The Opioid Crisis: Effectiveness of State Responses Gordon H. Smith, Esq. Maine Medical Association American Society of Medical Association Counsel Mauna Lani Bay, November 2017
Opioids: the difficult truth We know of no other medication routinely used for a nonfatal condition that kills patients so frequently. NEJM: 374;16 4-21-16 Dosage >200 MME: Number Needed to Kill = 32 Median time to opioid-related death: 2.6 years
Maine Led the Nation Maine led the nation in prescribing long acting opioids at 21.8 Rx/100 people. (2014 based on 2012 CDC data) 60 to 65 pills for every man, woman and child in Maine annually.
More than One Death per Day in Maine Maine led nation in rate of long-acting opioid prescriptions Overdose death rate in Maine increased 40% from 2015 to 2016 272 Mainers lost to opioid/heroin deaths in 2015 376 overdose deaths in 2016 (313 involving opioids) Projected decrease in 2017 to 330 Contrast: During the last decade, there were 258 homicides in Maine.
175 lives lost per year Nationally Over 64,000 overdose deaths in 2016 Contrast: 58,000 American Casualties during Vietnam War.
Limited Treatment Options for Opioid Use Disorder or Substance Use Disorder It is estimated that 28,000 Mainers have Opioid Use Disorder with capacity to treat only 3500 to 7000 Nationwide: Only 10.6% of youth and adults who need treatment for SUD receive treatment (From President s Commission Report, November 2017)
1,024 Maine Babies Drug Affected in 2016 1,013 in 2015 Maine s infant mortality rate (7.1/1000) exceeds the national average 1 out of every 11 babies in Maine was born drug-affected in 2016 3 drug affected babies born each day
Evidence of Over-Prescribing C-Section patients 1 53% report taking no or very few (<5) opioid pills prescribed post-operatively 83% report taking half or fewer Thoracic surgery patients 1 45% report taking no or very few (<5) opioid pills prescribed post-operatively 71% report taking half or fewer 1: PLoS One 2016 29;11(1); e0147972. Epub 2016 Jan
Growing Evidence of Over-Prescribing General surgery patients 2 75% partial mastectomy pts did not take any of their prescribed opioids 34% lap choly pts took no prescribed opioids 45% lap inguinal hernia pts took no prescribed opioids Pts reported having 67% to 85% opioid pills remaining Wisdom tooth extraction patients 3 On average, received 28 pills but used <50% of amount prescribed Extrapolates to >100 million opioid pills unused nationally! 2: Ann Surg, Hill et al, Sept 14, 2016 3: Drug Alcohol Depend. 2016 Nov 1; Epub 2016 Sep 20.
Maine s Response to Opioid Crisis 2002 Educational effects began by state DEA and Maine Medical Association 2013 MaineCare (Medicaid) limits on opioids prescribed for chronic pain 2015 Maine Opiate Collaborative established US Attorney Attorney General Department of Public Safety Staffed by Maine Medical Association Three Task Forces, 22 Community Forums 2016 (March 2016) CDC Guidelines Issued 2016 Enactment of PL 2016 Chapter 488 effective date: July 29, 2016 2017 Enactment of PL 2017, Chapter 213 2017 Legislative Task Force Established, Report due December 6, 2017
Maine s Response continued Limits on prescribing, including maximum daily dose (100MME) Electronic Prescribing mandate Mandated PMP check Increased use of Naloxone via statutory changes (2014-2016) Medical Board guidelines/rules (1999-2017) Enhanced treatment options, particularly medication assisted treatment (MAT) Prescriber Education; MICIS Live 3 hour programs On-line modules (web-based CME) One hour presentations on Chapter 488 and implementing regulations
Overview of Chapter 488 Effective 90 days after adjournment of the Second Regular Session of the 127 th Maine Legislature, though some provisions have other timeframes specified (July 29, 2016) As Amended by P.L. 2017, Chapter 213 As further described by OSAMHS Rule Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription Opioid Medications Components include: Required PMP check for prescribers and dispensers (1/1/2017) Prescribing limits on MMEs per day (7/29/2016) Prescribing limits on length of scripts (1/1/2017) Exception for emergency rooms, inpatient hospitals, long-term care facilities, or residential care facilities or in connection with a surgical procedure. Exception for medication-assisted treatment for substance use disorder Exceptions for active and aftercare cancer treatment, palliative care, and end-of-life and hospice care Other exceptions may be determined by rule Mandatory CME (12/31/2017) Mandatory electronic prescribing (7/01/2017) Partial filling of prescriptions at patient request (7/29/2016)
Required PMP check Prescriber Responsibilities Upon initial prescription of benzodiazepine or opioid medication Every 90 days following Delegation of PMP check Exception Prescribers may delegate PMP check to any staff member duly authorized by prescriber and PMP Office Despite delegation, prescriber must review patient s aggregate MME (including new prescription); number of prescribers currently prescribing controlled substances to patient; and number of pharmacies currently dispensing same Staff members of a group practice of prescribers who are authorized by a designated group practice leader, may check PMP on patients receiving care from the practice. No PMP check is required for benzodiazepine or opioid medication directly administered in an emergency room setting, an inpatient hospital setting, a long-term care facility (assisted living or nursing home), or a residential care facility. No PMP check is required for hospice or end-of-life patients.
Prescriber Responsibilities Electronic Prescribing Beginning July 1, 2017, prescribers with the capability to electronically prescribe must prescribe all opioid medication electronically A waiver may be available in some circumstances: Written waiver application required Penalties for failure to comply Continuing Education Every prescriber must complete 3 hours of CME on the prescription of opioid medication every 2 years as a condition of prescribing opioid medication First 3 hours must be completed by 12/31/2017. Beginning in 2018, all MD s must complete the 3 hours of CME regardless of prescribing.
Prescriber Responsibilities Required notations on opioid prescriptions Note prescriber s DEA number Note Acute or Chronic on the prescription (including suboxone) On prescriptions for acute on chronic pain (Exemption Code F), use Acute On prescriptions for palliative care (Exemption Code B), note the diagnosis (ICD-10) code On any prescriptions where an exemption is claimed, the exemption code (A through H) must be noted Exemption codes are not required on veterinary prescriptions New: Pharmacists may contact prescribers by telephone to verify and document missing information on the script.
Exceptions to limits on opioid medication prescribing By Statute 1. Pain associated with active and aftercare cancer treatment. Providers must document in the medical record that the pain experienced by the individual is directly related to the individual s cancer or cancer treatment. Exemption Code A 2. Palliative care in conjunction with a serious illness (includes injury). Code B, (ICD 10 Code must be included on script as well as Code B ) 3. End-of-life and hospice care. Code C 4. Medication-Assisted Treatment for substance use disorder. (Original 12-month limit has been removed.) Code D
Exceptions to limits on opioid medication prescribing By Rule 5. A pregnant individual with a pre-existing prescription for opioids in excess of the 100 Morphine Milligram Equivalent aggregate daily limit. This exemption applies only during the duration of the pregnancy. Code E 6. Acute pain for an individual with an existing opioid prescription for chronic pain. In such situations the acute pain must be postoperative or new onset. The seven day prescription limit applies. Code F 7. Individuals pursuing an active taper of opioid medications, with a maximum taper period of six months, after which time the opioid limitations will apply, unless one of the additional exceptions in this subsection apply; or Code G 8. Individuals who are prescribed a second opioid after proving intolerant to a first opioid, thereby exceeding the 100 MME limit. Neither prescription may exceed 100 MME. Code H
Partial fill Upon patient request, pharmacist may dispense lesser quantity of medication than is prescribed Remainder of prescription is void Pharmacist must, within 7 days, notify prescriber of quantity actually dispensed Notification may be by notation in patient s EHR, by electronic transmission or fax or telephone In cases of pharmacist shortage, lesser quantity may be dispensed. Remainder may be dispensed only if within 72 hours.
Effective July 1, 2017 E-prescribing Mandate MMA relationship with Dr. First. Contact is Eric Landry at 888-481-4303 or elandry@drfirst.com No exceptions for any specialties, locations Long term care facilities may use fax per DEA rules For homeless patients, use address of shelter, street name, if possible; if no address, may prescribe on paper Exemption from limits/pmp checks is NOT exemption from E- prescribing requirement!
E-prescribing Mandate - Exceptions Waiver applications now available Pharmacists not required to verify waivers or exceptions Exceptional circumstances allowing written prescriptions: Valid waiver from PMP Temporary technological or electrical failure To be dispensed by VA or Indian Health Service pharmacy, or outside Maine Prescriber reasonably determines that it would be impractical, patient could not obtain medication timely, and delay would adversely impact patient s medical condition
Licensing Board Response Licensing Boards, Joint Rule Chapter 21 amendments Universal precautions Urine screens Random pill counts Treatment agreement MaineCare Rules Board of Licensure in Medicine, Chapter 1 Rule amendments Mandatory CME requirement may be broadened to all physicians, regardless of whether opioids are prescribed
Impact of Response 3 consecutive-year decline in number of opioid scripts totaling 21.5% (4 th largest decline in the country) 1 year decline in overdose deaths (2017) 2017 Anthem announces 15% decline in opioid prescribing for their insureds in the state.
Additional MMA Activities MMA receives annual funding ($150-$250,000) from state to offer prescriber education (MICIS). Two thousand prescribers reached in 2017) EVP serves on Legislature s Task Force to Address Opioid Crisis (2017) MMA, through grants staffed Maine s Opioid Collaborative and hosted twenty-two community forums (2016). Funded partially by Maine Health Access Foundation and Maine Community Foundation. Most recent efforts focused on increasing treatment options and advocating for insurance coverage of more non-pharmacological options for treating pain. Support for making naloxone more widely available Support for more detox beds
The Future Attorney General and community litigation against Pharma Malpractice cases against prescribers More legislation and regulation President s Commission 56 recommendations (November, 2017) But will there be funding? More efforts re treatment and prevention
Resources MMA s Opioid Crisis page: https://www.mainemed.com/advocacy/opioid-crisis Opioid laws & rules, Maine Opiate Collaborative task force Reports, CDC guidelines, naloxone, Q and A, DHHS clarifications. Caring for ME page: https://www.mainequalitycounts.org/page/2-1488/caring-for-me Webinars, opioid laws & rules, information on pain management and tapering, etc.
Questions? Maine Medical Association 30 Association Drive, P.O. Box 190 Manchester, Maine 04351 207-622-3374 207-622-3332 Fax gsmith@mainemed.com Cell # 207-215-7461