Clinical Trial Medication

Implementation guidance for medication records for patients participating in clinical trials.

Known dm+d coded Medication

If the medication is known within the NHS dm+d, and the patient is definitely taking the medication and not a placebo, the dm+d coded medication must be added to the patient's medication record (e.g. within a GP system medication record) and made available for sharing with other systems.

Unknown and/or non dm+d coded Medication

If the medication is not known within the NHS dm+d, e.g. for trial medications not yet licensed, or where the patient does not know if they are taking the actual trial medication or a placebo, add the following SNOMED CT UK Drug Extension concept to the patient's medication record and made available for sharing with other systems.

419841000001106 | Clinical trial medication

If the patient is taking multiple unknown trial medications then a single instance of the above SNOMED-CT concept must be added to their medication record. There shall always only be a maximum of one active instance of this concept in a patient's medication record.

The presence of this code is simply intended to act as a notification/ flag/alert to the clinician viewing the medication record. It would not be subject to any automated decision support.

The minimum dataset for this record shall be as per the minimum viable content as defined for a UKCore-MedicationStatement, with the exception of an omitted dosage instruction. Note the use of an effectivePeriod with a start date but no end date.

<MedicationStatement xmlns="http://hl7.org/fhir">
    <id value="922a7b73-914e-47dd-9a88-8fa156c783aa" />
    <meta>
        <profile value="https://fhir.hl7.org.uk/StructureDefinition/UKCore-MedicationStatement" />
    </meta>
    <status value="active" />
    <medicationCodeableConcept>
        <coding>
            <system value="http://snomed.info/sct" />
            <code value="419841000001106" />
            <display value="Clinical trial medication" />
        </coding>
    </medicationCodeableConcept>
    <subject>
        <reference value="urn:patient-3204221854" />
        <display value="Mr Scott Chegg" />
    </subject>
    <effectivePeriod>
        <start value="2022-04-18" />
    </effectivePeriod>
    <dateAsserted value="2022-04-21" />
    <informationSource>
        <reference value="urn:organization-K82076" />
        <type value="Organization" />
        <identifier>
            <system value="https://fhir.nhs.uk/Id/ods-organization-code" />
            <value value="K82076" />
        </identifier>
        <display value="WATLING VALE MEDICAL CTR" />
    </informationSource>
</MedicationStatement>

{
    "resourceType": "MedicationStatement",
    "id": "922a7b73-914e-47dd-9a88-8fa156c783aa",
    "meta": {
        "profile":  [
            "https://fhir.hl7.org.uk/StructureDefinition/UKCore-MedicationStatement"
        ]
    },
    "status": "active",
    "medicationCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "419841000001106",
                "display": "Clinical trial medication"
            }
        ]
    },
    "subject": {
        "reference": "urn:patient-3204221854",
        "display": "Mr Scott Chegg"
    },
    "effectivePeriod": {
        "start": "2022-04-18"
    },
    "dateAsserted": "2022-04-21",
    "informationSource": {
        "reference": "urn:organization-K82076",
        "type": "Organization",
        "identifier": {
            "system": "https://fhir.nhs.uk/Id/ods-organization-code",
            "value": "K82076"
        },
        "display": "WATLING VALE MEDICAL CTR"
    }
}

Clinical User Guidance

Where the above SNOMED-CT concept exists as an active record for a patient's medication the clinical user must take this into consideration and ask the patient, or responsible carer, for details of the clinical trial.

The clinician or clinically responsible organisation that adds the record of an unknown trial medication must be responsible for updating the medication record when the clinical trial concludes, or the patient is withdrawn from the study, to indicate the patient is no longer taking the medication (or placebo).

When a clinical trial has concluded, here is an example of the resulting MedicationStatement generated by the clinical system for sharing with another system(s). Note the effectivePeriod.end defines when the patient stopped taking the medication and the status is completed.

<MedicationStatement xmlns="http://hl7.org/fhir">
    <id value="922a7b73-914e-47dd-9a88-8fa156c783aa" />
    <meta>
        <profile value="https://fhir.hl7.org.uk/StructureDefinition/UKCore-MedicationStatement" />
    </meta>
    <status value="completed" />
    <medicationCodeableConcept>
        <coding>
            <system value="http://snomed.info/sct" />
            <code value="419841000001106" />
            <display value="Clinical trial medication" />
        </coding>
    </medicationCodeableConcept>
    <subject>
        <reference value="urn:patient-3204221854" />
        <display value="Mr Scott Chegg" />
    </subject>
    <effectivePeriod>
        <start value="2022-04-18" />
        <end value="2022-05-04" />
    </effectivePeriod>
    <dateAsserted value="2022-05-05" />
    <informationSource>
        <reference value="urn:organization-K82076" />
        <type value="Organization" />
        <identifier>
            <system value="https://fhir.nhs.uk/Id/ods-organization-code" />
            <value value="K82076" />
        </identifier>
        <display value="WATLING VALE MEDICAL CTR" />
    </informationSource>
</MedicationStatement>

{
    "resourceType": "MedicationStatement",
    "id": "922a7b73-914e-47dd-9a88-8fa156c783aa",
    "meta": {
        "profile":  [
            "https://fhir.hl7.org.uk/StructureDefinition/UKCore-MedicationStatement"
        ]
    },
    "status": "completed",
    "medicationCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "419841000001106",
                "display": "Clinical trial medication"
            }
        ]
    },
    "subject": {
        "reference": "urn:patient-3204221854",
        "display": "Mr Scott Chegg"
    },
    "effectivePeriod": {
        "start": "2022-04-18",
        "end": "2022-05-04"
    },
    "dateAsserted": "2022-05-05",
    "informationSource": {
        "reference": "urn:organization-K82076",
        "type": "Organization",
        "identifier": {
            "system": "https://fhir.nhs.uk/Id/ods-organization-code",
            "value": "K82076"
        },
        "display": "WATLING VALE MEDICAL CTR"
    }
}

Future Enhancements

The above guidance is intended as an initial implementation for this clinical scenario. It is intended to be simple and easy to implement. No attempt has been made to identify or share details of the clinical trial or the actual medication within the trial.