1. I need a medicine while abroad…
Contact:
is a project funded by the in the context of

2. I get a presciption…
Country A
(place of prescribing)

3. I go abroad…
Country B
(place of dispensing)

4. Dispensed medicine dataset
Let’s match product data…that’s easy
COUNTRY A
COUNTRY B
Prescription dataset
Dispensed medicine dataset
Prescribing Provider
Dispensing Provider
Prescription
Dispensed medicine
Patient
Prescriber
Dispenser
Source: Christian Hay, ‘ISO, the IDMP Standards and Their Impact in the Community’

5. Medicine prescription methods (1)
By brand name…
In Country A (FR), a prescriber issues a prescription specifying the following:
ABASAGLAR 100 unités/ml solution injectable en stylo prérempli
This corresponds to several products in country A, with different pack sizes.
In country B, a different or no product might exist…
Invented Name/INN
Strength
Pharmaceutical dose form
Route of administration
Content
Pack size
MA(EU) Number
Abasaglar
100 units/ml
Solution for injection in a pre filled pen
SC (IMPLICIT)
3 ml
1x3ml
EU/1/14/944/005
SC (IMPLICIT)
2x3ml
EU/1/14/944/006
5x3ml
EU/1/14/944/007
10x3ml
EU/1/14/944/008

6. Medicine prescription methods (2)
By generic name or INN (international nonproprietary name)…
In country A, Spain, a doctor issues a prescription specifying the following:
BETAMETASONA 50mcg, suspension acuosa nasal, 1 frasco
This information is sent to country B, France, where the following products can be found in the French drug database:
BECLO-RHINO
HUMEX RHUME
BECLOMETHASONE URGO…

7. INN Prescribing Specifying the physicians’ choice with 3 elements
If needed specifying additional elements (minor specifications)
Fillling a structured signatura (presentation unit / posology / route of administration /
Duration of therapy (and hence quantity to be delivered)
2 type of exemptions : No SWITCH and NO INN
Active substance
Virtual Therapeutic Moiety VTM
Form/Route
Ontology
Strength
Source: Robert Vander Stichele, MD, PhD, Ghent University

8. First step : Defining the INN group

9. Second step : Deciding on additional specifications in function of what is possible

10. Third step : Finalizing the instructions for patient and pharmacist

11. Data matching between countries is cumbersome and not always successful…
Different prescription methods: by brand name, by generic name, by INN (international nonproprietary name)…
Non-compatible identifiers
Product identifiers and identifying attributes are understood nationally
Different substitution aspects
No harmonized approach
No common European database

12. e-health reality…
It works well within one country but in a cross-border setting, it causes confusion…
Source:

13. How standards prolifearte…
Source:

14. OpenMed concept
Development if a concept to enable cross-border e-prescribing and e-dispensing by means of:
A common data model (to be intended as a set of coherent conceptual, logical and implementable data models )
A common nomenclature (a set of code and identification systems) for the unambiguous definition, description, and identification of medicinal/ pharmaceutical products throughout Europe and globally

15. Activities of the European Medicine Agency based on ISO IDMP
Possible solution
Activities of the European Medicine Agency based on ISO IDMP
IDMP

16. EMA activities
Process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)
Standardization of data formats outside EU and to improve the common format
Legal basis: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council

17. Using IDMP standards in the clinical context

18. The solution (…continue):
12 September 2018
The solution (…continue):
Standard attributes
ISO IDMP defines a set of attributes and their relations to identify different levels of products.
It harmonizes the concepts and the data elements (attributes)
It is ready for adoption and manufacturers are adhering.
How does this help in cross-border identification?
PhP
Identifier = PhPID
Substances
Strength
Dose Form
...
“Is
produced
as” MP
Identifier= MPID
Country
MAH
MPCode
...
“Is
packaged
as”
Package
Identifier=PCID
...
PCID (GTIN)

19. Prescription of an abstract (virtual) medication
Common level is
usually PhPID
PhP
Identifier = PhPID
PhP
Identifier = PhPID
Product is further
specified, thanks to
standardized attributes MP
Identifier= MPID MP
Identifier= MPID
Product is specified
at any of the IDMP
levels (...)
Package
Identifier=PCID
Package
Identifier=PCID

20. End-to-end view EU Home Country Foreign Country .
1. EMA governs the data structure and values
End-to-end view
EMA SPOR DB
ID (PhPID)
Substance
Strength
Dose form
...
ID (MPID)
Brand Name
MAH Number
Indications
ID (PCID)
Qty / Pack
Presentation EU
2. Each country has a DB in sync with EMA
7. finally, any ADE or information about use is also compatible with IDMP and can be reused in clinical settings or by the regulators
National DB
National DB
Home Country
Foreign Country .
ClinicalDB
ClinicalDB
3. Every clinical system uses the centrally defined values
6. …Because & assuming the other national and
Clinical DBs are in sync with the EMA IDMP DB
4. Every time a medication is specified,
it is done according to the IDMP attributes…
Substance
Product ID
PhPID
MPID
Product Data
Other x
PCID
PhPID
Posology
Other (Cluster, National ID..
5. …which allows the product attributes
and identifier to be recognized anywhere...
Indication
Patient weight
ePresc
(/other)
MPID
Allow Substit.
...
...
Dispense
PCID

21. Identification levels enable data matching
Pharmaceutical product: acetylsalicylic acid, tablets, 500 mg
Pharmaceutical product identifier – PhPID – no common identifier yet
Medicinal product: Aspirin PRO, tablets, 500 mg
Medicinal product identifier – MPID – no common identifier yet
Medicinal product in a packaging: Aspirin PRO, tablets, 500 mg, in a pack of 8
Packaging identifier – PCID – can be a GTIN

22. Selection of e-health standards
Source: own material based on ITU-T Technology Watch report [2012]

23. Summary Increasing role of standards within healthcare services
Increasing number of applications using interoperable standards
Fitting into a global approach towards harmonization of solutions
And at the same time….
Constant need to promote interoperable standards
Constant need to demonstrate how existing standards fit into current and coming legislative requirements – there is NO need to invent new standards

24. Thank you
Tel