Controlled Substances NY State Part 4 PDF

CONTROLLED SUBSTANCES NY STATE PART 4 PHM 525 Fall 2024 Bureau of Narcotic Enforcement New York State Department of Health Bureau of Narcotic Enforcement http://www.health.ny.gov/professionals/narcotic  Newsletters and notices  The Law The Regulations ...

CONTROLLED SUBSTANCES NY STATE PART 4 PHM 525 Fall 2024 Bureau of Narcotic Enforcement New York State Department of Health Bureau of Narcotic Enforcement http://www.health.ny.gov/professionals/narcotic  Newsletters and notices  The Law The Regulations  6 Bureau Overview  7 Bureau of Narcotic Enforcement (BNE) Health Initiatives Investigation & Enforcement Regulatory Compliance Unit (Licensing) & Drug Destruction Data Management & Analysis  8 Bureau of Narcotic Enforcement (BNE) Public Health Initiatives & Administration Administers Official Prescription Program, Prescription Monitoring Program, Electronic Prescribing Mandate, Mandatory Provider Training and grants Conducts education and outreach Helps formulate policy and regulations Narcotic Investigations Conducts investigations, inspections, outreach Partners with law enforcement and regulatory agencies  9 Bureau of Narcotic Enforcement (BNE) Regulatory Compliance Issues licenses, certifications, and permits Data Analysis Reviews incoming data to ensure timeliness and accuracy Works with IT on all new initiatives Conducts data analysis for Bureau initiatives  What about the DEA??  Rules for prescribing….Why do I have to know these? Prescribing Regulations 80.63 Prescribing. (a) A prescription as defined by the Public Health Law means: (1) an official New York State prescription; (2) an electronic prescription; (3) an oral prescription; or (4) 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 (b) The use of preprinted prescriptions which indicate the controlled substance or the strength, dosage and/or quantity of the controlled substance is prohibited. Such prohibition shall not apply to printed prescriptions generated by means of a computer or an electronic medical record system, provided such printed prescriptions are generated at the time a practitioner prescribes a controlled substance for a patient. c)(1) Prior to prescribing for or dispensing to a patient any controlled substance listed on schedule II, III, or IV of section 3306 of the public health law, every practitioner shall consult the prescription monitoring program registry for the purpose of reviewing that patient's controlled substance history. 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. A practitioner shall document such consultation in the patient's medical chart or, if the practitioner does not consult the prescription monitoring program registry, the practitioner shall document in the patient's medical chart the reason such consultation was not performed. Such documentation shall include the specific exception listed in paragraph (2) of this Subdivision.  What about transfers?  (c)(1) No controlled substance prescription shall be issued prior to the examination of the patient by the practitioner except as otherwise permitted by this subdivision.  (2) Once the initial examination has been completed, the frequency and necessity for future examinations prior to prescribing, either for the same acute or chronic condition, will be made by the practitioner utilizing generally accepted medical standards, including taking into account the drug to be prescribed and the patient's condition, history and disposition toward the use of controlled substances.  (3) In the temporary absence of the initial prescriber, an authorized practitioner may issue a controlled substance prescription for a patient as part of a continuing therapy if the practitioner: (i) had direct access to the patient's medical records and such records warrant continued controlled substance prescribing, or  (ii) had direct and adequate consultation with the initial prescriber, who assures the necessity of continued controlled substance prescribing and with which the practitioner concurs. If the patient record is not available, the practitioner shall document the activity for his or her own record and shall transmit to the initial prescriber the prescription information. The initial prescriber shall include the prescription information in the patient's record  (4) 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.  (5) If a patient develops a new condition that would warrant the issuance of a prescription for a controlled substance, a practitioner may issue such prescription prior to performing an examination if: (i) the prescribing practitioner has a previously established practitioner/patient relationship with the patient; and (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 of section 80.68 and section 80.70 of this Part. (80.68 defines emergency and 80.70 are the rules for oral Rxs for controls)  Who May Prescribe Controlled Substances (NY)? A physician (including DOs), dentist, podiatrist, veterinarian, scientific investigator (limited), or other person licensed, or otherwise permitted to dispense, (including duly authorized Midwives, Nurse Practitioners, Physician Assistants and , pharmacists in a CDTM setting But not yet) NOT TO INCLUDE OPTOMETRISTS MIDWIVES http://www.op.nysed.gov/prof/midwife/ midwifeqa.htm 80.64 Who may issue. A prescription for a controlled substance may be issued only by a practitioner who is: (1) authorized to prescribe controlled substances pursuant to his licensed professional practice; and (2) either registered under the Federal Controlled Substances Act and in possession of a registration number from the Drug Enforcement Administration, United States Department of Justice, or its successor agency, or exempted from such registration as an exempt official. (b) A practitioner issuing an electronic prescription for a controlled substance, in addition to meeting the provisions as noted in paragraph (a) of this section, shall also: (1) use an electronic prescribing application that is consistent with federal requirements; and (2) register the certified electronic prescribing application with the New York State Department of Health, Bureau of Narcotic Enforcement. (c) Prescriptions excepted from any electronic prescribing requirement set forth in Article 2-a of the public health law include prescriptions: (1) issued by veterinarians; (2) issued in circumstances where electronic prescribing is not available due to temporary technological or electrical failure. For the purposes of this Part, temporary technological or electrical failure shall be defined as: any failure of a computer system, application, or device, or the loss of electrical power to that system, application, or device, or any other service interruption to a computer system, application, or device in such a manner that is reasonably prevents a practitioner from utilizing his or her certified electronic prescribing application to transmit an electronic prescription for a controlled substance in accordance with this section and federal requirements. In the instance of a temporary technological or electrical failure, a practitioner shall, without undue delay, seek to correct any cause for the failure that is reasonably within his or her control; (3) issued by practitioners to whom the commissioner has granted a waiver, or a renewal thereof, from the requirement to use electronic prescribing. A waiver may be issued by the commissioner based upon a showing of a practitioner that his or her ability to issue an electronic prescription in accordance with this section is unduly burdened  Official prescriptions written by a Physician's Assistant must contain the imprinted (stamped or typed) name of both the Physician's Assistant and the Supervising Physician and DEA # of PA (same for non controls). Same applies to RPh in CDTM -includes ERxs- It is not required to be countersigned by the supervising physician. Rx’s only within scope- must be patient of supervising MD  Certified Nurse Practitioner (NP) Uses own Rx Blank All Rx info including “F” reg number May prescribe controlled substances if registered with DEA for all classes Own signature appears on Rx Prescribing within scope of practice MDs Vets DDS Podiatrists RPAs NP ** Nurse Practitioners specialty prefixes (in appendix) And the letter “F” Acute care 43 Adult care 30 College Health 31 Community Health 32 Family Health 33 Gerontology 34 Holistic Nursing 45 Neonatology 35  CNPs continued Ob/Gyn 36 Oncology 37 Palliative Care 44 Pediatrics 38 Perinatology 39 Psychiatry 40 School Health 41 Women’s Health 42 AUTHORIZED PRESCRIBERS must have DEA number. - It begins with the letter “A” or “B” or “F” - Then the first letter of the prescribers last name - Then 7 integers TO VERIFY A PRESCRIBERS DEA NUMBER: - Take the first 6 digits of the 7 integers - Add nos. 1 + 3 + 5 = _______ = _______ - Add nos. 2 + 4 + 6 = ________ x 2 = + ________ ________ = last digit An example using the first six digits = 1 8 5 9 4 4 ___ What is the last digit (proof number)? Answer: 2 Purpose of issue 80.65 80.65 Purpose of issue. A prescription, in order to be effective in legalizing the possession of controlled substances, shall be issued for legitimate medical purposes only. The responsibility for the proper prescribing and dispensing of controlled substances shall be on the physician, dentist, podiatrist, veterinarian or other authorized practitioner, but a corresponding liability shall rest with the pharmacist who fills the prescription. The U.S. Drug Enforcement Administration filed legal documents Friday detailing why it wants to block two Sanford CVS pharmacies from selling controlled substances — a measure, federal officials have said, that is part of the agency's efforts to combat Florida's prescription-drug epidemic. DEA officials said CVS "did not have the adequate measures in place—or at least none that were actually practiced by the employees," to ensure prescriptions were legitimate at two of their busiest pharmacies in the state. 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 comfortable by maintaining his customary use, is not a prescription within the meaning of subdivision 30 of section 3302 of the Public Health Law and the person knowingly filling such an order, as well as the person issuing it, shall be subject to the penalties provided for violation of the provisions of law relating to controlled substances. Internet…. It is illegal to receive a prescription for a controlled substance without the establishment of a legitimate doctor/patient relationship, and it is unlikely for such a relationship to be formed through Internet correspondence alone. New York……Internet prescribing Section 80.63 requires a practitioner to physically examine a patient prior to initially prescribing a controlled substance. Issuing an Rx for a c.s. solely on the basis of a questionnaire or other medical history submitted to a practitioner over the internet does not meet the requirements of a physical examination or establish a legitimate practitioner-patient relationship and is not a valid Rx…… Once the initial examination has been made, the necessity for future examinations, and their frequency, is a matter of clinical judgment based on generally accepted medical standards.  Written prescriptions for controlled substances All prescriptions written in NY must be written on an official NYS Rx (no matter where they are to be filled) or electronically transmitted How long is a c.s. Rx valid? 80.73 Pharmacists. (a)…… presented within 30 days of the date such prescription was signed by the authorized practitioner What is Required on a Written Controlled Substance Prescription ? Prescriber Name Address Phone Number Profession DEA # Date written Signature Serial # What is Required on a Written Controlled Substance Prescription ? Patient Information Name (species and owner if animal) Address (not PO Box) Age Sex What is Required on a Written Controlled Substance Prescription ? DRUG Information Name Strength Quantity (numerical & word) (or by Sig) Specific Directions for use Maximum Daily Dose** Refill # (numerical and word)  What is Required on a Written Controlled Substance Prescription ? Patient Information Prescriber Name Name (species and owner if animal) Address Address (not PO Box) see appendix 2 Phone Number Age Profession Sex DEA # Date written Signature DRUG Information Serial # Name Strength Quantity (numerical & word) (or by Sig) Specific Directions for use Maximum Daily Dose** Refill # (numerical and word) AS1857020 John Q Public Today’s Date 123 Main Street Anytown NY 11111 51 x Acetaminophen with Codeine #3 #30 S: Take one tablet q 4 h prn 4 pain C.A.SalzbergCA Salzberg Note: DEA # in most cases will not be imprinted. In order for a controlled substance Rx that is written to be valid, the DEA # of the prescriber MUST be on the Rx…. Adhesive stickers and labels containing only patient information are valid for use on official prescriptions for non-controlled substances if they are affixed permanently to the prescription. Patient information includes the patient name, address, and date of birth **Maximum Daily Dose It is the view of BNE that controlled substance regulations require the prescriber to indicate the MDD on all controlled substance Rxs. The pharmacist is required to indicate the specific directions for use, as stated on the prescription, on the label. Therefore, if the prescriber indicates an MDD on the Rx, the pharmacist should indicate this on the label. What is missing?? DEA # auth by? MDD NPI sex of patient