Naloxone: Saving lives in an opioid epidemic

Transcription

1 Naloxone: Saving lives in an opioid epidemic Shannon N. Saldaña, PharmD, MS, BCPP Psychiatry Advanced Clinical Pharmacist Intermountain Primary Children s Hospital Adjunct Assistant Professor of Psychiatry The University of Utah School of Medicine December 2017

2 Conflict of interest disclosure I have no conflicts to disclose.

3 Objectives Explain the role and use of naloxone in opioid overdose Describe Utah legislation on naloxone prescribing and dispensing Identify situations in which to consider co-prescribing naloxone with opioids Outline opioid risk and naloxone talking points for conversations with patients and caregivers

4 Outline Opioid epidemic Risks of opioids: opioid overdose Naloxone rescue kits and how they work Utah legislation on naloxone prescribing and dispensing Opioid prescribing Co-prescribing naloxone Conversations to have with patients Questions, thoughts, discussion

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6 Opioids

7 Opioids Prescription medications For pain For opioid use disorder Heroin Interact with opioid receptors (body, brain) Control pain signals (analgesia) Produce euphoria Decrease breathing (can lead to death) Generic nameas Hydrocodone Oxycodone Morphine Codeine Fentanyl Hydromorphone Oxymorphone Meperidine Tramadol Buprenorphine Methadone Common brand name Norco, Lortab, Vicodin, Zohydro OxyContin, Percocet, Percodan, Roxicodone MSIR, MS Contin Tylenol #3, Phenergan with codeine Duragesic, Actiq Dilaudid Opana Demerol Ultram, Conzip Subutex, Suboxone, Butrans, Zubsolv Dolophine, Methadose

8 How opioids work Opioid fits exactly in receptor and activates it (turns it on) Opioid activates receptor blocked pain signals, euphoria Brain has many opioid receptors Opioid receptor on brain cell Too much opioid in too many receptors slows and stops the breathing (overdose) Adapted from

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10 Andy Plumb Penny Cormani Maline Hairup Tennyson Cecchini Ryan Ainsworth Grant Seaver Tony Lewis Opioid overdose Utah loved ones lost

11 Utah drug poisoning deaths, by county, Rate of Drug Poisoning Deaths Per 100,000 Population Web-based Injury Statistics Query and Reporting System, US Census Bureau. 83% involved prescription opioids Utah: 7 th in US

12 Rate per 100,000 population Rate of prescription opioid death in Utah in Male Female * Total Age group Utah Department of Health Violence and Injury Prevention Program graph courtesy of Utah Department of Health. February 14, 2017.

13 Utah prescription opioid overdose and death in 2015 Utah overdose death rate was 12.6 (per 100,000 adults) 566 overdose deaths 347 involved prescription drugs 282 deaths from prescription opioids Top circumstances Top 3 Utah areas Death rate (per 100,000 adults) Carbon/Emery Counties 47.3 Downtown Ogden 31.6 Physical health problem (71%) Substance use problem (68.3%) Current mental health/substance use treatment (60.4%) Southwest Local Health District Beaver, Garfield, Kane, Iron, Washington counties 23.9 Drug use not per a prescription (27.4%) Alcohol dependence/problem (17.1%) History of suicide attempt (13.7%) Utah Department of Health Violence & Injury Prevention Program, Utah Violent Death Reporting System.

14 Naloxone Naloxone rescue kits and how they work Erin Finkbiner Mitch Blain

15 Overdose Education and Naloxone Distribution (OEND) Centers for Disease Control and Prevention (CDC) report in 2012 Reported on OEND programs from programs 53,032 people received naloxone kits and training 10,171 overdose reversals CDC report in 2015 Shows large increase in number of OEND programs Reported on OEND programs from programs 152,283 naloxone kits distributed 26,463 overdose reversals Wheeler E, Jones TS, Gilbert MK, Davidson PJ. Opioid Overdose Prevention Programs Providing Naloxone to Laypersons - United States, MMWR 2015:64(23);

16 Opioid overdose Opioid receptor activated (turned on) by opioid Opioid receptor on brain cell Brain has many opioid receptors Too much opioid in too many receptors slows and stops the breathing (overdose) Adapted from

17 Naloxone reversing an overdose Opioid/ Heroin Naloxone Opioid receptor Adapted from Naloxone has a stronger attraction to opioid receptors than other opioids or heroin Naloxone knocks opioid/heroin off the receptors and blocks them for a short time This lets the person breathe again

18 Naloxone can prevent death from opioid overdose Opioid overdose is reversible when Naloxone is given soon after overdose Emergency care is provided Used for decades to reverse opioid overdose Naloxone should be given while waiting for emergency medical services Utah Opiate Overdose Response Act A person who acts in good faith to administer naloxone to someone they believe is experiencing an opioid overdose is not liable for civil damages Administering naloxone is voluntary Wheeler E, Jones TS, Gilbert MK, Davidson PJ. Opioid Overdose Prevention Programs Providing Naloxone to Laypersons - United States, MMWR 2015:64(23); Utah HB 119, Utah HB 238, Utah HB 240, 2016.

19 Naloxone Safe prescription medication Not a controlled substance Does not cause euphoria Does not lead to addiction Only function is to block opioid receptors/reverse overdose Will have no effect and will not harm a person who has not overdosed on opioids Can only reverse an opioid overdose Does not reverse other drug overdoses Available to the public in some states since 1996; in Utah since 2014

20 What to know about naloxone Can start working as quickly as 1 minute Effects can last minutes Another dose is needed when effect wears off Can be sprayed in the nose, injected in a muscle, or injected under the skin Same dose for everyone (young, old, pregnant, medical diseases, pets) Goal: unblock enough receptors to restore breathing (not cause withdrawal) Naloxone may trigger withdrawal in people who are opioid-dependent Can feel unpleasant Some people may get agitated or combative and need help to remain calm

21 What to know about naloxone Store naloxone around room temperature (avoid extremes) In an overdose, if there is no alternative, give naloxone even if it has expired or been in extreme temperatures Keep it with you (or with the person at risk) or where it is accessible Do not keep naloxone with the opioids or locked up Tell other people where naloxone is Teach others how and when to use naloxone Naloxone Access: A Practical Guideline for Pharmacists, College of Psychiatric and Neurologic Pharmacists,

22 Opioid withdrawal Goal of naloxone is to unblock enough opioid receptors to restore breathing, not precipitate withdrawal Naloxone may trigger withdrawal in people who are opioid-dependent Can feel unpleasant Some people may get agitated or combative and need help to remain calm Vomiting is also relatively common SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) Rockville, MD, 2016.

23 4 naloxone products Intramuscular (IM) kits Naloxone and IM syringes Intranasal kits Naloxone and nasal atomizers Narcan Nasal Spray Auto-injector (Evzio) Not all pharmacies will have all products

24 Intramuscular naloxone kit 2 single-dose vials of naloxone 0.4 mg/ml 2 intramuscular syringes

25 Intramuscular kit instructions Inject in large muscle (shoulder may be more accessible) Be careful and pinch the thigh if administering to an infant Do not re-cap the needle; put used syringe away from people, if possible in a strong plastic container with a narrow opening Keep at room temperature (avoid extremes) and away from light

26 Intranasal naloxone kit Absorption is through nasal mucosa, the person does not need to inhale 2 pre-filled needless syringes of naloxone 1 mg/ml 2 nasal atomizers (spray cones)

27 Intranasal kit instructions Do not insert naloxone into tube until ready to use (expires in 2 weeks, once inserted) Be careful naloxone glass cartridges can shatter if dropped ½ of the syringe goes in one nostril, and the other ½ goes in the other nostril If nose is blocked, clear it (wipe away vomit) and/or insert tip as far into nose as possible

28 Narcan Nasal Spray Each package has 2 nasal spray devices Each device contains only one spray dose Do not prime the pump Do not reuse after first spray Go give, place the tip of the nozzle in either nostril (until your fingers touch the bottom of the person s nose), then press the plunger If nose is blocked, clear it (wipe away vomit) and/or insert tip as far into nose as possible

29 Auto-injector (Evzio) Naloxone 2-mg auto-injector 2 auto-injectors and 1 trainer per package May pose more risk for opioid withdrawal due to the higher dose of 2 mg Cost ~$5,000+ May give in a muscle or under the skin Electronic voice instruction system Remove from case Pull red guard off Follow instructions

30 Cost Some form of naloxone is covered by most insurances and Medicaid Intranasal and intramuscular kits Costs are usually $ without insurance Intramuscular kits are usually less expensive Naloxone often covered at a generic copay Pharmacies may have a separate charge for syringes or nasal atomizers 4-mg nasal spray without insurance: around $150 2-mg auto-injector without insurance: $4,700-6,100 * Costs/estimates as of Dec 2016-Jan 2017; vary among pharmacies; call pharmacy for current information, due to large price changes over short time periods.

31 Outline Opioid epidemic Risks of opioids: opioid overdose Naloxone rescue kits and how they work Utah legislation on naloxone prescribing and dispensing Opioid prescribing Co-prescribing naloxone Conversations to have with patients Questions, thoughts, discussion

32 Health care provider may prescribe naloxone Without a prescriber-patient relationship Without liability for any civil damages for acts or omissions made as a result of prescribing or dispensing naloxone in good faith To anyone at increased risk of experiencing an opioid overdose To a family member, friend, or other individual in a position to assist someone at risk To an outreach provider for Furnishing to someone else Administering to a person experiencing an overdose Utah Opiate Overdose Response Act, Utah Code

33 Overdose outreach providers Overdose outreach providers are not civilly liable when administering naloxone to someone believed to be experiencing an overdose The definition of overdose outreach provider includes Law enforcement Fire departments Mental health and substance use disorder treatment programs Organizations serving people experiencing homelessness Emergency medical service providers/personnel Local health departments Pharmacists An individual Utah Opiate Overdose Response Act, Utah Code

34 Health care provider who dispenses naloxone Shall provide education that includes written instruction How to recognize an opiate-related drug overdose event How to respond appropriately to an opioid overdose, including how to: Administer naloxone Ensure that an individual to whom [naloxone] has been administered receives, as soon as possible, additional medical care and a medical evaluation

35 Naloxone in Utah pharmacies without a prescription Naloxone is a prescription medication Naloxone does not require a prescriber-patient relationship in Utah Pharmacists may prescribe and dispense naloxone under a protocol with a prescriber: Collaborative Practice Agreement or standing order Do not have to see a medical provider to get a naloxone prescription Can request naloxone at a pharmacy Dispensed as a prescription, with a label, patient name, prescriber name, instructions Some pharmacy protocols do not include all naloxone products Some pharmacies may not participate in a naloxone protocol Utah Pharmacy Practice Act. Utah Code 58-17b-102 Utah Opiate Overdose Response Act, Utah Code

36 Outline Opioid epidemic Risks of opioids: opioid overdose Naloxone rescue kits and how they work Utah legislation on naloxone prescribing and dispensing Opioid prescribing Co-prescribing naloxone Conversations to have with patients Questions, thoughts, discussion

37 Opioid prescribing in Utah % increase in rate of opioids dispensed Each year there were more prescriptions, and higher doses, for females than males 2015: 89 opioid prescriptions per 100 Utahns 2015 Utah population: 2.98 million (all ages) 2.6 million opioid prescriptions filled in Utah in ,000 opioid prescriptions every day Enough for every Utah adult to have a bottle of opioids Opioid prescribing practices in Utah UDOH VIPP

38 Morphine Milligram Equivalents (MMEs) Also called morphine equivalent dose (MED) Convert opioids to a standard value (based on morphine) MME = amount of opioid taken daily x conversion factor If taking multiple opioids, calculate MME for each, then add together

39 CDC Vital Signs, July 2017

40 CDC Vital Signs, July 2017

41 Ages experienced greatest increase (70%) Ages experienced greatest decrease (63%) Violence and Injury Prevention Program. Opioid Prescribing Practices in Utah Salt Lake City, UT: Utah Department of Health

42 Outline Opioid epidemic Risks of opioids: opioid overdose Naloxone rescue kits and how they work Utah legislation on naloxone prescribing and dispensing Opioid prescribing Co-prescribing naloxone Conversations to have with patients Questions, thoughts, discussion

43 Co-prescribing naloxone Some guidelines recommend co-prescribing or offering a prescription for naloxone when patients have risk factors for overdose/overdose death Utah S.B. 258 (2017) required Utah Department of Health to establish guidelines for prescribing naloxone along with a prescription for an opioid Co-prescribing guidelines rule (R ) published for public comment This rule establishes scientifically based guidelines for controlled substance prescribers to co-prescribe an opiate antagonist to a patient Inquiries and comments due by December 15, 2007 at 5:00 PM Utah S.B UTAH STATE BULLETIN November 15, 2017, Vol. 2017, No. 22

44 R Guidelines for the Issuance of a Prescription for an Opiate Antagonist Along with a Prescription for an Opiate 1. Co-prescribing guidelines are applicable when prescribing opioids. 2. Clinicians shall consider offering a co-prescription for an opiate antagonist, such as naloxone, and education on overdose prevention to patients and the patient's household members and/or close contacts, especially when factors that increase risk for opioid overdose are present. These risk factors include: a. history of overdose; b. history of substance use disorder; c. underlying mental health condition that make a patient susceptible to overdose; d. risk for returning to a high dose to which they are no longer tolerant (e.g., patients recently released from prison); e. medical conditions, such as respiratory disease, sleep apnea, or other comorbidities that make a patient susceptible to opioid toxicity, respiratory distress or overdose; f. higher opioid dosages (greater than or equal to 50 MME/day); and g. concurrent benzodiazepine use. 3. Clinicians shall consider offering a co-prescription for an opiate antagonist, such as naloxone, and education on overdose to persons in a position to aid someone who is at risk of overdose. DAR File No NOTICES OF PROPOSED RULES. UTAH STATE BULLETIN November 15, 2017, Vol. 2017, No. 22

45 Common risks for opioid overdose or death High opioid doses Long-acting opioids (also called controlled-release, sustained-release) Rotating opioid regimens Illicit/non-medical opioid or injectable drug use Recent release from treatment or incarceration (lost/decreased tolerance) Veterans Age greater than 65 years Cognitive impairment Children or pets in the home Difficulty accessing emergency medical services (not close to a hospital) Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, MMWR Recomm Rep 2016;65(No. RR-1):1 49. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) Rockville, MD, World Health Organization. Community Management of Opioid Overdose. Geneva, Switzerland, 2014.

46 Factors that increase risk for overdose death Smoking or breathing problems, such as COPD (chronic obstructive pulmonary disease), asthma, sleep apnea, or respiratory illness Kidney disease Liver disease Medical or physical problems History of overdose Drinking alcohol with opioids Taking with other medications Benzodiazepines Sedatives/hypnotics Antidepressants Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, MMWR Recomm Rep 2016;65(No. RR-1):1 49. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) Rockville, MD, World Health Organization. Community Management of Opioid Overdose. Geneva, Switzerland, 2014.

47 Outline Opioid epidemic Risks of opioids: opioid overdose Naloxone rescue kits and how they work Utah legislation on naloxone prescribing and dispensing Opioid prescribing Co-prescribing naloxone Conversations to have with patients Questions, thoughts, discussion

48 Why is it so tough to talk about opioids and naloxone? Conversation takes time Concern that star ratings will go down Pharmacists feel like they are trying to sell patients more medication the pharmaceutical industry got us into the opioid epidemic now companies are going to make money on a drug to reverse overdose Concerned about perceptions Doctor or pharmacist not safely prescribing/dispensing People do unsafe things on purpose or aren t smart or strong enough to be safe Not sure how to tell people they could experience withdrawal, become addicted, or unintentionally die from a medication we are giving them Stigma around drug use and addiction

49 Strategies for success For all medications, explain potential side effects and risks Be honest and get comfortable, patients deserve to know risks Focus on medication safety Opioids are dangerous drugs Not dangerous people (patients, doctors, nurses, pharmacists) Tell patients what to expect from opioids, including risks Mention and briefly explain tolerance, dependence, addiction, overdose Example A risk of this medication is decreased breathing, which can cause sudden death Reversing this process quickly is crucial Naloxone can reverse this effect of the opioid medication

50 Examples A risk of this opioid medication is decreased breathing, which can cause sudden death Reversing this process quickly is crucial Naloxone can reverse this effect of the medication Sometimes, even when people are using the medications as prescribed, something changes, like the person starts taking a new medication, and that could mean that this medication is not as safe anymore Opioids can cause drowsiness and confusion, it is possible that someone could forget if/when they took a dose A tablet could fall on the floor and could be enough to hurt a baby or a pet

51 Examples Even after taking a short time, people may need a higher dose for the same effect, which is called tolerance Physical dependence happens within a week If you take this regularly and then stop, you may feel withdrawal symptoms This does not mean you are addicted Addiction is a risk, especially when taking for longer than 3-7 days This is a chronic brain disease with harmful consequences I have seen people and their families with addiction, and I don t want to see that happen to you or anyone who could access your opioids We didn t tell people about this risk like we should have in the past. Now I tell everyone, to help keep you safe and minimize the risks of opioids.

52 Questions, thoughts, discussion

53 Naloxone: Saving lives in an opioid epidemic Shannon N. Saldaña, PharmD, MS, BCPP Psychiatry Advanced Clinical Pharmacist Intermountain Primary Children s Hospital Adjunct Assistant Professor of Psychiatry The University of Utah School of Medicine December 2017