Opioid education programs and nasal naloxone rescue kits

Transcription

1 Opioid education programs and nasal naloxone rescue kits Arne Skulberg PhD student NTNU Consultant Anaesthetist, Oslo

2 Epidemiology Europe 2

3 Epidemiology US 200 % increase in opioid overdoses since Now at 9.0: deaths Prescription opioids and heroin are main culprits. Actions needed (CDC): Safer prescribing of opioid pain relievers Expanding availability and access to naloxone Increasing access to medicationassisted treatment in combination with behavioural therapies, 3

4 Harm reduction Interventions that seek to reduce the health, social and economic harms of drug use to the individual, communities and society. A pragmatic response to drug use to reduce health- related harm. Basis in both public health and the field of human rights Traditional measures: Needle exchange, safe injection rooms, opioid substitution therapy, 4

5 International shift WHO 2014: People likely to witness an opioid overdose should have access to naloxone and be instructed in its administration to enable them to use it for the emergency management of suspected opioid overdose EMCDDA 2015: Training in responding to overdoses, including the distribution of the opioid antagonist drug naloxone, can save lives in overdose situations. UN 2016: Promote the prevention and treatment of drug overdose, in particular opioid overdose, including the use of opioid receptor antagonists such as naloxone to reduce drug-related mortality. 5

6 Overdose risk factors Male Single Unemployed History of heroin dependence Not being in treatment for heroin dependence Using intravenously Alcohol or benzodiazepines. At autopsy a large proportion of overdose fatalities have relatively low blood morphine concentration Reasons: Loss of tolerance Drug interactions Systemic dysfunction Drug purity Injecting alone 6

7 Aim of education and naloxone programs Reduce overdoses with education about risk factors for-, recognition of-, first aid and administration of safe and effective antidote. 7

8 Basics in most programs What is an overdose? Recognise signs Know risk factors What is naloxone How to administer naloxone IN or IM First aid/ rescue breathing 8

9 Example programs of take home naloxone First example is Chicago/ Cook County in as an activist project. This was formalised in 2001 Estonia- extremely high overdose problem, mainly fentanyl. Naloxone distribution started Germany: 1999 Spain: Underground since 1999 Norway: State initiated naloxone distribution as part of national overdose strategy UK: National programs in Scotland and Wales 9

10 Nasal naloxone Easy and quick access Administered with minimal training Reduced risk of blood exposure Bypass hepatic 1 st pass metabolism Must have high concentration and low volume! (max 0.2 ml/nostril) 10

11 Compare formulations Producer Route Concentration Dose/ volume Device Bioavailability IN/IM T max (min) NTNU (research) IN 8 mg/ml 0.8 mg/ 0.1 ml Unitdose 75% 28 AntiOp (research) IN 1 mg/ml 2 mg/ 2 ml MAD 10% 16.2 Narcan Nasal (commercial) IN 40 mg/ml 4 mg/ 0.1 ml Unitdose 47% 30 PatentScope, World Intellectual Property Organization (WIPO) WO/2015/ (AntiOp Inc.) Highlights of prescribing information Narcan Nasal spray. 11

12 What IN naloxone to use? First approved IN naloxone (FDA) November 2015 Narcan nasal 4 mg (0,1 ml naloxone hydrochloride 40 mg/ml) There is widespread use of dilute naloxone formulation with high volumes- off label No pharmacokinetic in peer reviewed literature we have a responsibility to be confident that the non-injectable form is absorbed equivalently or to a sufficient extent so as to produce the life-saving reversal of opioid effect. Strang J 12

13 Obstacles to take home naloxone Legal Naloxone is on prescription only Standing orders/ prescription Fear of malpractice litigation Good Samaritan Act Safety Concerns regarding IN formulation- reintoxication? Does it reduce 112/ 911 calls? Changing many places Does it increase risk behaviour? 13

14 Way forward Proper IN formulations- with marketing authorisation for human use. More research on naloxone formulations in the public domain Systems for over-the-counter/ legal distribution of naloxone Education programs for recreational/ street- drug users and their peers Reduce opioid prescription, particularly in the US 14

15 References Rudd, R.A., et al., Increases in Drug and Opioid Overdose Deaths - United States, MMWR Morb Mortal Wkly Rep, (50-51): p Harm reduction: evidence, impacts and challenges, EMCDDA, Lisbon, April 2010 European Drug Report 2015: Trends and Developments, EMCDDA, Lisbon, June 2015 United Nations Economic and Social Council Commission on Narcotic Drugs E/CN.7/2016/L.12/Rev.1* EMCDDA: Preventing opioid overdose deaths with take-home naloxone, Insight 20, 2016 Warner-Smith, M., et al., Heroin overdose: causes and consequences. Addiction, (8): p Wheeler E, Burk K, McQuie H, Stancliff S. Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects. Harm Reduction Coalition, Unpublished data: Skulberg, AK. Strang J, McDonald R, Tas B, Day E. Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures? Addiction. 2016;111(4): PatentScope, World Intellectual Property Organization (WIPO) WO/2015/ (AntiOp Inc.) 15

16 Thank you EAPCCT Prof. Ola Dale- NTNU Dr. Fridtjof Heyerdahl Ida Tylleskar Declaration of interest: My employer Norwegian University of Science and Technology have a cooperation and licence agreement with Den Norske Eterfabrikk to seek commercialization of a nasal naloxone formulation developed by Ola Dale 16