Maine Law Update 2017 Jessica Bates Pharm D

Maine Law Update 2017 Jessica Bates, Pharm. D Clinical Assistant Professor, University of New England Clinical Pharmacist, Penobscot Community Health Care October 14 th, 2017

Learning Objectives – Discuss opioid prescribing and dispensing laws in the State of Maine. – Recall recent pharmacy-related legislation. – Apply recent pharmacy-related legislation to pharmacy practice.

LD 1646: An Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program Timeline Exceptions Prescription Requirements

Timeline July 29, 2016 • Limit MMEs to <300 mg/day for pre-existing Rx or <100 mg/day for new Rx • 3 hours of CME for prescribers every 2 years • Pharmacists able to shortfill opioid prescriptions January 1, 2017 (Delayed until 03/17) • “Acute” or “chronic” designation • Limit 7 day supply for acute pain • Limit 30 day supply for chronic pain • Exemption code/ICD-10 • PMP requirements • Fines in effect July 1, 2017 • Limit MMEs to <100 mg/day for non-exempt prescriptions • All opioid prescriptions must be electronic (unless waiver from DHHS; delayed until 7/31/17) December 31, 2017 • Deadline for first 3 hours of CME for providers LD 1646 (Public Law 488)

Non-Exempt Opioid Prescription Requirements for Non-Exempt Opioid Prescriptions (<100 MME/day) “Acute” or “Chronic” Required Day Supply ICD-10 Code Acute: ≤ 7 days Chronic: ≤ 30 days PMP Check At initial prescription then every Not required 90 days as long as script is renewed (prescribers)

Exempt Opioid Prescription Requirements for Exempt Opioid Prescriptions (>100 MME/day) Exemption Code “Acute” or “Chronic” ICD-10 Code Day Supply Provider PMP Check A: Active and aftercare cancer treatment Not required ≤ 30 days Every 90 days B: Palliative care Not required Required ≤ 30 days Every 90 days C: End-of-life and hospice care Not required ≤ 30 days Every 90 days D: Medication-assisted treatment Not required ≤ 30 days Every 90 days E: Pregnant with pre-existing condition Not required ≤ 30 days Every 90 days Required Not required ≤ 7 days Every 90 days and at initial prescription for acute condition Not required ≤ 30 days Every 90 days Required Not required ≤ 30 days Every 90 days and at initial prescription for acute condition F: Acute pain with existing chronic pain G: Active tapering H: Opioid intolerance

Exceptions to the PMP Check PMP check is not required for benzodiazepine or opioid prescription directly administered in*: Emergency room Inpatient hospital Long-term care facility Residential care facility *PMP check required in these settings if the prescription is for use outside of that setting; does not preclude practitioner from e-prescribing opioids

Pharmacist PMP Checking Requirements – Required for benzodiazepine and opioid prescriptions – Patient not a resident of this State – The prescription is from a prescriber with an address outside of this State – The person is paying cash when the person has prescription insurance on file – According to the pharmacy prescription record, the person has not had a prescription for a benzodiazepine or an opioid medication in the previous 12 month period

Adding & Changing Information on Electronic Prescription Pharmacist may add or change with practitioner authorization: Practitioner DEA number “Acute” or “chronic” designation Institutional DEA number/suffix ICD-10 code Directions for prescription Dosage form (may be changed, not added) Maximum daily dosage (MDD) Quantity (may be changed, but not added) Strength of prescription Exemption code Pharmacist may add or change without practitioner authorization: Patient address Patient gender Patient age Pharmacist may NEVER add or change: Patient name Date written Practitioner signature Drug name

Opioid Dispensing FAQs – Exemption code H: pharmacists should provide patients with information for safe disposal of opioid prescriptions they were unable to tolerate – https: //www. fda. gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ ensuringsafeuseofmedicine/saf edisposalofmedicines/ucm 186187. htm – Refills not permitted on C-II’s, and C-III and IV’s are not to exceed 5 refills/6 months – Verify out of state prescriptions – Uploading ICD-10 and exemption codes will be required 7/1/18

Exceptions for Electronic Opioid Prescribing Exceptional Circumstances Temporary technological failure Temporary electrical failure SAMHS PMP-approved e-prescribing waiver Practitioner reasonably determines it would be impractical for the patient to obtain the medication in a timely manner and such a delay would adversely impact the patient’s medical condition To be dispensed by a pharmacy located outside of the state To be dispensed by a VA or IHS pharmacy

Electronic Prescribing FAQs – Pharmacist is NOT required to verify that a practitioner has a waiver or properly falls under one of the other exceptions – Unable to e-prescribe for patients with foreign addresses – If transmission fails, print & sign script, most EMRs will generate verbiage indicating a transmission failure – LTCF, nursing home, hospice care facility may still fax C-II’s – If homeless, use shelter address, if not, written rx acceptable – Out of state scripts are exempt Buzzell J. DHHS. Electronic Prescribing Clarifications. July, 2017.

CDC Opioid Conversion Algorithm*

MME Calculators Washington State New York City – No cellphone app currently available, web-based – Cellphone app available, no website – Has calculator for tapentadol – Calculates non-linear methadone MMEs Website: http: //www. agencymeddirectors. wa. go v/Calculator/Dose. Calculator. htm – No calculator for tapentadol – Calculates linear methadone MMEs Download the app: https: //www 1. nyc. gov/assets/doh/dow nloads/pdf/hcp/opioidcalc-app. pdf

100 MME Opioid Comparison Table Opioid Medication Dose Equivalent to 100 MMEs Morphine 100 mg Fentanyl ~41 mcg Hydrocodone 100 mg Hydromorphone 25 mg Methadone ~20 mg Oxycodone ~66 mg Oxymorphone ~33 mg Tapentadol 250 mg Tramadol 1000 mg http: //www. agencymeddirectors. wa. gov/Calculator/Dose. Calculator. htm

Veterinarians – Veterinary offices do not report pet prescriptions to the PMP – Variability in pharmacy pet profile entry – DOB often unknown – Variability in name entry – Issues with billing pet prescriptions under owner’s name or reporting to PMP under owner’s name – Insurance fraud – Mislabeling prescription – Veterinarians not bound by HIPAA LD 1646 (Public Law 488)

Knowledge Check A cancer patient presents a prescription to your pharmacy in Maine for Fentanyl 100 mcg/hr q 72 h #10 from his cancer specialist in Boston. The prescription is hand -written and meets the security requirements for Massachusetts state law. How should you proceed? a) Fill the prescription as is b) Call and request an electronic prescription including exemption code, ICD-10 code, the denotation of “chronic pain, ” and destroy the hand-written script c) Call to verify the prescription and then fill as is d) The prescription cannot be filled

Why Taper? Reasons for Tapering 2016 CDC Guideline Review Opioid Prescribing Rates in Maine

Why Taper? High Dose Opioid and Overdose Risk 12 Adjusted Hazard Ratio 10 8 6 4 2 0 1 -19 mg 20 -49 mg MME per day 50 -99 mg >100 mg Overdose: death, hospitalization, unconsciousness, or respiratory failure Dunn KM, et al. Ann Intern Med 2010.

Key Points from the CDC Opioid Prescribing Guideline – Number needed to kill for all doses: 550 – Number needed to kill for doses >200 MME/day: 32 – Median time to opioid-related death: 2. 6 years Opioid dependence as high as 26% for chronic non-cancer prescription opioid patients Dowell D, et al. CDC Guideline for Prescribing Opioids for Chronic Pain. MMWR.

Evidence for Opioid Effectiveness: 2016 CDC Literature Review – Key findings: – Evidence for long-term opioid therapy for chronic pain (excluding end-of-life care) is limited – Most placebo-controlled randomized trials ≤ 6 weeks – Risk factors for developing a substance use disorder identified: – History of SUD – Young age – Major depression – Use of psychotic medications – Insufficient evidence to determine if there is a benefit over no opioid – Evidence that serious risks are dose-dependent Dowell D, et al. CDC Guideline for Prescribing Opioids for Chronic Pain. MMWR.

Maine has an Opioid Epidemic – Drug overdose deaths in 2016 increased by same period in 2015 – 2015 (Jan-Dec): 272 overdose deaths – 2016 (Jan-Dec): 378 overdose deaths – Illicit opioids a factor in 60% – Prescription opioids present in 64% – 2017 (Jan-Jun): 185 overdose deaths – Illicit opioids increasing (sufentanil, carfentanil) Lawlor J. Portland Press Herald 2016. 40% compared to the

2014: Exceptionally High Prescribing Rates in Maine – Maine has the nation’s highest rate of prescribing long-acting opioids – 16, 000 on >100 MME/day – 1, 200 on >300 MME/day – 60 opioid pills person per year prescribed – Majority of misused prescription opioids obtained from a friend or relative – 21% prescribed by a doctor – 1/3 rd of parents believe their teens could access opioids in their homes without permission Paulozzi, et al. MMWR 2014. Farwell J. Bangor Daily News 2016. State Epidemiological Outcomes Workgroup Report (SEOW) Report. 2015.

2016: Opioid Prescribing Rates – Fell from 21. 5% from 2013 to 2016 – Now on par with national average: 0. 7 per-capita opioid prescription – Easy access to painkillers cited as major factor in opioid epidemic – 4/5 new heroin users started with Rx opioids – Prescribing has increased in Kennebec and Somerset counties What about access to recovery programs? Lawlor J. Portland Press Herald. 2017.

Knowledge Check Although the overdose rates in Maine do not appear to be increasing from last year to this year, which of the following are being reported as factors in overdose deaths more frequently? a) Prescription opioids b) Benzodiazepines c) Sufentanil and carfentanil d) Buprenorphine e) Naloxone

Other Pharmacy-Related Legislation LD 6: An Act To Prohibit Insurance Carriers from Charging Enrollees for Prescription Drugs in Amounts That Exceed the Drugs' Costs LD 455: An Act Relating to the Provision of Nicotine Replacement Products by Pharmacists LD 456: An Act To Increase Access to Vaccinations LD 572: An Act to Amend the Laws Governing the Practice of Pharmacy LD 1594: An Act Regarding the Dispensing of Naloxone Hydrochloride by Pharmacists

LD 6: An Act To Prohibit Insurance Carriers from Charging Enrollees for Prescription Drugs in Amounts That Exceed the Drugs' Costs – Enacted, signed 5/7/17 – Requires fair reimbursement for clean pharmacy claims – Inhibits retroactive payment reductions – Direct and indirect remuneration (DIR) fees – Based on reimbursement rates or other performance metrics – Have not been shown to impact outcomes – Costly to patients and (independent) pharmacies

LD 455: An Act Relating to the Provision of Nicotine Replacement Products by Pharmacists "Practice of pharmacy" means the interpretation and evaluation of prescription drug orders; the compounding, dispensing and labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records for these drugs and devices; the administration of vaccines licensed by the United States Food and Drug Administration that are recommended by the United States Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, or successor organization, for administration to adults; the performance of collaborative drug therapy management; the responsibility for advising, when necessary or regulated, of therapeutic values, content, hazards and use of drugs and devices; the ordering and dispensing of over-the-counter nicotine replacement products approved by the United States Food and Drug Administration; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy.

LD 456: An Act To Increase Access to Vaccinations – Died on adjournment 8/2/17 – Passed in the House – Senate placed on special appropriations table pending enactment – Would allow pharmacists to administer FDA-approved vaccines listed on the immunization schedule for the US CDC Advisory Committee on Immunization Practices to patients ≥ 11 yoa (current age limit ≥ 18 yoa) pursuant to valid prescription

LD 572: An Act to Amend the Laws Governing the Practice of Pharmacy – Died between Houses 6/19/17 – “Pharmacist provider status” – Highly supported by pharmacy community – Passed in Senate, defeated in House (76 -72, 3 absences) – "Pharmacist" means an individual provider of health care services 5 licensed by this State to engage in the practice of pharmacy – “Practice of pharmacy” is the provision of health care services that includes…

LD 1594: An Act Regarding the Dispensing of Naloxone Hydrochloride by Pharmacists – Emergency enacted, emergency unsigned 6/24/17 – Allows a pharmacist to prescribe and dispense naloxone hcl in accordance with protocols established under Title 32, section 13815 to an individual at risk of experiencing an opioid-related drug overdose or to an immediate family member, friend, or another person in the position to assist the individual if the individual is at risk of experiencing an opioid-related drug overdose – Rules adopted by the Maine BOP must establish adequate training requirements and protocols for prescribing and dispensing naloxone when there is no prescription drug order, standing order, or collaborative practice agreement authorizing naloxone to be dispensed to the intended recipient

Knowledge Check What is the current status of LD 572: An Act To Amend the Laws Governing the Practice of Pharmacy? a) Passed in the House and Senate, but was vetoed by the Governor b) Passed in the Senate, but not the House c) Bill passed and pharmacists are now recognized as health care providers d) Bill did not pass either the House or the Senate

References 1. 2. 3. 4. 5. 6. Dunn KM, Saunders KW, Rutter CM, et al. Overdose and prescribed opioids: Associations among chronic non-cancer patients. Ann Intern Med 2010; 152(2): 85 -92. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016; 65(No. RR-1): 1– 49. Lawlor J. Fueled by opioid crisis, drug overdose deaths on record pace in Maine. Portland Press Herald. 2016. Paulozzi LJ, Mack KA, Hockenberry JM. Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines – United States, 2012. MMWR 2014: 63(26); 5638. Farwell J. CDC: Maine tops nation in rate of long-term opiate prescriptions. Bangor Daily News. 2016. Diomede T. SEOW Special Report: Heroin, Opioids, and Other Drugs in Maine. State Epidemiological Outcomes Workgroup. 2015.