Legislative Bulletin March 4, 2016

Updated Outline of S. 243 with Preliminary Amendments from the Senate Health & Welfare Committee and VMS Positions

VMS supports the goal of S. 243, to combat opioid abuse, and has created a task force to work on improving opioid prescribing.  The most recent draft of S. 243 includes a number of helpful provisions designed to reduce misuse of opioids. Having a no-charge statewide drug take-back program that is easy for patients to use will help get rid of unneeded controlled substances.  Requiring licensing boards to develop evidence-based standards to guide prescribers in the use of controlled substances to treat chronic pain and acute pain also is reasonable.  Increasing options for care coordination for buprenorphine patients and increasing payments to physicians who prescribe buprenorphine would help to address challenges of providing this treatment.   Similarly authorizing the use of telemedicine to provide addiction specialist treatment for stable patients on buprenorphine may increase availability of these specialty services.  VMS supports using the pharmaceutical manufacturer fee to fund naloxone and would also support using this fee to support academic detailing, analysis of the VPMS data, and continuing education.  There are however, three provisions in the bill that are of concern to VMS. 

Section 1 - Checking Vermont Prescription Monitoring System (VPMS):
Section 1 requires prescribers to check the VPMS every time prior to writing a prescription for refill for an opioid controlled substance except for patients receiving end-of-life care or hospice care or in the event of technical difficulties with the VPMS.  The Commissioner of Health is also authorized to create additional exceptions by rule.  

VMS believes that checking the VPMS for every opioid every time, is administratively burdensome and low yield.  VMS’ recommends that the law authorize the Department of Health to promulgate rules about the frequency of required VPMS checking.  The authorizing language should clarify that mandated VPMS querying would not be required for every prescription or refill particularly for stable primary care patients, cancer patients, palliative care patients, post-operative patients or emergency department, post-operative patients, and patients with acute injuries.  

Section 16 – Rules Governing Prescription of Opioids for Acute and Chronic Pain and Use of the VPMS
Section 16 authorizes the Department of Health to promulgate opioid prescribing rules for acute and chronic pain that may include numeric and temporal limitations on the number of pills prescribed, including a maximum number of pills to be prescribed following minor medical procedures.  The Committee removed a provision in an earlier version of the bill that mandated the Commissioner to adopt rules addressing prescribing limits, including a maximum of 10 pills following minor procedures and is considering adding language to ensure that patients are not left in pain. 

Section 16 also requires the rules to mandate informed consent that explains the risks of opioids including: addiction, physical dependence, side effects, tolerance, overdose and death.  The rules must also require prescribers to provide information concerning safe storage and disposal of controlled substances.

 VMS believes that one-size-fits-all opioid prescribing rules could have unintended consequences for patients.   It will be difficult to define “minor procedures.”  Practice guidelines, on the other hand, are helpful and have the flexibility to change as the practice of medicine and evidence of effectiveness and safety evolves. Practice guidelines should be reviewed to ensure that they are consistent with current best clinical practices and must applied in individual patients’ cases consistent with clinical judgment.

VMS also believes that a one-size-fits-all list of items required to be included in informed consent may have unintended consequences.  Many patients who could benefit from taking opioids, such as palliative care patients, cancer patients, hospice patients and end-of-life care patients, could be deterred from taking opioids by specific informed consent lists that are not designed for their condition.  For example, informing patients about the risks of opioid addiction/dependence is not relevant for dying patients, whose treatment goal is comfort. 

Section 9 Continuing Education
Section 9 requires licensing boards for professionals that prescribe or dispense controlled substances to require at least two hours of continuing education for each licensing period on the topics of abuse and diversion, safe use, appropriate storage and disposal of controlled substances; appropriate use of the VPMS, risk assessment for abuse or addiction, pharmacological and nonpharmacological alternatives to opioids for managing pain, medication tapering, and relevant laws and rules concerning the prescription of opioids. 
VMS has asked that any required education be meaningful to providers and has recommended that the Academic Detailing program at the UVM College of medicine be charged with identifying or developing courses or programs.  VMS has also asked that individual prescribing data from the  VPMS be used in an educational peer review context to inform professionals about their prescribing and to offer tools and materials to improve practice.  Using data in this way has been shown to influence prescribing by Emergency Department providers at Central Vermont Medical Center. 

Please contact VMS with thoughts and concerns about opioid prescribing initiatives in S. 243. 

Opioid Prescribing Taskforce Report and Update 
VMS has established an Opioid Prescribing Taskforce with approximately 40 members that includes primary care physicians, emergency medicine physicians, surgeons, pain specialists, addiction specialists, nurse practitioners, physician assistants, pharmacists, and representatives of licensing boards, the UVM Academic Detailing program, the UVM Medical Center, the Department of Health and the Vermont Association of Hospitals and Health Systems (VAHHS).  The goal of the taskforce is to improve policy and treatment for patients with chronic pain, acute pain, and addiction.  Please contact VMS if you are interested in joining this effort. 

As VMS members know well, there is a serious problem with prescription opioids and heroin nationally and in Vermont.  The Department of Health reports that more than 1 patient per week dies of an accidental opioid overdose each year, including prescription opioids, heroin and fentanyl.  According to the Department of Health, starting in 2013 heroin and fentanyl-related fatalities have risen sharply while deaths involving prescription opioids have begun to decrease, 

In the last five years, practices across the state of all sizes have been working to develop protocols and tools to address this problem.  UVM medical center has developed protocols for management of chronic opioid prescribing which they are willing to share with other practices.  Similarly, Mount Anthony Primary Care in Bennington County has developed protocols and tools for addiction treatment that they are willing to share.   The Emergency Physicians have developed consensus prescribing guidelines for use in emergency departments and Central Vermont Medical Center has used peer review data on opioid prescribing to reduce prescribing in their emergency department significantly. The UVM academic detailing program has developed an Opioid Prescribing Toolkit.  The Vermont Board of Medical Practice (VBMP) has developed guidelines for the Use of Controlled Substances for the Treatment of Pain and Treatment of Opioid Addiction in the Medical Office. 

Progress is being made in reducing diversion of legitimately prescribed controlled substances.  Non-medical use of pain relievers is decreasing nationally.  In Vermont according to a data brief from the Department of Health, reported misuse of prescription pain relievers is decreasing significantly while the number of Vermonters receiving treatment for opioid abuse and dependence has increased significantly. 

The Department of Health reports that the frequency of checks to the Vermont Prescription Monitoring System (VPMS) has increased.  The VPMS system is queried about 12,000 times per month or about 144,000 times per year, a significant increase.  The number of high threshold letters the Commissioner sends out quarterly to prescribers when their patients are receiving prescriptions from multiple prescribers or pharmacies has declined significantly from 20 to about 5, which may indicate a reduction in doctor/pharmacy shopping.  The Department of Health plans to upgrade the VPMS software in the next few months so that pharmacies will be able to provide data to the system daily, instead of weekly.  Similarly, Vermont should be able to share prescription monitoring data with Maine, Massachusetts and New York by June of 2016 and agreements are planned that will enable physicians to check when patients fill prescriptions in other states.  The Veterans Administration is rolling out data sharing across the country which will enable Vermont practitioners to see if patients are receiving drugs prescribed in the VA system.  The Commissioner of Health is working to improve the Department’s ability to analyze the data from the VPMS.  The new VPMS vendor system is linked to the licensing database which should make it possible to compare prescribing by specialty.  The Academic Detailing program and the Department of Health are analyzing the VPMS data to review opioid prescribing by dentists and to follow-up with UVM-MC patients after operations at seven and fourteen days to ask if they received too much, too little, or just the right amount of analgesic medicine. 

Practitioners and pharmacists on the taskforce recognize that there is more to be done.  The Commissioner of Health has expressed concern that the total number of opioid analgesics prescriptions in Vermont continues to rise from 410,600 in 2010 to 426,007 in 2014.    Many legislators or their constituents report receiving “big bottles” of controlled substances that they do not use after procedures.  Some practitioners may not be comfortable confronting patients they are prescribing opioids for long term.  Pharmacists on the task force have expressed concern that it appears from their perspective that some prescribers appear to be prescribing too many opioids for chronic pain.  Addiction specialists have expressed concern that all prescribers may not know how to appropriately taper their physically dependent patients from opioids or other controlled substances (medication assisted monitored outpatient detox).  Sharing the data in the VPMS with prescribers through a peer review process has great potential to drive behavior, but may take time. The Opioid Prescribing Taskforce also discussed the public perception that practitioners with less training may be prescribing larger doses of pain medicine than other prescribers.  VMS and the Opioid Prescribing Taskforce are ready to work with the Department of Health on proposals to address issues and concerns around opioid prescribing. 

References and Materials:
Vermont Department of Health Data brief: Vermont Drug-Related Fatalities 2010-2014

UVM MC: Management of Chronic Opioid Protocol

Consensus Opioid Prescribing Guidelines for Vermont Emergency Departments

Mount Anthony Primary Care – Consent for Treatment with Buprenorphine and Contract for Use of Buprenorphine
UVM AHEC Opioid Toolkit

Vermont Board of Medical Practice (VBMP) Policies:
Use of Controlled substances for Treatment of Pain
Treatment of Opioid Addiction in the Medical Office
Vermont Department of Health - Data Brief: Opioid Misuse, Abuse and Dependence July 2015
Sample Report Card – Emergency Department Providers