Why must ketamine not become a scheduled drug Dr Jannicke Mellin-Olsen Bærum Hospital, Norway Jannicke@mellin. no With input from Haydn Perndt, Jason Nickerson and Susilo Chandra 1
Conflict of interest: • Nothing that involves money • Past president European Board of Anaesthesiology/UEMS • Secretary European Society of Anaesthesiology • President-Elect World Federation Society of Anaesthesiologists 2
Presentation overview • Ketamine is an essential medicine, especially in LMICs • The alternatives to Ketamine • Is it possible to ensure the availability of ketamine for medical use if scheduled? Lessons learned. • Conclusions and Recommendations 3
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WHA - May 2015 Historic moment for the WHO Emergency and Essential Surgical Care Program: The 68 th WHA passes the resolution A 68/15 on Strengthening Emergency and Essential Surgical Care and Anaesthesia as a Component of Universal Health Coverage 5
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International Drug Control System
Administration of Treaties Nickerson et al. (2016). Can J Anesth (accepted)
A Brief History of Ketamine and International Drug Controls • 2004: INCB first encourages the international community to consider initiating scheduling procedure • 2006, 2012, 2014, 2015: Expert Committee on Drug Dependence reviews ketamine and recommends against international controls • March 2014: Thailand proposes a resolution at CND calling for states to pursue national scheduling (resolution passed) • To be continued
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12 countries excluded for providing data for <4 facilities 22 countries, 590 facilities surveyed 11
Daniel Vo et al. , J Anesth Clin Res 2012, 3: 4 http: //dx. doi. org/10. 4172/2155 -6148. 1000207 12
Daniel Vo et al. , J Anesth Clin Res 2012, 3: 4 http: //dx. doi. org/10. 4172/2155 -6148. 1000207 13
Daniel Vo et al. , J Anesth Clin Res 2012, 3: 4 | http: //dx. doi. org/10. 4172/2155 -6148. 1000207 14
Daniel Vo et al. , J Anesth Clin Res 2012, 3: 4 http: //dx. doi. org/10. 4172/2155 -6148. 1000207 15
Ketamine is also on the WFSA list at ALL levels of health care facility (health centre, district hospital, referral hospital) 16
All these societies of anaesthesiologists, have written to the ECDD, to ask that no further restriction be placed on Ketamine. The WFSA alone includes 123 member societies who represent anaesthesiologists from over 140 countries. 17
Emergency Care in LMICs Médecins Sans Frontières: Ketamine used for • 90 % of C-Sections • 95 % of procedures in Trauma centres (mainly minor wound surgery) Ketamine remains essential The alternatives are limited 18
Anaesthesia in Sub Saharan Africa Examples by Dr. Haydn Perndt, Australia 19
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Burundi facts and figures • Population 10. 1 million (23. 1) • 45% under 15 (19%) • Life expectancy 52/56 years (80/84) • Infant mortality 55/1000 (4) • Maternal mortality 740/100, 000 (6) • Fertility rate 6. 1 (1. 9) World Bank Data: http: //data. worldbank. org/ 22
Health facts and figures • Health expenditure $20 per capita/annum ($6140) • 4 doctors per 100, 000 (320) • 190 hospital beds per 100, 000 (390) • 60% births attended by skilled personnel (>99%) 23
Kinyinya Case load • 40% O &G • Caesareans, ruptured uterus, retained placenta, • 25% Trauma • Fractures, wound debridement • 25% Infection and Neglect • Abscess, burns, osteomyelitis • 10% Elective • Hernia repair, hysterectomy 24
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A selection of cases…. How would you do them? 26
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Emergency Caesarean Section 39
Veranda Anaesthesia No suction, oxygen or Trendelenburg 40
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Burn Debridement 42
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The Elective Hernia Repair 45
Neonatal Surgery 46
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PYNE GOULD BUILDING 48
PATIENT 3 • 53 years • Financial Planner • Trapped both knees in rear stairwell • In pain • Non extractable 49
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Is it possible to ensure the availability of Ketamine for medical use if labelled as a controlled drug? The example of morphine: 52
One of the fundamental objectives of the international drug control treaties is to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to promote the rational use of narcotic drugs and psychotropic substances. Most national laws were found not to contain measures that ensured adequate provision of opioid drugs for medical and scientific purposes. Moreover, the model legislation provided by the United Nations Office on Drugs and Crime did not establish an obligation on national governments to ensure the availability of these drugs for medical use. Bulletin World Health Organisation 2014; 92: 108– 116 53
From International Recommendation to National Legislation “Although the Single Convention and interpretations of the Convention made by competent international authorities are clear about national governments’ obligation to ensure that opioid drugs are available for medical and scientific purposes, balanced legal provisions were scarce among national laws. Less than half the countries we studied had laws that acknowledged an intention to implement international drug conventions. Even fewer acknowledged responsibility for ensuring drug availability” Examined Data from 15 countries: Armenia, Australia, Georgia, India, Jamaica, Jordan, Kenya, Nepal, Nigeria, Philippines, Serbia, Sierra Leone, Uganda, United States, Vietnam Bull World Health Organ 2014; 92: 108– 116 54
Any legislation regarding Ketamine must consider the effects before it is enacted. Any such recommendation must be based on complete data and on a sufficient number, depth and quality of trials or pilot studies to consider access and availability for medicinal purposes. 55
Access to essential medicines that are controlled under the UN conventions is often limited, especially in LICs. Access to morphine for pain treatment has increased over the past two decades - but only in a small number of countries. 2003: 6 HIC accounted for 79% of the total global morphine consumption LIC, representing 80% of the world's population, accounted for just 6%. Medicines: access to controlled medicines (narcotic and psychotropic substances) WHO Fact sheet N° 336 June 2010 56
Morphine – the India experience “In November, 1985, India enacted the Narcotic Drugs and Psychotropic Substances Act. . The resulting string of procedures to acquire opioids and narcotics for scientific or medicinal purposes is dizzyingly complex: up to six licenses are required for every consignment of morphine. Many hospitals and medical schools have reacted by simply not stocking morphine. Most manufacturers, which are subject to the same legal restrictions, in turn have stopped producing it, and over the years, since the N. D. P. S. Act came into force, treatment for acute pain in India has greatly diminished. Data from the International Narcotics Control Board and World Health Organization shows that medicinal use of morphine dropped by ninety-seven per cent in the country after the law was enacted, from seven hundred kilograms in 1985 to a low of eighteen kilograms in 1997. ” The New Yorker, December 2013 57
On Ensuring Access • Overwhelmingly, emphasis has been on restricting the production, supply and use of drugs, rather than promoting rational use of medicines (in most countries) “equal emphasis has not been placed on the other fundamental objective of the treaties of ensuring that [licit] controlled substances are available for medical and scientific purposes” Hamid Ghodse President of INCB, 2011
Anna Badkhen, San Francisco Chronicle Published 4: 00 am, Saturday, May 17, 2003 59
International Medical and Veterinary Community’s Response
Indonesia Brazil Colombia Australia
USA Australia Italy Canada
Petrozavodsk, Russia, Oct 16 th, 3015 64
Ketamine – new uses Ketamine and Preemptive Analgesia Ketamine and Neurosurgery Ketamine in major depressive illness Ketamine to prevent opioid-induced acute tolerance • Ketamine and postoperative pain • PSA • Local anesthetic • • Susilo Chandra, Indonesia 65
Pre-emptive analgesia • NMDA receptors seem to be responsible for pain memory • At small doses (0. 1 -0. 5 mg/kg) --> preemptive analgesia. • NMDA antagonists prevent the induction of central sensitization and even abolish hypersensitivity once it is established • • Ketamine is the only NMDA antagonist approved by the USFDA 66
Ketamine and ICP Ketamine decreases intracranial pressure and electroencephalographic activity in traumatic brain injury patients during propofol sedation. Albanèse J 1, Arnaud S, Rey M, Thomachot L, Alliez B, Martin C. Anesthesiology. 1997 Dec; 87(6): 1328 -34. 67
Ketamine and neurosurgery The ketamine effect on ICP in traumatic brain injury. Zeiler FA, Teitelbaum J, West M, Gillman LM Neurocrit Care. 2014 Aug; 21(1): 163 -73. • Meta-analysis • Ketamine does not increase ICP in severe TBI patients that are sedated and ventilated, and in fact may lower it in selected cases. 68
Major depressive illness 69
Prevent opioid-induced acute tolerance 70
Post-operative Pain • Postoperative • Neuropathic • Inflammatory • Ischemic limb • Myofascial • Procedure-related 71
Ketofol • Ketamine and Propofol Mixture for Procedural Sedation and Analgesia • Has been used with great success in anesthesia, and begun to spread into other fields of medicine • Preserve sedation efficacy while minimizing adverse events • More stable hemodynamic and respiratory profile 72
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Local Anaesthetic Action of Ketamine • Mechanism of action : Need more evidence in humans • Ketamine : • Blocking the opening of Na Channels in peripheral nerve cell’s membrane, which will inhibit depolarize • etamine works at NMDA receptors on peripheral nerve as non competitive NMDA antagonist • Several studies reported the successful of using ketamine as Local Anesthetics agents 74
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Ketamine in Neonates 76
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A Brief History of Ketamine and International Drug Controls • 2004: INCB first encourages the international community to consider initiating scheduling procedure • 2006, 2012, 2014, 2015: Expert Committee on Drug Dependence reviews ketamine and recommends against international controls • March 2014: Thailand proposes a resolution at CND calling for states to pursue national scheduling (resolution passed) • (later in) 2014: China notifies UN of its intention to recommend ketamine be placed in Schedule I of 1971 Convention on Psychotropic Substances • March 2015: China changes its proposal to Schedule IV of 1971 Convention • (later in) March 2015: China proposes a deferral of its scheduling proposal to a later date • March 2016: Ketamine not on CND agenda for scheduling decision, but discussed. China again proposes a deferral.
Conclusions & Recommendations • Very good evidence of the reliance upon Ketamine as safe anaesthetic medicine, particularly in LMICs. • Past experience indicates that further restriction on essential medicines can and does limit availability for medical purposes. • Any decision to further restrict Ketamine is premature at the very least, and - more alarmingly - a potential risk to large numbers of patients around the world. Therefore: • Any legislation regarding Ketamine must consider the effects before it is enacted. • Such recommendation must be based on valuable trials that provide evidence to consider access and availability for medicinal purposes. 80
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