No more PDF: XML-based drug-labeling becoming FDA requirement

New "SPL" drug labeling standard brings many advantages, but could cause start-up pains for pharmaceutical companies. DCLnews reports.

An XML-based format for pharmaceutical labeling promises to make medication safer, but could prove a headache for drug companies. Until now, pharmaceutical firms have submitted their labeling data to the Food and Drug Administration (FDA) in PDF format, generated from Microsoft Word files.

From October 31, however, they will be required to submit label data in Structured Product Labeling (SPL) format. And by the end of 2007 the requirement to submit label information in SPL will extend to all FDA-regulated products, including OTC medications, devices, diagnostics, veterinary medicines - or any product with package information or a package insert.

Series of initiatives

What’s more, Structured Product Labeling is just the first of a series of initiatives by the FDA and the European Agency for the Evaluation of Medical Products (EMEA) designed to take advantage of XML, the increasingly influential computer language that promises to transform the way companies handle data and documentation.

"SPL is one of the FDA's highest priorities," said James Rinaldi, the agency's chief information officer. The new system will also be an important step towards the creation of an electronic prescribing information system, as dictated by the Medicare Modernization Act (MMA).

Getting into compliance

Getting into compliance with SPL, however, requires changes to current documentation processes and is likely to cause some initial difficulties for many pharmaceutical firms.

Firms are dealing with this in many ways, including:

·      Extending their existing systems.

·      Building new systems that will deal with SPL and other XML-based future requirements.

·      Keeping their core process intact for now, and using outside firms to create the SPL from the current input.

Some larger firms are already setting up long-term strategies to meet the requirements of SPL and other new initiatives. Others are using less-invasive procedures like using outside vendors to provide the new output – thus giving the dust chance to settle. This can reduce the risk involved in creating new systems while the full scope of requirements is not yet clear.

Since the additional requirements may take a number of years to clarify some firms may choose to stay with their existing systems, while outsourcing the SPL output requirements for a longer period of time. Smaller companies in the pharmaceutical industry, however, may well see outsourcing as a viable long-term strategy.

Electronic initiative

It all began in late 2003. The FDA announced a ruling requiring the submission of drug labeling in electronic format. Working with Health Level Seven (HL7), a standards development organization, the agency proposed the SPL standard for describing the content of prescription drug labeling in an XML document.

Structured Product Labeling is, in essence, an XML document that contains the text and images from an approved prescription package insert, along with additional information for the machine processing of label content. The SPL is rendered in a web browser using a stylesheet, displaying the information in a consistent format for viewing.

Benefits for everyone

"There are multiple groups who will benefit from the use of this standard," says Dr Randy Levin, director for health and regulatory data standards for the FDA. "The FDA itself will be able to review label changes more quickly than it can currently; 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."

He adds that: "All of 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."

The SPL format is part of the FDA's and the National Library of Medicine's (NLM) DailyMed initiative, which involves storing all pharmaceutical label information at the NLM. This provides a single, easily accessible repository for the data. Health-care providers will then be able to retrieve the information and make it available to patients.

Period of grace

DailyMed was originally scheduled for deployment in June 2004, and pharmaceutical companies would have been required to move to SPL by that date. But technical delays pushed the SPL deployment to October this year.

“This was good news for the pharmaceutical companies involved, as there was originally no grace period planned for the transition,” said Sarah Powell, director of product strategy for a pharmaceutical consulting group "Most of the companies involved have their current labeling in Microsoft Word rendered to PDF for submission to comply with DailyMed," she adds. "Now they must convert Microsoft Word to XML and then add all the meta-data associated with the format."

But most in the industry now agree this is good news as SPL offers many advantages over PDF. These include:

·      Reuse of common sections of content between labels and other relevant documents, such as promotional literature, packaging, web site content, package inserts for different formulations, submissions to regulatory bodies outside the U.S.

·      Exchange of information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.

·      Automated exchange of information between different computer platforms and applications.

·      Delivering labeling content into multiple output formats (such as PDF and HTML) from the same XML source file.

DCLnews editorial