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

Data Element
Medication Administration
Description
A record of a patient actually consuming a medicine, or if it has otherwise been administered to them. https://www.hl7.org/fhir/medicationadministration.html
Submitted By: Joel Andress / CMS
Data Element Information
Data Element Description Indication that a medication was administered to the patient
Rationale for Separate Consideration Current concept of medications in USCDIv1 does not differentiate those that are active, ordered, and actually administered to the patient. The completion of an administration is important clinical information for care, as well as for quality measurement.
Use Case Description(s)
Use Case Description Medication information, including medications administered with administration details, ordered, dispensed, at discharge, and negation rationale for not using a medication are key data elements currently used in CMS eCQMs across hospital and clinician reporting programs. These data are necessary to confirm appropriate and high quality of care is received for patients across different populations. It is clinically relevant from a care perspective and a quality measurement perspective to distinguish information about medication orders, medications dispensed, medications administered, and medications at discharge.
Additionally, negation rationale, or the reason a medication was not ordered/administered is important to accurately reflect quality of care in measurement, and avoid penalizing providers/hospitals (by a lower measure score). This information is also important for interoperability to ensure relevant clinical information about not taking a medication is clear.
Estimate the breadth of applicability of the use case(s) for this data element More than 4,000 hospitals and 1 million providers are currently capturing, accessing and exchanging this encounter level information. This information is currently electronically exchanged/submitted by providers and hospitals to CMS for quality measurement purposes.eCQI resource center, includes measure specifications for CMS program eCQMs, many of which (i.e. CMS 506, CMS 108, CMS 128) use these medication details.
Link to use case project page https://ecqi.healthit.gov/ecqms
Use Case Description Data exchange of medication information is also critical for clinical care. Each step in the chain of events between a clinician’s request for a medication and the complete administration of that medication is critical for vigilance and surveillance of patient safety. Assessment, improvement and accountability around quality measurement is a consistent and critical focus of human and financial resources throughout the healthcare system. It is important to have the capacity to evaluate the clinician’s intent, the actual administration, and ongoing provision of medications across care settings and across time. Clinician’s need to exchange information about each aspect, medication orders, active medications, and medications administered to guide new treatment decisions and identify near harm and actual harm events. The metadata associated with medications (route, dose) are also critical to clinical care.
Negation rationale provides important clinical information related to deviation of care from guidelines or supported pathways. Because clinicians might be included to implement guideline driven care regardless of the setting, it is important for them to communicate negation rationale for decisions to deviate from guidelines at previous encounters. Additionally, negation rationale can provide information about patient preference that is important to travel with the patient across settings and time to optimize their experience of care.
Medication information including medications administered, discharge medications, medication orders, and medication instructions can be exchanged via C-CDA for patient care coordination.
Estimate the breadth of applicability of the use case(s) for this data element All healthcare providers using certified electronic health record technology (CEHRT) should be capturing, accessing, using and exchanging these medication data elements. The capture of medication route and dose should also be common in EHR systems.
Link to use case project page http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Medications (including medications with dose): RxNORM
Medication Route: SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.222)
Negation Rationale (reason codes): SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.93)
https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm
Negation Rationale: https://www.hl7.org/fhir/valueset-reason-medication-not-given-codes.html , http://hl7.org/fhir/us/qicore/ValueSet-qicore-negation-reason.html

https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm
Additional Specifications HL7 FHIR US Core Implementation Guide STU3 based on FHIR R4, MedicationRequest. (https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html ) This profile supports specification of dose/route, intent (order, plan), status (active), status reason (for not done) and category (discharge)
HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, specifies MedicationAdministration, MedicationDispense profiles (http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationdispense.html ; http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationadministration.html )
HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, MedicationAdministration, MedicationDispense, MedicationRequest, NotDone profiles, for negation rationale: http://hl7.org/fhir/us/qicore/profiles.html
CMS Quality Data Model (QDM) version 5.5 Guidance (https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf)
HL7 C-CDA Release 2.0 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492)
ePrescribing NCPDP SCRIPT Standard Implementation Guide Version 2017071
Current Use Extensively used in production environments
Supporting Artifacts Medication data is routinely captured in EHR systems used by hospitals, providers, and other healthcare stakeholders including pharmacies. Medication data used in CMS program eCQMs across IQR, QPP, and Promoting Interoperability and therefore are widely stored in production environments.
Widely available in EHR systems. Medication orders and instructions are most commonly available in FHIR standards:
https://open.epic.com/Interface/FHIR
https://mydata.athenahealth.com/fhirapidoc
https://fhir.cerner.com/millennium/r4/medications/medication-request/
https://developer.allscripts.com/FHIR?PageTitle=Resources
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
https://ecqi.healthit.gov/ecqms

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Medication data for quality measurement is electronically exchanged from organization’s EHR systems to CMS for reporting and payment quality measurement programs, via QRDA files and other architectures. Negation rationale for medications is particularly relevant in quality measurement and has been used at scale in measurement. Ongoing testing for exchanging these data in FHIR standards via HL7 Connectathons.
Medication data is also routinely electronically exchanges with external organizations via C-CDA, as part of ONC’s CEHRT criteria, and a part of data exchange for electronic prescribing to support the continuum of care, particularly with prescribers, dispensers, intermediaries, and post-acute care settings.
https://ecqi.healthit.gov/qrda
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7
https://www.healthit.gov/isa/section/electronic-prescribing
https://confluence.hl7.org/display/FHIR/2020-09+Clinical+Reasoning

https://ecqi.healthit.gov/qrda
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) No challenges anticipated. This data is available in standard terminology that can be publicly access via the VSAC and HL7.
Restrictions on Use (e.g. licensing, user fees) We are not aware of any restrictions.
Privacy and Security Concerns This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.
Estimate of Overall Burden Medication data is regularly captured as part of EHR systems. Most hospitals, including critical access hospitals, and providers are already capturing and exchanging these medication data for quality measurement to CMS. Some additional efforts may be necessary to specify negation rationale, for those stakeholders not using for measurement, but the information is clinically relevant for a variety of use cases.
Many Medication FHIR profiles also required by the US Core Capability Statement and therefore will be stood up by those stakeholders complying with the ONC requirement for the Standardized API for patient and population services—some additional efforts to add in profiles to clarify medication administration and dispensing.
Other Implementation Challenges N/A
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.
Submitted By: Shelly Spiro / Pharmacy HIT Collaborative
Data Element Information
Data Element Description A record of a patient actually consuming a medicine, or if it has otherwise been administered to them. https://www.hl7.org/fhir/medicationadministration.html
Rationale for Separate Consideration These FHIR resources are part of a suite of resources and should all be under USCDI Medication as they are needed for eCare Plans, including but not limited to the Pharmacist eCare Plan.
Use Case Description(s)
Use Case Description These foundational FHIR resources are part of a suite of resources and should all be under USCDI Medication as they are needed for eCare Plans, including but not limited to the Pharmacist eCare Plan.
Estimate the breadth of applicability of the use case(s) for this data element At least 21 pharmacy system vendors are FHIR enabled and are created millions of Pharmacist eCare Plans throughout the US.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) RxNorm and SNOMED CT
Additional Specifications https://www.hl7.org/fhir/medications-module.html
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts https://www.ecareplaninitiative.com/
https://216b2f95-65cb-4e7e-bd94-a9b066b0a193.filesusr.com/ugd/b303f5_a66df3115abd40a58659bae8f51b4aad.pdf
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) MedicationKnowledge resource is draft
Restrictions on Use (e.g. licensing, user fees) None known.
Privacy and Security Concerns None known.
Estimate of Overall Burden Burden is on the EHR and pharmacy system vendors to implement.

Comment

Submitted by BLampkins_CSTE on

Medication Administration - CSTE Comment

CSTE supports Medication Administration inclusion in USCDI v7. See additional CSTE comments on medication-related data elements of importance for public health. Medication data are critical for exchange with public health and is included in eCR standards. They are particularly important for STI programs, HIV and TB surveillance, as well as for public health response and surveillance for antimicrobial resistant pathogen infections. The ability to exchange data on prescribing of opioid medications in particular is of great importance to public health programs which aim to reduce opioid overdoses and deaths.

Submitted by jessilott on

Medication Administration

TDH-OIA supports the inclusion of the Medication Administration data element as it strengthens the completeness of medication histories and enhances interoperability across health information systems.

Submitted by CDC_DSMH_WG on

CDC's comment for inclusion in USCDI v7

CDC supports inclusion of the Medication Administration element to the Medications class in USCDI v7. The facility worksheet required to complete the live birth certificate requests information about the course of labor and delivery. Characteristics of labor encompass the administration of medications to the mother during the labor or delivery.  An example of medication administration may include antibacterial medication given systemically to the mother between the onset of labor and actual delivery. Medication administration as defined in Draft USCDI v7 would improve the electronic exchange between the hospital electronic medical record and the birth registration systems.

Sources: Facility Worksheet for the Live Birth Certificate (https://www.cdc.gov/nchs/data/dvs/facility-worksheet-2016-508.pdf)

Submitted by CDC_DSMH_WG on

CDC's comment for inclusion in USCDI v7

CDC recommends that Medication Administration is included in USCDI v7. Medication Administration documents that a medication was actually given to a patient. Without standardized, reliably exchanged medication administration data, accurate determination of medication use is limited, which affects identification of medication-related harm or treatment success.

CDC quality measures, including NHSN measures, rely on confirmed medication administration to evaluate harm-related events, such as whether a hypoglycemic event occurred within 24 hours of receiving a diabetes medication

Submitted by SuzyRoy on

Support for vocabulary standard designation

SNOMED International commends ONC for the continued designation of SNOMED CT U.S. Edition as an applicable vocabulary standard for Route of Administration within the Medications data class, alongside NCI Thesaurus and FDA SPL Terminology. 

SNOMED CT provides hierarchically structured, internationally recognised route concepts that enable computable safety queries across medication records. For example, identifying all patients receiving intravenous medication for infection control surveillance. This designation aligns with HL7 FHIR US Core medication profiles, which reference SNOMED CT for route coding.

For the new Medication Administration data element proposed in Draft v7, SNOMED International recommends that ONC explicitly name SNOMED CT U.S. Edition as an applicable vocabulary standard for administration method, route, and site concepts, in addition to NCPDP and NCI code sets. SNOMED CT includes 18629005 |Administration of drug or medicament (procedure)| and related concepts that support structured documentation of the full administration event. Including SNOMED CT ensures interoperability with clinical documentation systems already using SNOMED CT and supports ONC's FHIR-based MedicationAdministration resource implementation guidance. 

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