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

“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…

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

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

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.

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

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

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

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

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

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

Expected results A common datamodel and a common vocabulary based on standards: Several ISO/CEN standards Older ENV12610 MPID Available ISO/CEN 11615 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

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