HL7 Europe Medication Prescription and Dispense
1.0.0 - trial-use 150

HL7 Europe Medication Prescription and Dispense, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/mpd-r5/ and changes regularly. See the Directory of published versions

## Challenges

### Crossborder services

Crossborder ePrescription and eDispensation services are operational in several countries in Europe, and joining these services will become mandatory with the EHDS regulation.

Currently, crossborder ePrescription and eDispensation data exchange is using HL7 CDA, as the original pilots and their specifications date back over a decade. In the long term, all crossborder services will switch to HL7 FHIR as the new crossborder services are already implemented using HL7 FHIR.

Operational crossborder services is more than simply sending data between countries. Country A needs to transform their data into a format understandable for country B. This includes:

- transformation of data structure to the crossborder format published by MyHealth@EU (country A),
- transcoding coded elements to concepts defined in Master ValueSet Catalogue (country A),
- translating the coded elements in the received data to local language (country B),

Optionally, country B may transform the data into their national format in order to store the data (most commonly done for dispensation information).

Operating the service and maintaining mappings and translations is the responsibility of the National Contact Point (NCP).

Crossborder data exchange relies heavily on structured data and common value sets. A national prescription may include just a product code for the prescribed product, but for crossborder use, this prescription needs to be enriched with detailed structured information about the prescribed product. Same crossborder requirement for explicit, detailed, structured representation of concepts extends also to dosage, especially when coded route/method is to take part in dispensed product selection.

### Leveraging ISO IDMP

European Medicines Agency has implemented ISO IDMP (FHIR R5) for marketing authorisation applications and registered product data. Therefore, many national medicines agencies are implementing ISO IDMP compatible systems or mapping layers to conform to the IDMP data model used by EMA and marketing authorisation holders. Also, electronic product information projects use ISO IDMP data model through FHIR R5 MedicationDefinition resources.

At the same time, eHealth services are motivated to use a similar data model in order to use good quality data from the original source. As ISO IDMP model is regulatory-oriented and too granular for most eHealth services, we have identified a core data set applicable for prescription and dispensation services. This subset is compliant with ISO IDMP, but is significantly reduced and slightly simplified. This ensures consistency between regulatory data and the eHealth data - on a real as well as virtual product level.

All data elements in Medication profile are optional, allowing each implementation to implement the granularity needed for their use case. While national systems often rely on a common medicinal product dictionary and may just exchange medication codes, crossborder services expect the medication information to be described on attribute level. Also, many national specifications prefer to include medication attributes in addition to the code in order to simplify the process on the receiver side.

ISO IDMP identifiers and EMA PMS identifier can be used for identifying a medication for prescriptions or dispenses. PhPID is more likely to be used only for prescriptions. The prerequisite for using these identifiers is their availability in the implementing prescribing-dispensing ecosystem.

### HL7 FHIR versions

European countries who already have a FHIR implementation, are using mostly R4, but some are also using R5. European Medicines Agency and national medicines agencies use R5 for ISO IDMP compatible data. Many countries don't have any FHIR implementations yet.

Considering the context, this FHIR Implementation Guide is created in R4 and R5 in parallel. Both IG versions contain the same content, but differences in FHIR core specification result in slightly different profiles, extensions, and examples. However, functionally the two specifications are the same, and should be perfectly compatible. Please report any discrepancies you may find.