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

Data Element

Additional Information

Medications
Description
Pharmacologic agent used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Applicable Vocabulary Standard(s)

Applicable Standards
  • RxNorm Full Monthly Release January 3, 2023
Optional:
  • National Drug Code (NDC), January 6, 2023

Comment

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. 

NCPDP Comment

  • 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.
    • NCPDP recommends: NDC be added to acceptable values for Draft Version 2.

Three medication lists

Within this data class, I suggest specification of three medication lists: 1. The Pre-Admission Medication List (PAML) including all prescription medications, supplements, OTC meds that the individual takes.  Importantly, this represents the medications that the individual will have access to after discharge. 2. The Discharge Medication List including all medications that the individual is to continue after discharge. 3. The "Delta Report", which is a list of all of the differences between the PAML and Discharge Medication List with an explanation for each change.  Adding this list provides several important safety benefits'      a.  it is an opportunity for the discharging clinician to replace changes made to the medication list for formulary reasons with the comparable pre-admission medication.  This help individuals avoid inadvertently taking differently named, but similarly acting, medications from both medication lists.      b.  by providing an explanation for the change, the list provides the receiving clinician with information to determine the importance of maintaining the change.     c.  by explicitly identifying medications that have been stopped and the reasons for which they were stopped, it informs the receiving clinician that the medication wasn't inadvertently omitted but rather omitted for a specific reason The "Delta Report" does not replace medication reconciliation, rather it provides another opportunity to correctly reestablish discharge medications and reduce risks of injury.

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