Opioid Prescribing The Good, The Bad, and The Ugly!

Transcription

1 Opioid Prescribing The Good, The Bad, and The Ugly! Randy Danielsen, Ph.D., PA-C Emeritus, DFAAPA, Professor & Dean Arizona School of Health Science A.T. Still University O.T. Ted Wendel, Ph.D. Senior Vice-President Planning & Strategic Initiatives A.T. Still University

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3 1. Recognize the factors causing the opioid crisis 2. Review epidemiological data on opioidrelated morbidity and mortality 3. Identify key aspects of the medical assessment for patients suffering from pain syndromes 4. Use preferred modalities and medications for the treatment of acute and chronic nonterminal pain 5. When opioids are prescribed, describe appropriate risk assessment and risk reduction strategies 6. Review best practices in prescribing opioids for acute and chronic pain, using the 2018 Arizona Opioid Guidelines.

4 Roots of the Opioid Crisis Millenia of History Opium has been around forever! Bayer Markets Heroin in 1898 OxyContin marketed by Purdue Pharma in 1995 Two decades of misinformation, overproduction and over-prescribing Opioid effects: Pain Relief Euphoria Dependence

5 Opioid overdose now exceeds motor vehicle accidents as the leading cause of injury-related deaths ( cidental-injury.htm) More than 72,000 Americans died of opioid over dosage in 2017 two fold increase in a decade

6 Annual Number and age-adjusted rate of drug overdose deaths involving an opioid and prescription opioids* United States * By gender Source: CDC at

7 Annual Number and age-adjusted rate of drug overdose deaths involving an opioid and prescription opioids* United States * By Age Group Source: CDC at

8 Annual Number and age-adjusted rate of drug overdose deaths involving an opioid and prescription opioids* United States * By Sex & Age Group Source: CDC at

9 Annual Number and age-adjusted rate of drug overdose deaths involving an opioid and prescription opioids* United States * By Race & Hispanic origin Source: CDC at

10 Assessment of patients with chronic pain Chronic pain is a public health concern affecting 20 30% of the population of Western countries. Researchers and clinicians agree that, because chronic noncancer pain (CNCP) is a multifaceted condition, assessment must include more than measures of pain intensity Resource: NCBI at

11 Assessment of patients with chronic pain Element Assessment Factor Pain & Coping Location, character (e.g., shooting or stinging, continuous or intermittent) Pain types (i.e., nociceptive, neuropathic, mixed) Lowest and highest extent of pain in a typical day, on a 0-to-10 scale Usual pain in a typical day, on a 0-to-10 scale When and how the pain started Exacerbating factors (e.g., exertion/activity, food consumption, elimination, stress, medical issues) Palliating factors (e.g., heat, cold, stretching, rest, Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at medications, complementary and alternative treatments) Prior evaluations to determine the source of pain Response to previous pain treatments, including complementary and alternative treatments and interventional treatments Goals and expectations for pain relief

12 Tools to Access Pain Level Tool Strength Weakness Faces Pain Scale Easy to use Usable with people who have mild to moderate cognitive impairment Translates across cultures and languages Visual impairment may affect accuracy or completion May measure pain affect, not only pain intensity Numeric Rating Scale (NRS) Easy to use if patient can translate pain into numbers Easy to administer and score Can measure small changes in pain intensity Oral or written administration Sensitive to changes in chronic pain Translates across cultures and languages Difficult to administer to patients with cognitive impairments because of difficulty translating pain into numbers Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at

13 Tools to Access Pain Level Tool Strength Weakness Verbal Rating Scale/Graphic Rating Scale Visual Analog Scale (VAS) Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at BK92053/ Easy to use Oral or written administration High completion rate with patients with cognitive impairments Sensitive to change and validated for use with chronic pain Correlates strongly with other tools Easy to use, but must be presented carefully Precise Sensitive to ethnic differences Easily translated across cultures and languages Some evidence that a horizontal line may be better than a vertical ( thermometer ) orientation Not as sensitive as NRS or Visual Analog Scale Visual impairment may affect accuracy Can be time consuming to score, unless mechanical or computerized VAS tools are used Low completion rate in patients with cognitive impairments Difficult to administer to patients with cognitive impairments Cannot be administered by phone or Subject to measurement error

14 Assessment of patients with chronic pain Element Collateral Information Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at Assessment Factor It is crucial to obtain such information as: Findings of other clinicians, prior and current Family concerns, beliefs, and observations Pharmacist concerns, where relevant Data from State electronic prescription monitoring programs, if available Medical records, including psychiatric and substance use disorders (SUDs) treatment records

15 Assessment of patients with chronic pain Element Function Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at Assessment Factor Effect of pain on: Activities of daily living/ability to care for oneself Sleep Mood Work/household responsibilities Sex Socialization and support systems Recreation Goals and expectations for restored function

16 Assessment of patients with chronic pain Element Assessment Factor Contingencies Family support of wellness versus illness behavior Vocational incentives and disincentives Financial incentives and disincentives Insurance/legal incentives and disincentives Environmental and social resources for wellness Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at

17 Assessment of patients with chronic pain Element Substance Use History and Risk for Addiction Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at Assessment Factor Current use of substances, including tobacco, alcohol, over-the- counter medications, prescription medications, and illicit drugs (confirmed by toxicology) Focus on opioids to the exclusion of other treatments Adverse consequences of use (e.g., functional impairment; legal, social, financial, family, work, medical problems) Age at first use Treatment history, including attendance at mutualhelp groups Periods of abstinence Strength of recovery support network (e.g., sponsor, sober support network, mutual-help meetings) Family history of SUD History of physical, sexual, or emotional abuse or trauma

18 Assessment of patients with chronic pain Element Assessment Factor Co-Occurring Conditions and Disorders Psychological conditions (e.g., depression, anxiety, post-traumatic stress disorder [PTSD], somatoform disorders) Medical conditions (e.g., hepatic, renal, cardiovascular, metabolic) Cognitive impairments (e.g., dementia, delirium, intoxication, traumatic brain injury) Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at

19 Assessment of patients with chronic pain Element Assessment Factor Physical Exam Relevant associated signs of pain disorder Signs of substance abuse (e.g., track marks, hepatomegaly, residua of skin infections, nasal and oropharyngeal pathology) Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at

20 Assessment of patients with chronic pain Element Assessment Factor Mental Status Medication focused Somatic preoccupation Mood Suicidal ideation and behavior Cognition (e.g., attentional capacity, memory) Source: Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series, No. 54. Center for Substance Abuse Treatment at

21 Guidelines for the Treatment of Acute and Chronic Pain There are more than two Arizonans dying every day from an opioid overdose, and the majority of deaths are due to prescription opioids. It is imperative that Arizona clinicians have prescribing practices that maintain safety for their patients and community, while also addressing their patients pain. The following seventeen guidelines for non-cancer, nonterminal pain are designed to provide information and assist decision-making for providers. Each patient and clinical presentation is unique, however, and these statements must not supersede medical judgment and risk-benefit analyses.

22 Patients should receive treatment for pain that provides the greatest benefits relative to risks. There is evidence that acute pain can be ameliorated by nonpharmacologic and non-opioid therapies, including psychological therapies, exercise treatments (aerobic exercise, physical therapy) and NSAIDs 1. Use non-opioid medications and therapies as firstline treatment for mild and moderate acute pain.

23 Evidence shows that the longer duration of early opioid exposure is associated with greater risks for long-term use. 2. If opioids are indicated for acute pain, initiate therapy at the lowest effective dose for no longer than a 3-5 day duration; reassess if pain persists beyond the anticipated duration.

24 Multiple national agencies, including the Veterans Administration and Centers for Disease Control and Prevention, recommend against using long-acting opioids for the treatment of acute pain. There is a higher risk for overdose among patients who initiate treatment with extended-release/long-acting opioids than among those who initiate with immediate release opioids 3. Do not use long-acting opioids for the treatment of acute pain.

25 Self-management approaches should be recommended to all patients with chronic pain. Self-management refers to management of the pain, its symptoms, and of one s relationship with the symptoms 4. Prescribe selfmanagement strategies, nonpharmacologic treatments and non-opioid medications as the preferred treatment for chronic pain.

26 While benefits for pain relief, function and quality of life with long-term opioid use for chronic pain are uncertain, risks associated with longterm opioid use are significant and increase with increasing dose and duration of opioid use 5. Do not initiate long-term opioid therapy for most patients with chronic pain.

27 There is an increased risk of poor outcomes including opioid overdose, opioid use disorder and death, for patients taking opioids that have substance use disorders or behavioral health conditions. 6. Coordinate interdisciplinary care for patients with high-impact chronic pain to address pain, substance use disorders and behavioral health conditions.

28 The degree of risk associated with long-term opioid therapy (see Guideline #5) warrants completion of informed consent, to ensure and document patient and provider understanding of the risks and benefits of opioid therapy. Informed consent should be obtained prior to initiation and following any changes to the treatment plan. 7. For patients on long-term opioid therapy, document informed consent which includes the risks of opioid use, options for alternative therapies and therapeutic boundaries.

29 The recommendation against long-term opioid therapy for patients with substance use disorders is supported by at least five large studies and national recommendations. 8. Do not use long-term opioid therapy in patients with untreated substance use disorders.

30 Concurrent use of opioids and benzodiazepines is associated with an increased risk of overdose and death and there is a FDA Black Box Warning, the FDA s strongest warning, 9. Avoid concurrent use of opioids and benzodiazepines. If patients are currently prescribed both agents, evaluate tapering or an exit strategy for one or both medications

31 Checking the Arizona Controlled Substances Prescription Monitoring Program (AZ CSPMP) before prescribing an opioid analgesic or benzodiazepine controlled substance and at least quarterly during treatment is good medical practice and a mandate under Arizona Revised Statutes Check the Arizona Controlled Substances Prescription Monitoring Program before initiating an opioid or benzodiazepine, and then at least quarterly.

32 There are studies that have shown an association of opioid use in pregnancy with birth defects, including neural tube defects, congenital heart defects, gastroschisis, preterm delivery, poor fetal growth, stillbirth and neonatal abstinence syndrome 11. Discuss reproductive plans and the risk of neonatal abstinence syndrome (NAS) and other adverse neonatal outcomes prior to prescribing opioids to women of reproductive age.

33 There is no absolutely safe dose of opioids! 12. If opioids are used to treat chronic pain, prescribe at the lowest possible dose and for the shortest possible time. Reassess the treatment regimen if prescribing doses 50 MEDs. Opioid dosages between MEDs have been found to increase risks for opioid overdose by factors of 1.9 to 4.6 compared with dosages < 20 MEDs, and dosages 100 MEDs are associated with increased risks of overdose 2.0 to 8.9 times the risk at <20 MEDs.

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35 13. Counsel patients who are taking opioids on safety, including safe storage and disposal of medications, not driving if sedated or confused while using opioids and not sharing opioids with others.

36 14. Reevaluate patients on long-term opioid therapy at least every 90 days for functional improvements, substance use, highrisk behaviors and psychiatric comorbidities through face-to-face visits, PDMP checks and urine drug tests.

37 15. Assess patients on long-term opioid therapy on a regular basis for opioid use disorder and offer or arrange for medication-assisted therapy (e.g. methadone and buprenorphine) to those diagnosed.

38 16. Offer naloxone and provide overdose education for all patients at risk for opioid overdose.

39 17. Individualize an exit strategy from the use of long-term opioid therapy for chronic pain, while carefully monitoring for risks.

40 Greetings, Arizona PA & NP Prescribers! In June 2017, Governor Doug Ducey issued a Declaration of Emergency due to an alarming increase in the opioid deaths and overdoses in Arizona. This was followed in January 2018 by an enactment of SB1001/HB2001: The Arizona Opioid Epidemic Act. More than two Arizonans die each day due to opioid overdose, over half of which are related to prescription opioids. Executive Order , Enhanced Surveillance Advisory expands reporting requirements by healthcare, justice, law enforcement, information exchange, and public health entities to include opioid overdoses and deaths, naloxone dispensing and administration, and Neonatal Abstinence Syndrome cases, and other data that are reported by the Arizona Department of Health Services

41 The Arizona Opioid Epidemic Act provisions include: Having ADHS convene working groups Educating providers licensed in Arizona Working on an opioid curriculum with institutions educating health providers Training first responders Limiting the duration of first fill opioid prescriptions to five days Aligning opioid dosage levels with federal prescribing guidelines, and Protecting people calling 911 for a potential opioid overdose.

42 Avoid concurrent use of opioids and benzodiazepines. If patients are currently prescribed both agents, evaluate tapering or an exit strategy for one or both medications. Check the Arizona Controlled Substances Prescription Monitoring Program (PMP) before initiating an opioid or benzodiazepine, and then again at least quarterly. Discuss reproductive plans and the risk of Neonatal Abstinence Syndrome (NAS) and other adverse neonatal outcomes prior to prescribing opioids to women of reproductive age. If opioids are used to treat chronic pain, prescribe at the lowest possible dose and for the shortest possible time. Reassess the treatment regimen if prescribing doses 50 MEDs. Counsel patients who are taking opioids on safety, including safe storage and disposal of medications, not driving if sedated or confused while using opioids, and not sharing opioids with others.

43 Reevaluate patients on long-term opioid therapy at least every 90 days for functional improvements, substance use, high-risk behaviors and psychiatric comorbidities through face-to-face visits, PDMP checks, and urine drug tests. Assess patients on long-term opioid therapy on a regular basis for opioid use disorder (OUD) and offer or arrange for medication-assisted therapy (e.g. methadone and buprenorphine) to those diagnosed with OUD. Offer naloxone and provide overdose education for all patients at risk for opioid overdose. Individualize an exit strategy from the use of long-term opioid therapy for chronic pain, while carefully monitoring for risks.

44 SB 1283: CSPMP Use Mandated for Opioid/Benzodiazepine Prescribing SB 1283, which went into effect January 2017, mandates that before prescribing opioid analgesics or benzodiazepine in schedules II-IV, physicians must obtain a patient utilization report for the preceding 12 months from the AZ Board of Pharmacy Controlled Substances Prescription Monitoring Program (CSPMP) central database tracking system. HB 2355: Expanding Access to and Use of Naloxone HB 2355 allows pharmacists to dispense naloxone, or any other opioid antagonist, without a prescription. This includes dispensing to a person at risk of experiencing an opioid-related overdose, a family member of that person, or a community member in a position to assist the person at risk of an opioid-related overdose. This measure includes immunity for the dispensing pharmacist from professional liability and criminal prosecution.

45 The Arizona Opioid Epidemic Act provisions include: 1. Requiring prescribing providers to check Arizona's Controlled Substance Prescription Monitoring Program (PMP)when first prescribing opioids or benzodiazepines, and periodically thereafter; 2. Requiring pharmacies to check the PMP before filling and dispensing opioids; 3. Transitioning to electronic prescribing of all schedule II controlled substances by 2019; 4. Designating the Arizona State Board of Pharmacy to implement prescribing and dispensing regulations; clarify exemptions and exceptions; and educate providers, dispensers and the public via "frequently asked questions" (FAQs) and other updates; 5. Assessing obstacles and using data to inform strategies and interventions to improve access to non-opioid approaches to acute and chronic pain and to refer individuals with opioid use disorder and substance abuse/addiction for treatment; 6. Requiring health insurers to have at least one MAT provider in their contractual network. 7. Regulating pharmaceutical companies, providers, and pain management clinics to eliminate fiscal and other incentives that encourage "pill mills" and other activities that promote inappropriate opioid prescribing and dispensing.

46 ADHS, in collaboration with experts in primary, emergency and specialty care; the field of pain management; oral, behavioral and public health; and others updated and finalized guidelines in 2018 for Arizona providers licensed to prescribe opioid medications and other controlled substances. 1. The guidelines are intended as an educational tool for promoting best practices when prescribing opioids for acute or chronic pain. 2. The effort was in response to an alarming four-fold increase in U.S. prescription analgesic overdose deaths from 1999 to 2010 (4,030 deaths in 1999 to 16,651 in 2010) (CDC, 2013). 3. Arizona ranked 6th highest in the nation in 2010 for drug overdose deaths and had the 5th highest opioid prescribing rate in the U.S. in 2011 (Paulozzi, Len. Prescription Drug Overdose National Perspective, presented at the Arizona Opioid Prescribing Summit, March 15, 2014).

47 The Arizona Opioid Prescribing Guidelines provide voluntary, consensus guidance to Arizona prescribers. They are not a substitute for appropriate assessment and professional judgment. They offer best practice guidance and are founded on the best available evidence, national guidance, and Arizona-specific data on opioid overdoses. The guidelines are not a substitute for appropriate assessment and professional judgment.

48 The key messages in the Arizona Opioid Prescribing Guidelines are consistent with Federation of State Medical Boards' Guidelines for the Chronic Use of Opioid Analgesics, and the CDC Guidelines:

49 Important Changes to the Prescribing, Administering and Dispensing of Drugs for Physician Assistants The Arizona State Legislature passed HB2250, amending portions of the Physician Assistant Practice Act (A.R.S et. seq.). The effective date of the changes was August 3, 2018, unless stated otherwise. The full text of the bill can be found at: g/2r/laws/0233.pdf

50 Important Changes to the Prescribing, Administering and Dispensing of Drugs for Physician Assistants With regard to prescribing, physician assistants should be aware of the following changes: 1. The bill eliminates the requirement that prescription orders from physician assistant contain the name, address and telephone number of the supervising physician. Instead, prescription orders are required to contain the name, address and telephone number of the physician assistant. 2. Consistent with the Opioid Epidemic Act, the bill requires physician assistants to obtain supervising physician approval before authorizing a refill of a schedule II or III medication that is an opioid or benzodiazepine. 3. Requires drugs dispensed by a physician assistant to be prepackaged by a pharmacist, rather than a supervising physician, or a pharmacist acting on a supervising physician s written order.

51 Important Changes to the Prescribing, Administering and Dispensing of Drugs for Physician Assistants Beginning October 1, 2018, the Board will be authorized to certify physician assistants to prescribe schedule II and III medications that are not opioids or benzodiazepines for up to 90 days, upon the physician assistant meeting certain criteria. Previously, the Board was allowed to authorize the prescribing of controlled substances for up to 30 days. The full text of the Opioid Epidemic Act and its companion bill HB2549, which made additional changes to prescribing and dispensing of opioids for all prescribers, can be found at: These bills were effective April 25, 2018.

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54 THANK YOU Special thanks to Rick Christensen, PA and the Staff at the Arizona Regulatory Board of Physician Assistants for their contribution to this presentation. And thank you for playing!!!