(a) Unusual response or lack of response to drug administration: pounding heart, mental status changes, apnea, muscle weakness and visual disturbances
(b) Extreme or unexpected increase or decrease in blood pressure or heart rate
(c) Unexpected or persistent muscle relaxation
(d) Unexpected change, or lack of change, in level of consciousness
(e) Incorrect ampule found to be open in work area
While maintaining cardiovascular and respiratory functions , clinicians should attempt to ascertain whether a wrong drug was administered and , if so, which drug (see Table 28.2).
Table 28.2
Checklist: steps to determine drug administered
(a) Check the syringes and ampules used during the case |
(b) Check to see if low volume unexpectedly remains in syringe |
(c) Inspect open ampules |
(d) Impound the “sharps” container to allow inspection of ampules and syringes at later time |
(e) Consider drawing blood levels to ascertain drug given |
Clinical Management of Apnea
The most common drugs that may lead to apnea in the operating room include muscle relaxants or highly potent opiates (such as sufentanil, which is ten times as potent as fentanyl). Alternatively, the patient may have a previously unrecognized metabolic disorder such as a neuromuscular disease (i.e., myasthenia gravis) or a structural abnormality (i.e., stroke or embolism) that needs to be evaluated. Treatment of medication-induced respiratory depression adverse event varies by cause (see Table 28.3). When respiration is depressed by opiates, as evidenced by miotic, unresponsive pupils, naloxone (Narcan) in 0.04 mg increments may be titrated to reverse the condition. In the case of persistent peripheral muscle blockade, typically due to residual muscle relaxants, reversal with neostigmine is initiated. Other interventions include discontinuation of anesthetics, determination of arterial blood gases, and appropriate adjustment of ventilation.
Table 28.3
Clinical management of apnea
(a) Ensure adequate oxygenation and ventilation |
(b) If the error in drug administration is recognized immediately after injection: a. Stop the IV carrying the drug b. Attempt to aspirate or drain the IV tubing to point of injection c. If there is blood pressure cuff on the arm of IV, inflate to slow down entry of drug to central circulation |
(c) Maintain normocarbia or slight hypercarbia |
(d) Increase O2 flow to breathing circuit to enhance elimination of inhalation anesthetics |
(e) Check neuromuscular function with nerve stimulator |
(f) If residual blockade is present: a. Give reversal medication to max of neostigmine dose of 70 mcg/kg along with glycopyrrolate up to 1 mg to reverse blockade b. Reassure the patient and continue short-acting sedation c. Consider potential synergistic effects of muscle relaxants and aminoglycosides—if so give 1 g calcium chloride to promote reversal of neuromuscular blockade |
(g) Review the doses of medication administered and check for syringe or ampule swap of opiates, hypnotics, muscle relaxants, anticholinergics |
(h) Consider reversal of specific drugs such as opiates (check the pupils), benzodiazepines, anticholinergics |
(i) Send blood samples for ABG and serum electrolyte levels |
(j) Conduct a neurological examination to exclude focal CNS injury as cause of failure to breathe |
Because the apneic episode lasted longer than 30 min, the anesthesia team began to question their initial assumption that the apnea was due to opiate sensitivity. They had obtained the cefazolin from the medication drawer of the anesthesia cart. The anesthesia team examined the drawer and found vials of cefazolin and vecuronium (a long-acting paralytic agent) in adjacent medication slots. The vials were of the same size and shape, with similar red plastic caps (see Fig. 28.1). The team realized that the patient had received vecuronium 10 mg, not cefazolin 1 g, and that the observed apnea was therefore due to unrecognized muscle relaxation.
Fig. 28.1
Look-alike drug vials
There are few accurate measures of the morbidity and mortality associated with anesthesia [15]. It has been estimated that between 2000 and 10,000 patients die each year from causes at least partially related to anesthesia, but those estimates are based on circumstantial data and include all patients regardless of age or physical status [16]. A recent study in the United Kingdom found that only one patient in 185,000 died solely as result of anesthesia, although 1 in 1351 deaths was in part related to anesthesia [17]. An estimated 44,000–98,000 Americans die in hospitals each year as a result of preventable medical errors [18]. Bates and colleagues have shown that medication errors were the number one cause of adverse and preventable patient events that 6.5 % of admitted patients suffered an adverse drug event, and they lead to more than 7000 deaths annually [19]. Of these events, 28 % were due to errors, and an additional 5.5 % involved near misses caught due to interception of the error. In the Harvard Medical Practice Study, adverse drug events accounted for 19.4 % of all disabling adverse events, 45 % of those events were caused by errors [20]. In a large insurer’s study, injuries due to drugs were the most frequent cause of procedure-related malpractice claims [21]. The prevalence of medication errors in the operating room is not accurately known. A recent study demonstrated that about half of all surgeries involve some kind of medication error or unintended drug side effects, a rate calculated by researchers who observed 277 procedures and found that 1 in 20 perioperative medication administrations included a drug error and/or an adverse drug event [22]. Perioperative areas are among the only remaining patient care areas that have not had rigorous assessments of medical errors to guide proposed solutions. Reductions in MEs in other patient care areas, including inpatient units and outpatient clinics, have occurred because error rates were measured, errors were categorized to determine their root causes and potential for harm, solutions were designed and implemented, and error rates were then systematically measured again to show a reduction. This process has occurred with solutions such as computerized physician order entry systems, bar-code scanning systems for medication administration in hospital pharmacies, and outpatient electronic prescribing systems [4, 23–25].
Wrong medication administration in the operating room is due to failure to label syringes, incorrect matching of labels on syringes and drug ampules, failure to read the label on the vial/ampule, misuse of decimal points and zeroes, and inappropriate abbreviations. What happened to this patient illustrates an example of faulty drug identity checking, where two drugs were packaged in similar vials, so that one was easily mistaken for the other. Poor system design also makes errors difficult to intercept before injury occurs. Leape and colleagues discovered that failures at the system level were the real culprits in more than three-fourths of adverse drug events [26]. Reason and colleagues suggested that some complex healthcare systems are more vulnerable and therefore more likely to experience adverse events [27].
Medication Errors in Operating Room
Documenting errors at the administration stage is difficult, because it requires direct observations and reliable, robust near-miss and adverse-event reporting systems . Currie and colleagues found 144 incidents related to drugs, of which 58 were related to syringe or drug swaps [28], among the first 2000 incidents of the Australian Incident Monitoring System . Of those 58 events, 71 % involved muscle relaxants. Implementing a red syringe color change for all succinylcholine drug administration in Australia has helped to reduce drug and syringe swap by 70 % [29]. A large, retrospective study of anesthesiologists’ self-reported incidents found that of a total of 1089 incidents, 71 were related to either syringe or drug ampule swap (7 %) [30]. Leape and colleagues found that 40 of 334 errors (12 %) at the stage of drug ordering and delivery were due to imperfect dose and identify checking [26]. Studies in intensive care units have produced similar results [31].
Administrative medication errors in the operating room and intensive care unit are believed to be more common in unfamiliar settings, when drug packaging or ampules have changed, when similarly appearing ampules are stored close together in the medication carts , when syringes are prepared by other personnel, when handwritten labels are used, and when lighting conditions are poor [32]. There is an exponential relationship between the number of drugs administered to a patient and the prevalence of adverse drug events [33].
System Theory and System Checks to Prevent Wrong Drug Administration
Although there is no excuse for failing to read medication and syringe labels, the occasional failure to do so represents an expected “slip,” more likely to occur with fatigue, distraction, or other causes of momentary lapses in concentration and failures in automatic behaviors [34, 35]. Not until recently did the pharmaceutical industry realize the importance of packaging medications to easily facilitate rapid identification of and discrimination between potent drugs used in operating rooms. For years muscle relaxants such as pancuronium vials were very similar to those of heparin. Some manufacturers continue to package ephedrine in ampules similar to those of oxytocin and epinephrine. This problem also occurs with different doses of the same drug—the vials for at least three concentrations of atropine sulfate from one manufacturer are similar. This results in inadvertent over- and underdosing.
Any medication drawn into a syringe for later use should be labeled immediately. Unlabeled and incorrectly labeled syringes invite errors in drug administration and dosing and should be discarded. Routine use of approved, commercial color-coded labels may reduce these errors. The labels should conform to the standards of the American Society for Testing and Materials (ASTM) [36].
A cluttered and disorganized workspace also predisposes to medication errors and searches that can delay administration of emergency medications. All anesthesia and resuscitation medication carts should be standardized (see Fig. 28.2), by applying a systematic method for stocking new and discarding outdated medications.
Fig. 28.2
A well-organized anesthesia cart that keeps similar-looking and/or similar-sounding drugs well separated
To understand the causes of errors, we must examine what happened, what was the root cause, and what were the underlying system failures. In a system analysis, people are viewed as an important safety resource, not only a source of errors. Designing robust transparent systems, with built in feedback control strategies, is important given human flexibility and fallibility. This was a case of unintentional administration of a paralytic agent in place of an antibiotic due to similar packaging. System checks that could be implemented here to avoid inadvertent drug swaps include color-coded labeling and reorganization of the anesthesia cart (see Table 28.4).
Table 28.4
System checks to prevent wrong drug administration
(a) Check for correct patient, drug name, concentration, dose, route, time |
(b) Use drug labels that conform to ASTM standards |
(c) Label syringes carefully—use preprinted color-coded adhesive labels |
(d) For emergency drugs, use “ready-to-use” syringes that are prepared according to ASTM standards |
(e) Standardize location of medications |
(f) Discard unlabeled vials, syringes |
Training all healthcare professions in the six rights—patient, drug, dose, route, time, and concentration—is critical to effective and safe medication administration. Recognizing environmental factors that predispose and distract clinicians is paramount. These include noise, interruptions, fatigue and lack of adequate rest, poor lighting, and poor information systems.
Part II: Organizational Medication Safety Management and Procurement
Formulary Management
While the hospital setting historically has a formal pharmacy and therapeutic committee that oversees the approved drugs endorsed by the medical staff, such structure usually does not exist in the ambulatory surgery centers (ASC) . This function is traditionally incorporated into the responsibilities of the “Medical Executive Committee” or similarly named committee. The charge to this committee should be to assure that the medications utilized in the facility are FDA approved, are appropriate for the size and scope of the facility, and will be safely managed using required equipment where necessary (such as calibrated pumps) and that the nursing staff has a pathway to assure safe handling of these medications.
Specifically, in addition, the committee should endorse the contents of the emergency “code cart” as well as, where applicable, the drugs required for reversal such as the malignant hyperthermia requirements and reversal agents availability, such as naloxone and flumazenil. It is in the purview of this committee to assure that the list is reviewed annually, as is the entire formulary, to assure continuing appropriateness with an eye toward contemporary and published guidelines and standards. Not only identified drugs, but the quantities of the agents in the “code cart” should be memorialized in the minutes of the meetings.
Controlled Drug Management
Perhaps the most focused area to review is the status of controlled drug management in the hospital or ASC. The management of controlled drugs represents significant challenges. The system has to afford easy access for both the nursing and anesthesia staff, be in compliance with state and federal laws and regulations, as well as being managed in such a way as to limit unauthorized access.
There are several interested parties who may present themselves with inquiry into the management of controlled drugs. The external parties might include the Department of Health, Board of Medicine, Centers for Medicare and Medicaid Services (CMS), accrediting bodies such as The Joint Commission or DNV GL (Det Norske Veritas), the federal Drug Enforcement Administration (DEA) , the Accreditation Association for Ambulatory Health Care (AAAHC) which oversees a majority of ASCs, as well as sections of the state government, which may have responsibilities on the state level for medication compliance.
Controlled drug records should reveal, in detail, basic documentation of drug, dose, and time administered, who administered, and, importantly, attestation of drug discard of partial doses. It is this latter requirement that is most vulnerable to review and, if not done properly, subject to inquiry as to the authenticity of the discarding providers’ procedures. Controlled drug discards should be done in real time and not at the end of the workday. Drugs should be rendered “non-recoverable,” which by definition, and may vary from state to state. Facilities could avail themselves of commercial products for such purpose, or, if allowable by individual states, discard to absorbable products and then to traditional waste systems.
One of the challenges in controlled drug management is to meet the needs of the anesthesia providers and, at the same time, assure that they are in step with the facility’s overall responsibility of documentation and safe medication management . Regarding the latter, it is imperative that single-dose products be preferentially utilized as indicated and not for multiple patients. This extends to other products, which at this writing are not “controlled” except in a few states, such as propofol, but are clearly designated as single patient use only.
The recording of retention of control drugs may vary from state to state, but it is recommended that a three-year retention be a minimal standard practice in hospitals and ASC.
Finally, as facilities move toward computerized medical records, as well as automated drug dispensing systems, the maintenance of control drug records will be less of a challenge. We will address automatic drug dispensing systems in another section of this chapter.
Safe Medication Management Education
One of the contemporary expectations of the pharmacist as well as the medical staff leadership is to assure that the nursing, surgical, and anesthesia staffs have access to drug information as well as presentations that are stipulated in accreditation standards. In fact, one such stipulation is in the area of malignant hyperthermia preparedness. It is imperative that the staff be well acquainted with the management of this sudden and life-threatening challenge. Further complicating this initiative is that the dantrolene sodium used for reversal tends to be difficult to manage under a time-dependent scenario that could have negative outcomes if drug management falls short. Likewise, incorrect administration could cause serious adverse outcomes including central nervous system side effects, speech and visual disturbances, mental depression and confusion, respiratory depression, and sedation [37]. While in the case of MH preparedness, an annual presentation is expected/required; the facility must also train new employees who have joined the facility after such a presentation.