Today, when you talk about healthcare organizations, many healthcare services are using digitization to deliver better patient results and to improve patient care. In today’s hectic schedule, managing product information is challenging.
Many sections in the enterprise use product information for different purposes like labeling and product web sites. Each department takes a copy of the content and re-creates it for further use.
Furthermore, you may find several customers of this product information, including academic research centers, and healthcare professionals. They depend on consistent information about drug products, independent of the manner how they would access information.
The ability to have greater control over this product information has led to the development of the standard for product labeling. This standard is termed as Standard Product Labeling and is adopted by the FDA to assist in improving patient’s safety.
What Do You Understand by Structured Product Labeling?
SPL is an HL7 standard
that defines the content of human prescription drug labeling in an XML format. It includes different publishing material that accompanies a drug, such as the prescribing information, which contains detailed information about the drug. It contains both the content of labeling and machine-readable information.
The data elements that it contains include information about the product like dosage forms, packaging quantity, ingredients’ strength, proprietary names, and more. The presentation of the labeling content stored in XML
is done through the use of stylesheets. It is a file that shares the instructions on how to format an XML document. Different sheets can be used with a single XML file to produce different outputs.
The new format of SPL not only allows healthcare professionals to search and access prescribing information but also supports initiatives to improve patient care. It improves the drug labeling review by enabling the FDA to provide access to recent drug information.
Structured Product Labeling consists of two major components. The first component includes tables and figures for the product. Secondly, it contains the machine-readable information that constitutes the drug listing data elements such as dosage forms, appearance, generic names, and other important information.
Requirements and Goals of Structured Product Labeling (SPL)
Several requirements are defined for SPL. For instance, the existing labeling content should be convertible XML format. Consistent product information should be maintained across labels, packages, and promotional outputs.
It ensures human readability and machine processing for labeling content. Additionally, it makes the product labeling information available at any time.
The Importance of Structure Product Labeling
The reason for creating the SPL specification was to make a uniform approach to develop a labeling content. The potential benefits of SPL include the ease of information exchange and allowing the content to be available to all computer systems.
Furthermore, it promotes the use of standard terminology and coding across the content, such as package types and routes of administration. It reduces the amount of product information provided to health authorities.
Reusing the SPL content to generate product information such as promotional materials reduces the risk of non-compliance by the incidence of inconsistent product information.
Development of SPL Specification
The developments around SPL began with the members of the HL7 Regulated Clinical Research Information Management Technical Committee. It comprised of FDA, HL7 representatives, and other experts in the technical and business aspects.
The SPL was made to develop a standard for the exchange of labeling content that would serve the needs of health authorities. The analysis was performed on the labeling content such as USPI’s.
Submission requirements were taken into consideration to check that the standard could accommodate different things like the identification of the inserted and deleted content from the previous submissions. The format of the SPL Document is XML. It consists of three components that comprise an XML document. These components are:
1. Data Model
Data Model sets the rule through which the structure of the document will be enforced. This file is also known as Document Type Definition (DTD). It uses the schema to ensure the validity of the content.
It is an open standard and can be viewed in different text editors. The content is created with the data model and results in a document according to the specific business rules.
The content can be used multiple times for different outputs. XML content is presented using stylesheets. The FDA provides a stylesheet that enables any SPL-compliant document to be viewed in a web browser.
Objectives of SPL Working Group
The objective of the SPL working group is to review changes to the HL7 SPL Model, to sponsor industry webcasts and meetings, to produce revisions to implementation guide in line with schema releases, and to raise industry awareness concerning SPL.
Structured Product Labeling supports the retention of product labeling in the database. Furthermore, it improved the interoperability of the agency systems with clinical information systems.
It targets pharmaceutical companies, biologic drug companies, and producers of bulk drug products. SPL documents are also known as product information, package insert, medicine information, and product label.