1,000 Expert Volunteers and Government Liaisons who make our work possible.
USP has a long history of protecting global public health through public standards and related programs that help ensure the quality and benefit of medicines and foods. Through our entire history, we have depended on volunteers who offer deep knowledge and expertise to fulfill this legacy and keep our work on the cutting edge, and this is still very much true today. Volunteers represent a cross-section of scientists, academicians, regulatory professionals, healthcare practitioners and others who work with medicines and foods. They serve USP’s mission as both decision-making and advisory bodies. The standards developed and informed by these independent experts ensure the quality and safety of medicines and foods, enabling public trust.
Addressing real-world problems
USP Expert Volunteers and Government Liaisons work on new and emerging, critical issues every day, including at times of crisis. Volunteers recently recognized by USP – two individuals and two expert bodies – have helped drive USP leadership on pressing issues, including the need to address the potential for nitrosamine impurities, maximize COVID-19 shots in arms, ensure appropriate opioid drug labeling, and make the medicines supply chain more resilient. These honorees include James De Muth, Ph.D., and Karen McCullough, M.S., who received the 2019 and 2020 Jacob Bigelow Awards, respectively. The award was named after Jacob Bigelow, M.D., the leading botanist and Harvard Medical School Medical Professor who co-founded USP and was an important figure in the development of the first American pharmacopeia in 1820. In addition, the USP Nitrosamines Joint Subcommittee and Healthcare Safety and Quality Expert Committee received the organization’s Award for Outstanding Contribution to Standards.
Volunteers honored by USP, through their involvement on various USP Expert Bodies, contributed to the continuous process of reviewing and revising USP standards based upon new evidence, emerging public health concerns, and public requests for revision. These volunteers have made a timely impact on the health and safety of people across the globe by creating new or updating existing chapters to the United States Pharmacopeia–National Formulary (USP–NF). Highlights include:
- Development of the USP COVID-19 Toolkit. Since its initial release in January 2021, the Toolkit has helped stakeholders:
- Accelerate the pace of vaccinations,
- Prevent waste while maintaining quality, and
- Build confidence in becoming a vaccine administrator
- Simply put, the Toolkit has helped build public trust and get more shots in arms—a success for USP and for all those involved in the fight against COVID-19.
- Contribution to USP’s Medicine Supply Map, an innovative insights platform designed to support early detection and prevention of drug shortages. Improved visibility into supply chain risks through the USP Medicine Supply Map data analytics platform can help guide risk mitigation and investment strategies to promote supply chain resilience.
- Publication of a revision to USP General Chapter <17> Prescription Container Labeling, which includes a framework for opioid warning label development to mitigate the misuse of opioids. The framework recommends patient-centered labeling of prescription opioid containers to help give patients consistent and useful information about safe opioid use.
- Development of a new informational General Chapter <1469> Nitrosamine Impurities to help prevent harmful levels of the carcinogens. A Joint Subcommittee was formed in February 2020, and by September of the same year had proposed the new chapter for public comment in Pharmacopeial Forum 46(5) [Sep.–Oct. 2020]. The new chapter will help to ensure the appropriate control of nitrosamine impurities in drug substances and products.
The lifeblood of USP
USP standards, guidelines, and best practices are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers is crucial for maintaining these high standards and preserving public trust in quality-assured medicines. For more information about opportunities to volunteer with USP, visit callforcandidates.usp.org.
