1. Inaugural Expert Council Meeting at E.M.A. London June 25, 2015
Limits and options
Inaugural Expert Council Meeting
at E.M.A.
London June 25, 2015

2. “Don’t raise or try to solve problems that aren’t yours”
Very precise 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…

3. Purpose is…. NOT to NOR how 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
WELL to address the identification of the product in each of these applications and for each kind of product

4. 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

5. Products: From Substance to Cluster
Cluster : no identifier << possible?
Pharmaceutical class
Medicinal Product Package
Package identification NATIONAL
Extended identification: each instance of a medicinal product package
Medicinal Product
Marketing authorisation holder
NO / not always an identifier
Pharmaceutical product
Manufacturer => batch / Batchnumber
NO identifier. No name. Description of a composition
Manufacturer => batch => batch number
Substance => Ingredient => active ingredient OR excipient
Ingredient Identifier <= ATC e.g.

6. Prescribing & Dispensing & e-
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

7. Processing a MPP prescription nationally
MPP Prescr. National
MPP-ID
Full Description (100 tabl of Inderal 40mg by AstraZeneca)
Name / Brandname
Number of product units per package
Dosage Form
Strength
Route of Administration

8. Processing cross-border
MPP Prescr. National C
MPP-ID
Full Description (100 tabl of Inderal 40mg by AstraZeneca)
Name / Brandname
Number of product units per package
Dosage Form
Strength
Route of Administration

9. Actual Scenario
If a medicinal product available with the same description (name, strength, dosage form…)
=> deliver, but still a risk
If important differences, go for the active ingredient
consulting an international drug database
using service providers, type epSOS
Once active ingredient(s) defined
select – if available - an equivalent
using usual ocal drug database
No active ingredient retrieved : stop

10. openMedicine scenario
openMedicine prescriptions
are electronic
contains (always) the PhPID (hidden)
PhPID should be
globally unique
linked to a “full identification”
manufacturer / license holder / reseller independent
Pharmacy system
reads the PhPID code
select a product with the same PhPID from the national drugdatabase
If no equivalent product available / accepted
return to standard scenario

11. About Substitution Status praesens: you can help us !
Different levels:
No substitution
Only package level
At medicinal product level
At pharmaceutical product level
At ingredient level
At pharmacological class level
At different pharmacological class level
Kind of substitution
should be documented (in dispensing message)
should be regulated across Europe

12. Expected results
A common datamodel and a common vocabulary based on standards:
Several ISO/CEN standards
Older ENV12610 MPID
Available ISO/CEN IDMP > suite of standards
Industry standards GS1
Are not always purely identification
Not all of them are “clinical use” oriented
A report on substitution
Economic versus care based substitution
Levels of substitution: brand name, pharmaceutical product, active substance, therapeutic class

13. Expected results
A roadmap for full implementation of the conclusions and recommendations of this project
To realise a full and open exchange of medication and/or medicinal product related information in the union.
Transatlantic and global coordination of the practical issues and recommendations, in the context of the eHealth Memorandum of Understanding