Module 7
Populating the Indications & Contraindications Sections of a CCDS
The classical labeling structure requires that the continuum of information that describes the target population in positive and/or negative terms is split into a set of criteria to be presented under Indications and a set to be listed in Contraindications. Local labeling is found to be rather inconsistent in allocating items that can be presented either in positive or negative terms. Ideally, CCDS authors should possess a defined set of criteria that direct how to word and allocate information on population subsets for which there is insufficient or no information on effectiveness and/or safety, or that should be excluded from treatment either for reasons of insufficient expected benefit, for reasons of unacceptable risks, or for a combination thereof.
Many CCDS authors perceive the following as particular challenges:
- Finding the best timing for the inclusion of new indications and uses
- Finding an appropriate way of representing indications and uses for which there are no – or no "state-of-the-art" – supporting data available at headquarters
- Finding the best way of designing a CCDS Indications section where the product has a multitude of slightly different approved uses
The solution for such challenges usually lies in a combination of good business rules for the use of the CCDS, corresponding CCDS features, and well-chosen CCDS content and content timing.
Curriculum topics of this module include:
- Possible business rules for the information in the Indications section of a CCDS and its use in the context of periodic safety reporting
- Review of the types of information to be included in the US Indications and Usage section compared with the information in the Indications section of other local labels
- Expressing criteria in positive or negative terms – practical approaches for borderline situations
- When to put information in the Warnings and Precautions section or in sections on specific populations (e.g. Pregnancy section)
- Expressing indications and usage criteria in general terms; using indication examples; the minimum needed to generate a good reference document for safety purposes
- Updating the Indications section in coordination with a global regulatory roll-out plan for new uses – pros and cons
- The hypersensitivity–contraindication dilemma
- Are contraindication lists always complete? Why not, and where to put the rest?
- Section placement of "non-indications" and information about "prohibited modes of administration"
- How much information to provide per contraindication