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Chair and Members Rome, 23 May 2014 WHO Expert Committee on Drug Dependence (ECDD) Geneva Switzerland Dear ECDD Chair and Members, Ketamine in Italy Ketamine is not the only or the most commonly adopted anaesthetic in Italy in OR for elective surgical procedure, but many of those answering to a “call for opinion”, declared that they consider Ketamine a safe drug, adopted for many reasons in delivering safe surgery and analgosedation (included in ICU, Emergency Department, for NORA and for out of hospital procedures), including it’s adoption by emergency providers not specialized (OutofH emergency team). Some of them (ED Chair or front line physician) declared that some time ago there was a shortage of Ketamine, solved by acquiring through Swiss or Vatican Pharmacy. We don’t have certain and homogeneous data for consumption but you can consider about 450.000/yr ampules confirmed for the following indications: RSI in ICU, Out of hospital and ED patients * severe hypovolaemia, dehydration, acute haemorrhage anaemia, shock and cardiovascular instability trapped casualties, maxiemergency and disaster care ** burned patients at low dose for analgesia and sedation, in emergency setting or in OR or during procedural pain in ED, ICU, Radiology (percutaneous tracheotomy, debridement and skin grafting, dressing changes, liver oncologic hyperthermic procedure…) useful combined with midazolam (ketazolam) o propofol (ketofol) in adjunct to local or regional anaesthesia; as upplement for inadequate block Respiratory failure or COPD with bronchospasm, intractable bronchial asthma*** Difficult Airway Management, awake intubation, risk for respiratory depression (OSA, obese patients), procedural endoscopies… Major thoracoabdominal procedures Cardiac tamponade and constrictive pericarditis Paediatric anaesthesia, cannulation, central lines Obstetric patients and transient analgesia at the time of delivery Postoperative analgesia in adjunct with morphine PCA Aged and poor risk patients Outpatient surgery and NORA for diagnostic and therapeutic
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Chair  and  Members                             Rome,  23  May  2014  

 WHO  Expert  Committee  on  Drug  Dependence  (ECDD)  Geneva  Switzerland    Dear  ECDD  Chair  and  Members,    Ketamine  in  Italy  Ketamine   is   not   the   only   or   the   most   commonly   adopted  anaesthetic  in  Italy  in  OR  for  elective  surgical  procedure,  but  many  of   those   answering   to   a   “call   for   opinion”,   declared   that   they  consider   Ketamine   a   safe   drug,   adopted   for   many   reasons   in  delivering   safe   surgery   and   analgo-­‐sedation   (included     in   ICU,  Emergency   Department,   for   NORA   and   for   out   of   hospital  procedures),   including   it’s   adoption   by   emergency   providers   not  specialized  (Out-­‐of-­‐H  emergency  team).  Some   of   them   (ED   Chair   or   front   line   physician)   declared   that  some   time   ago   there   was   a   shortage   of   Ketamine,   solved   by  acquiring  through  Swiss  or  Vatican  Pharmacy.  We   don’t   have   certain   and   homogeneous   data   for   consumption  but  you  can  consider  about  450.000/yr  ampules  confirmed  for  the  following  indications:  

• RSI  in  ICU,  Out  of  hospital  and  ED  patients  *  • severe  hypovolaemia,  dehydration,  acute  haemorrhage  anaemia,  

shock  and  cardiovascular  instability    • trapped  casualties,  maxiemergency  and  disaster  care  **  • burned  patients    • at  low  dose  for  analgesia  and  sedation,  in  emergency  setting  or  in  OR    

or   during   procedural   pain   in   ED,   ICU,   Radiology   (percutaneous  tracheotomy,  debridement  and  skin  grafting,  dressing  changes,   liver  oncologic   hyperthermic   procedure…)   –   useful   combined   with  midazolam  (ketazolam)  o  propofol  (ketofol)  

• in  adjunct  to  local  or  regional  anaesthesia;  as  upplement  for  inadequate  block  

• Respiratory  failure  or  COPD  with  bronchospasm,  intractable  bronchial  asthma***    

• Difficult  Airway  Management,  awake  intubation, risk  for  respiratory  depression  (OSA,  obese  patients),  procedural  endoscopies…  

• Major  thoracoabdominal  procedures  • Cardiac  tamponade  and  constrictive  pericarditis  • Paediatric  anaesthesia,  cannulation,  central  lines  • Obstetric  patients  and  transient  analgesia  at  the  time  of  delivery  • Postoperative  analgesia  in  adjunct  with  morphine  PCA  • Aged  and  poor  risk  patients    • Outpatient  surgery  and  NORA  for  diagnostic  and  therapeutic    

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         • procedures  and  Recovery  Room  • It’s   anti-­‐NMDA  mechanism  make   it   consider  by  pain   specialists   too.  

for   complex   pain   treatment   and   chronic   pain   prevention,  tachiphilaxis  and  opioid  rotation****  

• Even  if  ketamine  has  been  contraindicated  in  patients  with  increased  ICP,   reports   of   neuroprotective   and   even   neuroregenerative   effects  have  generated  adoption  in  such  patients.    *   Intubation   care   in   ICU:   “bundle   management”   (ketamine   1.5–3   mg/kg  combined   with   succinylcholine     or   rocuronium)   -­‐   S.Jaber   et   al.   Intensive  Care  Med  (2010)  36:248–255  

**  Anesthetic  practice  in  Haiti  after  the  2010  earthquake.  Anesth  Analg.  2010  Dec;111(6):1445-­‐9.  doi:  10.1213/ANE.0b013e3181fa3241.  Epub  2010  Oct  1.  Rice  MJ1,  Gwertzman  A,  Finley  T,  Morey  TE.  Earthquake  injuries  and  the  use  of  ketamine  for  surgical  procedures:  the  Kashmir  experience.  Mulvey  JM,  Qadri  AA,  Maqsood  MA.  Anaesth  Intensive  Care.  2006  Aug;34(4):489-­‐94.  Anaesthesia  in  a  disaster  zone:  a  report  on  the  experience  of  an  Australian  medical  team  in  Banda  Aceh  following  the  'Boxing  Day  Tsunami'.  Paix  BR,  Capps  R,  Neumeister  G,  Semple  T.  Anaesth  Intensive  Care.  2005  Oct;33(5):629-­‐34.  ***   S-­‐Ketamine   0.5   –   1   mg/kg   i.v.   has   been   included   as   further   action   in  “Severe  Broncospasm”   by  ESA  Pocket   Safe  Alghorithm  2013   -­‐  Sven   Staender  (CH)  Andrew   Fairley-­‐Smith   (UK)  Guttorm   Bratteboe   (Norway)  David  Whitaker   (UK)  and  Jannicke  Mellin-­‐Olsen   (Norway;  ESA  board  member)  and  David  Borshoff  (Australia;  non  Task  Force  member)  ****  Pain  management  in  the  wilderness  and  operational  setting.  Wedmore  IS,   Johnson   T,   Czarnik   J,   Hendrix   S.   Emerg   Med   Clin   North   Am.   2005  May;23(2):585-­‐601,  xi-­‐xii.  Review  S+   -­‐ketamine   for   control   of   perioperative   pain   and   prevention   of   post  thoracotomy   pain   syndrome:   a   randomized,   double-­‐blind   study.   Mendola   C,  Cammarota  G,  Netto  R,  Cecci  G,  Pisterna  A,  Ferrante  D,  Casadio  C,  Della  Corte  F.  Minerva  Anestesiol.  2012  Jul;78(7):757-­‐66.  Epub  2012  Mar  22.    As   already   I  wrote   you   in  my   previous   letter,   I   can   confirm   that  Ketamine   unavailability   would   be   surely   dangerous   for   many  Italian   anaesthesiologists   and   ED   providers   in   our   Country:   any  effort  should  be  done  to  avoid  it.  Yours  faithfully,  

 Prof.  Massimo  Antonelli,  MD  President   of   the   Italian   Society   of   Anesthesiology,   Analgesia   and  Intensive  Care  Medicine    (SIAARTI)  cc.      Prof.   Daniela   Filipescu,   President,   European   Society   of   Anaesthesiolgy   (ESA),  [email protected],   Dr   David   Wilkinson,   President,   World   Federation   of  Societies   of   Anaesthesiologists   (WFSA),     [email protected];   Dr   Meena   Cherian,  WHO   Global   Initiative   for   Emergency   and   Essential   Surgical   Care   (GIEESC)  [email protected]      

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JAPANESE SOCIETY OF ANESTHESIOLOGISTS Kobe Kimek Center Building 3F, Minami machi 1-5-2,

Minatojima, Chuo ward, Kobe city, Japan

Dear ECDD Chair and Members,

We, the Japanese Society of Anesthesiologists, ask you to help ensure the safety,

quality and availability of anesthetic and surgical care around the world.

As you know, ketamine is one of the most commonly used anesthetic agents

globally. However, United Nations’ Commission on Narcotic Drugs recently called

for the imposition of stricter and more rigorous import and export controls on

ketamine. In many low and middle-income countries, ketamine is the only

available anesthetic agent. For WHO Level 1 hospitals, ketamine is the only

anesthetic on the WHO essential medicine list. We also use ketamine in Japan as

an indispensable anesthetic agent for induction of shock patients, for sedation of

excited pediatric patients, and for analgesia of somatic pain during ambulatory

treatment.

Whilst we recognize the concern that some countries have over the increasing

abuse of ketamine as a recreational drug, any decrease in availability of

ketamine would have catastrophic effects and, in many countries, force

anesthesia and surgery back to unsafe practices from past centuries. This would

be disastrous for patients, surgeons and anesthesia providers in countries where

ketamine is the most common – and sometimes only – anesthetic available.

We thus caution against attempts to restrict the availability of ketamine and

urge the WHO to take immediate and strong action to ensure unimpeded access

to ketamine for anesthesia and surgical use.

Yours faithfully,

President

Japanese Society of Anesthesiologists

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Rwanda Society

of Anaesthesiologists®

MAY2014

Email:[email protected];[email protected]:(+250)788512516:(+250)785387852Website:rsa‐online.org

ChairandMembers

WHOExpertCommitteeonDrugDependence(ECDD)

Geneva,Switzerland

DearECDDChairandMembers,

We,theRwandaSocietyofAnesthesiologists,urgeyoutohelpensurethesafety,qualityandavailabilityofanaestheticandsurgicalcarearoundtheworld.

Asyouknow,Ketamineisoneofthemostcommonlyusedanaestheticagentsglobally.InmanyLowandMiddleIncomeCountriesitistheonlyavailableanaestheticagent.ForWHOLevel1hospitalsitistheonlyanaestheticontheWHOEssentialMedicinesList.Itisdefinitelythemostaffordableandsuitableagentusedforbothemergenciesandelectivesurgerycountrywide.

TheUnitedNations’ Commission onNarcoticDrugs recently called for the impositionof stricterandmorerigorousimportandexportcontrolsonKetamine.WhilstwerecognisetheconcernthatsomecountrieshaveovertheincreasingabuseofKetamineasarecreationaldrug,anydecreaseinavailability of the drug for anaesthesia usage would have catastrophic effects and, in manycountries, forceanaesthesiaandsurgerybacktounsafepractices frompastcenturies.Thiswouldbedisastrousforpatients,surgeonsandanaesthesiaprovidersincountrieswhereKetamineisthemostcommon–andsometimesonly–anaestheticavailable.

We caution against attempts to restrict the availability of Ketamine and urge theWHO to takeimmediateandstrongactiontoensureunimpededaccesstoKetamineforanaesthesiaandsurgicaluse.

Yoursfaithfully,

Dr  Jeanne d’Arc UWAMBAZIMANA 

President, Rwanda Society of Anesthesiologists 

CC: ‐ Dr Meena Cherian, WHO Global Initiative for Emergency and Essential Surgical Care(GIEESC)

‐ DrDavidWilkinson,President,WorldFederationofSocietiesofAnaesthesiologists(WFSA)

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