What role does conditional processing play in tailoring labeling and packaging documentation for different drug formulations, patient populations, and regulatory guidelines?

November 10, 2023
|By Bryan Tipper

Conditional processing in DITA XML plays a pivotal role in tailoring labeling and packaging documentation to meet the specific requirements of different drug formulations, patient populations, and regulatory guidelines. It enables pharmaceutical companies to efficiently manage content variants within a single document structure, ensuring that the right information is delivered to the right audience while complying with various regulatory standards.

Content Variants

DITA allows for the creation of content variants or conditions within a document. These conditions can be based on factors such as drug formulations (e.g., tablets, capsules, injections), patient populations (e.g., adults, children, elderly), or regulatory guidelines from different regions (e.g., FDA, EMA). By applying conditions to specific sections of content, organizations can include or exclude information as needed. For example, dosage instructions for pediatric use can be conditionally included for documents targeting children but omitted for documents intended for adult patients.

Efficient Management

Conditional processing simplifies the management of content variants. Instead of maintaining separate documents for each combination of drug formulation, patient population, and regulatory guideline, organizations can create a single master document that includes all possible variants. Conditions are then applied to control which variant is visible in the final output. This approach streamlines content updates, as changes made to the master document automatically propagate to all variants, reducing the risk of inconsistencies and errors in documentation.

Example:

Here’s an example of how conditional processing can be used in DITA XML:


<topic id="dosage_instructions">
  <title>Dosage Instructions</title>
  <body>
    <section id="adults">
      <title>For Adults</title>
      <p>...

    </section>
    <section id="children">
      <title>For Children</title>
      <p>...

    </section>
  </body>
  <revhistory>
    <revision>
      <revdescription>Added pediatric dosage instructions.</revdescription>
      <date>2023-06-01</date>
      <author>PharmaDocTeam</author>
    </revision>
  </revhistory>
</topic>

<map id="labeling_document">
  <title>Labeling Document</title>
  <topicref href="dosage_instructions.dita#adults" conkeyref="adults_condition" />
  <topicref href="dosage_instructions.dita#children" conkeyref="children_condition" />

In this example, a DITA topic “Dosage Instructions” includes variants for both adults and children. Conditional processing is applied using conkeyref attributes to include the relevant section based on the target audience, allowing for tailored documentation within a single DITA source.