USP standards are being tailored to allow meaningful implementation within modern Health IT Systems. These digital solutions are part of a broader safety net that USP Healthcare Quality and Safety creates related to patient safety, drug nomenclature, access to medicines and healthcare worker safety. The goal is to ensure continuity, quality and accuracy of healthcare information in digital environments.
Knowledge sharing, decision support, and reporting of data through digital tools to improve patient outcomes
Rapid evolutions in healthcare practices have shifted medical care to rely on electronic information and technology within healthcare settings. These advancements have significantly improved practices and care; however, there are still challenges and gaps in the usage, knowledge sharing, decision support, and reporting of data that limit its use.
The USP Healthcare Information & Technology experts are developing information and technology related standards and solutions that standardize terminology, inform clinical decision-support, and enhance data quality.
HQS Digital Solutions
USP is actively working to provide the healthcare community with translational products to advance health and healthcare ranging from digital applications to alignment files and core nomenclature alignment. To date USP has several solutions in digital environments and systems that manage drug information, clinical decision support, and formulary design. These solutions are typically derived from our standards-setting activities that are informed by our volunteer Expert Committees and their associated body of works.
The Exchange of Compounded Drug Preparation Information in Health IT Systems
While efforts to standardize concentrations for compounded medication preparations have been initiated, standardization across Electronic Health Records and electronic prescribing platforms is minimal. USP is exploring the standardization of compounded medication preparations through health IT solutions implemented across healthcare settings. The idea is to develop a set of rules that govern how compounded medication preparations are encoded and exchanged in patient records, pharmacy systems, e-prescribing, and other Health IT systems where patient medication information is critical. This proposal builds upon and complements existing ideas and architecture provided by NCPDP SCRIPT and Pharmacy HIT to improve the overall landscape of compounded drug preparation information transmission.
Recent Work
HQS Digital Partners & Collaborators
Partnerships and collaborations in this space are essential to meeting healthcare needs.
USP and the National Library of Medicine partner for accuracy in electronic drug nomenclature
USP and the National Library of Medicine (NLM) are pleased to announce that USP Compendial Nomenclature is now integrated into the RxNorm vocabulary. This integration aims to reduce drug nomenclature errors that can occur in electronic environments that may lead to patient safety issues. The inclusion of USP Compendial Nomenclature into RxNorm will help ensure that compendial drug names used on manufacturer labels are preserved when they are used in digital environments.
Background
In the United States, unless FDA has designated an official nonproprietary name for a drug by notice and comment rulemaking under FD&C Act section 508, then the compendial/USP name will apply. USP's critical role in establishing drug nomenclature dates back to the Food, Drug, and Cosmetic Act of 1938. Per sections 501(b) and 502(e)(3)(B) of the FD&C Act, any drug with a name recognized in USP-NF must comply with compendial identity standards or be deemed adulterated, misbranded, or both. The USP Nomenclature Expert Committee within Healthcare Quality and Safety approves non-proprietary drug names each month, which then become the required nomenclature used on drug labels. RxNorm, a vocabulary standard published by the National Library of Medicine, is the U.S. standard for representing medications within electronic health information per 45 CFR § 170.207. More broadly, NLM is the central coordinating body for clinical terminology standards within the Department of Health and Human Services (HHS).
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Content representation
The collaboration allows RxNorm and USP staff to work to jointly make determinations of synonymy where appropriate to further enhance interoperability and usability of drug vocabulary. Integrating USP Compendial Nomenclature into RxNorm allows electronic systems that process drug information (such as those for patient records and for claims) to accurately connect to the USP name for the drug substance or product from an NDC Code or Structured Product Label in DailyMed. Within RxNorm, each USP monograph title for a drug substance or product is accompanied by an alphanumeric string that uniquely identifies that drug monograph.
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Interested in Volunteering
Everyone deserves access to safe, high-quality medicines, dietary supplements and foods. USP Expert Volunteers play a critical role in helping to ensure that’s possible. With a range of scientific, academic, and professional backgrounds, our Expert Volunteers collaborate with other scientific leaders on solutions that have a real and lasting impact by shaping and setting USP quality standards and solutions that safeguard and advance global public health.
Share your scientific, professional and real-world insights to help find solutions to current and emerging health information and technology challenges. The Health Information and Technology Expert Committee will be exploring standards and solutions related to information exchange of compounded drug preparation information, barcode scanning, and other health information and technology topics in the 2025-2030 USP Cycle. Submit your application to become a USP Expert Volunteer and amplify your impact.
Questions?
Any questions related to USP’s work in health information and/or technology can be directed to healthinfotech@usp.org.