FDA Update

of 63

Please download to get full document.

View again

All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
PDF
63 pages
0 downs
4 views
Share
Description
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
Transcript
FDA UpdateRandy Levin, MD and William A. Hess, CAPT USPHSHL7 16th Annual Working Group MeetingBaltimore, MDOctober 2002FDA UpdateNew Ingredient DictionaryPharmaceutical Dosage FormsE2BM Data ElementsLabeling EffortNDCFDA Update
  • New Ingredient Dictionary
  • History
  • Need
  • Collaboration
  • Design
  • Non-structures
  • FDA UpdateNew Ingredient Dictionary
  • History
  • Original Ingredient Dictionary
  • two tables
  • no structures (WLN)
  • no processes
  • non-random identifier
  • mostly drugs, some biologics
  • FDA UpdateNew Ingredient Dictionary
  • Need
  • searchable structures
  • describe processes (vaccines)
  • randomly assigned unique identifier
  • drugs, biologics, foods, natural products, devices
  • FDA UpdateNew Ingredient Dictionary
  • Collaboration
  • FDA
  • NLM
  • HL7
  • NCI
  • Others
  • FDA UpdateNew 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
  • FDA UpdateNew 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.
  • FDA UpdateNew Ingredient Dictionary
  • Design Data Model
  • LogoRegister StructureRegister MixtureSearchPlease enter search criteriaStructureZoomMDL NumberBD NumberNameSearchStructureMDLNumBDNumTypeName A8VIERA3F 0002346AA Structure Neomorphine8C9KSKL22 0002391AA Structure PseudomorphineGK934KF1S 0002528AA Mixture Conjugated EstrogensRecords 6 through 10 of 19 << PreviousNext >>FDA UpdateNew Ingredient DictionaryScreenDesignFDA UpdateNew Ingredient Dictionary
  • Non-structures
  • Gelatin
  • Vaccines
  • Plants (e.g., oregano)
  • FDA UpdateNew Ingredient Dictionary
  • Non-structures
  • VSWG being formed
  • Mostly FDA
  • Advisors from Other Organizations
  • Ground-rule development
  • FDA UpdateNew Ingredient Dictionary
  • Questions and Comments
  • FDA Update
  • Pharmaceutical Dosage Forms
  • Initial HL7 terms
  • Australian and U.S. collaboration
  • Ordering
  • Definitions
  • FDA Update
  • E2BM Data Elements
  • Data Elements for the Transmission of
  • Individual Case Safety Reports
  • International Conference on Harmonisation
  • 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)
  • FDA Update
  • Labeling Effort
  • Bar-coded Products
  • Hand-held Bar-code Scanner
  • Viewpad
  • Reformatted labels (8.5x11)
  • FDA UpdateLabeling EffortFDA UpdateLabeling EffortFDA Update
  • National Drug Code(NDC)
  • Background
  • Problems
  • Sufficiency
  • Possible Solutions
  • FDA UpdateNational Drug Code (NDC)BackgroundFDA UpdateNational 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:MedicareFDA UpdateNational 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
  • FDA UpdateNational Drug Code (NDC)FDA UpdateNational Drug Code (NDC)ProblemsFDA UpdateNational 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
  • FDA UpdateNational 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.
  • FDA UpdateNational Drug Code (NDC)Thelabeler code isassigned by the FDA when a person whoowns or operates any establishmentregisterstheir establishment.4- 4 - 25- 3 - 25- 4 - 1FDA UpdateNational 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.
  • FDA UpdateNational 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 - 1FDA UpdateNational 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.
  • FDA UpdateNational Drug Code (NDC)
  • Problem 3: Package Code
  • As with the product code, the package code is not controlled.
  • FDA UpdateNational 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 - 1FDA UpdateNational 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.
  • FDA UpdateNational 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.
  • FDA UpdateNational 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 01234-5678-9012345-678-90 (5-3-2 configuration)becomes 12345-0678-9012345-6789-0 (5-4-1 configuration)becomes 12345-6789-00FDA UpdateNational Drug Code (NDC)...and then remove the hyphens, we get...012345678901234506789012345678900FDA UpdateNational 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
  • FDA UpdateNational 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)FDA UpdateNational 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.
  • FDA UpdateNational 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.
  • FDA UpdateNational 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.
  • FDA UpdateNational 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.FDA UpdateNational Drug Code (NDC)SufficiencyThe NDC, to be a robust identifier for packaged products, should include the following features... FDA UpdateNational Drug Code (NDC)
  • Unique identifier – each NDC should identify only one package product
  • FDA UpdateNational Drug Code (NDC)
  • Comprehensive – there should be one NDC for each packaged product marketed legally marketed in the US
  • FDA UpdateNational Drug Code (NDC)
  • Unambiguous – the NDC should represent only a single concept
  • FDA UpdateNational Drug Code (NDC)
  • Permanence - the NDC should be associated with the same packaged product indefinitely
  • FDA UpdateNational Drug Code (NDC)
  • Non semantic identifier (Meaningless concept identifier, nonsense codes) - the NDC should not be hierarchical allowing for later relocation and multiple classification
  • FDA UpdateNational Drug Code (NDC)
  • Centrally assigned- the NDC should be assigned by a central authority to enforce rules and eliminate invalid codes
  • FDA UpdateNational Drug Code (NDC)
  • Publication and distribution by central authority – a complete and up to date list of all valid NDC should be published and freely distributed to all users
  • FDA UpdateNational Drug Code (NDC)Non proprietary – the NDC should be free for all usersFDA UpdateNational Drug Code (NDC)Timely assignment – a new NDC should be available in a timely manner as not to unreasonably slow the movement of products to the marketFDA UpdateNational Drug Code (NDC)
  • Automated management – the assignment and maintenance of the NDC should be automated to reduce costs and improve efficiency
  • FDA UpdateNational Drug Code (NDC)
  • Works with bar codes – the NDC should work with current bar code technology
  • FDA UpdateNational Drug Code (NDC)
  • Longevity – there should be sufficient codes to allow the NDC to be used in its current state for many years
  • FDA UpdateNational Drug Code (NDC)Possible solutionsFDA UpdateNational Drug Code (NDC)Code format
  • Change to a non semantic, unambiguous, standardized code.
  • Maintain current 10 digits allowing NDC to continue to fit into current bar codes and potential future international bar codes systems.
  • Numeric codes alone allow up to 10 billion codes
  • FDA UpdateNational Drug Code (NDC)NDC assignment
  • NDC assigned by FDA as the central authority to oversee that only valid products are assigned codes
  • Assign NDC to products when listed to ensure a complete list of NDC for all marketed packaged products
  • Use automated systems with quality controls to allow timely assignment of standardized codes
  • NDC permanence assured by never deleting codes and not allowing a new code to be assigned to the same product.
  • FDA UpdateNational Drug Code (NDC)Additional codes
  • Create codes for ingredients, clinical drug, and product to fulfill needs not adequately met by the NDC
  • FDA UpdateNational Drug Code (NDC)Distribution
  • NDC freely distributed in FDA/NLM system associated with other useful medication codes and information including: ingredient, product, RxNorm, imprint codes and labeling.
  • FDA UpdateNational Drug Code (NDC)Questions and CommentsFDA UpdateNational Drug Code (NDC)The End
    Related Search
    We Need Your Support
    Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

    Thanks to everyone for your continued support.

    No, Thanks