Document Conversion Becomes Dress Rehearsal for SPL Conversion
Few external documents are as critical to a pharmaceutical company as product labels. Closely regulated by the FDA and other regulatory agencies, these documents deliver critical information to doctors, pharmacists and patients on drug interactions as well as instructions on how to take the medicine. Faced with increasing requirements to put more information on those packages – as well as customize the inserts for local markets in other countries – pharmaceutical companies have begun looking for ways to automate and streamline the content supply chain for those package inserts.
When one leading pharmaceutical decided to build a more efficient system for generating product labels, they also seized the opportunity to build a system that would ease the process for creating documents that meet the labeling requirements of both U.S. and European agencies. That step required them to create new core data sheets that could deliver different content for each market.
To that end, a key requirement was to devise a solution that would enable them to reuse content for both agencies, while tweaking other sections to meet unique local requirements. For example, interactions with other drugs and instructions for taking the medicine are often similar, they just need to be translated or customized.
The key then was to convert the documents into a format that would allow the documents to share content and be converted into a template that could be customized for local markets. The company had already begun to create core data sheets in XML, which they would use to deliver specific content elements to the final documents that would be created for each market. To take this solution to the next level, the company had engaged a consulting firm that specialized in the pharmaceutical industry. Both parties recognized that they also needed to work with an experienced partner to help them create and deploy the document to document conversion protocols that would ensure the smooth transfer of information. They called on Innodata Isogen to help them go the final mile.
The central document the client was using for this project was the core data sheet, a repository for the various information components that would later be distributed to key audiences. To get the published outputs they wanted, the company had to get that data from these XML source documents. In addition, the project team also had to address the innate complexity of submitting documents to two different regulatory agencies, each with their own unique rules and reporting requirements.
For example, each format has more differences than similarities, although they share several key elements such as the names, chemical composition, empirical formula, and distribution information. Additionally, once either the USPI or SPC was completed, there was a possibility that some of the text would be acceptable to both regulatory agencies. As a result, much of the text from the first document could be extracted as an initial rough draft for the other.
To facilitate the authoring of the labels, Innodata Isogen created stylesheets to render the documents for printing and editing purposes. The project team created transformations that merged the formats into a template that set the stage for the next step in the authoring workflow, which meant that they could now use the core data sheet as the source to convert the documents into the other labeling formats.
In addition, the Innodata Isogen team created Word and PDF renditions from XPL to meet the SPC requirements. The team completed the eight-month project by transforming the XML documents to ease the steps required to add new content to the core data sheet.
For the pharmaceutical company, the streamlined process is driving significant time and cost savings. In addition, while the final documents were converted in Word, the core data sheet is in XML. That means the company has already taken an important step toward meeting the FDA’s decision to require that all product labeling be submitted using structured product labeling, a format based on XML. This head-start could give the company an edge in the months ahead as other drug manufacturers adapt their content management systems to meet the requirements.