N.J.A.C. 13:35-7.6 Limitations on prescribing, administering or dispensing of controlled substances; special exceptions for management of pain
(a) When prescribing, dispensing or administering controlled substances, a practitioner shall ensure that a patient's medical history has been taken and physical examination accomplished, including an assessment of physical and psychological function, underlying or coexisting diseases or conditions, any history of substance abuse and the nature, frequency and severity of any pain. The medical record shall reflect:
1. A recognized medical indication for the use of the controlled substance;
2. The complete name of the controlled substance;
3. The dosage, strength and quantity of the controlled substance; and
4. The instructions as to frequency of use.
(b) With respect to Schedule II controlled substances, unless the requirements of (c) below are met, a practitioner shall not authorize a quantity calculated to exceed 120 dosage units or a 30-day supply, whichever is less.
(c) A practitioner may exceed the 120 dosage unit limitation for Schedule II controlled substances in (b) above, if the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness.
The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of controlled substances with the patient, guardian or authorized representative.
(d) When controlled substances are continuously prescribed for management of pain for three months or more, the practitioner:
1. Shall review, at a minimum of every three months, the course of treatment, any new information about the etiology of the pain and the patient's progress toward treatment objectives;
2. Shall remain alert to problems associated with physical and psychological dependence; and
3. Shall periodically make reasonable efforts, unless clinically contraindicated, to either stop the use of the controlled substance, decrease the dosage, try other drugs such as nonsteroidal anti-inflammatories, or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.
(e) If treatment objectives are not being met, the practitioner:
1. Shall assess the appropriateness of continued treatment with controlled substances or undertake a trial of other drugs or treatment modalities; and
2. Shall consider referring the patient for independent evaluation or treatment in order to achieve treatment objectives.
(f) A practitioner shall remain alert to the possibility that controlled substances may be misused or diverted.
A practitioner managing pain in a patient with a history of substance abuse shall exercise extra care by way of monitoring, documentation and possible consultation with addiction medicine specialists, and should consider the use of an agreement between the practitioner and the patient concerning controlled substance use and consequences for misuse.
(g) The practitioner shall keep accurate and complete records including that information required by (a) above as well as:
1. The medical history and physical examination of the patient;
2. Other evaluations and consultations;
3. Treatment plan objectives;
4. Evidence of informed consent;
5. Treatments and drugs prescribed or provided, as in (a) above;
6. Any agreements with the patient; and
7. Periodic reviews conducted.
N.J.A.C.13:35-7.7 Prohibitions on prescribing, administering or dispensing of controlled substances for detoxification; limited exceptions
(a) A practitioner shall not issue a prescription for a narcotic drug listed in any schedule which drug is intended for the purpose of "detoxification" or "maintenance treatment."
(b) Unless registered with the New Jersey Department of Health and Senior Services to conduct a narcotic treatment program pursuant to N.J.S.A. 24:21- 10 and N.J.A.C. 8:65-11.2, a practitioner shall not dispense or administer a narcotic drug listed in any schedule which drug is intended for the purpose of "detoxification" or "maintenance treatment," except:
1. To relieve acute withdrawal symptoms, provided that:
i. Such treatment shall not exceed 72 hours;
ii. No more than one day's supply of the drug is provided to the patient at a time; and
iii. Arrangements are made for referring the patient to an addiction specialist or a drug treatment program for treatment; or
2. As an adjunct to other medical or surgical treatment for conditions other than addiction in a licensed health care facility.
N.J.A.C.13:35-7.8 Prohibitions and limitations in the prescribing, administering or dispensing of amphetamines and sympathomimetic amines
(a) A practitioner shall not prescribe, order, dispense, administer, sell or transfer any amphetamine or sympathomimetic amine designated as a Schedule II controlled substance for use in weight management, dieting or any other anorectic purpose, or for the treatment of fatigue.
(b) A practitioner may prescribe, dispense or administer amphetamine or sympathomimetic amine drugs or compounds designated as Schedule II controlled substances, only as follows:
1. For the treatment of the following conditions:
i. Narcolepsy established by recognized diagnostic criteria;
ii. Idiopathic Central Nervous System Hypersomnia established by recognized diagnostic criteria;
iii. Attention Deficit Disorder established by recognized diagnostic criteria;
iv. Drug-induced brain dysfunction;
v. Epilepsy;
vi. Depression shown to be refractory to other therapeutic modalities; and
vii. Senile apathetic behavior;
2. For immediate use in a hospital for acute conditions such as depression associated with illness or surgery;
3. For the differential diagnostic psychiatric evaluation of depression; or
4. For the clinical investigation of the effects of such drugs or compounds in which case, in addition to other requirements of applicable law, prior application therefor shall have been made to the Board and approval granted before any such investigation is begun.
(c) A practitioner who prescribes, dispenses or administers amphetamines or sympathomimetic amines shall prepare and maintain patient medical records which accurately reflect the utilization of any drug subject to this section, the specific diagnosis, the information upon which the diagnosis is based, including testing and consultations, and the treatment objectives for which the drug is being prescribed.
(d) The following list, although not exhaustive or exclusive, includes many of the generic and brand-name Schedule II drugs which are subject to this section:
Adderall
Amphetamine
Desoxyn
Dexedrine
Dextroamphetamine
Methamphetamine
Methylphenidate
Ritalin
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