Structured Product Labeling Overview

Structured Product Labeling Overview SPL/DailyMed Jamboree - October 2013 Lonnie Smith U.S. Food and Drug Administration Overview

Structured Product Labeling (SPL) Overview Exchange of SPL Data Indexing SPL Overview Other SPL-related topics SPL Overview SPL Standard

HL7 health and regulatory data international standard Adopted by FDA Exchange of product and facility information FDA initiative to improve patient safety through better access to product information Components of Product SPL

Content of Labeling Product Data Elements Product Name Dosage Form Route of Administration

Ingredient (active/inactive/adjuvant) DEA Schedule Product characteristics (color, shape, size, etc) - Packaging - Marketing Information (category, status, start and end dates) Representative samples of carton/container labels Identity of distributor and manufacturer (may not be disclosed) of product SPLIMAGE SPL Implementation Highlights

Exchange of SPL Data SPL Data Received for Entities Located in Over 80 Countries Owners/operators of drug establishments around the globe which commercially

market drug products in the US register sites in SPL format. SPL files are submitted for drug products manufactured at these facilities. Exchanging SPL Data DailyMed

FDA-to-NLM - Daily transmissions of up-todate product information received from drug companies MOU (FDA/NLM) NLM makes all SPL files available via download Types of SPL Product Data Currently Exchanged

Drug Products Human Rx Drugs Approved & Unapproved Rx drugs Unapproved medical gases Unapproved homeopathic Human OTC Drugs OTC monograph final OTC monograph not final OTC homeopathic

Animal Rx drugs Approved Rx Unapproved Rx Animal OTC Drugs Other Indexing (pharmacologic class & billing unit) Medical device (content of labeling) (Voluntary submissions only)

SPL Data Flow Consumer Access to Up-to-Date Product Information Access to same package insert info available to healthcare professionals Can review SPL data while awaiting filling of prescription. Updated medication guides,

patient package inserts, etc Access to updated drug facts labels for OTC drug products Indexing SPL Overview Indexing SPL Indexed clinical data (e.g. pharmacologic class, indications) Indexing SPL files - generated by FDA (No need to alter

companies product SPL files to index them.) Inserted machine readable tags not in printed content of labeling Allows users to rapidly search and sort information Supports automated health information systems electronic health records, electronic prescribing, clinical decision support systems Pharmacologic Class Indexing SPL Pharm Class Indexing

SPL Active moiety UNII Active moiety Name Physiologic Effect & NUI

Mechnism of Action & NUI Chemical Structure & NUI Established Pharmacologic Class & NUI Product SPL

Active moiety UNII Product Names Product Type

Dosage Form Active Ingredient Name Strength of Active Ingredient Basis of Strength DEA Schedule Route of Adminstration Marketing Category Content of labeling text sections (e.g. 12.1 Mechanism of Action) Application Number Distributor's Name

Billing Unit Indexing SPL Billing Unit Indexing SPL NDC Package Code Billing Unit (e.g. mL) Product SPL

NDC Package Code Product Names Product Type Dosage Form Active Ingredient Name Strength of Active Ingredient Basis of Strength DEA Schedule Route of Adminstration

Marketing Category Application Number (if applicable) Distributor's Name Other SPL-related Topics Amount of Product SPL Files on DailyMed Dec. 2010 Oct. 2013 Lets Not Forget About the Animals In 2013, significant

increase in Animal Drugs Product SPL Data October 2012: 2,505 NDC Package Codes October 2013: 4,253 NDC Package Codes Collaboration = SPL Success Stay Informed

FDA Data Standards Council website listserv http://www.fda.gov/ForIndustry/DataStandards/default.htm SPL-related Questions SPL e-mail account ([email protected]) Thank You