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Perhaps I also need to stress another aspect not related directly to patient safety. The 10 ml bottle of 100 mg/ml solution will often only have less than one ml used in a procedure and then the rest is discarded. We should routinely cut the top of the bottle off and discard the remaining solution witnessed by the nurse, before placing the bottle in the sharps bin. Ketamine does have a street value, so there is potential for the used bottle with 9 mls to be pocketed once it has been signed out from the Drugs Book. An individual could even search through a sharps bin for a partially used bottle of ketamine. If there was a problem with ketamine use in the community in the future we need the above system in place so that we can defend ourselves from any accusations! Hence this is another reason for the 100 mg/ml solution to be produced in a 2 ml glass vial! Ray McGlone Lancaster From: Accident and Emergency Academic List [mailto:[log in to unmask]] On Behalf Of Ray McGlone Sent: 13 March 2010 19:39 To: [log in to unmask] Subject: Re: Familiarity breeds contempt I have contacted the company but have had no response.... except what was the Lot number on the Bottle....... I would favour...." as the doctor normally uses only a fraction of the 10 ml (100 mg/ml conc) for i.m. use perhaps this could be produced in a 2 ml vial. Obviously more expensive for the company. But the multidose vial following NHS guidelines is only being used for one dose and then being discarded." Ray McGlone Lancaster From: Accident and Emergency Academic List [mailto:[log in to unmask]] On Behalf Of Robinson, Susan Sent: 13 March 2010 14:54 To: [log in to unmask] Subject: Re: Familiarity breeds contempt As Co-chairs on the CEM Patient Safety Subcommittee Ruth and I regularly meet with colleagues at the NPSA. I have contacted the head of medical specialties at the NPSA regarding Ketamine and the need for standardisation. Their medication team had a look at the reports they had received on this prior to the Channel 4 documentary (having been pre-warned) but as it is still causing concern she will present it at this coming weeks meeting for further discussion and action. Sue -----Original Message----- From: Accident and Emergency Academic List [mailto:[log in to unmask]] On Behalf Of Coats Tim - Professor of Emergency Medicine Sent: 10 March 2010 20:49 To: [log in to unmask] Subject: Re: Familiarity breeds contempt Several 'near miss' incidents in the early days of the London HEMS system led to a standardisation on one concentration of ketamine (10 mg / ml). It astounds me that with all the drug safety regulation that the MHRA has in place confusion through similar packaging is not regulated! Any root cause analysis would suggest that different concentrations of ketamine should be in containers that both looked and felt different (imagine a safety conscious industry such as aviation allowing this sort of potential confusion to continue - the CAA would be down on the manufacturer like a ton of bricks). The Medical Devices Agency are as bad as the MHRA when it comes to patient safety. Several years ago I reported an incident in which a central line was placed but the dilator was left in place and the iv infusion was connected to the dilator - which had a leur-lock type connection on it (but a tiny bore so little fluid could be infused). The child died of hypovolaemia. There is no reason for a dilator to have a Leur-lock so my suggestion was that the manufacturer be required to change the device. However the MDA's response was that this was a training issue for the doctors! Tim. Coats. _____ From: Accident and Emergency Academic List [mailto:[log in to unmask]] On Behalf Of Ray McGlone Sent: 06 March 2010 22:36 To: [log in to unmask] Subject: Re: Familiarity breeds contempt I managed to download the Paper from the European Journal of Emergency Medicine (enclosed). A 3 yr old had cement in his eye. The Spanish dept only stocked 50 mg/ml solution as suggested by Green in his Paper to prevent problems. "Some EDs that use primarily the intravenous route but occasionally administer ketamine intramuscularly might consider the 50-mg/mL concentration as suitable for both purposes." Nurse was instructed to give 45 mg ketamine i.m. but thought that it was 50 mg in 10 ml. So gave 9 mls of the solution i.m. (ouch!) Child got 450 mg. Had 5 episodes of airway manoeuvres / oxygen desaturation.... returned to normal state 20 hrs after At Lancaster we have added the volume to be injected as well as the dose on the dose chart. Ray McGlone Lancaster UK From: Accident and Emergency Academic List [mailto:[log in to unmask]] On Behalf Of Mark Nicol Sent: 06 March 2010 18:12 To: [log in to unmask] Subject: Re: Familiarity breeds contempt I agree with everything Ray has to say.In addition it may be worth noting the NPSA alert regarding inadvertent hi dose midazolam.has anyone suggested to NPSA that they should issue guidance to all trusts to ring fence the hi dose ketamine to maj incidnet cupboard... mark @macc _____ From: Ray McGlone <[log in to unmask]> To: [log in to unmask] Sent: Sat, 6 March, 2010 13:52:49 Subject: Familiarity breeds contempt The Hospital program on Channel 4 at 2100hrs on 7th April 2009 highlighted a recurring problem. Based at Coventry A&E it's theme was on the problem of alcohol and teenagers A teenager with orthopaedic injuries was accidently given a gram of ketamine iv on camera and she went into cardiac arrest. After prolonged CPR .... twice.... she made a good recovery weeks later. Illustrated the importance of checking on the strength of ketamine given to you. Doctor had given the 100 mg in 1 ml concentration accidently..... so gave 10 times the normal amount stat i.v.. At Lancaster we keep the 100 mg/ml in the Major Cupboard and the weaker 10 mg/kg for i.v. use in the resus cupboard. Prior to this Consultants had been offered the wrong concentration in the past by a nurse.... though it was the weaker concentration......and it was noted. A Case Report of inadvertent overdose was published in the European Journal of Emergency Medicine. See reference below. I had previously heard of a case in Manchester in 2002 whilst on an ATLS, "A woman received 10 times the amount of ketamine because the doctor didn't realise the concentration he was using was 100 mg/kg and not 10 mg/kg. It was being given IV. She was OK, but her operation was cancelled!" Our critical incident occurred recently. A locum who had worked in the Trust a few years ago did not familiarise himself with the Protocol again and gave x10 the normal i.m. dose (2.5 mg/kg) that we give in A&E because he thought the nurse was giving him the 10mg/ml solution. The volume given 3.2 ml was a large i.m. volume to give a small child and he realised then what he had done. The child needed supplemental oxygen and was admitted for observation but came to no harm. We intend to do a case report on this case. Departments that only give ketamine via the im or iv route can standardise on one strength of solution, BUT this would not get around the problem of locums working in different departments. To illustrate the point we had a similar case at Kendal over 5 years ago when a locum gave x5 the amount i.m. again the child simply slept off the dose. Whilst at the FCEM exams this week I heard of another case of a child given 10x the dose but as it was via the oral route the child simply slept it off. Again a mix up with the concentrations. Giving the wrong dose x10 via the iv route is obviously the one most likely to cause a problem. Enclosed is a Paper by Green detailing many cases of inadvertent medical overdose with ketamine. There are 2 possible solutions. The cheapest would be to clearly mark in RED that the 100 mg/ml dose is for i.m. use and the 10 mg/ml dose is for i.v. use. Not sure of the need for 50 mg/ml dose. Alternatively as the doctor normally uses only a fraction of the 10 ml (100 mg/ml conc) for i.m. use perhaps this could be produced in a 2 ml vial. Obviously more expensive for the company. But the multidose vial following NHS guidelines is only being used for one dose and then being discarded. One can never rule out human error, but as getting the concentration strength mixed up seems to be a regular critical incident perhaps we need a solution. I suspect there are many cases occurring around the UK, but not being reported. Ketamine is a safe drug even when such a mishap occurs, but sooner or later there could be a fatality. The case at Coventry was a near miss. I would be interested of hearing about any cases you might have come across so that I can quote more evidence to the company. You can contact me confidentially on [log in to unmask] Regards Dr Ray McGlone Prolonged sedation and airway complications after administration of an inadvertent ketamine overdose in emergency department. Capape S. Mora E. Mintegui S. Garcia S. Santiago M. Benito J. European Journal of Emergency Medicine. 15(2):92-4, 2008 Apr. [Case Reports. Journal Article] UI: 18446071 Authors Full Name Capape, Susana. Mora, Elena. Mintegui, Santiago. Garcia, Silvia. Santiago, Mikel. Benito, Javier. AB The use of ketamine for pediatric sedation in the Emergency Department for painful procedures has become increasingly popular. Ketamine is a safe and effective sedative for diagnostic or therapeutic procedures in the Emergency Department. Sedation with this dissociative agent produces a rapid onset action, potent analgesia, adequate sedation, amnesia and minimal side effects. We report a case of prolonged sedation and airway complications after administration of an inadvertent intramuscular ketamine overdose in a healthy child. This e-mail, including any attached files, may contain confidential and / or privileged information and is intended for the exclusive use of the addressee(s) printed above. If you are not the addressee(s), any unauthorised review, disclosure, reproduction, other dissemination or use of this e-mail, or taking of any action in reliance upon the information contained herein, is strictly prohibited. If this e-mail has been sent to you in error, please return to the sender. 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