The United States Food and Drug Administration (FDA) released draft guidance focused on improving the consistency of information in the dosage and administration section of prescription drug labels. The draft is a rewrite of a withdrawn March 2010 guidance, though the new draft guidance is more than twice as long and goes into much greater detail about the dosage and administration information for specific drug types and special populations.
In the draft guidance, the FDA notes that language in the dosage and administration section of drug label should be “presented in a clear, concise manner, using active voice and command language whenever possible” and that the Prescribing Information section should be “presented in a manner that is pertinent and understandable to health care practitioners, which can help reduce medication errors.” FDA also recommended that applicants should use the term “dose” to refer to a specific amount of drug taken at one time and the term “dosage” to refer to a specific amount of drug administered at a specific frequency (and over a certain duration, if applicable). The correct term should be used throughout the labeling when appropriate.
Additionally, dosing regiments are not to be implied or suggested in other sections of the labeling if not included in the dosage and administration section and applicants should not put any “distracting” information in the section, including contraindications or efficacy data. Information that is general medical knowledge and not drug-specific should generally not be included in the dosage and administration section.
In the guidance, FDA noted that the most “clinically relevant” dosage and administration information should appear first, such as the recommended dosage, the route of administration and instructions on use. If there is information that is “particularly critical to the safe and effective use of the drug (e.g., lack of knowledge of this information or nonadherence to a recommendation could have serious consequences for patients), this information should appear as the first information” in the dosage and administration section. Information on dosage modifications and instructions on how to administer the dosage form (with liquids or soft foods) should be next. The dosage information should also include an upper dosage range, or the limit beyond which safety and effectiveness have not been established. A list of recommended information to include in the dosage and administration section as well as the order of appearance is included in the draft guidance.
The guidance also calls out parenteral drugs and certain dosage forms, noting that any specific containers or devices that are needed for dose administration should be included in the labeling. Labeling should also indicate the risk of manipulating different dosage forms, such as modified-release drugs; for example, if there is a risk associated with manipulating modified release tablets, the labeling should indicate that tablets should be swallowed whole and should not be split or crushed.
FDA also recommended applicants review the labeling information at least annually to ensure the dosage and administration section “contains accurate, clear, and up-to-date information.”
As is always the case, the draft guidance does not enforce any legally enforceable responsibilities but describes the FDA’s current thinking on the topic and is only meant for recommendation purposes, unless a specific regulatory or statutory requirement is cited.