Providing Safe, High Quality Treatment in the Office Molly Rutherford, MD Family Physician Bluegrass Family Wellness Crestwood, KY I have no commercial interests to disclose Went kicking and screaming into this – hired – no hurry – bad rep in Eastern KY – knew peopleknow did it -- $$ - more rewarding part of my practice Their stories – they get better – build relationships Doesn’t always work For me, had to build skills as a clinician, interviewer and become seasoned, before doing this, or I don’t know that I would have been as successful

Learning Objectives Review the ASAM decision making guidelines Explain how to obtain a DEA waiver Identify how to find appropriate/approved training Understand the KBML regulations for buprenorphine treatment Review the 2016 CARA Act Identify the prescribing regulations in Kentucky for home use naloxone In a nod to Jenny Potter’s lecture on Thursday, we’re going to PRACTICE a brief in office counseling intervention.

Drug Addiction Treatment Act (DATA), 2000 Permits qualified physicians to treat opiate dependence with controlled substances approved by the FDA for that indication in settings other than traditional opiate treatment programs (methadone clinics). Waives the requirement for obtaining a separate DEA registration as a Narcotic Treatment Program (NTP). A brief History of Opiate Laws in the US: 1914 Harrison Narcotics Tax Act was a United States federal law that regulated and taxed the production, importation, and distribution of opiates products. However a clause applying to doctors allowed distribution "in the course of his professional practice only." This clause was interpreted after 1917 to mean that a doctor could not prescribe opiates to an addict, since addiction was not considered a disease. So physicians could prescribe narcotics to patients in the course of normal treatment, but not for the treatment of addiction. 1970 Controlled Substance 1970 – created the Five schedules of controlled substances 1974 narcotic addiction Treatment act – regulation of methadone for opiate maintenance treatment Cut the red tape

DATA, 2000 To receive a waiver, a physician notifies the Center for Substance Abuse Treatment (CSAT) at SAMSHA of notice of intent (NOI) to begin treatment. The NOI must contain: physician’s qualifying credentials proof of capacity to refer patients to counseling Notice that physician will not have more than 30 patients at any one time for the first year. Address of physician’s primary practice location One year after the date the physician submits initial NOI, the physician may submit a second NOI stating the need and intent to treat up to 275 patients.

DATA Qualifying Credentials To qualify for a waiver, a licensed physician (MD or DO) must meet any one or more of the following criteria: Board certified in addiction psychiatry or addiction medicine Addiction certification from the American Society of Addiction Medicine. Completed ≥8 hours of training in addiction medicine by any CSAT approved organization.

Buprenorphine Training for Physicians The Buprenorphine Waiver Training at the American Academy of Addiction Psychiatry covers legislation, pharmacology, safety, patient assessment, and more. Complete all the modules and pass the post-test at the end. The American Society of Addiction Medicine offers the ASAM Buprenorphine Course for Office-Based Treatment of Opioid Use Disorders in multiple formats that all provide the required 8 hours needed to obtain the waiver to prescribe buprenorphine in office-based treatment of opioid use disorders. The Providers Clinical Support System for Medication Assisted Treatment Self Study at the American Osteopathic Academy of Addiction Medicine developed by the Providers’ Clinical Support System for Medication Assisted Treatment (PCSS-MAT), consists of a 4.25-hours webinar session and a 3.75-hours online session.

DATA, 2000 DEA processes the application and issues practitioner a Unique Identification # DEA: AB123456 UIN: XB123456 Must be on the prescription Practitioner may practice in multiple locations in one state or in multiple states. One state – many practices Records or prescriptions for drug treatment must be maintained at the DEA registered location Multiple States Records must be maintained at the DEA registered location in each state from which the prescription was written

DEA Inspection DEA is required to ensure the registrants comply with the Controlled Substance Act. Inspections are unannounced DEA issues a Notice of Inspection to inspect required records Records must be available for DEA inspection for at least 2 years

201 KAR 9:270 Professional Standards for prescribing or dispensing Buprenorphine

Qualifications Obtain and maintain in good standing a DEA waiver to prescribe buprenorphine for the treatment of opioid dependence Complete the following educational requirements: Buprenorphine certification training through a SAMSHA certified course. For each 3 year cycle, complete at least 12 hours of cat 1 CME in addiction medicine Enroll in the Kentucky Health Information Exchange

Medications Buprenorphine +/- naloxone may only be dispensed or prescribed for medically supervised withdrawal or as maintenance treatment for patients diagnosed with opioid dependence. Transdermal buprenorphine may be used for the treatment of pain Buprenorphine monoproduct may only be used for: Pregnant patients Patients with demonstrated hypersensitivity to naloxone as injectable treatment in a facility

Use of other Controlled Medications A patient on buprenorphine for opioid dependence may not also be prescribed benzodiazepines, stimulants, other opioids or sedative hypnotics without the consultation of a board certified psychiatrist or addiction specialist. A physician may prescribe Buprenorphine to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants, or other opioids, without consultation in order to address an extraordinary and acute medical need not to exceed a combined period of thirty (30) days (ex: acute injury, surgery, psychiatric crisis).

History, Laboratory Evaluation Prior to initiating treatment, the prescribing physician will: Obtain and record a complete and appropriate evaluation of the patient which shall at a minimum include the patient’s: History of present illness History of substance use Social and family history Past medical and psychiatric histories Physical exam of the patient The patient’s injection use history Appropriate laboratory tests, which MUST include a CBC, a drug screen, a CMP, screening for HIV and hepatitis serology

Medical Records, KASPER, Informed Consent Obtain the patient’s prior medical records. Review and incorporate the information from the records into the evaluation and treatment of the patient. If, despite your best efforts to obtain the patient’s prior medical records, you cannot, document those efforts in the patient’s chart Obtain and review a KASPER report for that patient for the twelve (12) month period immediately preceding the initial patient encounter Explain treatment alternatives and the risks and the benefits of treatment with Buprenorphine to the patient Obtain written informed consent from the patient

Women of Child Bearing Age For women of child bearing age: Prior to initiating treatment, obtain a pregnancy test Counsel patients on the risk of neonatal abstinence syndrome in a way consistent with the guidelines from ACOG, AAP and ASAM Offer means to prevent pregnancy. If the patient is pregnant or breast feeding, prior to initiating treatment with buprenorphine, a consultation with an addiction specialist, psychiatrist or an obstetrician qualified to prescribe buprenorphine must be documented as to whether the potential benefit of Buprenorphine use outweighs the potential risk of use.

New Starts In office induction protocol is preferred and reccomended. Before starting induction, document the presence of withdrawal with a standardized scale, like the COWS. Initiate treatment with a dose equivalency of not more than four (4) milligrams buprenorphine generic tablet, which: May be followed by subsequent doses if withdrawal persists and is not improving; and Cannot exceed the dose equivalency of sixteen (16) milligrams buprenorphine generic tablet on the first day of treatment.

Patients Who Transfer Care If the patient is transferred from another treatment provider and has previously experienced withdrawal without a relapse, the prescribing or dispensing physician may: Document that fact; Educate the patient about the potential for precipitated withdrawal Continue maintenance treatment of the patient on the same dosage as established by the previous treatment provider

Visit Frequency The patient should be seen by the prescribing physician: No later than ten (10) days after induction and then at intervals of no more than ten (10) days for the first month after induction At intervals of no more than fourteen (14) days for the second month after induction If the patient demonstrates objective signs of positive treatment progress, the prescribing physician must see the patient at least once monthly thereafter. If two (2) years after initiation of treatment, the patient has demonstrated objective signs of positive treatment progress, then the prescribing physician may require that the patient be seen only at least once every three (3) months.

Behavior Modification The prescribing physician must implement a treatment plan that requires objective behavioral modification by the patient. This may include counseling or a twelve (12) step program.

Prescription Amounts The physician may prescribe an amount of Buprenorphine that: Is necessary to minimize craving and opiate withdrawal Does not produce opiate sedation Is to be taken no more frequently than once daily Is able only to supply the patient until the next physician visit

Treatment Parameters Every twelve (12) months following initiation of treatment, if a patient’s prescribed daily dosage exceeds the dose equivalency of sixteen (16) milligrams buprenorphine per day and the prescribing physician is not a board certified addiction specialist or psychiatrist, then the prescribing physician must refer the patient for consultation by an addiction specialist or psychiatrist for an opinion as to whether continued treatment and dosage is appropriate and must document the results of that consultation in the patient chart. Every twelve (12) months following initiation of treatment, the prescribing physician shall evaluate for and document the medical necessity for continued treatment at the established dose.

KASPER Reports A KASPER report must be obtained on the patient at least once every three months. If the KASPER indicates any abnormal findings, the prescribing physician must incorporate those findings into appropriate clinical reasoning to support the continuation or modification of treatment and document the reasoning in the patient’s record. Appropriate clinical reasoning may include adjustment of dose strength or frequency of visits, increased screening, a consultation with a specialist, or an alternative treatment.

Drug Screens The prescribing physician must obtain at least eight (8) drug screens from the patient within each twelve (12) month period of treatment. For patients who have demonstrated objective signs of positive treatment progress for at least two (2) years from the date of initiation of treatment, including documented evidence that the patient has been compliant with the treatment plan and all treatment directives, the prescribing physician must obtain at least six (6) drug screens from the patient within each twelve (12) month period of treatment. At least two (2) of the drug screens must be random and coupled with a pill count. Each drug screen must, at a minimum, screen for buprenorphine, methadone, oxycodone, other opioids, THC, benzodiazepines, amphetamines, and cocaine. If a drug screen indicates any abnormal findings, the prescribing physician must incorporate those findings into appropriate clinical reasoning to support the continuation or modification of treatment and document this in the patient record. Appropriate clinical reasoning may include adjustment of dose strength or frequency of visits, increased screening, a consultation with a specialist, or an alternative treatment.

Lost/Stolen Medications The prescribing physician must document a plan for handling any lost or stolen medication, which: Will not provide for the automatic replacement of medication prior to the specified interval date; and If the prescribing physician determines that it is necessary to minimize improper or illegal diversion of medications, must require the patient to first report the lost or stolen medications to police.

Violation Failure to comply with or a violation of the professional standards established in this administrative regulation shall constitute a "departure from, or failure to conform to the standards of acceptable and prevailing medical practice within the Commonwealth of Kentucky.”

CARA ACT, July 2016 On July 13, 2016, the US Senate passed CARA with a vote of 92-2, and President Obama signed it into law on July 22, 2016. The Comprehensive Addiction and Recovery Act (CARA) of 2016 is the most expansive federal, bipartisan legislation to date for addiction support services. CARA authorizes $181.1 million per year for five years, for a total $905 million in funding.

KRS 217.186 This administrative regulation establishes the minimum requirements for the pharmacist to be able to dispense naloxone pursuant to a physician- approval protocol.

Procedures for Dispensing of Naloxone The pharmacist has met the requirements of this administrative regulation The pharmacist has received his or her certification The pharmacist has a physician-approved protocol that meets the minimum requirements The pharmacist documents dispensing events in the pharmacy management system including: Documentation as required for the dispensing of prescription medication Documentation that the individual receiving naloxone was provided with the required training and education

Pharmacist Training Required Dispense Naloxone Risk factors for opioid abuse and overdose Opioid overdose prevention Recognizing and responding to opioid overdoses Indications for use of naloxone as rescue therapy Contraindications for use of naloxone Administration of naloxone Adverse effects associated with naloxone rescue therapy Identification of patients who meet criteria for provision of naloxone Required education to provide to persons receiving naloxone Required elements of protocol to initiate dispensing of naloxone Required documentation when initiating dispensing of naloxone

Eligibility for Naloxone Kits 1. Persons with history of receiving emergency medical care for acute opioid poisoning or overdose 2. Persons with a suspected history of substance abuse or nonmedical opioid use 3. Persons receiving high-dose opioid prescriptions (E.g. >100 mg morphine equivalent) 4. Persons who are opioid naïve and receiving a first prescription for methadone for pain 5. Persons starting buprenorphine or methadone for addiction treatment 6. Persons on opioid prescriptions for pain in combination with: a. Smoking, COPD, emphysema, sleep apnea, or other respiratory illness b. Renal dysfunction, hepatic disease, or cardiac disease c. Known or suspected alcohol use d. Concurrent benzodiazepine or other sedative prescription e. Concurrent antidepressant prescription 7. Persons who may have difficulty accessing emergency medical services 8. Voluntary request by person or agency

Education to be Provided to Person Receiving Naloxone Prescription Under Protocol Risk factors of opioid overdose Strategies to prevent opioid overdose Signs of opioid overdose Steps in responding to an overdose Information on naloxone Procedures for administering naloxone Proper storage and expiration of naloxone product dispensed