PRESCRIBING GUIDELINES

Ohio Department of Health RESPONSE TO OHIO S PRESCRIPTION DRUG OVERDOSE EPIDEMIC: PRESCRIBING GUIDELINES MIPA CONFERENCE PREVENTING INJURY: FROM RESEARCH TO PRACTICE TO PEOPLE SEPTEMBER 30, 2013 Christy Beeghly, MPH Program Administrator Violence and Injury Prevention Program Ohio Department of Health

2 OVERVIEW Ohio Emergency and Acute Care Facility Opioid and Other Controlled Substances Prescribing Guidelines 80 MED Trigger Point Opioid Prescribing Guidelines Ohio Department of Health

Number of drug overdose deaths OHIO DEATHS AND DEATH RATES PER 100,000 DUE TO UNINTENTIONAL DRUG OVERDOSE BY YEAR, 1999-2011 1 Death rate per 100,000 3 1800 1500 1200 900 600 300 0 327 Death Rate per 100,000 Number of Deaths 411 ~1 per day 555 702 658 904 1,020 1,544 1,475 1,423 1,261 1,351 ~5 deaths per day 1,765 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 1 Source: ODH Office of Vital Statistics, The number of drug overdose deaths in Ohio increased 440% from 1999-2011. Year 16 14 12 10 8 6 4 2 0

Number of deaths Unintentional drug overdose deaths of Ohio residents by specific drug(s) involved, by year, 2000-2011 1,2 4 900 800 700 600 500 400 300 200 100 138 Still more deaths from prescription opioids than from cocaine, heroin, and marijuana combined. 199 cocaine benzodiazepines heroin prescription opioids 257 221 319 388 462 508 546 550 694 789-2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Year 2 Multiple substances are usually involved in one death. Ohio Department of Health

5 opioids distributed in grams per 100,000 population death rate per 100,000 CONTRIBUTING FACTORS: OHIO DATA There is a strong relationship between increases in exposure to prescription opioids and fatal unintentional overdose rates. 100,000 Unintentional drug overdose death rates and distribution rates of prescription opioids in grams per 100,000 population by year, Ohio, 1997-2011 1-3 80,000 16 14 12 60,000 40,000 20,000 - Total Rx Opioid Grams (MME) per 100,000 Unintentional overdose death rate Drugs distributed 643% increase Death rate 365% increase 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Year 10 8 6 4 2 - Sources: 1. Ohio Vital Statistics; 2. DEA, ARCOS Reports, Retail Drug Summary Reports by State, Cumulative Distribution Reports (Report 4) Ohio, 1997-2007 http://www.deadiversion.usdoj.gov/arcos/retail_drug_summary/index.html; 3. Calculation of oral morphine equivalents used the following assumptions: (1) All drugs other than fentanyl are taken orally; fentanyl is applied transdermally. 2) These doses are approximately equianalgesic: morphine: 30 mg; codeine 200 mg; oxycodone and hydrocodone: 30 mg; hydromorphone; 7.5 mg; methadone: 4 mg; fentanyl: 0.4 mg; meperidine: 300 mg ; 4. US Census Bureau, Ohio population estimates 1997-2007; Ohio 5. preliminary Department data for of Health 2007

6 STATE RESPONSE TO EPIDEMIC Ohio Department of Health

7 STATE LEGISLATION HB 93 addresses (Became law April 2011): Pain management clinic licensure (i.e., Pill mills) and related changes Sets In-office physician dispensing limits Medicaid and Bureau of Workers Comp Lock-in Programs Required changes to OARRS rules (Ohio s PMP) Link to Bill Analysis: http://www.lsc.state.oh.us/analyses129/11-hb93-129.pdf

8 GOVERNOR S CABINET OPIATE ACTION TEAM (GCOAT) Established fall of 2011 to address the continuing epidemic of misuse, abuse and overdose from prescription opioids. Five work groups: 1. Treatment includes Medication Assisted Treatment 2. 3. Public Education 4. Enforcement 5. Recovery Supports

9 GCOAT PROFESSIONAL EDUCATION WORKGROUP Co-Chaired by Ted Wymyslo, M.D., Director, Ohio Department of Health Bonnie Kantor-Burman, Director, Ohio Department of Aging Two subcommittees formed: Opioid Prescribing Guidelines for Ohio Emergency/Acute Care Facilities - Lead: Director Wymyslo Reforming Prescribing Practices in Ohio Lead: Director Kantor-Burman

10 PROFESSIONAL EDUCATION WORKGROUP: INITIATIVE #1 OHIO EMERGENCY AND ACUTE CARE FACILITY OPIOID AND OTHER CONTROLLED SUBSTANCES PRESCRIBING GUIDELINES (ED GUIDELINES) Ohio Department of Health

11 OPIOID PRESCRIBING GUIDELINES FOR E.D.s & URGENT CARE FACILITIES Ohio Process o ED treatment of pain is frequently indicated without the benefit of an established doctor-patient relationship and often in an environment of limited resources. Closure of pill mills may lead to increased doctor shopping in EDs. o Active ED Physicians brought this issue to the PEW and requested action. o Based project on Washington State ED Guidelines.

12 OPIOID PRESCRIBING GUIDELINES FOR E.D.s & URGENT CARE FACILITIES Ohio Process Consensus-based process developed in partnership with key medical/health care organizations as members of the work group: o Ohio ACEP o Ohio State Medical Assn. o Ohio Hospital Assn. o Urgent Care Facilities o Ohio Pharmacists Assn. o Ohio Osteopathic Assn. o Ohio Association of PAs o Ohio ENA o Ohio BWC o Ohio Medicaid o Ohio Assn. of Health Plans o State Medical Board o Board of Pharmacy

13 OPIOID PRESCRIBING GUIDELINES FOR ED S & ACUTE CARE FACILITIES GUIDELINES PATIENT HANDOUT Ohio Opiate Action Team Public Education Work Group

14 OPIOID PRESCRIBING GUIDELINES FOR E.D. S & ACUTE CARE FACILITIES POCKET CARDS Distributed in partnership with the Ohio Hospital Association and the Ohio Chapter, American College of Emergency Physicians, and upon request.

15 ED GUIDELINES: SUPPORTING MATERIALS Professional Education Background document Patient Handout Pocket Cards Sample Tools Discharge Instructions SBIRT resources Pain Agreement Frequently Asked Questions Promotional materials: Introductory Letter for Professional Organizations Facebook Posts Website Content Press Release template Newsletter Article

16 DISSEMINATION & PROMOTION o Pubic announcement and press conference in May 2012 at Ohio Opiate Summit o Promotion through: o Endorsing organizations and committee members o Health care association communications (e.g., websites, newsletters, webinars, etc.) o Pocket card mailing o Continuing education courses o Media and social networking sites o Organization press releases o April 16, 2013 Webinar on Lessons Learned in Implementing EDGs.

17 SOME OF THE OHIO HOSPITAL SYSTEMS ADOPTING THE ED GUIDELINES Ohio Opiate Action Team Public Education Work Group

18 EVALUATION OF GUIDELINES Follow-up evaluation survey on implementation and impact of the ED Guidelines planned: Process evaluation among ED administrators and ED physicians. Assess implementation, use and any reported prescribing behavior change based on guidelines. Assess any changes made to ED Guidelines when implementing. Surveys developed and to be implemented in conjunction with OHA and Ohio ACEP. Tracking OARRS (Ohio PMP data) Ohio Department of Health

19 PROFESSIONAL EDUCATION WORKGROUP: INITIATIVE #2 80MG MED OPIOID TRIGGER POINT GUIDELINES Ohio Department of Health

20 REFORMING PRESCRIBING PRACTICES COMMITTEE THE GOALS THE GOALS Reduce the misuse and abuse of prescription opioids in Ohio by: Establishing a trigger point for re-assessment and pressing pause in opioid prescribing. Develop and implement guidelines for all prescribers of opioids for chronic, non-terminal pain. Actively promote registration and use of OARRS.

21 REFORMING PRESCRIBING PRACTICES COMMITTEE Consensus Process with Key Stakeholders: Professional licensing boards State agencies (ODH, OhioMHAS, ODA, Medicaid, BWC etc.) State professional associations Practicing pain and palliative care professionals State and federal public health agencies Ohio Department of Health

22 REFORMING PRESCRIBING PRACTICES COMMITTEE 80mg morphine equivalent daily dose (MED) for 3 consecutive months established as trigger point based on CDC expertise and research studies finding: Increased mortality rates at 50-100+mg morphine equivalent daily dose (MED). Other adverse effects for long-term use of high MEDs for chronic, non-terminal (CNT) pain. Limited evidence on effectiveness of opioids for longterm treatment of CNT pain. In 2011, over 50% of Ohio prescribers saw a patient with an MED >80mg. Ohio Department of Health

23 80 MED TRIGGER POINT ACTION STEPS: 80 MED for 3 months is established trigger point at which prescriber should press pause and consider the following action steps: Re-establish informed consent Review patient s functional status Review progress toward treatment objectives to determine benefit of opioid therapy Re-check OARRS Consider a patient pain agreement Consider referral to a pain or other appropriate specialist OARRS data needed to determine MEDs. Ohio Department of Health

CHANGES TO OARRS REPORTS

28 OHIO OPIOID TRIGGER GUIDELINES Officially Approved by: State Medical Board of Ohio Ohio State Dental Board Ohio Board of Nursing Ohio State Board of Optometry Ohio Board of Pharmacy http://www.med.ohio.gov/pdf/news /Prescribing%20Opioids%20Guidlin es.pdf Ohio Department of Health

29 SUPPORTIVE MATERIALS Education committee created a 1-hour CME training video which will be available online: Scope of the problem Director of Health Clinical guidelines State Medical Board Representative Action steps Pain Management Specialist Metrics & conclusion Addiction Medicine Specialist Letter to describe guideline and changes to OARRS report for: Prescribers Pharmacists Patients Ohio Department of Health

EDUCATIONAL PACKET September 12, 2013 OHIO STATE BOARD OF PHARMACY 77 South High Street, Room 1702; Columbus, Ohio 43215-6126 -Equal Opportunity Employer and Service Provider- PHONE: 614/466-4143 FAX: 614/752-4836 E-MAIL: exec@pharmacy.ohio.gov TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov Attention Pharmacists: Major change in the O.A.R.R.S. report to address the M.E.D. Ohio initiative This letter is intended to educate you on the M.E.D. initiative which was created to curtail the prescription drug epidemic and rising overdose death rates from opiates and combinations therein. M.E.D. stands for morphine equivalency dosing. This is essentially a system to equate different opiates and potencies into a standard morphine equivalent value via a conversion chart created by the Centers for Disease Control (CDC). This chart will be located on the last page of the new O.A.R.R.S. report. Each active opiate prescription (identified by having days supply remaining), will have a daily M.E.D. value. All active (concurrent) prescription values are then combined into one daily M.E.D. value, which will be bolded and located on the upper right portion of the O.A.R.R.S report. It is important to note that this value is a snapshot of the day when you run the report. It is not a 90 day average. This could mean that something may not show up on the report (due to lag in report time to O.A.R.R.S versus the fill date) or that tomorrow the score may lower due to active prescriptions running out the next day. These are scenarios that you should understand when viewing this M.E.D. value. Where did the 80 M.E.D. threshold recommendation come from? The threshold of equal to or greater than 80 M.E.D. was identified by a team of pain management physicians and specialists that were convened by the Governor s office. For a specific example, #16, 5mg Hydrocodone tablets taken in one day would equate to a M.E.D. value of exactly 80. However, be aware that normal dosing (Oxycontin 40mg twice daily) may also generate a value of 80 M.E.D. for that prescription. At 80 M.E.D., it was deemed that prescribers should press pause before prescribing the opiate. This includes a number of clinical considerations that the prescriber should take into account prior to issuing the prescription, as specified in the Medical Board s statement on this issue. This can be viewed via the link at http://www.med.ohio.gov/pdf/news/prescribing%20opioids%20guidlines.pdf. That is all that is required. If a patient s M.E.D. value is greater than 80, it does NOT preclude the prescriber from issuing or the pharmacist from filling the prescription, just that you should press pause, making sure that your patient absolutely requires this treatment. For pharmacists, things to consider when pressing pause may include: review of the O.A.R.R.S. report, review of the drug profile in your system, prior knowledge of this patient and physician, and professional judgement. Remember that this is a tool, not a definitive number to determine whether you fill or do not fill the prescription. However, if after review of the OARRS report you suspect a legitimacy issue, do not fill the prescription and notify us of your concern. There are a number of nice additions to the O.A.R.R.S. report that have been added to assist you. Please see the following O.A.R.R.S. report example with explanations for each section. Kyle Parker, M.B.A, R.Ph Executive Director Ohio State Board of Pharmacy

31 TIMELINE Rollout and education period October 1 December 31, 2013 Evaluation period January 1 December 31, 2014 Ohio Department of Health

32 METRICS 1. Percentage of prescribers of controlled substances registered in OARRS. 2. Percentage of registered prescribers of controlled substances using OARRS. 3. Proportion of patients at 80mg MED and above who have at least one OARRS inquiry over specified time period. 4. Number and percentage of patients prescribed both opioids and sedative/hypnotics. 5. Percentage of prescriptions filled with a quantity of 120 or more capsules or pills per prescription. 6. Average MED per prescription. Ohio Department of Health

33 BENEFITS OF GUIDELINES TO DATE Metrics committee established to review how guidelines impact would be measured. Additional resources provided by state to bring in an evaluation expert. Increased collaboration and critical use of PMP data as a public health tool for state level analysis. Functional changes to the OARRS report to serve as a more useful clinical tool to help curtail over- or inappropriate opioid prescribing. Increased education about OARRS to prescribers and pharmacists. Ohio Department of Health

CONTACT ODH Christy Beeghly, MPH, Program Administrator Violence and Injury Prevention Program Ohio Department of Health (614) 728-4116 Christy.beeghly@odh.ohio.gov