A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: New Jersey

General Requirements for All Schedules

• Physicians may only distribute or dispense controlled medications for a legitimate medical purpose. A bona fide practitioner-patient relationship must exist when controlled substances are prescribed.
• All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, and directions for use and the name, address, and registration number of the practitioner.
• A practitioner shall sign a prescription in the same manner as he or she would sign a check or legal document (eg, JH Smith or John H. Smith). As of October 1, 2008, New Jersey requires the use of preprinted special forms with serialized numbering. See New Jersey Board of Medicine letter to practitioners.
• Where an oral order is not permitted, prescriptions shall be written in ink or indelible pencil or typewriter or other mechanical means of printing and shall be manually signed by the practitioner.
• A secretary or agent may prepare the prescriptions, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.

Pharmacist Has Corresponding Responsibility

• The responsibility for the proper prescribing and dispensing of controlled substances is on the prescribing practitioner, but a corresponding liability rests with the pharmacist who fills and ultimately dispenses the prescription. In addition, a corresponding liability rests on the pharmacist who fills a prescription that is not prepared in the form prescribed by this regulation.

Dispensing or Administering Controlled Medications to a Patient

• A physician shall not dispense more than a 7-day supply of drugs or medicines to any patient. The drugs or medicines shall be dispensed at or below the cost the physician has paid for the particular drug or medicine, plus an administrative cost not to exceed 10% of the cost of the drug or medicine. The provisions of this section shall not apply to a physician: (a) who dispenses drugs or medicines in a hospital emergency room, in a student health center at an institution of higher education, or at a publicly subsidized community health center, family planning clinic, or prenatal clinic, if the drugs or medicines that are dispensed are directly related to the services provided at the facility; (b) whose practice is situated 10 miles or more from a licensed pharmacy; (c) when a physician dispenses allergenic extracts and injectables; (d) when a physician dispenses drugs pursuant to an oncologic or AIDS protocol; or (e) when a physician dispenses salves, ointments, or drops.

Requirements for Issuing Written Prescriptions for Medicines

• A practitioner acting within the scope of lawful practice and after an examination or evaluation of the patient's condition may issue a written prescription for a drug to a patient, guardian, or authorized representative in the form authorized by this section. The practitioner shall assure that appropriate follow-up is provided and that the effects of the drug are properly evaluated and integrated into the treatment plan for the patient.

Use of New Jersey Prescription Blanks

• A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New Jersey Prescription Blanks (NJPB) bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs, or other prescription items. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. A licensed practitioner practicing in this State shall maintain a record of the receipt of NJPB.
• IMPORTANT: The practitioner shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 72 hours after being made aware that any New Jersey Prescription Blank in the practitioner's possession has been stolen. The state must take action after receiving such a report. New requirements for serialized forms must be met by October 1, 2008.

Prescription Requirements

• The following are required for all written prescriptions in the State of New Jersey:
  1. The prescribing practitioner's full name, address, telephone number, license number, and proper academic degree or identification of professional practice for which licensed;
  2. The full name, age, and address of the patient;
  3. The date of issuance;
  4. The name, strength, and quantity of the drug prescribed;
  5. Words, in addition to numbers, to indicate the drug quantity authorized if the prescription is for a schedule II controlled substance (eg, ten (10) Percodan or five (5) Ritalin 5 mg);
  6. The number of refills permitted or time limit for refills or both;
  7. The handwritten original signature of the prescribing practitioner;
  8. An explicit indication, by initials placed next to "do not substitute" (see (e) below), if it is the prescribing practitioner's intention that a specified brand name drug be dispensed;
  9. The prescribing practitioner's US Drug Enforcement Administration number if the drug is a controlled substance; and
  10. Adequate instruction for the patient regarding frequency; a direction of "prn" or "if needed" alone may be used if appropriate.
• A prescribing practitioner shall advise each patient by adequate notice, for example, by a sign or pamphlet in the waiting room of the office, that he or she may request that the practitioner substitute a generic drug for any brand name drug prescribed.
• Each practitioner shall use only written prescription blanks imprinted with the words "substitution permissible" and "do not substitute," with a space for the prescribing practitioner's initials next to the chosen option. These prescription blanks must not include preprinted information designed to discourage or prohibit substitution.
• When using healthcare facility or multiprescriber prescription blanks, the full name and license number of the prescribing practitioner shall be legibly printed at the top of the prescription or the identity of the prescriber shall be designated by a checkmark or other legible means.
• Each prescription for a controlled substance shall be written on a separate NJPB. An NJPB that contains prescriptions for 2 or more controlled substances shall be invalid. An NJPB that contains a prescription for only one controlled substance and contains other prescription(s) other than another controlled substance shall be valid. All controlled substance prescriptions must be preprinted on special NJPB forms that include serialized numbers by October 1, 2008.
  • Schedule II Prescriptions and Quantity Limitations. Schedule II controlled substance prescriptions cannot be refilled. A physician may prescribe a schedule II controlled dangerous substance for patient use in any quantity that does not exceed a 30-day supply, as defined by regulations adopted by the State Board of Medical Examiners in consultation with the Department of Health and Senior Services. The physician shall document the diagnosis and the medical need for the prescription in the patient's medical record, in accordance with guidelines established by the State Board of Medical Examiners.
  • Prohibitions on Prescribing, Administering, or Dispensing of Controlled Substances for Detoxification; Limited Exceptions. A practitioner shall not issue a prescription for a narcotic drug or for a depressant drug listed in any schedule if the drug is intended for the purpose of "detoxification" or "maintenance treatment.'' Unless the practitioner is properly registered by the State to conduct a narcotic treatment program, a practitioner shall not dispense or administer a narcotic drug or a depressant drug listed in any schedule if that drug is intended for the purpose of "detoxification" or "maintenance treatment," except:
    1. To relieve acute withdrawal symptoms, provided that:
       1. Such treatment does not exceed 72 hours;
       2. No more than 1-day's supply of the drug is provided to the patient at a time; and
       3. Arrangements are made for referring the patient to an addiction specialist or a drug treatment program for treatment.
    2. As an adjunct to other medical or surgical treatment for conditions other than addiction in a licensed healthcare facility.
  • Faxing of Schedule II Controlled Substance Prescriptions. Faxing of prescriptions for schedule II controlled substances is allowed, so long as the original prescription, on a NJPB form, is presented to the pharmacist before the prescription is dispensed/filled. The "original NJPB form” is not required when
    1. a schedule II narcotic substance is prescribed for pain management in a compounded format for direct administration to the patient during a pain management procedure;
    2. the substance is prescribed for a resident of a long-term care facility;
    3. the prescription is for a schedule II narcotic substance to be used for pain management by a patient receiving hospice care. Additional documentation requirements apply and it is important that all practitioners read the New Jersey state regulations.

    NOTE: If a fax is issued for a controlled substance prescription for compounding and use via direct administration to a patient during a pain management procedure, or to a patient in long-term or hospice care, giving the original prescription to the patient, a caregiver, or family member is prohibited. This rule should be read carefully.

    Partial filling of schedule II medication is permitted and subject to the 72-hour rule, as stated in New Jersey CSA and rules. These rules should be read carefully.

    Faxing of schedule III, IV, and V controlled substance prescriptions is permitted.

  • Schedule III Through V Prescriptions. The life of a schedule III through V prescription is six (6) months. Prescriptions for schedule III through V controlled substances may be refilled pursuant to the New Jersey Controlled Substances Act, and no more than 5 refills shall be given during the 6-month life of the prescription.

    Physicians must not self-prescribe and must not prescribe to family members unless it is a documented emergency.

Duty to Report Inappropriate Conduct of Another Practitioner

• A practitioner who is in possession of information which reasonably indicates that another practitioner has prescribed, dispensed or administered any drug or drugs in a manner which jeopardizes the public health, safety or welfare or for purposes deemed to be unlawful pursuant to this subchapter shall report such information to the Board.

Physician Assistant Authority to Prescribe Controlled Substances

• A physician assistant treating a patient in an inpatient or outpatient setting may order or prescribe medications, subject to the following conditions. A controlled dangerous substances may be ordered or prescribed if:
  1. A supervising physician has authorized a physician assistant to order or prescribe schedule II, III, IV, or V controlled dangerous substances to:
     1. Continue or reissue an order or prescription previously issued by the supervising physician;
     2. Otherwise adjust the dosage of an order or prescription originally ordered or prescribed by the supervising physician, provided there is prior consultation with the supervising physician;
     3. Initiate an order or prescription for a patient, provided there is prior consultation with the supervising physician if the order or prescription is not pursuant to subparagraph (d) of this paragraph; or
     4. Initiate an order or prescription as part of a treatment plan for a patient with a terminal illness, which for the purposes of this subparagraph means a medical condition that results in a patient's life expectancy being 12 months or less as determined by the supervising physician.
  2. The physician assistant has registered with and obtained authorization to order or prescribe controlled dangerous substances from the appropriate state and federal agencies; and
  3. The physician assistant complies with all requirements of the Board regarding controlled dangerous substances and continuing professional education programs and complies with protocols or specific physician direction. The prescription must state whether it is written pursuant to protocol or specific physician direction, and the physician assistant must sign his or her own name, print his or her name and license number, and print the supervising physician's name. In the case of an order or prescription for a controlled dangerous substance, the physician assistant's Drug Enforcement Administration registration number must also be printed on the prescription.

Out-of-State Prescriptions

• A pharmacist shall only fill a written prescription issued in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank, except as otherwise provided by New Jersey law. A pharmacist shall only fill a prescription issued by an authorized prescriber licensed to write prescriptions in the United States or any territory of the United States. Such prescription orders shall be filled pursuant to New Jersey law. All other prescriptions shall not be filled by a pharmacy in New Jersey.

Emergency Dispensing

• In the absence of a current, valid prescription, a pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance drug (except controlled dangerous substances) or device if, in his or her professional judgment, refusal would endanger the health or welfare of the patient, provided the following conditions are satisfied:
  1. the pharmacist first ascertains to the best of his or her ability, by direct communication with the patient or caregiver, that such a medication or device was prescribed, or that patient by order of a licensed practitioner; and
  2. the pharmacist documents the communication and requires the patient or caregiver to provide suitable identification and sign a statement attesting to the need before dispensing.

Professional Judgment in Dispensing Drugs

• The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional judgment,
  1. the prescription is outside the scope of practice of the prescriber, or
  2. if the pharmacist has sufficient reason to question the validity of the prescription or to protect the health and welfare of the patient.

Special Requirements for Dispensing Schedule V Over-the-Counter Substances

• New Jersey has several pharmacy regulations relating to this topic. The reader should review these regulations carefully. Restating them here is beyond the scope of this project.

Limitations on Prescribing, Administering, or Dispensing of Controlled Substances and Special Exceptions for Management of Pain

• When prescribing, dispensing, or administering controlled substances, a practitioner shall ensure that a patient's medical history has been taken and a physical examination has been 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 must 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. instructions to the patient about frequency of use.
• As a general rule, the State of New Jersey limits prescribing to any quantity calculated to exceed 120 dosage units or a 30-day supply of a controlled substance, whichever is less. The 120-dosage unit or 30-day supply limitations for schedule II controlled substances may be exceeded under certain circumstances.
• The 120-dosage unit limitation may be exceeded if the practitioner follows a treatment plan designed to achieve effective pain management that has been tailored to the needs of a patient who has pain from cancer, who has intractable pain, or who has pain as a result of 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 whether any further diagnostic evaluations or other treatments are planned. The practitioner must discuss the risks and benefits of the use of controlled substances with the patient, guardian, or authorized representative.
• With regard to the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump that is used to achieve pain management for patients with cancer, intractable pain, or terminal illness. A prescription for such an implantable infusion pump may provide up to a 90-day supply as long as the physician evaluates and documents the patient's continued need at least every 30 days.

Chronic Controlled Substance Prescribing for Pain Management

• When practitioners continuously prescribe controlled substances for a period of 3 months or more to a patient for pain management, the practitioner
  1. should review, at a minimum of every 3 months, the course of treatment, any new information about the cause of the pain, and the patient's progress toward treatment objectives;
  2. must remain alert to problems associated with physical and psychological dependence; and
  3. should periodically make reasonable efforts, unless clinically contraindicated, to stop the use of the controlled substance, decrease the dosage, and try other drugs such as nonsteroidal anti-inflammatory drugs or other treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.
• If treatment objectives are not being met, the practitioner:
  1. should assess the appropriateness of continued treatment with controlled substances or undertake a trial of other drugs or treatment modalities; and
  2. should consider referring the patient for independent evaluation or treatment to achieve treatment objectives. Practitioners must remain alert to the possibility of controlled substance misuse or diversion. When managing pain in a patient with a history of substance abuse, extra care should be taken with monitoring and documentation, and there should be possible consultation with addiction medicine specialists. The use of an agreement between the physician and the patient concerning controlled substance use and consequences for misuse should be considered.
• In all cases, New Jersey states "The practitioner shall keep accurate and complete records including that information required 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;
  6. any agreements with the patient; and
  7. periodic reviews conducted."

Definitions

• New Jersey uses the following definitions relating to pain management and controlled substances, and these terms are found in various laws and regulations promulgated by the State and the Board.
• Intractable pain means pain that has been shown to be refractory or resistant to management with standard methods of treatment or for which insufficient relief has been found after reasonable efforts.
• Narcotic means an analgesic drug that chemically and pharmacologically acts as an opioid.
• Terminal illness means a diagnosed medical condition with a prognosis of less than 1 year.

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Author Information

Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee

Disclosure: Jennifer Bolen, JD, has disclosed no relevant financial relationships.