Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Data Element

Medications

Applicable Vocabulary Standard(s)

Applicable Standards (*Please confirm or update this field for the new USCDI version*)
  • RxNorm®, January 6, 2020 Full Release Update

View guidance on Applicable Vocabulary Standards and versioning.

Comment

CDC comment on data element-Medication Data Class

CDC recommends that ONC should expand the Medications data class to include Medication Status, representing whether a medication is currently in active use, with values such as active, inactive, and entered-in-error. Rationale: Medication Status provides important information about whether a medication is actively being used and is distinct from dispensing or administration status. Including it within the Medications data class would improve alignment with FHIR/QI-Core and support accurate medication lists, clinical care, and quality measurement.

FHIR path(s): Medication.status

Coding completeness of medication entries (RxNorm/NDC)

Medication entries in ambulatory EHR data frequently carry a medication name without an RxNorm identifier or NDC. A named but uncoded medication cannot be reliably reconciled across systems, grouped by drug class, or used in pharmacovigilance or AI models. I recommend that USCDI encourage implementers to report the proportion of medication entries carrying an RxNorm identifier, so receiving systems can assess fitness for use.

"Medications" listed as a data class and data element

"Medications" listed as a data class and data element 

This could be an issue if ASTP decided to transform USCDI into an ontology.

An ontologist would not able to add the data element into an ontology in Protege for example.

The data element would need to be more specific.

UHG comment on adding NDC

UnitedHealth Group requests that ONC add the FDA’s National Drug Code (NDC) Directory as an Optional item in the Allergies and Intolerances class Substance (Medication) data element list of Applicable Vocabulary Standards. This would improve consistency with the Medications class Medications data element which already includes NDC in the list of Applicable Vocabulary Standards as of USCDI V3. Many electronic health record (EHR) and pharmacy applications store both medications and drug intolerances using NDC codes rather than RxNorm, and are unable to automatically convert patient data from NDC to RxNorm when sending data to external applications. While RxNorm is preferred for most use cases, for interoperability purposes it is always better to exchange coded data rather than unstructured text. Adding NDC as an option will enhance meaningful interoperability and improve patient safety by allowing automatic detection of potential adverse drug reactions during electronic prescription (eRx) workflows.

NACDS Comments on USCDI Draft v3

The National Association of Chain Drug Stores (NACDS) strongly encourages ONC to include the National Drug Code (NDC) in addition to RxNorm as a Vocabulary Standard for the Data Class of Medication. The NDC Code is a HIPAA-named code set and is pervasive in describing specific medications in the ambulatory care setting. The majority
of NCPDP standards include the NDC as the primary drug identifier. The NCPDP Telecommunication Standard is used to process over 4.5 billion claims transactions per year, the vast majority of whichrequire only the NDC to be used in identifying the dispensed medication. 1.91 billion prescriptions are sent electronically from prescribers to pharmacies using the NCPDP SCRIPT Standard, where NDCs are almost exclusively used to represent the medication prescribed. Additionally, the industry uses the NDC in other important electronic prescribing transactions to accurately report the specific product in patient medication history, prescription renewals, prescription transfers, prior authorizations, medication changes, product recalls, adverse event reporting, REMS reporting and Real Time Prescription Benefit. RxNorm does not identify the specific packaged product dispensed and would not be as useful in most of these transactions.

NDC should be added as an acceptable value

Although RxNorm is adequate for many purposes, it is not granular enough for the dispensing of medication in the ambulatory care setting or the exchange of dispensed medication information. It is critical that NDC Codes be included because converting to RxNorm codes would require significant system changes and compromise patient safety. 

This Data Class needs more Data Elements and Code Sets

This Data Class needs more data elements and also needs to include NDC code as a code set. 

The National Drug Code (NDC) is a HIPAA-named Code Set and the majority of NCPDP standards include the NDC as the primary drug identifier. The NCPDP Telecommunication Standard is used to process over 4.5 billion claims transactions per year, the vast majority of which include the NDC of the dispensed prescription. 1.91 billion prescriptions are sent electronically from prescribers to pharmacies using the NCPDP SCRIPT Standard, where NDCs are almost exclusively used to represent the drug prescribed.

NCPDP Comments on USCDI draft V3

NCPDP recommends ONC add the NDC as an acceptable value to be used in these transactions. The NDC is the key, unique, product identifier and is the standard of practice used throughout the pharmacy industry to identify the specific product. The industry heavily relies on the NDC in all aspects of its business, including, but not limited to, drug ordering, medication dispensing, reporting, billing and patient safety. RxNorm lacks the specificity required to uniquely identify a product and utilizing it as the single source terminology set would compromise patient safety and unnecessarily increase healthcare administrative burden and cost.

RxNorm is not intended to be applicable to the purpose of being a universal product identifier for drugs in the United States. RxNorm may be a clinically appropriate identifier, but it is not and should not become one that is administratively appropriate. Making it so is likely to compromise the value of the identifier for clinical uses. These are necessarily dissimilar and relatively opposed use cases.

Medications

NCPDP Transactions utilize Rx Norm or Representative NDC on NewRx transactions in the NCPDP SCRIPT Standard Version 2017071. Transactions originating from the pharmacy (Change, RenewalRequest, RxFill) contain the specific NDC of the product dispensed. RxCancel must contain the specific NDC of the product dispensed.

  • We  recommend: NDC be added to acceptable values for Draft Version 2 and 3.

FDA Comment

Consider adding NDC to USCDI v2. 

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