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Code Systems and Controlled Vocabulary in SPL

Randy Levin, M.D.
Director for Health and Regulatory Data Standards
Food and Drug Administration

Overview

• Section data elements
• Drug listing data elements
  • Ingredients
  • Product
  • Packaged product
  • Related to product
  • Characteristics
• Highlights data elements 

Section Headings

Section headings (section codes)

• Codes for section heading outlined in 21 CFR 201.57
• Source
  • LOINC (Logical Observation Identifiers Names and Codes)
  • SPL Implementation Guide
  • Regenstrief Institute -- http://www.regenstrief.org/loinc/

Drug Listing Data Elements

• Product
  • Product names
• Description
  • Ingredients
  • Strength
  • Dosage form
  • Route of administration
  • Controlled substance code
  • Appearance
• How supplied
  • Packaged product

Product

• Proprietary name (Medicine name)
  • “Brand” name, Trade name
  • Source -FDA
• Nonproprietary name (generic medicine)
  • “Generic” name, established name
  • Source -FDA
• Product codes (Medicine code)
  • Labeler and product codes from NDC
  • Source –FDA and manufacturer

Ingredients

• Ingredient name (substance name)
  • Established name of ingredient (active and inactive)
  • Source -FDA
• Ingredient code (substance code)
  • Unique Ingredient Identifier
  • Source –FDA Substance Registration System
• Active moiety name (active moiety entity name)
  • Active portion of the active ingredient (without counter ion)
  • Source –FDA
• Active moiety code (active moiety code)
  • Unique Ingredient Identifier (UNII)
  • Source –FDA Substance Registration System (SRS)

Strength and Dosage Form

• Strength units of measure (quantity)
  • Names for potency
  • Source
    • FDA
    • NCI Thesaurus OID and codes
• Dosage form (Medicine form)–Name for the drug dosage form (e.g., tablet)
• Source
  • FDA
  • NCI Thesaurus OID and code

Route of Administration and Controlled Substance

• Labeled route of administration (substance administration)
  • Name and code for the route of administration (e.g., oral)
  • Source
    • FDA
    • NCI Thesaurus OID and code
• Controlled substance classification (policy)
  • Drug Enforcement Administration code for controlled substances
  • Source•DEA•HL7 OID

Appearance

• Imprint code
  • Alphanumeric text on solid dosage forms
    • Include –embossed, debossed, engraved, printed
    • Exclude –trademark letters, marks, symbols, internal and external cut outs
    • Start top left with semi colon to show separation between words or line divides
  • Source
    • Manufacturer
    • HL7 OID

Appearance

• Size
  • Longest single dimension for an oral solid dosage form
    • Length for rectangle, diameter for circle
    • Millimeters rounded to the nearest millimeter
  • Source
    • Manufacturer
    • HL7 OID

Appearance

• Color
  • Predominant color or colors of oral solid dosage form
    • Approximate color, not the specification for the name in the labeling
    • Includes color of the sides of a tablet and halves of capsules
    • Excludes imprints, bands on capsules
    • 12 colors –black, gray, white, red, purple, pink, green, yellow, orange, brown, blue, turquoise
  • Source
    • FDA
    • NCI OID and code

Appearance

• Symbol
  • Mark or symbol on oral solid dosage form for easy and definite recognition
    • Excluded –score lines, letters, numbers, cutouts
    • True for presence, false for absence
  • Source
    • Manufacturer
    • HL7 OID

Appearance

• Scoring
  • The number of equal pieces that an oral solid dosage form can be divided using the score lines
    • For example, one score line creating two equal pieces is given a value of 2
    • No scoring given a value of 1
    • Dosage forms that can only be divided into unequal pieces using score lines are given the value “other”
  • Source
    • Manufacturer
    • HL7 OID

Appearance

• Coating
  • Presence or absence of one or more coatings on an oral dosage form
    • Including sugar, film, enteric coating
    • Excludes coated beads that are inside an uncoated capsule shell
    • True for presence, false for absence
  • Source
    • Manufacturer
    • HL7 OID

Appearance

• Shape–2-D representation of the outside perimeter of a solid dosage form
  • Includes rounding of corners
  • Excludes embossing, scoring, debossing, internal cutouts
  • 19 shapes -bullet, capsule, clover, diamond, double circle, freeform, gear, heptagon, hexagon, octagon, oval, pentagon, rectangle, round, semi circle, square, tear, trapezoid, triangle
• Source
  • FDA
  • NCI OID and code

Packaged Product

• Packaged product code (Packaged medicine code)
  • National Drug Code (NDC = labeler, product and package codes)
  • Source –FDA and manufacturer
• Package type (Packaged medicine form code)
  • Name for the drug packaging (e.g., bottle)
  • Source
    • FDA
    • NCI Thesaurus OID and code

Highlights Data Elements

• Activity
  • Mechanism of action, physiologic effect
• Clinical effects
  • Interactions (drug, food , lab tests)
  • Adverse events
• Indications
• Dosing

Resources -- www.fda.gov/oc/datacouncil/spl.html

• Guidance to Industry: Providing Regulatory Submissions in Electronic Format –Content of Labeling
• SPL Implementation Guide for FDA Content of Labeling Submissions –Release 2a
• FDA SPL Schema for Implementation
• FDA SPL style sheets
• Terminology
• Content of Labeling 92S-0251 docket memo
• Presentations
• Contact information (new drugs, generic drugs, HL7)

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