By Dan Dube, Innodata IsogenManaging product information, always an ongoing challenge for pharmaceutical companies, is about to become even more complicated. The FDA’s decision to mandate Structured Product Labeling (SPL) adds another layer of complexity to a process that already requires pharmaceutical companies to shepherd huge volumes of content through multiple internal and external hurdles for drugs on the path from the research lab to the marketplace.
The FDA plans to complete the regulations, standards, and systems needed to switch labeling content from PDF to SPL, an XML output schema, for prescription drugs by Fall 2005 and for all drugs by 2006. Without question, converting product-labeling documents to an XML output format like SPL represents a major challenge. But at the same time, savvy pharmaceutical companies are not viewing the SPL requirement as just another regulatory burden, but as an opportunity to increase productivity and efficiency.
Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, these companies recognize that implementing XML-based content management systems will enable them to automate and streamline the business processes required to create, manage and distribute all labeling-related content.
But the road to SPL compliance is also filled with potholes that could derail these benefits. I have identified four pitfalls or traps that often plague organizations deploying new content management and publishing systems. Common content supply chain traps typically arise in one of four areas: inefficient business processes, organizational boundaries, technological limitations, and inadequate resource utilization. These issues are often compounded when existing legacy systems are “enhanced” to support minimal SPL compliance without analyzing the entire content supply chain.
Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential while avoiding these pitfalls, will clearly seize a clear competitive advantage and drive significant improvements throughout their organization.
New FDA RequirementsIn late 2003, the FDA published a rule that required the submission of the content of labeling in electronic format for marketing applications for drugs and biologics. Working with interested parties in Health Level Seven (HL7), a standards development organization, the agency adopted a proposed standard called SPL for describing the content of prescription drug labeling in an XML (eXtensible markup language) document.
An SPL document consists of an XML document that contains the text and images in an approved prescription package insert (e.g., the content of labeling), along with additional information for machine processing of label content (e.g., header information and data elements). A set of files collectively referred to as a stylesheet converts the SPL XML file to a human-readable format. The stylesheet displays the information in the XML file in a consistent format for viewing.
SPL offers numerous advantages over PDF, enabling, for example:
• the automated exchange of information among disparate IT platforms, applications and interfaces
• a more efficient exchange of changes to labeling content
• the comparison of text and specific data elements
• the exchange of information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency
• reuse of common components of content between labels and other relevant documents (e.g., promotional literature, packaging, Web site content, package inserts for different formulations, submissions to regulatory bodies outside the U.S.)
• the rendering of labeling content into multiple output formats (e.g., PDF, HTML) from the same XML source file
At a minimum, complying with the SPL initiative will require pharmaceutical companies to:
• Convert the content of all new and current labeling content to XML format
• Submit the narrative content of the labeling and the structured data for the drug listing
• Ensure that product information remains consistent and accurate across all relevant channels
Ultimately, the FDA intends to create a single-source, streamlined flow of consistent and accurate product information from the manufacturer to end users such as health care professionals and members of the public.
The Benefits of an XML-Based Product Information SystemOriginally designed to meet the challenges of large-scale electronic publishing, XML has emerged as an increasingly important means for exchanging a wide variety of data. XML is a simple, application-neutral mark-up language designed to provide information within a structured format and with semantic knowledge. One of its primary benefits is its ability to store any kind of structured document that can be shared between different operating systems. Most important, it also preserves the narrative structure of SPL documents so they can be published in standard presentation outputs like PDF and html that can be read by both humans and machines.
By separating content from the limitations of various formats, XML supports the reuse of the same information in a variety of documents and channels. Pharmaceutical companies can maintain product information in a single source format, thus ensuring that product information remains consistent whether the output is a package insert, packaging, a Web site, marketing material, or a submission to the FDA. For example, a change in product indications[bt1] made in one section, would automatically be published to all appropriate outputs both print and electronic.
Moreover, XML’s uniform formatting and the centralizing of content control it affords, enables companies to search all of their product information more efficiently and use it more effectively in all contexts. One of the major benefits of XML is its ability to support single-source publishing systems, which creates multiple outputs from one source document.
SPL Compliance vs. Streamlined Content Supply ChainAccording to the FDA’s guidance, the SPL standard will apply only to the content of labeling provided with original submissions, supplements, and annual reports for human drug and biologic products. This includes new drug applications (NDAs), abbreviated new drug applications (ANDAs), and most biological license applications (BLAs).
Before moving forward, however, many companies need to consider whether they wish merely to comply with the SPL initiative or take the opportunity to assess the entire business process required to create content for their labeling and documentation systems – what I call the content supply chain. Companies that simply convert documents to XML and then return to business as usual will be managing information in much the same way it was managed prior to SPL, only now with another step in the labeling process. Instead of increasing efficiency, such an approach requires even more time, manpower, and money – a tremendous waste of resources in an industry where speed to market is critical.
Companies that decide to overhaul their entire content supply chain, however, need to adopt a measured, comprehensive approach to ensure that the entire company is poised to exploit and leverage XML throughout the organization. This approach doesn’t always require a massive transformation right at the outset. Rather, a company can embark on the process by taking relatively small, carefully planned steps that enable it to assess various needs, identify opportunities, and convert those opportunities into operational and competitive advantages.
Common pitfallsWhile evaluating content supply chains for our clients, I’ve recognized consistent patterns – areas where potential improvements could help companies dramatically reduce risk during implementation and achieve a significant payback. Many of these areas will need to be addressed as companies move forward to become SPL compliant.
• Using highly skilled people on manually intensive tasks. To achieve maximum efficiency, you need to be sure that your new XML system will enable you to utilize your highly skilled staff and subject matter experts in the areas they are most adept in, such as making sure that writers don’t waste time troubleshooting issues with document formatting.
• Automating existing processes with little change. Careful analysis of your business processes will usually uncover a host of redundant tasks and other inefficiencies. This is the time to streamline and optimize your business processes; it will demonstrate greater value to your user community and greatly increase the chances for a successful production implementation.
• Make sure that departments are not duplicating effort across departments. For example, there may be overlapping content development requirements between labeling preparers and R&D (who usually initiate work requests), Marketing (who need current information when creating sell sheets), and Packaging (who usually need to distill key information from Instructions for Use to meet packaging requirements).
• Be careful you don’t get bogged down by proprietary systems, which would make it difficult to migrate legacy content, metadata, links, and automated workflows into a new system.
• Beware of “standards-based” systems that manage content in proprietary ways. A corollary to the above pitfall; make sure you investigate how a content management system manages linking relationships and reuse between content components. Many systems that purport to be XML-compliant actually use proprietary function calls and API “extensions” to XML that constrain the environment and create a closed architecture. In essence, this establishes a “vendor lock-in” and makes it extremely difficult to migrate to other systems in the future.
• Don’t use tools for something they aren’t designed for, such as using MS-Word for final composition.
• Patchwork integration of systems. One of the key benefits of the SPL initiative is the use of XML as the foundation. Leverage the power of XML to incorporate a standards-based approach for communicating information between disparate systems.
Separately, each of these traps can severely impair an organization’s efforts to build an efficient content supply chain. Collectively, they make it all but impossible. But if pharmaceuticals fail to address them, they will be missing many of the benefits that come with converting their documents to SPL.
About the Author:
Dan Dube is director of business analysis for Innodata Isogen, a leading provider of content supply chain solutions for the information industry. Innodata Isogen (www.innodata-isogen.com) provides business services that help organizations create, manage, use and distribute information more effectively and economically. Innodata Isogen provides outsourced content services and content-related information technology (IT) professional services. Innodata Isogen is headquartered in Hackensack, New Jersey, just outside of New York City. It has two additional solution centers in North America, seven production facilities in Asia (the Philippines, India and Sri Lanka) and a technology and tools development center in India.[bt1]”indications” is the correct word. There are indications (things the drug is for) and contraindications (things you shouldn’t use the drug for or with).