Submitted By: Scott Gordon / Food and Drug Administration | |
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Data Element Information | |
Use Case Description(s) | |
Use Case Description | Healthcare usecase: The assurance of the accuracy and details of a recorded drug will differ depending on it being officially recorded in the healthcare system versus conversationally reported information. This does not inherently place more or less intrinsic value between primary source-of-truth records versus reported records.But it does supply critical differential information with which a physician can make a more informed judgement regarding treatment options, potential drug-drug interactions, etc. An FDA/cliinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for saftey 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 whether or not a listed medication was reported versus captured in a source-of-truth system as a prescription. This does not inherently place more or less intrinsic value between primary source-of-truth records versus reported records.But it does supply critical differential information with which a researcher or regulatory reviewer can assess the relative value of the listed drug 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 |
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Maturity of Use and Technical Specifications for Data Element | |
Applicable Standard(s) | In FHIR R4, MedicationRequest.reported[x] (https://www.hl7.org/fhir/medicationrequest-definitions.html#MedicationRequest.reported_x_) supplied either a boolean or Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | Organization) In FHIR R4 MedicationStatement - FHIR v4.0.1 (https://www.hl7.org/fhir/medicationstatement.html) which is still sometimes used to represent reported medications, a number of key terminologies are utilized |
Additional Specifications | Present in US Core Profiles https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html The MedicationRequest resource can represent that information is from a secondary source using either a boolean flag or reference in MedicationRequest.reportedBoolean, or a reference using MedicationRequest.reportedReference to Practitioner or other resource. Although both are marked as must support, the server system is not required to support both a boolean and a reference, but SHALL support at least one of these elements. The client application SHALL support both elements. |
Current Use | This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
Supporting Artifacts |
HL7.FHIR.US.CORE\US Core MedicationRequest Profile - FHIR v4.0.1 https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Specifications - Epic on FHIR https://fhir.epic.com/Specifications?api=996 MedicationRequest | R4 API (cerner.com) https://fhir.cerner.com/millennium/r4/clinical/medications/medication-request/ |
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 |
HL7.FHIR.US.CORE\US Core MedicationRequest Profile - FHIR v4.0.1 https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Specifications - Epic on FHIR https://fhir.epic.com/Specifications?api=996 MedicationRequest | R4 API (cerner.com) https://fhir.cerner.com/millennium/r4/clinical/medications/medication-request/ |
Potential Challenges | |
Restrictions on Standardization (e.g. proprietary code) | none |
Restrictions on Use (e.g. licensing, user fees) | Other than what is required for use of HL7 FHIR, none. |
Privacy and Security Concerns | none |
Estimate of Overall Burden | Some standards and system implementations provide more than one location for this type of information – and different options are used by different implementations resulting in highly non-standardized usage of this critical information. Proposal is that this information is captured ONLY in one way, universally across systems. Transitioning legacy data and/or business practices from current state to desired future stat may be challenging. |
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data Element |
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Reported Medication (unique)
Description
“Indicates if this record was captured as a secondary 'reported' record rather than as an original primary source-of-truth record.” (from FHIR R4 MedicationRequest.reported[x]). This would clearly identify a medication that only exists in the data system not as part of any direct data for an original prescription (within the same EHR or across an EHR network, etc) but, instead, via descriptive communication or narrative (verbal, written, etc) by a relevant person (the patient, family, a caregiver, another physician, etc.) This may either be represented as a simple Boolean choice or, additionally, include information of the person and/or nature of the reporting. Additionally, some standards and system implementations provide more than one location for this type of information – and different options are used by different implementations resulting in highly non-standardized usage of this critical information. Proposal is that this information is captured ONLY in one way, universally across systems. |
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Submitted by gsgordon on 2022-09-30
The lack of consistency in…