Bill Text - HB1466 (2022)

Relative to the off-label use of prescription drugs and relative to pharmacy prescriptions.


Revision: May 17, 2022, 3:20 p.m.

May 17, 2022

2022-2039-CofC

05/10

 

 

 

Committee of Conference Report on HB 1466, relative to the off-label use of prescription drugs and relative to pharmacy prescriptions.

 

Recommendation:

That the House recede from its position of nonconcurrence with the Senate amendment, and concur with the Senate amendment, and

That the Senate and House adopt the following new amendment to the bill as amended by the Senate, and pass the bill as so amended:

 

Amend the bill by replacing sections 1-3 with the following:

 

1  New Paragraph; Physicians and Surgeons; Disciplinary Action; Off-Label Use of Prescription Drug.  Amend RSA 329:17 by inserting after paragraph VI-a the following new paragraph:

VI-b.  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:

(a)  Off-label use of the drug product for this indication has longstanding common use;

(b)  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  

(c)  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.

2  New Paragraph; Nurse Practice Act; Advanced Practice Registered Nurse; Disciplinary Action; Off-label Use of Prescription Drug.  Amend RSA 326-B:37 by inserting after paragraph III the following new paragraph:

III-a.  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:

(a)  Off-label use of the drug product for this indication has longstanding common use;

(b)  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

(c)  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.

3  New Section; Physician Assistant; Disciplinary Action; Off-label Use of Prescription Drug.  Amend RSA 328-D by inserting after section 6 the following new section:

328-D:6-a  Off-label Use of Prescription Drugs; When Permitted.  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.

The signatures below attest to the authenticity of this Report on HB 1466, relative to the off-label use of prescription drugs and relative to pharmacy prescriptions.

 

Conferees on the Part of the Senate Conferees on the Part of the House

 

 

_________________________________________ _______________________________________

Sen. Bradley, Dist. 3 Rep. Layon, Rock. 6

 

 

_________________________________________ _______________________________________

Sen. Avard, Dist. 12 Rep. Merchant, Sull. 4

 

 

_________________________________________ _______________________________________

Sen. Sherman, Dist. 24 Rep. Kofalt, Hills. 4

 

 

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Rep. B. King, Hills. 23