I need a medicine while abroad… Contact: Anna.Gawronska-Blaszczyk@ilim.poznan.pl www.open-medicine.eu is a project funded by the in the context of

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

I go abroad… Country B (place of dispensing)

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’

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

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…

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

First step : Defining the INN group

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

Third step : Finalizing the instructions for patient and pharmacist

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

e-health reality… It works well within one country but in a cross-border setting, it causes confusion… Source: http://hangingtogether.org/?p=4613

How standards prolifearte… Source: https://pl.pinterest.com/pin/274649277251838918/

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

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

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

Using IDMP standards in the clinical context

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)

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

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

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

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

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

Thank you Anna.Gawronska-Blaszczyk@ilim.poznan.pl Tel. +48 887870262