An SPL label has three basic parts:
- a header, with general information about the label and product
- the sections that divide the label into blocks of text, much as the headings on a paper label do
- the individual data elements about the product—what the active ingredient is, how it is supplied, etc.
The SPL system would be useful even if it were only a way for FDA to manage its own records, but the system's greatest use
will come when it is used to disseminate information. When the plan is fully operational, manufacturers will submit labeling
information to FDA in SPL via the Electronic Labeling Information Processing System (ELIPS). (See "Expected SPL Information
Flow,") FDA will review the information, and on a daily basis, export updated information to the National Library of Medicine's
DailyMed system, a repository of information on all US marketed medications. DailyMed will make the data freely available
to health information suppliers such as prescription benefit managers, publishers, and others.
Thanks to the structure supplied by SPL, these information suppliers will be able to use the data in a variety of ways—printing
it in book form, putting it into proprietary databases, displaying it on the web, repackaging it for use on a PDA, or searching
it for facts that support decision making.
The advantages of being able to move data between systems and compile data from multiple sources are clear to FDA, which has
projects under way to use XML for data submission at virtually every stage of clinical development. The initiatives include:
The Standard for Exchange of Nonclinical Data (SEND), a consortium of the industry, contract laboratories, software developers, and FDA, which is developing standards
for data on toxicology, pharmacology, and pharmacokinetics
The Clinical Data Interchange Standards Consortium (CDISC), which is working on data models to manage the flow of clinical trial data all the way from source to regulatory
E2B, a system for reporting adverse events developed by the International Committee on Harmonization (ICH).
The move toward using XML as a vehicle for pharmaceutical information is an international one. At EMEA, the PIM initiative
has been under development for a several years. (See "XML in the EU,") After completion of a two-phase pilot, the final PIM
specification was issued on October 8, 2004.
Like SPL, the PIM specification is based on XML, and it is designed to solve a problem similar to the one SPL attempts to
solve. But PIM is significantly more complex because of its focus on all labeling document types, including the Summary of
Product Characteristics, the Patient Information Leaflet, and primary and secondary container labels. In addition, EMEA requires
labeling information to be submitted in 23 languages, which increases the complexity of PIM's information-management task
Taking the Long View
Obviously the pharmaceutical industry is concerned with converting existing labeling documents into SPL and determining what
the needs are for providing updates. There is an obvious, easy solution: Companies can outsource conversion to XML or purchase
a conversion tool and not concern themselves with management of the content itself. But there are risks in that sort of approach.
For example, companies must consider whether they will inadvertently put themselves in violation of their own electronic record
policies or other 21 CFR Part 11 mandates.
More important, if companies focus only on complying with SPL, they're putting themselves behind the eight ball. XML in the
pharmaceutical industry is a reality. It is a requirement for doing business that, in fact, provides new opportunities for
improving and streamlining business processes—even in areas of the business that do not have regulatory drivers forcing change
in the organization. (See "XML Across the Business,")
Companies must implement solutions that not only comply with SPL but also enable the enterprise to adapt to other initiatives
as they are adopted by the agencies and permit them to enjoy the other benefits of XML.
One approach is to utilize component-based authoring (CBA). CBA is the result of marrying structured content such as XML with
an intelligent content management system (CMS) and offers two critical benefits: