A COLLABORATIVE PRACTICE AGREEMENT FOR OPIOID OVERDOSE PREVENTION AND RESPONSE NALOXONE OVERDOSE KIT DISTRIBUTION PROTOCOL

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1 A COLLABORATIVE PRACTICE AGREEMENT FOR OPIOID OVERDOSE PREVENTION AND RESPONSE NALOXONE OVERDOSE KIT DISTRIBUTION PROTOCOL Purpose: To reduce morbidity and mortality from opioid overdose. Policy: Under this collaborative practice agreement, in accordance with Utah Code 58-17b-102 and Utah Rules R58-17b-611, eligible pharmacists, may initiate naloxone overdose kit distribution and educate patients based on the criteria below. Education/skills required for eligibility: Eligible pharmacists must be able to perform any of the following related to drug overdoses: Educate individuals on opioid overdose prevention Educate individuals on reducing the risk of prescription opioid abuse Provide information on the safe use of opioids for the management of chronic pain Use screening tools to detect opioid abuse or dependency and provide specialist referrals for management of difficult individuals Means to prevent diversion of prescribed opioid medications Recommend treatment for patients with pain and addiction How to administer naloxone in intranasal and intramuscular dosage forms Naloxone Overdose Kit description: 1) Intra-nasal kit: a. Naloxone 1mg/ml in vial or syringe with luer-lock tip #2 b. Nasal spray luer-lock adapter #2 2) Intramuscular kit: a. Naloxone 0.4mg/ml vial or syringe (or FDA approved naloxone auto-injector device) #2 b. Syringe for IM administration (3 cc x 1 inch needle) #2 3) Evzio (naloxone) intramuscular device. All kits will also contain: a. Instruction card b. Label with expiration date and instructions related to expired or used kit contents c. Optional:

2 i) CPR face shield ii) Vinyl/latex gloves Procedure: 1. [INSERT PHARMACY HERE] pharmacists will identify patients eligible for participation in naloxone overdose kit distribution, meeting any of the criteria of overdose risk: a. Voluntary request from patient, family member or friend b. Recipient of emergency medical care for acute opioid poisoning c. Suspected illicit or nonmedical opioid user d. High dose opioid prescription (>100 morphine equivalence per day) e. Any methadone prescription to opioid naïve patient f. Any opioid prescription and smoking/copd or other respiratory illness or obstruction g. Any opioid prescription for patients with renal dysfunction or hepatic disease h. Any opioid prescription and known or suspected concurrent alcohol use i. Any opioid prescription and concurrent benzodiazepine prescription j. Any opioid prescription and concurrent SSRI or TCA anti-depressant prescription k. Release prisoners from correctional facilities l. Release from opioid detoxification and mandatory abstinence program m. Patients entering methadone maintenance treatment programs (for addition or pain) An additional consideration may be: Patients who may have difficulty accessing emergency medical services 2. Pharmacists will be allowed to initiate naloxone prescriptions if individual meets criteria above: a. Naloxone HCl will be dispensed for intramuscular or intranasal administration (as noted above) b. Naloxone must have a shelf life of at least 12 months at time of dispensing c. Before dispensing naloxone, the pharmacist shall ensure that patients are properly trained in over opioid overdose recognition, response, and naloxone administration 3. Prior to providing services to patients pursuant to this CPA, the pharmacy will obtain informed consent from each patient, which shall include: a. A signed authorization for the release of protected health information by and between the pharmacy and the Collaborating Physician b. A provision allowing the patient to withdraw at any time from the collaborative practice described in this CPA c. An acknowledgment that patient has been offered the education and training d. Pharmacy will retain a copy of the informed consent 4. Pharmacists will provide patient education on the following:

3 a. Purpose for Naloxone, correct way to administer Naloxone, precautions regarding medications that may interact with Naloxone. b. High-risk overdose situations, risk reduction strategies, and appropriate response sets in addition to Naloxone administration, including rescue breathing and call 911. c. Review indications for use and naloxone administration. 5. Pharmacists will document each patient s participation information by the following: a. Record the date the prescription was dispensed, the manufacturer and lot number, and the name and title of the person providing mediation and education. b. Provide written notification via fax to medical provider listed on collaborative agreement of patient participation and/or naloxone dispensing within 7 days. c. Maintain records for a minimum or 5 years i. Informed consent ii. Prescription fill/re-fill records iii. Log of monthly activity to be reviewed by collaborating physician iv. Licensing and liability insurance information of participating pharmacist(s) and prescriber (s) will be maintained 6. Contact the medical provider listed on collaborative agreement in the event that the pharmacist requires medical consultation for a particular patient. 7. The collaborating medical provider may override a collaborative practice decision made by the pharmacist, if appropriate and/or in the best interest of the patient 8. Both parties shall maintain a copy of licensing and liability insurance information in their respective records for both the pharmacist and physician named below. This policy and procedure shall remain in effect for 2 years after the effective date unless rescinded earlier. Physician or Medical Provider Date Utah License number Pharmacist Date

4 Utah License number Date of implementation: Proof of liability insurance will be included for above signatories in the appendix to this document.

5 Title. This chapter is known as the Emergency Administration of Opiate Antagonist Act Definitions. As used in this chapter: (1) Health care facility means a hospital, a hospice inpatient residence, a nursing facility, a dialysis treatment facility, an assisted living residence, an entity that provides home- and community-based services, a hospice or home health care agency, or another facility that provides or contracts to provide health care services, which facility is licensed under Chapter 21, Health Care Facility Licensing and Inspection Act. (2) Health care provider means: (a) a physician as defined in Section ; (b) an advanced practice registered nurse as defined in Subsection 58-31b-102(13); or (c) a physician assistant as defined in Section 58-70a-102. (3) Opiate is as defined in Section (4) Opiate antagonist means naloxone hydrochloride or any similarly acting drug that is not a controlled substance and that is approved by the federal Food and Drug Administration for the treatment of a drug overdose. (5) Opiate-related drug overdose event means an acute condition, including a decreased level of consciousness or respiratory depression resulting from the consumption or use of a controlled substance, or another substance with which a controlled substance was combined, and that a person would reasonably believe to require medical assistance Voluntary participation. This chapter does not create a duty or standard of care for a person to prescribe or administer an opiate antagonist Authority to obtain and use an emergency opiate antagonist -- Immunity from liability. (1) (a) Except as provided in Subsection (1)(b), a person other than a health care facility or health care provider who acts in good faith to administer an opiate antagonist to another person whom the person believes to be suffering an opiate-related drug overdose event is not liable for any civil damages or acts or omissions made as a result of administering the opiate antagonist. (b) A health care provider: (i) does not have immunity from liability under Subsection (1)(a) when the health care provider is acting within the scope of the health care provider s responsibilities or duty of care; and (ii) does have immunity from liability under Subsection (1)(a) if the health care provider is under no legal duty to respond and otherwise complies with Subsection (1)(a).

6 (2) Notwithstanding Sections , 58-17b-501, and 58-17b-502, a health care provider who is licensed to prescribe or dispense an opiate antagonist may, without a prescriber-patient relationship, prescribe or dispense an opiate antagonist without liability for any civil damages or acts or omissions made as a result of prescribing or dispensing an opiate antagonist in good faith, to: (a) an individual who is at increased risk of experiencing or who is likely to experience an opiate-related drug overdose event; or (b) a family member of, friend of, or other person who may be in a position to assist an individual who may be at increased risk of experiencing or who is likely to experience an opiate-related drug overdose event. (3) A person who prescribes or dispenses an opiate antagonist shall provide education to the individual described in Subsection (2)(a) or (b) that includes instructions to take the person who received the opiate antagonist to an emergency care facility for a medical evaluation. Enacted by Chapter 130, 2014 General Session

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8 Detach for patient Naloxone for Overdose Prevention patient name date of birth patient address patient city, state, ZIP code prescriber name prescriber address prescriber city, state, ZIP code prescriber phone number Naloxone HCl 1 mg/ml 2 x 2 ml as pre-filleld Luer-Lock needless syringe (NDC ) Refills: 2 x Intranasal Mucosal Atomizing Device (MAD 300) Refills: For suspected opioid overdose, spray 1mL in each nostril. Repeat after 3 minutes if no or minimal response. Pharmacist: Call to order MAD 300. prescriber signature date How to Avoid Overdose Only take medicine prescribed to you Don t take more than instructed Call a doctor if your pain gets worse Never mix pain meds with alcohol Avoid sleeping pills when taking pain meds Dispose of unused medications Store your medicine in a secure place Learn how to use naloxone Teach your family + friends how to respond to an overdose Are they breathing? Signs of an overdose: Slow or shallow breathing Gasping for air when sleeping or weird snoring Pale or bluish skin Slow heartbeat, low blood pressure Won t wake up or respond (rub knuckles on sternum) Airway Make sure nothing is inside the person's mouth. Prepare Naloxone Are they any better? Can you get naloxone and prepare it quickly enough that they won t go for too long without your breathing assistance? Call 911 for help All you have to say: Someone is unresponsive and not breathing. Give clear address and location. Rescue breathing Oxygen saves lives. Breathe for them. One hand on chin, tilt head back, pinch nose closed. Make a seal over mouth & breathe in 1 breath every 5 seconds Chest should rise, not stomach PrescribeToPrevent.org 1 Pull or pry off yellow caps 2 Pry off red cap PLASTIC TUBE NALOXONE 5 Insert white cone into nostril; give a short, vigorous push on end of capsule to spray naloxone into nose: one half of the capsule into each nostril. 3 Grip clear plastic wings. 4 Gently screw capsule of naloxone into barrel of tube. If no reaction in 3 6 minutes, give the second dose. Push to spray. Source: HarmReduction.org Evaluate + support Continue rescue breathing Give another 2 sprays of naloxone in 3 minutes if no or minimal breathing or responsiveness Naloxone wears off in minutes Comfort them; withdrawal can be unpleasant Get them medical care and help them not use more opiate right away Encourage survivors to seek treatment if they feel they have a problem v

9 How to Use EVZIO Visual and voice instructions help guide the way EVZIO is designed to be easy to use for patients, their family members, and other caregivers who do not have medical training. 1 It contains the Intelliject Prompt System (IPS ) with visual and voice instructions that help guide the user through the injection process. Administration steps 1- Pull EVZIO from the outer case. Do not go to Step 2 (do not remove the red safety guard) until you are ready to use EVZIO. If you are not ready to use EVZIO, put it back in the outer case for later use. 2- Pull off the red safety guard. To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away. Note: The red safety guard is made to fit tightly. Pull firmly to remove. Do not replace the red safety guard after it is removed. 3- Place the black end against the middle of the patient's outer thigh, through clothing (pants, jeans, etc) if necessary, then press firmly and hold in place for 5 seconds. If you give EVZIO to an infant less than 1 year old, pinch the middle of the outer thigh before you give EVZIO and continue to pinch while you give EVZIO. Note: EVZIO makes a distinct sound (click and hiss) when it is pressed against the thigh. This is normal and means that EVZIO is working correctly. Keep EVZIO firmly pressed on the thigh for 5 seconds after you hear the click and hiss sound. The needle will inject and then retract back up into the EVZIO auto-injector and is not visible after use. 4- After using EVZIO, the user should immediately seek emergency medical help. If symptoms return after an injection with EVZIO, an additional injection using another EVZIO may be needed. Give additional injections using a new EVZIO auto-injector every 2 to 3 minutes and continue to closely watch the person until emergency help is received. EVZIO cannot be reused. After use, place the auto-injector back into its outer case. Do not replace the red safety guard. Do not throw away the EVZIO in household trash. Do not recycle EVZIO. Used EVZIO should be taken to a healthcare setting for proper disposal in a sharps container. There may be local or state laws about how to throw away used autoinjectors.*