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

Data Element
Therapeutic Medication Response
Submitted By: Laura Conn
Data Element Information
Data Element Description Represents a therapeutic response (as opposed to an undesired reaction) to the administration of a medication.
Use Case Description(s)
Use Case Description Documentation of the response after the administration of a medication. For example, the positive response to naloxone administration (after a suspected opioid overdose).
Estimate the breadth of applicability of the use case(s) for this data element N/A
Link to use case project page https://www.cdc.gov/ecr/index.html
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) HL7 FHIR: Therapeutic Medication Response extension HL7 CDA: Therapeutic Medication Response observation LOINC: 67540-5 "Response to medication" VSAC Value Set: Therapeutic Response to Medication
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436 https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.10.20.15.2.5.12/expansion
Additional Specifications HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) based on FHIR R4 HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) HL7 FHIR: Therapeutic Medication Response extension HL7 CDA: Therapeutic Medication Response observation
Current Use Extensively used in production environments
Supporting Artifacts Soon to be published: HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) STU Release 2 Soon to be published: HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 1, STU Release 3.0
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
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 Soon to be published: HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) STU Release 2 Soon to be published: HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 1, STU Release 3.0
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data.
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 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 represents a specialized use or subset of the Level 0 data element Outcome in the Outcomes data class.

Comment

Submitted by CDC_DSMH_WG on

CDC's Consolidated Comment

In the treatment of Tuberculosis, there is not an easy-to-obtain biomarker for treatment response. Instead, a patient’s response to treatment is determined by improving symptoms and culture results. Culture results can take up to 6 weeks. In Tuberculosis, and other conditions without an easy-to-obtain biomarker, a data element capturing therapeutic medication response is critical to document whether a patient’s medications are achieving the expected therapeutic results.

Collected for Tuberculosis (TB) and Latent Tuberculosis Infection (LTBI) Surveillance and are included in the TB and LTBI Message Mapping Guides (MMG). https://ndc.services.cdc.gov/mmgpage/tuberculosis-and-latent-tb-infection-message-mapping-guide/

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