1. FHIR Catalog Support

2. Drivers
ISO IDMP
openMedicine (EU Project)
(Orderable Lab Tests)

3. Goal To have one consistent approach to transfer “catalog” information
List of prescribable medications
List of orderable devices
List of orderable services
Including metadata / properties / expected behavior about orderable items

4. Use Cases:
Hospital queries and retrieves list of authorized medications / devices from national authority
Hospital publishes list of authorized medications /devices by departments
Hospital systems (OR, EHR, Dispensing) consult list of medications
All medications/devices
Only updated since Aug-13
Physician queries the full properties for a device before implant
Physician wants to order lab studies / other...

5. Catalog of Items - Approach
Provide “catalog entries” to ensure each “items” has necessary definitional data
Medication
compatible with regulators (can contain all information defined and needed by the FDA / EMA)
compatible with clinical use cases (can contain the common subset to be used in prescriptions, dispenses)
Devices
Compatible with Regulators
Compatible with clinical uses, including UDI (implant, etc).
Tests
Compatible with furnishing labs, etc.
Create a resource for Catalog
Bundling, Transmission handshake
Date last submitted,
Catalog entry valid until (not the same as physical device expiry),...

6. Catalog of Items – Scope exclusions
Clinical
Current clinical use cases (prescription, dispense, etc.) do not need to be changed. They need to be supported by the existence of a catalog
Inventory management
Quantities at hand, location, or whether items are physically in warehouse – not needed. Only need is “Items in catalog”
Supply
Deliveries, orders, etc. are already handled by Supply resources which already follow the approach: Generic “supply” resources which can use the “items” resources.

7. 3 Projects
Medication PSS – enable Medication Resources to be catalog-compatible
Others: devices, etc. Would work the same. Medication is interesting for openMedicine and regulators.
Lab Test PSS – “eDOS on FHIR”
Cataloging mechanism PSS – provide the exchange mechanisms.
Catalog Entry - Data Element? Activity Definition? XYZ Definition?
Catalog

8. Stakeholders: OO
RCRIM
Pharmacy
Terminologies
FMG
Medication (PSS 1)
Devices
Lab tests (PSS 3)
...
CATALOG (PSS 2)

9. PSS 1: Medication formulary
Defining a resource (or adjust the existing resource) to enable the exchange of product descriptions – not just to be able to specify the product from a formulary, but to actually fill in that formulary, echanging characteristics of a medication.
ISO IDMP-ready resource
Able to convey the product information generated at regulators, and enriched throughout the chain until reaching the clinical systems.

10. PSS 2: “Catalog” exchange
Before a “medication” definition resource can be populated, there are several questions around the exchange of product information:
Bulk download of product data? Or query mechanism to download as needed?
How to handle differential updates?
When updating one product (e.g. a Pharmaceutical Product), what to do with ancestors or descendants? Are they also updated?
...

11. PSS 3: eDOS on FHIR
For a catalog consumer (order placer) to know which lab services are orderable, and all the characteristics – from pricing info to availability per provider. – Exchange characteristics of lab services.
From lab providers to lab catalog broker, and from catalog broker to individual consumers

12. Open Questions
Is FDA GUDID a type of Catalog with each Device being a Catalog Entry?
 Yes
Do we always need to exchange / provide access to a full Catalog? Individual Catalog Entries? A set of Catalog Entries?
 Yes. And even a set of characteristics, or filter based on a set of characteristics. This is allowed by the handshake part + filtering Some cases:
Get full catalog
Get full catalog for “new “ items (changed after ddmmyyyy)
Get updates for medications containing paracetamol
Get the devices that do not have latex
Get the lab services and locally defined prices…
How does this relate to Ordering Service efforts?
Needs to be harmonized.