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Memo – shortage of supply
To:
From:
Date:
Re: Ketamine (Ketalar®) injection (all strengths)
Description of product affected
Each ampoule contains 10, 50 or 100mg of ketamine hydrochloride per ml.1
Background
Ketamine injection is licensed for:1
· use as an anaesthetic agent for diagnostic and surgical procedures.
· induction of anaesthesia prior to administration of other general anaesthetic agents.
· supplementation of other anaesthetic agents.
· use in specific types of procedures application or specific areas of application (see SPC for further details)
Why we are providing this information
Pfizer, as the sole licensed supplier, is currently experiencing supply problems of Ketalar 10mg/ml, 50mg/ml and 100mg/ml presentations in the UK. The 10mg/ml and 100 mg/ml strengths are anticipated to be out of stock until March 2015. Current stock of the 50 mg/ml strength is anticipated to be exhausted during May 2014.2 Pfizer are however working to ensure that further supplies of this strength are made available as soon as possible.
Implications for patient care
Ketamine is mainly used for paediatric anaesthesia.3 Occasionally it is used in theatres for poor-risk patients with depression of vital functions or where depression of vital functions must be avoided; and in the asthmatic patient to minimise the risks of bronchospasm. It has also been used off-label for the treatment of chronic pain refractory to standard therapies.4 In these situations, practitioners are of the opinion that alternative treatment options are limited.
Management options
In the absence of a suitable alternative in certain scenarios, supplies of unlicensed product are available via pharmaceutical importers.
However it is important to note that there are potential patient safety issues associated with the imported products as follows:
· Imported Ketalar® (same brand name and packaging) from Australia contains ketamine 200mg in 2ml (i.e. the strength is between 1 and 20 times higher than the licensed versions used in the UK).
· The ketamine used in the UK is a racemic mixture of two enantiomers. There is potential that imported versions will be S-ketamine which is about twice as potent as the original product and thus doses should be halved.
· European-sourced ketamine injection may be available at the same concentrations as used in the UK but the volumes of presentation may differ.
Trusts are advised to check carefully which version of the product they receive and that communication of the relevant issues outlined above to departments (especially theatres) and practitioners is critical so that patients are not exposed to inadvertent overdoses of the drug.
References
1. Pfizer Ltd. Ketalar Injection. SPCs (all strengths); data of revision: 01/2014
2. Pfizer Ltd. Ketalar injection supply notification. Healthcare professional communication, May 2014.
3. BNF 66 (September 2013 – March 2014): Drugs used for intravenous anaesthesia
4. Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol 2014; 77: 357–367
Acknowledgements
· Ruth Wan, Perioperative, Critical care and Pain Specialist pharmacist, Guy’s and St Thomas’ Hospital NHS Foundation Trust
· Sara Arenas-Lopez, Consultant Pharmacist-Paediatric Critical Care. Evelina London Children’s Hospital
· Will Berry. Critical care pharmacist. Guy’s and St Thomas’ Hospital NHS Foundation Trust
· Steve Wanklyn, Consultant Pharmacist for Palliative & End of Life Care, Guy’s and St Thomas’ Hospital NHS Foundation Trust
Original document prepared by:
Guy’s and St Thomas’ NHS Foundation Trust Medicines Information Centre
Prepared 16 May 2014
Document modified by:
Name of individual at other centre using the product with modifications, centre, date
For all correspondence please contact:
Name of person at base hospital where memo is circulated (i.e. NOT the original author at Guy’s and St Thomas’ NHS Foundation Trust
Disclaimer: The content of some of this memo is based on consensus opinion from clinical practitioners. Users should bear this in mind in deciding whether to base their policy on this document. Individual trusts should ensure that procedures for unlicensed medicines are followed where a foreign import drug is required in the interim.