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XML in the pharmaceutical Industry:
 
STRUCTURED PRODUCT LABELLING
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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

        CLINICAL PHARMACOLOGY

1.     Pharmacodynamics

2.     Pharmacokinetics

3.      Controlled Trials Supporting Safety and Efficacy 

 

        INDICATIONS AND USAGE

        CONTRAINDICATIONS

        WARNINGS

        PRECAUTIONS

 

1.     General 

2.     Drug Interactions

3.     Drug/Laboratory Test Interactions

4.     Pregnancy

5.     Labor and delivery:

6.     Nursing mothers

7.     Pediatric use

8.     Geriatric use

 

        ADVERSE REACTIONS

 

1.     Associated with Discontinuation of Treatment

2.     Incidence in Controlled Clinical Trials

3.      Adverse Event Incidence Across the Entire Preapproval  Database

 

        DRUG ABUSE AND DEPENDENCE

        OVERDOSAGE

 

1.     Signs and Symptoms

2.     Recommended Treatment:

3.      Poison Control Center:

 

        DOSAGE AND ADMINISTRATION

        SIDE EFFECTS                           

 

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