Characteristics Extension

The characteristic extension is a loosely defined key–value pair that allows implementations to add any other information about the medicinal product. Such information may include details relevant to requests (for example lactose-free = true) or additional data about the product actually dispensed (for example special precaution for storage = "Store in a refrigerator (2°C – 8°C)"). The data type of the value depends on the type of the characteristic.

Availability of this information depends on its presence in the source data. In FHIR, MedicationKnowledge and resources in the Medication Definition module include elements for characteristics or properties, which allow medicinal product dictionaries to communicate this type of data when necessary. Other elements in detailed product descriptions may also be conveyed using this extension.

Strength Representation with basisOfStrengthSubstance Extension

The basisOfStrengthSubstance extension is used when the substance listed as the ingredient differs from the substance on which the strength is expressed.

In many medicinal products, the ingredient may be represented as a precise substance (for example a salt form), while the strength is expressed in terms of the active moiety. When the ingredient substance and the strength reference substance do not match, the basisOfStrengthSubstance extension indicates which substance the strength value refers to.

The following examples represent different representations of the concept:

1193768007 | Product containing precisely cefuroxime (as cefuroxime sodium) 750 milligram/1 vial powder for conventional release solution for injection (clinical drug)|

Depending on the medicinal product dictionary, the substance and strength provided may differ.

If the ingredient substance and the strength refer to the same substance, the extension can be used for explicit clarity, but it does not add additional information.

Data element	Example 1	Example 2
Ingredient	cefuroxime	cefuroxime sodium
Strength	750 mg	789 mg

If the ingredient is a different form of the substance (for example a salt), but the strength is expressed for another substance (typically the active moiety), the extension is needed to remove this ambiguity.

Data element	Example 3	Example 4
Ingredient	cefuroxime	cefuroxime sodium
Strength	789 mg	750 mg
basisOfStrengthSubstance	cefuroxime sodium	cefuroxime

The approach described here aligns with the SNOMED CT medicinal product concept model and can be derived from the ISO IDMP representation.

Medicinal Product Name

The Medication resource does not include an explicit element for the medicinal product name. In countries where medication information is distributed as a code system, the de facto elements used for holding the medication name have been Medication.code.text or Medication.code.coding.display. This is also the recommendation of HL7 Pharmacy.

However, analysis of extensions in national implementation guides showed that many countries prefer to extend the Medication resource in order to include an explicit element for the authorised name of the product. It is also evident that countries often add multiple codings to the .code element, which makes it difficult to understand which coding is associated with the official product name.

Therefore, this implementation guide includes a simple extension for the authorised medicinal product name. National implementations are not required to use this extension when their functional requirements are covered by the .code element.

Identifier vs Code

In case of medications, the line between .identifier and .code is not always clear, and the practice of using these elements differs between countries.

This implementation guide allows the use of the .identifier element for non-instance identifiers such as IDMP identifiers or product codes from a national product registry or EMA PMS. It should be noted that identifiers do not have display names, which requires the consumer of the data to have lookup access to the source system of the identifier or the producer of the data to populate additional descriptive elements describing the product.

Code vs Classification (e.g. ATC)

The classification extension was introduced after reviewing how different countries implement medication classifications. Some implementations include ATC codes in Medication.code.coding, while others use extensions.

Because classifications such as ATC represent a categorisation of a medication rather than the medication itself, the preferred approach is to convey them in a separate classification element.

National implementations that currently include ATC as an additional coding may continue to do so, but should maintain the ability to map it to the classification extension, particularly for cross-border use.

If ATC itself is used as the medication code (for example in certain MedicationStatement contexts), it should remain in Medication.code. ATC is not recommended for ingredient representation, as the code system lacks the required granularity.

Additional Information and Examples

Additional information and example instances can be found in the HL7 Europe Medication Prescription and Dispense Implementation Guide.