Responsible Pain Management Highlighting New Regulations of Indiana’s Medical Licensing Board and Best Practices for Patient Care Your Name Here

Goals and Objectives Identify trends and consequences of the current opioid epidemic Increased Use Paucity of data supporting COT Data demonstrating perils of COT Review new Indiana laws for opioid prescribing Outline “pearls” for office implementation of best practices and compliance monitoring

Trends and Consequences

We Treat, but Do We Help? JAMA. 2008; 299(6):656-664 Aggressive use of opioids and interventional technologies between 1997 and 2005 resulted in ~ 65 % increase in expenditures without evidence of improvement in self-assessed health status and pain. Many outcomes were worse JAMA. 2008; 299(6):656-664

Pew Health Group

Indiana falls into the second highest rate category of drug poisoning deaths CDC. Death rates for drug poisoning, by state of residence, United States, 2010. Available at http://www.cdc.gov/nchs/pressroom/states/drug_deaths_2010.pdf

Drug Overdose Death Rates Versus Motor Vehicle Accidents Now have more deaths from drug overdose than mva Years 1980-2010 NCHS Data Brief, December, 2011, updated with 2009 and 2010 mortality data

Percent Change in Ten Leading Causes of Injury Death Percent Change in Ten Leading Causes of Injury Death* Indiana, 2000–2010 In Indiana, there was a >350% increase in unintentional poisoning injury deaths from 2000-2010. It is important to note these are the ten leading causes of injury deaths from 2000-2010, not just randomly selected causes of injury deaths. Source: WISQARS *Age-adjusted rates 8

Unintentional Poisoning Death Rates, Age-Specific, Indiana, 2005 – 2010 * Rates based on 20 or fewer deaths may be unstable. Use with caution. * Rates based on 20 or fewer deaths may be unstable. Use with caution. Source: Centers for Disease Control and Prevention, WISQARS Database 9

Other Adverse Outcomes emergency department visits Other important adverse outcomes SAMHSA NSDUH, DAWN, TEDS data sets Coalition Against Insurance Fraud. Prescription for Peril. http://www.insurancefraud.org/downloads/drugDiversion.pdf 2007.

Copyright © 2012 American Medical Association. All rights reserved. Neonatal Abstinence Syndrome and Associated Health Care Expenditures:  United States, 2000-2009 2009 NAS vs. Other LOS 16.4 d vs. 3.3d Costs $53,400 vs. $9,500 Marked increase in neonatal abstinence syndrome Figure Legend: NAS indicates neonatal abstinence syndrome. Error bars indicate 95% CI. P for trend < .001 over the study period. The unweighted sample sizes for rates of NAS and for all other US hospital births are 2920 and 784 191 in 2000; 3761 and 890 582 in 2003; 5200 and 1 000 203 in 2006; and 9674 and 1 113 123 in 2009; respectively. JAMA. 2012;307(18):1934-1940. doi:10.1001/jama.2012.3951 Date of download: 1/6/2013 Copyright © 2012 American Medical Association. All rights reserved.

Youth and Controlled Substances 50% of teens believe that prescription drugs are much safer than illegal street drugs. 60-70% say that home medicine cabinets are their source of drugs.

Percentage of College Students Reporting Rx Misuse in the Past Six Months in Indiana, 2013 Rx Drug Prevalence Adderall 10.1% Vicodin 3.6% Xanax 3.5% Codeine 2.7% Ritalin 1.7% Lortab 1.5% Percocet 0.9% Oxycontin 1.3% Morphine 0.4% Methadone 0.2% Steroids 0.1% Key: Opioid Stimulant CNS Depressant Other * Indiana College Substance Use Survey, 2011 * Most widely misused Rx is Adderall, a stimulant (used/abused by one in ten college students) Source: Indiana College Substance Use Survey, 2013. Indiana Prevention Resource Center.

Narcotic Sources National Survey on Drug Use and Health 2011. More than half of nonmedical users get their prescription drugs from family or friends free National Survey on Drug Use and Health 2011.

Source Where Pain Relievers Were Obtained for Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2010-2011 Source: SAMHSA, National Survey of Drug Use and Health, 2011

Cost of Opioid Prescriptions in US 2006 estimated total cost nonmedical use of prescription opioids was $53.4 billion $42 billion (79%) was attributable to lost productivity $8.2 billion (15 %) to criminal justice costs $2.2 billion (4%) to drug abuse treatment $944 million to medical complications (2%) CDC’s estimate for 2009 is $ 72 billion Very expensive problem Clin J Pain 2011;27:194–202

Primary Care Monitoring of Long-Term Opioid Therapy among Veterans with Chronic Pain Inconsistent or inefficient monitoring of folks on prescription drugs has been an issue Pain Medicine 2011;12:740-746

Opioid Prescribing Rules

The NEW Medical Licensing Rules The MLB rules take effect on December 15, 2013 and apply to: Any patient taking >60 opioid pills per month for ≥ 3 months Any patient taking a morphine equivalent dose (MED) of >15 mg for ≥ 3 months Senate Bill 246 required the medical Licensing Board to draft narcotic prescribing rules

The NEW Medical Licensing Rules Patients that are exempt from monitoring under these rules include those who are: Terminally ill Involved with palliative care service Managed in a hospice program Registered nursing home resident We encourage safety monitoring practices for all patients

Physician Shall Do: Perform detailed history and physical Review records from previous healthcare providers Have the patient complete objective pain assessment tool Assess mental health status

Physician Shall Do: Tailor a diagnosis and treatment plan with functional goals When appropriate – use non-opioid options Counsel women on Neonatal abstinence syndrome

Treatment Agreement The physician and patient shall review and sign a “Treatment Agreement” which shall include the following: Goals of treatment Consent to toxicology screening Permission to conduct random pill counts Information on pain meds prescribed by other physicians

Physician Shall Do: Have face to face visits with patient every 4 months Conduct an initial INSPECT query on patient and then annually thereafter (the initial requirement goes into effect December 2013 but the annual requirement is extended to November 1, 2014).

Physician Shall Do: Perform drug screens annually (this provision is not required until January 2015) If the patient’s opioid dose reaches a morphine equiv of 60 milligrams/day, face to face review of the treatment plan is required. Due to a lack of standardization in current laboratory practices, urine drug monitoring will not be required until January 2015

Morphine Equivalent Dose (MED) Commonly used opioids a (MED) of 60 mg include: Hydrocodone (short-acting): 50 mg daily (e.g. Vicodin® 10/300 mg, one tablet q4-6h) = 5 tabs per day Oxycodone (short-acting): 40 mg daily (e.g. Percocet® 10/325 mg, one tablet q6h) = 4 tabs per day Oxycodone (long-acting): 40 mg daily (e.g. Oxycontin® 20 mg, one tablet twice daily) = 2 tabs per day Fentanyl (transdermal patch): 25 mcg daily (e.g. Duragesic® patch, 25 mcg applied once every 3 days) Patient’s being prescribed these equivalent doses of narcotics will fall into this category.

“First Do No Harm” Indiana’s Safe Prescribing Recommendations

Healthcare Provider Working Group Goal was to have geographic, professional and specialty diversity represented. Formed a “working group” with folks that were already working with this issue in the private sector as well as in academics. Met a number of times with all day work meetings to discuss issues. All recommendations have been vetted through this group. The providers that generated the recommendations were a diverse group of people like yourselves.

Recommendations 1. Do your own evaluation. Perform a detailed history/physical exam and obtain appropriate tests, as indicated. Obtain and review records from previous caregivers Ask your patient to complete a Brief Pain Inventory (BPI) survey to document and better understand their specific pain concerns. Establish a working diagnosis and a treatment plan

Evaluation Ask your patient to complete a pain assessment survey like the: Brief Pain Inventory This may be completed at check-in, with guidance from a nurse or medical assistant. Patients occasionally provide very striking information on the drawings. This survey forms the basis for a discussion and goal-setting.

Risk Stratification – 2 Main Areas to Address Mental Health Assessment Risk for substance abuse The use of chronic opioids in “high risk” individuals is strongly discouraged 2 key areas to address when attempting to stratify risk ….

Mental Health Assessment Tools Chronic pain may be caused, influenced or modulated by … Depression (PHQ-2,PHQ-4 PHQ-9) Post Traumatic Stress Disorder Anxiety/Panic Disorder (GAD-7) PHQ-2 assesses whether either of the following have been present in the past 2 weeks: Feeling down, depressed or hopeless AND Diminished interest or pleasure in doing things. All are validated tools. PHQ4- screend for anxiety and depression The lack of benefit that opioids provide here will result in rapid dose escalation, increased adverse effects and more harm than benefit in the end. Treat the underlying psychiatric diagnosis first and foremost! At least do that in parallel with the pain-generating condition.

Substance Abuse Assessment Tools Ask patients about any past or current history of substance abuse (alcohol, Rx meds, or illicits) prior to initiating treatment for chronic pain with opioids ORT – Opioid Risk Tool SOAPP – Screener/Opioid Assessment for Patients in Pain (starting opioids) COMM – Common Opioid Misuse Measure (pts already using opioids) * A risk assessment survey (e.g. ORT, SOAPP) should be completed for every patient seeking tx for chronic pain. * Risk levels may vary over time, so repeat these assessments periodically at follow-up visits. Important to document this, even if the patient is not truthful when completing the form. These survey tools will be available at: www.bitterpill.in.gov

Opioid Risk Tool (ORT) Webster & Webster. Pain Med. 2005;6:432. Mark each box that applies: Female Male Family history of substance abuse Alcohol 1 3 Illegal drugs 2 3 Prescription drugs 4 4 Personal history of substance abuse Alcohol 3 3 Illegal drugs 4 4 Prescription drugs 5 5 Age (mark box if between 16-45 years) 1 1 History of preadolescent sexual abuse 3 0 Psychological disease ADO, OCD, bipolar, schizophrenia 2 2 Depression 1 1 Scoring totals: 1. Webster & Webster. Pain Med 2005;6:432-442.[p433] Webster & Webster. Pain Med. 2005;6:432.

Keep in Mind … The use of chronic opioids in high risk patients is discouraged unless the underlying issues are appropriately addressed. Specialty consultation may be appropriate. High Risk = significant mental health issues, past or current history of substance use/abuse. Also consider family hx and the patient’s social situation (e.g. living in a setting with other substance abusers).

Recommendations 3. Set functional goals with your patients that include achievable targets for pain management. It is unrealistic for patients to expect complete resolution of their chronic pain. Work together towards improving pain control and achieving specific functional goals, as both are key outcomes. Functional goals might include increasing physical activity level, resuming a job/hobby or improving the quality of sleep. The goal is to establish functional outcomes that are relevant to the patient.

Functional Goals and Managing Pain Working together with your patient determine: Specific Achievable Functional Goals Assess progress at each visit Reframe expectations: A realistic “Pain Score” target isn’t zero! Functional goals might include increasing physical activity level or resuming a job/hobby. Set realistic goals for improvement, including a plan for improving pain control. Driving a pain score to zero is not realistic. Reframe expectations; a 30% improvement in pain level often facilitates improved functioning.

Recommendations 4. Utilize evidence based treatments, including non-opioid options initially, where possible. Consider non-pharmacologic therapies, in addition to the various medications available. Utilize first-line pharmacologic options before prescribing opioids. Expand the options of treatment to include non-pharmacologic options

Recommendations 4. Utilize evidence based treatments, including non-opioid options initially, where possible. Use the lowest dose of medication required to reduce pain and improve functioning. Don’t begin a treatment that you are not prepared to stop.

A very under-utilized category of options in the past A very under-utilized category of options in the past. Basic exercise (like walking and stretching … or yoga) + review of sleep hygiene may be highly beneficial, but require patient commitment and effort. Include these in the plan to help meet functional goals.

Anti-inflammatory /Transdermal pain creams are available from compounding pharmacies that are becoming more prolific  shipping directly to your patients when you fax a prescription. Ingredients may include the multiple components, including: Baclofen 2%, Bupivacaine 1%, Cyclobenzaprine 2%, Diclofenac 5%, Gabapentin 6%, Lidocaine 5% (to name a few). Respect allergies, but there is minimal systemic absorption and potentially significant local benefit.

Evidence Based Treatment AVOID opioids in patients with: Chronic headache Chronic low back pain Chronic pelvic pain Fibromyalgia Functional bowel disorders (IBS) You will likely see lack of sustained benefit ( greater than 4 months) from opioids in these patients, triggering more rapid dose escalation and an increasingly difficult situation to manage. Adverse effects are common and may override the intended benefit in many of these patients. Opioid reduction or discontinuation is recommended if overall functioning is to improve. Use non-opioid pharmacologic agents and other treatment modalities for pain management in these situations.

Prescribing Opioids Start with the lowest dose possible. After reasonable titration, consider discontinuing opioids if pain does not improve and or functional goals are not met. Don’t begin a treatment that you are not prepared to stop! Always have an EXIT strategy! An airline pilot doesn’t take off if he doesn’t know how to deal with emergencies or if he doesn’t possess the required skill to land the aircraft. It is your responsibility as a professional to have the ability and willingness to exit a failed strategy (with assistance, when necessary).

Recommendations 5. Discuss the potential risks and benefits of opioid treatment for chronic pain, as well as expectations related to prescription requests and proper medication use. Together, review and sign a “Treatment Agreement”, which includes the details of this discussion for all patients that are prescribed controlled substances (opioids, benzodiazepines, stimulants) on an ongoing basis. Refer to the sample “Opioid Consent Form and Treatment Agreement” included in the Tool Box.

Prescribing Opiates: Informed Consent Discuss the risks and benefits of opioid treatment (including common adverse effects). Counsel women of child-bearing age about the potential for fetal opioid dependence and neonatal abstinence syndrome (NAS).

Review and Sign a Treatment Agreement Consider including the following information in your treatment agreement: Long term benefit of treatment with opioids has not been established One prescriber, one pharmacy No sharing or selling meds Keep medications safe; lost or stolen Rx will not be replaced Renewals are contingent on scheduled appointments Nurse and physician may work to address this together for efficiency; answer any questions your patient may have in a straightforward manner to ensure their understanding.

Review and Sign a Treatment Agreement Consider including the following information in your treatment agreement: There is potential for addiction, and abstinence syndrome if the medication is stopped abruptly Prescription Drug Monitoring (INSPECT) will be reviewed regularly Participation in Urine Drug Monitoring, as directed Nurse and physician may work to address this together for efficiency; answer any questions your patient may have in a straightforward manner to ensure their understanding.

Review and Sign a Treatment Agreement Consider including the following information in your treatment agreement: Failure to follow policies or lack of functional benefit with the treatment will result in discontinuation of the opioid trial (taper) No phone refills Nurse and physician may work to address this together for efficiency; answer any questions your patient may have in a straightforward manner to ensure their understanding.

Recommendations 6. Avoid prescribing for patients without periodic scheduled visits.  It’s the Law. Evaluate patient progress and compliance with their treatment plan regularly and set clear expectations along the way (e.g. attending PT, counseling or other treatment options).  Follow-up visits should occur at least once every 3-4 months.  More frequent visits would be appropriate.

Recommendations 7. Remember the 5 A’s when managing your chronic pain patients with opioids:  Activities of Daily Living Analgesia Affect (screen for mental illness & substance use) Adverse effects Aberrant drug use behaviors

Recommendations 8. INSPECT: Indiana’s prescription drug monitoring program, helps us all.  Use INSPECT regularly for both new and established patients.  It tracks all controlled substance prescriptions filled by patients state-wide and some neighboring states. You can register with the state at www.in.gov/inspect INSPECT reports should be run at least once every 3-6 months; or more often as desired or appropriate. 

INSPECT: Indiana Scheduled Prescription Electronic Collection & Tracking COLLECTS Controlled substances dispensed to Indiana residents from: Retail pharmacies Hospital Outpatient pharmacies Mail Order pharmacies Non-resident pharmacies Physician dispensing out of office that is more than a 72-hour supply DOES NOT COLLECT Any substance that is not controlled Pseudoephedrine Morphine/Methadone (that is less than 72-hour supply) VA facility dispensing - will be included by 2014 Any substance dispensed that is less than a 72-hour supply Any substance that is administered directly to a patient INSPECT – INdiana Scheduled Prescription Electronic Collection & Tracking Ask patients, “Have you received Rx’s for pain meds (or other c/s) from any other HC provider in the past 3 months?” … and see how things stack up with INSPECT and UDM.

Demo patient Ease of Use - Providers with EHR software have the opportunity to have the PDMP data directly integrated into their software. This is in limited use (beta testing) at present. Prescribers already using the IHIE (Indiana Health Information Exchange) may have access to a NARxCHECK score: <200 (75% of patients) – OK, 200-500 (20% of patients) – Be curious, 500-650 (4% of patients) – Be careful, 650+ (1% of patients) – Look out!

Recommendations 9. Urine drug monitoring (UDM) protects you and your patients.  UDM is a useful objective tool that complements your other risk assessments. Discussion with patients regarding the need for UDM should legitimately be based on their SAFETY

Urine Drug Monitoring (UDM) UDM has evolved to become a standard of care when prescribing opioids for patients with chronic pain. It will assist in: Detecting illicit substances Monitoring patient adherence to prescribed medications Frequency of INSPECT and UDM use may be driven by your risk assessments. Greater risk (or concern) translates into more frequent monitoring on all levels.

Urine Drug Monitoring UDM should be performed at the initiation of an opioid trial and at least annually. Test frequency may vary depending on the level of identified risk or prescriber concern. Higher risk patients and patients receiving high doses of opioids or other controlled substances should have UDM performed more frequently. When ordering a confirmatory UDM test, record all c/s medications that the patient is taking (along with time of last dose) on the requisition.

Mass spectrometry (GCMS) Urine Drug Monitoring Immunoassay (IA) Gas Chromatography Mass spectrometry (GCMS) Quick, inexpensive, point of care Identifies classes of drugs (e.g. Opioids, THC) Can have false positives (e.g. NSAIDS  + THC) Can have false negative (e.g. low dose Vicodin®) Will need confirmatory test if results are not consistent The definitive confirmatory test Specific for medication and/or the metabolite(s) More expensive ($60-$500) Send out to lab (~2d for results) Actionable intelligence Semi-synthetic and synthetic opioids do not reliably trigger a positive opioid (IA) test, as this test is geared to the “natural opioids”, codeine and morphine. Specific test strips for individual drugs are available at additional cost. False positive reactions are common, with multiple OTC and prescription meds contributing to confusion here. Tough to take action based on IA results, unless the patient agrees with the findings. Given the multiple limitations listed for IA testing, it is wise to obtain confirmation testing prior to taking definitive action based on these results.

Urine Drug Monitoring Data in a Practice Setting UDM data for a FMC – full year reporting. Downtown clinic in a moderate-sized U.S. city. Some of the values reported in the 3rd category may be higher than indicated, when a prescribed (and tested for) medication had not been taken by the patient in the 2-3 days leading up to the UDS (e.g. the patient ran out of their medication early, which in itself, may be a “red flag”). Fort Wayne Medical Education Program; Reporting Period: January – December 2012

10. Reassessment is Required when ≥ 60 MED Face-to-face review to reassess your patient if pain is poorly controlled or there is lack of functional improvement Formulate/document a revised assessment and treatment plan Discuss the increased risk for adverse outcomes with higher opioid doses if that is what you plan to do MLB guidelines say reassess when MED is 60 mg/day, but realistically, this should occur sooner (>30 mg/day) based on expert opinion.

Overdose Risk Based on Dose, Group Health, 1997-2005 As you can see, overdose risk increases with higher doses and this is why we need to pause and reconsider when patients reach a dose of 60 Meq per day. Dunn et al, Opioid prescriptions for chronic pain and overdose. Ann Int Med 2010;152:85-92.

Additional Options … Opioid adjustments may include: a slow wean, modified dose (up/down) or rotation to another formulation Collaboration with a mental health professional, as needed. Referral to a pain management specialist for evaluation/treatment. Referral to an addiction specialist for evaluation when a substance use disorder is suspected. When rotating opioids, dial back the equianalgesic dose by 25-50% to minimize the risk of overdose.

Co-Morbid Risks with Opioids … Patient mortality risk is more pronounced for patients that have any of the following active co-morbid issues: Benzodiazepine use Illicit substance use/abuse Alcohol overuse/abuse Untreated mental health issues (e.g. depression, hx of suicide attempt) Chronic respiratory problems (e.g. Asthma, COPD, OSA, CHF) Also watch out for other “sneaky” sedating meds, like antihistamines (e.g. Benadryl – diphenhydramine) and muscle relaxants (e.g. Flexeril - cyclobenzaprine) to name a few. Alcohol is a CNS depressant and also increases some opioid drug levels when present to excess. Patients with poor respiratory reserves are also at increased risk.

Pearls for High-Risk Patients ALWAYS refer for Chemical Dependency Evaluation & Treatment Non-judgmental ∙ Empathetic care Do not abandon your patient

Putting it All Together

Challenges to Adoption of Opiate Guidelines Lack of Time Lack of knowledge Patient expectations Decreased patient satisfaction Strained physician-patient relationship Beliefs that opioids are safe Physician belief that this change is not necessary Many challenges but this is do-able

Healthcare Provider Toolbox: www.bitterpill.in.gov A comprehensive “Clinical Resource” to assist you in managing your patients with chronic pain A starting point for you and your staff In 2012, the Indiana Attorney General’s office invited a broad multidisciplinary coalition of volunteer physicians together to develop an educational resource as a guide for Indiana physicians using Opioids in chronic pain. This task force developed the materials on the Attorney General’s website, bitterpill.in.gov The toolbox is intended to be used as a resource for all physicians who treat chronic pain or prescribe opioids.

Toolkit - Format Not a dissertation; “designed for the busy doc” Designed to be easy to read Provides links to resources/tools Provides templates for various surveys & forms Links to websites with more in-depth information for you and your patients Talking points for difficult conversations While the toolkit is comprehensive, it is designed such that each section is an easy read – 15 min – with all of the necessary resources embedded into the document for your use. Would recommend that you have your staff all read as well, as they will likely be administering the screening tools and they will want to familiarize themselves with the documents.

A number of topics to choose from to assist you in coming into compliance with recommendations and rules

Specific Recommendations Just the facts ma’am Key Stat To engage Overview Has a bit more depth than the recommendations and includes links to forms, additional info, etc Specific Recommendations Just the facts ma’am Each section is issue specific and again, a quick read

Includes “Talking Points” Conversation starters with patients In the margins will be testimonials and other useful info

Resources Includes resources for implementation: Screening tools Templates FAQs Drug Information Primer on Urine Drug Monitoring

Develop Policy & Optimize Workflow Educate office staff Protocol for new patients Protocol for existing patients Refill policy Lost scripts Missed visits Drug Monitoring Ceiling for opioids? Benzo policy One of the first steps in tackling this issue is to develop a well thought out policy for your practice or your office. Aside from following the new requirements, the policy should also address: new patient med requests and your office’s medication refill policy for c/s.

Educate patients Letter Policy Framed around safety to them, their family and their community You may consider sending a letter to patients to inform them of the changes they will notice on their next appointment.

Changing the Paradigm Need to begin educating public about the new rules and recommendations for physicians and the impact on healthcare delivery. Focus is on functionality as well as pain control. Resetting expectations of the public – they will need to be more actively engaged in their treatment. Op ed pieces throughout the next year Posters for exam rooms and other public areas

Posters for your work area can be downloaded that highlight the rules and recommendations for prescribing narcotics.

Summary

Summary Preserve patient safety first and foremost. Screen for mental health problems and substance abuse, using available survey tools to supplement your history. Set Functional Goals and expect your patient to play an active role in their treatment plan. Not just pills! Monitor compliance using objective tools; INSPECT and UDM are valuable resources. Please use them!