Effective communication of information regarding drug interactions is vital to ensure appropriate use of pharmaceuticals and optimal decision-making by practitioners. On October 22, 2024, the FDA released draft guidance titled “Drug Interaction Information in Human Prescription Drug and Biological Product Labeling”. The aim of this guidance is to provide companies with guidelines for completing the DRUG INTERACTIONS section of the Prescribing Information labeling.
At a high level, the DRUG INTERACTIONS section:
- Must include specific practical instructions for preventing or managing clinically significant drug interactions (“DIs”)
- Must briefly describe the mechanism of clinically significant DIs, if known
- Should include the clinical effects of clinically significant DIs
DIs that are described in the CONTRAINDICATIONS and/or WARNINGS AND PRECAUTIONS sections must be discussed in more detail in the DRUG INTERACTIONS section. Practical guidance on known interference of the drug with laboratory tests must also be included in the DRUG INTERACTIONS section.
Some of the more specific recommendations can be categories as follows:
Communicating a Clinically Significant DI
Information about clinically significant DIs should be communicated in the DRUG INTERACTIONS section in a manner that is understandable and clinically informative. Descriptions of DIs should generally contain information presented in the following order to promote consistency, as applicable: (1) instructions for preventing or managing the clinically significant DIs, (2) mechanisms of the clinically significant DIs, and (3) clinical effects of the clinically significant DIs. This labeling approach prioritizes the information that is most actionable and may impact clinical decision-making.
Communicating the Absence of a Clinically Significant DI
Generally, the FDA does not recommend that the DRUG INTERACTIONS section describe the absence of a DI. However, there are two specific situations that the FDA references where it is recommended to communicate this absence as follows:
- If the drug has clinically significant DIs with all drugs in a drug interacting class except for one drug in this class, this exception should be described in this section of the labeling.
- If a drug class is known to have a clinically significant interaction with a drug; however, the subject drug, a member of that class, does not interact with that concomitant drug, this exception should be described in this section of the labeling.
Communicating a Drug Interference with Laboratory Tests
The DRUG INTERACTIONS section must contain practical guidance on known interference of the drug with laboratory tests. When the drug interferes with a laboratory test, it can cause an inaccurate test result. A clinically significant drug-test interference should be included in this section when an erroneous test result would negatively affect clinical decision-making. This section should provide instructions to prevent or manage the interference and the clinical effects of the interference, if feasible. Additionally, the WARNINGS AND PRECAUTIONS section must briefly describe the drug interference with laboratory tests and cross-reference to the DRUG INTERACTIONS section for more details.
Additionally, the guidance document lays out the proper organization and formatting of the DRUG INTERACTIONS section, and it also describes content that should not be included in this section of the labeling such as In Vitro and/or animal data.
A link to the full guidance document is provided here:
https://www.fda.gov/media/182893/download
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