Safe medication administration in anaesthesia practice: new developments (Whitaker)
Intravenous medication administration is an essential part of anaesthesia practice and a large amount of an anaesthetist’s clinical work. Very significant developments and improvements have been made in patient monitoring and airway management that have transformed the safety of patient care several folds. However, advances in the safety of medication administration have largely been lacking. The Helsinki Declaration on Patient Safety in Anaesthesiology highlighted several relevant issues, which led to the development of more specific and practical advice in the EBA recommendation for Safe Medication Practice. Recently the wider appreciation of the importance of medication safety has led to the WHO launching its third WHO Global Patient Safety Challenge ‘Medication without Harm’. EBA Recommendations for Safe Medication Practice have now been updated and these and some more recent developments will be discussed in this chapter.
Safe medication administration in anaesthesia practice has not received the attention it deserves over the years and the last major improvement was the introduction of single use plastic syringes and disposable needles in the 1950s.571 In 2010, the Helsinki Declaration on Patient Safety in Anaesthesiology referred to the importance of a supply of safe drugs, the checking of drugs and the labelling of syringes.1,572 It also made reference to the large part played by human factors in delivery of safe care to our patients. Around 70% of errors are due to human factors and this is particularly applicable to medication safety. The aim should always be to promote best practice in human factors, a science that has successfully helped make other safety critical industries safer by ‘making it easy to do the right things’ (https://chfg.org). The same year the Anesthesia Patient Safety Foundation (APSF) hosted its landmark medication safety conference (https://www.apsf.org/article/apsf-hosts-medication-safety-conference/) and in 2011 the EBA published the first European Recommendations for Safe Medication Practice.573
The incidence of medication errors varies from one in 450 through one in 133 to one in 20 and over 600 medication incidents are voluntarily reported by anaesthetists every month in the United Kingdom (https://www.salg.ac.uk/sites/default/files/PSU-September-2019.pdf) and they represent 28% of all peri-operative incident reports in the Spanish Anaesthesia Incident Reporting System.574–577 In 2017, the GMC report on Preventable patient harm across healthcare services (understanding harmful care) said that 13% of patients experienced total harm but only 6% of patients experience preventable harm. The most common type of this preventable patient harm was medication-related incidents which represented 25% of the identified harm.219,348 A further acknowledgement of this issue was the instigation of the third WHO Global Patient Safety Challenge ‘Medication without Harm’ (https://www.who.int/patientsafety/medication-safety/en/). This intends to reduce the incidence of iatrogenic medication-related harm by 50% in 5 years. It is hoped to mirror the success of the first Global Patient Safety Challenge ‘Clean Care is Safer Care’ in 2005 (https://www.who.int/patientsafety/information_centre/ICHE_Nov_05_CleanCare_1.pdf) which promoted handwashing, and the second Global Patient Safety Challenge ‘Safe Surgery Saves Lives’ 2008 which changed practice with the Surgical Checklist (https://www.who.int/patientsafety/safesurgery/knowledge_base/SSSL_Brochure_finalJun08.pdf).
In the first instance, the WHO wish to prioritise harm associated with high-risk medicines, polypharmacy and transitions of care. All these three areas are particularly relevant to anaesthetic practice. The WHO do not feel it is necessary to reinvent the wheel as guidance on these is already available, but this just needs to be widely and consistently implemented. For European anaesthesia, it would seem appropriate to try and implement the EBA Recommendations for Safe Medication Practice second edition 2015. To help and encourage their implementation these recommendations also included a 13-point checklist so that departments can monitor their progress.573
To raise the profile of safe medication administration at a local level and focus departments thinking about it, it is suggested that all departments of anaesthesiology should develop a peri-operative medication policy and implement it. The Royal College of Anaesthetists now have this as one of the departmental accreditation standards in their Anaesthesia Clinical Services Accreditation scheme (https://www.rcoa.ac.uk/safety-standards-quality). They expect this policy to incorporate relevant items from the Royal Pharmaceutical Society Professional guidance on the safe and secure handling of medicines (https://www.rpharms.com/recognition/setting-professional-standards/safe-and-secure-handling-of-medicines/professional-guidance-on-the-safe-and-secure-handling-of-medicines). At least one medication safety item could be included in the Annual Safety Report recommended by the Helsinki Declaration on Patient Safety in Anaesthesiology (https://bit.ly/2Zf7INa). Suitable items for inclusion in this peri-operative medication policy could also include some others discussed later in this chapter. The logical way to develop this might be considered a ‘chain of safe medication administration’ and follow the pathway from purchasing and acquisition of injectable medicines through their storage, preparation, administration to patients and recording and finally analysis of the outcomes.
Because of the complexity of the process of selecting, preparing and administering injectable medicines, human factor considerations must be taken into consideration throughout. It is remarkable to note that in a recent Health Service Investigation Branch report on a medication incident they commented that the NHS Specialist Pharmacy Service has no reference to human factors considerations anywhere in their procurement overview (https://www.hsib.org.uk/investigations-cases/inadvertent-administration-oral-liquid-medicine-vein/). Without this, nurses and medical staff in certain circumstances are being set up to fail when they become an end user of some of the particular medicines that they have been purchased and that they are required to use. Look-alike and sound-alike medicines and poor labelling are well known examples of these, as are frequent changes of supplier without notification. Implementing a ‘purchasing for safety’ policy to promote procurement of injectable medicines with inherent safety features should be a priority.
Although in low and middle-income countries drug shortages are a daily occurrence, a recent development has been their appearance in high-income countries. The reasons for this can be complex. However, reductions in the number of suppliers, manufacturer and commercial considerations require that departments are aware of this possibility and are prepared with contingency plans for drug shortages. Adequate supplies of essential medicines should be kept and maybe buffer stocks of say 6 months of some particularly important ones. The WFSA has produced an essentials medicine list (https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1) and national ones are available as well (https://anaesthetists.org/Portals/0/PDFs/Safety/NEADL_2015_FINAL.pdf?ver=2018-09-25-154824-287).
Storage of medicines
It has long been recognised that local anaesthetic drugs should be stored separately from general anaesthetic drugs to avoid their inadvertent intravenous administration. Similarly it has been recommended that potassium should be kept separately in a locked cupboard.578
Errors with the administration of medicines of a different pharmacological class group from the intended one, for example, a muscle relaxant instead of a sedative drug are likely to cause more harm than errors within the same pharmacological class. To reduce the possibility of not selecting the intended drug, medicines should be stored in their pharmacological class groupings rather than say alphabetical order (see WHO Essential Medicines and Health Products Information Portal and recommendation on drug storage: http://helid.digicollection.org/en/d/Js4885e/4.4.html).579 It is not uncommon for alphabetical storage to cause administration incidents and recently there was a report of a patient mistakenly being given Vecuronium instead of the intended Vancomycin (http://www.salg.ac.uk/sites/default/files/PSU-September-2019.pdf) and this has been commented upon.579
Preparation of injectable medicines
This should take place on a clean uncluttered, adequately sized surface and not on a spare corner of an anaesthetic machine. Recently standardised surface arrangements for this have been recommended and demonstrated to reduce the incidence of medication errors.580 At this time departments should probably try and use a logical local arrangement in all possible locations. Not only will this ensure clarity and safety for individual practitioners but also when working in teams and with assistance (https://www.sps.nhs.uk/wp-content/uploads/2018/02/2007-NRLS-0434-Injectable-medicines-PSA-2007-v1.pdf). Anaesthesia drug storage trays incorporating ISO coloured compartments have also been developed.581 Each injectable medicine should be prepared in one syringe, one medicine, one at a time and standard operating procedures are available for this purpose (https://www.sps.nhs.uk/wp-content/uploads/2018/02/2007-NRLS-0434F-Promoting-safeSOP-template-2007-v1.pdf). All syringes should be clearly labelled. The purpose of the label is to identify the syringe before it is picked up and so the label should be fully visible when the syringe is resting on the work surface. Existing standardised arrangements suggest that at least one label or the writing should be longitudinal along the barrel of the syringe (https://www.safetyandquality.gov.au/our-work/medication-safety/safer-naming-labelling-and-packaging-medicines/national-standard-user-applied-labelling-injectable-medicines-fluids-and-lines) and they should then be placed horizontally (rather than vertically) on the work surface so the labels are clearly readable.
Ideally, syringe labelling should be further standardised and all labels applied while the syringe is pointing from right to left (‘right-handed’ syringe orientation). This is essential anyway for all syringes being used in syringe drivers, which all drive from right to left, if the label is to be readable and checkable while in use (Fig. 14).
Every syringe should be labelled immediately after drawing the medicine into the syringe and before the syringe leaves the operator’s hand (https://www.usp.org/compounding/general-chapter-797). In emergency situations where the filled syringe never leaves the operator’s hand before the drug is administered to the patient this may be omitted but it is still good practice to label the syringe if possible. Errors are more likely to occur in stressful emergency situations.
Empty syringes should never be labelled, as the purpose of a label is to indicate what is in the syringe; therefore, any label is always wrong if the syringe is empty. Another reason why syringes should always be labelled after the injectable medicine is drawn up into them is the many errors from prelabelling syringes and other containers that have been reported elsewhere in health care, for example, ‘wrong blood in tube’ incidents from blood transfusion practice (https://b-s-h.org.uk/media/16505/shot-report-summary-2017.pdf).
All syringes labels should meet the ISO 26825 standards for coloured user-applied labels for syringes containing drugs used during anaesthesia – colours, design and performance (https://www.iso.org/standard/43811.html; https://anaesthetists.org/Portals/0/PDFs/Guidelines%20PDFs/Guideline_syringe_labelling_critical_care_review_2014_updated_2016_final.pdf?ver=2018-07-11-163757-317&ver=2018-07-11-163757-317). Using the different ISO colours for different pharmacological classes of drugs has been shown to reduce the potentially very dangerous syringe swap errors between drug classes by 66%.582 If the use of ISO labels is not possible then handwritten labels using paper or tape with a strong adhesive can be used or a marker pen that will not rub off the syringe. No standard abbreviations for drug names currently exist so they should be avoided.
During the preparation of injectable medicines it is important to avoid any distractions. Explain this to team members in advance and if it happens the operator should stop what they are doing, attend to the distraction and then carefully restart the process. If in any doubt about at what stage they were up to then, discard any unlabelled drugs and start that part of the process again. At any stage of the process particularly during medicine verification, consider asking a colleague to help double check. It is advisable to not use a leading question, but for example say ‘What is the drug and the dose in this ampoule please?’ When administering an injectable medicine always be certain of the identity of the patient. This should have taken place as part of the WHO checklist but if in doubt always recheck. Also be aware of any drug allergies and clearly record them in the patient records.
Microbial contamination of syringes during preparation must be avoided and to minimise the risk of cross infection between patients the contents of any one ampoule should only be administered to one patient (https://www.cdc.gov/injectionsafety/one-and-only.html).583,584 The use of multidose ampoules is not recommended.585,586 Storing the empty ampoules that have been drawn up and administered to a patient in a safe container until the end of the anaesthetic enables any further checks that may be necessary during or at the end of the case if it appears there has been an error during the anaesthetic. This can also help medication practice learning to occur; finally they can be disposed into a sharps bin.
Administration of medicines
From reports of peri-operative critical incidents the administration phase is the most prevalent and harmful.577,587 Ensure you have a correctly prepared syringe and before commencing the injection always consider the expected dose of the drug you intend to give. When titrating an injectable medicine always consider the most suitable injection rates, increments and time intervals to use. After administration of an injectable medicine promptly record this on the anaesthetic record with the drug name, dose and time of injection. It is important particularly at the end of a procedure to flush any residual anaesthetic or sedative drugs from all intravenous lines and cannulae. If this is not done the residual drug can be later inadvertently introduced into the patient’s circulation in the recovery unit or on the ward causing muscle paralysis, unconsciousness and respiratory and cardiac arrest. It is even more important in paediatric practice where fatal incidents have been reported (https://improvement.nhs.uk/documents/1922/Patient_Safety_Alert_-_Confirming_removal_or_flushing_of_lines_and_cannulae_af_EVC1Yb2.pdf).
Wrong route medication errors due to tubing misconnections are potentially life threatening complications that have been made possible by the universal use of the luer connector. With an initial target of implementation in 2011, the non-luer initial prototypes resulted in technical and non-technical problems. Following a delay of the widespread use of the non-luer connectors, the new ISO standards for small bore connectors, ISO 80369 series, have been developed to reduce the risk of these types of erroneous connections. The nonluer ISO 80369-6 standard has now been tested and seems to be acceptable in terms of its ease of use, reliability, lack of leakage and versatility.588
Unsafe injection practices are still putting patients and healthcare personnel at risk of disease transmission, including bacterial infections like MRSA or blood borne pathogens like hepatitis C virus.589 The Safe Injection Practices Coalition One & Only Campaign is a public health effort to eliminate unsafe medical injections that promotes the rule to remember is ‘One Needle, One Syringe, Only One Time’ (https://www.cdc.gov/injectionsafety/one-and-only.html).
Although 28% of the 10 billion units of injectable medicines sold annually are supplied in ready to administer/prefilled preparations, only 4% of those used in the acute sector are, and prefilled syringes have not been commonly used in anaesthesiology at all (https://www.grandviewresearch.com/industry-analysis/pre-filled-syringes-market). Recent developments, however, have led to a number of anaesthesia drugs being available in prefilled syringes and this is to be welcomed. A significant number of the potential human factor error steps in preparation of injectable medicines can be completely eliminated when using prefilled prelabelled syringes. There are very few areas of medicine where such a major step change in safety can be so easily achieved.
The latest Royal Pharmaceutical Society Safe and Secure Handling of Medicines (https://www.rpharms.com/recognition/setting-professional-standards/safe-and-secure-handling-of-medicines/professional-guidance-on-the-safe-and-secure-handling-of-medicines) now includes a section on operating theatres including interventional areas, for example, radiology and cardiac catheterisation labs. This says that, as outlined in its core guidance, manipulation of medicines in clinical areas should be minimised and medicines be presented as prefilled syringes or other ‘ready-to-administer’ preparations wherever possible. Many other specialities have stopped preparing their treatments and equipment at the bedside or operating table and anaesthesiology should regard this phase as inevitable and follow other specialties’ good practice as soon as possible. Patient transfers are also a complex process and prefilled syringes are recommended as part of the essential equipment to go with the patient in the ambulance.590 The manual preparation of intravenous syringes in moving vehicles is fraught with hazard particularly when the circumstances are not ideal (Fig. 15).
Prefilled syringes usually have a higher purchase cost than ampoules, but they can be economical in circumstances where they reduce wastage and expensive medication errors.591 They simplify work processes and reduce cognitive complexity during medication delivery.592 Prefilled syringes have zero contamination as against 6% for manually prepared syringes.583,584 The advantages of prefilled syringes may actually be of even greater benefit if they were made available in many of the difficult circumstances in low-income and middle-income countries. By eliminating packaging, ampoules, drawing up needles, and transportation, prefilled syringes also have environmental advantages.593 About 59% of anaesthesia departments in Japan use prefilled syringes a practices stimulated by the breaking of glass ampoules during the Great Hanshin earthquake in 1995.594
There are two main types of prefilled syringes and both are now usually plastic. The first type are compounded prefilled syringes where the medicine is added to the syringe in a clean room and because of this these usually only have a shelf life of around 8 weeks. Although this appears short for high-usage medicines such as insulin in 50 ml prefilled syringes, or intensive care infusions of inotropes, sedatives, and analgesics, insulin in 50 ml prefilled syringes (Fig. 16) this does not materially affect clinical practice.
Infusion syringes prepared by nurses on ICU show wide variations in concentrations which do not occur with prefilled syringes.595 One-third of all inpatient medical errors leading to death within 48 h of the error involve insulin administration and 50 ml prefilled syringes for insulin infusions are a robust systemic barrier to such concentration errors.596,597 Compounded prefilled syringes are now used in theatres by over 1000 departments in the United States where a wide range of anaesthetic drugs are now available.
The second type are manufactured prefilled syringes where the syringe is filled and prepared and then the whole combination of the syringe and its contents are sterilised at the end of the process providing a shelf life of around 3 years (https://www.aguettant.fr/nos-medicaments/nos-produits-en-details/). Having a long shelf life makes pharmacy stock management easier and more economical and the sterilisation at the end of the process adds the new possibility of using these pre labelled syringes directly on the sterile field.
Other technological advances
Technological advances to improve the safety and accuracy of administering intravenous medicines have been around for some time, initially using barcodes (https://safersleep.com/about-safersleep/company-history/).598 The electronic aspects of these arrangements can work satisfactorily but the whole system can still rely on the operator self-filling the syringes and applying the barcode themselves.599 Until departments are using almost a complete range of their anaesthetic drugs in appropriately labelled prefilled syringes it seems hard to justify the investment and training in this technology as one of the major benefits of giving the right drug will not be guaranteed. Perhaps the money should be spent providing prefilled syringes first. Barcodes also may not be the ultimate technology as embedded radio frequency identification tagging is available and other technologies will surely be developed. Such systems also have the benefit of linkage to electronic anaesthetic record systems both for recording doses and timing and also for identifying potential drug interactions, alerting the operator when about to give a drug to which the patient is allergic (http://www.bd.com/intelliport/).
Incident reporting and learning
Local and national incident reporting systems have existed for some time (https://www.rcoa.ac.uk/salg) and many of the recommendations above have been developed from consideration and analysis of previous critical incidents.345 Local Incident Reporting Systems provide the additional opportunity for the implementation of corrective measures and system improvements particularly adapted to the local circumstances.577 This process has reduced the amount of patient harm produced, but it is a continuous and never-ending process. With learning, its dissemination and reliable implementation it is hoped that lessons will not need to be relearnt, but as new medicines and administration techniques are introduced it is only natural for unintended incidents to occur and so critical incident reporting should be a routine part of clinical practice. Without a linked system to analyse these incidents and then recommend and promote ways to reduce them it is not coherent. Also, for an effective and sustainable reporting system the staff needs to be given regular feedback and their must be demonstrable learning from their reporting efforts: without this they will naturally see no good purpose in spending their time continuing to submit reports and stop, to the detriment of all.
Anaesthetists are becoming increasingly aware of the potential pitfalls of administering intravenous medicines and medication safety has been recognised as a global problem by the WHO with their third WHO Global Patient Safety Challenge ‘Medication without Harm’. Following on from the Helsinki Declaration the EBA produced Recommendations for Safe Medication Practice. This chapter has discussed many of these and other recent developments in this complex area. Guidelines without implementation are of limited value and the latest edition of these recommendations also included a 13-point checklist to help and encourage departments to implement them and monitor their progress.573 Every individual anaesthetist should be mindful of medication safety issues in their own daily practice as they prepare and administer the necessary medicines to the patients in their care.
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