|
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
Purpose
. 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 Benefits
Of SPL
The benefits of SPL accrue to the medical care community and to patients and consumers: timely, accurate information means better treatment decisions with fewer errors; machine-processable drug description means more accurate dispensing; and, additional semantics for indications and dosage, contraindications and side effects will support knowledge based e-prescribing. 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
 TOP
If your interest in our software is for use within your organization or if you are looking to resell our solution. contact us... |
