Evolution impacting healthcare practitioners, patients and health systems
For over 200 years, USP has been working to ensure a strong, consistent supply of safe, quality medicines. Through scientific expertise and capability-building solutions, USP provides standards, practical tools and resources to support healthcare practitioners in delivering optimal personalized care to patients in all healthcare settings.
Personalized Medicine – medications and treatments tailored to meet the unique needs of individual patients, including vulnerable and underrepresented populations – have expanded in recent years.
USP collaborates with various stakeholders to create standards that support healthcare practitioners as they implement the personalized medicine approach to healthcare delivery, specifically around digital therapeutics (DTx) and pharmacogenomics (PGx).
Standards
The USP standards-setting process allows anyone to bring a standards-setting issue to USP’s attention. In a 2019 USP survey, healthcare practitioners in the US identified personalized medicine as an area where they look to USP for support.
Based on the survey feedback and other stakeholder engagements, the USP Healthcare Quality and Safety (HQS) Center of Excellence considers documentary standards (e.g. monographs, general chapters) and other resources to support healthcare practitioners as they navigate personalized medicine, DTx and PGx.
To advance personalized medicine, HQS identifies areas where quality standards can fill existing gaps through digital therapeutics and pharmacogenomics. USP engages with scientific thought leaders in personalized medicine to address current and future public health challenges and improve quality of and access to personalized medicine. Click here to learn more about the impact of USP on personalized medicine.
Digital Therapeutics (DTx)
The International Organization for Standardization (ISO) defines digital therapeutics (DTx) as, “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.”
DTx has the potential to help patients prevent, manage or treat a wide range of physical, mental and behavioral conditions. As this field continues to expand, DTx creates opportunities to strengthen current clinical treatments and disease management options for patients with diabetes, asthma, heart disease, substance abuse and other serious conditions.
The implementation of quality standards for digital therapeutics will require insights and expertise from regulators, software engineers and designers, healthcare providers, among others. USP is tapping into industry expertise to conduct quality assessments, understand quality and safety gaps, and help protect patients.
The USP HQS Center of Excellence DTx objective is to develop a gap analysis of current and future DTx quality considerations to propose standards and establish a framework that improves the quality of DTx products. Quality standards can help healthcare practitioners establish trust in these new therapies.
Recent Work
- September 9, 2024: USP describes the importance of developing standards to help ensure the safety, quality, and effectiveness of digital therapeutics (DTx) in a new Quality Matters blog “Why Standards Matter in Digital Therapeutics".
- In spring 2024, USP collaborated with the Digital Therapeutics Alliance (DTA) to assess the inclusion of health equity factors in DTx products. The following is a study outlining the results of a survey and interviews with DTx developers.
- On August 23, 2023, USP invited several key stakeholders to address the HQS Expert Committees in a presentation and discussion called “Digital Therapeutics: Opportunities for USP Quality Standards.” The meeting explored the changing landscape of DTx and emphasized the role that USP can play in shaping its future.
HQS digital collaborators
- Digital Therapeutics Alliance (DTA)
- National Council for Prescription Drug Programs (NCPDP)
- Personalized Medicine Coalition (PMC)
- Digital Medicine Society (DiMe)
- University of Pittsburgh’s Pharmacy Innovation Lab
For updates on future events, sign-up here
Pharmacogenomics (PGx)
The National Institutes of Health (NIH) defines pharmacogenomics (PGx) as the “field of research that studies how a person’s genes affect how he or she responds to medications.”
Pharmacogenomics is another area of personalized medicine in which medication treatment is based on an individual’s genetic make-up. As healthcare practitioners integrate this approach, they face challenges around validating evidence of gene-drug interactions, determining which genes and/or alleles to test in their patients, integrating PGx data into the electronic health record and more.
The USP HQS Center of Excellence serves as a trusted informational resource for physicians, pharmacists and other healthcare professionals to address these challenges. Here, USP collaborates with key stakeholders to expand its standard- and solution-setting process and address PGx hurdles for healthcare practitioners.
USP is engaging a wide audience using its consensus strategies and science-based methodologies to increase reliability and confidence in the utilization of PGx and expand the scale of implementation across the U.S. and globally.
Recent Work
- Article: Preliminary Insights from a Survey of Physician Utilization of Pharmacogenomics in Various Healthcare Systems
- On August 23, 2023, USP invited several key stakeholders to address the Healthcare Quality & Safety Expert Committees to underscore the pivotal role of PGx in reshaping healthcare and the need to drive quality in standards and guidelines.
HQS digital collaborators
- Standardizing Laboratory Practices in Pharmacogenomics (STRIPE)
- Clinical Pharmacogenetics Implementation Consortium (CPIC)
- Pharmacogenomics Knowledge Base (PharmGKB)
- Pharmacogene Variation Consortium (PharmVar)
- NIH’s National Human Genome Research Institute (NHGRI)
Questions?
Any questions related to USP’s work in digital therapeutics or pharmacogenomics can be directed to blaine.groat@usp.org.