Dr. Mark Levine, Commissioner of Health Update to the Opioid Prescribing Rules Controlled Substances and Pain Management Advisory Council July 31, 2018 Dr. Mark Levine, Commissioner of Health

Charge to the Commissioner and Council Act 173 (2016) An act relating to combating opioid abuse in Vermont Following the adoption of the initial rules, the Commissioner of Health may consult the Council Limit prescribing of opioid for acute pain Require VPMS queries for pharmacists Examine new queries for prescribers Co-prescription of naloxone Require informed consent and education to patients concerning the hazards of opioid use, safe storage, and disposal

The Problem Opioids are powerful and useful pain killers. Opioids are highly addictive. Opioid addiction and overdose is a growing public health problem. Opioids are overprescribed. Prescribers play a role in the supply and use of opioids in our communities.

Major Factors Driving the Prescription Opioid and Heroin Epidemic https://www.nga.org/files/live/sites/NGA/files/pdf/2016/1607NGAOpioidRoadMap.pdf Vermont Department of Health Source: NGA

The more opioids prescribed during the first episode of opioid use, the greater the likelihood of continued opioid use One- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of days’ supply* of the first opioid prescription — United States, 2006–2015 One- and 3-year probabilities of continued opioid use among opioid-naïve patients, by number of prescriptions* in the first episode of opioid use — United States, 2006–2015 https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm?s_cid=mm6610a1_e Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use — United States, 2006–2015. MMWR Morb Mortal Wkly Rep 2017;66:265–269. DOI: http://dx.doi.org/10.15585/mmwr.mm6610a1. Source: Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use — United States, 2006–2015. MMWR Morb Mortal Wkly Rep 2017;66:265–269. DOI: http://dx.doi.org/10.15585/mmwr.mm6610a1.

Higher doses of prescription painkillers increase risk of overdose http://www.agencymeddirectors.wa.gov/guidelines.asp Recent studies support a dose-related risk and shed new light on significant risks occurring at doses lower than 120 mg/day MED. Overdose risk approximately doubles at doses between 20 and 49 mg/day MED, and increases nine-fold at doses of 100 mg/day MED or more (Figure C). Although the 2015 guideline maintains the 120 mg/day MED threshold for consultation and some guidelines have lower dose thresholds ranging from 50 to 90 mg/day MED, there is no completely safe opioid dose. MED = Morphine equivalent dose Vermont Department of Health Source: AMDG 2015 Interagency Guideline on Prescribing Opioids for Pain

Quarterly Trends - Total MME Opioid Analgesics per 100 Residents began to decrease after Act 173 was signed and prior to implementation Act 173 signed by Governor 6/8/16 Rulemaking process begins Rule goes into effect 7/1/17 There was a 32% decrease in MME/100 people dispensed between Q1 2016 and Q1 2018 Data Source: VPMS

The Vermont rate of opioid analgesic dispensed decreased between 2013 to 2017 and is among the lowest in the U.S. Note that this is based on the number of prescriptions. VT prescribing practices have changed so each prescription is for fewer days supply and lower MME. There was a 26% reduction in total MME dispensed in VT between 2015 and 2017. Prescriptions: http: files.constantcontact.com/ce920c6e201/a7d6f6a0-5735-440b-89e9-37c8b973bab4.pdf?ver=1524258585000 Data Sources: Prescriptions: Xponent, Payer Trak, data compiled by IQVIA. Population: Annual Estimates of the Resident Population for the United States, Regions, States, and Puerto Rico: April 1, 2010 to July 1, 2017. United States Census Bureau.

Principles Universal precautions Minimum length and dose Justification in the medical record Informed consent and patient education Non-pharmacological and non-opioid treatments first

Proposed changes An emergency rule was put in place to exempt hospice patients Technical fixes Clarification of definitions

Section 9: Prescribing Opioids for Hospice, and Hospice-eligible Patients Removing hospice and hospice-eligible patients from the body of the rule and creating a separate section Hospice benefit does not cover naloxone Naloxone use could be contraindicated in many hospice cases Could cause unnecessary suffering and expense Safe storage and disposal & patient education still required

Clarifying “skilled nursing facility” Adding definitions from Vermont statute for: Assisted living residence Nursing home Residential care home Changing exemptions to be more specific based on the above definitions

Clarifying “palliative care at end of life” Adding definitions for: Hospice Care (from statute) Hospice eligible means a person who is terminally ill and qualifies to receive hospice services but is not enrolled in a hospice program

Clarifying “prescribe” A critical part of the rule involves the definition of prescribe: “Prescribe” means to issue an order a practitioner advises or authorizes the use of a medication for a patient made or given electronically or in writing so that the patient may obtain that medication from a pharmacy. It does not include ordering prescription medication to be administered dispensed to the patient in a health care setting.

Updating the Co-Prescription of Naloxone Allowing providers to not prescribe in instances where a patient already has access to naloxone or already has a prescription. Clarifying which provider is required to prescribe naloxone in the instance of multiple providers for the same patient.

Mark Levine, MD — Commissioner of Health Vermont Department of Health healthvermont.gov