MedicinalProduct FHIR Resource Proposal

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MedicinalProduct

Owning work group name

BR&R

Committee Approval Date:

13th September 2017

Contributing or Reviewing Work Groups

  • Pharmacy
  • O&O

FHIR Resource Development Project Insight ID

TBC


Scope of coverage

To support the content of the ISO 11615 IDMP Medicinal Product standard and its ISO/TS 20443 Technical Specification, and other domain areas with similar requirements. 11615 covers detailed definition of products, their submissions to regulators, authorization activitues, ingredients, packaging, accompanying devices, clinical particulars etc). Not all of those are expected to be covered in this single resource.

RIM scope

Similar in scope to the product parts of CPM. Entity: Material (EntityClass="MAT")

Resource appropriateness

There is an upcoming requirement to support the standardised exchange of detailed Product data, as covered by the ISO 11615 specification.

This resource does not intend to clash with the existing Medication FHIR resource, but complements with an extra level of detail. It is seen as a sibling rather than a parent or a superclass to be profiled.

It is intended to add an extra level of product specification detail, such as is typically used by regulators, and only indirectly used during normal medication related work flows (e.g. for lookups of unfamiliar products).

Manufacturers submit this data to regulators, when products are registered or altered, or marketing situations change.

Expected implementations

EMA European Drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format. They will be required to move to IDMP, and this is a good opportunity to use a standards based FHIR solution. FDA (currently using SPL, which is not likely to change in the near term, but have expressed an interest in researching what can be done with FHIR).

Content sources

Basis for the resource is the information in ISO 11615 Substances standard. Actual data exists in the EMA XEVMPD data base and XEVPRM XML messages.

Example Scenarios

Substance definitions for the various categories (Chemical, Polymer, Protein etc). Use of "Specified Substance" area of 11238 to add extra information around manufacturing process etc.

Resource Relationships

Reference to Organization, for the manufacturer.

SubstanceSpecification and Substance

There is expected to be a reference from Substance to SubstanceSpecification, to be able to point to a more detailed definition. This may be an actual FHIR reference, or, perhaps more likely, it could operate via Substance.Code, which would correspond to SubstanceSpecification.code.

This resource is not expected to replace the existing Substance resource - which is limited in scope to the small number of items needed to support direct clinical/medicinal use. (The Substance resource could be considered to be a "Substance Use".)

SubstanceSpecification is a collection of definitional information that an instance of a Substance resource (e.g. in a Medication, within a MedicationDispense) can refer to.

It is not expected that a SubstanceSpecification would ever directly substitute for the use of Substance.

In theory, all the SubstanceSpecification information could be contained in a hugely expanded Substance resource (and then the existing Substance scope could be profiled back out again). But this would create an unmanageably large Substance resource for the very common and narrow medical/clinical use cases.

Since the key regulatory use of SubstanceSpecification is almost orthogonal to the clinical use cases, it seems appropriate to have the SubstanceSpecification resource available as a sibling to Substance, not a parent. The SubstanceSpecification resource would also be used on its own, unrelated to any Substance instance, in those regulatory and drug information use cases.

Overlap between SubstanceSpecification and Substance

In practical terms there very little overlap of attributes between SubstanceSpecification and Substance. The Substance resource has only a few fields that are definitional (which are the only ones that would overlap).

Identifier and status are specific to this substance instance.

Category is definitional, and so does overlap, but could also be a local classification.

Code is the link between the two, and description could be considered a very small (possibly local) summary of the whole SubstanceSpecification, and so be a useful overlap.

The Instance component is not definitional so does not clash.

The Ingredient component is primarily for cases when the main Substance is made up on-demand - mixed rather than manufactured - and so would not itself be covered by a global SubstanceSpecification (hence no overlap).

SubstanceSpecification and Medication

The Medication resource has a reference to Substance. That is not expected to change. As described, SubstanceSpecification is additional, definitional information about substances. It is not itself expected to be used as a substance instance - which is what Substance is for.

SubstanceSpecification and Device

There is no direct relationship between SubstanceSpecification and Device anticipated.

In theory, since devices are made of substances, it would be possible, as with any physical object, to use a SubstanceSpecification to describe the details of materials that comprise it. However this is not a currently proposed use case and device material is not supported by the existing Device resource.

Side note: The separate IDMP Product use case (not proposed here, but a possible future concept) does also include details of manufactured devices, and their materials. An expanded Device resource to cover the requirements of IDMP Products, could include a Device.Material field, which could be a reference to a Substance, or to a SubstanceSpecification. (For that future use case, Device could be expanded with a large set of extensions, or possibly via an analogous DeviceSpecification resource, to keep the Device resource small).

Timelines

Early draft by December 2017 comment-only ballot.

gForge Users

riksmithies (already has commit permission)

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes