The use of computers and sophisticated software systems that generate, curate, aggregate and analyze data impacts all aspects of drug development, including research and development as well as quality processes. In this new data-centric ecosystem, USP seeks to not only tailor and integrate our standards into these digital environments but also apply informatics to provide science-driven innovations that can be used by a variety of stakeholders to improve medicinal quality as well as patient safety.
Pharmaceutical manufacturing: USP joins the Allotrope Foundation
On September 10th, 2019, USP joined the Allotrope Foundation as a member of their Allotrope Partner Network. The Allotrope Foundation's focus on scientific reproducibility, digital integration and data integrity align with USP's core mission of supporting the development of quality medicines to improve public health.
For 200 years, USP volunteers have developed monographs and general chapters that ensure the quality of medicines, through an established compendial process as well as the production of high-quality chemical reference standards that have broad adoption in manufacturing. However, USP recognizes that a data revolution has arrived in the pharmaceutical industry. The adoption of sophisticated lab instrumentation, the increased use of Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Internet of Things (IoT) sensors in factories and the use of machine learning are fundamentally changing approaches to drug research, development and quality processes. The massive volume of data (much of which is unstructured or specific to one vendor) generated by these systems has led to the need for structured and interoperable data models that can be leveraged for insight, predictive analytics and improved quality.
USP is excited about the opportunity to collaborate with the Allotrope Foundation and its members to explore how our quality standards can be better integrated into digital systems to provide opportunities for innovation and process optimization.
Healthcare Quality and Safety
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.
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.