“The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.” (1) “Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information.
Structured Product Labeling documents include a header and body. The header includes information about the document such as the type of product, author and versioning. The body of the document includes product information in both structured text and data element formats. The United States Food and Drug Administration (FDA) uses SPL documents to exchange information covering a growing number of product related topics.” (2)
“With the exception of the billing unit data in the NDC SPL Data Elements (NSDE) document, this file is generated from SPL documents sent to FDA for inclusion in the FDA Online Label Repository at labels.fda.gov. The information in the SPL documents is for products in final marketed form. … Inclusion of information in the NSDE does not indicate that FDA has verified the information provided. The content of the information is the responsibility of the author of the SPL document. The author is designated in the SPL document and may be either a manufacturer, including a repackager or relabeler, or, for products subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed. Assignment of a National Drug Code (NDC) or National Health Related Item Code (NHRIC) does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC or NHRIC number is misleading and constitutes misbranding. Neither inclusion in the NSDE nor possession of an NDC number is a determination that a product is a drug as defined by the FD&C Act, nor does either denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.” (3)
“On October 31, 2005, FDA stated that SPL in extensible markup language (XML) format is the only electronic format for content of labeling that CDER can process, review, and archive. This also applied to annual report submissions. Currently, the content of labeling must be submitted to CBER in electronic format (21 CFR § 601.14; see also guidance for industry: Providing Regulatory Submissions in Electronic Format-Content of Labeling). CBER soon will begin recommending that content of labeling be submitted in SPL. SPL is also a key component of Facts@FDA, which makes regulated product information in SPL format publicly available on the National Library of Medicine’s DailyMed Web site and on the FDA Data Standards Council Web site (“Data Standards Web site”). A Health Level Seven (HL7) standard, SPL is used to make possible the electronic exchange of the content of labeling and other regulated product information using the extensible markup language (XML). Specifically, the SPL standard enables the inclusion of indexing elements, which are machine-readable tags that can be added to product labeling to enable users to rapidly search and sort product information.
Indexing the content of labeling with SPL will greatly enhance users’ ability to automatically search and sort product information. The American healthcare community (e.g., federal healthcare agencies, healthcare providers, healthcare professionals, and industry) is working toward the creation of a fully-automated health information system. Eventually, patients, healthcare professionals, and providers will have electronic health records, electronic prescribing systems, and an array of clinical decision support systems and tools at their disposal. Being able to electronically access labeling information and to search and sort that information is an important step toward the creation of a fully automated health information exchange system. Currently, health information suppliers take the information from the content of product labeling to populate databases that are used in clinics and hospitals to help prevent prescribing errors. In the past, much of this information was input by hand. Since October 31, 2005, FDA has been making labeling information for prescription drugs available free of charge on the Internet through the use of SPL. Full-text search of the content of labeling has obvious limitations, however. For example, users searching for hepatotoxicity will miss labelings that use the term liver toxicity. The addition of indexing elements, chosen from standards adopted for use in the healthcare setting, will address this problem.
Once FDA has indexed the content of labeling using SPL, health information suppliers will be able to package indexed information about a product and make it available to healthcare professionals and others through health information systems, such as clinical decision support tools and electronic prescribing systems. In addition, the prescription drug information that FDA already has made available on the Internet will be much more useful, because the indexing elements will enhance user ability to quickly access, search, and analyze the labeling information needed to make critical healthcare decisions. SPL indexing elements are not intended to be used by clinicians in lieu of the full prescribing information, nor do they serve as the basis for product promotional activities. Having consistently and accurately indexed content of labeling also will greatly enhance the safe use of medical products. In July 2006, the Institute of Medicine of the National Academy of Sciences estimated that more than 1.5 million people annually are injured due to medication errors. The cost of treating hospital-based medication errors alone is conservatively estimated at more than $3.5 billion annually, and this cost does not include estimates for lost wages and lost productivity.
One source of many errors is prescribing errors, which can result in avoidable adverse drug reactions. For instance, if a patient with asthma is taken to the hospital in an emergency situation for an unrelated physical injury, the SPL indexing elements would enable the hospital to use its computer system to quickly identify all drugs contraindicated in patients with asthma and treat the patient accordingly. Among other benefits, the SPL indexing elements also could enable the hospital’s computer system to ensure that medications prescribed by the hospital to treat the patient’s injury do not adversely interact with other medications that the patient is taking to treat his or her asthma. In short, the SPL indexing elements, when coupled with other computer technologies, will provide patients and healthcare providers with better and more timely access to important healthcare information.
Finally, indexing the content of labeling directly supports FDA’s mission, because this effort will help Americans “get the accurate, science-based information they need to use medicines … to improve their health.” Indexing also addresses a recommendation in the Institute of Medicine’s 2006 report on drug safety, which identified the need for improved communication between FDA and the public about drug safety and efficacy information.10 SPL indexing will greatly facilitate this communication by helping create a more robust nationwide system for promoting the safe and effective use of drugs.”(4)
1. US Food and Drug Administration, F.D.A. (2016). FDA.gov. Retrieved 15 April, 2016.
2. USDHHS et al. (2016). Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. (Version 1 Revision 201601140739 ed.). Retrieved 15 April, 2016.
3. US Food and Drug Administration, F.D.A. (2016). FDA.gov. Retrieved 15 April, 2016.
4. Us Department of Health and Human Services, U.S.D.H.H.S. (2008). Guidance for Industry Indexing Structured Product Labeling . (2nd ed.). US: Food and Drug Administration.