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Prefilled syringes, Patient Safety and total intravenous anaesthesia (TIVA) Guidelines for safe practice.

Last post 11 Dec 2018, 10:02 PM by Alastair Nimmo. 1 replies.
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  •  25 Nov 2018, 8:28 PM 2695

    Prefilled syringes, Patient Safety and total intravenous anaesthesia (TIVA) Guidelines for safe practice.

     I wish to congratulate the authors for the useful information contained within the recent Association of Anaesthetist's guidelines for the safe practice of total intravenous anaesthesia [1]. I was surprised, however, to see that these guidelines are not 'state of the art' for safe practice. In particular, they identified syringe labelling, accuracy of drug concentration and infection risks as important safety issues and also say “robust mechanisms should be in place to minimise the risk of drug error” but then failed to mention the one strong systemic protective barrier to all of these, the use of prefilled syringes.These were the strong systemic barrier referred to by NHS England in their Revised Never Events Policy and Framework in 2015 [2]; surely in 2018, a key recommendation must be, therefore, that ‘when administering TIVA, prefilled syringes should be used whenever possible’.

    Propofol is one of the anaesthetic drugs for which infections have been reported and have caused patient deaths [3]. Compared to 6.3% of all medications drawn up in operating theatres being contaminated with microorganisms [4] (particularly when multiple ampoules and diluents are used), syringes drawn up in a clean room are likely to remain uncontaminated. The 2018 Royal Pharmaceutical Society consultation to revise their Professional Guidance on the Safe and Secure Handling of Medicines highlighted a fundamental safety principle that “manipulation of medicines in clinical areas should be minimised” and there therefore seems an incontrovertible argument for adopting the strong systemic barrier of prefilled syringes. It is as if many of the TIVA enthusiasts have developed the technique in a very unbalanced way concentrating on expensive high tech syringe drivers and sophisticated pharmacokinetic models whilst illogically overlooking simple implementations to reduce total patient harm from the whole TIVA system. Inhalational anaesthesia long ago introduced the strong systemic barrier of keyed/funnel filling systems on vaporisers to stop the wrong agent being used. The opportunity was also missed to say we should be working towards only using syringe drivers that recognise the syringe contents by barcode or other technology.

    Apart from remifentanil, most of the other opiates used for TIVA have been available in 50ml prefilled syringes for many years [5] and, when caring for patients undergoing TIVA for over 20 years, I have always used prefilled syringes of propofol. As acknowledged leaders in patient safety elsewhere, anaesthesia should be embarrassed at best on continuing to neglect established measures of injectable medication safety, when they are already much more widely used throughout the rest of medicine, heparin, vaccines etc.

    The WHO 3rd Global Patient Safety Challenge, which aims to reduce iatrogenic medication related harm by 50% in 5 years, calls upon all stakeholders to ensure that already known safety measures are fully implemented as a first step [6]. All the worthy organisations involved therefore have a responsibility to amend this oversight of not recommending prefilled syringes as soon as possible to stop them appearing out of date and to make this document truly guidelines for safe practice.

    D. K. Whitaker

    Manchester, UK.

    Email whitaker2000@gmail.com

     

    DKW is a Past President of AAGBI, Chairman of Patient Safety Committee of European Board of Anaesthesiology and has received lecture fees from Aguettant Ltd and Medtronic, all donated to Lifebox.

     

    References

    1. Nimmo AF, Absalom AR., Bagshaw O. et al. Guidelines for the safe practice of total intravenous anaesthesia (TIVA) Joint Guidelines from the Association of Anaesthetists and the Society for Intravenous Anaesthesia. Anaesthesia, First published: 31 October 2018 https://doi.org/10.1111/anae.14428

    2. NHS England, Revised Never Events Policy and Framework 2015 https://webarchive.nationalarchives.gov.uk/20160606151745/https://www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2015/04/never-evnts-pol-framwrk-apr2.pdf (accessed 19/11/2018).

    3. Zorrilla-Vaca A, Arevalo JJ, Escandón-Vargas K et al. Infectious Disease Risk Associated with Contaminated Propofol Anesthesia, 1989-2014. Emerging Infectious Diseases 2016; 22: 981-92.

    4. Derryn A. Gargiulo M. Simon J. et al. Microbiological contamination of drugs during their administration for anesthesia in the operating room. Anesthesiology 2016;124: 785-94.

    5. Donnelly RF. Chemical stability of fentanyl in polypropylene syringes and polyvinylchloride bags. International Journal of Pharmacological Compounding 2005; 9: 482-3.

    6. World Health Organization. WHO Global Patient Safety Challenge: Medication Without Harm. http://www.who.int/patientsafety/medication-safety/medication-without-harm-brochure/en/ (accessed 19/11/2018).

  •  11 Dec 2018, 10:02 PM 2701 in reply to 2695

    Prefilled syringes, Patient Safety and total intravenous anaesthesia (TIVA) Guidelines for safe practice. A reply

    We thank Dr Whitaker for his comments on the Association of Anaesthetists guidelines for the safe practice of total intravenous anaesthesia (TIVA) [1] and agree that the use of prefilled syringes can reduce the potential for intravenous drug administration errors. Indeed, this will apply to both intravenous drug infusions and intravenous bolus injections. In NAP5, amongst more than 160 cases of accidental awareness during general anaesthesia, there were 18 cases due to error involving a drug swap [2]. Only one of these involved a drug error during TIVA whereas the other 17 were the result of a bolus injection of the wrong drug. This suggests that bolus administration may be at least as error prone as infusion anaesthesia.

    We also agree with Dr Whitaker that prefilled syringes are likely to reduce the risk of contamination with microorganisms and subsequent transmission of infection to patients. The recommendation in the quoted paper on propofol contamination by Zorrilla-Vaca et al. is to draw up propofol into a sterile syringe immediately before use after cleaning the top of the propofol vial with 70% isopropyl alcohol and while wearing gloves [3]. However, it seems likely that the use of prefilled syringes would be at least as effective.

    There are some barriers to the widespread use of prefilled syringes. There are often competing pressures regarding safety and cost and prefilled syringes may be considerably more expensive than ampoules or vials of the same drug. Moreover, some drugs are not stable in solution during storage in a syringe. The Association of Anaesthetists has established a working party to produce guidelines on injectable drug labelling and packaging which will consider the use of prefilled syringes in anaesthesia.

    The first-generation target-controlled infusion (TCI) pumps for TIVA were controlled by Diprifusor microprocessors (AstraZeneca, Cambridge, UK) and contained a syringe recognition system. Diprifusor systems only operated if they were loaded with glass syringes, pre-filled with 1 or 2% propofol, that were supplied by one propofol manufacturer. While this had safety benefits, eventually the high cost of the glass syringes relative to that of generic propofol drawn into ordinary syringes, and the restricted functionality of the Diprifusor pumps, resulted in most hospitals and anaesthetists abandoning their use. Although the glass pre-filled syringes are still being sold in Europe, the Diprifusor pumps specifically designed to use them are now only sold in Japan. As far as we are aware there are no other commercially available syringe-content recognition systems for IV anaesthetic infusions.

    Prefilled syringes of remifentanil are not commercially available. Currently few, if any, hospitals in the UK, and very few hospitals in Europe, have a system where syringes are filled by pharmacists and supplied daily to anaesthetists. Widespread adoption of such a system would be financially and logistically challenging and the benefits would be limited unless syringe recognition technology were also incorporated.

    In our guidelines we set out to recommend current best practice for the safe use of intravenous anaesthesia. There may be lessons from the experience with Diprifusor for future developments of syringe-content recognition systems and we would welcome the availability of such systems. Under the current circumstances, however, we do not feel that it is appropriate to recommend that prefilled syringes should be used whenever using TIVA.

    A. F. Nimmo

    A. R. Absalom

    T. M. Cook

    D. Mulvey

    S. Shinde

    On behalf of the Association of Anaesthetists and Society for Intravenous Anaesthesia working party on the Safe Practice of Total Intravenous Anaesthesia

    Email: alnimmo@gmail.com


    No external funding. ARA has undertaken occasional consulting work for BD/Carefusion, the money from which was paid to his institution.   

     

    Reference

    1. Nimmo AF, Absalom AR., Bagshaw O. et al. Guidelines for the safe practice of total intravenous anaesthesia (TIVA) Joint Guidelines from the Association of Anaesthetists and the Society for Intravenous Anaesthesia. Anaesthesia, First published: 31 October 2018 https://doi.org/10.1111/anae.14428

    2. Pandit JJ, Andrade J, Bogod DG, et al. The 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: summary of main findings and risk factors. Anaesthesia 2014; 69: 1089-101.

    3. Zorrilla-Vaca A, Arevalo JJ, Escandón-Vargas K et al. Infectious disease risk associated with contaminated propofol anesthesia, 1989-2014. Emerging Infectious Diseases 2016; 22: 981-92.

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