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Pharmacy Outlook: Ronald Piervincenzi, USP

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This year marks an important milestone for USP — and the entire health care sector. As we celebrate our 200th anniversary and gear up for our 2020 Convention, it’s an appropriate time to look at the work we’ve done and what lies ahead of us. From new technologies such as digital therapeutics, immunotherapy and artificial intelligence to traditional medicines, USP continues to collaborate with health innovators, scientists and academia at the center of a vast and growing field of groundbreaking change.

Ronald Piervincenz

Our 2020 gathering promises to be a memorable event as we look at opportunities to explore new developments while protecting and improving public health. At the heart of all we do is commitment to quality — the essential element that offers patients, physicians and pharmacists unshakable confidence in the medicines that improve health and save lives.

Looking toward the future and back at where we’ve been, a number of important areas emerge as critical focal points. Among these — the growth of the dietary supplement market, technological advances in pharmaceuticals, and the continued need for volunteers to provide their expertise and input as developments in these and other areas continue.

Dietary supplements

Today, about 80% of adults make dietary supplements part of their daily health regimen. And while supplements may offer distinct benefits, there are also questions around their quality and the quality of their ingredients. In many cases, defining quality for supplements can be more complex than for pharmaceuticals.

Many considerations go into manufacturing dietary supplements — from identifying their various ingredients to measuring their potential strength and contaminants. Singling out ingredients alone can be an onerous task, as a vast number of different botanicals and non-botanicals can go into making just one supplement. And because so many ingredients have similarities, it is of extreme importance that they be identified with a high degree of accuracy.

At USP we’re working with dietary supplement manufacturers to help ensure higher quality standards and educate consumers. The USP Dietary Supplements Verification Program enables companies to assess the quality of their facilities, processes, ingredients and products. Making it to the final stage of the process qualifies products to carry a USP verification mark.

Digital pills

As technology advances and becomes more sophisticated and complex, so does the health technology market. Today, we’re seeing leading-edge technology starting to play a role in monitoring and treating diseases, potentially offering some promising complementary therapies. For example, medicines with sensors and digital therapeutics are emerging as alternatives to treating diseases ranging from cancer to schizophrenia.

At the same time, however, the potential benefits of breakthrough treatments mark a moment to recognize the significant responsibility of the pharmaceutical industry. For example, while medicines with sensors may be designed to help patients stay on their medication schedules and help providers more closely monitor them, we must also acknowledge the uncertainties around the science — from both a pharmaceutical and technological point of view. What’s more, these new advancements underscore a number of growing practical ethical concerns.

At USP, we are prudently optimistic over the possibilities that new treatment modalities offer. For example, some digital therapies enable a software alternative to partially or completely replace a medication for addiction support or ADHD management. Digital pills may allow care providers and family members to track cancer patients’ progress and adherence to medication. In addition to these capabilities, medicines with sensors may also enhance a physician’s ability to track patients’ data associated with the medicine (changes in heart rate, for example). While these advances offer great promise to the future of medicine and treatment, there are important implications inherent with any pharmaceutical and technological breakthrough, including concerns over privacy and patient independence.

That’s one of the many reasons we’re eager to develop collaborations with organizations such as the Institute of Electrical and Electronics Engineers (IEEE), a standard-setting group like USP, to explore the future of digital pills. We’re combining our pharmaceutical science expertise with IEEE’s prominent footprint in the electronics community to gain a better understanding of our role in ensuring quality, safety and privacy, among other critical factors. We need to pursue important questions around how medicine and electronics can operate harmoniously and what their regulatory implications may be.

Trust

At the center of our pursuits — from exploring the quality of dietary supplements and digital pills, and beyond — is the concept of trust. Trust is imbued in every effort we undertake and every decision we make. From our long-standing partnerships with research organizations and government agencies to our efforts to recruit the volunteers that develop our quality standards, USP builds trust where it matters most — in the world’s medicines, dietary supplements and foods. Through our rigorous science and the standards we set, we have helped protect patient safety and improve the health of people around the world for two centuries. Trust is the essential ingredient that gives patients, physicians and pharmacists confidence in the medicines that improve and save lives.

Our staff collaborates with a network of more than 800 independent experts who work in the public interest, volunteering their knowledge to further the organization’s mission and create the standards that build trust in the world’s medicine. These important relationships bring to life one of the central tenets of our most crucial work: Trust needs champions. For 200 years, USP has partnered with scientific and professional associations, academic institutions, government bodies, consumer organizations, manufacturer and trade associations, pharmaceutical companies and manufacturers, and non-governmental standards-setting and conformity assessment bodies around the world. These are crucial in helping us achieve our two-century mission.

While these collaborations are important elements in our quest to set critical quality standards and improve health, perhaps none are as unique and crucial to our work as our individual volunteers, our champions. Volunteers are the very lifeblood of our mission and our accomplishments. These independent experts come from academia, industry, regulatory and health care fields working collaboratively to develop and update USP’s standards. They are essential to ensuring that our standards reflect current and emerging technologies and address ever-changing public health requirements.

As science and medicine make rapid advances, we will continue to rely on these strong partnerships to help ensure tomorrow’s remarkable innovations can be trusted in the same way we have helped to build trust in quality medicines over the past 200 years. USP envisions a world in which all have access to quality, safe and beneficial medicines and foods, and we continue working diligently to make that vision a reality.

We invite you to become a champion of trust. Applications are open until May 8, 2020. Learn more at usp.org/trustneedschampions.

Ronald Piervincenzi is the CEO at the U.S. Pharmacopeia Convention.


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