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XML based SPL - FDA drug labeling standard for pharmas makes for safer medication

The FDA's Structured Product Labeling (SPL) initiative promises greater safety and will help pharmaceutical companies better disseminate critical drug information. DCLnews reports.

A new XML-based standard, known as Structured Product Labeling (SPL), has been introduced by the Food and Drug Administration (FDA) to help pharmaceutical companies comply with regulations that came into force in 2003. These require that all labels for prescription, over-the-counter, and veterinary medicines be filed with the FDA in electronic format. The deadline for this is currently set for October 2005.

"There are multiple groups who will benefit from the use of this standard," says Dr Randy Levin, director of health and regulatory standards for the FDA.

The FDA itself will be able to review label changes more quickly than it can now. Drug companies will be able to exchange label information more efficiently, and health information providers will have access to the data in a computer-usable format.

"All these [capabilities] are geared to benefiting the users of the labeling - including the prescriber, dispenser and patient - by promoting patient safety and by making the medication information more accessible," Levin adds.

Single data repository

The SPL format is now an approved ANSI standard. The effort was started in mid 2002 when the FDA approached Health Level Seven (HL7), a pharmaceutical organization, with the idea to develop a standard for drug product labeling based on another HL7 document standard — the Clinical Document Architecture (CDA). The FDA needed the standard to facilitate review of labeling and support the DailyMed initiative, which involves provision of up-to-date drug product labeling through a National Library of Medicine (NLM) database.

Under this initiative, all the pharmaceutical label information will be stored at the NLM, providing a single, easily accessible repository of the data. Healthcare providers could then retrieve this data and make it available to patients.

DailyMed was originally scheduled for launch in June last year and pharmaceutical companies would have been required to move to SPL by that date. Companies have the option of making submissions using SPL, but technical delays have pushed the requirement of SPL back to October of this year.

Despite the reprieve, pharmaceutical firms still face the challenge of converting existing labeling to SPL format. Most of the firms involved have their existing labeling in Microsoft Word, which is turned into PDF for submission. To comply with DailyMed they will need to convert Microsoft Word files to XML and then add the necessary meta-data associated with the format.

Master labeling document

While all this might take time to implement, there are benefits to be gained from the change over. Because SPL is based on XML, it means the content is separate from the formatting. Consequently manufacturers can create one format-independent XML master document, which includes all the labeling information for a given product. From that master document, all of the other labeling documents for that product can be generated and formatted automatically. In other words, the data is created once, but used many times throughout the organization.

Kris Spahr, of the SPL Working Group, believes there is a whole list of benefits to be gained from using XML to create labeling documents.

"XML helps with eliminating redundant data collection used for other submissions," he says. "It also increases efficiency in internal label management, allowing the potential for more reusable product content across the enterprise. Plus it defines a consistent, predictable means of exchanging labeling content."

As well as this, the FDA says SPL enables users to easily search all of its documents for keywords, something that could not readily be done with PDF files.

European initiative

The European equivalent of the FDA – European Agency for the Evaluation of Medicinal Products (EMEA) - also got in on the act when it introduced its Product Information Management (PIM) standard, which is aimed at creating consistent labeling across the region. Like the SPL standard, PIM also relies on XML. Multinational companies, however, expect to incorporate both standards into their business processes.

The FDA is becoming increasingly interested in introducing structured authoring into FDA submissions. Electronic labeling is amongst the first, but others look set to follow.

DCLnews Editorial
March 21st, 2005

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