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Pharmaceuticals

Reflecting on the past, anticipating the future: 200 years of USP

by Ronald T. Piervincenzi
February 1, 2020 | APPEARED IN VOLUME 98, ISSUE 5

 

This is a guest editorial by Ronald T. Piervincenzi, CEO of the US Pharmacopeia.

In 1820, eleven physicians took action to protect the people of their young nation from poor-quality medicines. These pioneers recognized that a lack of uniform standards for preparing medications put patient lives at risk. They founded the US Pharmacopeia (USP), and for 200 years, our organization has been setting official quality standards to build the public’s trust in medicines, dietary supplements, and foods.

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Credit: United States Pharmacopeia
Ronald Piervincenzi

I feel privileged to serve as USP’s CEO, particularly as we embark on our third century. In some ways, nothing has changed. We still work to help ensure patient safety. In other ways, everything has changed: the digitization of health care; new medicine modalities; a complex, globalized supply chain; and innovative manufacturing technologies. So what has contributed to USP’s resilience?

Core to our success are the organizations and individuals with whom we partner, including more than 460 USP convention member organizations, of which the American Chemical Society is one, and the more than 800 independent volunteer scientists who contribute their expertise to develop and approve the standards that build trust in the world’s medicines.

A willingness to embrace change is also crucial. Consider how USP has adapted to advances in chemistry over the years. The first United States Pharmacopeia, published in 1820, was essentially a collection of recipes and a list of materia medica used to prepare the most common medications of the day. That changed in 1880, when under the leadership of visionary chemist and pharmacist Charles Rice, the sixth version of the United States Pharmacopeia was transformed. It was no longer a recipe book but became a viable chemistry resource that included formulations and purity tests grounded in the latest principles of analytical chemistry.

Today, USP’s existing standards are in continuous review on the basis of new evidence and technologies, emerging public health priorities, and open requests for revision. We are also continually developing new standards and related educational programs driven by need and emerging pharmaceutical innovations. Two hundred years ago, our founders focused on ensuring the quality of US medicines. Over the decades, our reach has expanded. Now USP is a global enterprise, and over 150 countries use our public quality standards.

True to its mission of improving global health through public standards and related programs, USP helped safeguard the world’s pharmaceutical supply when the Food and Drug Administration began to recall angiotensin II receptor blockers because of the threat of nitrosamine impurities, including N-nitrosodimethylamine and N-nitrosodiethylamine, that may cause cancer. To tackle broader concerns about impurities, specifically in medicines under development, USP has instituted a service that identifies, isolates, synthesizes, and characterizes impurities with the combined goal of accelerating the development process and delivering quality medicines to market.

Given the current pace of innovation in science, I wonder whether USP’s forebears could have envisioned how the field of medicine would change in 200 years. Digital therapeutics, 3-D printing, immunotherapy, gene and stem cell therapies, precision medicine, and artificial intelligence—all have arrived or are on their way.

At USP, we believe trust and quality must remain at the heart of each advancement. That’s why, as part of our anniversary celebration, we have partnered with the Massachusetts Institute of Technology Center for Collective Intelligence in the development of an online platform, the Trust CoLab, that explores the developments that will shape people’s health between now and 2040 and seeks to understand how trust in medicine and health care will evolve during that time. Copies of a report on the findings will be available by email request at trustcolab@usp.org.

Strengthened by our 200-year legacy, USP is poised to be at the forefront of innovations in medicine and to remain adaptable in delivering solutions that safeguard the quality of medicines around the world. USP will work to ensure tomorrow’s remarkable innovations can be trusted in the same way quality medicines have been trusted in the past 200 years.

Views expressed on this page are those of the author and not necessarily those of ACS or C&EN.

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Comments
Dr V Srini Srinivasan (February 6, 2020 2:00 PM)
Excellent and timely article As United States Pharmacopeia is celebrating the great organization’s 200 th birth year it is indeed fitting to remember the American chemical Society ‘s contribution to USP public standards establishment process through various ways Great ACS scientists like Dr Sam Tuthill worked tirelessly for the advancement of USP ‘s public health mission by serving the then USP Committee of revision as a volunteer elected member and chairperson of some of their expert committees
USP’s global reach today covering all the six continents is indeed remarkable under the dynamic leadership of Ron Piervincenzi We should be proud of the tireless contribution of scientists from all over the world as volunteers by serving the USP Expert committees that develop and establish public standards for medicines moving in international commerce. Ron’s citation of nitrosamines impurities in certain drugs reported recently and how USP is tirelessly working with their staff and volunteer scientists and Regulatoy agencies around the globe indeed is something we should be proud of
Wishing USP many more centuries of service to protect the global health through their public standards

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