Criteria for unlabeled use of the drug:
(1) change in dose
(2) use in a different patient population other than that for which the drug was approved, such as for a different age range
(3) different indication
(4) different route of administration
The FDA cannot prevent a physician from prescribing a legally marketed drug for an unlabeled use. However, if an untoward event occurs, then the physician might face medical liability for the practice. In addition, an medical insurance company may refuse to pay for the medication.
The FDA may regulate what a company says about how a drug can be used in advertising and promotions.
Some factors contributing to unlabeled use of a drug:
(1) slowness of regulatory process to adapt to changes in practice
(2) slowness of regulators to approve new or existing drugs
(3) conditions such as AIDS when standards of practice are not well-established
(4) economics
If the healthcare provider prescribes off-label then he or she must:
(1) become very knowledgable about the drug and its metabolism
(2) make decisions based on strong evidence for potential benefit to the patient
(3) document effects and report adverse outcomes
(4) obtain informed consent from the patient
Hazards of off-label use:
(1) harm to the patient and malpractice risk to the physician
(2) economical, since it may not be reimbursed by insurance or government agencies
