Take Home Naloxone: Law Update and Considerations for Pharmacy Professionals

Transcription

1 Take Home Naloxone: Law Update and Considerations for Pharmacy Professionals Clint Ross, PharmD, BCPP Clinical Pharmacy Specialist Psychiatry Residency Program Director Psychiatric Pharmacy Medical University of South Carolina March 12, 2017

2 Learning Objectives For Pharmacists At the completion of this activity, the participant will be able to: List characteristics of patients most at risk for opioid overdose Explain important details of recently passed harm reduction legislation in South Carolina as it relates to pharmacists Compare various strategies to increase "take home" naloxone access for high risk patients Given a patient case, identify the most appropriate formulation(s) of naloxone for dispensing and important counseling points

3 Learning Objectives For Pharmacy Technicians At the completion of this activity, the participant will be able to: List characteristics of patients most at risk for opioid overdose Explain important details of recently passed harm reduction legislation in South Carolina as it relates to pharmacy technicians Compare various strategies to increase "take home" naloxone access for high risk patients Identify the different formulations of naloxone and important points regarding their use

4 Disclosures No financial conflicts to disclose Off label use (administration) of medications will be discussed Trade names included for clarity

5 Overdose Epidemic Since 1999 overdose deaths involving opioids have quadrupled 91 Americans die every day from an opioid overdose Americans consume 80% of world s opioid supply Addressing Prescription Drug Abuse in the United States Available from: Pain Physician 2007;10:

6 Epidemic in United States

7 Epidemic in United States

8 Epidemic in South Carolina 761 overdose deaths in 2015 Over 60% involved opioids

9 Epidemic in South Carolina

10 Reasons for Epidemic Thought to be multifactorial Increased availability of prescription medications Higher purity heroin and addition of other synthetics Lower cost Others Addressing Prescription Drug Abuse in the United States Available from: Pain Physician 2007;10: SAMHSA Opioid Overdose Toolkit Available from:

11 Risk Factors Opioid Overdose Risk Factors Route(s) of administration Higher dose Variable definitions Sedative-hypnotic co-prescription Benzodiazepines Multiple prescribers/pharmacies Psychiatric comorbidities Substance Use Disorder(s) J Addict Med. 10(6); 2016.

12 Risk Factors Opioid Overdose Risk Factors, cont. Discharge from facility requiring relative abstinence Hospital Jail Substance abuse treatment facility Others J Addict Med. 10(6); 2016.

13 Case CD is a 47 y/o male who presents to your hospital s Emergency Department for severe pain PMH includes: Chronic pain w/ multiple surgeries, anxiety and depression SCRIPTs report indicates he consistently fills Methadone 20 mg #90 (for 30 days) and Clonazepam 2 mg #90 (for 30 days)

14 Case Which of the following are risk factors that put CD at risk for intentional or unintentional overdose? A. High dose opioid B. Co-prescription with benzodiazepine C. Psychiatric Comorbidity D. All of the above

15 Strategies to Combat Epidemic Nationally, multiple strategies Prescription Drug Monitoring Program (PDMP) +/- mandatory use Doctor Shopping or Pharmacy Lock-In Prescription Drug Take Back Days Increasing access to treatment Good Samaritan Laws Take Home Naloxone

16 Harm Reduction Set of practical strategies and ideas aimed at reducing negative consequences associated with drug use Recognizes abstinence will not be achieved in every patient, all the time Recognizes use (licit or illicit) is always present Provides non-judgmental, non-coercive services Attempts to meet them where they are Variety of successful and novel strategies Principles of Harm Reduction Available from:

17 Good Samaritan Laws Protect those who choose to serve and tend to others who are injured or ill Commonly thought of regarding Cardiopulmonary Resuscitation Also involved in opioid overdoses Liability Criminal Civil Professional Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012

18 SC Overdose Prevention Overdose Prevention Act passed in June 2015 Protects prescribers and pharmacists from liability Criminal/civil/professional Requires education of non-healthcare professionals who administer naloxone

19 SC Overdose Prevention Amendment passed in June 2016 to create a Joint Protocol Allows pharmacists to dispense without a prescription Protocol approved in November

20 SC Joint Protocol

21 SC Joint Protocol

22 SC Joint Protocol

23 SC Joint Protocol

24 SC Joint Protocol

25 SC Joint Protocol

26 SC Joint Protocol

27 Case CD s wife informs the team that she is worried about her husband. Due to his pain, he occasionally overtakes his medication to be able to get some sleep. She mentions she saw a story about Narcan on the news and wonders if her husband should have this medication

28 Case According to SC law, which of the following are true regarding CD s ability to have naloxone? A. CD could only receive it if EMS arrived to address an overdose B. CD could only receive it by prescription from a physician or mid-level prescriber (PA, ANP) C. CD or his wife could either get a prescription or go to a local pharmacy to purchase D. CD or his wife could purchase over the counter, as it no longer requires a rx

29 Opioid Overdose Signs and symptoms Respiratory depression Stupor Miosis Decreased bowel sounds Treatment Reversal with naloxone Supportive care (oxygenation, etc.) New Engl J Med 2012;367:

30 Naloxone Potent Mu opioid receptor antagonist Antidote for opioid overdose Onset of action Minutes Half-life minutes Naloxone [Package Insert]. Lake Forest, IL. Hospira, Inc.;2007. Pharmacotherapy 2010;30(7):627-31

31 History of Take Home Use 1995 Distributed in Germany and England for individuals who used heroin Available over the counter in Italy 1999 Underground use in Chicago, then San Francisco (SF) Ann Emerg Med 2007;49:

32 History of Take Home Use 2001 SF Department of Health piloted opioid education and naloxone dispensing New Mexico becomes first to encourage physicians to prescribe for individuals who use heroin 2002-present Many states, including SC, pass laws to increase availability/use New formulations available Ann Emerg Med 2007;49:

33 Take Home Naloxone Kits Image available from:

34 Generic Naloxone Kits Intramuscular (IM) Injection Kit typically includes 2 naloxone vials (0.4 mg/ml) Syringe(s) +/- shield for rescue breathing Requires ability to assemble and administer Cost <$100 Rarely reimbursed by insurance

35 Generic Naloxone Kits Intranasal (IN) Spray Kit typically includes 2 naloxone prefilled syringes (2 mg/2 ml) Mucosal Atomizers (MADs) +/- shield for rescue breathing Requires ability to assemble and administer Generally easier than the injection Cost <$100 Rarely reimbursed by insurance MAD recall

36 Mucosal Atomizing Device J Emerg Med 2005;29:

37 Naloxone Auto-Injector Evzio (Naloxone HCl auto-injector) Typically dispensed with Two injectors for IM or subcutaneous use 0.4 mg vs. 2 mg One training device Intelligent device Simple administration May cost thousands of dollars EvzioTM [Package Insert]. Richmond, VA. Kaleo, Inc;2014.

38 Naloxone Nasal Spray Narcan (naloxone nasal spray) Typically dispensed with Two single-spray devices 2 mg vs 4 mg Simple administration, no preparation Cost can range from ~$75 to ~$200 Narcan Nasal Spray [Package Insert]. Radnor, PA. Adapt Pharmac, Inc;2015.

39 Comparison of Formulations Generic Naloxone Injection Intranasal Auto-injector Brand name intranasal

40 Case CD s wife believes she would like to pursue getting a naloxone kit to have at home

41 Case Which of the following would best help you determine which formulation to recommend? A. Insurance coverage B. Experience using nasal sprays C. Where it will be stored D. All of the above are equally important

42 Methods of Dispensing Needle exchange programs Prescription with opioid Pharmacist dispensing in Opioid Agonist Therapy Program States with open order Public funding vs. grant funding Others Community Based Opioid Overdose Prevention Programs Providing Naloxone CDC MMWR. February 17, Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012.

43 Methods of Dispensing Current practices OHIO project DAWN Massachusetts NOMAD Project North Carolina Project Lazarus New York SKOOP San Francisco DOPE Project Pittsburgh Prevention Point Pittsburgh Others Community Based Opioid Overdose Prevention Programs Providing Naloxone CDC MMWR. February 17, Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012.

44 Highlight Project Lazarus Wilkes County, NC Started in 2008 Community education Provider education Academic detailing Policy changes Quantity limits Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects Available from: Pain Medicine 2011;12:77-85

45 Highlight Project Lazarus Began naloxone distribution in 2010 Video and education at clinic Prescription filled for naloxone kit at pharmacy In Wilkes County Overdose death rates dropped 42% Prescriptions from the county responsible for fatal overdose decreased 82% in 2008 to 10% in 2010 Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects Available from: Pain Medicine 2011;12:77-85

46 Highlight DOPE Project Started in 2000 Rescue breathing, calling 911 and other prevention Began naloxone distribution in 2003 Standing orders Intranasal in 2010 Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012

47 Highlight DOPE Project As of June 2012 Over 3400 trained 5540 kits distributed 782 reported reversals Current access to naloxone Needle exchange sites Opioid maintenance programs Others Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012

48 Naloxone in South Carolina Currently no widespread, consistent dispensing Emergency Medical Personel

49 Barriers to Take Home Use Concerns for repercussions Liability Concerns for increasing use Concerns for withdrawal Hesitancy to dispense needles Ann Emerg Med 2007;49: Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012.

50 Barriers to Take Home Use Prescribing/administering medication to someone who it was not prescribed for Generic intranasal formulation is off-label Coverage for naloxone Insurance vs. government vs. patient/caregiver Ann Emerg Med 2007;49: Take-Home Naloxone for Opioid Overdose: Exploring the Legal, Policy, and Practice Landscapes Harm Reduction Coalition Webinar. October 18, 2012.

51 Case Based on insurance coverage and fear of needles, you work with CD s wife to have a Narcan Nasal Spray dispensed from your hospital s outpatient pharmacy

52 Case Which of the following are the most important counseling points to provide to CD s wife and CD? A. Do not give unless breathing has stopped B. Importance of calling 911 C. This kit should only be used on CD D. Be sure to prime the nasal spray before use

53 Future Directions Currently introduced legislation Good Samaritan Law Need for funding

54 Conclusions Take-home naloxone can be used as a tool to reduce deaths from our opioid overdose epidemic Pharmacist and Pharmacy Technicians should play a key role in increasing access to take home naloxone and other harm reduction strategies

55 Questions?