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

Data Element
Medication Administration
Submitted By: Joel Andress / CMS
Data Element Information
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

Comment

Submitted by BLampkins_CSTE on

CSTE Comment - v5

Medication data is critical for exchange with public health and is included in eCR standards. It is especially important for STI programs, HIV and TB surveillance as well as for public health response and surveillance for antimicrobial resistant pathogen infections.   CSTE also strongly agrees that 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 nedragarrett_CDC on

CDC's Comment for draft USCDI v5

CDC-CMS Joint Priority Data Element. 

See letter here (submitted on 1/29/2024): https://www.healthit.gov/isa/sites/isa/files/2024-02/FINAL_CDC%20and%20CMS-CCSQ%20Joint%20USCDI%20v5%20submission%20letter_012924.pdf

Submitted by erjones on

Please Include Medication Administration in USCDI v5

Vizient recommends adding the Medication Administration data element to USCDI v5 as this element allows for further insight and analyses of which medications were administered within visits.

Submitted by gsgordon on

FDA Joint Support for Medication Administration in USCDI v5

Posting as a member of the FDA USCDI Working Group: we are re-iterating the multiple requests to add support for distinction of medical records of the Administration of Medications to patients.  US Core, as an approximate representation of USCDI in HL7 FHIR, currently has made "must support" requirements for use of MedicationRequest (for records of requests/prescriptions of medications) and MedicationDispense (for pharmacy dispensing of a medication).  It is still surprising that USCDI continually omits the final ubiquitous type of record for patient medications, one which when it exists is the most definitive proof that a person has a medication in their body.  

Please refer to my previous comment in strong support with a range of justifications of this in 2022: https://www.healthit.gov/isa/comment/11701 . 

Further, over the past four years in addition to FDA, repeated support for inclusion of this in USCDI has come in comments to this request from multiple agencies (CDC, CMS) and public health organizations (CSTE, NACCHO), and FHIR developers.  (see multiple comments here: https://www.healthit.gov/isa/uscdi-data/medication-administration )

As part of the Vulcan FHIR Accelerator work on real world data (RWD) use in clinical research, it was found that the requirement of consistent standardized use of FHIR for Medication Requests, Dispensation, Administration, and Statements was critical to assess how clearly one can determine the medication status of a patient (currently using, periodic use, previously used, etc).  The Vulcan RWD FHIR Implementation Guide for this work ( https://build.fhir.org/ig/HL7/vulcan-rwd/index.html ) was published in May 2023.   During IG testing at FHIR connectathons a participant data providers even found the transformation of Medication Administration Records from legacy or proprietary standards to be relatively non-burdensome, demonstrating the feasibility of this inclusion in USCDI for EHRs.

Cerner also appears to be supporting this in their implementations: https://fhir.cerner.com/millennium/r4/clinical/medications/medication-administration/ suggesting this will be a low level of effort for adoption.

Please consider this inclusion in support of healthcare and public health with downstream benefits for clinical research and pharmaceutical development

Submitted by yale-coredQMRoadmap on

CDC and CMS-CCSQ Joint Support for Medication Administration

Thank you for opportunity to comment on this data element. The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) emphasize the importance of patient safety being reflected in the USCDI standards. As an integral aspect of patient safety, medication management is critical to patient care and coordination between providers, and related quality and public health enterprises. Medication administration, specifically, is a critical concept for CMS and CDC programs that support quality improvement and public health surveillance. We continue to emphasize the need for greater specificity in the USCDI Medications data class. The medications data class in USCDI is currently inadequate to support patient safety, quality improvement, or public health. The medication data elements do not differentiate among medications that are active, ordered, and administered/prescribed to the patient. Given these complexities, more clarity and structure are necessary in this data class to accurately evaluate and provide clinical care and promote patient safety. CMS and CDC strongly recommend the Medication Administration (Level 2)/Medication Administered Code (Level 0) in the Medications data class be added to USCDI.

Submitted by Lantana_Consul… on

Support for Medication Administration

Lantana Consulting Group supports the CDC/CMS-CCSQ recommendation and emphasizes the important role these data elements play in supporting patient safety. 

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment for USCDI v5

  • Medication Administration is an available API by some of the major vendors that operate in the United States as well as in the Netherlands. However, the use of the API has been restricted to their Netherlands users. Med administration is a separate function for most EHRs in bar code medicationadministration and the Medication resource is not distinguishing that specific functionality in its current data capture.
  • CSTE Comment: CSTE agrees with CDC's recommendation for this data element. 
  • NACCHO Comment: Supports CDC"s recommendation.

Submitted by erjones on

Please Include Medication Administration in USCDI v4

Vizient recommends adding the Medication Administration data element to USCDI v4 as this element allows for further insight and analyses of which medications were administered within visits.

Submitted by yale-coredQMRoadmap on

CMS-CCSQ/CDC Joint USCDIv4 Priority - Medication Administration

We continue to urge adding more specificity to the USCDI Medications Data Class. These medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access. Medication administration, along with medications prescribed, discharge medications, medication administration route, medication administration dose, and medication administration date and time serve the ONC USCDI v4 stated priorities related to mitigating health inequities and disparities, addressing needs of underserved populations, and addressing public health reporting needs.

Submitted by yale-coredQMRoadmap on

CMS-CCSQ/CDC Joint USCDIv4 Priority - Medication Administration

We continue to urge adding more specificity to the USCDI Medications Data Class. These medication data elements are necessary for understanding adverse drug events, opioid use and misuse, and medication access.  serve the ONC USCDI v4 stated priorities related to mitigating health inequities and disparities, addressing needs of underserved populations, and addressing public health reporting needs.

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