Kent S. Hoffman, D.O. Board Certified Addiction Medicine Board Certified Family Practice Team Physician Orlando Magic

The Harrison Narcotics Tax Act (Ch. 1, 38 Stat. 785) was a United States federal law that regulated and taxed the production, importation, and distribution of opiates. The act was proposed by Representative Francis Burton Harrison of New York and was approved on December 17, “An Act To provide for the registration of, with collectors of internal revenue, and to impose a special tax on all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes.” The courts interpreted this to mean that physicians could prescribe narcotics to patients in the course of normal treatment, but not for the treatment of addiction.

Identifying opioid-dependent patients

The Landscape Today >100 million people in the US have chronic pain >200 million Rx’s are written for opioid’s The opioid-dependent population in the US is estimated at 5 million. The actual diagnosed opioid-dependent population is only 2 million. The number of opioid-dependent patients getting treatment is only about 800,000 (300K on Methadone and 500K on Suboxone, generic buprenorphine, Bunavail and Zubsolv). Suboxone prescription growth is at 15% annually.

DATA 2000 DATA 2000 permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with Schedule III, IV, and V opioid medications or combinations of such medications that have been specifically approved by the Food and Drug Administration (FDA) for that indication. Such medications may be prescribed and dispensed. In order to qualify for a waiver under DATA 2000, physicians must hold a current State medical license, a valid DEA registration number, and must meet one or more of the following conditions: The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. The physician holds an addiction certification from the American Society of Addiction Medicine. The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association. The physician has completed not less than eight hours of training with respect to the treatment and management of opioid-addicted patients. This training can be provided through classroom situations, seminars at professional society meetings, electronic communications, or otherwise. The training must be sponsored by one of five organizations authorized in the DATA 2000 legislation to sponsor such training, or by any other organization that the Secretary of the Department of Health and Human Services (the Secretary) determines to be appropriate. The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in Schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug. The physician has other training or experience, considered by the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) to demonstrate the ability of the physician to treat and manage opioid-addicted patients. The physician has other training or experience the Secretary considers demonstrates the ability of the physician to treat and manage opioid-addicted patients. In addition, physicians must attest that they have the capacity to refer addiction treatment patients for appropriate counseling and other non-pharmacologic therapies, and that they will not have more than 30 patients on such addiction treatment at any one time unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.

Dopamine Reward Pathway

Treatment Several forms of medical assisted therapy (MAT) are available for opioid dependency today: Suboxone (buprenorphine/naloxone); also Zubsolv, Bunavail Buprenorphine Methadone Naltrexone (Vivitrol injection and generic tabs) 12 step program, counseling, and spiritual program are added to all forms of MAT as no drug, pill or shot gets anyone into recovery! In my office optimal length of medication treatment is 9-12 months. But… I am not a harm reductionist.

Suboxone Pharmacology  Suboxone is the combination of buprenorphine and naloxone. Buprenorphine, a partial–opioid agonist, is the primary active ingredient. Naloxone, an opioid antagonist, is present to discourage diversion and IV use.  Suboxone is used as a sublingual film. Suboxone comes in 2/0.5 mg and 8/2 mg films Suboxone has been available since 2002 for opioid dependency

Properties of Suboxone  Suboxone has a strong affinity for the mu receptor. 16 mg of Suboxone binds 95% of the mu receptors Suboxone has a 36-hour half-life  Suboxone prevents withdrawal and cravings.  Suboxone forms a covalent bond with the mu receptor like the endorphins. It blocks other full agonists (insurance policy) It allows the brain to heal (neurotransmitters regenerate) It creates reverse tolerance and allows the mu receptor to “heal”  Suboxone doesn’t produce euphoria in opioid tolerant patients.  Suboxone is very safe - it has 6% respiratory depression of morphine and it has a ceiling effect regardless of dosage.

Buprenorphine Single agent buprenorphine became generic in Single agent buprenorphine use is discouraged due to it’s increased illicit use (IV) and diversion potential. The single agent was originally used for the initial induction phase of treatment but this is no longer considered best practice. Single agent buprenorphine should be reserved for pregnant patients.

Methadone Dosed once daily for addiction (every 6 hours for pain) Half-life of 24 to 36 hours (for addiction purposes) Dosed daily at an Opioid Treatment Program (OTP) which are registered by the DEA and licensed by the State of Florida Relieves cravings and withdrawal Allows normal functioning Some patients require this daily monitoring and accountability Has been the drug of choice for opioid-dependent patients during pregnancy

Methadone (cont.) Counseling and 12-step meetings are encouraged. Methadone has many potential drug interactions. Prozac, Tagamet, Ketoconazole, Flagyl, several HIV meds, and others - increase Methadone levels. Rifampin, Tegretol, Barbiturates, Verapamil, amitriptyline (Elavil), alcohol, and others decrease Methadone levels. Increased serum Methadone levels have been associated with QT prolongation and “Torsades” arrhythmia.

Naltrexone – Vivitrol injection An opioid antagonist (it blocks the opioid receptor producing an opioid blockade for 28 days) Has no potential for euphoria, abuse or diversion Costs $1,000 per shot Cannot be given until days after last opioid ingestion

What’s in the research pipeline? Implantable buprenorphine rods – implantable “suboxone” rods stay in the upper arms for 6-8 months, prevent cravings and withdrawal, allow brain to heal and provide and opioid barrier for “slips/relapse” Monthly Depot Buprenorphine injection – early studies to show a total opioid blockade is achieved on a monthly basis. This eliminates potential for misuse, abuse and diversion Ibogaine/Noribogaine – psychedelic plant used to treat addiction to various drugs (most studied in opioids) historically banned in the U.S.

How does my world mesh with NA In a perfect world… All my patients would go to counseling All my patients would go to NA I would pick up the phone and call someone to meet my new patient at their first NA meeting All my patients would be off their MAT in 9-12 months and live to be happy joyous and drug free In reality, I tell my patients to go to NA, I give them a highlighted list of the best meetings in town and I tell them to say nothing about their meds to people at the meeting.

What does NA do well? Fellowship – we need new fiends in early recovery 12 divinely inspired steps – instructions and structure to live by Spiritual program – help in finding a HP

The shortcomings of NA No real connection with medical/addiction doctors (similar to the disconnect between doctors & counselors) The opioid population is greatly underrepresented in NA, a recent NA survey showed a 1:1 membership ratio of opioid to stimulant addicts, when nationally the ratio is greater than 3:1 in opioid addicts vs. stimulant addicts Bulletin #29 was authored in 1996, 6 years before Suboxone came to market in the U.S. and 9 years before it reached Florida

One last thought Is the newcomer still the most important person at the meeting?