Module 6
How Labeling Supports the Process of
Selecting the Right Medicine for the Right
Patient/Consumer
One of the main purposes of labeling is to describe as precisely as possible the population for which, in general, the expected benefit of use is considered to outweigh the risks of use. In addition, labeling is supposed to provide information and advice for individualized decision making wherever the authors of labeling cannot list black-and-white inclusion and exclusion criteria. Such advice can be explicit or implied.
This module provides a general overview of considerations that drive the content of the Indications, Contraindications, Warnings and Precautions, and other sections that provide information relevant for patient/consumer selection.
Curriculum topics of this module include:
- Generic process of medication selection
- The role and information needs of the patient/consumer and healthcare professionals
- How labeling meets these needs
- The logic and limitations of labeling structures in capturing the relevant information
- The concepts: Indication, target population for use, inclusion criteria, intent of use, exclusion criterion, contraindication, relative contraindication, and advice to consider avoidance
- What we mean when we say a product is safe and effective
- The elements of a positive benefit–risk balance; factors to weigh
- Threshold criteria for including benefit claims
- Threshold criteria for using a risk as a basis for a categorical exclusion of a population subset from treatment (absolute contraindication)
- Pointing to the need for individualized decision making in a way that reflects the anticipated proportion of "opt-outs"
- The concept of "non-indication"
- The concept of "prohibited mode of administration"
- Advice to discontinue in case of an adverse reaction
- Stringency of advice; "should not" and other terminology issues