Pharmaceutical and Medical Packaging News
Magazine
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Originally Published PMPN November 2005
Regulatory Focus
Firms Prepare for XML Standards
by David Vaczek, Senior Editor
FDA’s Structured Product Labeling initiative is changing label-content
management.
FDA’s initiative adopting Clinical Document Architecture based on extensible markup language (XML) for managing and archiving drug labeling and other content hit a milestone last month. As of October 31, pharmaceutical companies have to submit their package insert (PI) information in the Structured Product Labeling (SPL) format.
The SPL requirement is just the first stage of many expected FDA XML-standard requirements for content submissions, as the agency converts to an XML-based environment. Over the next few years, it is expected that all submissions—from research to clinical trial reports to voluminous new drug applications (NDAs)—will have to be submitted in eCTD (Electronic Common Technical Document) formats.
In an April 2005 guidance document, which can be viewed at www.fda.gov/cder/guidance/6719fnl.htm, FDA noted that recommendations from Institute of Medicine and mandates in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 “have created a new role for electronic labeling information.”
One of the advantages of SPL (over the PDF format that FDA previously used) is that it will make exchange of labeling changes more efficient. Only the sections or data elements that are changed would require checking, FDA notes. Comparison of text by section and of specific drug information data elements can be automated.
SPL also supports health information technology initiatives for improving patient care.
The XML effort backs the creation of an up-to-date authoritative electronic repository of healthcare information. Content will be housed at the National Library of Medicine.
SPL submissions will support the creation of an electronic health record (EHR), electronic prescribing, and the Daily Med program. SPL is an ANSI-approved standard (ANSI/HL7 SPL, R1.0–2004) developed by Health Level Seven (HL7), the ANSI-accredited standards development organization.
FDA’s conversion to the XML standard for processing, reviewing, and archiving information has broad implications for manufacturers, healthcare professionals, and end-user consumers.
“One of the greatest benefits of XML is that it is format and systems neutral. [A manufacturer] can generate paper and electronic documents from the same source files,” says Dan Dube, director, product marketing, of Innodata Isogen, a content services company. “And then that information can be provided to users in the format most convenient for them.”
“XML, and more specifically SPL, can be leveraged to reduce costs, increase content accuracy, and streamline processes across the enterprise through content reuse and the ability to create multiple outputs from a single source of labeling content,” adds Joe Jenkins of Parametric Technology Corp. (PTC). “Once in XML, content can manifest itself in an SPL file, in PDF format, in HTML for product Web sites, in promotional materials, and in packaging and labeling software.”
Doctors or pharmacists could research proprietary databases via the Web, accessing content that would be rendered in HTML. Consumers searching for drug advice through sites such as WebMD, or at HMO proprietary databases, could receive specific content, and be assured that it is up-to-date. Since the SPL format is metadata rich—highly structured and indexed—users can get information more tailored to their needs. Instead of flipping between PDF files, a user, for example, might obtain side-by-side summaries of specific drug information on multiple drugs.
Some users are already reaping the pluses of XML in their internal document management. “The top pharmaceutical manufacturers have recognized the benefits of moving to an XML-based environment, and have adopted enterprise content management (ECM) systems,” says Dube.
Programs such as EMC Documentum by EMC Corp. and PTC’s Arbortext Structured Product Labeling software support XML modular authoring where component sections of a document are treated as quasiindependent units. The Arbortext solution converts content from Word and other documents into XML in reusable modules for meeting FDA’s rules and for publishing PIs, prescribing information, labels, product Web sites, and promotional materials.
Companies produce an authoritative single source of information that can be duplicated through all documents. “Rather than storing a complete document, you are storing chunks of information,” says Dube.
Most small- to mid-sized drug companies have turned to data conversion companies for rendering their PDF files into SPL to meet FDA’s deadline. “These companies have taken a band-aid approach. This will help them meet the letter of the law, but they have to understand that eCTD is coming, and that sooner or later everything will be in XML. [Going forward], their processes will be much more inefficient and costly,” says Dube.
“Companies may also be concerned about sending labeling information outside their organizations before FDA approval, especially for new compounds coming to market,” says Jenkins. “An XML solution keeps processes in-house for content control. This mandate is the impetus to move to XML.”
XML’s flexibility as a format will be critical for doing business in Europe where new standards and trends, such as telemedicine, are taking off. “The beauty of having all your content in XML is that it can be rendered into the Product Information Management (PIM) standard,” Dube notes. The European Agency for the Evaluation of Medical Products (EMEA) is adopting PIM for labeling of drugs and medical devices across Europe.
Companies will also need software for translating content to other languages. Idiom Technologies offers WorldServer, software that addresses the global content life cycle of information as it is managed and translated.
Companies will need to “manage content in a flexible and systematic manner by relying on the capabilities of the online environment for organizing, storing, and sharing information,” says Geoffrey Bock, principal, Bock & Co. “But they must keep the end-users foremost in mind, as consumers increasingly go to e-health portals for critical care information.”
“You need to create one authenticated source of information that can then be distributed worldwide, so end-users get accurate information directly from the pharmaceutical company. At the end of the day, you are improving the quality of the customer experience,” Bock says.
Copyright ©2005 Pharmaceutical & Medical Packaging News
