Difference between revisions of "RegulatedMedicinalProduct FHIR Resource Proposal"

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==Committee Approval Date:==
 
==Committee Approval Date:==
<i>13th September 2017</i>
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6th May 2019 (earlier approval with different, as "MedicinalProduct" 13th September 2017)
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
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==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
  
TBC (PSS has been created and submitted)
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1367
  
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
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==Resource appropriateness==
 
==Resource appropriateness==
  
There is an upcoming requirement to support the standardised exchange of detailed Product data, as covered by the ISO 11615 specification.  
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There is an outstanding 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.  
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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. This resource has been designed in close consultation with Pharmacy, and in conjunction with the MedicationKnowledge resource
  
 
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).
 
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).
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EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format. They are required to move to IDMP, and this is a good opportunity to use a standards-based FHIR solution.
 
EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format. They are 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).
+
 
 +
FDA for drug submission (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).
 +
 
 +
FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource June 2019)
  
 
==Content sources==
 
==Content sources==
  
The basis for the resource is the information in ISO 11615 Substances standard. A large amount of actual data exists in the EMA XEVMPD data base and XEVPRM XML messages. Example FHIR data of several full product data sheets exists based on prototyped resources.
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The core basis for the resource is the information in ISO 11615 Medicinal Products standard. A large amount of actual data exists in the EMA XEVMPD data base and XEVPRM XML messages. Example FHIR data of several full product data sheets exists based on prototyped resources.  
  
Draft resources covering some of IDMP are here: [[MedicinalProduct]]
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Also information gained from early stage implementation of these resources at EMA, and from FDA (for PQ/CMC) and other workgroup review (BR&R, Pharmacy) and their comments.
  
 
==Example Scenarios==
 
==Example Scenarios==
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Pharmacies and prescribers can view and download this information for reference and integration with their systems.
 
Pharmacies and prescribers can view and download this information for reference and integration with their systems.
 +
 +
Specific use cases include:
 +
 +
Submission of products from drug companies and NCAs (National Competent Authorities - the national regulators) to regional regulators. This is already implemented in Europe (by EMA and EU-wide stakeholders) with an earlier non-HL7 format (XEVPRM/XEVMPD). Currently being re-implmented with this resource as part of the EU wide SPOR project.
 +
 +
Drug Manufacturing Quality information (aka PQ/CMC, Pharmaceutical Quality), as used by the FDA in the US. Specific plans to use this resource for that project.
  
 
==Resource Relationships==
 
==Resource Relationships==
  
See diagram below and also associated proposal: [[SubstanceSpecification_FHIR_Resource_Proposal]]
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See diagram below. <!-- and also associated proposal: [[SubstanceSpecification_FHIR_Resource_Proposal]]-->
  
 
Reference to Organization, for the manufacturer, regulator and other establishments.
 
Reference to Organization, for the manufacturer, regulator and other establishments.
 
Reference to DocumentReference, for the regulatory submission documentation.
 
Reference to DocumentReference, for the regulatory submission documentation.
 
Reference to (proposed) SubstanceSpecification to describe ingredients in detail.
 
Reference to (proposed) SubstanceSpecification to describe ingredients in detail.
Reference to directly supporting (proposed) resources such as MedicinalProductAuthorization, MedicinalProductPackaged
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Reference to directly supporting (proposed) resources such as RegulatedAuthorization, RegulatedPackagedProduct
  
===MedicinalProduct and Medication===
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===RegulatedMedicinalProduct and Medication===
  
This resource is intended to complement the Medication resource, which is focused on what is commonly needed for medical/clinical use cases. MedicinalProduct adds information needed for regulatory use cases, of which there is little overlap, and also may be appropriate for drug database use.
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This resource is intended to complement the Medication resource, which is focused on what is commonly needed for medical/clinical use cases. RegulatedMedicinalProduct adds information needed for regulatory use cases, of which there is little overlap, and also may be appropriate for drug database use.
  
Most aspects of MedicinalProduct are not present in Medication at all, and are not current candidates for inclusion in the prescribe/dispense/administer workflow.
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Most aspects of RegulatedMedicinalProduct are not present in Medication at all, and are not current candidates for inclusion in the prescribe/dispense/administer workflow.
  
 
Clinical particulars - indications, contra-indications etc
 
Clinical particulars - indications, contra-indications etc
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IDMP does include descriptions of devices that are included with medicinal products. These include physical properties and characteristics that apply at the model level rather than the "instance" or usage level, that the Device resource is primarily concerned with.
 
IDMP does include descriptions of devices that are included with medicinal products. These include physical properties and characteristics that apply at the model level rather than the "instance" or usage level, that the Device resource is primarily concerned with.
[[Image:Resources_sketch_2.png|center||Relationship to other resources]]
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[[Image:Resources_sketch.png|center||Relationship to other resources]]
  
 
==Timelines==
 
==Timelines==

Revision as of 12:54, 13 June 2019



RegulatedMedicinalProduct

Owning work group name

BR&R

Committee Approval Date:

6th May 2019 (earlier approval with different, as "MedicinalProduct" 13th September 2017)

Contributing or Reviewing Work Groups

  • Pharmacy
  • O&O

FHIR Resource Development Project Insight ID

1367


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 activities, 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 outstanding 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. This resource has been designed in close consultation with Pharmacy, and in conjunction with the MedicationKnowledge resource

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 and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format. They are required to move to IDMP, and this is a good opportunity to use a standards-based FHIR solution.

FDA for drug submission (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).

FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource June 2019)

Content sources

The core basis for the resource is the information in ISO 11615 Medicinal Products standard. A large amount of actual data exists in the EMA XEVMPD data base and XEVPRM XML messages. Example FHIR data of several full product data sheets exists based on prototyped resources.

Also information gained from early stage implementation of these resources at EMA, and from FDA (for PQ/CMC) and other workgroup review (BR&R, Pharmacy) and their comments.

Example Scenarios

Pharma companies submit details of new products to regulators. Updates are made when necessary e.g. Clinical particulars change (a new contra-indication), a new marketing authorization exists etc.

Pharmacies and prescribers can view and download this information for reference and integration with their systems.

Specific use cases include:

Submission of products from drug companies and NCAs (National Competent Authorities - the national regulators) to regional regulators. This is already implemented in Europe (by EMA and EU-wide stakeholders) with an earlier non-HL7 format (XEVPRM/XEVMPD). Currently being re-implmented with this resource as part of the EU wide SPOR project.

Drug Manufacturing Quality information (aka PQ/CMC, Pharmaceutical Quality), as used by the FDA in the US. Specific plans to use this resource for that project.

Resource Relationships

See diagram below.

Reference to Organization, for the manufacturer, regulator and other establishments. Reference to DocumentReference, for the regulatory submission documentation. Reference to (proposed) SubstanceSpecification to describe ingredients in detail. Reference to directly supporting (proposed) resources such as RegulatedAuthorization, RegulatedPackagedProduct

RegulatedMedicinalProduct and Medication

This resource is intended to complement the Medication resource, which is focused on what is commonly needed for medical/clinical use cases. RegulatedMedicinalProduct adds information needed for regulatory use cases, of which there is little overlap, and also may be appropriate for drug database use.

Most aspects of RegulatedMedicinalProduct are not present in Medication at all, and are not current candidates for inclusion in the prescribe/dispense/administer workflow.

Clinical particulars - indications, contra-indications etc Authorisations and Marketing - key area for regulators, of little interest to prescribers. Dates, statuses, territories etc. Product packaging - details of packages, including contents, sizes etc Ingredients - Typically at a prescribing level these are inherent in the medication code. The Medication resource does allow specifying ingredients of a medicine but this is typical for extemporaneous mixtures, and not the manufacturing of products.

MedicinalProduct and Device

IDMP does include descriptions of devices that are included with medicinal products. These include physical properties and characteristics that apply at the model level rather than the "instance" or usage level, that the Device resource is primarily concerned with.

Relationship to other resources

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