XML in the pharmaceutical Industry:
STRUCTURED PRODUCT LABELLING
Structured Product Labeling (SPL) is for describing the content of prescription drug labeling in an XML document. An SPL document consists of an XML (extensible markup language) document that contains the text and images in an approved prescription package
The SPL XML file is converted to a human-readable format by the use of a set of files collectively referred to as a stylesheet. The stylesheet displays the information in the XML file in a consistent format for viewing. Currently, the standard stylesheet supports display in webbrowsers only.
The Structured Product Labeling initiative is intended to transform pharmaceutical regulatory filings from the traditional text document paradigm into a true digital information paradigm. SPLuses XML in documents containing narrative text and complex data inorderto: define structure for rendering as per federal regulations, control semantics for data &knowledge management,and identify component versions for life cycle management .
SPL is intended to facilitate the timely distribution of authoritative drug information to the health care community and to consumers, initially for human interpretation, and ultimately for machine processing.
Labeling Life Cycle
. Improve patient safety through accessible productinformation
. Support initiatives to improve patient care bybetter management of health care information
- Electronic prescribing
- Decision support systems
. Meet mandates to provide standards for druginformation (labeling, terminology, code sets)
- Medicare Modernization Act
- Electronic Health Record
The XML schema is generated
programmatically from the RMIM such that:the root class is an element containing,
. each class attribute as an element . each relationship as an element that
contains the target class
as an element and so on.(with some additional hand 'tweaking')
Benefits Of SPL
XML Schema Generation
The XML schema is generated programmatically from the RMIM such that:the root class is an element containing,
. each class attribute as an element
. each relationship as an element that
contains the target class as an element and so on.(with some additional hand 'tweaking')
FIGURE OF ZOLPIDEM TARTRATE: An example of a file that goes to FOOD AND DRUG ADMINISTRATION (FDA)
Also a list of profles about the tablet that goes to FDA is indexed below
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