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

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

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

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

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 (http://www.open- 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

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

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

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.

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

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.

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.

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)20 3660 7168 Facsimile +44 (0)20 3660 5555 E-mail paolo.alcini@ema.europa.eu Follow us on @EMA_News