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 presense of a prescription record without the supplementary status risks providers within the healthcare system and/or in EHR networks will not be aware of prescriptions that was halted before dispensation and/or if the prescription was carried out to the next step. This ambiguity can result in misjugements on patient medication usage. 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 enough information of the status of a prescription to determine if the drug at least reached the next phase (ie, dispensing) 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 |
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Maturity of Use and Technical Specifications for Data Element | |
Applicable Standard(s) | In FHIR R4, https://www.hl7.org/fhir/medicationrequest-definitions.html#MedicationRequest.status |
Additional Specifications | Present in US Core Profiles https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Each MedicationRequest must have: a status |
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 known |
Restrictions on Use (e.g. licensing, user fees) | none known |
Privacy and Security Concerns | none known |
Estimate of Overall Burden | This shouldn’t be terribly difficult especially with FHIR. However, consistency in the actual Vocabulary being used to represent Status will be important for interoperability. |
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data Element |
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Medication Prescription Status
Description
“A code specifying the current state of the order. Generally, this will be active or completed state” (from FHIR R4 MedicationRequest.status). This would clearly identify the current status of a prescription. At any time, some codes may be ambiguous, such as “active”, in that it is not currently clear if the prescription process moved forward. Other codes will provide definitive states of the prescriotion. For instance, “completed” shows the prescription was pushed forward to next steps (typically dispensing is next), while “cancelled” or “enetered-on-error” indicate the prescription process was halted and the drug from this Prescription request did not move forward. |
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