Caring for ME Pharmacy Lunch & Learn Webinars Opioid Prescribing Regulations : Updates on Chapter 488 and Related Rules Audio is available through your computer speakers For audio by phone, call 1-646-558-8656 (US Toll) and enter Webinar ID # 597-167- 502
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Speakers The speakers today do not have any relevant financial relationships with the manufacturers(s) of any commercial products(s) and/or provider of commercial services discussed in this activity. Gordon H. Smith, Esq. Gordon is Executive Vice President of the Maine Medical Association. He graduated from the University of Maine with highest distinction and from the Boston College Law School, magna cum laude. He currently serves as a member of the Steering Committee of the AMA's Scope of Practice Partnership. He is also a member of the Board of Maine Quality Counts. A frequent lecturer to medical groups on various medical legal subjects, Mr. Smith has served as EVP of the Maine Medical Association since September 1993. Stephanie Nichols, Pharm.D., BCPS, BCPP Stephanie graduated from the University at Buffalo with her Doctor of Pharmacy degree and completed a residency at Maine Medical Center. She is currently an Associate Professor with the Husson University School of Pharmacy in Bangor and a Psychiatric Pharmacist at MMC in Portland. She has been practicing clinical pharmacy for a decade and is board certified as both a Pharmacotherapy Specialist and a Psychiatric Pharmacist. Her research focuses on Substance Use Disorders.
Maine s New Opioid Prescribing Law & the Opioid Crisis: Implications for Prescribers Gordon H. Smith, Esq. Maine Medical Association Updated July 1, 2017
Disclosure There are no significant or relevant financial relationships to disclose.
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
More than One Death per Day Maine leads nation in rate of longacting 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) Contrast: During the last decade, there were 258 ho micides in Maine.
Maine Leads the Nation Maine leads the nation in prescribing long acting opioids at 21.8 Rx/100 people. 60 to 65 pills for every man, woman and child in Maine annually.
Narcan Administrations 1,565 in 2015 2,380 in 2016
Opioid Use Disorder It is estimated that 28,000 Mainers have Opioid Use Disorder with capacity to treat only 3500 to 7000
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 Gen l 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 avg, received 28 pills but used <50% of amnt rx d Extrapolates to >100 million opioid pills unused nat ly! 2: Ann Surg, Hill et al, Sept 14, 2016 3: Drug Alcohol Depend. 2016 Nov 1; Epub 2016 Sep 20.
Maine Opiate Collaborative
Overview of P.L. 2015, 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 endof-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)
Key Definitions Acute pain Normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus. Typically associated with invasive procedures, trauma or disease and is usually time-limited. Chronic pain Persists beyond the usual course of an acute disease or healing of an injury. May or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years
Opioid medication Key Definitions A controlled substance containing an opioid; includes tramadol, does not include loperamide Prescriber Licensed health care professional with authority to prescribe controlled substances Includes MDs, DOs, PAs, NPs, podiatrists, dentists, and veterinarians Administer Action to apply prescription drug directly to a person by any means by a licensed or certified health care professional (the statute and rule do not define order, as in ordering a medication to be administered by an RN) Does not include delivery, dispensing, or distribution of a prescription drug for later use
Key Definitions Palliative care Patient-centered, family-focused medical care that optimizes quality of life by anticipating, preventing, and treating suffering caused by serious medical illness or physical injury or condition that substantially affects quality of life Addresses physical, emotional, social, and spiritual needs Facilitates patient autonomy and choice of care Provides access to information Discusses patient s goals for treatment and treatment options, including hospice care, when appropriate Manages pain and symptoms comprehensively Palliative care does not always include a requirement for hospice care or attention to spiritual needs. (new)
Serious illness Key Definitions Medical illness or physical injury or condition that substantially affects quality of life for more than a short period of time Includes, but is not limited to, Alzheimer s disease and related dementias, lung disease, cancer and heart, renal or liver failure and chronic, unremitting or intractable pain such as neuropathic pain. (new)
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. (Effective date not yet known)
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: Technological limitations beyond the prescriber s control other exceptional circumstances demonstrated by the practitioner Written waiver application required 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.
Prescriber Responsibilities Required notations on opioid prescriptions Note prescriber s DEA number Note Acute or Chronic on the prescription 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
By Rule Exceptions to limits on opioid medication prescribing 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
E-prescribing Mandate Effective July 1, 2017 Waiver applications now available MMA relationship with Dr. First Contact is Eric Landry at 888-481-4303 or elandry@drfirst.com Grace period from penalties for 31 days, until August 1, 2017
Deadlines Effective date was 90 days after adjournment (July 29, 2016) January 1, 2017 Mandatory checks of the PMP Limits on scripts for acute (7 days) and chronic pain (30 days) March 31, 2017 Final Rule effective July 1, 2017 Mandatory electronic prescribing Patients with active prescriptions in excess of 100 MMEs must be tapered to an aggregate amount of 100 MMEs or less per day December 31, 2017 CME requirement (3 Hours)
Penalties Civil violation Subject to fine of $250 per incident up to a maximum of $5000 per calendar year More serious concern is Licensing Board action PMP will report violations to Board, prescriber will receive 2 weeks advance notice and opportunity to comment
What will the Maine CDC Be Looking For? High number of prescribers in a short time High number of doses in a short time Days supply of prescriptions for the same drug overlapping by more than a few days Inappropriate combinations of controlled substances More than one method of payment within a short time More than one out-of-state prescriber for the same patient, within a short time More than one pharmacy on the same day More than one pharmacy in different public health districts within one month Dangerous levels of specific drugs
Other Provisions Prescription Monitoring Program (PMP) PMP data access to other states and Canadian provinces (coming) Automatic registration of pharmacists and veterinarians Enhancements (New software: Appriss PMP AWAR x E ) Dosage converter to/from MME Automatic distribution of de-identified peer data to prescribers annually Improved delegation to non-prescriber staff Improved speed and communication DHHS and Bureau of Insurance reporting requirements
Still to Come Licensing Boards, Joint Rule Chapter 21 amendments Universal precautions Urine screens Random pill counts Treatment agreement MaineCare Rules Patients to be seen every 30 days Board of Licensure in Medicine, Chapter 1 Rule amendments Mandatory CME requirement may be broadened to all physicians, regardless of whether opioids are prescribed
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. 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 amaclean@mainemed.com pmichaud@mainemed.com
This image cannot currently be displayed. Provider Collaboration Task Force Stephanie Nichols, PharmD, BCPS, BCPP Associate Professor, Husson University Psychiatric and Substance Use Disorder Pharmacist, MMC nicholss@husson.edu
Maine Quality Counts Leadership Group Let s convene a Task Force! Prescrib ers... Chap ter 488... Pharmacist s... Collaborati on...
2017 CDC Document About Pharmacist-Provider Collaborations
Purpose and Goals Purpose: The purpose of this group is to improve communication and collaboration between pharmacists and prescribers in Maine, because it will improve patient care and medication safety. Goals: Facilitate a smooth transition through the final implementation phase of Chapter 488, including the Identification of problems and subsequent solutions. Improve communication and collaboration between Maine pharmacists and providers. Foster and improve Maine pharmacist-prescriber relations to optimize and assure provision of holistic, team-based patient care. Provide networking opportunities to grow connections between pharmacists and providers that might result in interprofessional research, education, or practice opportunities.
Members Chair: Stephanie Nichols - Psychiatric Pharmacist, member of Maine Quality Counts, and Associate Professor at Husson - Nicholss@husson.edu Gordon Smith - Prolific lawyer with the Maine Medical Association and Maine Quality Counts Noah Nesin - Physician Member of Maine Quality Counts and Vice President of Medical Affairs at PCHC Steve Diaz - Physician Member of Maine Quality Counts and Sr VP and CMO at Maine General Health Cassandra Parsons - President Elect of Maine Pharmacy Association and Assistant Professor at Husson Kenneth McCall - Past President of the Maine Pharmacy Association and Associate Professor at UNE Jason Tremblay - Maine Board of Pharmacy member and Director of Acute Care Pharmacy at Maine Medical Center Andrea Lai - Maine Society of Health System Pharmacists member and Director of Ambulatory Pharmacy at MMC Greg Cameron - Maine Pharmacist at Large, former pharmacy inspector and Assistant Professor of Pharmacy Law at Husson Heidi Wierman - American College of Physicians, Maine - Geriatric Medicine Renee Fay-Leblanc - Medical Director of Greater Portland Health (FQHC in Portland) and American College of Physicians, Maine - Internal Medicine Solomon Olabiyi -American College of Physicians, Maine - Internal Medicine Rhonda Selvin - FNP at Augusta Family Medicine Meghan Gorman - Maine Pharmacist at Large - Community Pharmacist at Large Kari London Maine Pharmacist at Large - Clinical Pharmacist with Lincoln County Healthcare - Andrea Truncali - Internal Medicine Physician at Large and buprenorphine prescriber @ Mercy Amy Belisle- Medical Director, Maine Quality Counts Kris Raven Ambulatory Care Pharmacy Resident @ PCHC Alisa Hughes-Stricklett Clinical Pharmacy Specialist in the Maine VA Healthcare system and member of the Opiate Safety Initiate
Meeting Times Monthly on Thursdays at 1pm via Zoom video conference Guest attendees are always welcome, just reach out for the zoom link! Are you interested in joining our group? Send me an email @ nicholss@husson.edu In particular, we are seeking: Another member from the Board of Pharmacy, from the Board of Medicine, and a member or two from representing the State.
Some examples of things we ve learned and shared.
Timely Communication Between Providers and Pharmacists Problem: Pharmacy call back from Provider can sometimes occur after 5pm while a patient is waiting for hours, as it is batched in with refill requests. Are there better ways for communication? Potential Solution: Reach out to your local providers and establish a new communication method Text message or text pager message please call xxx-xxxx number around chapter 488 Rx If no response in reasonable amount of time, can go to usual routes Models consult-provider communications and inpatient pharmacist-provider communications Long term: Explore HIPAA compliant texting app Docbookmd, Cortext, Athena, Dochalo $8/month
Timely Communication Around Chapter 488 Law Chapter 488 https://legislature.maine.gov/legis/bills/bills_127th/chapters/public488.asp Chapter 16 amendment (LD 1363) https://legislature.maine.gov/legis/bills/getpdf.asp?paper=hp0940&item=3&snum=128 Chapter 213 (LD 1031) https://legislature.maine.gov/legis/bills/getpdf.asp?paper=sp0338&item=3&snum=128 Helpful Links https://www.mainequalitycounts.org/image_upload/3%20chptr%20488%20fact%20sheet_2 017-01-31.pdf http://www.mparx.com/2016/07/maines-new-opioid-prescribing-and-pmp-law-chapter-488- update/ http://www.maineafp.org/docs/opioid%20resources/2016-july_7-chptr-488-fact-sheet.pdf Our Google Drive Resources with updated information and a guide from the state! (This will be updated continuously as new information is shared or received. ) https://drive.google.com/drive/folders/0b8uabtovkp51zem0r1vptmt4vkk?usp=sharing
PMP Connects to Other Nearby States!
VA PMP Documenta tion Template courtesy of C. Parsons
Frequently Asked Questions/Concerns Tramadol and refills Tramadol and phone scripts Buprenorphine and e-prescribing How to identify who has an e-prescribing waiver
Any Questions or Comments? nicholss@husson.edu
Upcoming Caring for ME Webinars September 26, 2017, 12-1 pm, Strengthening Connections: Knitting together the substance use prevention efforts of communities, schools, and health care. Liz Blackwell-Moore, Birch Consulting. Register via zoom. October 3, 2017, 12-1 pm, Hub and Spoke Model: Creating a Substance Use Disorder Services System of Care in Vermont Successes, Challenges and Future Opportunities. Barbara Cimaglio, Deputy Commissioner, Vermont Department of Health, Anthony Folland, BA, State Opioid Treatment Authority Alcohol and Drug Abuse Programs. Register via zoom. October 24, 2017, 12-1 pm, Vermont Project to Reduce Post-Op Prescribing of Pain Medication, Kelly Fillippe and James Poole. Register at zoom. January 23, 2018, 12-1 pm, Update on Chapter 488, Gordon Smith, MMA Register via zoom
QC will be launching 6 Online CME Modules with the Support of the Board of Licensure in Medicine (BOLIM) and the MMA in August The modules and presenters will include: Compliance with Maine Prescribing Laws Safe Prescribing & Prescribing Limits Chronic Pain Management Appropriate Diagnosis and Treatment of Addiction Safe & Compassionate Tapering Maternity Care and the Snuggle ME Guidelines