1 / 20

OpenMedicine: Inaugural Expert Council Meeting

OpenMedicine: Inaugural Expert Council Meeting. 25 June 2015 Vada Perkins, FDA. Scope. Unique (ISO, EU, EU-US) identification of a pharmaceutical product dispensed in another country.

davisdonna
Download Presentation

OpenMedicine: Inaugural Expert Council Meeting

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. OpenMedicine: Inaugural Expert Council Meeting 25 June 2015 Vada Perkins, FDA

  2. Scope • Unique (ISO, EU, EU-US) identification of a pharmaceutical product dispensed in another country. • If and when substitution is permitted or required dispensation of an equivalent or similar product in line with national regulations.

  3. By the Numbers… • The global market for e-prescribing will reach $887.8 million in 2019, according to a recent report published by Persistence Market Research. • The market, valued at $250.2 million in 2013, is expected to grow at a 23.5 percent annual compound rate from 2013 to 2019, reaching an estimated value of 887.8 million. • The report reflects similar findings on the increasing uptake of e-prescribing recently indicated by Suresripts, which noted in its most recent progress report last month that its network handled more transactions in 2014 than American Express (6 billion) and PayPal (4.2 billion). Taken from: http://www.healthit.myindustrytracker.com/en/article/105527

  4. By the Numbers… • Office of the National Coordinator for Health IT (US): • U.S. more than 70 percent of physicians e-prescribe, showing  an upward trajectory from 7 percent of docs e-prescribing in 2008, growing to 24 percent in 2011.

  5. Regulatory Data Flow

  6. Regulated Medicinal Product Pharmaceutical Product Substance Substance Substance Substance Substance Strength Strength Strength Strength Strength Standard Terminology Dose Form Dose Form Dose Form Dose Form Pharmaceutical Dose Form ISO Identification of Medicinal Products The cornerstone of the ISO standards for the Identification of Medicinal Products 11615: Regional 11616: Derived 11238: G-SRS & SMS 11240:UCUM 11239:EDQM

  7. Pharmaceutical Product Identification Elements (PhPID) • Pharmaceutical Product Identification (PhPID) based on the following subset of elements that describe the pharmaceutical product: • Substance(s)/Specified Substance(s) • Strength(s) - Strength units (units of measurement and/or unit of presentation) • Reference Strengths (basis of strength) • Administrable Dose Form • Medical device: when it is a component of a medicinal product • Adjuvants

  8. PhPID Strata and Levels • PhPIDs generated utilizing the IDMP substance (ISO 11238), the pharmaceutical dose form/units of presentation (ISO 11239) and units of measurement (11240) standards. • PhPIDs represented within two strata for each pharmaceutical product contained in a medicinal product: • PhPID Active Substance Stratum • PhPID Specified Substance Stratum *PhPID Strata will comprise of 4 different Levels from 1 to 4.

  9. PHPID Active Substance Stratum PhPID_SUB_L1  Substance(s) Term PhPID_ SUB _L2  Substance Term(s) +Strength + reference strength PhPID_ SUB _L3  Substance Term(s) + Administrable Dose Form PhPID_ SUB _L4  Substance(s) Term+ Strength + reference strength+ Administrable Dose Form

  10. PHPID Specified Substance Stratum PhPID_SpSUB_L1Specified Substance(s) Term PhPID_SpSUB_L2 Specified Substance(s) Term+ Strength + reference strength PhPID_SpSUB_L3 Specified Substance(s) Term+ Administrable Dose Form PhPID_SpSUB_L4 Specified Substance(s) Term + Strength + reference strength+ Administrable Dose Form

  11. ISO 11238: Substances/Specified Substances • Substance: • Is defined based on its main, general characteristics • Can have different roles e.g. active, adjuvant, basis of strength, excipient • Specified Substance: • More granular, specific description of a substance e.g. including manufacturing information, purity, grade • Allows for the specification of multiple substances (“Intermediate Products” e.g. AS03 - adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams))

  12. ISO 11239-Dosage Forms/Routes of Administration/Units of Presentation

  13. ISO 11240: Units of Measurement

  14. Medicinal Product MPID Pharmaceutical Product (PhPID) Substance(s) Units of Measurement 11240 Pharmaceutical Dose Form 11239 Reference Strength Specified Substance IDMP Standards for PhPID Generation

  15. ISO Implementation: Global Harmoni(sz)ation • Medicinal Product ID (MPID) • Regional Identification • Pharmaceutical Product ID (PhPID) • IDMP (algorithm) • Based on core elements for identification of medicinal products • Demands harmonization of terminologies/IDs for globally unique identification (internal and external to EU). • Substances • Global Substance Registration System (G-SRS) • EMA/EU-FDA Bilateral (governance) • Units of measurement • Unified Code for Units of Measure (UCUM) • Dosage forms-mapping exercise (ongoing) • European Directorate for the Quality of Medicines (EDQM)

  16. EMA/EU-FDA Substance/Product Data Sharing Concept Establishment of a EU-Network/FDA (IDMP) Joint Scientific/Technical Governance Board(s) for registration and maintenance operations

  17. Paracetamol (aka acetaminophen)

  18. Example: Paracetamol/Acetaminophen • PhPID_SUB_L1 paracetamol • PhPID_SUB_L2 paracetamol, 1000 mg • PhPID_ SUB _L3 paracetamol, tablet • PhPID_ SUB _L4 paracetamol, 1000 mg, tablet • PhPID_SUB_L1 paracetamol (xyz123) • PhPID_SUB_L2 paracetamol, 500 mg • PhPID_ SUB _L3 paracetamol, capsule • PhPID_ SUB _L4 paracetamol, 500 mg, capsule • PhPID_SUB_L1 paracetamolPhPID_SUB_L2 paracetamol, 750 mg • PhPID_ SUB _L3 paracetamol, tablet-film coated • PhPID_ SUB _L4 paracetamol, 750 mg, tablet-film coated

  19. Thank You

More Related