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Drug Administration Errors in Anesthesia: A Review PDF

53 Pages·2004·0.6 MB·English
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Drug Administration Errors in Anesthesia: A Review D. John Doyle MD, PhD, FRCPC Pema T. Tulotsang BSc Revision 1.1 DRAFT NOTES May 12, 2004 Refer to file drug review ww 8g2.doc for color scheme for references and additional information Department of General Anesthesiology Cleveland Clinic Foundation 9500 Euclid Avenue E31 Cleveland, Ohio, USA 44195 Email [email protected] Tel 216-444-1927 Fax 216-444-9247 KEYWORDS Drug administration errors, error prevention, medical ergonomics, human factors in medicine, risk management 53 Pages 1 Abstract Drug administration errors have been an increasing focus of concern in anesthesiology. These errors usually pertain to the type of drug administered, the drug dosage, the rate of administration or the site of administration. Past studies have attempted to identify and understand the underlying etiology of these common forms of errors, so as to avert its often serious and sometimes fatal consequences. These studies have focused on errors relating to the administrator's theoretical knowledge, clinical experience, individual technique and other such related factors. This growing body of research has proven invaluable, not only by addressing the preventability of drug errors by clinicians, but also in leading constructive efforts to minimize their repeated occurrence. This article attempts to highlight the current understanding of drug administration error in clinical anesthesia and discusses the risk management techniques that may be of value in dealing with this problem. 2 Introduction Error is an inevitable aspect of all human endeavor, but in medicine, and especially in the field of anesthesia, it can take on life or death consequences.1-3 The overall rate of critical incidents in anesthesia is cited at less than 1% of all reported cases. However, 50% to 80% of these preventable 'critical incidents' are due primarily to human error, with nearly 7% resulting in otherwise avoidable, "substantive negative outcomes".4 One of the most serious type of errors, comprising a significant subset of these events, involves drug administration.5 Approximately 15% of all anesthetic critical incidents involve drug administration errors, which can include administration of the wrong drug, the wrong dosage, the wrong route, an incorrect speed of delivery or any combination of these.5 Past reports analyzing various aspects of these drug incidents, including error etiology and future prevention, have been published.4,5 Nevertheless, numerous incidents of otherwise preventable drug errors continue to occur. This article attempts to summarize the current understanding of drug errors in anesthesia as an aid to clinical risk management. 3 Drug Administration Errors 'Error' has been defined as "a planned sequence of mental or physical activities which fails to result in an intended outcome" 6. In this review, 'drug errors' in anesthesia are addressed specifically in the context of the following four categories: wrong drug, wrong route, drug overdose, and drug rate. Wrong Drug This is the most pervasive type of drug administration error, whereby a drug other than the one intended is administered to the patient. In one survey, 30% of anesthesiologists admitted to having made this type of error at least once in their career.7 According to one report, wrong drug errors constituted approximately 60%8 of all drug administration errors and in another study, these were responsible for nearly 8% of all reported anesthetic critical incidents.9 Anesthetics most frequently implicated in “wrong drug” errors were non- depolarizing relaxants followed by opioids, succinylcholine (suxamethonium), and local anesthetics. Table 1 lists the anesthetic drugs most commonly “intended” for administration, while Table 2 lists those most often incorrectly “selected” instead.9 The primary source of wrong drug incidents are generally "syringe swaps" or ampule errors, both of which refer to the accidental interchanging of the intended container with another, resulting in the wrong drug being administered. Syringe swaps 4 occur more frequently than do ampule errors, and they are the underlying factor of at least 46% of wrong drug incidents.9 By contrast, ampule errors constitute only 25% of these cases.9 Table 3 lists some syringe and ampule errors in anesthesia. In both instances, over half of the drug errors involved ampules or syringes of similar size, label and/or color. This occurs despite the fact that, in nearly two-thirds of the syringe swaps, the syringe or ampule was correctly labeled and, thus, readily identifiable.9 Other contributing factors cited in wrong drug incidents include errors involving drug location, labeling, assisting personnel and equipment use. In the study done by the Australian Incident Monitoring Study (AIMS), 'fatigue' was a major factor in 10% of reported wrong drug cases, while 'inattention' was cited nearly 50% of the time. Fortunately, none of the 144 reported drug error incidents resulted in serious long-term complication.9 Wrong Route Critical incidents involving the administration of an anesthetic drug via an incorrect route are sometimes a result of risks inherent to a particular procedure. For example, the incidence rate of inadvertent dural puncture during epidural analgesia is cited at one in 100 (although inversely proportional to experience of the anesthesiologist).10 Alternately, migration of an epidural catheter into the subarachnoid 5 space may sometimes occur. In such cases, the drugs believed to be administered in the epidural space may end up in the subarachnoid space. A quite different situation exists when drugs normally given intravenously (IV) are given via the wrong route. For example, Stedmon and Hammond11 documented a case of midazolam and fentanyl being accidentally infused through the epidural route. In 1987, Chong and Davis reported a case of intra-arterial injection of propofol.12 In comparison, the number of documented cases involving an inappropriately chosen route, using either an intended or unintended drug, is much fewer. Drug Overdose The administration of an unintended dose of drug is a relatively common error in clinical anesthesia. These errors can include large doses of the intended drug or, in some instances, be compounded by errors in drug selection.13 Such errors are sometimes a direct result of arithmetic mistakes in dilution. Confusion between preparations of varying concentrations commonly occur despite the warnings and markings prominently displayed on drug labels and packages.14 An example of such an incident was cited by Edgren and colleagues 15 in 1986. This incident involved a mix-up between a 5% dextrose solution with lidocaine hydrochloride, which resulted in the IV delivery of 1200 mg of lidocaine over a one-hour 6 period. Although the patient was only 6-years old and fatal outcomes in adult patients administered similar dosages have been previously documented, the child recovered fully without sequelae. However, in the Cooper et al. 4 study, which examined over 1000 preventable critical incidents across 4 hospitals, approximately 20% of the cases classified as 'substantive negative outcomes' were associated with drug overdose. Drug Rate The speed of anesthetic injection can become a serious concern when it involves drugs such as vancomycin or ritodrin, which dictate a specific rate of administration (Table 4). This instant flooding of the circulation by toxic drug doses can produce serious, if not fatal, consequences. For instance, in 1983, Chalmers 16 reported the inadvertent administration of etomidate at a rate of 250 mg over 45 minutes, rather than the prescribed 35 mg/hr, or a tenfold increase in the intended rate. Patient death resulted within the following week, succumbing to a deteriorating cardiac condition. This case is representative of other incidents of incorrect rates of drug administration, usually resulting from misuse of anesthetic devices. Other cases result from problems with drug labeling or other causes 17, 18, 19 7 Risk Management Drug error usually remains undetected until the patient manifests unexpected physiological reactions or, in fewer cases, fails to exhibit an expected result.9 Either of these situations can signal to the anesthesiologist that a procedural error has occurred. Ideally, this event will initiate a series of steps to successfully manage and resolve the crisis. Comprehensive procedural outlines governing anesthetic risk management are an essential aspect to reducing drug error. As discussed in previous reports, once the mistake has been recognized, action should be directed to reducing or reversing drug toxicity to maximize patient safety. Fortunately, most drug errors are quickly detected and successfully reversed.20 Second, an immediate investigation into the incident is necessary so as to identify the primary source of drug error (e.g., ampule swap), thereby reducing the likelihood of another similar occurrence. Third, all drug error incidents, whether major or minor, should be reported to the relevant parties. These parties may include hospital risk management officers as well as various national agencies. Regretfully, there are strong incentives against such reporting, particularly when anonymous reporting is not available. 8 International forums, such as the Critical Incident Reporting System (CIRS) in Switzerland and the Australian Incident Monitoring Study (AIMS), both distribute and collect critical incident reports. They guarantee a maximal degree of anonymity and medico-legal safety, a situation that tends to elicit very honest and detailed accounts from anesthesiologists. These reporting systems provide insight into contextual details and contributing factors to critical incidents, thus guiding correcting strategies to curb such future occurrences 9 INTERNET These reporting systems are universally applicable and in fact, often draw parallels between common anesthesia-related errors across the world. For example, the first 2000 reports collected from Australia and New Zealand in the AIMS study shared some similarity with the pattern, nature and proportion of incident reports found in the United States “closed-claims” studies. 9 INTERNET In Canada, it is recommended that incidents associated with drug labeling be directed to The Canadian Society of Hospital Pharmacists (CSHP), as well as the Canadian Drug Manufacturers Association (CDMA). 21 In the United States, the Food and Drug Administration (FDA) oversees both drug experience and drug quality reporting systems, which monitor adverse events resulting from drug labeling, packaging and other related factors. Specific factors often implicated include similarity between drug packages and drug names. These reporting systems are invaluable not only in alerting manufacturers 9 and health care workers of error-prone situations, but also in implementing the necessary changes to reduce their future occurrence. 22 Preventive Measures Lack of experience was one of the most commonly cited factors in anesthesia critical incidents, reflecting the need for greater and improved instructional training of anesthetic administrators. This is most relevant to residents, whose "sudden immersion" into the often stressful environment of the operating room (OR) may possibly increase their susceptibility to error.4 For instance, a survey conducted by Cooper et al. 13 reported that over 50% of the mistakes made by staff anesthesiologists during their careers had occurred while they were residents. These figures suggest that closer supervision of residents and stricter adherence to standard protocol could minimize these sources of error. Similarly, past studies have consistently emphasized the need for "meticulous attention" during anesthetic administration. 21 Another preventive strategy includes the standardization of drug arrangements in the anesthesia workplace so as to avoid placing similar sized and shaped drug ampules, syringes and other items close together on the anesthetic cart.23 Some even researchers suggest changing suppliers, if need be, to obtain different labels and reduce the likelihood of drug confusion. 21 10

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to human error, with nearly 7% resulting in otherwise avoidable, such future occurrences 9 INTERNET These reporting systems are universally applicable
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