I need a medicine while

Transcription

1 Meeting the global challenge of unique identification of medicinal products I need a medicine while abroad Contact: Anna.Gawronska-Blaszczyk@ilim.poznan.pl is a project funded by the in the context of

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

3 I go abroad Country B (place of dispensing)

4 Let s match product data that s easy Prescription dataset COUNTRY A Prescribing Provider Prescription Dispensed medicine dataset COUNTRY B Dispensing Provider Dispensed medicine Patient Prescriber Dispenser Patient Source: Christian Hay, ISO, the IDMP Standards and Their Impact in the Community PHC

5 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. Invented Name/INN Abasaglar Abasaglar Abasaglar Abasaglar Strength 100 units/ml 100 units/ml 100 units/ml 100 units/ml Pharmaceutical dose form Route of administration Solution for injection in a pre filled pen SC (IMPLICIT) 3 ml 1x3ml Solution for injection in a pre filled pen SC (IMPLICIT) 3 ml 2x3ml Solution for injection in a pre filled pen SC (IMPLICIT) 3 ml 5x3ml Solution for injection in a pre filled pen SC (IMPLICIT) 3 ml 10x3ml Content Pack size MA(EU) Number EU/1/14/944/005 EU/1/14/944/006 EU/1/14/944/007 EU/1/14/944/008 In country B, a different or no product might exist

6 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

7 INN Prescribing Specifying the physicians choice with 3 elements Active substance Virtual Therapeutic Moiety VTM Strength Form/Route Ontology 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 Source: Robert Vander Stichele, MD, PhD, Ghent University

8 First step : Defining the INN group PHC

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

10 Third step : Finalizing the instructions for patient and pharmacist

11 Data matching between countries is cumbersome and not always successful No common European database Non-compatible identifiers No harmonized approach Different prescription methods Product identifiers and identifying attributes are understood nationally Different substitution aspects PHC BUT One common need for a harmonized and standardized approach!

12 e-health reality It works well within one country but in a cross-border setting, it causes confusion Source:

13 How standards prolifearte PHC Source:

14 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

15 openmedicine participants Different classes of involved stakeholders Partners, including NEN,GS1, HL7 Structural expert partners EMA, WHO Uppsala, WHO Geneva, IHTSDO, FDA.. Nominated experts with different roles: Organisations or individuals with specific expertise Healthcare professionals Medicinal product databases editors EHR / prescribing & pharmacy system providers Pharma industry National drug agencies

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

17 EMA activities PHC 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

18 Using IDMP standards in the clinical context PHC See Christian Hay s ppt on this subject

19 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) Identifier = PhPID Is produced as PhP Identifier= MPID MP Substances Strength Dose Form... It is ready for adoption and manufacturers are adhering. Is packaged as Country MAH MPCode... How does this help in cross-border identification? Identifier=PCID Package... PCID (GTIN)...

20 Prescription of an abstract (virtual) medication Identifier = PhPID PhP Common level is usually PhPID Identifier = PhPID PhP Identifier= MPID MP Identifier= MPID MP Product is further specified, thanks to standardized attributes Product is specified at any of the IDMP levels (...) Identifier=PCID Package Identifier=PCID Package

21 EU Product ID Product Data Posology Indication Patient weight Allow Substit EMA governs the data structure and values 2. Each country has a DB in sync with EMA National DB ClinicalDB 3. Every clinical system uses the centrally defined values x Substance PhPID MPID PCID Other (Cluster, National ID.. EMA SPOR DB ID (PhPID) Substance Strength Dose form... ID (MPID) Brand Name MAH Number MAH Number Indications... ID (PCID) Qty / Pack Presentation Every time a medication is specified, it is done according to the IDMP attributes epresc (/other) End-to-end view PhPID MPID PCID National DB ClinicalDB Other Dispense 7. finally, any ADE or information about use is also compatible with IDMP and can be reused in clinical settings or by the regulators 6. Because & assuming the other national and Clinical DBs are in sync with the EMA IDMP DB 5. which allows the product attributes and identifier to be recognized anywhere... Home Country Foreign Country.

22 Identification levels enable data matching PHC 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 GTIN

23 Place of the GS1 standards PHC IDMP FMD Logistics

24 Place of the GS1 standards PHC Source: own material based on ITU-T Technology Watch report [2012]

25 Thank you Tel PHC