SENATE, No. 1864
STATE OF NEW JERSEY
INTRODUCED MARCH 10, 1997
By Senator SINAGRA
An Act concerning narrow therapeutic index drugs and supplementing and amending P.L.1977, c.240.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. (New section) a. Notwithstanding the provisions of any law to the contrary, if any of the narrow therapeutic index drug formulations listed in subsection b. of this section is prescribed by their brand name, a different brand name or the drug's generic name, the prescribed drug formulation shall not be substituted by a pharmacist without the informed consent of the prescriber. The pharmacist shall record in his record of prescription the date that the informed consent was given.
In the event the pharmacist substitutes the drug formulation pursuant to the provisions of this act, the selection of the interchangeable drug product shall be the responsibility of the pharmacist dispensing the product, subject to the provisions of subsection d. of this section, and no employer, agent or other person may require the dispensing of a particular drug product which in the professional judgment of the dispensing pharmacist is not in the best interest of the patient.
b. Narrow therapeutic index drug formulations subject to the provisions of this bill include: carbamazepine, conjugated estrogens, digoxin, levothyroxine sodium, phenytoin sodium, theophylline, valproic acid, quinidine and warfarin sodium.
c. The provisions of this section shall apply to any pharmacist subject to the provisions of P.L.1977, c.240 (C.24:6E-1 et seq.) and to a licensed inpatient health care facility with respect to a patient admitted to the facility who was being treated with a narrow therapeutic index drug at the time of admission.
d. The Drug Utilization Review Council may designate other narrow therapeutic index drug formulations, including drug formulations identified by the federal Food and Drug Administration after the effective date of this act, to be subject to the provisions of subsection a. of this section. The council shall provide public notice in the New Jersey Register of any drug formulations designated by the council pursuant to this subsection and shall make available, upon request, the complete list of narrow therapeutic index drug formulations subject to the provisions of this act.
e. The Drug Utilization Review Council shall adopt criteria, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C. 52:14B-1 et seq.), for designating narrow therapeutic index drug formulations that shall be subject to the provisions of this act. The council shall adopt, by regulation, a list of interchangeable drug products for the designated narrow therapeutic index drug formulations that shall be permitted for substitution by a pharmacist in the event that a prescriber gives informed consent for substitution or the original prescription is written for the drug formulation's generic name.
2. Section 12 of P.L.1977, c.240 (C.24:6E-11) is amended to read as follows:
12. Any person violating any provision of [this act]P.L.1977, c.240 (C.24:6E-1 et seq.) or PL. , c. (C. )(pending before the Legislature as this bill) shall be liable to a penalty of not less than $100.00 for the first offense, and not less than $200.00 for each subsequent offense. Such penalty shall be collected and enforced by summary proceedings pursuant to the Penalty Enforcement Law (N.J.S. 2A:58-1 et seq.). Process shall issue at the suit of the Board of Pharmacy or the Attorney General, and shall be either in the nature of a summons or warrant. In addition, the Board of Pharmacy may suspend or revoke the certificate of a registered pharmacist for violating any provision of [this act] P.L.1977, c.240 (C.24:6E-1 et seq.) or PL. , c. (C. )(pending before the Legislature as this bill). However, failure of the prescriber to utilize the form of prescription designated in section 8 of [this act] P.L.1977, c.240 (C.24:6E-1 et seq.) shall not invalidate the prescription as written, if said prescription is otherwise valid.
(cf: P.L.1977, c. 240, s. 12)
3. This act shall take effect immediately.
STATEMENT
The purpose of this bill is to protect the interests and safety of patients who are prescribed narrow therapeutic index (NTI) drugs.
Accordingly, this bill exempts certain NTI drugs from mandatory substitution pursuant to the "Prescription Drug Price and Quality Stabilization Act," but allows substitution if the prescriber gives informed consent for the substitution. The bill specifically recognizes as NTI drugs subject to the provisions of the bill: carbamazepine, conjugated estrogens, digoxin, levothyroxine sodium, phenytoin sodium, theophylline, valproic acid, quinidine and warfarin sodium. The bill also authorizes the Drug Utilization Review Council to exempt other NTI drugs, including drugs designated by the federal Food and Drug Administration, as appropriate.
In order to ensure that the most appropriate drug product is dispensed in the event that the pharmacist substitutes the drug formulation pursuant to the provisions of this bill, the bill provides that the selection of the interchangeable drug product shall be the responsibility of the pharmacist dispensing the product and no employer, agent or other person may require the dispensing of a particular drug product which in the professional judgment of the dispensing pharmacist is not in the best interest of the patient.
The Drug Utilization Review Council is directed to adopt, by regulation, criteria for designating NTI drug formulations that shall be subject to the provisions of the bill. The council also shall adopt, by regulation, a list of interchangeable drug products for the designated NTI drug formulations that shall be permitted for substitution by a pharmacist in the event that a prescriber gives informed consent for substitution or the original prescription is written for the drug formulation's generic name.
The provisions of this bill apply to any pharmacist subject to the provisions of the "Prescription Drug Price and Quality Stabilization Act" and to a licensed inpatient health care facility with respect to a patient admitted to the facility who was being treated with a NTI drug at the time of admission.
The penalty for violating the provisions of the bill is at least $100 for the first offense and $200 for each subsequent offense. These penalties are the same as those provided for any violation of the "Prescription Drug Price and Quality Stabilization Act."
NTI drugs are widely used for the treatment of a number of critical medical conditions, including heart attack, stroke, asthma, epilepsy and depression. These drugs are designated as having a narrow therapeutic index because of the narrow margin that exists between patient benefit and patient risk. Too low a dosage means the drug will not have the desired therapeutic effect; too high a dosage can lead to toxic effects in the patient. In the case of NTI drugs, the margin between too low and too high a dosage is extremely narrow.
NTI drugs have highly individualized dosing, requiring close, careful and skilled patient monitoring to ensure that the level of the prescribed drug in the patient's blood stays within the narrow therapeutic range, or window, appropriate for that medication. A change in formulations of a NTI drug has the potential of causing the dosage to vary outside the therapeutic window, exposing the patient to the risks associated with too low or too high a dosage. Changes in formulation can include changing from a brand name formulation to a generic formulation or another brand name formulation, or from one generic formulation to another, or from a generic formulation to a brand name formulation. This bill will prohibit any change from the formulation upon which the patient was stabilized, to any other formulation, without the knowledge and consent of the prescriber of the drug.
Exempts certain narrow therapeutic index drugs from mandatory substitution requirements.