HL7 FHIR based implementation of ISO Identification of Medicinal...

HL7 FHIR based implementation of ISO Identification of Medicinal Products standardIHIC 2019

Rik Smithies, NProgram Ltd., UK

rik@nprogram.co.uk

NProgram 1

Who am I?

• Name: Rik Smithies

• Company: Independent Consultant (NProgram Ltd., UK)

• Background:• Technical Committee Chair, HL7 UK (and former Chair)

• HL7 International Standards Governance Board

• FHIR trainer, consultant

• Architect, analyst and software developer. 20 years in healthcare IT

• Contact:• rik@nprogram.co.uk

• www.nprogram.co.uk

NProgram 2

IDMP - a logical data model standard

• Identification of Medicinal Products

• "Data elements and structures for the unique identification and exchange of Medicinal Products"

• An ISO standard, in development for several years and finished in 2017

• Actually a set of standards (with long names and hard to remember numbers)

• Main two are:• 11615 – “Products”

• 11238 – “Substances”

NProgram 3

OK so what is it?

• Detailed logical model for medicines and their ingredients• To the level that drug manufacturers need

• And "regulators" need• Official bodies that make the laws about drugs (in EU - EMA, European

Medicines Agency. And each country has its own too. MHRA for UK.)

• The detail is much more than is used by doctors when prescribing

• Packaging details, legal approvals, ingredients, indications and contraindications etc.

• Not a physical model (no XML etc., no FHIR)

NProgram 4

ISO IDMP 11615 Medicinal Products

• A logical/conceptual model for “Products”

• Things that can be packaged up and administered to a patient

• A product is more than just a “substance", or even a medication

NProgram 5

IDMP 11615: Authorised Medicinal Product - Details

(Chance to see the full model, but not intended to be read in detail. About 50 classes.)

NProgram 6

ISO IDMP 11615 - Detail views (example)

NProgram 7

Different product aspects

Product as licensed

("regulatory")

Product as

supplied

("physical")

Product as consumed

("pharmaceutical" or

"administrable")

NProgram 8

Different layers

NProgram 9

Different layers, add components of containers

NProgram 10

Different layers, add materials, ingredients, characteristics

NProgram 11

Manufacturers, etc.

NProgram 12

IDMP Messaging

• IDMP is not a message, and it has no physical expression (it’s a "logical" model)

• We want to implement IDMP* but the resources didn’t exist in FHIR (in 2017)

• There are similar concepts in the FHIR Medication resource (as used in MedicationAdministration etc) and the Substance resource

• But the level of detail is not enough

* In Europe, EMA want to implement IDMP in 2019, and were preparing for this in 2017

NProgram 13

IDMP on FHIR - Challenges

• There is lots of IDMP to model…• Product ~50 classes (and far more in IDMP Substance)

• How to combine with what is there, and not break things• modelling challenge• (see next slides…)

• FHIR community doesn’t know much about regulatory…!• FHIR is mainly about patients and the EHR• FHIR people said "what's all this stuff!" "who needs all this?"

• (ongoing education challenge :-)

NProgram 14

3 main sets of use cases (for Products)

• Day to day prescribing, primary care, secondary care• By far the most common by volume

• Medication, MedicationRequest/MedicationAdministration etc., Substance

• Pharma Regulation/Submission of products to regulators• Needs full product info, much more than for above

• Packaging details, ingredients, authorisations granted, dates, territories

• Clinicals – indications, contra-indications etc.

• Prescribing support, Medication Knowledge Bases• A hybrid of the two. Needs more than basics, but not the whole lot

From Clinical to Regulatory - Clinical practice workflow

From Clinical to Regulatory - 2

From Clinical to Regulatory - 3

From Clinical to Regulatory - 4

From Clinical to Regulatory - 5

From Clinical to Regulatory - 6 - add in all the IDMP classes? (not this way…)

VS

From Clinical to Regulatory - 7 (not this way…)

VS

2 level modelling - a new layer

2 level modelling - 9

2 level modelling - 10

2 level modelling - 11

2 level modelling - 12

2 level modelling - now

2 level modellingcomplete picture

NProgram 29

IDMP and resource names (cross reference)

* Resource name approved by committee but not yet by FHIR management group (September 2019)

IDMP Name Current Name (build.fhir.org) Old names - FHIR R4 (hl7.org/fhir)

Medicinal Product MedicinalProductDefinition MedicinalProduct

Marketing Authorization RegulatedAuthorization MedicinalProductAuthorization

Ingredient Ingredient MedicinalProductIngredient

Packaged Medicinal Product PackagedProductDefinition MedicinalProductPackaged

Manufactured Item ManufacturedItemDefinition * MedicinalProductManufactured

Pharmaceutical Product AdministrableProductDefinition * MedicinalProductPharmaceutical

Contraindication ClinicalUseIssue MedicinalProductContraindication

Indication ClinicalUseIssue MedicinalProductIndication

Interaction ClinicalUseIssue MedicinalProductInteraction

Undesirable Effect ClinicalUseIssue MedicinalProductUndesirableEffect

NProgram 30

IDMP FHIR is draft (as is a lot of FHIR)

The IDMP resources are in FHIR R4 (December 2018), but they have moved on since, quite significantly.The latest is in the "Build" version of FHIR: http://build.fhir.org. (Which will be R5)Whichever version, the way to access is the same. From the homepage, pick "Resource Types" (formerly just "Resources")

NProgram 31

IDMP FHIR Resources Location

From the Resource index, scroll to the section in the far bottom right.

© 2019 Health Level Seven ® International. Licensed

under Creative Commons Attribution 4.0 International

HL7, Health Level Seven, FHIR and the FHIR flame logo

are registered trademarks of Health Level Seven

International. Reg. U.S. TM Office.

IDMP FHIR Resources LocationThere is a specific section. Most but not all are listed there. All are listed in the alphabetic view

IDMP and resource names (11615, Product)Current Name (build.fhir.org) What is it? Status (9/2019)

MedicinalProductDefinition Detailed version of a medication. Includes same product in different packages. Approved

RegulatedAuthorization The regulatory authorization of a medicinal product Not yet approved, pending some research

Ingredient The ingredients, to a more detailed level than in the Medication resource Approved

PackagedProductDefinition A packaged version of a product Not yet submitted

ManufacturedItem The actual medicinal item e.g. a tablet or some powder Not yet submitted

AdministrableProductDefinition The pharmaceutical aspects of the medicinal product, possibly after mixing - ready to be administered

Approved

ClinicalUseIssue Criteria for giving or not giving a medication, and other interactions Approved

NProgram 34

IDMP and resource names (11238, Substance)

IDMP Name Current Name (build.fhir.org) What is it? Status (9/2019)

Substance / Specified Substance

SubstanceDefinition Details of a substance used as an ingredient. More detail than Substance resource.

Approved

Polymer SubstancePolymer Specifics that only apply to polmers Not yet submitted

Nucleic Acid SubstanceNucleicAcid Specifics that only apply to nucleic acids Not yet submitted

Protein SubstanceProtein Specifics that only apply to proteins Not yet submitted

Source Material SubstanceSourceMaterial Derivation of the substance Not yet submitted

Reference Information SubstanceReferenceInformation General background information Not yet submitted

NProgram 35

FHIR Resources compared to IDMP Product

• Scope is similar, almost everything is covered, Authorized and Investigational medicines

• Also some additions for veterinary use, that are current requirements but were never in IDMP (proposal for adding to IDMP later).

• FHIR models are slightly smaller. IDMP is verbose.• FHIR names are simplified• We reuse some FHIR resources: Organization, DocumentReference as

references• IDMP has classes for some things that can just be attributes in FHIR (using a

codeableConcept for code and text)• Some common parts became FHIR datatypes, those that don’t merit being a

standalone resource

• As people see these and apply them to their own uses cases, the resources are evolving, but staying backwards compatible with IDMP.

NProgram 36

FHIR IDMP Resources - MedicinalProduct

http://build.fhir.org/medicinalproduct.html

NProgram 37

IDMP Medicinal Product (for comparison)

FHIR example

Draft resource, subject to change

JSON is also supported

NProgram 39

FHIR IDMP Resources - RegulatedAuthorization

http://build.fhir.org/regulatedauthorization.html

NProgram 40

FHIR IDMP Resources - MedicinalProductPackaged and ManufacturedItemDefinition

http://build.fhir.org/packagedproductdefinition.html andhttp://build.fhir.org/manufactureditemdefinition.html

NProgram 41

FHIR IDMP Resources - AdministrableProductDefinition

http://build.fhir.org/administrableproductdefinition.html

NProgram 42

FHIR IDMP Resources – ClinicalUseIssue

http://build.fhir.org/clinicaluseissue.html

NProgram 43

FHIR IDMP Resources – Ingredient

http://build.fhir.org/ingredient.html

NProgram 44

What next for the FHIR resources

• Resources are still draft. Most are "approved", but not yet all.

• Product scope for 11615 is more mature than Substance scope for 11238 (which is huge, and very specific).

• But basics of SubstanceDefinition are approved

• Some restructuring still possible. Also lots of detail to review.

• More content needed. Explanatory text, examples, mappings etc

• EMA are developing with these resources now (October 2019), for the SPOR project

NProgram 45

FHIR to IDMP mappings are published (for MedicinalProductDefinition)

Mappings exist in draftYou can use this to see the differences. Some new items e.g. Domain (human or animal) and Description (a commonly used field, but doesn’t exist in the "pure" world of IDMP products).

NProgram 47

FHIR IDMP Resources – SubstanceDefinition

http://build.fhir.org/substancedefinition.html (more detail next slide)

http://build.fhir.org/substancedefinition.html

NProgram 49

EMA SPOR Project – EU implementation of IDMP

• SPOR – Substances, Products, Organisations, Referentials• Referentials being codes

• 4 distinct systems, that back each other up• SMS, PMS (active development using FHIR September 2019)

(SMS = Substance Management System, etc.)• RMS, OMS (delivered June 2017 - non-FHIR)

• Registry of products and substance they are made from

• Single source of truth. Pharma industry submits data only once, in FHIR, for registration/approval/variations of products and substances.

• To support Pharmacovigilance, eSubmissions, Clinical Trials, for human and veterinary use

Slide thanks to Paolo Alcini, Isabel Chicharo, EMA

NProgram 50

EMA SPOR Project – EU implementation of IDMP

• Using FHIR for (P)roducts and (S)ubstances

• (O)rganisation was completed before move to FHIR

• (R)eferentials ("codes") is based heavily on earlier system and is compelee and doesn’t use FHIR

• Has been a key driver for creation of FHIR IDMP resources

• FDA also involved and using FHIR for PQ/CMC project (drug quality monitoring)

• Other national projects likely, e.g. Norway

Thank you. Questions?