New Hampshire Revised Statutes 328-D:6-a – Off-label Use of Prescription Drugs; When Permitted
Current as of: 2023 | Check for updates
|
Other versions
The state of New Hampshire confirms its strong support for shared decision making between healthcare professionals and their patients. A licensee may lawfully prescribe an FDA approved drug product for an off-label indication and be held to the same standard of care as when prescribing for on-label indication when:
I. Off-label use of the drug product for this indication has longstanding common use;
II. There is medical evidence to support this use and no known evidence contraindicating such use, including but not limited to peer reviewed studies and practice guidelines from relevant medical societies; or
III. The licensee has provided and the patient, or if the patient is a minor, the patient’s parent or guardian, has signed an informed consent form that includes the known potential benefits, known potential risks, alternative treatment options, expected prognosis without treatment, and a disclosure that a prescription is for an off-label indication. The signed informed consent form shall remain part of the patient’s medical record.
I. Off-label use of the drug product for this indication has longstanding common use;
Terms Used In New Hampshire Revised Statutes 328-D:6-a
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- state: when applied to different parts of the United States, may extend to and include the District of Columbia and the several territories, so called; and the words "United States" shall include said district and territories. See New Hampshire Revised Statutes 21:4
II. There is medical evidence to support this use and no known evidence contraindicating such use, including but not limited to peer reviewed studies and practice guidelines from relevant medical societies; or
III. The licensee has provided and the patient, or if the patient is a minor, the patient’s parent or guardian, has signed an informed consent form that includes the known potential benefits, known potential risks, alternative treatment options, expected prognosis without treatment, and a disclosure that a prescription is for an off-label indication. The signed informed consent form shall remain part of the patient’s medical record.