AU Core Implementation Guide
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AU Core Implementation Guide - Downloaded Version 3.0.0-ballot1 See the Directory of published versions

## Medicine Information

Page standards status: Informative

The FHIR standard defines the following resources for exchanging medicine information:

- Medication
- MedicationAdministration
- MedicationDispense
- MedicationRequest
- MedicationStatement

AU Core defines the following profiles:

- AU Core Medication: to support medicinal product identification.
- AU Core MedicationDispense (with AU Core Medication): to support dispense records and medication management.
- AU Core MedicationRequest (with AU Core Medication): to support prescription, ordering, and ePrescribing.
- AU Core MedicationStatement (with AU Core Medication): to support summary statements of medicine use.

It is anticipated that future releases of AU Core will define profiles of MedicationAdministration (with AU Core Medication) to support medication chart and other administration use cases.

The guidance below addresses how medicinal product identification can be structured in FHIR conformant to AU Core.

### Medicinal Product Identification

For extemporaneous medications, the medication code element is the primary mechanism to identify a medicine. In this case, a list of ingredients including strength and form is recommended to be provided as text in the medication code element e.g. `Medication.code.text` or `MedicationRequest.medicationCodeableConcept.text`.

For non-extemporaneous medications, the medication code element is the primary mechanism to identify a medicine. In this case, information identifying the medicinal product including strength and form is recommended to be provided as a code from a terminology in the medication code element, e.g. `Medication.code.coding` or `MedicationRequest.medicationCodeableConcept.coding`, and the description of the medicinal product as presented to the user is provided in the text e.g. `Medication.code.text` or `MedicationRequest.medicationCodeableConcept.text`.

Australian Medicines Terminology (AMT) is the national terminology for identification and naming of medicines in clinical systems for Australia. The AMT is published monthly to include new items on the Australian Register of Therapeutic Goods from the TGA, as well as items listed on the Pharmaceutical Benefits Scheme. The AMT is published as part of SNOMED CT-AU (Australian edition of SNOMED CT) and can be downloaded in a variety of formats from the National Clinical Terminology Service (NCTS). For more information on using SNOMED CT-AU in FHIR, see the guidance defined in AU Base SNOMED CT Australian Edition.

In addition to the medication code, the majority of use cases support exchange of structured medicine information as separate data elements covering brand name, generic name, item form and strength, ingredient strength and manufacturer. These data elements can be supported as coded, or text, and systems are likely to use a combination of coded and text elements when constructing a Medication resource.

The guidance for how to support coded or text identification of medicinal products is summarised below:

1. For coded support of a medication, the preferred method is to use a single medication code that captures all information required for identification of the medication in code.coding.
   - AMT contains both generic or branded medication concepts. Depending on the concept level selected, an AMT concept can convey the following detail: brand name, generic (ingredient) name, item form, strength, pack size, container type.
   - AMT concepts are defined by relationships which detail the properties or components that identify a medication. Detailed information about the medication such as the brand name, generic (ingredient) name, form and strength can be retrieved via terminology lookup operation.
   - When there is a requirement to explicitly state the type of medicinal coding (e.g. branded product with strength or form), Medication Type extension can optionally be used in the resource (i.e. MedicationAdministration, MedicationStatement, MedicationDispense, MedicationRequest, Medication):
     - generic item form and strength = `code.coding` with Medication Type extension using `UPDSF` from the Medication Type code system
     - branded item form and strength = `code.coding` with Medication Type extension using `BPDSF` from the Medication Type code system

   Example: Medication with single code identifying brand name, item form and strength.

        {
          "resourceType": "Medication",
           ...
          "code": {
              "coding": [
                {
                  "system": "http://snomed.info/sct",
                  "code": "933664111000036105",
                  "display": "Benpen 3 g powder for injection, 1 vial"
                },
              ]
            }
        }

   Example: Medication with single code identifying generic name, item form and strength, with identification of product type.

        {
          "resourceType": "Medication",
           ...
          "code": {
              "coding": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org.au/fhir/StructureDefinition/medication-type",
                      "valueCoding": {
                        "system": "http://terminology.hl7.org.au/CodeSystem/medication-type",
                        "code": "UPDSF",
                        "display": "Unbranded product with strengths and form"
                      }
                    }
                  ],
                  "system": "http://snomed.info/sct",
                  "code": "933664081000036101",
                  "display": "Benzylpenicillin sodium 3 g injection, vial"
                },
              ]
            }
        }

2. For coded support of brand name, generic name, manufacturer, item form and ingredient strength, where the individual components for medication identification are separately coded:
   - Coded support for the following can be provided using code.coding with an optional Medication Type extension to explicitly declare the type of product identification in the resource (i.e. MedicationAdministration, MedicationStatement, MedicationDispense, MedicationRequest, Medication), for example:
     - brand name = `code.coding` with Medication Type extension using `BPD` from the Medication Type code system
     - generic name = `code.coding` with Medication Type extension using `UPD` from the Medication Type code system
   - If the resource is a Medication resource and the form or ingredient strength are not implicit in `Medication.code`, they can be separately coded:
     - form in `Medication.form`
     - ingredient strength in the FHIR R5 to R4 pre-adoption extension ExtensionMedication_Ingredient_Strength, with the ingredient identified in `Medication.ingredient.itemCodeableConcept` and the strength represented in the extension's `valueCodeableConcept.coding`
       - Note that where possible, ingredient strength is to be represented using the native FHIR `Medication.ingredient.strength` element as a Ratio instead of using the FHIR R5 to R4 pre-adoption extension.

   Example: Medication with coded brand name, generic name, item form and igredient strength.

        {
          "resourceType": "Medication",
            ...
            "code": {
              "coding": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org.au/fhir/StructureDefinition/medication-type",
                      "valueCoding": {
                        "system": "http://terminology.hl7.org.au/CodeSystem/medication-type",
                        "code": "UPD",
                        "display": "Unbranded product with no strengths or form"
                      }
                    }
                  ],
                  "system": "http://pbs.gov.au/code/item",
                  "code": "02647H",
                  "display": "BENZYLPENICILLIN"
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org.au/fhir/StructureDefinition/medication-type",
                      "valueCoding": {
                        "system": "http://terminology.hl7.org.au/CodeSystem/medication-type",
                        "code": "BPD",
                        "display": "Branded product with no strengths or form"
                      }
                    }
                  ],
                  "system": "http://snomed.info/sct",
                  "code": "3539011000036105",
                  "display": "Benpen"
                },
              ]
            },
            "manufacturer": {
              "identifier": {
                "system": "http://pbs.gov.au/code/manufacturer",
                "value": "CS"
              }
            },
            "form": {
              "coding": [
                {
                  "system": "http://snomed.info/sct",
                  "code": "129011000036109",
                  "display": "Injection"
                }
              ],
              "text": "Injection"
            },
            "ingredient": [
              {
                "itemCodeableConcept": {
                  "coding": [
                    {
                      "system": "http://snomed.info/sct",
                      "code": "323389000",
                      "display": "Benzylpenicillin"
                    }
                  ]
                },
                "extension": [
                  {
                    "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-Medication.ingredient.strength",
                    "valueCodeableConcept": {
                      "coding": [
                        {
                          "system": "http://hl7.org/fhir/CodeSystem/medication-ingredientstrength",
                          "code": "qs",
                          "display": "QS"
                        }
                      ]
                    }
                  }
                ]
              }
            ]
        }

3. For non-coded support for brand name, generic name, manufacturer, item form, item strength (as a whole), and ingredient strength:
   - Non-coded support is provided using the Medication resource
     - brand name = `Medication.extension` Medication Brand Name extension
     - generic name = `Medication.extension` Medication Generic Name extension
     - item form and strength = `Medication.code.text`
     - when medication form, item strength or ingredient strength are not implicit in `Medication.code.text`, they may be separately represented in:
       - form = `Medication.form.text`
       - item strength (medication strength as a whole) = `Medication.extension` Medication Strength extension, representing the strength of the medication as a whole
       - ingredient strength = `Medication.ingredient.strength` ExtensionMedication_Ingredient_Strength, representing the strength of an individual ingredient, with the ingredient identified in `Medication.ingredient.itemCodeableConcept.text` and the strength represented in the extension's `valueCodeableConcept.text`.

   Example: Medication with text only brand name, generic name, item form and strength.

       {
         "resourceType": "Medication",
          ...
          "extension": [
            {
              "url": "http://hl7.org.au/fhir/StructureDefinition/medication-generic-name",
              "valueString": "Benzylpenicillin"
            },
            {
              "url": "http://hl7.org.au/fhir/StructureDefinition/medication-brand-name",
              "valueString": "Benpen"
            }
          ],
          "code": {
            "text": "Benpen 3 g powder for injection, 1 vial"
          }
       }

   Example: Medication with text only medication form and medication strength as a whole.

       {
         "resourceType": "Medication",
         ...
         "extension": [
           {
             "url": "http://hl7.org.au/fhir/StructureDefinition/medication-strength",
             "valueString": "3 g"
           }
         ],
         "code": {
           "text": "Benpen"
         },
         "form": {
           "text": "Powder"
         }
       }

   Example: Medication with text only medication form and medication ingredient strength.

         {
           "resourceType": "Medication",
           ...
           "code": {
             "text": "Benpen"
           },
           "form": {
             "text": "Powder"
           },
           "ingredient": [
             {
               "itemCodeableConcept": {
                 "text": "Benzylpenicillin sodium"
               },
               "strength": {
                 "extension": [
                   {
                     "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-Medication.ingredient.strength",
                     "valueCodeableConcept": {
                       "text": "3g"
                     }
                   }
                 ]
           ...

4. Manufacturer information is not typically included in a medication code. Support for manufacturer information is provided using a Medication resource:
   - coded support: manufacturer = `Medication.manufacturer.identifier`
   - non-coded support: manufacturer = `Medication.manufacturer.display`

   Example: Medication with coded manufacturer.

        {
          "resourceType": "Medication",
            ...
            "code": {
              "coding": [
                {
                  "system": "http://snomed.info/sct",
                  "code": "933664111000036105",
                  "display": "Benpen 3 g powder for injection, 1 vial"
                }
              ]
            },
            "manufacturer": {
              "identifier": {
                "system": "http://pbs.gov.au/code/manufacturer",
                "value": "CS"
              }
            }
        }

   Example: Medication with non-coded manufacturer.

        {
          "resourceType": "Medication",
           ...
           "code": {
             "text": "Benpen 3 g powder for injection, 1 vial"
           },
           "manufacturer": {
             "display": "Seqirus"
           }
        }