How is DITA used for creating documentation on pharmacovigilance, adverse event reporting, and drug safety assessments?

November 10, 2023
|By Bryan Tipper

DITA XML is a valuable tool for creating comprehensive documentation in the pharmaceutical industry, particularly in the critical areas of pharmacovigilance, adverse event reporting, and drug safety assessments. These topics require precise and structured documentation due to the importance of patient safety and regulatory compliance.

Structured Information

DITA XML’s structured authoring capabilities are well-suited for documenting complex processes in pharmacovigilance and adverse event reporting. It allows for the creation of structured topics, maps, and hierarchies, enabling authors to break down complex concepts into manageable pieces. For instance, you can create separate topics for adverse event definitions, reporting procedures, and regulatory requirements, ensuring clarity and organization in your documentation.

Reuse and Consistency

Pharmaceutical companies often deal with overlapping content in different documents, such as safety assessments for multiple drugs. DITA’s content reuse features allow you to efficiently manage this content. By creating reusable topics or elements, you can ensure consistency across documents. For example, if a safety assessment process is common to multiple drugs, you can create a single topic for it and reuse it in various documents, reducing redundancy and the risk of inconsistencies.

Example:

Here’s an example of how DITA XML can be used to structure pharmacovigilance documentation:


<topic id="adverse-event-reporting">
  <title>Adverse Event Reporting</title>
  <body>
    <p>Adverse event reporting is a critical process in pharmacovigilance. This topic provides guidance on how to identify, document, and report adverse events related to our drugs.</p>
    <ul>
      <li><a href="reporting-procedures.dita">Reporting Procedures</a>
      <li><a href="regulatory-requirements.dita">Regulatory Requirements</a>
      <li><a href="common-definitions.dita">Common Definitions</a>
    </ul>
  </body>

In this example, DITA XML helps structure adverse event reporting documentation by breaking it down into topics, allowing for efficient content reuse and consistent documentation practices.