8 Simple Rules for Prescribing Opioids…That Many Doctors Ignore

Medication Errors, Opioid

Controlled substances include opioids, stimulants, hallucinogens, and anabolic steroids.

Drugs that are considered controlled substances under the Controlled Substance Act are divided into five schedules. Substances are placed in their respective schedules based upon their relative abuse potential and likelihood of causing dependence when abused.

Under the Federal Narcotics Substance Act, Schedule II controlled narcotics include oxycodone (OxyContin), percocet and fentanyl. Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.

A practitioner may prescribe a controlled substance to their patient after a review of the patient’s record if the record contains the result of an examination performed by a consulting physician and such record warrants the prescribing. Initial opioid prescribing for acute pain is limited to a 7-day supply.

Rule #1: Controlled Substances Should Not be Prescribed for Addicts or Habitual Users of Controlled Substances

“Controlled substances shall not be prescribed for, administered, or dispensed to addicts or habitual users of controlled substances….” 10 N.Y.C.R.R. section 80.76.

Rule #2: Doctor Must Consult with the Prescription Monitoring Program Registry

Prior to prescribing or dispensing to a patient any controlled substance every practitioner shall consult the prescription monitoring program registry for the purpose of review that patient’s controlled substance history. The registry can be accessed 24 hours a day, 7 days a week.

“Every practitioner shall consult the prescription monitoring program registry prior to prescribing or dispensing any controlled substance.”

New York State Controlled Substances Act section 3343-a.

The patient’s controlled substance history shall be obtained from the prescription monitoring program registry no more than 24 hours prior to the practitioner prescribing or dispensing any controlled substance to that patient. 10 N.Y.C.R.R. section 80.63.

Documentation of registry consultation to verify every patient’s narcotic prescription history is mandatory.

Rule #3: Doctor must Document the Need for the Controlled Substances in the Patient’s Medical Record

A practitioner shall document each consultation in the patient’s medical chart or hospital.

“Such practitioners shall maintain a written patient record of administration, dispensing and prescription of all controlled substances.” 10 N.Y.C.R.R. section 80.62(b). The patient’s record shall contain sufficient information to justify the diagnosis and warrant the treatment.

The record shall contain at least the following information: patient identification, chief complaint, present illness, physical examination as indicated, diagnosis, other data which support the diagnosis or treatment and the regiment involving the amount, strength and directions for use of the controlled substance.

Rule #4: Requirements for Doctors Who Prescribe a Controlled Substance

“A prescription for a controlled substance may be issued only by a practitioner who is: (2) either registered under the Federal Controlled Substance Act and in possession of a registration number from the Drug Enforcement Agency…or exempted from such registration as an exempt official.” 10 N.Y.C.R.R. section 80.64(b)

“A practitioner issuing an electronic prescription for a controlled substance shall also: (1) use an electronic prescribing application that is consistent with federal requirements; and (2) register the certified prescribing application with the New York State Department of Health and Bureau of Narcotic Enforcement.” 10 N.Y.C.R.R. section 80.64(b).

Under section 3332 of the NYS Controlled Substances Act, “Such prescription…must contain the following: (c) specific directions for use including but not limited to the dosage and frequency of dosage and the maximum daily dosage” as well as “the date upon which such prescription was actually signed by the prescribing practitioner.”

“The practitioner shall deliver the original official New York State prescription to the ultimate user or shall transmit the electronic prescription to the pharmacy.” NYS Controlled Substances Act section 3332(4).

“No controlled substance may be dispensed or sold unless it is enclosed within a suitable container and (a) affixed to such container is a label upon which is indelibly printed the following: (v) the legend, prominently marked or printed in either boldface or upper case lettering: CONTROLLED SUBSTANCE DANGEROUS UNLESS USED AS DIRECTED” and (vi) the number of the prescriptions under which it is recorded in the pharmacist’s prescription file.” NYS Controlled Substances Act section 3333(2).

Within 24 hours prior to a practitioner prescribing or dispensing a controlled substance, the practitioner must log in to their individual established HCS account at wwww.commerce.health.state.ny.us.

Rule #5: Requirements for Doctors Who Prescribe Controlled Substances Out of State

The Controlled Substances Act requires practitioners prescribing controlled substances to patients in another state via telemedicine to be registered in those patients’ states. The Controlled Substances Act requires all practitioners to be registered in the state in which the patient to which they are prescribing controlled substances are located, regardless of whether the prescribing is taking place via telemedicine. 21 U.S.C. section 822.

DEA regulations require that the practitioner obtain a separate DEA registration in each state in which a patient to whom he or she prescribes a controlled substance is located when the prescription is made regardless of whether the prescription is made via telemedicine. 21 U.S.C. section 822.

Prescription information for all out-of-state prescriptions for a controlled substance shall be filed with the Department of Health. 10 N.Y.C.R.R. section 80.78.

Rule #6: Doctor Must File Information about the Prescription with the New York Department of Health

“A practitioner who issues a prescription pursuant to paragraph 2 of subdivision (c) of this section shall file the information about the issuance of such prescription with the department as soon as practicable, but in no instance more than 72 hours.” 10 N.Y.C.R.R. section 80.64(d).

“The practitioner shall submit dispensing information, for all controlled substances dispensed, electronically to the department utilizing a transmission format acceptable to the department, not later than 24 hours after the substance was delivered.” 10 N.Y.C.R.R. section 80.71(e).

Practitioners and pharmacists must electronically file prescription dispensing information with the Bureau of Narcotic Enforcement on a real-time basis within 24 hours prior to dispensing Schedule II, III or IV controlled substances.

Rule #7: Doctor Must Use Required Federal Forms for Prescribing Controlled Substances

“No practitioner shall obtain Schedule II controlled substances except by means of his or her Federal written order forms.” 10 N.Y.C.R.R. section 80.60.

The Controlled Substances Act provides that every person who dispenses, or proposes to dispense, any controlled substance shall obtain from the Drug Enforcement Agency a registration issued in accordance with the DEA rules and regulations. 21 U.S.C. section 822(a)(2).

“Prescriptions shall not be refilled for Schedule II substances….” 10 N.Y.C.R.R. section 80.67(b).

Rule #8: Doctors Must Perform an In-Person Examination of the Patient for Prescriptions Issued via the Internet

Under the Controlled Substances Act, a prescription for a controlled substance issued by means of the internet must generally be predicated on an in-personal medical evaluation. 21 U.S.C. section 829(e)(1).

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was created to regulate online internet prescriptions. The Act requires any practitioner issuing a prescription for a controlled substance to conduct an in-person medical evaluation prior to prescribing controlled substances.