State Agencies Approval PA

State Agencies Approval PA99-0480 Version 1.0 1

ACPE Information The Illinois Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The online training is approved for 1.75 hours (0.175 CEUs) of continuing pharmacy education credit. UAN: 0135-0000-16-002-H04-P Contact Hours: 1.75 Hours Initial Release Date: Planned Expiration Date: March 11, 2019 Target Audience: Pharmacists in all practice settings Continuing Pharmacy Education Requirements This activity is structured to meet knowledge-based educational needs and acquire factual knowledge. Information in knowledge-type activities is based on evidence as accepted in the literature by the health care professions. Continuing pharmacy education (CPE) credit will be earned based on participation in the activity. Participation is required before obtaining CPE credit. Participants must complete an activity evaluation and posttest (if applicable) with a passing score of 70 percent or greater. This activity is accredited through ACPE for pharmacist continuing pharmacy education credit. If all requirements are met, participants will receive continuing pharmacy education credit in the following manner. Partial credit will not be awarded. Please allow 60 days for processing. Pharmacists CPE Monitor, a national, collaborative effort by ACPE and the National Association of Boards of Pharmacy (NABP) to provide an electronic system for pharmacists and technicians to track their completed CPE credits, went into effect on January 1, 2013. IPhA, as an ACPE-accredited provider, is required to report pharmacist CPE credit using this tracking system. Pharmacist participants must provide their NABP e- Profile Identification Number and date of birth (in MMDD format) when they register for a CPE activity or complete activity evaluations. It will be the responsibility of the pharmacist to provide the correct information (e-profile Identification Number and Date of birth in MMDD Format). If this information is not provided, NABP and ACPE prohibit IPhA from issuing CPE Credit. Online access to their inventory of completed credits will allow pharmacists to easily monitor their compliance with CPE requirements and print statements of credit. Therefore, IPhA will not provide individual printed statements of credit to pharmacists. For additional information on CPE Monitor, including e-profile set-up and its impact on pharmacists and pharmacy technicians, go to www.nabp.net. Faculty Kelly Gable, PharmD, BCPP Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville kgable@siue.edu Chris Herndon, PharmD, BCPS Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville cherndo@siue.edu Jessica Kerr, PharmD, CDE Assistant Chair and Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville jekerr@siue.edu Garth Reynolds, BSPharm, RPh Executive Director Illinois Pharmacists Association greynolds@ipha.org Version 1.0 2

Disclosures/Conflicts of Interest The Speakers of this continuing education program, do not have financial relationships or conflicts of interests. The content of this webinar may include information regarding the use of products that may be inconsistent with, or outside the approved labeling for, these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult the prescribing information for these products Learning Objectives 1. Describe the opioid abuse and overdose epidemic on a state and national level. 2. Review unique pharmacological properties of commonly prescribed opioids and heroin. 3. Discuss the neurobiology of addiction and opioid use disorder. 4. Understand risk factors, signs of an opioid overdose, and the role of opioid antagonist therapy. 5. Describe the role of pharmacy personnel in opioid overdose management. 6. Evaluate key elements of patient and caregiver education on opioid overdose management. 7. Discuss standardized procedures, naloxone standing order sets, and clinical documentation. Version 1.0 3

Opioid Abuse and the Overdose Epidemic Kelly Gable, PharmD, BCPP Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville Alarming Statistics - An Epidemic The CDC has officially declared prescription drug abuse in the US an epidemic 1 in 20 people report using prescription opioids for non-medical reasons In 2010, enough opioid pain relievers were sold to medicate every adult in the US with 5 mg of hydrocodone every 4 hours for 1 month In 2014, ~1.9 million people had an opioid use disorder related to prescription pain relievers and ~586,000 had an opioid use disorder related to heroin use Only 16% of Americans believe that the US is making progress in its efforts to reduce prescription drug abuse Version 1.0 4

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Overdose Deaths Each day, ~46 people in the United States die from overdose of prescription pain medications >47,000 Americans died of a drug overdose in 2014, an increase of 7% from 2013 >50% were related to pharmaceuticals (~70% involved opioid analgesics and 30% involved benzodiazepines) The increase was driven largely by deaths from heroin + prescription opioids Women who lost their lives opioid overdoses rose 415% between 1999 and 2010 Heroin Use Rising Version 1.0 6

Heroin Abuse Risk Factors Male gender, aged 18 25 years Non-Hispanic white race/ethnicity Residence in a large urban area <$20,000 annual household income with no health insurance or Medicaid Past-year abuse or dependence on alcohol, marijuana, cocaine, or opioid pain relievers National Survey on Drug Use and Health (NSDUH), 2002-2013. CDC Vital Signs, July 2015. Opioid Abuse - Illinois 12 th lowest drug overdose mortality rate in the US, with 10 per 100,000 drug overdose fatalities Drug overdose deaths increased by 49% since 1999 ~8 people die from prescription drug overdoses/week in Illinois (81% involve opioid pain relievers) Hydrocodone was the most available opioid to nonprescribed users for nonmedical use in 2013 In 2012, there were 15,350 primary heroin treatment admissions in Chicago Heroin purity at the street level remains between 10 and 20%- cut with quetiapine, diphenhydramine, fentanyl Illinois Department of Human Services. Prescription Drug Abuse: Strategies to Stop the Epidemic. Version 1.0 7

Top Abused Prescription Drugs in America Clinical Pharmacology of Opioids Chris Herndon, PharmD, BCPS Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville Morphine Version 1.0 8

Opioid Receptors μ mu (MOR) κ kappa (KOR) δ delta (DOR) N/OFQ (Noceptin) Commercially Available Opioids Pure MOR (mu) agonists morphine, methadone, codeine, hydrocodone, fentanyl, oxycodone, oxymorphone, levorphanol, hydromorphone, heroin, dihydrocodeine, sufentanil, alfentanil, remifentanyl Partial MOR (mu) agonist buprenorphine Mixed agonist-antagonists nalbuphine, butorphanol, pentazocine Centrally acting MOR agonists tramadol, tapentadol Nonselective antagonists naloxone, naltrexone Peripherally acting MOR opioid antagonists alvimopan, methylnaltrexone, naloxegol MOR = mu-opioid receptor Version 1.0 9

What is High Dose for Opioids? Canadian Guidelines 200mg/day OME American Pain Society Guideline 200mg/day OME Washington State Work Comp 120mg/day OME OME = Oral Morphine Equivalent Prescription Opioids and Illicit Heroin Quantitative questionnaire using street outreach, venue-recruitment, and needle-exchange advertisement (n = 123) Median age 29 yrs (75% male, 53% white, 28% hispanic, 19% black or other) 39.8% reported problematic prescription opioid use prior to first heroin use Heroin rapidly metabolized to morphine in CNS Version 1.0 10

Relative Equianalgesia Drug IV (mg) Oral (mg) Morphine 10 30 Buprenorphine 0.3 0.4 (SL) Codeine 100 200 Fentanyl 0.1 Hydrocodone 30 Hydromorphone 1.5 7.5 Meperidine 100 300 Oxycodone 10 20 Oxymorphone 1 10 IV = intravenous; mg = milligram; SL = sublingual Let s Get Some Practice. CH is a 42 year old male who is currently using opioid and non-opioid analgesics for severe low back pain (failed back surgery syndrome). His current regimen includes: CR morphine 60mg by mouth every 8 hours IR oxycodone 15mg by mouth every 4 to 6 hours as needed Pregabalin 50mg by mouth every 12 hours What is CH s total daily Oral Morphine Equivalent (OME)? CR = controlled-release; IR = immediate-release Version 1.0 11

Calculate 24 hour Oral Morphine Equivalent (OME) CR morphine 60mg Q8h = 180mg OME IR oxycodone 15mg Q4-6h (actually take Q4h) = 90mg of oxycodone Ratio is 2:3 (90mg/2)(3) = 135mg OME Total OME is 315mg daily Drug IV (mg) Oral (mg) Morphine 10 30 Buprenorphine 0.3 0.4 (SL) Codeine 100 200 Fentanyl 0.1 Hydrocodone 30 Hydromorphone 1.5 7.5 Meperidine 100 300 Oxycodone 10 20 Oxymorphone 1 10 CR = controlled-release; IR = immediate-release; SL = sublingual Distinct Opioid Concerns Fentanyl Incredibly potent and lipophilic Abusers may cheek cut patches and accidentally swallow Continued delivery may prolong exposure and require repeated dosing of reversal Buprenorphine Significantly higher MOR binding affinity More difficult to antagonize with reversal agent requiring higher doses for longer Methadone Highly variable terminal half-life May require repeated doses of reversal antagonist Heroin Patients recently abstaining cannot tolerate previously high doses used Often cut with acetyl fentanyl increasing potency and respiratory depressant risk Version 1.0 12

The Neurobiology of Addiction Kelly Gable, PharmD, BCPP Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville Why Do People Use Substances? Version 1.0 13

Substance Use Disorders Complex biological health conditions involving the brain Encompass many different drug classes: Caffeine Alcohol Cannabis Hallucinogens Inhalants Sedative-hypnotics / anxiolytics Stimulants Nicotine Opioids Neurochemical Imbalance: Addiction Receptor DOPAMINE OPIOID SEROTONIN Roles Mood Attention Psychosis Reward Pleasure Analgesia Euphoria Sedation Dysphoria Respiratory depression Appetite Mood Sleep Drug Effects Opioids, Nicotine, Alcohol, Stimulants increase dopamine release Reinforcing effects of endogenous opiates Stimulants inhibit removal of serotonin synapses Alcohol depletes Version 1.0 14

Drugs of Abuse Targeting of the Brain s Pleasure Center Risk / Protective Factors for Addiction Risk Factors Aggressive behavior in childhood Poor parental supervision Poor social skills Drug experimentation Availability of drugs at school Community poverty Protective Factors Good impulse-control Parental support Positive relationships Academic competence School anti-drug policies Neighborhood pride Version 1.0 15

Substance Use Disorders Substance Use Disorders: Relapse and Recover Version 1.0 16

Substance Use Disorders: Barriers to Treatment Only 1 in 10 Americans with a substance use disorder actively receive treatment. Stigmas that prevent treatment: Treatment doesn t work They have an addictive personality People with addiction are bad, crazy, can t be helped, don t want to be helped Treatment outcomes are improved if the substance use disorder / psychiatric disorder are addressed collaboratively with other medical conditions. 1. Traditional 12 step programs Substance Use Disorders Recovery Options 2. Inpatient / outpatient programs 3. Harm reduction and behavioral therapy 4. Pharmacotherapy: treatment of withdrawal syndromes, anti-craving medication (naltrexone), buprenorphine, methadone maintenance 5. Screening, Brief Intervention, and Referral to Treatment (SBIRT): evidenced-based practice used to identify, reduce, and prevent problematic use, abuse, and dependence on alcohol and drugs Version 1.0 17

Opioid Use Disorders: Risk Factors for Abuse and Overdose Kelly Gable, PharmD, BCPP Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville Warning Signs of Abuse Jason is a 25 year-old patient who you see routinely at the pharmacy. He is receiving treatment for chronic low back pain and panic disorder. He is prescribed the following regimen from his psychiatrist: Alprazolam (Xanax) 0.5 mg twice daily Oxycodone 10mg every 6 hours prn pain Paroxetine (Paxil) 10 mg daily Jason shows up 2 weeks early for his refills reporting that he lost the rest of his medication and really needs his Xanax. Version 1.0 18

Warning Signs of Abuse 1. Frequently running out of medication 2. Reporting lost or stolen prescriptions 3. Presenting with prescriptions from multiple prescribers 4. Filling prescriptions at multiple pharmacies 5. Urine drug screen negative 6. Reports allergies to all other drugs but. 7. Frequently demonstrating signs and symptoms of intoxication Opioid-Related Disorders Opioid Use Disorder Opioid Intoxication Opioid Withdrawal Version 1.0 19

Opioid Use Disorder, Withdrawal, or Intoxication Stacy is a 34 year-old female presenting to the emergency department for treatment of an infected abscess on her arm. She experiences chronic back pain from a car accident 2 years ago. In an effort to gain better control of her pain, she started using heroin 3 months ago, on top of her routine treatment with oxycodone, cyclobenzaprine, and alprazolam. After testing positive for heroin use, she was released from treatment by her PCP. She now uses heroin daily. Opioid Use Disorder Problematic pattern of opioid use leading to clinically significant impairment within a 1 year period, consisting of 2 of the following: 1. Taken in larger amounts over longer period then intended 2. Unsuccessful efforts to stop or decrease use 3. Excessive time spent obtaining opioid, using, or recovering from use 4. Craving to use 5. Use results in failure to fulfill work, school, home obligations 6. Use continues despite negative consequences 7. Opioid use becomes more important than social, work, or recreational activities 8. Continued use despite risky situations 9. Persistent use despite knowledge of physical or psychological problems 10.Tolerance has developed (need more opioid to achieve desired effects) 11.Withdrawal occurs when opioid is stopped Version 1.0 20

Prescription Opioid Abuse Almost all prescription drugs involved in overdoses come from prescriptions originally (not pharmacy theft) Frequently diverted to people using them without prescriptions Most prescriptions come from primary care physicians, internal medicine physicians, and dentists; not specialists Roughly 20% of prescribers prescribe 80% of all prescription opioids Prescription Opioid Abuse Risk Factors Those who abuse prescription opioids (vs heroin): 1. Are more likely to have complaints of pain 2. Are more likely to be in psychiatric treatment 3. Have greater social stability 4. Are less likely to use other illicit substances Version 1.0 21

Opioid Use Disorder, Withdrawal, Intoxication? Shane is a 53 year-old male diagnosed with prostate cancer with bone metastasis. On top of his chemotherapy treatment, he receives treatment for bone pain with oxycodone controlled-release (OxyContin) 80 mg daily and oxycodone 10 mg q 4 hours for break-through pain. Last month his wife phoned 911 because she found Shane unresponsive on the couch. Opioid Intoxication vs. Withdrawal Euphoria Dysphoria Apathy Motor Retardation Sedation Slurred speech Attention impairment Pinpoint pupils Respiratory depression Opioid Intoxication Opioid Withdrawal* Lacrimation Rhinorrhea Dilated pupils Goosebumps Sweating, fever Diarrhea Yawning Insomnia Muscle aching *Duration of withdrawal = 7 to 14 days Version 1.0 22

Opioid Overdose Reduced sensitivity to changes in O2 and CO2 outside of normal ranges Decreased tidal volume and respiratory frequency Respiratory failure and death due to hypoventilation Signs and symptoms: 1. Pinpoint pupils 2. Not arousable with sternal rub 3. Breathing less then 8 per minute 4. Choking, gurgling, snoring sounds 5. Blue/gray lips and fingertips Who is at Risk for Overdose? 1. Taking multiple controlled substance prescriptions from multiple providers doctor shopping 2. Taking high daily dosages of prescription opioids and/or misuse multiple abuse-prone prescription drugs 3. People with chronic medical conditions (HIV, cardiovascular disease, respiratory diseases, mental illnesses) 4. Changes in opioid purity 5. Previous history of overdose 6. Lower socioeconomic status and those living in rural areas 7. Recent discharge from incarceration or substance use facility Version 1.0 23

Risky Situations Pam is a 50 year-old female patient diagnosed with Crohn s Disease, fibromyalgia, generalized anxiety disorder, PTSD, chronic back pain, and sleep apnea She receives treatment from her primary care physician, rheumatologist, and psychiatrist. She struggles with ongoing pain and frequently over takes her pain medication. She is prescribed: Olanzapine (Zyprexa), lorazepam (Ativan), amitriptyline (Elavil), oxycodone (OxyContin), trazodone (Desyrel), zolpidem (Ambien), tramadol (Ultram), duloxetine (Cymbalta), quetiapine (Seroquel), diazepam (Valium), hydrocodone / acetaminophen (Vicoden), prednisone PTSD = Post Traumatic Stress Disorder Dangerous Combinations Multiple CNS Depressants: Opioids Benzodiazepines- alprazolam, diazepam, clonazepam, chlordiazepoxide Barbiturates Z-hypnotics- zolpidem, zaleplon, eszopiclone Muscle relaxants- cyclobenzaprine, nabumetone, carisoprodol Alcohol Sedating antipsychotics: quetiapine Version 1.0 24

Opioid Overdose and Naloxone Rescue Therapy Kelly Gable, PharmD, BCPP Associate Professor, Department of Pharmacy Practice Southern Illinois University Edwardsville Image taken from hpubchem.ncbi.nlm.nih.gov. Accessed Feb 14, 2016 Naloxone Rescue Therapy Naloxone (Narcan): a competitive antagonist at all opioid receptor sites Reverses analgesic, dysphoric, and other pharmacologic effects of opioids 1 mg can reverse the effect of ~25mg heroin Naloxone is NOT naltrexone (a long-acting opioid antagonist) Naloxone is NOT effective in reversing an overdose with benzodiazepines, barbiturates, or stimulants Is it safe to use? FDA-approved and used by EMS to reverse opioid overdose for > 40 years Has minimal interaction in the body without the presence of opioids Rapid opioid reversal causes: hypertension, tachycardia, sweating, recurring pain, agitation, other withdrawal symptoms Version 1.0 25

s that Work Rhode Island All Walgreens and CVS pharmacies supply and dispense IM and IN naloxone through a collaborative practice agreement Project Lazarus A public health model based on the premises that drug overdose deaths are preventable and that all communities are ultimately responsible for their own health. Facilitated overdose prevention in Wilkes in collaboration with Health Department, law enforcement, schools, clinicians, hospitals, and faith community. Over 3 years: overdose deaths 42%; drug-related hospital visits 15%; the number of prescriptions for controlled substances stabilized IM = intramuscular; IN = intranasal Why at the Pharmacy? 1. Many patients at risk for an overdose do not visit routine providers. 2. There is a shortage of physicians/providers prescribing naloxone. 3. Patients may not report opioid misuse due to fear of loss of access to pain management. 4. It ensures easier access to a life saving treatment. 5. An opioid overdose can happen within minutes to hours. 6. Naloxone is rapid-acting, safe, and effective at reversing opioid overdose. 7. Bystanders are easily trainable to recognize and respond to an overdose. 8. Risk of liability is no higher than with other prescription medications. *The practice of harm reduction follows a patient-centered philosophy of care with the primary goal focusing on a reduction of harm, rather than complete cessation of opioid use. When a patient is offered naloxone rescue therapy, it allows the healthcare provider to further discuss opioid use, safety concerns, and overdose risk. Version 1.0 26

Who Should Get Naloxone? 1. Prescribed long-term opioid therapy; doses > 50 mg of morphine equivalent/day 2. Prescribed rotating opioid medication regimens 3. Prescribed methadone 4. Taking an opioid plus other CNS depressants (benzodiazepines, alcohol) 5. Prescribed or taking an opioid with co-occurring renal/hepatic dysfunction, cardiovascular disease, respiratory disorders (sleep apnea), mental illness, or HIV/AIDS 6. Using heroin 7. Recently discharged from a substance abuse treatment facility or from an acute medical center following opioid intoxication or poisoning 8. Recently released from jail and history of opioid abuse Naloxone Dispensing Steps Patient requests overdose prevention product Perform real-time claim submissions to determine coverage; patients can pay cash if uninsured Initiate education with caregiver present Filling an opioid prescription Check prescription monitoring program database and review current medications prescribed Discuss any potential overdose risk with current medications Educate on opioid overdose and naloxone rescue therapy Version 1.0 27

Prescription Monitoring s Teaching Patients, Friends, Family, Caregivers Education specific to prescription opioid use: 1. Use prescription opioids only as directed by a health care provider 2. Ensure that all prescribers and pharmacists know of all medications you are taking 3. Don t mix opioids with alcohol or other sedating drugs 4. Store your medication in a safe and secure place and dispose of unused medication 5. Know that not taking your opioids for a period of time and change your tolerance and you may need a lower dose when you restart 6. Ensure that your friends and family know how to respond to an overdose and administer naloxone Version 1.0 28

Teaching Patients, Friends, Family, Caregivers Requirements during naloxone training session: 1. Review the signs of opioid intoxication, overdose, and withdrawal 2. Ensure understanding of naloxone purpose 3. Review insurance coverage and personal preference for IM or IN delivery system 4. Discuss the contents of the naloxone kit 5. Demonstrate naloxone administration (IM or IN) and verify understanding of method 6. Re-enforce importance of calling 911 7. Provide informational brochure 8. Document/record required patient information Throughout your session, try to avoid stigmatizing terminology- addict, user, abuse Teaching Patients, Friends, Family, Caregivers Version 1.0 29

Identify the Overdose STEP 1: Identify if someone is experiencing an overdose -- No response upon yelling their name or vigorously rubbing chest with knuckles -- Blue lips or fingertips -- Slow breathing (< 8 breaths/minute) -- Limp body or choking/gurgling/snoring noise STEP 2: Call 911 for help STEP 3: If breathing is shallow or non-existent, perform mouth-to-mouth rescue breathing Perform Rescue Breathing Place the person on their back. Tilt their chin up to open the airway. Check to see if there is anything obstructing the airway. Place your mouth over the person s mouth to make a seal. Give 2 slow breaths. The person s chest should rise. Breathe again. Give one breath every 5 second. Version 1.0 30

Administer Naloxone and Stay Until Help Arrives! 1. Administer naloxone via IM or IN delivery system 2. Place the person in the recovery position. A. On their side with their top leg and arm crossed over their body 3. Stay with the person- do not leave someone alone after giving naloxone A. The effect of naloxone wears off in 30 to 90 minutes and patients can go back into overdose if a long-acting opioid was taken (methadone, oxycodone) B. Patients may want to take more opioids upon reversal due to feeling opioid withdrawal symptoms C. Some patients may become agitated or combative during withdrawal IM = intramuscular; IN = intranasal Naloxone Product Information Version 1.0 31

Administration of Naloxone IM 1. Single Dose or Multi-dose vials of naloxone are available 2. Use a 1-1.5 inch 25 gauge needle and 3mL syringe Do not draw up naloxone into syringe until ready to administer Remove cap from naloxone vial and uncover needle Insert needle through rubber plug with vial upside down; pull back on plunger and draw up 1 ml Inject 1mL at 90 degree angle into muscle, can be deltoid or outer thigh IM injection may be administered through clothing if needed 3. Prompt reversal of opioid agonist should occur within 3 to 5 minutes (hypotension and sedative effects) 4. A second dose may be administered if there is no response in 3 to 5 minutes IM = intramuscular Administration of Naloxone IM Auto-Injector 1. Pull auto-injector out of case from white end 2. Follow automated voice prompts 3. Remove red cap 4. Place black end against patients outer thigh, hold firmly for 5 seconds IM = intramuscular Version 1.0 32

Administration of Naloxone Intrasal (IN) 1. Remove yellow caps at both ends of syringe and red cap from naloxone 2. Attach to Luer lock syringe and twist naloxone into barrel of syringe 3. Place nasal applicator into one nostril of patient, administer half of medication with a short, vigorous push 4. Repeat for other nostril Contraindications to IN delivery nasal septal abnormalities nasal trauma epistaxis cocaine induced septal damage recent use of topical decongestants IN = intranasal Resources for Further Education Overdose prevention education and naloxone rescue therapy: Prescribe to Prevent: www.prescribetoprevent.org SAMHSA Opioid Overdose Prevention Toolkit Project Lazarus: http://www.projectlazarus.org/ Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/features/vitalsigns/painkilleroverdoses Harm Reduction Coalition: http://www.harmreduction.org/ College of Psychiatric and Neurologic Pharmacists (CPNP): http://cpnp.org/guideline/naloxone Opioid prescribing education: SAMHSA and NIDA: http://www.opioidprescribing.com Substance use treatment locator: http://findtreatment.samhsa.gov or call 1-800-662-HELP Version 1.0 33

Rationale and Method for Implementation Jessica L. Kerr, PharmD, CDE Associate Professor Assistant Chair Department of Pharmacy Practice Southern Illinois University Edwardsville School of Pharmacy Garth Reynolds, RPh Executive Director Illinois Pharmacists Association Springfield, Illinois Overview Key elements of Public Act 99-0480. The approved Naloxone Standardized Procedures Clinical documentation and record keeping Version 1.0 34

Illinois Naloxone Standardized Procedures PA-99-0480 amended the Illinois Pharmacy Practice Act by adding Section 19.1(b) Section 19.1(b) Dispensing naloxone antidote Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense and opioid antagonist in accordance with written, standardized procedures or protocols developed by the Department with the Department of Public Health and the Department of Human Services if procedures or protocols are filed at the pharmacy before implementation and are available to the Department upon request. the Department = Illinois Department of Financial and Professional Regulations Illinois Naloxone Standardized Procedures Definitions per Public Act 099-0480 Opioid antagonist means a drug that binds to opioid receptors and blocks or inhibits the effect of opioids acting on those receptors, including, but not limited to naloxone hydrochloride or any other similarly acting and equally safe drug approved by the U.S. Food and Drug Administration for the treatment of drug overdose. the Department = Illinois Department of Financial and Professional Regulations Version 1.0 35

Illinois Naloxone Standardized Procedures Definitions per Public Act 099-0480 Changes in the Alcoholism and other Drug Abuse and Dependency Act Health Care Professional means a physician licensed to practice medicine in all its branches, a physician assistant who has been delegated prescriptive authority by his or her supervising physician, an advanced practice registered nurse who has written collaborative agreement with a collaborating physician that authorizes prescriptive authority, or an advanced practice nurse or physician assistant who practices in a hospital, hospital affiliate, or ambulatory surgical treatment center and possesses appropriate clinical privileges in accordance with the Nurse Practice Act or a pharmacist licensed to practice pharmacy under the Pharmacy Practice Act. Illinois Naloxone Standardized Procedures Definitions per Public Act 099-0480 Changes in the Alcoholism and other Drug Abuse and Dependency Act Patient information included information provided to the patient on drug overdose prevention and recognition; how to perform rescue breathing and resuscitation; opioid antagonist dosage and administration; the importance of calling 911; care for the overdose victim after administration of the overdose antagonist; an other issues as necessary. Version 1.0 36

Illinois Naloxone Standardized Procedures A health care professional who, acting in good faith, directly or by standing order, prescribes or dispenses an opioid antagonist to: a patient who, in the judgment of the health care professional, is capable of administering the drug in an emergency A person who is NOT at risk of opioid overdose but who, in the judgement of the health care professional, may be in a position to assist another individual during an opioid-related drug overdose AND who has received basic instruction on how to administer an opioid antagonist Illinois Naloxone Standardized Procedures A health care professional SHALL NOT, as a result of his or her acts or omissions, be subject to: Any disciplinary or other adverse action under the Illinois Pharmacy Practice Act Any criminal liability, except for willful and wanton misconduct. Any civil liability, except for willful and wanton misconduct. Version 1.0 37

Illinois Naloxone Standardized Procedure Several amendments in other Acts Alcoholism and Other Drug Abuse and Dependency Act Illinois Criminal Justice Information Act Illinois Police Training Act Illinois Fire Protection Training Act School Code Emergency Medical Services (EMS) Systems Act Hospital Licensing Act Safe Pharmaceutical Disposal Act Environmental Protection Act Illinois Controlled Substance Act Others Other Changes of PA-099-0480 Provides guidance for drug overdose response policy Law Enforcement Officers, Fireman and EMS On-hand opioid antagonist Training Version 1.0 38

Other Changes of PA-099-0480 School Code amendment Administration of opioid antagonist School personnel or nurse on-hand carry May allow for school to obtain opioid antagonist through the standing order of Standardized Procedures. School must immediately active the EMS system and notify guardian and emergency contact and within 24 hours notify the health care professional who provided the prescription Within 3 days after administration the school must report to the Board Annual Training and proof of CPR and AE certification is required Other Changes of PA-099-0480 Safe Pharmaceutical Disposal Act amended to include: Coverage for opioid antagonist Includes medication product, administration devices and pharmacy administration frees Refills must be included for expired or utilized medication Version 1.0 39

Other Changes of PA-099-0480 Director of the Division of Alcoholism and Substance Abuse shall publish annual reports on drug overdose trends statewide that reviews State death rates Report shall also provide: Trends in drug overdose death rates Trends in emergency room utilization Trends in utilization of prehospital and emergency services and the cost impact of emergency services utilization Suggested improvements in data collection Descriptions of efforts undertaken to educate the public about unused medications Description of other interventions to achieve outcome Naloxone Standardized Procedures The Naloxone Standardized Procedures are divided into the following sections: Background Continuing Education Standardized Procedures Pharmacist Standardized Procedure to Dispense Naloxone Standardized Procedures for Naloxone Distribution for Overdose Prevention (December 2015) Counseling Protocol for Naloxone Standardized Procedures Version 1.0 40

Background Review that PA99-0480 was passed in September 2015 expanding access to opioid antagonists (including Naloxone). Establishes the Standardized Procedures and required training for pharmacists. Naloxone to the following patient (or patient s agent) group that would benefit: Individual at risk of overdose Family member, friend, or other person in a position to assist a person at risk of overdose Trained First Responder Trained School Nurse PA99-480 establishes that Department of Financial and Professional Regulation in accordance with the Department of Human Services and the Department of Public Health may approve the standardized procedures for pharmacists. Continuing Pharmacy Education Eligible pharmacists must have completed: A Certificate Training in Opioid Overdose Prevention; Be CPR certified, in accordance with 68 IAC 1330.50 (a) (4) The pharmacist shall maintain a current Basic Life Support Certification for Healthcare Providers issued by the American Heart Association, the American Red Cross, the American Safety and Health Institute, or an equivalent as determined by the Division. Training shall consist: Opioid overdose prevention; Reducing the risk of prescription opioid abuse; Safe use of opioids for the management of chronic pain; Use of screening tools to detect opioid abuse or dependency and management of difficult patients; Preventing diversion of prescribed opioid medications; Naloxone administration techniques; Knowledge of Protocol for Naloxone Standing Order for Opioid Antagonist Initiative. Version 1.0 41

Standardized Procedures Once pharmacists have completed the certified Naloxone Antagonist Training (such as this course) and wish to participate in the Illinois Naloxone Antagonist Overdose Prevention : The pharmacy may request a copy of the Standardized Procedures for Naloxone Opioid Overdose by contacting the Illinois Prescription Monitoring (ILPMP) at their website ilpmp.org. The Standardized Procedures covers dispensing and possession of Naloxone Kits. Kits include: Naloxone HCl, IM syringe, injection supplies, nasal atomizers, or commercial Naloxone auto-injectors. The Standardized Procedures authorizes the pharmacist to maintain supplies for Naloxone Kits to dispense according to the Protocol for the identified individuals. IM = intramuscular Pharmacist Standardized Procedure to Dispense Naloxone The Protocol allows the Pharmacist to dispense one Naloxone Kit to an identified individual. Individual is approved to receive Naloxone by meeting the criteria outlined in the standardized procedures. 1. Individual is a person at risk of experiencing an opiate-related overdose or a family member, friend, or other person in a position to assist a person at risk of experiencing an opiate-related overdose. 2. Individual has received counseling by a pharmacist trained in the use of Naloxone regarding the recognizing and responding to suspected opioid overdose. Family member, friend, or other person in a position to assist a person at risk of overdose Trained First Responder Trained School Nurse Version 1.0 42

Pharmacist Standardized Procedure to Dispense Naloxone Counseling is required to cover the proper use of the dosage forms listed below: Intramuscular Naloxone Kits contain the following, at a minimum: Two (2) single-use 1 ml vials Naloxone Hydrochloride (0.4mg/ml) Two (2) intramuscular needle syringes Overdose prevention information pamphlet with step by step instructions for use. Intranasal Naloxone Kits containing, at a minimum: Two 2 ml Luer-Jet Luerlock syringes prefilled with Naloxone Hydrochloride (2mg/2ml) Two mucosal atomization devices Overdose prevention information pamphlet with step by step instructions for use. Auto-injector Kits Containing the following: Naloxone HCL 0.4 mg/ml pre-packaged kits (Evzio, NDC 60842-030-01) Containing 2 autoinjectors with audio instructions and 1 training device and step by step instructions for administration of Naloxone by autoinjector. Standardized Procedures for Naloxone Distribution for Overdose Prevention - December 2015 The Pharmacist shall review the Directions for Use : 1. Evaluate the individual for signs and symptoms of potential Opioid or Heroin Overdose. 2. If individual is not breathing, start rescue breathing using a disposable rescue breathing device. 3. Administer Naloxone as follows (of the select dispensed dosage form). 4. Call 911 as soon as possible for a person suspected of an opioid overdose with respiratory depression or unresponsiveness. 5. Continue rescue breathing and monitor respiration and responsiveness of the Naloxone recipient until emergency help arrives. Version 1.0 43

Standardized Procedures for Naloxone Distribution for Overdose Prevention - December 2015 The Pharmacist shall cover how to administer Naloxone as follows (of the select dispensed dosage form): Intramuscular Naloxone: Uncap the Naloxone vial and uncap the muscle needlesyringe. Insert the muscle needle through the rubber membrane on the Naloxone vial, turn the vial upside down, draw up 1 ml of Naloxone liquid, and withdraw the needle. Insert the needle into the muscle of the upper arm or thigh of the victim, through clothing if needed, and push on the plunger to inject the Naloxone. Repeat the injection if there is no response after three minutes. Intranasal Naloxone: Pop off two colored caps from the delivery syringe and one from the Naloxone vial. Screw the Naloxone vial gently into the delivery syringe. Screw the mucosal atomizer device onto the top of the syringe. Spray half (1 ml) of Naloxone in one nostril and the other half (1 ml) in the other. Repeat if there is no response after three minutes. Auto-injector Naloxone: Pull auto-injector from outer case pull off red safety guard. Place the black end of the auto-injector against the outer thigh, through clothing if needed, press firmly and hold in place for 5 seconds. Repeat if there is no response after three minutes. Counseling Protocol for Naloxone Standardized Procedures The Pharmacist shall cover the following areas in counseling the individual on the use of Naloxone. Indications and Usage; Assessment; Provider Actions; Follow Up Requirements; Contraindications; Precautions; Adverse Reactions. Version 1.0 44

Counseling Protocol for Naloxone Standardized Procedures Indications and Usage: Naloxone is indicated for the complete or partial reversal of opioid overdose induced by natural or synthetic opioids and exhibited by respiratory depression or unresponsiveness. Counseling Protocol for Naloxone Standardized Procedures Assessment: Subjective Findings Individual is at risk of experiencing an opiate-related overdose or is in a position to assist a family member, friend, or other person at risk of experiencing an opiate-related overdose. Individual reports no known sensitivity or allergy of the intended recipient to Naloxone Hydrochloride. Objective Findings In the pharmacist s judgement, the client is oriented to person, place, and time and able to understand and learn the essential components of overdose response and Naloxone administration. Version 1.0 45

Counseling Protocol for Naloxone Standardized Procedures Provider Actions: Screen individual for contraindications / precautions to dispensing Naloxone. If a contraindication / precaution exists, refer individual to medical provider for evaluation. Provide Opioid overdose training information which covers at least the following: 1. Risk factors for opioid overdose and possible prevention actions; 2. Recognition of opioid overdose; 3. Calling 911; 4. Rescue breathing, using a disposable rescue breathing device. 5. Administration of Naloxone as described within the Standardized Procedures. Upon the successful counseling session, the pharmacist will dispense the Naloxone kit and explain contents to individual. The pharmacy is to report dispensed kits to the ILPMP with daily reporting of dispensed controlled substances. As part of the mandatory counseling function, the pharmacist shall provide information and /or referral for substance abuse or behavioral health treatment options. Counseling Protocol for Naloxone Standardized Procedures Follow Up Requirements: The pharmacist shall instruct individual/parent/guardian to call medical provider if questions, concerns, or problems arise. The pharmacist shall, instruct individual/parent/guardian to return for refill as needed, subject to use and expiration of Naloxone (approx. 18 months). The pharmacist shall encourage opioid user or other concerned individual to communicate with primary care provider regarding overdose, use of Naloxone, and availability of behavioral health services. Version 1.0 46

Counseling Protocol for Naloxone Standardized Procedures Contraindications: Patient is known to be hypersensitive to Naloxone Hydrochloride. Counseling Protocol for Naloxone Standardized Procedures Precautions: Pre-existing cardiac disease or seizure disorder Person is suspected to be physically dependent on opioids including newborns of mothers with narcotic dependence. (Reversal of narcotic effect will precipitate acute abstinence syndrome). Use in Pregnancy: 1. Teratogenic Effects: Pregnancy category C, no adequate or well-controlled studies in pregnant women. 2. Non-teratogenic Effects: Pregnant women known or suspected to have opioid dependence often have associated fetal dependence. Naloxone crosses the placenta and may precipitate fetal withdrawal symptoms as well. Nursing Mothers: Caution should be exercised when administering to nursing women due to transmission in human milk. Risk and benefits must be evaluated. Geriatric Use: Choose lower range dose taking precautions for potential decreased hepatic, renal and cardiac function, as well as, concomitant disease and other pharmacotherapies. Version 1.0 47

Counseling Protocol for Naloxone Standardized Procedures Adverse Reactions: Adverse reactions are related to reversing dependency and precipitating withdrawal and includes fever, hypertension, tachycardia, agitation, restlessness, diarrhea, nausea/vomiting, myalgia, diaphoresis, abdominal cramping, yawning, sneezing. 1. These symptoms may appear within minutes of Naloxone administration and subside in approximately 2 hours. 2. The severity and duration of the withdrawal syndrome is related to the dose of Naloxone and the degree of opioid dependence. Adverse effects beyond opioid withdrawal are rare. Clinical Documentation and Recordkeeping All records shall be kept for at least five (5) years as according to the Pharmacy Practice Act - 225 ILCS 85. This shall include: Prescription Records (including from a pharmacy workflow management system); Any corresponding clinical and/or patient documentation completed. Naloxone dispensing records shall be transmitted to the Illinois Prescription Monitoring within one (1) business day as required according to the authority given the ILPMP 720 ILCS 570/316, 570/318. Version 1.0 48

Claiming of CPE Credits The participant must complete the following: All components of the Illinois State Opioid Antagonist Training ; Successfully complete the post-test examination (70% passing score required); Complete the Training evaluation. The participant s information and CPE credit will be electronically submitted to the NABP CPE monitor by the Illinois Pharmacists Association. The participant s record of completion of the Illinois State Opioid Antagonist Training will be electronically submitted to the Illinois Prescription Monitoring by the Illinois Pharmacists Association. Any questions: Concerning the completion of the Training, please contact the Illinois Pharmacists Association at 217/522-7300 or via email at kimc@ipha.org. Concerning your record of completion or access to the Standardized Procedures, please contact the Illinois Prescription Monitoring at 217/524-1311, 217/785-9013, or 217/524-2158 or via email at ilpmp.org contact page. Recourses to Further Education Public Act 099-0480 http://www.ilga.gov/legislation/publicacts/99/pdf/099-0480.pdf http://www.ilga.gov/legislation/publicacts/fulltext.asp?name=099-0480 Illinois Controlled Substance Act http://www.ilga.gov/legislation/ilcs/ilcs5.asp?actid=1941 Illinois Prescription Monitoring (ILPMP) https://www.ilpmp.org/ Opioid Treatment Directory - SAMHSA http://dpt2.samhsa.gov/treatment/ Version 1.0 49

State Agencies Approval PA99-0480 Version 1.0 50