Pharmacist Directed Opioid Antagonist Dispensing MARK BOESEN, PHARM.D., J.D. CHAIRMAN AND CEO GENRX PHARMACY C0-CHAIRMAN ARIZONA PHARMACY ASSN. LEGISLATIVE COMMITTEE DECEMBER 15, 2016
Opioid Substance Use Disorder: The Epidemic Substance Use Disorder is a Profoundly Deadly Disease Drug Overdoses Kill More People than Car Crashes or Guns (47,055 in 2014, United States Centers for Disease Control) Drug overdose is the leading cause of accidental death in the US; 47,055 lethal drug overdoses in 2014; Opioid addiction is driving this epidemic; 18,893 overdose deaths related to prescription pain relievers; and 10,574 overdose deaths related to Heroin in 2014. Arizona Ranks 10th Nationally for Overdose Among the 50 States
Arizona's Elected Officials Take A Stand and Act
HB 2355 (Ariz. Rev. Stat. 32-1979) TITLE: Pharmacists; dispensing opioid antagonists without a prescription; board protocols; immunity. Authority to Dispense Without a Prescription Section A: A pharmacist may dispense without a prescription, according to protocols adopted by the board, naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration [sic] for use according to the protocols specified by board rule to a person who is at risk of experiencing an opioid-related overdose or to a family member or community member who is in a position to assist that person.
Ariz. Rev. Stat. 32-1979 (cont.) Documentation and Counseling Required Section B. A pharmacist who dispenses naloxone hydrochloride or any other opioid antagonist pursuant to subsection A of this section shall: 1. Document the dispensing consistent with board rules. 2. Instruct the individual to whom the opioid antagonist is dispensed to summon emergency services as soon as practicable either before or after administering the opioid antagonist. Dispensing Pursuant to a Prescription is, of course, Permitted Section C. This section does not affect the authority of a pharmacist to fill or refill a prescription for naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration.
Ariz. Rev. Stat. 32-1979 (cont.) Immunity Provisions Section D. A pharmacist who dispenses an opioid antagonist pursuant to this section is immune from professional liability and criminal prosecution for any decision made, act or omission or injury that results from that act if the pharmacist acts with reasonable care and in good faith, except in cases of wanton or wilful [sic] neglect.
Arizona State Board of Pharmacy Issues Emergency Rule Excerpt from the Rationale for an Emergency Rule: In 2014 in Arizona, 1,018 individuals required emergency room treatment for a prescription drug overdose. There were 494 deaths from pharmaceutical opioids and benzodiazepines. That is more than one individual every day. Arizona has the fifth highest opioid prescription rate in the country. The rate of drug-induced deaths in Arizona (15.5 per 100,000 population) exceeds the national average.
Emergency Rule: R4-23-407.1. Dispensing an Opioid Antagonist Definitions Subsection A. As used in this Section: 1. Community member means a person in position to assist an individual at risk of experiencing an opioid-related overdose. This includes emergency first responders, peace officers or other law enforcement personnel, fire department personnel, school district employees, and personnel of a facility or center that provides services to individuals at risk of experiencing an opioid-related overdose. 2. Opioid antagonist means any drug approved by the U.S. Food and Drug Administration that binds to opioid receptors, effectively blocking or inhibiting the receptor and preventing the body from responding to the opioid. Naloxone hydrochloride is an opioid antagonist. 3. Opioid-related overdose means an acute condition in which the opioid overdose triad of symptoms, decreased level of consciousness, pinpoint pupils, and respiratory depression, is present. Other symptoms may include seizures, muscle spasms, and coma or death. An opioid-related overdose requires medical assistance.
Emergency Rule: R4-23-407.1. (cont.) Subsection B. Before allowing an opioid antagonist to be dispensed under A.R.S. 32-1979, a pharmacy permit holder shall have written policies and procedures regarding: 1. Documentation of opioid antagonists dispensed under A.R.S. 32-1979. The documentation shall: a. Include the information required under R4-23-407(A)(1)(a, c, d, f, and l) and (A)(2); and b. Include the following: i. Quantity dispensed; ii. iii. Directions for use; and If available, the patient s name, address, telephone number, and birth date; or iv. Name, address, telephone number, and birth date of a family member in position to assist the individual at risk of an opioid-related overdose; or v. Name, address, telephone number, and entity at which employed of a community member in position to assist an individual at risk of an opioid-related overdose ; and vi. Name of the individual providing the education required under subsection (B)(2);
Emergency Rule: R4-23-407.1. (cont.) Subsection B (cont.) 2. Education to be provided to the individual to whom the opioid antagonist is dispensed. The education shall include: a. How to prevent an opioid-related overdose; b. How to recognize an opioid-related overdose; c. How to administer an opioid antagonist safely to an individual experiencing an opioid-related overdose; d. Precautions regarding: i. Potential side effects, and ii. Possible adverse events associated with administration of the opioid antagonist; and e. Importance of seeking emergency medical assistance for the individual experiencing an opioid-related overdose before or after administering the opioid antagonist; and 3. Confidentiality, security, and privileged nature of documentation of opioid antagonists dispensed under A.R.S. 32-1979.
Emergency Rule: R4-23-407.1. (cont.) Subsection C. Before dispensing an opioid antagonist under A.R.S. 32-1979(A), a licensed pharmacist shall: 1. Complete an opioid prevention and treatment training program that includes the following information: a. How to recognize the symptoms of an opioid-related overdose, b. How to respond to a suspected opioid-related overdose, c. How to administer all preparations of an opioid antagonist, and d. The information needed by an individual to whom an opioid antagonist is dispensed, and 2. Comply fully with the policies and procedures developed under subsection (B).
Emergency Rule: R4-23-407.1. (cont.) Subsection D. A pharmacist who has completed an opioid prevention and treatment training program described in subsection (C): 1. May administer an opioid antagonist to an individual the pharmacist believes is experiencing an opioid-related overdose, and 2. Is exempt from civil liability under the terms of A.R.S. 36-2267(B). Subsection E. Dispensing an opioid antagonist under A.R.S. 32-1979 by invoice to a community member is not wholesale distribution as defined at A.R.S. 32-1981.
Among the Next Steps: Paying for Naloxone Legislative Action is Expected to Continue in 2017 to Improve Access to Naloxone. In general, if medications are dispensed without a prescription, it is difficult for the pharmacist to bill for the medication. The notion that you re going to cover a broken leg but not going to cover an illness in which your child might die? That doesn t make sense, -President Obama on Insurance Benefit Design as it Relates to SUDs. The leadership at the State Board of Pharmacy, with support of the Association, will seek prescriptive authority for RPhs to write for and bill for opioid antagonists dispensed to the populations described in the new law and regulation.
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Opioid overdose recognition, response, administration, and counseling AMY KENNEDY, PHARMD, BCACP 12/15/16
Preventing opioid overdose Community outreach Agencies Caregivers Counsel on safe use Take as prescribed Do not modify delivery systems Avoid large fluctuations in dose If coprescribing, use risk stratification Opioid risk tool
Mechanism of an opioid overdose Respiratory drive slows and eventually fails Permanent damage can occur in as little as 4 minutes Fatality often occurs 1-3 hours after ingestion
Overdose Myths Ice down the pants Salt water injection Balancing out with stimulants Burning bottoms of feet, kicking testicles, etc.
Recognizing an overdose High Muscles become relaxed Speech is slowed or slurred Sleepy looking Responsive to shouting, sternal rub, or ear lobe pinch Overdose Pale or gray, clammy skin Breathing is infrequent or has stopped Deep snoring, gurgling, or rattling Unresponsive to any stimuli Normal heart rate and/or pulse Normal skin tone Slow or no heart rate and/or pulse Blue or gray lips and/or fingertips
Responding to an opioid overdose 1. Assess the signs 2. Stimulation 3. Call for help 4. Breathing status 5. Administer naloxone 6. Breathing status 7. Aftercare Harm Reduction Coalition. www.harmreduction.org
Assess the signs Are they breathing? Are they responsive? Do they answer when you shake and shout their name? Can the person speak? How has their skin color changed? (lips and fingertips)
Stimulation Sternal rub Form a fist Place knuckles against patient s sternum Apply firm downward pressure Rub up and down across the sternum Can be quite painful Face flick or hand drop test
Call for help If the patient does not respond to previous stimuli, call 911 Why don t patients call 911? Fear of arrest Warrants/parole violation DCS involvement May jeopardize housing
Calling for help Avoid using words like drugs or overdose Not breathing, turning blue, unconscious I don t know why Keep loud noise to a minimum if it sounds chaotic, dispatchers may send police to secure the scene Clearly give address or nearest intersection If naloxone has been given and was ineffective, convey that If you MUST leave, place patient in recovery position
Administering naloxone Administer one dose Return to rescue breathing Should work within 2-5 minutes; if it doesn t, give 2 nd dose Does not work on other types of overdose Stay with the person and observe them for 3 hours, or transfer care to EMS Prescribe to Prevent. www.prescribetoprevent.org
Intranasal naloxone Three components Plastic delivery device Nasal adaptor Medication vial
Intranasal naloxone Easy for laypersons to use 4 mg/0.1 ml Allows for temperature excursions
Intramuscular naloxone Assembly required Can titrate dose as needed 0.4 mg/ml or 4 mg/10 ml
Intramuscular Naloxone Use an IM needle Pop off the orange top vial Draw up 1cc of naloxone into the syringe 1cc=1mL. Inject into a muscle thighs, upper, outer quadrant of the butt, or shoulder are best. Inject at 90 degree angle to make sure to hit the muscle.
Auto-injector naloxone Each prescription comes with two single use auto-injectors and one trainer Voice recording for guidance Pull device from casing Inject IM in upper thigh 0.4 mg/ml Allows for temperature excursions
Breathing status The difference between survival and death in an opioid overdose depends on how quickly enough oxygen gets into the person s body If there is an obstruction (undissolved pills, cheeked fentanyl patch), remove if you can safely Same technique as with CPR rescue breathing 1 breath every 5 seconds Even with enough force to move the chest (not the stomach!) Continue to perform rescue breathing while waiting for naloxone to take effect
Aftercare Naloxone only lasts between 30 90 minutes, while the effects of the opioids may last much longer. It is possible that after the naloxone wears off the overdose could recur. It is very important that someone stay with the person and wait out the risk period just in case another dose of naloxone is necessary. Patient may be unhappy Ungrateful that I saved their life Individual will be sick causes immediate withdrawal symptoms May want to use again; likely to cause an overdose once naloxone wears off Withdrawal symptoms Hospital follow up
Patient/consumer counseling Recognition of overdose Response to overdose Administration techniques Product storage Adverse effects
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