Downstream Use of Structured Product LabelingThomas R. Bizzaro, R.Ph.Vice President, Health policy and Industry Relations

SPL/DailyMed Jamboree Workshop

Who is First DataBank?• A subsidiary of Hearst Corporation • Provide drug databases that are used within information systems that

touch every aspect of healthcare.• With our development partners, First DataBank helps reduce the

incidence of medication errors and adverse drug events• First DataBank supports thousands of drug knowledge base

implementations−pharmacy dispensing −claims processing −computerized physician order entry (CPOE)−electronic health records, electronic medical records−electronic prescribing−medication reconciliation−disease management and −electronic medication administration records (EMAR)

Data Acquisition

• FDA approved manufacturer prescribing information

• OTC monographs• Drug facts labeling• Secondary and tertiary references• AHFS, Harriett Lane, Briggs

• Primary medical literature−300+ journals, Beers list, treatment guidelines

Why are we using SPL documents?• Single point of truth• To benefit clinicians and patients• To improve internal efficiencies using

electronic documents and automation when possible

• To compare First DataBank information against other sources for accuracy and comprehensiveness

What content is in active use?

• The entire Structured Product Label as viewed by staff using a browser

• Computer-aided drug product physical description and characteristic extraction and editing

• Computer-aided inactive ingredient and other foreign substance or “impurity”

• Extensive use of xml structure• Using text in “electronic format”

A Thank You

• Great increase in the number of SPLs available

• Numerous discrepancies corrected• Data updates made whenever a substantive

change is made to labeling• FDA outreach to manufacturers/distributors

Future Possibilities

• Programmatic review of content changes•Timely triggers

• Improved access to content to support timely update to clinical knowledge bases

• Consistent codification to support Clinical Decision Support

Future Possibilities, continued

• Codification of medical conditions•Indications•Disease Contraindications

• Support Interoperability•National Standard Vocabularies−RxNorm−SNOMED CT−LOINC

Conclusion

The value currently provided through electronic Structured Product Labeling is huge.

The value and benefit to healthcare providers and patients that can be achieved with the inclusion of additional content and codification of content is exciting to contemplate.