Updated 26 th May 2016 Date on which guideline must be reviewed (this should be one to 26 th May 2019

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1 Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Contact Name and Job Title (author) Directorate & Speciality Anaesthetic Department Guidance Notes on Standards for Safe Drug Administration Dr Jo Lamb 23/10/11 (Original author) Consultant Anaesthetist, Head of Service Dr Jess Flack 26/05/16 (Update) Consultant Anaesthetist Theatres and Anaesthesia, Specialist Support Date of submission Originally submitted 23 rd October 2011 Updated 26 th May 2016 Date on which guideline must be reviewed (this should be one to 26 th May 2019 three years) Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Patients undergoing general and regional anaesthesia at NUH Abstract Key Words Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-5) 1a meta analysis of randomised controlled trials 1b at least one randomised controlled trial 2a at least one well-designed controlled study without randomisation 2b at least one other type of well-designed quasiexperimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process This guideline describes guidance notes on standards for safe drug administration within Theatres and Anaesthesia, using previous local and national drug errors and incidents to highlight what can occur when guidance is not followed. Anaesthesia Drugs Patient safety Informed by incident analysis from the specialty. Input from: Clinical Governance Committee Theatres and Anaesthesia NUH Clinical Rick Committee NUH Medicines Safety Group Datix reports up to and including March 2016 Feasibility of confirming drugs administered during anaesthesia. A qualitative study in pilot NHS sites, England and Wales October 2010 A collaborative project of the National Patient Safety Agency (NPSA), Royal College of Anaesthetists (RCoA) and Association of Anaesthetists of Great Britain and Ireland (AAGBI) Consultation with consultant anaesthetists at NUH and a trainee representative. Consultation with Specialty pharmacist Target audience All anaesthetists at NUH

2 This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. NUH THEATRES and ANAESTHESIA GUIDANCE NOTES ON STANDARDS FOR SAFE DRUG ADMINISTRATION Drug errors are among the top five reported patient safety incidents occurring during anaesthesia nationally, and locally at NUH. Drug errors in anaesthetics are uncommon, particularly in relation to the number of drug administration episodes, but errors at NUH have resulted in serious patient harm, and in most cases the error was avoidable. Whilst current practice is generally very good, our aim is to achieve zero avoidable errors. The reporting of errors, incidents and near misses has led to a number of important safety measures. Error reporting is very important to this work for patient safety. NUH Theatres and Anaesthesia Specialty asks all anaesthetists to be INFORMED and VIGILANT RIGHT PATIENT: PATIENT IDENTIFICATION AND ALLERGY CHECK RIGHT DRUG, RIGHT DOSE, RIGHT ROUTE, RIGHT RECORD RIGHT DRUG Conscious check when drawing up Conscious check and accurate labelling Check and confirm all drugs if another anaesthetist involved One patient, one ampoule Conscious check for each administration RIGHT DOSE Check the dose extra care for paediatrics Check the concentration Check the infusion rate on pumps and syringe drivers Don t double dose check the record Conscious check for each administration RIGHT ROUTE Check the drug is correct for intrathecal route Check the drug is correct for epidural route Check the drug is suitable for a peripheral vein Conscious check for each administration 2

3 RIGHT RECORD Timely and accurate anaesthetic chart, drug chart if applicable Essential for paracetamol, NSAIDs, antibiotics, anti emetics RIGHT DRUG, RIGHT DOSE, RIGHT ROUTE, RIGHT RECORD DEAL with Higher Risk Situations Distractions minimize interruptions, give attention to the task Emergencies recognize time pressure and high task load Automatic Behaviour conscious checking and vigilance, especially if very routine Lack of familiarity beware unusual environments, drugs and patient factors SUPPORTING INFORMATION The points below will help anaesthetists and theatre practitioners to understand and therefore avoid errors. 1. Drawing up and Labelling Syringes Right Drug Misidentification of ampoules and syringes is an important cause of mistakes. Around 30% of anaesthetic drug errors involve ampoules and incorrect checking or labelling when drawing up drugs. Ideally, drugs should be drawn up and labelled as close as possible to the time of administration. The ampoule label must be read and reread before discarding, and the correct coloured adhesive label applied, with concentration noted (particularly if any dilution has taken place). The drug should only be drawn into a syringe by the person who will administer it. When two anaesthetists are working together they should whenever possible second check the syringes drawn up. As a minimum there should be verbal confirmation of the syringe contents and concentration. Confirmation of drugs with a second person at the time of preparation and administration has been recommended to help prevent drug errors outside anaesthesia practice. A recent collaborative qualitative study by NPSA, AAGBI and RCA examined the feasibility of confirming drugs administered during anaesthesia by second person checking or electronic barcode confirmation. Confirmation of drugs administered during anaesthesia by either of the studied methods was perceived to contribute to the prevention of drug errors. Second person confirmation was not always feasible due to lack of continued availability of an appropriate second person. This method also met with some resistance from staff at a few pilot sites. For this method to be carried out properly there should be no distraction or time pressure. There has been no overall recommendation from the report the executive summary comments that introduction of the two person confirmation method will require serious consideration of the implications for resources and the impact on existing working practices and this recommendation has not been implemented at NUH. Other points to note: a. The practice of drawing up emergency drugs in anticipation of their use can pose a risk. If drawn up in advance, these drugs should generally be kept on a separate cardboard tray and stored away from the immediate work area. Emergency drugs should have a cap placed on the end of the syringe and a red and silver sticker placed over the cap to indicate that the syringe has not yet been used. A broken seal indicates that the syringe has been used, and should not be used on subsequent patients. Drug cupboard stocks should be checked to ensure that any drugs which may be required are immediately available. b. All anaesthetists are responsible for discarding drugs they have drawn up which are not needed including emergency drugs. Drugs and syringes should be disposed of in the yellow sharps boxes. c. Similar looking ampoules from the same manufacturer are more easily confused especially if the anaesthetist fails to read and re read the label. d. Ampoules available in different concentrations are a source of error (e.g. ketamine) 3

4 e. Returning unused ampoules to boxes is a source of error. Unused ampoules taken from their original packaging should be discarded or stored in the drug cupboard separately, usually in front of the boxes of the same drug. f. All anaesthetists are at risk of developing automatic behaviour for such a routine task. Awareness of this should help anaesthetists develop techniques to help them maintain the vigilance needed for conscious checking. Equally the team should make every effort to avoid distracting anaesthetists during the important task of preparing and labelling syringes. A trainee anaesthetist administered midazolam to a patient before siting an epidural. The syringe had been prepared and labelled by the consultant working with the trainee on the same operating list. Shortly after the drug was administered the patient was unable to maintain the sitting position and complained of difficulty with her breathing. The patient became hypertensive, had a tachycardia and had significant ST segment elevation on the ECG monitor. Subsequent analysis confirmed that the syringe labelled midazolam contained atracurium. While in the anaesthetic room prior to induction of anaesthesia an anaesthetist administered midazolam as an anxiolytic to a frail elderly patient with ischaemic heart disease. Shortly thereafter the patient had difficulty breathing. On examination of the labelled syringes the anaesthetist considered that there was a possibility that atracurium had been administered instead of midazolam (as two 5ml syringes were both labelled midazolam). A patient was admitted to E12 from theatre recovery. On completing the bedside checks with the recovery Nurse, a syringe without any additive sticker or indication of the drug it contained was attached to patient. The Recovery Nurse believed it to be noradrenaline, although she had not been responsible for drawing it up. When monitoring was re-attached following transfer to the E12 bed, the patient was found to have a BP of 43/27mmHg via the arterial line. NIBP confirmed hypotension of 54/34mmHg and the unlabelled infusion was found to not be running. Doctors were informed, metaraminol was given & BP returned to normal. An infusion of noradernaline had been documented as commenced in theatres at 17:00 on the anaesthetic chart, but no prescription was found for recovery or the ward. 2. Administering Drugs from a Syringe Right Drug Misidentification of syringes is a common source of error, even when these are correctly labelled. Around 40% of drug errors involve syringes. A well-recognised problem for anaesthetists is the inadvertent administration of suxamethonium instead of fentanyl before the induction agent. Conscious checking of syringe contents prior to administration is just as important as checking when drawing up drugs. When two anaesthetists are working together ideally they should second check the syringes drawn up. As a minimum there should be verbal confirmation of the syringe contents and concentration. Distraction and time pressure predispose to error. a. Syringes of local anaesthetics should always be kept on a separate cardboard tray from syringes for IV drugs. b. Syringes of the same size are more likely to be confused even when correctly labelled. c. All anaesthetists are at risk of developing automatic behaviour for such a routine task. Awareness of this should help anaesthetists develop techniques to help them maintain the vigilance needed for conscious checking. d. Syringes prepared for infusion must always be correctly labelled before putting into infusion pumps. A trainee anaesthetist was working solo on a busy list. He had drawn up metaraminol as an emergency drug. Halfway through administering Flucloxacillin from a 20ml syringe he realised he was in fact administering metaraminol. Both syringes were correctly labelled. The patient became hypertensive but recovered without ill effects. A transplant patient with type 2 diabetes on IV tacrolimus went to theatre for a laparotomy and hernia repair for small bowel obstruction. The theatre team were under the impression that the IV tacrolimus was an insulin sliding scale and so the rate of infusion of tacrolimus was increased inappropriately. It is unclear how this mistake was made. 4

5 3. One Ampoule, One patient Right Drug Sharing ampoules is poor practice for a number of reasons. Firstly it introduces the risk of cross contamination and has been implicated in the transmission of infection. Sharing ampoules of midazolam has been shown to predispose to incorrect labelling and confusion with other drugs, particularly atracurium the label is less likely to be clearly read as the anaesthetist makes a cognitive error in taking for granted it has already been checked. Unsupervised open ampoules of controlled drugs are open to abuse. Never share ampoules. 4. The Right Dose Incorrect doses are less common when standard drug concentrations are used. Double dosing is a common problem. Drugs which are also given in recovery and on the wards (pre or post op) cause particular difficulty. The most common drugs involved in double dosing are antibiotics, heparin, NSAIDs, anti emetics and paracetamol. A record should be made on the anaesthetic chart and the drug chart. a. Extra vigilance is needed with paediatric patients. b. Extra vigilance with unfamiliar drugs. c. Extra vigilance is needed in emergency situations. An infant suffered a cardiac arrest in theatre. The anaesthetist realised that an error had been made in calculating the correct dose of epinephrine. This did not have any bearing on the outcome but made a difficult situation even worse for the anaesthetist. 5. The Right Route Anaesthetists will be aware of well publicized fatal cases where intravenous medications have been administered by the intrathecal route and epidural medications by the intravenous route. This has been the subject of an NPSA alert and these wrong route errors will always be possible while standard luer lock connectors are used for both routes. There are also reported incidents locally where drugs which are only suitable for infusion in a central vein have been administered peripherally. A trainee anaesthetist new to obstetrics sited an epidural for a patient in labour under immediate supervision by a consultant anaesthetist. The consultant supervised the initial dose down the epidural catheter and then was called away to another patient. The trainee anaesthetist subsequently connected the epidural infusion to the patient s IV cannula. A student midwife noticed this and pointed it out to the anaesthetic CT2 before the infusion was commenced. A trainee anaesthetist was working solo on an orthopaedic list and was new to NUH. The anaesthetist placed a spinal with intrathecal morphine. The anaesthetist did not realise that the morphine had to be preservative free for the intrathecal route and used an IV preparation, as in prior training elsewhere the anaesthetists had only seen diamorphine used intrathecally. There was no patient harm. An epidural line was found attached to an intravenous cannula infusing at 4 mls per hour by a deputy sister when recording observations on the ward. The epidural catheter had white bung in situ on the filter with no infusion attached. 6. The Right Record Accurate and timely records help to avoid double dosing. Drugs which are given in theatre but also potentially recovery and the wards (pre or post op) cause particular difficulty. The most common drugs involved in double dosing are antibiotics, heparin, NSAIDs, anti emetics and paracetamol. (This list is not exhaustive). A record should be made on the anaesthetic chart and the drug chart. A consultant anaesthetist was working solo on an all-day gynaecology list. The consultant was relieved for a lunch break by a colleague who administered enoxaparin during the break and recorded it on the drug chart but not the anaesthetic chart. After resuming responsibility for the case, the original consultant also gave enoxaparin. 5

6 An emergency patient arrived at theatre reception in a collapsed state. The patient was brought into Recovery for fluid resuscitation and was given IV antibiotics (including gentamicin) by an anaesthetist according to surviving sepsis guidelines. No record of this was made, partly because the anaesthetist was fully occupied with resuscitating the moribund patient. The patient was taken into theatre shortly afterwards for a laparotomy and a second anaesthetist administered IV gentamicin. A patient was given a second dose of paracetamol when he had already had one in the last four hours. The anaesthetist hadn't seen the previous dose given on the ward which was recorded on the drug chart. Patient Safety First: High Risk Drugs Concentrated Potassium is treated like a controlled drug in Theatres at NUH. It is kept in pre filled syringes in a locked cupboard and must be double checked according to the local guideline. This came about following a reported incident. A consultant anaesthetist was managing a sick septic patient. An ampoule of concentrated potassium was on the anaesthetic machine ready to be drawn up in order to treat severe hypokalaemia. Inadvertently the potassium became confused with the antibiotics and the patient received a bolus dose of concentrated potassium. The patient developed a life threatening arrhythmia but was successfully resuscitated. Heparin >1000units per ml. This is a potentially dangerous drug as the concentrations can easily become confused. We do not put heparin in infusions or 10ml flush syringes for arterial lines and heparin of concentration >1000units per ml is only kept in recovery. Insulin insulin syringes should always be used to draw insulin from ampoules when preparing insulin infusions. Insulin should always be given by a dedicated line and flushing should be avoided. Always label the syringe fully with the patient sa name, infusion fluid, drug additive and concentration. Always prescribe in units, and write units, not U or IU (an incident on a ward at NUH saw 24 units of insulin given instead of 2 units as the prescription read 2IU but was misread as 24). The Safe Environment Organise your environment to reduce the chance of error for example always separate emergency drugs and local anaesthetics Minimize complexity consider whether you really need to draw up drugs in advance Be prepared enough not over prepared Further Information All the incidents described have occurred at NUH in the last few years. All the anaesthetists involved are highly competent well regarded colleagues. The incident reports have allowed us to make some changes to improve safety. Reporting incidents also helps us to make colleagues aware of situations predisposing to risk and to help in understanding the human behaviour which contributes to error. Feasibility of confirming drugs administered during anaesthesia. A qualitative study in pilot NHS sites, England and Wales October 2010 A collaborative project of the National Patient Safety Agency (NPSA), Royal College of Anaesthetists (RCoA) and Association of Anaesthetists of Great Britain and Ireland (AAGBI) 6

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