Handling injectable medications in anaesthesia

Summary

Peri-operative medication safety is complex. Avoidance of medication errors is both system- and practitioner-based, and many departments within the hospital contribute to safe and effective systems. For the individual anaesthetist, drawing up, labelling and then the correct administration of medications are key components in a patient's peri-operative journey. These guidelines aim to provide pragmatic safety steps for the practitioner and other individuals within the operative environment, as well as short- to long-term goals for development of a collaborative approach to reducing errors. The aim is that they will be used as a basis for instilling good practice.

Recommendations

1. Safe handling of medicines requires clear institutional policy within multiple departments as well as careful individual practice.
2. Departments of anaesthesia should have policies for safe handling of medicines.
3. Pharmacy departments should promote purchasing for safety, consistent supply and purchase from those companies complying with good labelling practice.
4. Prefilled syringes have multiple advantages, and their purchase and use should be promoted.
5. Standardisation of fit-for-purpose physical structure and medicine storage in workplaces should be developed.
6. Technological solutions that reduce the opportunity for error should be explored and adopted whenever possible.
7. Standardisation of practice for syringe labelling and handling should be promoted and should form part of the curriculum for training anaesthetists. This should reduce the risk of errors when anaesthetists work together.
8. Individual anaesthetists may have characteristics that affect their working; these should be recognised by the individual as well as their department, and suitable adjustments to practice made.

What other guidelines currently exist?

Guidelines for safe management and use of medications in anaesthesia have been published by the Australian and New Zealand College of Anaesthetists (ANZCA). The European Board of Anaesthesiology have also published recommendations for safe medication practice.

Why were these guidelines developed?

This document has been produced by the Association of Anaesthetists in response to requests for guidance from members in view of continuing incidents of medication errors and patient harm. It ties in with the World Health Organization (WHO) 3rd Global Patient Safety Challenge ‘Medication Without Harm’ [1], which was the theme of the WHO World Patient Safety Day September 2022.

How and why does this statement differ from existing guidelines?

This document highlights published advice from UK bodies including NHS England, pharmaceutical organisations and the Royal College of Anaesthetists. It emphasises that medication safety does not depend solely on the individual practitioner, but many departments within the hospital should also contribute to safe systems.

Disclaimer

These practice recommendations come with the usual caveat that they are not binding for the individual practitioner or in the individual case but are based on a considerable body of evidence and expert consensus. In this document, we use the term ‘ampoule’ to include vials.

Introduction

There is growing awareness that safe medical practice should be addressed systematically and taught formally [2, 3]. Safe handling of medications applies to multiple different professional groups and clinical areas (the literature on safety and error often refers to ‘drug’, with equivalent meaning to ‘medication/medicine’).

These guidelines are focused on anaesthetic peri-operative practice in the UK, although the principles may apply to other clinical areas and countries. This document is written with the medically qualified anaesthetist in mind. Prescribing regulations for Anaesthesia Associates remain to be clarified.

Unlike other healthcare workers who often work in systems involving two-person checking (an independent check by a second person), medication preparation (transfer from labelled ampoules into unlabelled syringes) by the anaesthetist is usually undertaken in a solo capacity. General standards for professional practice are provided by the General Medical Council [4]. Although there is variability depending on case complexity, one estimate gave an average of 10 medication administrations per anaesthetic procedure [5]. There are various definitions of medication errors, complicating any analysis [6]. At one extreme, some patient safety databases may only include errors that lead to severe harm [7]; at the other end, authors include minor practice slips, such as picking up the wrong ampoule (pre-errors). As a ‘ballpark’ estimate of frequency, labelling errors were noted in around 1–1.25% of peri-operative medication administrations [8] and medication substitutions in 0.2% of administrations during anaesthesia [9], although these studies used different methodologies [10]. It is important to acknowledge that every practitioner is open to error and that the risk can increase over time during a case, especially in the presence of specific factors that diminish performance (e.g. fatigue) [11].

Understandably, there is considerable emphasis on medication errors. However, it is also important to give appropriate recognition to the fact that in virtually all cases the correct medication is given by the correct route, at the correct time [3]. Good practice should be highlighted; in most cases there is consensus on what this looks like [12, 13].

Standardisation in work practice is promoted in many industries to ensure consistency and reduce error [14]. In the peri-operative clinical arena, some practitioners may have differing and even conflicting systems; otherwise-successful individual approaches may become a problem when different work systems come together in the shared case or a ‘handed-over’ case, and therefore, convergence in practices should be strongly encouraged. Human factors describe processes to make ‘doing the right thing’ easier [15].

Clinical directors and senior management

It should be recognised that errors may be made by the best practitioners despite multiple safety steps. A culture of blaming individuals, sometimes to deflect from corporate accountability, may lead to secretive and defensive practice that may be counterproductive. Organisational safety culture has been demonstrated to be most successful when boards and senior management ‘listen up’ to concerns from frontline staff [16].

The ‘hierarchy of intervention effectiveness’ puts system-focused improvements in design (forcing and nudge functions, physical design blocks to error) at the highest level and the individual at the lowest level. All investigations of an individual should be made in the context of wider system responsibility and, where appropriate, with input from independent specialists with human factors expertise. Clinical directors in anaesthesia should promote the following: cultural improvements in the general work environment [16]; a culture of safety consciousness; and the implementation of safety initiatives and equipment.

Every department of anaesthesia should have guidelines for the safe and secure handling of medicines and the recommendations in this document should inform any revisions [17]. To assist departments that may wish to implement these guidelines and monitor their introduction locally, an implementation assessment/checklist might be used [13].

Errors and near-miss incidents should be reported using the organisations local risk management system (e.g. Datix (RLDatix, London, UK) or Ulysses Risk Management (Ulysses, Havant, UK)). Reported errors should be circulated and discussed within the department at designated meetings, and agreed outcomes and actions recorded.

The clinical director should preserve a specific record of system accountability in a log or risk register. For example, if they are unsuccessful in procuring and/or implementing sufficient safety equipment, staffing or other organisational changes required for the department, the barrier(s) to implementation should be identified and recorded such that individuals or committees can be identified to share accountability if errors occur. This is particularly important if the desired implementation is supported by guidance from professional bodies. Senior management should similarly promote organisational safety consciousness, collaborative cross-departmental and cross-speciality working. Organisational risk registers should acknowledge the indirect costs of medical errors within the ‘purchasing-to-save’ equation.

Pharmacy

If feasible, a Medication Safety Officer [18] should liaise with a designated pharmacy procurement professional and a clinical pharmacist in the department of anaesthesia over all decisions relevant to medication purchasing and presentation. There should be a named anaesthetist to liaise with the pharmacy team. Management of purchasing and inventory should include consideration of factors relevant to minimising the risk of medication error. The development of a ‘purchasing for safety’ policy is encouraged. Further detailed suggestions are included in Box 1.

Box 1. Pharmacy purchase and supply

• Purchase ready-to-administer products wherever possible [19]. Prefilled syringes have the following advantages: reduction in labelling errors; reduction in bacterial contamination; potential for tamper-evidence; and potential for medication recognition mechanisms.
• Ideally the supplier should be standardised to ensure consistency of the product packaging. However, this sometimes cannot be achieved, e.g. if there are supply problems.
• When there is a switch from one supplier to another for a particular medication, all reasonable steps should be taken to inform clinicians. Medication cupboards/trays should not contain boxes of the same medication from different suppliers.
• We recognise that there are times when a preferred medication may not be available, and a different medication from the same class may have to be used [20].
• Wherever practicable, medications should be purchased and supplied in ready-to-use concentrations that abolish or minimise the need for dilution before administration, especially vasoactive medications.
• Purchase from suppliers who comply with best practice guidelines on packaging [21]. Colouration on ampoule boxes should be consistent with ISO standard colours for syringe labels as much as is practicable.
• Standardise concentrations supplied to the operating theatre suite (e.g. lidocaine).
• Standardise ampoule size (dose) supplied to the operating theatre suite (e.g. glycopyrronium).

Practice within the operating theatre environment

A good safety culture within the work area will include all professional groups and multiple aspects of practice, with medication administration being just one. The culture should allow staff to ‘speak up’ if they observe something that seems wrong; comments or queries from any member of the team should be taken as clarifications that may avert mistakes rather than criticism [16]. Work areas should be standardised as much as possible [22, 23]. This can be achieved in the short term by consistency in medication lists within cupboards, but in the long term requires structural alterations to fittings within rooms and even commissioning of buildings.

There should be separate general and neuraxial (to include local anaesthetics) lockable drug cupboards [17]. Some requirements for storage of specific medications are over-riding, such as controlled medications (i.e. medications with potential for abuse) [24], high-risk medications such as strong potassium solutions, and refrigerated items [25]. See Box 2 for further detailed suggestions.

Box 2. Medication storage and supply

• Store medications according to their pharmacological group in cupboards and refrigerators (as mistakes within a group are likely to be less consequential than those involving a different group), and alphabetically within groups [13, 26].
• Standardise concentrations (e.g. intravenous lidocaine 1%, heparin 10 unit.ml^-1 flushing solution); exceptions include different local anaesthetic concentrations required for nerve blocks.
• Standardise ampoule size, e.g. glycopyrronium 3 ml for adult practice; saline 10 ml ampoules.
• Supply standard ISO 26825-compliant medication labels [27] according to local practice requirements, including for frequently used medications as well as higher-risk medications. Encourage purchase from printers who adhere to these standards. Supply blank labels and permanent marker pens. Replace labels if the adhesive is ineffective.

Technological solutions

Encourage short-term solutions such as colour-coded trays. These can be integrated, e.g. Rainbow Tray™ (Uvamed, Loughborough, UK; Fig. 1) [28, 29] or Anesthesia Medication Template (Fig. 2) [30]. Medium-to long-term solutions include: bar-coding technology [31, 32]; non-injectable connectors with a valve to prevent accidental intra-arterial injection (e.g. needle-free non-injectable connector (NIC), AmDel Medical Ltd, Liverpool, UK) [33]; NRFit® connector to minimise intravenous to neuraxial wrong route errors or vice versa (this will become mandatory in the NHS when a full range of equipment is available) [34]; and electronic prescribing/medicines administration.

Figure 1

Rainbow Tray™ [28].

Figure 2

Anesthesia medication template [30].

Personal safe practice for the anaesthetist

Consistent working patterns are likely to reduce error-prone behaviour. Medication preparation has been identified as a ‘critical moment’ during operating theatre working [35]. Preparation before the start of a case is the opportunity to establish plans and communicate with the assistant, i.e. before the arrival/sign in of the patient when other distractions may occur. Medication handling may be included in a more general operating list brief for the anaesthetic team. The ‘sterile cockpit’ concept promotes the reduction of distractions during particularly sensitive phases of work. The anaesthetist should be prepared to concentrate fully on drawing up medications and be empowered to request that there are no distractions during this period. See Box 3 for detailed suggestions.

Box 3. Personal practice for the anaesthetist: labelling and handling

• Perform the complete drawing up/labelling process for one medication at a time. Only remove an ampoule from its packaging at the time of drawing up. Complete the process before starting on the next medication. Restart the process if a significant interruption could have introduced error for instance in a dilution process.
• Read the ampoule label from top to bottom. Remember that there may be a combination of medications.
• Draw up medication into syringe, cap off or cover nozzle and label immediately before setting the syringe down. Consider adding more than one label if the first cannot be read when the syringe rests with the label downwards.
• After drawing up, compare the medication label on the ampoule/vial and the syringe (e.g. holding the syringe in one hand and the ampoule in the other, see Fig. 3). Keep the ampoule (with the syringe wherever possible) until clearing at the end of the case.
• Consider placing an extra label to straddle syringe and cap if medication is a reserve/emergency medication.
• Use standard dilutions of medications - preferably per local protocol. Record the dilution on the label.
• Draw up medications intended for different routes in separate batches and keep segregated. Beware of ‘colour confusion’: for example, the use of yellow colouring to denote both intravenous anaesthetics and neuraxial-route medication.
• Do not draw up medications that are not time-critical until they are needed. These may include: antibiotics; oxytocin; other uterotonics; and reversal agents.
• Do not replace single ‘stray’ ampoules into boxes if discovered; they should be thrown away.
• Encourage two-person checking for increased-risk practice, such as: medications being injected on behalf of someone else such as the surgeon; and administration of medications that are unfamiliar to the anaesthetist. If a medication or dilution step is unfamiliar, check the procedure with an external source.
• Physically separate access points that are used for different routes of administration (e.g. place epidural catheters and central venous lines on opposite sides of pillow).
• Ensure residual medications are not retained in equipment dead space by flushing appropriately.
• Discard all syringes at the end of the case into the appropriate container, except for ‘stand-by’ or ‘emergency’ medications.
• Joint working: recognise that opportunities for error arise when two practitioners work together; and ‘talk through’ the medications that are going to be used during the case, so that if there are any different conventions (e.g. syringe size for a particular medication) these are clarified. Standard syringe sizes and dilutions are strongly encouraged.

Drawing up medications requires careful selection of the medication and syringe label. The ISO labelling standards document warns “The use of colours is intended only as an aid in the identification of medication groups and does not absolve the user from the duty of reading the label and correctly identifying the medication prior to use” [27]. Once a solution has been drawn up into a syringe, it should always be labelled (Fig. 3) [36]. The only exception is when it will be used immediately, i.e. the syringe does not leave the practitioner's hand [12]. When labelling a syringe, there are arguments for placing the label in line with the syringe barrel or circumferentially at the plunger end of the barrel. However, the top (coloured) surface of a label should be visible no matter how the syringe is placed; this may require more than one label. Do not place a label so that it obscures the syringe volume markers. Applying labels to the syringe plunger can emphasise the contents [37]. It is a logical consequence of the recommendation to label syringes only after drawing up the medication that empty syringes should not be prelabelled. If coloured syringes (e.g. red syringe for neuromuscular blocking drugs) are used, extra care should be taken when filling. Medications should not ordinarily be drawn up in batches for multiple patients [38].

It is advisable to retain empty ampoules till the end of the case as this acts as an early check, as well as a means to investigate the circumstances in the event of a putative medication error. Single ‘stray’ ampoules should not be replaced into boxes but should be thrown away, as an ampoule outside its packaging incurs a higher risk of mistaken identity. When a plastic tray containing ampoules is taken out of its box, it should be returned to the box without delay.

There may be occasions when an anaesthetist is asked to prepare and administer a medication on behalf of someone else, e.g. the surgeon who is scrubbed during an operation. In the event of any uncertainty in its dose, effects or method of administration, the anaesthetist should check with an external source such as the British National Formulary or MEDUSA [39, 40]. An anaesthetist may delegate the preparation of a medication to someone else in the theatre team, in which case it should be prepared in their presence, as close to the time of administration as possible, and they should check the drugs and diluents used in its preparation.

Total intravenous anaesthesia (TIVA) involves considerable complexity in safe setting up and administration, and resources for good practice should be consulted [41]. It is essential to ensure that medications are not retained within the dead space of lines and cannulae [42].

Figure 3

Six steps for syringe labelling.

Anaesthetic assistant

The anaesthetist should always work with a trained assistant [43]. The assistant may assist the anaesthetist in drawing up medications where there are clear departmental policies/standard operating procedures that contain directives on accountability [22, 44]. As discussed above, we emphasise that the assistant should not replace single ampoules into boxes when ‘tidying up’.

Sterile procedures

Key points are shown in Box 4. Invasive procedures that require a sterile technique will require the initial use of skin disinfectant solutions that are toxic if injected, and there should be scrupulous care to avoid contamination of equipment. Medications and cleaning solutions must not be decanted into the sterile field [22, 45]. The risk of contamination will be reduced by performing skin preparation before exposing the equipment used for the procedure [46]. Sterile procedures will usually require a restricted number of medications and solutions compared with anaesthesia for surgical procedures. Typically, neuraxial procedures utilise local anaesthetic infiltration, loss-of-resistance solution and neuraxial injectate. Central venous catheterisation may require local anaesthetic infiltration, saline flush and heparin.

Box 4. Practice for sterile procedures

• Medications/solutions that are to be injected from a syringe must be drawn up directly into the syringe from the ampoule, and never transferred via a gallipot/container.
• Two-person checking is recommended when the practitioner draws up from an ampoule held by an assistant.
• Sterile labels should be used when they are available.
• If labels are not available, practitioners should develop consistency in syringe sizes and the order in which they prepare the solutions that they are going to use.
• A consistent layout for the work surface is encouraged.
• Procedures that involve two practitioners from the outset, or because of a ‘hand-over’, introduce error risks and detailed communication is essential.

We recommend that ampoules or prefilled syringes for sterile procedures should, wherever possible, be supplied within the sterile pack or in sterile wrapping, either from the manufacturer or from pharmacy services. We recommend that a complete range of standard sterile labels (UKCA-marked, CE-marked, or equivalent) should be available to enable labelling of syringes [47]. Certain syringes may have a unique function (e.g. epidural loss-of-resistance syringe or Luer syringe used only for skin infiltration within a NRFit pack). For other syringes, if labels are not available, the syringe should ideally not be put down until the administration is completed.

Although consistent practice by a solo practitioner should reduce the risk of error, potential problems arise when a second practitioner becomes involved. The most common situations are during training when there are two scrubbed practitioners or when a more senior practitioner takes over procedure attempts in the event of difficulties or failure. The specific danger of confusion between bupivacaine and tranexamic acid during spinal anaesthesia has been highlighted [48].

Individual/unique considerations

Anaesthetists may have physical or psychological differences that affect how they work and interact with safety systems. It is possible that an anaesthetist may use satisfactory individual approaches that they may choose not to advertise. However, in some cases they might need to build other routines into their practice, e.g. two-person checking, and this may require the sharing of such differences with colleagues. Box 5 contains more specific information.

Box 5. Individual/unique considerations for practitioners

• Reduced visual acuity: practitioners may require glasses to correct vision defects. The most common new-onset problem is age-related long-sightedness, with an inability to read small fonts, usually on 1-ml ampoules. Individuals should be prepared to seek assessment of visual acuity if they have difficulties with reading such script.
• Colour vision deficiency: a common pattern is an impaired ability to distinguish red and green, though there are other variants.
• Reduced hearing ability: hearing aids as appropriate. Consider best workstation arrangement if lip-reading is an important addition to verbal understanding. Consider closed loop communication as required (repetition of a communication by the recipient to ensure correct understanding).
• Dyslexia: the practitioner may recognise specific medications or terms that they frequently or importantly confuse and pay particular attention to these.
• Dyscalculia: consider standard calculation schemes and use of a calculator.
• Dyspraxia: practitioners will benefit from use of a large, uncluttered area with sharps disposal container within easy reach.
• Autistic spectrum conditions: attention to detail and diligently following specific routines may be a particular strength in autism. This may take longer and therefore adequate time should be allowed for medication preparation. Individuals may have difficulties accepting medications drawn up by colleagues, e.g. when a case is handed over [49].
• Attention deficit hyperactivity disorder/attention deficit disorder: practitioners may be prone to distraction and should use techniques to manage this, especially aiming to reduce interruptions by others during the procedure.

The importance of fatigue and stress on impairment of function has been highlighted recently [11, 50]. The individual practitioner should attempt to recognise that their performance might be impaired, heighten attention to practice steps that might lead to error and call for support. The culture of the department should encourage formal and informal mechanisms to provide support in these circumstances. Impairment of vision and hearing tends to increase with age, and this should be recognised by the individual as well as their department [51].

Teaching and assessment

Consistent safe practice depends not only on the individual but also on a positive culture that includes instilling good practice around the handling and drawing up of medications and labelling syringes to minimise risks. This should begin in medical school and continue through anaesthetic training.

The novice guide working party from the Royal College of Anaesthetists provides a list of the most commonly used anaesthetic medications encountered when starting anaesthetic practice, with guidance on doses for an average adult and how the medications are presented [52]. Although this helps to lay the foundations of safe care, this needs to be used in conjunction with practical strategies that highlight safe practice. Encouraging senior clinicians to use standardised systems and reduce inter-user variability should reduce the burden on novices.

The principles of safe practice in drawing up and labelling might be disseminated by e-learning. This should be supplemented by formal and informal assessment of practice through procedural observation and simulation.

Further reading

This document has drawn on Professional guidance on the safe and secure handling of medicines from the Royal Pharmaceutical Society [22], Recommendations for safe medication practice from the European Board of Anaesthesiology [13] and Guidelines for the safe management and use of medications in anaesthesia from the Australian and New Zealand College of Anaesthetists [12]. Readers are encouraged to consult those documents for more detail. Other resources include: Safe drug management in anaesthetic practice produced by the Royal College of Anaesthetists and the Association of Anaesthetists and endorsed by the Royal Pharmaceutical Society, Faculty of Intensive Care Medicine, and College of Operating Department Practitioners [53]; Storage of drugs in anaesthetic rooms from the Royal College of Anaesthetists and the Association of Anaesthetists [54]; Medication safety in the operating room: literature and evidence-based recommendations [55]; and Medication handling: towards a practical, human-centred approach [56].

Acknowledgements

PY is one of the inventors of the needle-free non-injectable connector (NIC; patent owned by Queen Elizabeth Hospital Foundation Trust, Kings Lynn, UK). We would like to thank P. Lockey (NHS England) and M. Doherty for helpful advice, as well as all those who gave constructive comments during the consultation process.