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. These digital solutions aim to help ensure continuity, quality and accuracy of healthcare information in digital environments.
USP is actively working to provide the healthcare milieu 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.
USP Digital Solutions
- USP Compendial Nomenclature Dataset: A cumulative data set of all Active Pharmaceutical Ingredients (API).
- USP<800> HazRx™ Drug Classification: A data set for institutions and organizations to identify hazardous drugs and provide handling instructions per established standards such as USP <800>.
- USP <800>HazRx™ Mobile App: An app for individual healthcare workers to identify hazardous drugs and provide handling instructions per established standards such as USP <800>.
- USP DC Alignment File: A tool that allows formulary managers to map and compare disparate formulary submissions to the USP Drug Classification.
- USP MMG 7.0 Alignment File: A tool that allows regulators and formulary managers to map Medicare Part D sponsor plans to a minimum baseline of drugs in the USP Medicare Model Guidelines.
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.
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) .
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.
Any questions related to the integration of USP nomenclature into RxNorm can be directed to HealthcareQuality@usp.org