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

Data Element
Medication Administration Status
Description
A code specifying the status of the Administration of a drug. This would clearly identify the current status of the drug administration. At any time, some codes may be ambiguous, such as “in-progress”, in that it is not currently clear if the administration process moved forward. Other codes will provide definitive states of the administration. For instance, “completed” shows the administration was completed, while “entered-on-error” indicates the prescription process was halted and the administration did not move forward
Submitted By: Scott Gordon / Food and Drug Administration
Data Element Information
Use Case Description(s)
Use Case Description Healthcare use case: The presence of a drug Administration record without the supplementary status risks providers within the healthcare system and/or in EHR networks will not be aware of administration requests that were halted before dispensation and/or if the administration was carried out and the person received the medication. This ambiguity can result in misjudgments on patient medication usage.

An FDA/clinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for safety or efficacy for new indications of existing medications. In such analyses there may be one or more “exposure” drugs (ie, the drug of interest) and one or many “concomitant” medications. Researchers and regualtory reviewers will need to know enough information of the status of a drug administration, when applicable, to determine if the drug was in fact ingested by the patient or if it was in fact halted before ever reching the patient. This information will supply critical differential information with which a researcher or regulatory reviewer can assess the relative probability of the listed drug record actually resulting in consumption by the patient. They can then determine the utility of the information in the context of the specific research and evidence generation needs of any given clinical study.
Estimate the breadth of applicability of the use case(s) for this data element All Electronic Healthcare Record systems, healthcare systems, clinical research users of healthcare data, regulatory reviewers of healthcare data
Link to use case project page https://confluence.hl7.org/display/FHIR/2021-09+Vulcan+-+Real+World+Data+%28RWD%29+Submission+to+FDA
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) In FHIR R4, https://www.hl7.org/fhir/medicationadministration-definitions.html#MedicationAdministration.status
Additional Specifications http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationdispense.html
http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-medicationadministration.html
http://hl7.org/fhir/us/qicore/profiles.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 Medication data is central for EHR systems used at healthcare sites and healthcare quality measures and payers track things such as completion of administrations etc. However the lack of *consistency* is the danger, and the lack of support in current FHIR implementations or US Core (for those providers that use in-house medication administration, is a glaring omission
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 is central for EHR systems used at healthcare sites and healthcare quality measures and payers track things such as completion of administrations etc. However the lack of *consistency* is the danger, and the lack of support in current FHIR implementations or US Core (for those providers that use in-house medication administration, is a glaring omission
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) none known
Restrictions on Use (e.g. licensing, user fees) none known
Privacy and Security Concerns none known
Estimate of Overall Burden While FHIR R4 fully supports this use, the fact that it is nor apparently implemented widely may make transition harder. Further, by not already being standardized, local proprietary data approaches to representing administration data may be widely divergent – another barrier to overcome for standardization.
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 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is represented by an existing USCDI data element Medication Adherence.

Comment

Submitted by gsgordon on

This must be included in USCDI

  • This MUST finally be included in USCDI.  Multiple agencies have made a STRONG case for this. Continued lack of inclusion in USCDI is difficult to comprehend as at is a basic healthcare component used widely around the globe.  Additionally, relegation all the way to Level 0 contradicts all fact:
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  • Not represented by a terminology standard or SDO-balloted technical specification or implementation guide:  FALSE: Represented by many FHIR IG's including Vulcan RWD IG (https://build.fhir.org/ig/HL7/vulcan-rwd/) , AU Base Medication Administration - AU Base Implementation Guide v4.2.2-ci-build (fhir.org), Home - Epic on FHIR, etc)
  • In the Vulcan RWD IG, the IG does not ask for very much, but it does expect Administered Medication to be standardized in HL7 FHIR.  The minimum the RWD IG requires is 
  • ... status        code    in-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
    ... medication[x]    CodeableConcept, Reference(Medication)    What was administered
    ... subject    S    1..1        Who received medication
    ... effective[x]    dateTime, Period    Start and end time of administration
  • Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
  • Data element is electronically exchanged in limited environments, such as connectathons or pilots: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
  • Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements: FALSE: any in-patient healthcare facility contains administered medication data and is a critical aspect of healthcare information.  If not used by TEFCA, there will be zero knowledge of actual administered medications which will cause a needless risk to the health of the public.
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  • Level 2 at minimum is more accurate, and it used to be in Level 2.  And it really should be part of USCDI
  • Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
  • Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
  • Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
  • Use cases apply to most care settings or specialties.

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