Home Use Medical Device Electronic Labeling - Structured Product Labeling Device Labeling Public Workshop - April 2013 Lonnie Smith Policy Analyst U.S. FDA Data Standards Council
Overview Home Use Medical Device elabeling Pilot Exchange of SPL Data Accessing SPL Data Via Mobile Devices
Home Use Medical Device elabeling Pilot
Home Use Medical Device elabeling Pilot Federal Register: FDA 2010 N 0229 Timeframe: October 2010 August 2011 Pilot participants Baxter Hospira Innovative Technologies KCI NxStage
SPL Standard HL7 health and regulatory data international standard Adopted by FDA Exchange of product and facility information Current use at FDA: Initiative to improve patient safety through better access to product information Drug product information (Rx and OTC human and animal drug products) Drug establishment registration Indexed clinical data (e.g. pharmacologic class, indications) Inserted machine readable tags not in printed content of labeling Allows users to rapidly search and sort information Support automated health information systems Electronic health records, electronic prescribing, clinical decision support systems Medical device labels voluntary submissions
Components Components of SPL Files With Labeling Information Content of labeling (e.g. package inserts, drug facts, instructions for use) Product data elements Images (e.g. graphs, chemical structures)
Creating SPL Files SPL implementation & step-by-step guides published by FDA. Non-proprietary (Not Microsoft, Apple, etc ) Controlled terminology (e.g. section headers) Stylesheet renders content via web or clinical decision support tools No XML Coding Experience Required Software: Commercially available tools/vendors (over 30) FDA-generated software
Example of Voluntary Submission of a Device SPL File Some device manufacturers/distributors are already VOLUNTARILY submitting device SPL files. Files are posted on FDA s Labels.fda.gov website V-Go TM is an example of a device SPL file recently submitted to FDA.
Stylesheet/Code View of Indications & Usage Section
Stylesheet/Code View of Warnings Section
Exchanging SPL Data
Exchanging SPL Data FDA NLM Industry Innovators Repackers
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 Others Medical device (content of labeling) (Voluntary submissions only)
Data Sharing CMS NSDE File Rx Norm for e-prescribing Patients Industry FDA NLM Physicians Nurses FDA Online Label Repository Healthcare Info Suppliers Educational & Research Institutions
Accessing SPL Data Via Mobile Devices
Access to Up-to-Date Product Information Your medical device labels in a format usable on mobile devices Disaster relief areas access to up to date labels via cell phones Healthcare professionals and patients have access to same electronic labeling
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
DailyMed Mobile NLM s version of their DailyMed website optimized for mobile devices
DailyMed Mobile: Content of Labeling Mobile version of DailyMed permits expansion of certain sections of labeling instead of all.
DailyMed Mobile Image of Container Label Permits users to view updated representative samples of carton/container label
DailyMed Mobile Structured Product Data Elements
DailyMed Mobile: Product Image Companies may now voluntarily provide images of their solid oral dosage form products via SPL files. Identification of products by consumers or poison control centers.
Other SPL-related Topics
Collaboration = SPL Success FDA NCPDP CMS NLM Drug Company SPL HL7 RCRIM SPL Tech Team ASHP NCI VA SPL INDUSTRY WG
Accomplishments FDA has been using the SPL standard for over 6 years DailyMed April 2013 over 10 million visits per month Unique SPL documents posted on DailyMed April 2012 over 49,000
Stay Informed FDA Data Standards Council website listserv http://www.fda.gov/forindustry/datastandards /default.htm
SPL-related Questions SPL e-mail account (spl@fda.hhs.gov)
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