7/24/2018. Two-Hour Opioid Prescribing Course. Total national filled opioid prescriptions:

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1 Course meets new BME rule. Two-Hour Opioid Prescribing Course Boyde J. Jerry Harrison, MD Steven P. Furr, MD Alabama Board of Medical Examiners June 28, 2018 Total national filled opioid prescriptions: ,814, ,462, ,780,915 Source: IMS Health Total Alabama filled opioid prescriptions:

2 Total hydrocodone/apa tabs dispensed in Alabama Methadone prescribed in the state of Alabama Past month misuse of prescription pain relievers, year olds 2

3 Is reduction of opioid prescribing effective? States with Greatest Decrease In Opioid Prescribing Rhode Island -19.1% Indiana -18.6% Oklahoma -17.5% Texas -16.8% Alabama -16.7% West Virginia -16.6% District of Columbia -14.7% Louisiana -14.1% Virginia -13.2% Ohio -13.1% California -12.8% Massachusetts -12.7% Maine -12.2% States with Highest Rate Of Opioid Deaths* 2015 Deaths per 100,000 population West Virginia 34.1 New Hampshire 28.6 Rhode Island 24.0 Ohio 23.2 Massachusetts 22.8 Kentucky 20.0 Connecticut 19.1 Maryland 18.1 Maine 17.9 New Mexico 16.8 Tennessee 15.7 Utah 15.0 *Includes heroin, in addition to C-II and C-III opioids Balanced message Excess prescribing is now part of how we got into this mess Opioid prescribing requires care and caution The epidemic has changed A LOT Not every pain patient is a person with addiction in waiting Per CDC, it s 0.9% at low doses, 5% at higher doses Making the same mistake backwards is not a solution ALBME Efforts to Combat Opioid Overuse 3

4 540-X-19, Pain Management Services Registration required for: Physician practice holding self out to public as a provider of pain mgt. services Physician practice which dispenses opioids Physician practice in which any providers of pain mgt. services are rated in top 3% of practitioners who prescribe c.s. as determined by the PDMP Pain Management Services continued Requirements for registration: Current DEA registration Current ACSC Current registration with PDMP Exemptions from registration: Hospice US government maintained/operated facilities Board may provide exemptions in its discretion and as deemed appropriate Pain Management Services continued If practice is owned wholly or partly by a person who has been convicted of or pled nolo contendere to a felony or misdemeanor relating to c.s., Board may interview applicant and approve or deny registration in its discretion Location must be owned and operated by: One or more physicians licensed to practice in AL Business entity registered with Secty. of State Governmental entity/body, political subdivision 4

5 Pain Management Services continued Medical Director is required Requirements for Med. Dir.: Current, unrestricted AL medical license Completion of residency or board or specialty certification in 11 specialties, board certification by Amer. Board of Pain Medicine or the American Board of Interventional Pain Physicians, or completion of 40 in person, live participatory CME credits Med. Dir. must be physically on site for a minimum of 10% of the clinic s operating hours Pain Management Services continued Grounds for revocation of regis. and/or fine up to $10,000: Conviction of a state or federal law relating to c.s. Suspension or revocation of DEA registration Excessive dispensing of c.s. Failure of physician who provides pain mgt. services to register Grounds for revocation of regis. and/or fine up to $1,000: Fraudulent/untrue statement on application Aiding/abetting providing of pain mgt. services by physician who is not registered Failure to register with PDMP Board Rule 540-X-4-.05, Registration of Dispensing Physicians and Osteopaths Dispensing = dispensing controlled substance to pt. for consumption/administration by pts. off practice premises, where c.s. purchased by practice for resale to pt. whether or not a separate charge is made Does not include prepackaged samples and starter packs. Does not include c.s. consumed by or administered to pts. while in the office, clinic, hospital, or other facility. Does not include c.s. dispensed to pt. in ER 5

6 Dispensing continued Registration is required for dispensing physicians Acting as dispensing physician without being registered may result in administrative fine up to $10,000 Dispensing physicians required to report c.s. info to ADPH/PDMP Registered dispensing physician who fails to report to PDMP may be fined up to $10,000 Board Rule 540-X-4-.09, Risk and Abuse Mitigation Strategies for Prescribing Physicians Complete Text of Rule (1) The Board recognizes that the best available research demonstrates that the risk of adverse events occurring in patients who use controlled substances to treat pain increases as dosage increases. The Board adopts the "Morphine Milligram Equivalency" ("MME") daily standard as set out by the Centers for Disease Control and Prevention ("CDC") for calculating the morphine equivalence of opioid dosages. Risk and Abuse Mitigation Strategies (2) It is the opinion of the Board that the best practice when prescribing controlled substances for the treatment of pain shall include medically appropriate risk and abuse mitigation strategies, which will vary from patient to patient. Examples of risk and abuse mitigation strategies include, but are not limited to: (a) (b) (c) (d) (e) Pill counts; Urine drug screening; PDMP checks; Consideration of abuse-deterrent medications; Monitoring the patient for aberrant behavior; (f) Providing a patient with opiate risk education prior to prescribing controlled substances; and (g) Using validated risk-assessment tools, examples of which shall be maintained by the Board. 6

7 Risk and Abuse Mitigation Strategies continued (3) For the purpose of preventing controlled substance diversion, abuse, misuse, addiction, and doctor-shopping, the Board sets forth the following requirements for the use of Alabama's Prescription Drug Monitoring Program (PDMP): (a) For controlled substance prescriptions totaling 30 MME or less per day, physicians are expected to use the PDMP in a manner consistent with good clinical practice. (b) When prescribing a patient controlled substances of more than 30 MME per day, physicians shall review that patient's prescribing history through the PDMP at least two (2) times per year, and each physician is responsible for documenting the use of risk and abuse mitigation strategies in the patient s medical record. (c) Physicians shall query the PDMP to review a patient's prescribing history every time a prescription for more than 90 MME per day is written, on the same day the prescription is written. Risk and Abuse Mitigation Strategies continued (4) Exemptions: The Board's PDMP requirements do not apply to physicians writing controlled substance prescriptions for: (a) Nursing home patients; (b) Hospice patients, where the prescription indicates hospice on the physical prescription; (c) When treating a patient for active, malignant pain; or (d) Intra-operative patient care. Risk and Abuse Mitigation Strategies continued (5) Due to the heightened risk of adverse events associated with the concurrent use of opioids and benzodiazepines, physicians should reconsider a patient's existing benzodiazepine prescriptions or decline to add one when prescribing an opioid and consider alternative forms of treatment. 7

8 Risk and Abuse Mitigation Strategies continued (6) Effective January 1, 2018, each holder of an Alabama Controlled Substances Certificate (ACSC) shall acquire two (2) credits of AMA PRA Category 1 continuing medical education (CME) in controlled substance prescribing every two (2) years as part of the licensee's yearly CME requirement. The controlled substance prescribing education shall include instruction on controlled substance prescribing practices, recognizing signs of the abuse or misuse of controlled substances, or controlled substance prescribing for chronic pain management. Risk and Abuse Mitigation Strategies continued (7) The Board recognizes that all controlled substances, including but not limited to, opiates, benzodiazepines, stimulants, anticonvulsants, and sedative hypnotics, have a risk of addiction, misuse, and diversion. Physicians are expected to use risk and abuse mitigation strategies when prescribing any controlled substance. Additional care should be used by the physician when prescribing a patient medication from multiple controlled substance drug classes. (8) A violation of this rule is grounds for the suspension, restriction, or revocation of a physician's Alabama Controlled Substances Certificate or license to practice medicine. DATA SHARING WITH OTHER STATES The Alabama Prescription Drug Monitoring Program PDMP is now sharing controlled substance data with several states and more are being added each month. Currently, you can access the prescription monitoring programs in Arkansas, Georgia, Kentucky, Maine, Massachusetts, Minnesota, Mississippi, and South Carolina. Tennessee and North Dakota should be added soon. Please note that, because state laws vary, not all disciplines can access every state. For example, delegates from other states cannot access Alabama data and some states do not allow delegates from Alabama to access their database. It is also important to remember that the more states you select in the Multiple State Query, the longer it will take to run your report. We suggest limiting your report to no more than three states. The Multiple State Query accepts the patients name only as an exact match. any questions you have to pdmp@adph.state.al.us or call the Help Desk at option 8 follow the prompts for Alabama. 8

9 How to use Poll Everywhere SEND A TEXT TO: MESSAGE: ALBME YOU WILL RECEIVE A REPLY: YOU VE JOINED THE SESSION SUBMIT YOUR ANSWER TO THE QUESTION (i.e., A, B, C, D, etc.) AS VOTES ARE RECEIVED, SCREEN UPDATES IN REALTIME YOU CAN ALSO RESPOND ON THE WEB AT PollEV.com/albme Opioid Risk Tool This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse. Mark each box that applies Female Male Family history of substance abuse Alcohol 1 3 Illegal drugs 2 3 Rx drugs 4 4 Personal history of substance abuse Alcohol 3 3 Illegal drugs 4 4 Rx drugs 5 5 Age between years 1 1 History of preadolescent sexual abuse 3 0 Psychological disease ADD, OCD, bipolar, schizophrenia 2 2 Depression 1 1 Scoring Totals The US Food and Drug Administration (FDA) The FDA announced new action today to combat the growing problem of abuse and misuse of the over-the-counter (OTC), opioid-based antidiarrheal medication Loperamide (Imodium, Johnson & Johnson), which is placing individuals At risk for cardiac dysrhythmia and death. To foster safe use of loperamide, the FDA is working with manufacturers to use Blister packs or other single-dose packaging and to limit the number of doses In a package, the agency said. The FDA is asking manufacturers of loperamide, which is available OTC and by Prescription, to change the way they label and package loperamide to stem Abuse and misuse that leaves us deeply concerned, FDA Commissioner Scott Gottlieb, MD, said in a statement. 9

10 The US Food and Drug Administration (FDA) In 2016, the FDA warned about life-threatening cardiac events, including QT Interval prolongation, torsades de pointes or other ventricular arrhythmias, Syncope, and cardiac arrest, with loperamide misuse and abuse. In 2017, The FDA added a warning to the product label about the risk of taking High doses of loperamide. The FDA notes that some individuals are taking higher-than-recommended doses Of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric Effects of opioid use. The maxium approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day For prescription use. Loperamide is safe at these approved doses, but the FDA Continues to receive reports of serious cardiac problems and death with much Higher than the recommended doses of loperamide, primarily among people who are Intentionally misusing or abusing the product, the agency said. Duragesic Duragesic should ONLY be used in patients who are already Receiving opioid therapy, who have demonstrated opioid Tolerance, and who require a total daily dose at least equivalent To Duragesic 25 mcg/h. Exalgo is indicated for opioid tolerant patients only. Avinza The daily dose of Avinza must be limited to a maximum of 1600 mg/day. Avinza doses of over 1600 mg/day contain A quantity of fumaric acid that has not been demonstrated to Be safe, and which may result in serious renal toxicity. 10

11 Methadone Methadone s plasma elimination half-life is substantially longer Than that of morphine (typically 8 to 59 hours versus 1 to 5 hours). Testosterone Often unappreciated adverse effect of long-term Opioid analgesic use is lowered sex hormone levels in Men. In those who are taking significant doses of opioid analgesics long-term, subnormal testosterone levels are the rule rather than the exception. PDMP The PDMP recommends that all PDMP Patient History reports be kept in a separate location which is only accessible to authorized personnel. Essentially, the PDMP Patient History Report should not be filed in the patient medical chart. This measure will prevent unauthorized disclosure of the PDMP Patient History Report from being accessed and distributed by unauthorized individuals. 11

12 Drugs increasingly detected in drivers responsible for fatal crashes, study indicates Drugs are being detected in a growing share of drivers responsible for fatal crashes, according to a new study by the Governors Highway Safety Association. Some 44% of drivers killed in crashes in 2016 who were tested afterward had drugs in their system, according to the study. That is up from 28% a decade ago. About 20 percent of the drug-positive drivers in 2016 tested positive for opioids, up from 17 percent, while for marijuana the number rose to 41 percent in 2016 from 35 percent in The report notes that nearly half of all fatally injured drivers were not tested for drugs because testing varies widely across the country. Opioids responsible for one in five deaths among young adults A study published in JAMA Network Open shows that in One in 65 deaths in the US involved opioids 2. Among younger adultsthat number skyrocketed to one in five 3. In 2016 opioids were involved in 28,496 deaths 4. More than 8,400 of these occurred among adults between the ages of 25 and 34, a number high enough to mean that 20% of all deaths in this age group in 2016 involved opioids. In case my life should end with the cannibals, I hope they will write on my tombstone, "We have eaten Dr. Schweitzer. He was good to the end." 12