Implementation of the Structured Product Labeling (SPL) initiative in the new animal drug pre-approval environment

The Structured Product Label (SPL) initiative offers a number of advantages versus traditional paper labels including:
  • the drug product label can be associated with electronic medical records systems giving unprecedented access to label information at the point of medical care
  • the ability to include, in a single XML document, information from all parts of the drug label information (including sound files and movie files)
  • users can reference a known up-to-date version of the label maintained at a central (web) location
  • it is possible to streamline label regulation, particularly as concerns validating a label against FDA style standards and business rules.
Adoption of the Structured Product Label initiative by the FDA Center for Veterinary Medicine (FDACVM) presents a number of significant challenges. The SPL was developed and adopted without significant input from veterinary professionals. Although human and veterinary pharmaceutical labels have much in common, terminologies selected as standards for human labels may lack necessary veterinary content. It can also be said that various label sections (e.g., Food Safety Warning Section) are simply not represented by sections defined for human labels. FDACVM's Office of New Animal Drug Evaluation (ONADE) and Office of Surveillance and Compliance (OSC) are each responsible for animal pharmaceutical labels, but their perspectives are different. ONADE sees and evaluates labels as they are being developed. OSC sees and evaluates labels as part of their interaction with the end users of veterinary pharmaceuticals. During their normal regulatory activities, ONADE will evaluate new drug indications and develop new animal classes. OSC will encounter new adverse drug effects and drug interactions.

The most significant challenge for FDACVM is the transition from current systems designed to regulate paper labels to those that support evaluation and maintenance of labels rendered in SPL. One of the major changes will be the expanded use of terminology standards external to FDA to create valid SPL-based labels based on FDA guildelines. It seems clear that FDACVM will require significant modification of its label management infrastructure. FDACVM must either adapt existing systems or develop new ones. In either case, it will be important to manage internal and external terminologies as part of any adequate regulation of SPL-based labels.

The Veterinary Terminology Services Laboratory's (VTSL) approach to this project will begin with a comprehensive assessment of existing ONADE and OSC information management systems and internal terminologies. Internal terminologies will be compared to terminology standards necessary for SPL compliance. Once the review is completed, alternate terminology management strategies will be developed so that the impact on FDACVM systems development can be assessed. VTSL will also provide training for key FDA personnel in the various information technologies employed in the SPL.