(b) A person acting in good faith who reasonably believes that another person is experiencing an opioid-related drug overdose may administer an

Transcription

1 Act AN ACT TO AMEND THE PROVISIONS OF ARKANSAS CODE CONCERNING THE PRACTICE OF PHARMACY; TO AUTHORIZE USE OF PHARMACISTS TO PROVIDE ACCESS TO AND ADMINISTRATION OF CERTAIN MEDICATIONS; TO AUTHORIZE DISPENSING OF CERTAIN MEDICATION BY PHYSICIANS; AND FOR OTHER PURPOSES This act, sponsored by Senators Cecile Bledsoe and Lance Eads as well as Representative Justin Boyd, added language to allow pharmacists to initiate therapy and administer or dispense or both Naloxone pursuant to a statewide protocol which is also published here. This act also allows physicians to dispense Naloxone without a dispensing permit. The statutory language includes the following: Requirements for administering and dispensing under a statewide protocol. When initiating therapy and administering or dispensing, or both, under a statewide protocol, a pharmacist shall: (1) Notify the primary care provider of the patient of any drug or device furnished to the patient or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by the primary care provider; (2) Provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient's choice, if the patient does not have a primary care provider; and (3) (A) Make a standardized fact sheet available to the recipient of the drug or device. (B) The standardized fact sheet shall include without limitation: (i) The indications and contraindications for the use of the drug or device; (ii) The appropriate method for the use of the drug or device; (iii) The need for medical follow-up; and (iv) Other appropriate information. OTHER RELATED STATUTES Opioid antagonist -- Immunity. (a) A healthcare professional acting in good faith may directly or by standing order prescribe and dispense an opioid antagonist to: (1) A person at risk of experiencing an opioid-related drug overdose; (2) A pain management clinic; (3) A harm reduction organization; (4) An emergency medical services technician; (5) A first responder; (6) A law enforcement officer or agency; or (7) A family member or friend of a person at risk of experiencing an opioid-related drug overdose.

2 (b) A person acting in good faith who reasonably believes that another person is experiencing an opioid-related drug overdose may administer an opioid antagonist that was prescribed and dispensed under section (a) of this section. (c) The following individuals are immune from civil liability, criminal liability, or professional sanctions for administering, prescribing, or dispensing an opioid antagonist under this section: (1) A healthcare professional who prescribes an opioid antagonist under subsection (a) of this section; (2) A healthcare professional or pharmacist who acts in good faith and in compliance with the standard of care that dispenses an opioid antagonist under subsection (a) of this section; and (3) A person other than a healthcare professional who administers an opioid antagonist under subsection (b) of this section.

3 Arkansas Naloxone Protocol Naloxone hydrochloride is an opioid antagonist that reverses or blocks the effects of opioid analgesics. Timely administration of naloxone in the event of an opioid overdose can stop the potentially fatal respiratory depression that is linked with an opioid overdose. I. Purpose The purpose of this standing order is to reduce the morbidity and mortality of opioid overdoses in Arkansas by allowing Arkansas-licensed pharmacists to initiate therapy including ordering, dispensing and/or administering naloxone, along with any necessary supplies for administration, to eligible persons who are at risk of experiencing an opioid-related overdose, or who are family members, friends, or others who are in a position to assist a person at risk of experiencing an opioid-related overdose. II. Authority This standing order is issued pursuant to Act 284 of 2017 (SB 142) (Arkansas Code (16)) to authorize licensed pharmacists in Arkansas to order, dispense and/or administer naloxone according to the provisions of Arkansas Code (16) and the requirements of this standing order. III. Dispensing Guidelines A. Eligibility Criteria: An Arkansas Licensed Pharmacist may initiate therapy to an individual who is at increased risk of an opioid overdose or who is a family member, friend, or other person who is in a position to assist an individual with an increased risk of an opioid overdose is eligible to receive naloxone. * Factors that may place an individual at an increased risk of opioid overdose include: a. Opioid use including prescription or illicit drugs b. History of opioid intoxication, overdose, and/or emergency medical care for acute opioid poisoning c. High opioid dose prescribed (>50 morphine milligram equivalents daily) d. Suspected or known concurrent alcohol use e. Concurrent prescriptions or use of benzodiazepines, tricyclic anti-depressants (TCA s), skeletal muscle relaxants and other medications f. Treatment of opioid use disorder with either buprenorphine or methadone. g. Concurrent history of smoking/copd or other respiratory illnesses or obstruction B. Contraindications: Do not administer naloxone to an individual with a known hypersensitivity to naloxone or any of the other components.

4 C. Product Availability: Naloxone products that may be dispensed/provided under this standing order: 1. Narcan Nasal Spray (naloxone HCl) 4 mg/0.1 ml Nasal Spray Directions for use: Administer one (1) spray of Narcan in one nostril. Repeat after three (3) minutes if no response. 2. Naloxone HCl Solution 1 mg/ml in a 2 ml pre-filled Luer-Lock Syringe Directions for use: Spray 1 ml (1/2 of syringe) into each nostril. Repeat after three (3) minutes if no response 3. Evzio (naloxone HCl injection) 0.4 mg/0.4 ml autoinjector Directions for use: Follow audio instruction from device. Place on thigh and inject 0.4 ml. Repeat after three (3) minutes if no response. D. Warnings/Precautions: 1. Abrupt reversal of opioid effects in a person with a physical dependence on opioids can cause acute withdrawal symptoms such as, but not limited to, the following: nausea/vomiting, diarrhea, fever, body aches, sweating, sneezing, yawning, shivering/trembling, irritability, chills, anxiety, combativeness/disorientation. 2. Abruptly reversing the effects of opioids could result in a pain crisis due to neutralization of the analgesic effects of the opioid. 3. Naloxone should be used with caution in patients with a history of seizures and/or cardiovascular disease. 4. Naloxone will have no effect on respiratory depression caused from non-opioid substances. 5. Whenever naloxone is administered to reverse a potential opioid overdose, medical followup is needed as naloxone s effects wear off quickly resulting in the need for further medical care. Naloxone should be considered a temporary overdose reversal agent with the potential need for multiple doses under acute medical care. Primary Care Physician s name and contact information if for own use. If you do not have a primary care provider you should consult a physician of your choice: Protocol Approved by the Arkansas State Medical Board and the Arkansas State Board of Pharmacy. The prescriber of record for any pharmacy related paperwork is Dr. Nathaniel Smith, MD, Director and State Health Officer, Arkansas Department of Health

5 Battling the Opioid Epidemic Success from the Field with Naloxone Kirk R. Lane Arkansas State Drug Director & John Clay Kirtley, PharmD Executive Director Arkansas State Board of Pharmacy 1

6 Disclosures and Objectives We do not have any financial interests or other disclosures of conflict for this program. Objectives What is Naloxone? How Naloxone works in preventing opioid overdose. Arkansas Act 1222 Naloxone for First Responders Program Success and the need to develop more programs and awareness 2

7 Background Drug overdose is now the leading cause of injury death in the United States. Opioid analgesics, such as prescription painkillers, account for about 80 percent of those deaths. Overdose rates have increased five-fold since

8 BNPD OFFICERS SAVE LIFE WITH NALOXONE KIT Benton Officers with the Benton Police Department saved the life of an individual late Sunday through the use of a Naloxone kit and through their previous Naloxone training. I think it is an understatement how important the Naloxone kits and training are to the public, Chief Kirk Lane said. Today the kits combined with our officers training saved the life of an individual and that is why we felt the Naloxone was so important to bring to and instill in this department. We were the first agency in the state to give Naloxone kits to every officer and the first to train every officer with Naloxone kits. We hope this incident in which Naloxone was used to save a life will positively influence every agency, across the state and country, to acquire Naloxone kits. At approximately 11:58 p.m. Sunday, officers responded to the I-30 Courts for a report of a person possibly overdosed from suspected heroin. The individual was found unresponsive with labored breathing. Officers administered the Naloxone into the right nostril of the individual, but received no response. Officers administered the Naloxone a second time into the left nostril of the individual as Emergency Medical Technicians from Saline Memorial Hospital MedTran unit arrived and began giving oxygen to the individual. An officer also rode with the individual in the ambulance, continuing to administer oxygen to the individual, while enroute to the Saline Memorial Hospital Emergency Room. Officers said the individual became responsive upon arrival to the Emergency Room. 4

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10 Arkansas Arkansas has the 25th highest drug overdose mortality rate in the United States, with 12.5 per 100,000 people suffering drug overdose fatalities *Trend was stabilized with PMP implementation 6

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17 DEA Fentanyl Warning Or go to youtube and look at DEA Fentanyl Warning 13

18 Pharmacy Prescription Drug Losses 106 Totals for Arkansas Drug Alprazolam (Xanax) 73,633 42,953 9,844 8,323 24,935 29,986 12,253 Hydrocodo ne 459, , ,988128, , , ,577 Oxycodone 16,538 32,422 18,448 28,336 65,163 74, ,639 Codeine 4,005 8,878 3,726 44,878 16,345 7,485 tabs 104,317 ml 4,358 Tabs 89,857ml

19 Burglaries / Robberies in Arkansas? Robberies, 68 Break Ins Robberies, 56 Break Ins Robberies, 33 Break Ins Robberies, 48 Break Ins Robberies, 38 Break Ins Robberies, 39 Break Ins Robberies, 44 Break Ins Robberies, 59 Break Ins 61 Break Ins in 2006 TALK TO YOUR STAFF ABOUT THIS 15

20 2015 Prescription Drugs Dispensed Drug # of RX Quantity Average Per RX Hydrocodone 1,714, ,987, Tramadol 762,766 58,672, Alprazolam 689,292 44,543, Oxycodone (all) 646,333 50,244, Zolpidem 568,550 17,718,

21 2016 Prescription Drugs Dispensed Drug # of RX Quantity Average Per RX Hydrocodone 1,691, ,648,138 Tramadol 770,322 59,400,035 Alprazolam 690,386 43,493,832 Oxycodone (all) 652,912 49,716, Zolpidem 552,912 17,402,

22 More Prescriptions than People 18

23 U.S. State Opioid Prescribing Rates 2016 per 100 People Alabama 121 Illinois 56.8 Montana 69.8 Rhode Island 60.3 Alaska 58.9 Indiana 83.9 Nebraska 62.8 South Carolina 89.4 Arizona 70.2 Iowa 64 Nevada 80.7 South Dakota 54.8 Arkansas Kansas 76.9 New Hampshire 64.3 Tennessee California 44.8 Kentucky 97.2 New Jersey 52.6 Texas 57.6 Colorado 59.8 Louisiana 98.1 New Mexico 65.1 Utah 70.4 Connecticut 55.9 Maine 66.9 New York 42.7 Vermont 58.6 Delaware 79.2 Maryland 58.7 North Carolina 82.5 Virginia 63.4 District of Columbia 32.5 Massachusetts 47.1 North Dakota 47.8 Washington 64.9 Florida 66.6 Michigan 84.9 Ohio 75.3 West Virginia 96 Georgia 77.8 Minnesota 46.9 Oklahoma 97.9 Wisconsin 62.2 Hawaii 41.9 Mississippi Oregon 76.3 Wyoming 71.1 Idaho 77.6 Missouri 80.4 Pennsylvania

24 County Opioid Prescribing Rates 2016 per 100 People Arkansas Dallas Lee 68.2 Pope Ashley Desha Lincoln 67.6 Prairie 82.1 Baxter Drew Little River Pulaski Benton 87.8 Faulkner 97.9 Logan 41.2 Randolph Boone Franklin 22.2 Lonoke St. Francis 94.8 Bradley Fulton Madison 79.3 Saline 97.4 Calhoun 83.6 Garland Marion 83.3 Scott Carroll 89.2 Grant 77.5 Miller Searcy 82.6 Chicot 77.7 Greene Mississippi Sebastian 169 Clark Hempstead Monroe 92.6 Sevier 65.5 Clay Hot Spring Montgomery 93.4 Sharp Cleburne Howard Nevada Stone Cleveland 1.1 Independence Newton 0.8 Union Columbia Izard 104 Ouachita Van Buren Conway Jackson Perry 51.2 Washington 98.5 Craighead Jefferson Phillips White Crawford 158 Johnson Pike 97.6 Woodruff 3.8 Crittenden Lafayette Poinsett Yell Cross Lawrence 37.5 Polk 117.8

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26 OPIDEMIC 22

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28 In a new analysis of overdose patient and emergency room data, Unick found that among younger drug users, heroin addiction appears to have split off as a phenomenon from the larger prescription painkiller epidemic, with deaths increasing fastest among people in their 20s. The approximately 15,000 people who die from painkiller overdoses, meanwhile, tend to be older, concentrated among people in their 50s and early 60s. 24

29 Circle of Addiction & the Next Generation Hydrocodone Heroin Oxycodone OxyContin

30 Take BACK APRIL 2016 Take BACK 25,289 Pounds APRIL 2017 Take BACK 24,483 Pounds 26

31 Drug Take Back Quantity in Pounds? 30,000 25,000 25,289 24,483 20,000 18,764 22,373 20,020 23,434 15,000 18,008 19,491 17,870 Alabama Arkansas 11,924 12,042 Mississippi 10,000 10,556 Louisiana 5,000 6,621 4,744 - Sep '10 April '11 Oct '11 April '12 Sep '12 April '13 Oct '13 April '14 Sept '14 April '15 Sept '15 April '16 Oct '16 April '17 27

32 The Solution What is Naloxone? Most users attempt to achieve abstinence from drugs, but on average this process takes 9 years and 4 episodes of care. Known by several names: (Narcan, Evzio, Naloxone) Naloxone is the actual generic name of the drug Naloxone is an Opioid Antagonist meaning that it is a drug used to reverse/block the effects of opioids. Naloxone is safe and effective. Naloxone has no effect on non-opioid overdoses. 28

33 Legislative findings The General Assembly finds that: (1) Naloxone is a relatively inexpensive opioid antagonist developed to counter the effects of opiate overdose, specifically the life-threatening depression of the central nervous and respiratory systems; (2) Naloxone will not adversely affect the human body if the person who receives Naloxone is suffering from an overdose of a drug that is not an opioid; (3) Naloxone is clinically administered via intramuscular, intravenous, or subcutaneous injection; (4) Naloxone is administered outside of a clinical setting or facility intranasally via a nasal atomizer, similar to the use of a common, otc anticongestion nasal spray; 29

34 Legislative findings (5) The American Medical Association has supported the lay administration of this lifesaving drug since 2012; (6) Similar Naloxone access laws have reversed more than ten thousand (10,000) opioid overdoses by lay people in other states; (7) The American Medical Association has acknowledged that more must be done to prevent these unnecessary opioid overdose fatalities that devastate families and communities; (8) The National Institutes of Health have found that Naloxone lacks any addictive qualities that could lead to potential abuse and that medical side effects or unintended consequences associated with the drug have not been reported; and (9) Any administration of Naloxone to an individual experiencing an opioid overdose must be followed by professional medical attention and treatment. 30

35 The Solution: Opioid antagonist Immunity-ACT 1222 of 2015 (a) A healthcare professional acting in good faith may directly or by standing order prescribe and dispense an opioid antagonist to: (5) A first responder; (6) A law enforcement officer or agency; or (b) A person acting in good faith who reasonably believes that another person is experiencing an opioid-related drug overdose may administer an opioid antagonist that was prescribed and dispensed under section (a) of this section. (c) The following individuals are immune from civil liability, criminal liability, or professional sanctions for administering, prescribing, or dispensing an opioid antagonist under this section: (3) A person other than a healthcare professional who administers an opioid antagonist under subsection (b) of this section. 31

36 In The United States Over 180 naloxone programs Over 50,000 people trained Over 10,000 overdose reversals (lives saved) Training Video 32

37 Opioid Basics Opioids are used primarily in medicine for pain relief, treatment of opioid use disorders, and cough relief. Opioids Natural Semi-synthetic Fully synthetic opium morphine codeine heroin hydrocodone oxycodone fentanyl methadone Demerol 33

38 How do opioids affect breathing? OVERDOSE Opioid Receptors Opioid 34

39 Naloxone Restores Breathing Opioid Receptors Naloxone occupies Opioid Receptors Displacing the Opioid and Reversing the Overdose *note that the opioid is still present thus the need for further medical treatment as Naloxone wears off Naloxone Opioid Restores breathing 35

40 Opioid Basics Naloxone knocks the opioid off the opiate receptor Only blocks opioid receptors; no opioids = no effect Not harmful if no opioids in system Temporarily takes away the high, giving the person the chance to breathe Naloxone works in 1 to 3 minutes and lasts 30 to 90 minutes Naloxone can neither be abused nor cause overdose Only known contraindication is sensitivity, which is rare Too much Naloxone can cause withdrawal symptoms such as: Nausea/Vomiting Diarrhea Muscle Discomfort Disorientation Combativeness Chills 36

41 Identifying an Opioid Overdose The despair here echoes across the country. But the opioid crisis is particularly acute in Ohio. Last year, a record 3,050 people in the state died of drug overdoses. Overdoses from the potent opioid fentanyl more than doubled, to 1,

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43 Identify an Opioid Overdose 39

44 Environmental Clues 1. Recognize overdose symptoms + 2. Recognize drug paraphernalia + 3. Recognize the drug = Recognize need for naloxone Look for symptoms, but if uncertain - land on the side of naloxone 40

45 Harmreduction.org 41

46 Remember Scene Safety Oncoming traffic Unstable surfaces Leaking gasoline Downed electrical lines Potential for violence Fire or smoke Hazardous materials Other dangers at crash or rescue scenes Crime scenes Needles Assume all body fluids present a possible risk for infection>> wear personal protective equipment! 42

47 Responding to an Opioid Overdose 1.Stimulate 2.Alert EMS 3.Administer naloxone 4.CPR Rescue breathing/ventilations 5.Repeat 3 & 4, if necessary 6.Recovery position, if breathing 43

48 Respond: Stimulate and Alert EMS 1.Stimulate victim with a sternal rub 2.If no response, delirious, or altered consciousness, call for EMS support 44

49 Respond: Administer Naloxone 3. If no response from stimulation, Kit contents: give naloxone One (1) individual prefilled syringes of Naloxone One (1) mucosal atomizer (nose pieces/spray device) 45

50 Naloxone Intervention Mucosal Atomization Device (MAD) Prefilled ampule of naloxone Luer-lock syringe 46

51 How to Administer Intranasal Naloxone 47

52 How to Administer Intranasal Naloxone 48

53 How to Administer Intranasal Naloxone 49

54 Respond: Rescue Breathing 4. Give rescue breaths, if you have proper safety equipment and training Place 1 hand on the chin and tilt head back to open airway Make sure the airway is clear and remove anything in their mouth Pinch the nose closed Give 2 slow rescue breaths into the mouth Use a rescue breathing mask if available Use a bag valve mask if you are trained 50

55 Respond: Rescue Breathing 4. Give rescue breaths, if you have proper safety equipment and training Make sure the chest (not the stomach) is rising with the breaths Give 1 breath every 5 seconds until the person can breath on their own If no pulse, start CPR 51

56 Respond: Repeat 3 & 4 if Necessary 5. After 3-5 minutes, if the victim is still unresponsive with slow or no breathing, administer another dose of naloxone and continue rescue breathing. 52

57 Respond: Recovery Position 6. Recovery position, when breathing is restored 53

58 Review: Respond to Opioid Overdose 1.Stimulate 2.Alert EMS 3.Administer naloxone 4.CPR Rescue breathing/ventilations 5.Repeat 3 & 4, if necessary 6.Recovery position, if breathing 54

59 Respond: Talk to EMS Make sure you tell EMS if you have administered Naloxone upon their arrival. 55

60 Documentation Write a detailed report documenting what you saw at the scene, what you were told by others at the scene, what actions you took at the scene, information you gained through follow-up interviews if possible. 56

61 Arkansas Naloxone Saves by LE DATE REPORTING AGENCY LOCATION SEX RACE AGE TYPE DRUG 10/2/2016 BENTON POLICE DEPARTMENT BENTON MALE W 36 HEROIN 5/11/2017 PULASKI COUNTY SHERIFFS OFFICE LITTLE ROCK MALE W 51 FENTANYL 5/12/2017 INDEPENDENCE COUNTY SHERIFFS OFFICE BATESVILLE MALE W 20 UNK OPIOID 5/16/2017 PULASKI COUNTY SHERIFFS OFFICE NORTH LITTLE ROCK MALE W 33 UNK OPIOID 5/18/2017 INDEPENDENCE COUNTY SHERIFFS OFFICE OIL TROUGH MALE W 59 UNK OPIOID 5/20/2017 MAUMELLE POLICE DEPARTMENT MAUMELLE MALE W 23 HEROIN 6/2/2017 INDEPENDENCE COUNTY SHERIFFS OFFICE NEWARK MALE W 34 UNK OPIOID 6/2/2017 PULASKI COUNTY SHERIFFS OFFICE NORTH LITTLE ROCK MALE W 52 OXYCODONE 9/9/2017 INDEPENDENCE COUNTY SHERIFFS OFFICE BATESVILLE MALE W 40 UNK OPIOID 8/15/2017 ARKANSAS STATE POLICE NORMAN FEMALE W 22 8/17/2017 ARKANSAS STATE POLICE (RURAL)OUACHITA FEMALE W 44 9/4/2017 INDEPENDENCE COUNTY SHERIFFS OFFICE BATESVILLE FEMALE W 20 MIXED DRUG (UNK OPIOID) MIXED DRUG (UNK OPIOID) 57 MIXED DRUG(UNK OPIOID)

62 Naloxone Video 58

63 There s an App for that

64 Narcan Now App 60

65 Last Points Prescription Drugs are Worth More Once they are Stolen or Diverted Circle of Addiction shows that as we do a better job with Prescription Drug Abuse, Issues with Heroin will increase 61

66 What is Next? Act 284 of 2017 by Senators Bledsoe and Eads as well as Representative Boyd will allow easier access to naloxone: Pursuant to a statewide protocol, a pharmacist may initiate therapy and administer or dispense, or both, Naloxone 62

67 Post Test Questions 1. Will naloxone be harmful to a patient not taking opioids? A. Yes B. No 63

68 Post Test Questions 2. When a healthcare provider or law enforcement agent administers naloxone to a patient that patient can sue them for administering the drug? A. True B. False 64

69 Post Test Questions 3. Naloxone is available OTC throughout Arkansas? A. True B. False 65

70 Questions? Kirk R. Lane Arkansas Drug Director John Clay Kirtley Executive Director Arkansas State Board of Pharmacy Pharmacyboard.arkansas.gov 66

71 Please plan to attend the 2017 Arkansas Prescription Drug Abuse Prevention Summit on November 9 at the Hot Springs Convention Center. We will offer four breakout tracks: Clinical, Criminal Justice, Education/Prevention and Counseling/Recovery. Early bird registration is open! Reserve your seat now as space is limited. 67

72 Monitor, Secure and Dispose Patients should Know what they are taking and how much they have Secure their prescription medications Properly dispose of prescription drugs

73 What Else are We Doing? 69

74 Updated Website with New Info 70