A Guide to State Opioid Prescribing Policies

 

State Opioid Prescribing Policy: New York

 

Jennifer Bolen, JD
Author Information

Pain Policy and Regulation: New York

New York Laws

New York has many levels of legal/regulatory materials relating generally to controlled substances and more specifically to their use to treat pain. It is not possible to summarize all of these materials in the space supplied, therefore links have been provided to New York forms and Web sites that contain relevant information. Materials supplied by the practitioner's specific licensing board should be read, and practitioners should take care to stay current. The New York Department of Health and Bureau of Narcotic Enforcement both post a great deal of relevant information about controlled substances. The New York Department of Health Web site can be found at: http://www.health.state.ny.us, and the Bureau of Narcotic Enforcement Web site is located at: http://www.health.state.ny.us/professionals/narcotic.

New York State Laws and Regulations pertaining to controlled substances can be found at: http://www.health.state.ny.us/nysdoh/phforum/nycrr10.htm, section 80.

License. Only practitioners who are properly licensed and registered may issue a prescription for a controlled substance. Section 80.64 contains the full information about who may issue controlled substances.

Purpose of a Prescription. A prescription is the instrument to legalize an ultimate user's possession of a controlled substance. To be effective then, a controlled substance prescription should be issued for legitimate medical purposes only. Section 80.65 contains the full text.

Initial and Corresponding Responsibilities: Prescriber and Pharmacist. The responsibility for the proper prescribing and dispensing of controlled substances is on the physician, dentist, podiatrist, veterinarian, or other authorized practitioner, but a corresponding liability rests with the pharmacist who fills the prescription.

A practitioner cannot supply prescriptions to maintain an addict or habitual user of controlled substances. There are some exceptions and practitioners should read the New York law very carefully. An order purporting to be a prescription issued to an addict or habitual user of controlled substances not in the course of professional treatment but for the purpose of providing the user with narcotics or other controlled substances sufficient to keep him or her comfortable by maintaining his or her customary use is not a prescription within the meaning of New York law. In this instance, both the prescriber and the person knowingly issuing/filling the prescription may be prosecuted and punished for violating New York law relating to controlled substances.

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 must ensure 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.

Legitimate Medical Use and Supply Described. You may dispense, administer, or prescribe controlled substances for legitimate medical purposes or treatment, other than treatment for addiction to controlled substances, when the practitioner regulates the dosage and prescribes or administers a quantity of such drugs no greater than that ordinarily recognized by members of the profession as sufficient for proper treatment in a given case.

The Patient Record. The practitioner must maintain a written patient record that includes administration, dispensing, and prescription of all controlled substances. The patient record must contain sufficient information to justify the diagnosis and warrant the treatment. The record must contain at least the following information: patient identification data; chief complaint; present illness; physical examination as indicated; diagnosis; other data that support the diagnosis or treatment; and the regimen, including the amount, strength, and directions for use of the controlled substance.

Prescriptions. Under New York law, "prescriptions" are those items issued on an official New York State prescription form; an oral prescription; or an out-of-state prescription, which means a prescription issued in lieu of an official prescription by a practitioner in another state who is licensed by that state to prescribe controlled substances. Practitioners are prohibited from using preprinted prescriptions that indicate the name of the controlled substance or the strength, dosage, and/or quantity of the controlled substance. This prohibition does not apply to preprinted prescriptions issued by computer or electronic medical record system, but only if such printed prescriptions are generated at the time a practitioner prescribes a controlled substance for a patient.

Examination Prior to Prescribing: Basic Requirements. Practitioners must not issue a controlled substance prescription prior to examining the patient unless otherwise permitted by law. After the initial examination has been concluded, generally accepted medical standards must be followed. Special issues relating to the drug to be prescribed, the patient's condition, and the patient's history and disposition toward the use of controlled substances must be considered when deciding on the frequency and necessity for future examinations prior to prescribing.

Temporary Coverage by Another Practitioner: Temporary Absence of Initial Prescriber. If the initial prescriber is temporarily unavailable, an authorized practitioner may issue a controlled substance prescription for a patient as part of a continuing therapy if the practitioner: (i) has direct access to the patient's medical records and such records warrant continued controlled substance prescribing, or (ii) has direct and adequate consultation with the initial prescriber, who assures the temporary practitioner that continuation of treatment with controlled substances is necessary, and the temporary practitioner concurs.

Record Unavailable: Covering Practitioner Issues. If the patient record is not available, the practitioner should document the activity for his or her own record and must transmit the prescription information to the initial prescriber. The initial prescriber must include the prescription information in the patient's record. A practitioner may prescribe a controlled substance to his or her patient after review of the patient's record if the record contains the result of an examination performed by a consulting physician or hospital and such record warrants the prescribing.

Issuance of New Prescription Prior to Examination in Event of Emergency. If a new condition develops that would warrant the issuance of a prescription for a controlled substance, the prescription may be issued prior to performing an examination if: (i) there is a previously established relationship with the patient; (ii) an emergency exists; and (iii) the prescription does not exceed a 5-day supply as determined by the directions for use. An emergency means that the immediate administration of the drug is necessary for the proper treatment of the patient and that no alternative treatment is available. If the practitioner prescribes such substance orally, the practitioner must comply with the requirements for emergency and oral prescriptions.

Technical Requirements for Prescription. The following technical requirements for prescriptions must be met.

For the Patient. The prescription form must include the name, sex, address, and age of the ultimate user for whom the substance is intended, or if the ultimate user is an animal, the species of such animal and the name and address of the owner or person in custody of such animal.

For the Prescriber. The prescription form must have the printed name, address, Drug Enforcement Administration registration number, telephone number, and handwritten signature of the prescribing practitioner. The printed name of the prescriber who has signed the prescription must be imprinted or stamped legibly and conspicuously on the prescription form, must appear in an appropriate location on the prescription form, and must not be entered in or on the space or line reserved for the prescriber's signature. The imprinted or stamped name must not be a substitute for or fulfill any legal requirement otherwise mandating that the prescription be signed by the prescriber.

Directions for Use. The prescription form must include information about the dosage and frequency of dosage and the maximum daily dosage. The practitioner may include additional information on the prescription form.

Proper Date. The prescription form must include the proper date; that is, date the prescription was prepared and actually signed by the prescribing practitioner. A prescription must be dated as of, and signed on, the date it is issued. The practitioner must write the quantity of dosage units prescribed in both numeric and written word form.

Supply Limitations and Specific Exceptions. Unless the patient's case qualifies for an exception, the practitioner must not issue a prescription for a quantity of substances that would exceed a 30-day supply if the substance were used in accordance with the directions for use specified on the prescription. No additional prescriptions for a controlled substance may be issued by a practitioner to an ultimate user within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a 7-day supply of that controlled substance provided by any previously issued prescription.

Exceptions to the 30-Day Supply Rule. Up to a 3-month supply of a controlled substance (or a 6-month supply of an anabolic steroid) may be issued if the prescription is issued in the treatment of (1) panic disorders, designated as code A; (2) attention deficit disorder, designated as code B; (3) chronic debilitating neurologic conditions characterized as a movement disorder or exhibiting seizure, convulsive, or spasm activity, designated as code C; (4) relief of pain in patients with conditions or diseases known to be chronic or incurable, designated as code D; (5) narcolepsy, designated as code E; or (6) hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia, and angioedema, designated as code F. The practitioner must specify the condition being treated on the face of the prescription form and must do so by either: (1) specifying the name of such condition on the face of the prescription form; or (2) specifying a code on the prescription form to denote the condition for which the prescription has been issued.

Faxes: Hospice, Residential Healthcare Facility. Facsimiles are allowed if the patient is enrolled in a hospice program or resides in a residential healthcare facility with appropriate licensing and permissions. The prescriber must note on the prescription form that the patient is a "hospice patient" or "residential healthcare facility patient," and within 72 hours of faxing the prescription, must ensure delivery of the original official New York State prescription form to the pharmacist. If the pharmacist fails to receive such prescription, he or she should notify the Department in writing within 7 days from the date of dispensing the substance. A second exception is allowed if the prescription is for controlled medications to be compounded for direct administration (via specific means). The 72-hour rule applies to both the original and the 7-day deadline prior to notification requirements.

Pharmacists: Permitted to Write in Missing Information Orally Supplied by Practitioner. When an official New York State prescription form prepared by a practitioner is incomplete, the practitioner may furnish the missing information to the pharmacist orally and authorize the pharmacist to enter such information on the prescription form. The pharmacist must write the date he or she received the oral authorization on the prescription form and must affix his or her signature. This procedure does not apply to unsigned or undated prescriptions or prescriptions in which the name and/or quantity of the controlled substance is not specified or where the name of the ultimate user is missing. This does not apply to prescriptions missing the practitioner's signature, date the prescription was signed by the practitioner, drug name, or name of the ultimate user. The pharmacist must write the date he or she received the oral authorization on the prescription form, the reason for the change, and his or her signature. The pharmacist must also indicate the change on the prescription and initial the change.

"Do Not Fill." The use of the "do not fill" prescribing format is prohibited. Practitioners may not use the "do not fill" format for controlled substance prescribing.

Check New York rules for specific requirements relating to the partial filling of any scheduled medication. Section 80.73 contains many of these rules.

Where an oral order is not permitted, prescriptions must be written with ink or indelible pencil or typewriter or other mechanical means of printing and must 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.

Emergency Prescriptions. Emergency oral prescriptions for schedule II substances and certain other controlled substances are allowed. The pharmacist is required to reduce the oral emergency order to writing and dispense according to label and only as much needed for the emergency period, which is limited to a 5-day supply according to the label. The pharmacist must further make a good-faith effort to verify the identity of both the practitioner and the ultimate user. Within 72 hours after authorizing the emergency oral prescription, the prescriber must deliver the prescription on an official state form to the pharmacist. The form must contain the words, "Authorization for emergency dispensing." If the pharmacist fails to receive such prescription, he or she should notify the department in writing within 7 days from the date of dispensing the substance. There are more requirements in this section. The entire rule is contained in section 80.68 of the New York State Laws and Regulations.

Definition of "Emergency": Emergency means that the immediate administration of the drug is necessary for proper treatment, and that no alternative treatment is available and it is not possible for the practitioner to provide an official prescription for the drug at the time.

Prescription Requirements. Schedule III through V controlled substance prescriptions must be on an official New York prescription form, must be issued in good faith, and must be issued in the course of professional practice. Prescriptions must contain patient information, prescriber information, and related items specified in the rule. Rules for dating the prescription apply. Dosage limit rules apply, but refills are allowed within these schedules. A second prescription for the same controlled substance to an ultimate user may not be issued within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a 7-day supply of that controlled substance provided by any previously issued prescription. A 3-month supply of a controlled substance may be issued, so long as the prescription is issued for the same exceptions designated above and pursuant to the same requirements for notification of prescribing rationale on the face of the prescription listed either by code or by named condition.

Unless an earlier refilling is authorized by the prescriber, no prescription may be refilled earlier than 7 days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use. When authorization for the prescription to be refilled or the 6-month limitation of the prescription has expired, the practitioner must execute a new prescription if the medication is to be continued.

Incomplete Prescription Information. When a prescription prepared by a practitioner is incomplete, the practitioner may orally furnish the missing information to the pharmacist and authorize him or her to enter the missing information on the prescription form. The pharmacist must write the date he or she received the oral authorization on the prescription and affix his or her signature. This procedure shall not apply to unsigned or undated prescriptions or where the name and/or quantity of the controlled substances is not specified or where the name of the ultimate user is missing. The pharmacist is not required to obtain authorization from the practitioner to enter the patient's address, sex, or age if the pharmacist obtains the information through a good-faith effort.

The full rules regarding prescription requirements can be found in section 80.69.

Oral Prescriptions for Schedule III, IV, and V Substances. The rules are essentially the same as for schedule II controlled substances. See section 80.70.

Practitioner Dispensing Controlled Substances. The state of New York allows practitioner dispensing of controlled substances, but it is subject to very specific rules. Read the New York materials in section 80.71. Practitioners registered to obtain controlled substances for professional use shall not use these substances to treat their own addiction or for their own habitual use.

Dispensing Prohibition. Controlled substances must not be prescribed for, administered to, or dispensed to addicts or habitual users of controlled substances except as provided by the Public Health Law or this Part.

Pharmacists Dispensing Schedule III, IV, and V Controlled Substances. This rule is very specific and too detailed to include in this summary. The full rule can be found in section 80.74.

New York Summary

The New York State Department of Health has prepared a document titled, "What Every Practitioner Needs to Know About Controlled Substance Prescribing," which is available at: http://www.health.state.ny.us/publications/1477/. The contents are summarized below.

Use of Controlled Substances. Controlled substances can be effective in the treatment of illness, pain, and disease and must, therefore, be accessible to persons who medically need them. These same drugs, however, have the capacity to cause addiction, injury, impairment, and death when abused, misused, or diverted to illegal use.

Prescribing Controlled Substances. Practitioners in good faith and in the course of their professional practice are encouraged to prescribe controlled substances for legitimate medical purposes, including pain management, when appropriate. Practitioners are expected to regulate the dosage and prescribe a quantity of such drugs that ordinarily are recognized by members of their profession as sufficient for proper treatment or medical purpose.

Record Keeping. Practitioners must maintain a written record of the prescribing of all controlled substances. The patient record must contain sufficient information to justify the diagnosis that warrants controlled substance treatment. The record should include the drug name, amount, strength, and directions for use of the controlled substance.

Practitioner Notification of "Doctor Shopping." Under the Official Prescription Program, the Department of Health will notify a practitioner when prescription data analysis indicates that a patient under his or her treatment who is receiving a controlled substance is also obtaining controlled substances from other practitioners, which is unlawful unless the patient informs each practitioner. The Department's notification will include a detailed drug utilization review and information on rehabilitation treatment if the practitioner deems it necessary for the patient.

New York State Forms

New York’s form for prescription request in emergency situations can be found at: http://www.health.state.ny.us/forms/doh-4358.pdf.

The New York form to request permission for the on-site destruction of controlled substances can be found at: http://www.health.state.ny.us/forms/instructions/doh-2340_instructions.pdf. An inventory must be made of all controlled substances to be destroyed and each substance must be listed on the Controlled Substances Inventory Form.

Pain Management for Patients

The New York Department of Health Office of Professional Medical Conduct has prepared a guide to pain management for patients, which can be found at: http://www.health.state.ny.us/publications/4180.pdf.

Pain Management for Practitioners

A guide to pain management for physicians can be found at: http://www.health.state.ny.us/publications/4179.pdf. The text of the guide is reprinted below.

An adequate assessment of the patient and the pain should be performed and documented.

Pain should be considered a fifth vital sign that is viewed as a fundamental assessment of well-being, and which is regularly monitored.

Communication is essential. Many patients, for various reasons, are unable to describe their pain adequately. Physicians should initiate conversations to identify pain and qualify/quantify it and its impact on the patient's life.

Treatment should be based on the diagnosis, type of pain, intensity and duration of pain, prior therapies, and the impact on quality of life.

Ongoing evaluation of pain, patient compliance, and treatment efficacy should be performed and documented.

The definition of addict under the controlled substances law excludes patients using controlled substances for legitimate medical purposes. The term addiction refers to compulsive use of controlled substances for nonlegitimate purposes and is associated with loss of control and use despite harm. Many patients are reluctant to seek pain relief because of the fear of addiction. Clarification from their physician is essential.

Certain patients with pain, such as those with history of substance abuse or a comorbid psychiatric disorder, may require extra attention, monitoring, documentation, and consultation.

The Board evaluates inappropriate vs appropriate prescribing, not the quality of drugs prescribed. The Bureau of Narcotic Enforcement has reviewed and concurs with these guidelines.

Misuse and Abuse of Prescription Drugs

The New York Bureau of Narcotics publishes news bulletins on topics related to prescription drug abuse. Samples are available at:

http://www.health.state.ny.us/publications/1020.pdf and http://www.health.state.ny.us/publications/1021.pdf.

The New York State Department of Health produced a question and answer guide for patents about the misuse of prescription drugs, which is available here.

A brochure titled, Substance Abuse and Treatment: Information for Practitioners, is available online at: http://www.health.state.ny.us/publications/1063.pdf.

Lost or Stolen Prescription Pads or Serialized Pads

The form used to report the loss or theft of New York State Prescription forms is available at: http://www.health.state.ny.us/forms/doh-4387.pdf

To search for lost or stolen New York State Prescription forms, go to: http://www.health.state.ny.us/professionals/narcotic/lost/lost.htm

Author Information

Jennifer Bolen, JD, Jennifer Bolen, JD, Founder, The Legal Side of Pain, Lenoir City, Tennessee http://www.legalsideofpain.com

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

Medscape Neurology & Neurosurgery.  2008; ©2008 Medscape

 

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Legal Disclaimer:  The purpose of these summaries is to inform and educate clinicians on the various legal/regulatory materials that govern the use of controlled substances to treat pain. The information contained within these summaries is not intended to serve as specific legal advice, and you should review the source material and consult your local attorney and/or state licensing board to determine the relevance to your practice.
 
 
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