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

Data Element

Applicable Vocabulary Standard(s)

Medications

  • RxNorm, January 6, 2020 Full Release Update

Data Element

Applicable Vocabulary Standard(s)

Medications

  • RxNorm Full Monthly Release, June 7, 2021 

Data Element

Applicable Vocabulary Standard(s)

Medications

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

  • RxNorm Full Monthly Release, July 5, 2022

Optional:

  • National Drug Code (NDC), July 19, 2022
Dose

Amount of a medication for each administration.

Dose Units of Measure

Units of measure of a medication. (e.g., milligrams, milliliters)

  • The Unified Code for Units of Measure, Revision 2.1
Indication

Sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure.

Fill Status

State of a medication with regards to dispensing or other activity. (e.g., dispensed, partially dispensed, not dispensed)

Data Element

Applicable Vocabulary Standard(s)

Medications

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

  • RxNorm Full Monthly Release July 3, 2023

Optional:

  • National Drug Code (NDC), July 20, 2023
Dose

Amount of a medication for each administration.

Dose Unit of Measure

Unit of measure of a medication.

Examples include but are not limited to milligram (mg) and milliliter (mL).

  • The Unified Code for Units of Measure, Revision 2.1
Indication

Sign, symptom, or medical condition that is the reason for giving or taking a medication.

  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, March 2023 Release
  • International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) 2023
Fill Status

State of a medication with regards to dispensing or other activity.

Examples include but are not limited to dispensed, partially dispensed, and not dispensed.

Medication Instructions

Directions for administering or taking a medication.

Examples include but are not limited to prescription directions for taking a medication, and package instructions for over-the-counter medications.

Usage notes: May include route, quantity, timing/frequency, and special instructions (PRN, sliding scale, taper).

Medication Adherence

Statement of whether a medication has been consumed according to instructions.

Examples include but are not limited to taking as directed, taking less than directed, and not taking.

  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, March 2023 Release

Data Element

Applicable Vocabulary Standard(s)

Medications

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

  • RxNorm Full Monthly Release, January 2, 2024

Optional:

  • National Drug Code (NDC), January 16, 2024
Dose

Amount of a medication for each administration.

Dose Unit of Measure

Unit of measure of a medication.

Examples include but are not limited to milligram (mg) and milliliter (mL).

  • The Unified Code for Units of Measure, Revision 2.1
Route

Physiological administration path of a therapeutic agent into or onto a patient.

Examples include but are not limited to oral, topical, and intravenous. 

  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, September 2023 Release
Indication

Sign, symptom, or medical condition that is the reason for giving or taking a medication.

  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2023 Release
  • International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) 2023
Fill Status

State of a medication with regards to dispensing or other activity.

Examples include but are not limited to dispensed, partially dispensed, and not dispensed.

Medication Instructions

Directions for administering or taking a medication.

Usage note: May include route, quantity, timing/frequency, and special instructions 
(PRN, sliding scale, taper).

Examples include but are not limited to prescription directions for taking a medication, and package instructions for over-the-counter medications.

Medication Adherence

Statement of whether a medication has been consumed according to instructions.

Examples include but are not limited to taking as directed, taking less than directed, and not taking.

  • Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2023 Release

Comment

CMS-CCSQ Continued Support of Medication data elements: USCDI v3

Management of medications is critical to patient care and coordination between providers, as well as related quality and public health enterprises. The current concept of medications in USCDI Draft version 3 does not differentiate those that are active, ordered, or actually administered to the patient, and do not provide necessary details for patient safety (i.e., dose and route). Medication details support an ONC criteria for public health reporting and investigation including using data to support safer use of opioids.

CMS-CCSQ recommend the following Medication data elements be added to Final USCDI v3:

  1. Medications Administration/Medication Administered Code; defined as a code (or set of codes) that specifies the medication administered to a patient
  2. Medications Dispensed; defined as a code (or set of codes) that specifies the medication dispensed
  3. Discharge Medications; specifies the medication(s) active at discharge which should be taken by the patient upon release from a facility
  4. Dosage (and route); defined as the dose and route instructions for medications

Maturity:

  • Current standards:
    • In FHIR US Core, there is a distinction between Medication and MedicationRequest; base FHIR and FHIR QI Core IG includes MedicationAdministration and MedicationDispense profiles.
    • Within MedicationRequest, the ‘category’ is used to define discharge medications.
    • Dose and route instructions are also contextualized within the MedicationRequest, MedicationAdministration, and MedicationDispense profiles in US/QI Core IGs.
  • Current uses, exchange, and use cases: Medication data is routinely captured in EHR systems used by hospitals, providers, and other healthcare stakeholders including pharmacies. Medication details are routinely exchanged across providers and payers. Medication data is used extensively in CMS quality measurement. Additionally, when prior authorization is necessary for a medication, details related to the medication (e.g., why the medication is given, the quantity needed) are exchanged to support the approval process.

CMS-CCSQ Support for Medication data elements for USCDI v3

CMS-CCSQ recommend the following Medication data elements be added to USCDI V3:

  1. Data Element: Medication Administration; defined as a code (or set of codes) that specifies the medication administered to a patient.
  2. Data Element: Discharge Medications; specifies the medication(s) active at discharge which should be taken by the patient upon release from a facility.
  3. Data Element: Medications Dispensed; defined as a code (or set of codes) that specifies the medication dispensed
  4. Data Element: Medication Dosage (and Route); defined as the dose and route instructions for medications
  5. Data Element: Medication Negation Rationale; defined as the reason a medication was not ordered/administered

Rationale: CMS recommends adding more specificity to the USCDI Medications Data Class because interoperability of medication information and management of medications is critical to ensure patients receive appropriate and safe care. The current concept of medications in USCDI does not differentiate among medications that are active, ordered, and actually administered/dispensed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care. Additionally, the currently required data lack important clinical specificity (dosage and route instructions). Finally, the reason a medication was not given (negation rationale) provides important context for clinical care and patient engagement and improves patient-provider communication when this information travels with the patient across care settings. These additional medication details are critical to contextualize a medication and ensure patients and clinicians understand the mediations necessary for a patient, and how those should be taken, throughout the continuum of care. These detailed medication data are used extensively in quality measurement and are routinely exchanged when prior authorization is required.

 

Maturity:

  • Current standards:
    • In FHIR US Core, there is a distinction between "Medication" and "Medication Request”; base FHIR and FHIR QI Core IG includes "Medication Administration" and “Medication Dispensed” profiles.
    • Within Medication Request, the ‘category’ is used to define discharge medications.
    • Dose and route instructions are also contextualized within the Medication Request, Medication Administration, and Medication Dispense profiles in US/QI Core IGs.
    • Negation details are expressed within the status reason (for not done) in Medication Request profile and Not Done profiles within QI Core.
  • Current uses, exchange, and use cases: Medication data is routinely captured in EHR systems used by hospitals, providers, and other healthcare stakeholders including pharmacies. Medication details are routinely exchanged across providers and payers. Medication data is used extensively in CMS quality measurement. Additionally, when prior authorization is necessary for a medication, details related to the medication (e.g., why the medication is given, the quantity needed) are exchanged to support the approval process.

More clarity is needed sooner for the Medications Data Class

Currently, the Medications data class presents many interoperability challenges.  Work done within C-CDA shows there remains a great deal of confusion over how to represent medication information that is gathered from a patient's report of the medications they say they take versus actual medication administration reports documented by providers who are administering medications to the patient. Also challenging is the representation of medications that are prescribed by a provider. Prescribed medications may or may not actually be taken by the patient. 

The growing number of data elements in the Medications data class is a sign of the complexity of this data class.  A much larger effort is needed to straighten out the definitions and representations of the many nuanced aspects of this data class. The assessment and planning for this data class needs to be done sooner rather than later. It needs to be a top-down exercise, not a bottom-up exercise in order for all the many data element parts to actually make sense together.

Medication Data Class

Please consider adding ContraIndications which automatically calculates the patients current medication to see if there is a health safety issues with their combined medications. I expect this functionaliy to be in all ehrs but needs to be pulled in and with an alert or notifications. This would expedite decision making and ultimately save lives

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