1. 13 September 2018
PHPID and its enabler role for identification of medicines for e-prescription
Towards a trans-atlantic solution to univocally identify medicinal products
USA-EU Workshop
21 June 2016
FDA White Oak Campus
Presented by Paolo Alcini on 20 June 2016
Head of Data Standardisation and Analytics
European Medicines Agency

2. Medicinal product information (MPID/PCID) - ISO 11615
The ISO IDMP standards establish definitions and concepts and describe data elements and their structural relationships that are required for the unique identification of:
Medicinal product information (MPID/PCID) - ISO 11615
Pharmaceutical product information (PhPID) - ISO 11616
Substances (Substance ID) - ISO 11238
Pharmaceutical dose forms, units of presentation, routes of administration and packaging - ISO 11239
Units of measurement (UCUM) - ISO 11240
ISO IDMP standards apply to both authorised and developmental medicinal products for Human use

3. Med. Product Classification
The solution (…continue):
ISO IDMP: Data model
Undesirable Effects
Country / Language
Med. Product Classification
Interactions
Interactant
Medicinal Product Name
Regulated Document
Contra-indications
Population Specifics
Version
Clinical Particulars
Therapeutic Indication
Other Therapy Specifics
Medicinal Product
PhPID Set
Manufacturer / Organisation
Pharmaceutical Product
Manufacturing Operation
Pharm. Product Characteristics
NCA
Route of Administration
Marketing Authorisation
Package Medicinal Product
Substance
Strength
Ingredients
Specified Substance
Preference Strength
MAH
Batch Identifier
Package Item (Container)
Marketing Status
Self Life / Storage
Manufactured Item
Periodic Safety Update Report
Data Carrier Identifier
Other Characteristics
Mark. Author. Procedure
Package (component)
Device
Physical Characteristics
Device Nomenclature
Mark. Auth. Application
Device Batch Identification

4. What is this medicine made of? For which indications is it used?
13 September 2018
The challenge:
One of the challenges in cross-border healthcare is how medicines can be safely and univocally identified on the other side of the border. In ePrescribing, the major difficulty is to ensure the univocal identification of a medicinal product for human use prescribed in country A (home country), and the dispensation of the same or equivalent product by a community pharmacist in a foreign country B
What is this medicine made of?
For which indications is it used?
A medicinal product containing:
500mg таблетка парацетамол

5. 13 September 2018
The solution:
A solution to this problem was initially proposed by EMA and now, it is being further developed and formally verified by the European openMedicine ( medicine.eu) project and by all the experts from EU and US that are working on it.
Open Medicines is leveraging synergies and dialog between experts involved in several fora:
ISO TC215/WG6
HL7 experts
Domain experts (e.g. physicians, pharmacists, etc)
Involvement of Regulatory Authorities- e.g. Ireland, Spain, FDA and EMA*
* EMA is the chair of the openMedicine Expert Council

6. The solution (…continue):
13 September 2018
The solution (…continue):
Pharmaceutical Product Identification Elements (PhPID)
Pharmaceutical Product Identification (PhPID) based on the following subset of elements:
Active Substance(s)/Specified Substance(s)
Strength(s) - Strength units (units of measurement and/or unit of presentation)
Reference Substance (active moiety)
Reference Strength (basis of strength per active moiety)
Administrable Dose Form
Medical device: when it is a component of a medicinal product
Adjuvants

7. The solution (…continue):
13 September 2018
The solution (…continue):
PhPID Active Substance Stratum
PhPID_SUB_L1  Active Substance(s)
PhPID_ SUB _L2  Active Substance(s)+Strength
PhPID_ SUB _L3  Active Substance(s) + Administrable Dose Form
PhPID_ SUB _L4  Active Substance(s)+ Strength + Administrable Dose Form
PhPID_SUB_L1paracetamol
PhPID_SUB_L2 paracetamol, 1000 mg
PhPID_ SUB _L3
paracetamol, tablet
PhPID_ SUB _L4
paracetamol, 1000 mg, tablet

8. The solution (…continue):
13 September 2018
The solution (…continue):
How does this work?
Common data structure
Centrally defined attribute values
Use of common data values across borders:
When an identifier is specified in one place, it can be mapped to the common structure in any other country.
Note:
Country A: Home Country
Country B: Foreign Country
The prescribed package ID (PCID) can be identified in country B, but the package/product is not available there. However, it can be mapped to the underlying PhPID, which in turn can be mapped to medicinal products available.

9. The solution (…continue):
1. EMA governs the data structure and values
The solution (…continue):
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
3. Every clinical system uses the centrally defined values
ClinicalDB
ClinicalDB
6. …Because & assuming the other national and
Clinical DBs are in sync with the EMA SPOR 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..
Indication
Patient weight
ePresc
(/other)
MPID
Allow Substit.
5. …which allows the product attributes
and identifier to be recognized anywhere...
...
...
Dispense
PCID

10. openMedicine: Proof of Concept
Country A (Prescribing)
Medicinal products are specified in the usual way (i.e. no altering of clinical or legal practices)
Because the national product DB is maintained centrally, any product can be “mapped” to its IDMP attributes
The electronic prescription contains the “usual” national information, but the values used are IDMP-compliant and therefore can be understood and translated into any language and alphabet.

11. Country B (Dispensing)
13 September 2018
Country B (Dispensing)
Dispenser application also shows the synchronisation with the central DB
The prescription information is understood since it is a common data structure.
The codes can be used to present information in the receiver’s language.
Even if the prescribed product is not available, it can be mapped to common identifiers.
And the corresponding product be found, enabling the dispenser to make the most informed choice- an exact match or an equivalent.

12. Thank you for your attention
13 September 2018
Thank you for your attention
Further information
Paolo Alcini
Head of Data Standardisation and Analytics
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0) Facsimile +44 (0)
Follow us on @EMA_News