Community Pharmacy Naloxone Distribution: Updates from the Field

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2 Community Pharmacy Naloxone Distribution: Updates from the Field Garth K. Reynolds, BSPharm, RPh Executive Director Illinois Pharmacists Association Marty Michel, BSPharm, RPh, MBA, CDE Owner Key Drugs Kelly N. Gable, Pharm.D., BCPP Associate Professor SIUE School of Pharmacy Psychiatric Care Provider Family Care Health Center

3 Disclosure and Conflict of Interest Kelly Gable, Marty Michel, and Garth Reynolds declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings and honoraria.

4 Pharmacist Objectives At the conclusion of this program, the pharmacist will be able to: 1. Discuss the role of pharmacy personnel in opioid overdose management. 2. Review risk factors for opioid overdose and symptoms of an opioid overdose. 3. Discuss naloxone rescue therapy mechanism of action, appropriate use, and available delivery systems. 4. Highlight key steps involved in educating and dispensing naloxone rescue therapy at the pharmacy. 5. Describe pharmacy-targeted opioid overdose reduction initiatives in Illinois and Missouri. 6. Review updates in IL and MO legislation allowing for direct consumer naloxone access.

5 Technician Objectives At the conclusion of this program, the technician will be able to: 1. Discuss the role of pharmacy personnel in opioid overdose management. 2. Review risk factors for opioid overdose and symptoms of an opioid overdose. 3. Discuss naloxone rescue therapy mechanism of action, appropriate use, and available delivery systems. 4. Highlight key steps involved in educating and dispensing naloxone rescue therapy at the pharmacy. 5. Describe pharmacy-targeted opioid overdose reduction initiatives in Illinois and Missouri. 6. Review updates in IL and MO legislation allowing for direct consumer naloxone access.

6 Which bill permits IL pharmacists dispensing of naloxone via statewide standing order? a) HB100 b) HB1 c) SB1 d) HB5223 e) SB480

7 After IL pharmacists complete the Training Program who do they need to contact to be activated on the Statewide Standing Order? a) Illinois Pharmacists Association b) Illinois State Board of Pharmacy c) Illinois Prescription Monitoring Program d) Illinois Department of Public Health e) Illinois Department on Aging

8 Opioid Overdose Deaths in US

9 Overdose Rates in Illinois Source: Illinois Department of Public Health

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11 Overdose Rates in Missouri

12 Heroin & Fentanyl in St. Louis St. Louis has the 6 th highest overdose rates of US cities driven by heroin and fentanyl, not Rx drugs In 2015, St. Louis accounted for 73% of statewide heroinrelated deaths. Increased purity, injection, combining drugs higher risk

13 Treatment & Recovery Programming Prevention Prescription drug monitoring Urine drug screens Mental health parity laws Treatment Expanded access to Medication Assisted Treatment Harm Reduction Syringe access Safe injection sites Good Samaritan laws Prescribing guidelines Alternative pain treatments Increased access to overdose education and naloxone Recovery Peer support, Community, Domains of health and wellness

14 State Targeted Response to the Opioid Crisis Grants (Opioid STR) Missouri: $10,015,898 x 2 years = $20,031,796 A state targeted approach to the prevention, treatment, and recovery from opioid use disorders

15 Sites for Naloxone Distribution Community Pharmacies Needle Exchange Jails Health Clinics Methadone Clinics

16 Missouri Pharmacist Naloxone Survey

17 Why Community Pharmacy? Knowledge: pharmacist expertise surrounds the safe and effective use of medications. Access: the community pharmacy is accessible and the pharmacist is ideally positioned to counsel patients on opioid safety and harm reduction. Ease: pharmacists can recommend naloxone for every at-risk person taking an opioid medication and potentially screen and refer to treatment when appropriate.

18 Who Should Receive Naloxone? Tina? Tina 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.

19 Who Should Receive Naloxone? Bobby? Bobby 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 OxyContin 80 mg daily and oxycodone 10 mg q 4 hours for break-through pain. Last month his wife phoned 911 because she found Bobby unresponsive on the couch.

20 Who Should Receive Naloxone? Lisa? Lisa 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: duloxetine (Cymbalta), quetiapine (Seroquel), diazepam (Valium), hydrocodone / acetaminophen (Vicoden), prednisone, trazodone, zolpidem (Ambien), tramadol No one has ever talked to her about naloxone.

21 Who Should Receive Naloxone? 1. Daily opioid doses the exceed 50mg MME 2. Taking an opioid with a benzodiazepine and/or alcohol 3. History of opioid abuse, overdose, or other substance use disorder 4. Receiving opioid prescriptions from multiple doctors and pharmacies 5. Currently using heroin 6. Receiving methadone treatment 7. Recent release from opioid treatment program, jail, or hospital Gwira Baumblatt JA, et al. High-risk use by patients prescribed opioids for pain and its role in overdose deaths. JAMA Intern Med. 2014;174(5):

22 Morphine Equivalent Dose Calculation Opioid Morphine 1 Codeine 0.15 Fentanyl transdermal 4 Multiplier (Opioid dose x multiplier = MED) Hydrocodone 1 Methadone 4-12 Oxycodone 1.5 Oxymorphone 3 Tramadol 0.10 The CDC recommends providing overdose prevention education & dispensing naloxone to patients with opioid Rx s totaling 50 mg/day MED or more.

23 Who Should Receive Naloxone? Trick Question: It should be offered to any person prescribed or taking an opioid. ANYONE WHO COMES INTO THE PHARMACY REQUESTING IT!!

24 Opioid Products Opioid Hydrocodone (Vicodin, Lortab) Oxycodone (OxyContin, Percocet) Codeine Hydromorphone (Dilaudid) Heroin Fentanyl Morphine Street Names Vikes, Watson-387, Norco, Hydro Oxy, Ox, OC, Hillbilly Heroin, Percs Captain Cody, Syrup, Schoolboy Juice, smack, dillies Smack, dope, junk, black tar, dragon, china white Apache, China Girl, Dance Fever, Friend Black Mollies, Black Pill, Tango & Cash, TNT, Murder 8, Morph

25 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

26 I am recommending that you get naloxone today. The medications you are taking can cause slowed breathing or even death. Naloxone is an antidote that you can keep on hand to reverse this situation. Is it okay to provide you with naloxone today?

27 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

28 Naloxone Product Information Initial dose Instructions When to repeat Intranasal kit (not FDA-approved) 1mg/mL per nostril Supply as 2, 2 ml prefilled Luer-Jet Luer- Lock needleless syringes Spray 1 ml (half of syringe) into each nostril After 3-5 min if no response or if apnea/hypopnea recurs Storage 59 to 86 degrees F; protect from light Intranasal spray Intramuscular kit IM autoinjector 2 mg/0.1 ml 4 mg /0.1 ml Supply as 2 single-use nasal spray devices Place device nozzle into nostril, press plunger firmly to release dose into nose After 2-3 min if no response 59 to 77 degrees F; excursions permitted up to 104 degrees F; protect from light 0.4mg/1mL IM Supply as 2 single-use 1 ml vials or 1, 10 ml multiuse vial Inject 1 ml IM in shoulder or thigh After 3-5 min if no response or if apnea/hypopnea recurs 68 to 77 degrees F; protect from light 2 mg/0.4 ml IM Supply as 1 twin pack Inject IM into anterolateral aspect of thigh After 2-3 min if no response 59 to 77 degrees F; excursions permitted between 39 and 104 degrees F Naloxone products should be replaced before the expiration date on the box and should be stored at room temperature.

29 Which Naloxone Product? IM Vials All components available at community pharmacies Third party reimbursement possible Pain patients may not be comfortable with needles Pharmacists may not know what to include in the kit

30 Which Naloxone Product? IM Autoinjector VERY easy to use Costly / limited insurance coverage New higher dose

31 Which Naloxone Product?: IN Prefilled Syringes No needles or risks of needle sticks Not as easy to assemble Confusion in the prescribing process Atomizer availability concerns; not FDAapproved

32 Which Naloxone Product?: Narcan Nasal Spray Easy to use; needleless Higher dose MO Medicaid coverage 2 mg vs 4 mg doses

33 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

34 Teaching Patients, Friends, Family, Caregivers Identify the overdose Call 911 for help Perform rescue breathing Administer naloxone Stay until help arrives

35 Teaching Patients, Friends, Family, Caregivers 1. Risk factors for opioid overdose. 2. Strategies to prevent opioid overdose, including signs of an opioid overdose. 3. Proper naloxone use and administration. 4. Adverse reactions and side effects. 5. Proper naloxone storage. 6. Product expiration. 7. Seeking emergency medical attention. Throughout your session, try to avoid stigmatizing terminology: - addict, user, abuse, overdose

36 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

37 No time? 5 10 minutes is all it takes With brief education, the pharmacist can improve: Overdose recognition Pin point pupils Not arousable with sternal rub Breathing less then 8 per minute Choking, gurgling, snoring sounds Blue/gray lips and fingertips Level of comfort using naloxone Ability to properly administer intranasal or IM formulation Capacity to discriminate opioid overdoses from other medical conditions Behar E. Drug and Alcohol Dependence 2015;148:

38 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

39 Naloxone: Myths vs Truths Naloxone is a competitive antagonist at opioid receptor sites It reverses analgesic, dysphoric, and other pharmacologic effects of opioids It is effective in reversing an overdose with benzodiazepines, barbiturates, or stimulants It has been FDA-approved and used by EMS to reverse opioid overdose for > 40 years It is the same thing as naltrexone (a long-acting opioid antagonist) It has minimal interaction in the body without the presence of opioids

40 Addressing Naloxone Stigma How to address concerns of risk compensation Current observational study data demonstrates reductions in community level opioid overdose death rates & reduced opioid-related ED visits among patients with chronic pain who were co-prescribed naloxone rescue kits. Studies that have looked for risk compensation from naloxone access among people who use heroin have found no clear evidence of it. Comparator public health interventions: Seat belts to prevent motor vehicle deaths Vaccination and condoms to prevent STIs Needle/syringe programs You don t have a fire extinguisher in your house because you re an arsonist. You have it because it s an accident.. the naloxone your provider is offering you is because of the possibility of an accident,.it s just that this is a high-risk medication and we don t want anything bad to happen to you. - pharmacist in MA

41 Consumer-Related Barriers to Receiving Naloxone Embarrassed to ask about it at the pharmacy Fear of future consequences if I ask for naloxone at the pharmacy Fear of being labeled as a criminal by the pharmacist Fear of getting tagged as an addict by police if discovered carrying naloxone Lack of public knowledge of naloxone availability at the pharmacy Misinformed that naloxone is only for someone who is using heroin T.C. Green et al. Journal of the American Pharmacist Association 57 (2017) S19-S27.

42 Practical Questions I am uncomfortable talking about overdose with my patients. What should I say? How do I know which naloxone product to dispense? Are there specific things that I have to say when I dispense naloxone? I am so busy, I m not sure I have time to do this Does naloxone really work? Wouldn t someone just use more opioids if they have it? Will I get in trouble if I dispense this without a prescription?

43 Naloxone Programming in Illinois

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45 Economic Costs Of Prescription Medication Abuse $55.7 billion in costs for prescription medication abuse in 2007 $24.7 billion in direct healthcare costs Opioid abusers 8.7 times higher direct healthcare costs than non-abusers 32,449 opioid overdoses in Midwest (23.9%) DEA Pharmacy Diversion Awareness Conference: Drug Trends Presentation, Schaumburg, Illinois June 22, 2013 DEA Pharmacy Diversion Awareness Conference: Drug Trends Presentation, Schaumburg, Illinois July 26, 2015

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47 Pharmacist Role with Opioid Antagonist Pharmacist as Educator: Motivating people to be obtain an opioid antagonist; Pharmacist as Facilitator: Working with other healthcare providers and community organizations to increase access to opioid antagonists; Pharmacist as Practitioner: Protecting vulnerable people, consistent with state law.

48 Illinois (PA aka HB1) Sponsor: Rep. Lou Lang (D-Skokie) Medication Take Back program to be established by 06/01/2016. Pharmacy participation will be voluntary. All Pharmacies will display a sign of local state-approved drop-off sites. Pharmacies need to have in place and post a policy regarding the type of identification, if any, necessary to receive a prescription. Requires for sequential C-II prescriptions that prescribers must document reason of medical necessity for the (2) additional 30-Day supply in patient s medical record. Additional data element of Days Supply required to be transmitted to the Prescription Monitoring Program (PMP). Reporting to the Prescription Monitoring Program (PMP) changes from within 7 days to the end of the next business day. Statewide standing order, developed by the Department with Dept of Public Health and Dept of Human Services, for pharmacists to dispense opioid antagonist (naloxone); pharmacists will need to complete a training program. Exemption of civil liability for dispensing or administering an opioid antagonist without fee or compensation.

49 Kelly Gable, PharmD, BCPP, Chris Herndon, PharmD, BCPS, Jessica Kerr, PharmD, CDE, & Garth Reynolds, BSPharm, RPh

50 Illinois State Opioid Antagonist Training Program Released: March 11, Contact Hours of CPE The Illinois State Opioid Antagonist Training Program has been approved by the Illinois Department of Public Health, the Illinois Department of Financial and Professional Regulation, and the Illinois Department of Human Services and meets the requirements set forth in PA Training Program 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.

51 Naloxone Standardized Procedure

52 Naloxone Standardize Procedure 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

53 Naloxone Standardize Procedure Review that PA 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 PA 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.

54 Naloxone Standardize Procedure Once pharmacists have completed the certified Naloxone Antagonist Training (such as this course) and wish to participate in the Illinois Naloxone Antagonist Overdose Prevention Program: The pharmacy may request a copy of the Standardized Procedures for Naloxone Opioid Overdose by contacting the Illinois Prescription Monitoring Program (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.

55 Naloxone Standardized Protocol Update 2017 (Pending)

56 Naloxone Standardized Protocol Update 2017 (Pending) Effective any day (projected August 31 st ) Revised dosage forms of naloxone to: Intramuscular Multi-step intranasal Single-step intranasal Auto-Injector Update on Naloxone Kits and NDC numbers Physician Information included for prescription order and billing.

57 Naloxone Programming in Missouri

58 Harm Reduction in Community Pharmacy Access to clean needles Review of Prescription Drug Monitoring Program (PMDP) Educate on safe vs risky medication combinations Collaborate with providers to ensure safe opioid prescribing Provide easy access to naloxone! A1RRLjwGWQ

59 What barriers do you see for yourself with regard to naloxone prescribing and dispensing?

60 Which bill permits IL pharmacists dispensing of naloxone via statewide standing order? a) HB100 b) HB1 c) SB1 d) HB5223 e) SB480

61 Which bill permits IL pharmacists dispensing of naloxone via statewide standing order? a) HB100 b) HB1 c) SB1 d) HB5223 e) SB480

62 After IL pharmacists complete the Training Program who do they need to contact to be activated on the Statewide Standing Order? a) Illinois Pharmacists Association b) Illinois State Board of Pharmacy c) Illinois Prescription Monitoring Program d) Illinois Department of Public Health e) Illinois Department on Aging

63 After IL pharmacists complete the Training Program who do they need to contact to be activated on the Statewide Standing Order? a) Illinois Pharmacists Association b) Illinois State Board of Pharmacy c) Illinois Prescription Monitoring Program d) Illinois Department of Public Health e) Illinois Department on Aging

64 Pharmacy Naloxone Resources Link to MO specific education resources: Overdose prevention education: Prescribe to Prevent: Prevent to Protect: Centers for Disease Control and Prevention (CDC): Harm Reduction Coalition: Opioid prescribing education: Pathways to Safer Opioid Use: SAMHSA & NIDA provide free of charge continuing medical education courses: Substance use treatment locator: or call HELP

65 Speaker Contact Information Kelly N. Gable, Pharm.D., BCPP Garth K. Reynolds, BSPharm, RPh