hl7 open medicine jan 2016

PHC-34 643796

Meeting the challenge of open access to medicinal products across the Union

Project presentation Support from and to HL7

PHC-34 643796

openMedicine

Mandate: produce recommendations on how to Solve the problem of identifying a medicinal product in a cross border setting

Address the issue of substitution across the European Union

Commitment to include all possible kind of medicinal products

Authorised as well as not (to be) authorized

Prepacked / per unit

Magisterial

etc…

openMedicine - Jasehn meeting 2

PHC-34 643796

Purpose is….

NOT to regulate on how to prescribe a brand medicinal product standardise dispensing and administrating medicines define how to document medication related information in the Electronic Health Record define the content and structure of a comprehensive drug database

NOR how to handle investigational medicinal products conduct clinical trials manage pharmacovigilance information do pharmacological research, pharamaco-economic research

But to address the identification of the product in each of these applications and for each kind of product


PHC-34 643796

eMedicines and eMedication

Two complementary domains eMedicine: about the products as such

eMedication: about the use of the products

Different Stakeholders

Use cases (prescription, administration, authorisation, dispensing, production, surveillance,…)

Initial goal

Terminology, expressing the context of origin

In common “Products” => identification

“the e” => challenges and opportunities


PHC-34 643796

22-01-2016

5

Standard Lifecycle of a medicine: development & production

Substance

Trial

> IMPID

EMA

European

> MAH

National

Authorisation > MAH

Production

> PhPID

> Batch

> Manuf.

PHC-34 643796

22-01-2016

6

Standard Lifecycle of a medicine: in the market

Marketing

> Manuf

> MPID

> PCID

Prescription

> MPID

> PCID

Dispensing

> MPID

> PCID

Administering > PhPID

PHC-34 643796

22-01-2016

7

Standard Lifecycle of a medicine: outcome

Clinical Research

Pharmaco-economics

Pharmaco-vigilance

Withdrawal

Change

PHC-34 643796

Each of this stages

Its own standards

Its own data model

Its own terminology

Its own descriptive attributes

.. Of course with a lot of commonalities

PHC-34 643796

What should be ideal?

Using one identifier for the whole lifecycle of a medicine ?

Each product has a “wallet” of identifiers Either included in the eIdentification

Or referenced to.

Using the same value set for the descriptive attributes used for identification

If not.. At least validated mapping tables

11.11.2015 PEB Milano November 10-11.2015 9

PHC-34 643796

Prescribing & Dispensing

Many different ways depending on nature of the prescribed product

regulation fully compatible

sufficient to enable dispensing

number of different packages / products available

acceptable degree of substitution

Most common: MPP prescription different de facto ways to do

ID in principle national

ePrescribing requires a national drug database


PHC-34 643796

ISO Identification of Medicinal Products

The cornerstone of the ISO standards for the Identification of Medicinal Products

Substance

Dose Form

Strength Substance

Dose Form

Strength

Substance

Dose Form

Strength

Substance

Dose Form

Strength

Regulated Medicinal Product

Pharmaceutical Product

Substance

Pharmaceutical Dose Form

Strength

Standard Terminology

11615: Regional

11616: Derived

11238: G-SRS & SMS

11240:UCUM

11239:EDQM

PHC-34 643796

EMA/EU-FDA Substance/Product Data Sharing Concept

Establishment of a EU-Network/FDA (IDMP) Joint Scientific/Technical Governance Board(s) for registration and maintenance operations

PHC-34 643796

Future work

Cross-border synchronization of product characteristics

Use of cross-border identifier or attributes in the clinical cycle

PHC-34 643796

Synchronization of product characteristics

SPL between manufacturers and regulators

GS1 between manufacturers and buyer

Inside / across institutions?


PHC-34 643796

Regulator

Marketing

Prescription Dispense Administration

Production Distribution

Monitoring

Monitoring

National Product Dictionary

Clinical Process data

Product Characteristics

SPL

GS1

Product Dictionary Product Dictionary

Product Characteristics (Art.57 DB)

Production/logistics data

Patient Summary

Regulatory process management data

PHC-34 643796

Attribute structure:

- Product attributes - Identifying attributes - Descriptive attributes - Clinical attributes - Product-related - Treatment-related

Wallet of Identifiers

Concept Identifier Name Scope Vocabulary

PhPID PhPID Local / XBorder National / EMA / GENUS

PhP Stratum PhP->Stratum Local / XBorder

Substance(s) PhP->Substance Local / XBorder ISO 11238

Administrable Dose Form PhP->AdminDoseForm Local / XBorder EDQM- Standard terms database; Pharmacopoeia; ISO 11239

Strength

Quantity PhP->Strength->Qty Xborder

Units PhP->Strength->Units Xborder UCUM; EMA Guidelines; ISO 11240

Reference Strength

Quantity PhP->RefStrength->Qty Local / XBorder

Units PhP->RefStrength-Units Xborder UCUM; ISO 11240

Medical Device PhP->Device Local / XBorder

Unit of Presentation PhP->UnitofPresentation ISO 11239

MPID

Medicinal Product Name MP->Name Local Volume 2A – Procedures for marketing authorisation

Marketing Authorization

Country MP->MA->Country Local ISO 3166-1

Holder MP->MA->Holder Local / Xborder

Number MP->MA->Number Local / Xborder EDQM- Standard terms database

Indication MP->Indication Local / Xborder

Pharmaceutical Dose form MP->DoseForm ISO 11239

Legal Status of Supply MP->LegalStatus

Classification MP->AdditionalClassification Local ATC +

PCID

Package Item Container ISO 11239

Type PC->Container->Type Local / Xborder

Quantity PC->Container->Qty Local / Xborder

Material PC->Container->Material Local / Xborder

Alternate Material PC->Container->AltMaterial Local / Xborder

Package Component ISO 11239

Component Type PC->Component->Type Local / Xborder

Material PC->Component->Material Local / Xborder

Alternate Material PC->Component->AltMaterial Local / Xborder

Manufactured Item

Manufactured Dose Form PC->Item->ManufDoseForm Local / Xborder ISO 11239

Unit of Presentation PC->Item->UoPresentation Local / Xborder ISO 11239

Manufactured Item QuantityPC->Item->Quantity Local / Xborder

Product identification Product->Identification

Identifier Product->Identification->ID N/A Several

Codeset Product->Identification->Codeset N/A Several

Product Name Product->Name N/A Several

Strength Product->Strength Local / Xborder

Dose Form Treatment->DoseForm

Code Treatment->DoseForm->Code ISO XXXXXX

Name Treatment->DoseForm->Name Local / XBorder ISO XXXXXX

Quantity to administer Treatment->QtyToAdminister Local / Xborder

Indication Treatment->Indication Local / Xborder

Route Treatment->Route Local / Xborder ISO 11239

Substitution handling Treatment->SubstHandling Local

Active ingredient Product->ActiveIngredient Local / Xborder ISO 11238

Name Product->ActiveIngredient->Name Local / XBorder

Code Product->ActiveIngredient->Code Local / Xborder

Exemption: brand name Product->BrandName Local None

Strength Product->Strength Local / Xborder

Pharmaceutical Dose Form Product->PharmaceuticalDoseForm Local / Xborder ISO 11239

Number of units per intake Treatment->UnitsPerintake Local / Xborder

Frequency of intakes Treatment->Frequency Local / Xborder

Duration of treatment Treatment->TreatmentDuration Local / Xborder

Treatment Start Treatment->TreatmentStart Local / Xborder

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PHC-34 643796

Use of cross-border identifiers in the clinical cycle

In clinical artefacts (prescriptions, dispense reports, messages), a product is specified or identified in a way that it is understood by the receiving party.

How to make this cross-border?


PHC-34 643796

OpenMedicine WP2 meeting, Dublin, Sept 29, 2015

18

PhP

MP

Package

• ... • GTIN • ...

• Substances • Strength • Dose Form • ...

• Country • MAH • MPCode • ...

PhP

MP

Package

• ... • GTIN • ...

• Substances • Strength • Dose Form • ...

• Country • MAH • MPCode • ...

Identifier = PhPID

Identifier = PhPID

Identifier= MPID

Identifier=PCID Identifier=PCID

Identifier=MPID

Country A Country B

Cross-border

PHC-34 643796

Prescription in openMedicine

OpenMedicine WP2 meeting, Dublin, Sept 29, 2015

19

1. Physician 2. Patient

3. Product 4. Substitution 5. Posology 6. Indications 7. ...

PhP

PCID

Cluster

Can refer to...

Prescription

• Substitution Rules

• ...

PhPID • Substance • Strength • Ref. Strength • Pharm. Dose Form

MPID • MAH • Brand Name • MAN • Country

???

PHC-34 643796

Joint work with HL7

Implementation guidance for existing standards – Use of HL7 in cross-border prescription

Validated for EU scope, but preparing truly global prescription exchange

Implementation guide ISO IDMP, HL7

Address problem of Medicinal Product information exchange

Current or upcoming standards? ISO MPD Compliance MPID-Compliant prescriptions, Admins, Dispenses, PSS for Product Catalog Exchange / Consult

V2 (CH17) + (FHIR) + V3

PHC-34 643796

Example – what we want to achieve

Assuming the need for sharing product characteristics across systems, openMedicine and HL7 can enable:

Physician prescribes (MPID) medication in country A Patient goes to country B for dispensing, where product is not available

Both country A prescriber and country B dispenser receive characteristics of their “local” products.

Pharmacist does not have the product but thanks to the common identifier in the wallet, he can substitute by selecting another product that has the same PhPID. The pharmacist queries the national or regional catalog for the characteristics of the prescribed product), to double-check that the substitution is according to the treatment (e.g. confirm that indication, is the same, and that the excipients are compatible with the patient’s allergies).


hl7 open medicine jan 2016

Healthcare