Draft Recommendations & Roadmap openMedicine Workshop Washington, June 21th , 2016

openMedicine US-EU Workshop 2016 Patient has the right to get the for him most appropriate medicinal treatment when being abroad this includes that: medicinal products, if available on that market, can be identified as identical, similar and/or equivalent to his usual products those medicinal products can be dispensed (same or similar rules of dispensing / substitution applicable) openMedicine US-EU Workshop 2016

openMedicine Workshop IHIC 2016 What do we need? an identifier, globally uniqe language independent country independent medicinal product name independent authorisation independent authorisation holder independent or a set of identifying attributes (active) substance(s) Strength dosage form route of administration expressed by using “using standards” openMedicine Workshop IHIC 2016

ISO Identification of Medicinal Products The cornerstone of the ISO standards for the Identification of Medicinal Products Substance Dose Form Strength Regulated Medicinal Product Pharmaceutical Product Pharmaceutical Dose Form Standard Terminology 11615: Regional 11616: Derived 11238: G-SRS & SMS Upcoming milestone information will be used to inform the Action Plan 11240:UCUM 11239:EDQM

openMedicine Workshop IHIC 2016 What do we have? Lifecycle of a medicine (from substance to package) Potential for 6 different identifiers 1 concept does not have an identifier 2 of them are “cross frontiers” Substance G-SRS Pharmaceutical Product Medicinal Product MPName MPID Package PCID European Market Authorisation Number EU-MAN National Market Authorisation Number PL-MAN openMedicine Workshop IHIC 2016

The solution (…continue): 27 June 2018 The solution (…continue): FDA algorithm (beta) for PhPID Generation Substance 1 Substance 2 Substance n Dose form Substance ID Strength Substance ID Strength Alphabetic order of UNII code ・・・ Input NCI thesaurus code UNII code Normalized unit UNII code Normalized unit MD5 digestion MD5 is a widely used algorithm for hash function. PhPID code (example) 128 bit (16 byte) number which, in hexadecimal presentation, is 32 digits long formatted in groups of 8-4-4-4-12  digits separated by hyphens -Globally Unique Identifier (GUID) Output

Recommendations (initial) … Target audience : to enable univocal identification European Commission: is about “cross border” EMA … as “coordinator” EMA … as “authentic source” EMA & FDA… issuing the unique identifier JAseHN… definition of the “guidelines” National regulatory authorities, as partners of EMA Ministry to issue laws and regulations based on the guidelines …Target audience: to get it operational Drug database providers EHR / Prescription system vendors Dispensing applications Patient summary managing systems openMedicine Workshop IHIC 2016

Recommendations regarding central services EMA, FDA, Regulatory authorities,.. Everything starts with the decision of EMA/FDA to initiate the process Make the EU_MAN available… unique identifier based on EU level authorisation sufficient as such within Europe Assign systematically a PhPID (first) to all new drugs ? distribution policy and tool developments The article 57 §2 database should be converted as soon as possible into a structured and as much as possible coded, based on the IDMP suite Develop viewer interface Develop export to the drug database providers openMedicine Workshop IHIC 2016

Recommendations regarding central services European Commission Issue adapted guidelines for ePrescription, eDispensing and Patient Summaries Initiate harmonisation of rules regarding substitution Regulatory authorities Assign centrally the EU_MAN or assign a national PL_MAN … involved in assigning the PhPID openMedicine Workshop IHIC 2016

Recommendations regarding ePrescription Functional integration of the PhPID in ePrescribing Either effective integration into the prescription message Or through centralised mappings services Drug databases Make the PhPID available at the point of prescription Make other ID’s available too HL7, IHE and analogues Enable more than one identifier in a prescription message EHR applications Enable storage of several identifiers Include at least the PhPID in a patient summary openMedicine Workshop IHIC 2016

Recommendations regarding the patient summary Distinguish the concept “medication” and “prescription history “ Include the PhPID in the patinet summary Use the package ID in the prescription history Use the MPID to identify a medicinal product in a medication list openMedicine Workshop IHIC 2016