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FDA Update

FDA Update. Randy Levin, MD and William A. Hess, CAPT USPHS HL7 16th Annual Working Group Meeting Baltimore, MD October 2002. FDA Update. New Ingredient Dictionary Pharmaceutical Dosage Forms E2BM Data Elements Labeling Effort NDC. FDA Update. New Ingredient Dictionary History Need

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FDA Update

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  1. FDA Update Randy Levin, MD and William A. Hess, CAPT USPHS HL7 16th Annual Working Group Meeting Baltimore, MD October 2002

  2. FDA Update New Ingredient Dictionary Pharmaceutical Dosage Forms E2BM Data Elements Labeling Effort NDC

  3. FDA Update • New Ingredient Dictionary • History • Need • Collaboration • Design • Non-structures

  4. FDA Update New Ingredient Dictionary • History • Original Ingredient Dictionary • two tables • no structures (WLN) • no processes • non-random identifier • mostly drugs, some biologics

  5. FDA Update New Ingredient Dictionary • Need • searchable structures • describe processes (vaccines) • randomly assigned unique identifier • drugs, biologics, foods, natural products, devices

  6. FDA Update New Ingredient Dictionary • Collaboration • FDA • NLM • HL7 • NCI • Others

  7. FDA Update New Ingredient Dictionary • Design Architecture • ·Platform: Active Server Pages (ASP) running on Microsoft Internet Information Server (IIS) • · Scripting language: JavaScript, for special processing and navigation • · Database: A standard RCG chemical database, set up using MDL tools, with fields allocated for needed extra data (see Data Model, below). This database runs on an Oracle 8.1.7.1 platform. • · Database access: ActiveX Data Objects (ADO) • · MDL Software: • ISIS/Direct 2.0, for access to stored structures using SQL commands • ChimePro 2.6, for visual rendering of molecular structures • ISIS/Draw 2.4, for creating and editing molecular structures • Autonom 2000 TT, for generating IUPAC names • · Other Software: Visual Basic 6.0 run time DLLs, for Autonom support • Browser: Microsoft Internet Explorer 5.x

  8. FDA Update New Ingredient Dictionary • Design Data Model • ·Structure: A binary field containing the chemical structure, in MDL standard molecule format. Structures will be represented in two dimensions. • · MDLNum: An alphanumeric string that will identify each unique structure in the database. It should have at least 9 characters, and should be generated non-sequentially, such that two consecutively-generated numbers are not related. • · BDNum: An alphanumeric identifier that will link each compound to the associated chemical in CDER's current Ingredient Dictionary. This field may be blank. A BDNum may be associated with more than one MDLNum. • · Name: A text field, of 240 characters, that will contain the chemical name. • · OR Group: An integer field that is associated with each structure in a mixture. If two or more structures in a mixture have the same OR Group number, at least one of them is present in the mixture.

  9. FDA Update New Ingredient Dictionary • Design Data Model

  10. Logo Register Structure Register Mixture Search Please enter search criteria Structure Zoom MDL Number BD Number Name Search StructureMDLNumBDNumTypeName A8VIERA3F 0002346AA Structure Neomorphine 8C9KSKL22 0002391AA Structure Pseudomorphine GK934KF1S 0002528AA Mixture Conjugated Estrogens Records 6 through 10 of 19 << PreviousNext >> FDA Update New Ingredient Dictionary Screen Design

  11. FDA Update New Ingredient Dictionary • Non-structures • Gelatin • Vaccines • Plants (e.g., oregano)

  12. FDA Update New Ingredient Dictionary • Non-structures • VSWG being formed • Mostly FDA • Advisors from Other Organizations • Ground-rule development

  13. FDA Update New Ingredient Dictionary • Questions and Comments

  14. FDA Update • Pharmaceutical Dosage Forms • Initial HL7 terms • Australian and U.S. collaboration • Ordering • Definitions

  15. FDA Update • E2BM Data Elements • Data Elements for the Transmission of • Individual Case Safety Reports • International Conference on Harmonisation

  16. FDA Update • E2BM Data Elements • Seriousness criteria (death, life threatening, etc) • Qualification (physician, pharmacist, etc) • Study Type (clinical trials, etc) • Sender type (Pharmaceutical Company, Health Professional, etc) • Receiver Type (similar to above) • Patient Age Group (Neonate, Infant, etc) • Outcome (Recovered/Resolved, Fatal, etc) • Characterization of Drug Role (Suspect, Interacting, etc) • Actions Taken with Drug (Dose Reduced, Drug Withdrawn, etc)

  17. FDA Update • Labeling Effort • Bar-coded Products • Hand-held Bar-code Scanner • Viewpad • Reformatted labels (8.5x11)

  18. FDA Update Labeling Effort

  19. FDA Update Labeling Effort

  20. FDA Update • National Drug Code(NDC) • Background • Problems • Sufficiency • Possible Solutions

  21. FDA Update National Drug Code (NDC) Background

  22. FDA Update National Drug Code (NDC) • The NDC was originally established as a voluntary essential part of out-of-hospital reimbursement program under Medicare in the late1960’s. Original Audience:Medicare

  23. FDA Update National Drug Code (NDC) • The NDC has expanded to include a number of additional functions • These functions are beyond the original purpose of the NDC • Significant deficiencies for the effectiveness of the NDC as an identifier even for the packaged product • Current processes for creating and maintaining the NDC is imperfect

  24. FDA Update National Drug Code (NDC)

  25. FDA Update National Drug Code (NDC) Problems

  26. FDA Update National Drug Code (NDC) • Basic Problems with the NDC as a robust identifier • NDC consists of three different “codes” separated by hyphens • NDC format design allows companies to independently assign NDC • The lack of control leads to reliability problems

  27. FDA Update National Drug Code (NDC) • Problem 1: Labeler Code • Companies could have more than one labeler code. • When companies change, such as through a merger or split, the labeler code does not necessarily change.

  28. FDA Update National Drug Code (NDC) Thelabeler code isassigned by the FDA when a person whoowns or operates any establishmentregisterstheir establishment. 4- 4 - 25- 3 - 25- 4 - 1

  29. FDA Update National Drug Code (NDC) • Problem 2: Product Code • Product code is not controlled. • More than one product code can be assigned to the same drug formulation.

  30. FDA Update National Drug Code (NDC) The product code assigned by the person who owns or operates any establishment. Productcodes have either 3 or 4 digits. 4 - 4 - 25 - 3 - 25 - 4 - 1

  31. FDA Update National Drug Code (NDC) • Even within the same company, a single product code can represent two different drug formulation because the company may have two different labeler codes. • A product code should not be relied on as a unique identifier for a drug formulation even with a within a single company or a single labeler code.

  32. FDA Update National Drug Code (NDC) • Problem 3: Package Code • As with the product code, the package code is not controlled.

  33. FDA Update National Drug Code (NDC) The package code is also assigned by the person who owns or operates any establishment. Package codes have either 1 or 2 digits. . 4 - 4 - 25 - 3 - 25 - 4 - 1

  34. FDA Update National Drug Code (NDC) Problem 4: NDC lacks a standardized form • The NDC is a standard but is not standardized. • It consists of three codes separated by hyphens for a total of 10 digits. • Because of differences in the length of the three codes, the NDC can be in one of three formats: • 5-4-1, 5-3-2 or 4-4-2.

  35. FDA Update National Drug Code (NDC) • Frequently the NDC is stored in a “normalized” 11 digit format of 5-4-2 by padding the “short” code with an extra zero. • This changes the actual number if the hyphens are removed such as for use in bar coding.

  36. FDA Update National Drug Code (NDC) For example, if we ‘pad’ the short code, so that we always have a 5-4-2 configuration, then: 1234-5678-90 (4-4-2 configuration) becomes 01234-5678-90 12345-678-90 (5-3-2 configuration) becomes 12345-0678-90 12345-6789-0 (5-4-1 configuration) becomes 12345-6789-00

  37. FDA Update National Drug Code (NDC) ...and then remove the hyphens, we get... 01234567890 12345067890 12345678900

  38. FDA Update National Drug Code (NDC) Problem 5: NDC is not a unique identifier for bar codes • NDC hyphens cannot be removed without potentially introducing redundant codes. • NDC relies on the separation of the three codes to maintain its uniqueness

  39. FDA Update National Drug Code (NDC) Each 10 digit number can have up to three NDC codes. For example, 1234567890 represents: 1234-5678-90 (4-4-2 configuration) 12345-678-90 (5-3-2 configuration) 12345-6789-0 (5-4-1 configuration)

  40. FDA Update National Drug Code (NDC) Problem 6: An NDC can be reused • The labeler code can be reused after a firm has been out of business for at least 5 years. • The product code for a discontinued product can be reused 5 years after the expiration date or after the last shipment, if no expiration date. • This means the NDC lacks permanence and is not unique for a specific package product.

  41. FDA Update National Drug Code (NDC) Problem 7: Lack of a complete, up to date valid list • The FDA does not have an up to date, or complete, list of all NDC used on packaged products. • Since the companies assign their own NDC, the FDA must rely on the companies to tell them when they have assigned a new number.

  42. FDA Update National Drug Code (NDC) • A company might not inform the FDA of a new NDC for months, if at all, after it is being used. • Most people who use the NDC receive the list of codes from third parties and not from the FDA. This results in productsbeing included that are not legally marketed drugs.

  43. FDA Update National Drug Code (NDC) This demonstrates that while the individual codes in the NDC appears to have meaning, the controls on these individual codes are not sufficient to be reliable.

  44. FDA Update National Drug Code (NDC) Sufficiency The NDC, to be a robust identifier for packaged products, should include the following features...

  45. FDA Update National Drug Code (NDC) • Unique identifier – each NDC should identify only one package product

  46. FDA Update National Drug Code (NDC) • Comprehensive – there should be one NDC for each packaged product marketed legally marketed in the US

  47. FDA Update National Drug Code (NDC) • Unambiguous – the NDC should represent only a single concept

  48. FDA Update National Drug Code (NDC) • Permanence - the NDC should be associated with the same packaged product indefinitely

  49. FDA Update National Drug Code (NDC) • Non semantic identifier (Meaningless concept identifier, nonsense codes) - the NDC should not be hierarchical allowing for later relocation and multiple classification

  50. FDA Update National Drug Code (NDC) • Centrally assigned- the NDC should be assigned by a central authority to enforce rules and eliminate invalid codes

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