1. Draft Recommendations & Roadmap
openMedicine Workshop
Washington, June 21th , 2016

2. openMedicine US-EU Workshop 2016
Patient has the right
to get the for him most appropriate medicinal treatment when being abroad
this includes that:
medicinal products, if available on that market, can be identified as identical, similar and/or equivalent to his usual products
those medicinal products can be dispensed (same or similar rules of dispensing / substitution applicable)
openMedicine US-EU Workshop 2016

3. openMedicine Workshop IHIC 2016
What do we need?
an identifier, globally uniqe
language independent
country independent
medicinal product name independent
authorisation independent
authorisation holder independent
or a set of identifying attributes
(active) substance(s)
Strength
dosage form
route of administration
expressed by using “using standards”
openMedicine Workshop IHIC 2016

4. ISO Identification of Medicinal Products
The cornerstone of the ISO standards for the Identification of Medicinal Products
Substance
Dose Form
Strength
Regulated Medicinal Product
Pharmaceutical Product
Pharmaceutical Dose Form
Standard Terminology
11615: Regional
11616: Derived
11238: G-SRS & SMS
Upcoming milestone information will be used to inform the Action Plan
11240:UCUM
11239:EDQM

5. openMedicine Workshop IHIC 2016
What do we have?
Lifecycle of a medicine (from substance to package)
Potential for 6 different identifiers
1 concept does not have an identifier
2 of them are “cross frontiers”
Substance
G-SRS
Pharmaceutical Product
Medicinal Product
MPName MPID
Package
PCID
European Market Authorisation Number
EU-MAN
National Market
Authorisation Number
PL-MAN
openMedicine Workshop IHIC 2016

6. The solution (…continue):
27 June 2018
The solution (…continue):
FDA algorithm (beta) for PhPID Generation
Substance 1
Substance 2
Substance n
Dose form
Substance ID
Strength
Substance ID
Strength
Alphabetic order of UNII code
・・・
Input
NCI thesaurus code
UNII code
Normalized unit
UNII code
Normalized unit
MD5 digestion
MD5 is a widely used algorithm for hash function.
PhPID code (example)
128 bit (16 byte) number which, in hexadecimal presentation, is 32 digits long formatted in groups of   digits separated by hyphens
-Globally Unique Identifier (GUID)
Output

7. Recommendations (initial)
… Target audience : to enable univocal identification
European Commission: is about “cross border”
EMA … as “coordinator”
EMA … as “authentic source”
EMA & FDA… issuing the unique identifier
JAseHN… definition of the “guidelines”
National regulatory authorities, as partners of EMA
Ministry to issue laws and regulations based on the guidelines
…Target audience: to get it operational
Drug database providers
EHR / Prescription system vendors
Dispensing applications
Patient summary managing systems
openMedicine Workshop IHIC 2016

8. Recommendations regarding central services
EMA, FDA, Regulatory authorities,..
Everything starts with the decision of EMA/FDA to initiate the process
Make the EU_MAN available… unique identifier based on EU level authorisation sufficient as such within Europe
Assign systematically a PhPID
(first) to all new drugs ?
distribution policy and tool developments
The article 57 §2 database should be converted as soon as possible into a structured and as much as possible coded, based on the IDMP suite
Develop viewer interface
Develop export to the drug database providers
openMedicine Workshop IHIC 2016

9. Recommendations regarding central services
European Commission
Issue adapted guidelines for ePrescription, eDispensing and Patient Summaries
Initiate harmonisation of rules regarding substitution
Regulatory authorities
Assign centrally the EU_MAN
or assign a national PL_MAN
… involved in assigning the PhPID
openMedicine Workshop IHIC 2016

10. Recommendations regarding ePrescription
Functional integration of the PhPID in ePrescribing
Either effective integration into the prescription message
Or through centralised mappings services
Drug databases
Make the PhPID available at the point of prescription
Make other ID’s available too
HL7, IHE and analogues
Enable more than one identifier in a prescription message
EHR applications
Enable storage of several identifiers
Include at least the PhPID in a patient summary
openMedicine Workshop IHIC 2016

11. Recommendations regarding the patient summary
Distinguish the concept “medication” and “prescription history “
Include the PhPID in the patinet summary
Use the package ID in the prescription history
Use the MPID to identify a medicinal product in a medication list
openMedicine Workshop IHIC 2016