Medication Safety in the Perioperative Setting
Drug administration errors are a major cause of morbidity and mortality in hospitalized patients. These errors result in major harm and incur dramatic costs to the delivery of health care. This article highlights this problem, especially as it deals with patients in the perioperative setting.
In 1999, the Institute of Medicine (IOM) reported that between 44,000 and 98,000 patients die annually as a result of preventable medical errors. These medical errors include adverse drug events, incorrect transfusion therapy, wrong-site surgery, and others. The IOM also found that at least 1.5 million preventable medication errors cause harm in the United States each year.1 The IOM concluded that the most serious consequences of these errors occur in operating rooms, intensive care units, and emergency departments.1
Drug administration errors are a major cause of morbidity and mortality in hospitalized patients. These errors result in major harm and incur dramatic costs to the delivery of health care. In the United States, medication errors are estimated to cause approximately 7000 deaths per year.2 Preventable drug errors are projected to directly cost a 700-bed teaching hospital $2.8 million annually,3 based on postevent lengths of stay and total costs.
In health care, and especially in anesthesia, medication errors represent one of most prevalent contributors of iatrogenic injury.4 The discipline of anesthesiology involves the delivery of multiple potent drugs, often given in rapid succession during high-acuity situations. The specialty is unique, as it is responsible for the direct preparation, dosing, and delivery of medications to patients by a physician and anesthesiologist, certified registered nurse anesthetist (CRNA), or anesthesia assistant (AA). In a survey of 687 Canadian anesthesiologists, 85% reported a drug error or near miss in clinical practice.5 In a New Zealand study, 12.5% of practitioners surveyed reported that they were aware of causing harm to a patient because of a drug administration error.4
The operating room milieu
The operating room is a distinct environment with a rapid workflow requiring immediate decisions and decision support. Research from the aviation industry indicates that errors occur more frequently in hectic, demanding and fast-paced environments,6 such as the operating room. Best practice methods from elsewhere in the hospital, however, are not readily transferable and applicable to this setting. Despite persistent education and best efforts, errors continue to occur in the perioperative environment.In most hospital areas, the typical workflow for medication administration to a patient involves important and time-consuming checks and balances (Fig. 1A). In this process, a physician first writes an order for a particular medication for a specific patient. A pharmacist then evaluates the order as it relates to the specific patient for appropriate dose, indication, patient allergy, and potential contraindications. The pharmacist next either approves the order or clarifies any questions. A nurse is next able to review the medication order in the hospital order entry system. If the medication is stocked on the patient floor, the nurse may obtain access to the medication after this approval process; otherwise a pharmacist must dispense the medication to the patient location. Before administration of the medication to the patient, the nurse reviews the five medication rights: right patient, right time and frequency of administration, right dose, right route of administration and right drug. After completing all of these steps, the nurse administers the medication to the patient. Not surprisingly, this process can take hours to employ, with several checkpoints and hard stops before a subsequent step in the process is undertaken.
| ||
Fig. 1 (A) Typical process for medication administration in the hospital. (B) Typical process for medication administration in the operating room. | ||
In the operating room, the process is dramatically abbreviated. The anesthetist internally writes an order, approves an order, prepares the medication, and administers the medication to a patient. This practice often takes seconds, and lacks the safeguards that exist in other areas of the hospital (see Fig. 1B).
Types of medication errors
Medication errors in anesthesia are not new, and unfortunately, they continue to occur despite being studied and reported since the earliest days of the specialty. Thirty years ago, Cooper and colleagues published a landmark study in anesthesia when they applied the model of critical incident reporting, a concept that originated in aviation, to the study of perioperative safety.7, 8 Critical incident analyses of major errors in anesthesia management revealed that human error was involved in nearly 70% of all events. One-fifth of all events discovered in this study were related to medication errors; yet of the incidents attributed to human error, approximately one-third were related to medications. Such events included inadvertent syringe substitutions, drug overdoses (syringe or vaporizer), and wrong choice of drugs. These findings began to bring awareness of patient safety to the fields of medicine and anesthesia.A study by Webster and colleagues,9 of nearly 8000 delivered anesthetics, reveals that one drug administration error occurs for every 133 anesthetics (0.75%) and a near-miss rate of 0.37% for all medication errors including boluses and infusions. The two largest categories of medication errors included incorrect dosing (20%) and accidental substitutions (20%). Sixty-three percent (63%) of all errors involved intravenous boluses. Amongs the intravenous bolus substitution errors, most occurred between different pharmacologic classes. These errors were implicated in subsequent negative outcomes, involving intraoperative awareness, prolonged mechanical ventilation, and transient physiologic effects requiring additional interventions. None of these reported errors resulted in death or permanent morbidity. More recent work, however, has approximated that 1 in every 250 drug errors is fatal.10
It is important to make a distinction between self-reporting studies and observational studies. The drug error rate of 0.75% as per Webster and colleagues may appear superior to error rates observed on medical wards (approximately 20%),11 but it must be noted that voluntary reporting study designs are much less sensitive than observational studies.
Webster and colleagues9 classify drug errors into the following categories
Omission—drug not given
Repetition—extra dose of an intended drug
Substitution—incorrect drug instead of the desired drug
Insertion—a drug that was not intended to be given at a particular time or at any time
Incorrect dose—wrong dose of an intended drug
Incorrect route—wrong route of an intended drug
Other—a complex event not falling into the previously mentioned categories.
Among 205 American Society of Anesthesiologists (ASA) closed claims for drug errors (representing 4% of all claims in the ASA Closed Claim Project Report in 2003), 31% of cases were described as incorrect dose; 24% were substitution, and 17% were cases of insertion. Other cases accounted for 24%.12
The similarity of medication names, drug vials, and label colors and frequently illegible documentation all play a major role in the occurrence of errors (Fig. 2). Additionally, the preparation of drugs and the need for specific calculations under time constraints may further promote medication errors. A medication error can be defined as an error in the prescription, dispensing, or administration of a drug with the result that the patient fails to receive the correct medication or the proper dosage.13 In anesthesia, prescription refers to the decision of which drug to administer; dispensing refers to the selection of the drug from the pharmacy or anesthesia workstation along with the preparation of the drug, as medications are often transferred from vial to syringe, and administration describes the delivery of a drug to a patient.
| ||
Fig. 2 (A) Medication labeling compliance in the operating room. (B) Medication labeling errors in the operating room—three different errors in drug concentration: Succinylcholine concentration listed as 10 mg/mL is actually 20 mg/mL; Propofol concentration listed as 20 mg/mL is actually 10 mg/mL; Atropine concentration listed as 0.04 mg/mL is actually 0.4 mg/mL. (C) Look-alike drug vials in the operating room. | ||
In an effort to promote safe administration of medications to patients and to standardize labeling practice, the ASA has developed medication labeling standards, and The Joint Commission (TJC) has developed national patient safety goals promoting safe administration of medications. Drug labeling requires time and vigilance, is prone to human error, and is a major compliance issue when hospitals are being evaluated and accredited.14, 15 Incomplete labeling by clinicians is common (see Fig. 2A), along with medication labeling errors (see Fig. 2B). Medication labeling errors have been found to approach 10%. These incomplete and incorrect labels can lead to administration errors and faults in communication during handoffs and relief.16
While the ASA medication color labeling standards have been adopted by most anesthetists, practitioners have struggled to comply with TJC labeling standards, with less than 50% of syringe labels meeting TJC requirements.14 This poor compliance causes one in five hospitals to be cited for poor medication labeling compliance on TJC surveys.14 The preparation of medications and their appropriate labeling of medications by the anesthesiologist, CRNAs, or AAs, are brief processes that have potential pitfalls and barriers to accuracy and safety. TJC has specific requirements for labeling medications as a means of mitigating this problem. As a national patient safety goal, TJC instructs to “label all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field.”15 Clinicians in the operating room understand the importance of drug labeling, but often find the time pressure too great to allow full compliance with the task. A 2004 study by the Institute of Safe Medication Practice (ISMP) found that 42% of clinicians label inconsistently.16 For anesthetists in the operating room, there are many competing demands, ranging from the time required to fill out multiple fields to writing legibly on a small and sometimes wet label.
Perioperative standards and regulations
In January 2010, the Anesthesia Patient Safety Foundation (APSF) issued consensus recommendations on perioperative medication safety.17The APSF proposed a new paradigm built upon the traditional requirements of medication label formatting and an emphasis on the careful reading of labels. The APSF recommended a new paradigm of standardization, technology, pharmacy, and culture (SPTC).
Standardization
High alert drugs should be available in standardized concentrations/diluents prepared by pharmacy in a ready-to-use (bolus or infusion) form that is appropriate for both adult and pediatric patients. Infusions should be delivered by an electronically controlled smart device containing a drug library. Ready-to-use syringes and infusions should have standardized fully compliant machine-readable labels.
Technology
Every anesthetizing location should have a mechanism to identify medications before drawing up or administering them (bar code reader) and a mechanism to provide feedback, decision support, and documentation (automated information system).
Pharmacy
Routine provider-prepared medications should be discontinued whenever possible. Clinical pharmacists should be part of the perioperative/operative room team. Standardized pre-prepared medication kits by case type should be used whenever possible.
Culture
Establish a just culture for reporting errors (including near misses) and discussion of lessons learned. Establish a culture of education, understanding, and accountability via a required curriculum and dissemination of dramatic stories. Establish a culture of cooperation and recognition of the benefits of these proposed changes within and between institutions, professional organizations, and accreditation agencies.
No matter how vigorously an individual or group of individuals attempts to perfect their drug delivery skills, human error persists. Health care professionals, who vow to protect patients from harm at all costs, must embrace this multifactorial approach to patient safety in the context of medication administration.
It is the duty of the anesthetist to care for and protect the patient during surgical procedures. It is crucial to understand the lapses in modern-day systems that lead to medication errors, so that they can be addressed and techniques optimized to keep patients from being harmed.
Solutions: techniques and technology
Given the known potential harm and frequency of medication errors in the perioperative setting, several recommendations have been introduced in an effort to reduce these errors. Traditionally, providers have been encouraged to read labels carefully, up to three or four times for confirmation.18 This simple technique may not suffice, as drug errors continue to occur in anesthesia and perioperative medicine.5 An anesthesiologist administers over 500,000 drugs during a career,5 and maintaining 100% accuracy is nearly impossible. Similar medication names, ambiguous or illegible labels on ampoules or syringes, and the lack of drug tray/cart standardization intertwined with intrinsic human factors continue to contribute to medication errors. The operating room environment, with abundant diversions and production pressures, dynamic physiologic changes in patients, and the potential for provider fatigue may all play key roles in errors.
Evidence-based solutions have been developed and studied to optimize the following objectives:
Compliance with regulatory standards and requirements
Elimination of medication delivery errors
Improvement in communication between providers
Improvement in real-time electronic documentation
Provide real-time clinical alerts.
Systematic review of the literature for recommendations that minimize errors in intravenous drug administration in anesthesia reveals strong suggestions19:
The label on any drug ampoule or syringe should be read carefully before a drug is drawn up or injected
The legibility and contents of labels on ampoules and syringes should be optimized according to agreed standards
Syringes should always be labeled
Formal organization of drug drawers and workspaces should be used
Labels should be checked with a second person or a device before a drug is drawn up or administered
Errors in intravenous drug administration during anesthesia should be reported and reviewed
Avoidance of similar packaging and presentation of drugs.
Modifications to the current system of practice to improve deficits in medication preparation, handling, and administration must be simple and easily integrated with operating room workflow. The implementation of standardization and technology to eliminate the human component has the potential of minimizing variability and inconsistency that leads to medication administration errors. Some of the solutions that have been developed and that are available will be discussed.
Many hospitals have begun using prefilled medication syringes. These syringes have the advantage of removing the necessary work of medication preparation and syringe labeling (transferring the medication from the vial to the syringe). Pharmacy compounding companies produce almost any medication and any concentration desired by clinicians. Individual anesthesia groups or hospitals can develop standard drug formularies, yet nationally there remains a struggle with consensus on a standardized drug formulary. This is also impacted currently by ongoing drug recalls.
Prefilled syringes are helpful for a portion of the anesthesiologist’s work but do not completely address all of the practitioner’s needs. Medications like propofol are not produced by compounding facilities. Other medications have only a 24-hour shelf life once transferred from the vial to the syringe or once they are diluted.
Some hospitals are developing in-house syringe preparation by using either pharmacy technicians or automated equipment such as the IntelliFill I.V. System (FHT, Inc, Daytona Beach, FL, USA). This system is designed to produce small-volume intravenous medications safely and quickly with a goal of improving medication safety.
In response to a report of 10,000 parenteral drug administration errors in the United Kingdom in 2006, 25 of which were fatal,20 a technological solution, SAFERamp (Cambridge Enterprise, Ltd, Cambridge, UK), was developed. SAFERamp is a single-use ampoule opening and syringe-labeling device developed to increase safety and consistency while decreasing reliance on clinician accuracy in the preparation of medications. This process involves a syringe and ampoule apparatus that automatically labels the barrel of the syringe.
SAFERsleep is a system developed by Dr Merry’s group in New Zealand. It is a system that uses bar-coded labels containing data for the drug name along with a standardized anesthesia drug tray. Upon administration, the clinician scans the medication’s bar code containing medication name, and the system provides both a visual and auditory confirmation of the administration. The time of administration is recorded electronically, excluding the need for written documentation.
Other solutions have been developed in an attempt to improve patient safety and reduce the impact of human error during the delivery of drugs. Docusys provides a computerized interface for medication management, closed-loop narcotic tracking, and medication error prevention support through its optional pharmacy and point-of-care technology, integrating drug administration and automatic documentation of the medication and medication dose.
Safe Label System by Codonics, Incorporated, (Codonics Middleburg Heights, OH, USA) uses a bar code-assisted method of medication identification and labeling. The machine readily deciphers the US Food and Drug Administration (FDA)-required medication vial bar code, runs a series of safety checks on the drug vial, and then provides audio and visual confirmation of the medication name while printing a label. The printed label has information including drug name, concentration, date/time of preparation, date/time of expiration, user name/initials, and a barcode containing all this information that can be used at the time of medication administration to the patient. In clinical use, labeling compliance was found to be 100% with the Safe Label System compared with poor compliance rates with traditional/manual methods of labeling.21 The time required to label medications with the Safe Label System was also faster compared with standard methods.22
Additional safety checks can be easily incorporated into new technological systems, without hindering workflow and convenience. Examination of medication recall and expiration, crosschecking for patient allergies, and real-time entry into the anesthesia record are all potential improvements that can keep patients safe during perioperative care. In addition, serialization of each bar code can allow safety checks that ensure syringes are not accidentally used on multiple patients.
Reporting errors: a new culture
As the health care industry continues to be increasingly regulated, physicians must accept responsibility, assume transparency, and embrace accountability to maintain best practices for patients.
One can again learn from the aviation industry as a new culture that is a just culture and a nonpunitive setting are developed for reporting errors or near-miss events. In aviation, accidents and errors are treated as evidence of a damaged system. These events are perceived as prospective opportunities to remedy faults in an overall structural design. The Swiss cheese model of hazards leading to losses in the context of a chain of errors through successful layers of defenses and safeguards provides a system-based understanding of the causes of error (Fig. 3).23
| ||
Fig. 3 The Swiss cheese model of accident causation. | ||
(From Reason J, Carthey J, deLeval M. Diagnosing “vulnerable system syndrome”. An essential prerequisite to effective risk management. Qual Health Care 2001;10(Suppl II):ii21–5; with permission.) | ||
In the operating room, multiple factors, including the prescriber, the drug administrator, the environment, the labels, and the formulations, all contribute to the medication delivery system and medication errors. Following an error, it may be easiest to blame an individual, but this is a culture that should be abandoned. An individualistic approach assigns blame and does not address the needed repair of broken systems. This rationale is unsound and often deters from the implementation of safety measures and honest reporting of lapses in an organizational schematic.
The development of modern reporting technologies in conjunction with quality assurance committees has led to potential improvements in transparency.24 A nonputative forum is likely to promote the willingness of clinicians to account for errors and near misses. Physicians are not good reporters of errors, and this is exacerbated if there is a lack of objective feedback or presence of an impartial setting.25 Opportunities to learn from errors require an integrated framework that is objective and can make formal recommendations on patient safety practices.26 It has been shown that as more critical incidents are reported, the number of adverse events decreases.27
Summary
In an era of health care reform and increased emphasis on the elimination of preventable errors, physicians have a moral and legal imperative to adapt and improve patient safety practices. Modern-day society is unrelenting toward clinicians and hospitals committing clinical errors leading to serious consequences and injury to patients. In addition to the costs of human suffering, clinical errors have been implicated in the rising of health care expenditures. Medical errors lead to additional health care use, lost employment time and income, increased need for rehabilitation services, and disability, all estimated to cost between $17 billion and $29 billion annually.1
Medication errors in the perioperative setting have been studied and reviewed, and anesthesiologists have a crucial role in developing safe drug delivery strategies. The standardization of medications, in conjunction with the implementation of technological solutions to provide real-time feedback is necessary for optimizing patient safety. The promotion of a culture of accountability and increased transparency is needed to encourage clinicians to report errors, so that further analysis and recommendations can be provided. The process of reporting in a formal and unbiased forum helps a clinician understand the specific nature of the error, and an opportunity is given to rectify systems-based factors that may have contributed.
References
1. . To err is human: building a safer health system. Committee on the Quality of Health Care in America, Institute of Medicine. Washington, DC: National Academy Press; 1999;.
2. . Increase in US medication error deaths between 1983 and 1993. Lancet. 1998;351:643–644. Full Text| Full-Text PDF (57 KB) | CrossRef
3. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group.J Am Med Assoc. 1997;277:307–311.
4. . Anaesthetists, errors in drug administration, and the law. N Z Med J. 1995;108:185–187.
5. . Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth. 2001;48:139–146.CrossRef
6. . Studies in cockpit task management errors. Int J Aviat Psychol. 1996;6:307–320.
7. Preventable anesthesia mishaps—a study of human factors. Anesthesiology. 1978;49:399–406.MEDLINE | CrossRef
8. . An analysis of major errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology. 1984;60:34–42. MEDLINE | CrossRef
9. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care.2001;29:494–500.
10. . Medication administration in anesthesia: time for a paradigm shift. APSF Newsletter. 2007;22:44–46.
11. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162:1897–1903.MEDLINE | CrossRef
12. . Drug administration errors from the ASA closed claims project. ASA Newsl. 2003;67:11–13.
13. . Medication errors in anaesthesia and critical care. Anaesthesia. 2005;60:257–273. MEDLINE | CrossRef
14. Top standard compliance issues for first half 2007. Jt Comm Perspect. 2008;28:1–3.
15. . Joint Commission on Accreditation of Healthcare Organizations requirements and syringe labeling systems. Anesth Analg.2007;104:242. CrossRef
16. Institute for Safe Medication Practices (ISMP) medication safety self-assessment. Available at: http://www.ismp.orgAccessed December 22, 2010.
17. . APSF hosts medication safety conference: consensus group defines challenges and opportunities for improved practice. APSF Newsletter. 2010;25:1–20.
18. . Reporting every look alike is no longer novel: similarities between labels are a fact of life. J Clin Anesth.1992;4:347–348.
19. Evidence-based strategies for preventing drug administration errors during anaesthesia.Anaesthesia. 2004;59:493–504. MEDLINE | CrossRef
20. Promoting safer use of injectable medicines. London (UK): British NHS/National Patient Safety Agency; 2007;.
21. Vernest KA, Nanji (Caputo) K, Driscoll WD, et al. Smart labels: improving syringe labeling compliance and patient safety in the operating room. Presented at the ASA Conference, 2009. New Orleans (LA). October 17–21, 2009.
22. Caputo (Nanji) K, Vernest KA, Driscoll WD, et al. Smart labels: improving syringe labeling efficiency and accuracy in the operating room. Presented at the ASA Conference, 2009. New Orleans (LA). October 17–21, 2009.
25. . The attitudes and beliefs of healthcare professionals on the causes and reporting of medication errors in a UK intensive care unit. Anaesthesia. 2007;62:53–61. MEDLINE | CrossRef
26. An integrated framework for safety quality and risk management: an information and incident management system based on a universal patient safety classification. Qual Saf Health Care. 2006;15:i82–i90. CrossRef
27. . Seven steps to patient safety: an overview guide for NHS staff. Available at:http://www.nrls.npsa.nhs.uk/resourcesAccessed December 22, 2010.
No comments:
Post a Comment