7/17/2017. FSHP 2017 ANNUAL MEETING Nothing to disclose. Opioid Overuse: National Epidemic. Opioid Epidemic: CDC Data

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1 FSHP Disclosure Nothing to disclose Opioid Utilization and Overdose Katie Neff-Golub, PharmD, BCGP, CPh CJ1 Objectives Gain understanding of the opioid overuse epidemic Review the role of opioid medications in non-cancer pain Learn how to calculate a morphine equivalency dose (MED) Review tools available to combat opioid overutilization Gain understanding of safeguards the Centers for Medicare & Medicaid Services (CMS) has enacted to help deal with the opioid epidemic Opioid Overuse: National Epidemic References: Police work to protect dog partners in opioid epidemic battle. Click On Detroit. Accessed online 5 June 2017 In Opioid Crisis, a New Risk for Police: Accidental Overdose. US News. Accessed online 5 June 2017 First dose of opioid money favors Central Florida over South Florida. My Palm Beach Post. Accessed online 5 June 2017 CJ2 Opioid Overuse Epidemic: Florida May 3, 2017 Governor Rick Scott declared the opioid epidemic a public health emergency Provides the state access to $54 million in U.S. Department of Health and Human Services grant money to pay for prevention, treatment, and recovery services Florida statistics: 2015: Heroin, fentanyl, and oxycodone were responsible for the deaths of 3,896 Floridians according to Florida Department of Law Enforcement statistics 2016: The morgues in Palm Beach County were strained to capacity by 525 fatal opioid overdoses according to the Sun Sentinel Newspaper Public Health Emergency Current Status in Florida: Priorities: Medical treatment for people addicted to heroin or other opioids and naloxone to reverse overdoses Florida Department of Children and Families (DCF) announced Central Florida would receive $8.7 million and South Florida $2.2 million (Total funds: $27 million) Purchased 3600 naloxone kits to local treatment centers and organization. 15,000 more to be purchased in upcoming year Bulk of funds will be used towards medication assisted treatment and the hiring of be havioral health consultants and peer specialists Florida Gov. Declares State s Opioid Epidemic Public Health Emergency. NBC News. Accessed 5 June 2017 First dose of opioid money favors Central Florida over South Florida. My Palm Beach Post. Accessed online 5 June 2017 Opioid Epidemic: CDC Data References: CDC. Wide-ranging online data for epidemiologic research (WONDER) Atlanta, GA. CDC. National Center for Health Statistics Available at Centers for Disease Control and Prevention. CDC Health Advisory: Increases in Fentanyl Drug Confiscations and Fentanylrelated Overdose Fatalities. HAN Health Advisory. October 26, Centers for Disease Control and Prevention. Increases in Drug and Opioid Overdose Deaths United States MMWR 2015: 64:1-5 1

2 Slide 3 CJ1 If you are able to adjust your objectives at Slide 5 CJ2 consider having this information presented over 2 slides to limit the words per slide. Seems a little overwhelming on 1 slide.

3 Opioid Epidemic: State Deaths Opioid Epidemic: Drug Sources Reference: CDC/NCHS, National Vital Statistics System, Mortality. Reference: Jones C, Paulozzi L, Mack K. Sources of opioid pain relievers by frequency of past-year nonmedical use: United States, JAMA Int Med 2014;174(5): Opioid Epidemic: Risk Factors What are opioids? The term opioid refers to all compounds related to opium The word opium is derived from opos, the Greek word for juice, the drug being derived from the juice of the opium poppy The term narcotic was derived from the Greek word for stupor and once used for any drug that induced sleep Reference: CDC. Prescription Opioids Risk Factors: Image Reference: Becker G, Blum H. Novel opioid antagonists for opioid-induced bowel dysfunction and postoperative ileus. Accessed online 2016 Oct 26 at: Types of Pain Role of Opioids in Pain Therapy First-line therapy: Cancer Pain Moderate to severe acute pain Chronic pain unresponsive to acetaminophen, NSAIDs, and co-analgesics Second-line therapy: Neuropathic Pain Osteoarthritis Reference: A Pharmacist s Roadmap to Pain Management. Differentiating Types of Pain. Accessed online 2016 October 26 at: 2

4 Classification of Opioids Benzomorphans Diphenylheptanes Phenanthrenes Phenylpiperidines diphenoxylate loperamide pentazocine methadone propoxyphene buprenorphine butorphanol codeine heroin hydrocodone hydromorphone levorphanol morphine oxycodone oxymorphone nalbuphine naloxone alfentanil fentanyl sufentanil alfentanil remifentanil CJ3 Principles for safe prescribing Single prescriber and single pharmacy Patient and prescriber sign pain management agreement Lowest possible effective dose should be used Use caution when using opioids with conditions that can worsen side effects COPD, CHF, sleep apnea, alcohol or substance abuse, elderly, or history of kidney or liver dysfunction Do not combine opioids with sedative hypnotics, benzodiazepines or barbiturates Unless there is a specific medical and/or psychiatric indication for the combination Routinely assess function and pain status Monitor for medication misuse Random urine drug screening Do not prescribe more than an average daily morphine equivalency dose (MED) of 120 mg without either the patient demonstrating improvement in function and pain or first obtaining a consultation with pain management specialist Reference: Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain. Agency Medical Directors Group Available online: Accessed 17 Oct 2016 Morphine Milligram Equivalents (MME) Practice MME Calculation 45 yo male is currently receiving Oxycodone ER 80 mg BID Oxycodone 30 mg QID Hydrocodone 10/325 mg TID Calculation: Step 1: Determine total daily dose of each opioid Oxycodone total daily dose: = 280 mg/day Hydrocodone total daily dose: 30 mg/day Step 2: Convert to MME Oxycodone > 280 * 1.5 = 420 Hydrocodone > 30 * 1.0 = 30 Step 3: Add components together Total daily morphine equivalency is 450 CDC Opioid Overdose Prevention Resources CDC Pain Guideline for Primary Care 3

5 Slide 14 CJ3 Recommend decreasing number of words per slide, consider spreading over 2 slides

6 CDC Pain Guideline for Primary Care CDC Guideline for Primary Care CDC Guideline for Primary Care CJ6 Tapering Off Opioids To safely discontinue opioids, they must be slowly tapered by the prescriber Rule of thumb: Reduce dosage by 10% per week Opioid abstinence syndrome may be encountered Symptoms include: nausea, diarrhea, muscle pain, and myoclonus (muscle twitches, jerking) If severe, may require dosage to be reduced monthly instead of weekly May use antidepressants to manage irritability, sleep disturbances or anti-epileptics for neuropathic pain (i.e. gabapentin) Referral to counseling or social support is recommended if significant behavior issues develop Referral to pain specialist or chemical dependency center for complicated withdrawal symptoms Tools available: PDMP State of Florida s Prescription Drug Monitoring Program, E-FORSCE Electronic-Florida Online Reporting of Controlled Substance Evaluation Program Report controlled substances II-IV within 7 days of dispensing Prescriber or Dispenser Designee access granted as of February 14, 2017 Prescribers or dispensers may designate another individual to have access on their behalf Prescribers and dispensers accept responsibility for the designee s actions within the database and ensure required training is completed Training Guide for Florida Practitioners and Pharmacists Information Security and Privacy Course for Designees Future? CJ7 Tools available: Naloxone July 1, 2016: Naloxone available without a prescription in Florida, HB1241: Authorizes a health care practitioner to prescribe and dispense, or a pharmacist to dispense, an emergency opioid antagonist pursuant to a non-patient specific standing order for an auto injection delivery system or intranasal application delivery system, which must be appropriately labeled with instructions for use. FDA supports greater access, offering manufacturer assistance in OTC application How to use: Recognize an overdose (not breathing, breathing very slow, turning blue/pale/gray, becoming limp) Check for breathing Call 911 Perform Rescue Breathing Give Naloxone Perform more rescue breathing If still not breathing, give another dose of naloxone, and repeat rescue breathing Put the person in recovery position Naloxone Reversal (Real Life): Naloxone Injection Training Video: Nasal Naloxone Training Video: Naloxone Auto-Injector Training Video: Reference: FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths. 4

7 Slide 22 CJ6 try to limit words per slide/spread over 2 slides Slide 24 CJ7 try to limit words per slide/spread over 2 slides

8 CJ8 CMS Tools: Medicaid AHCA Lock-in Policy - 09/15/16 Managed care plans may adopt a pharmacy lock-in program utilizing the following criteria or less restrictive criteria More restrictive criteria requires agency approval prior to implementation Enrollee Qualifications: 3 or more controlled substance medications + 3 or more pharmacies + 3 or more prescribers within 180 days, OR Been convicted of fraud through the unauthorized sale or transfer of a pharmaceutical product funded by Medicaid Utilized 10 or more prescribers in last 90 days Obtained 2 or more controlled substance prescriptions + 2 or more different prescribers + 2 or more pharmacies within 180 days AND have a documented diagnosis of narcotic poisoning or drug abuse within last 365 days Violated a pain management agreement/contract with their prescriber Exclusion Criteria: Enrollees diagnosed with sickle cell disease or cancer Enrollees residing in institutionalized settings (i.e. nursing homes) Enrollees dually enrolled in Medicare and Medicaid CMS Tools: Medicaid Lock-in Notification Required The managed care plan must notify the enrollee, the enrollee s prescriber, and the enrollee s pharmacy prior to implementation of the lock-in period What if pharmacy is out of stock? The managed care plans must take any and all necessary action to ensure that medically necessary services are provided to enrollees with reasonable promptness If enrollee disagrees: May appeal within 30 days of the date of the notification letter to the managed care plan May request a Medicaid Fair Hearing within 90 days of the date of the notification letter May request to use another pharmacy provider CMS Tools: Medicare Retrospective Drug Utilization Review (rdur) Opioid Overutilization Program Medicare Part D required as of 01/01/13 Managed Care Plans required to develop case management program Allows managed care plans to restrict access to specific opioid regimen through prescriber consensus or program policy if no prescriber response Goal: Medication Safety Program to reduce morbidity/mortality of Medicare patients Enrollee Qualifications 2017: 120 MED 90 days, and 3 or more pharmacies and 3 or more prescribers in 180 days Exclusion Criteria: Enrollees diagnosed with terminal condition (cancer or hospice care) CJ9 Federal Legislation: CARA July 22, 2016 Comprehensive Addiction and Recovery Act signed into law Comprehensive effort to address opioid epidemic $181 million each year in funding to fight the epidemic Coordinated effort: prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal Summary of provisions: Expand educational efforts Expand availability of naloxone to law enforcement and first responders Expand resources to treat addicted incarcerated individuals Expand Rx disposal sites to keep out of hands of children and teens Strengthen PDMPs to help states monitor and track diversion Launch evidence based opioid and heroin treatment & intervention program Reference: The Comprehensive Addiction and Recovery Act (CARA): Public Law References Police work to protect dog partners in opioid epidemic battle. Click On Detroit. Accessed online 5 June 2017 at: In Opioid Crisis, a New Risk for Police: Accidental Overdose. US News. Accessed online 5 June 2017 at: First dose of opioid money favors Central Florida over South Florida. My Palm Beach Post. Accessed online 5 June 2017 at: Florida Gov. Declares State s Opioid Epidemic Public Health Emergency. NBC News. Accessed online 5 June 2017 at CDC. Wide-ranging online data for epidemiologic research (WONDER) Atlanta, GA. CDC. National Center for Health Statistics Available at Centers for Disease Control and Prevention. CDC Health Advisory: Increases in Fentanyl Drug Confiscations and Fentanylrelated Overdose Fatalities. HAN Health Advisory. October 26, Centers for Disease Control and Prevention. Increases in Drug and Opioid Overdose Deaths United States MMWR 2015: 64:1-5 Jones C, Paulozzi L, Mack K. Sources of opioid pain relievers by frequency of past-year nonmedical use: United States, JAMA Int Med 2014;174(5): CDC. Prescription Opioids Risk Factors: E-FORCSE: Statistics and Data. Accessed online 5 June 2017 via FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths. Accessed 6 June 2017 at: The Comprehensive Addiction and Recovery Act (CARA): Public Law Accessed 6 June 2017 at FSHP Opioid Utilization and Overdose Katie Neff-Golub, PharmD, BCGP, CPh 5

9 Slide 25 CJ8 try to limit words per slide/spread over 2 slides Slide 28 CJ9 Recommend adding a final summary slide to summarize the major concepts reviewed in this presentation