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INTRODUCTION: CAUSES AND CONSEQUENCES OF MEDICATION ERRORS IN THE UNITED STATES

Medication errors are a leading cause of harm in healthcare and pose a significant risk to patient safety. Many definitions of medication errors have been published and multiple systems are used to categorize errors. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm.”¹ Additionally, NCC MERP states that a medication error can occur “while the medication is in the control of the healthcare professional, patient, or consumer.” This definition has been accepted by other agencies and organizations, including the Centers for Medicare and Medicaid Services and the Joint Commission.^1-3 Essentially, medication errors can occur through ignorance or inadvertence; they can occur during calculation, judgment, speech, writing, or action; and medication errors can be made by physicians, nurses, pharmacists, technicians, and other staff members or healthcare professionals, as well as patients themselves.⁴

Actual medication error rates are difficult to quantify. Estimates often vary by reason of diverse error reporting and detection methods used in data collection. In its sentinel report of medication safety, To Err is Human, the Institute of Medicine (IOM) estimated that as many as 98,000 people die in hospitals every year as a result of preventable adverse events in healthcare,^5-7 accruing more than $30 billion in direct and indirect costs annually in the United States (U.S.).⁶ Medication errors are common in healthcare and account for 19% of all adverse events, causing more than 7000 deaths each year. In addition, IOM estimates that 1.5 million adverse drug events—negative clinical outcomes as a result of medication use—occur annually, costing $3.5 billion in the hospital sector alone.^7,8 It is noteworthy to consider that the IOM report was based on data obtained from a review of medical records in 1984. New estimates of the rate and impact of errors may be more than twice as high as the original figures.⁹ A 2016 study from Johns Hopkins reported that 10% of all deaths in the U.S. are caused by medical errors (any incident in healthcare, related or unrelated to a medication, that does not achieve its intended outcome), ranking these errors as the third-leading cause of death in the U.S., an increase from the eighth-leading cause when the original IOM report was published.¹⁰ In addition to both direct and indirect costs and the obvious detriment to patient safety, a significant consequence of such errors is the loss of trust and confidence in the healthcare system by patients and healthcare professionals.³

The medication-use process involves multiple steps that offer several opportunities for errors. Patient characteristics, drug ingredients and formulation, and routes of drug administration all contribute to risk profiles and potential errors.^11,12 Major causes of medication errors involve communication errors, including oral and written communication and misinterpretation of information; name confusion, such as similar or confusing drug names; labeling errors; human factor errors, such as knowledge deficits and dose miscalculation; and errors related to the packaging or design of a drug product, such as confusion related to tablet or capsule formulations or device design.^3,13 Several factors that commonly contribute to medication errors are listed in Table 1.^3,13-15

Safe medication use involves several rights (listed below) that are the responsibility of not just the individual healthcare worker but the organization and system within which the worker function. A medication error often constitutes a violation of one of these rights¹⁶: 

• Right patient
• Right drug
• Right dose
• Right time
• Right route
• Right reason
• Right documentation 

Most medication errors are not the fault of a single individual or event; rather, they are caused by professionals operating in a highly variable and complex system of healthcare delivery and medication use.⁶ Errors are usually attributed to at least 1 of 10 key elements that affect medication safety. The 10 elements, identified by the Institute for Safe Medication Practices (ISMP),¹⁷ are listed in Table 2 and are related to the following steps of the medication-use process: prescribing, order processing, dispensing, administration, and monitoring.^6,14,16,17

According to several reports, medication errors most often occur during the prescribing, dispensing, and administration phases of the medication-use process.The prescribing stage of medication use is highly susceptible to errors, and illegible handwriting and misinterpretation of orders are frequent offenders during this process.¹³ One report approximated that 30% of medication errors occur because of similar product packaging/labeling and illegible handwriting.¹⁴ In addition, one-third of medication errors that occur in hospitals reportedly take place in the dispensing, administration, and monitoring phases of drug therapy.^16,18-20

Look-alike sound-alike (LASA) drug products are potential sources of confusion, which can be attributed to similar labeling and packaging of drugs. Most cases of LASA medication errors that occur are related to poor performance, overly burdened staff, and psychological factors such as confirmation bias, which is the tendency to interpret new information as confirmation of an existing belief. Errors with LASA products may be lessened by the following interventions: (1) continually reviewing and highlighting LASA medication errors and near misses, which are errors that do not reach the patient and are also called “close calls” or “good catches,” with all personnel involved in medication use; (2) using labeling or storage solutions to differentiate confusing drug names; (3) independently verifying LASA products, which involves 2 clinicians who separately check each component of the medication order or prescription and then compare results;¹⁴ (4) using indication during the prescribing process to differentiate among LASA products^21,22; and (5) emphasizing the importance of reporting LASA issues to organizational, manufacturing, and regulatory representatives.¹⁴

Consequences of medication errors range from causing no harm to causing patient discomfort to causing devastating harm or death.²³ Therefore, documenting and analyzing potential risks before they contribute to medication errors is essential to the process of improving patient safety.²⁴ Regulatory and accreditation agencies, including the Joint Commission, have made patient safety a top priority.⁶ Patient safety goals established by the Joint Commission are broad and cover multiple areas, including patient identification, improved communication, infection control and prevention, and reducing errors in the surgical setting.²⁵ Despite these efforts, medication error and patient safety reporting programs are often inconsistent. As a result, the means by which these programs affect an organization’s ability to investigate and draw conclusions from safety-related events is unclear.⁴ Experts and clinicians continue to debate the best methods to classify and define errors, good catches, and adverse events in healthcare.^26,27

THE SCIENCE OF SAFETY: QUANTIFYING RISK IN HEALTHCARE

The concept “science of safety” originated in a 2006 report by IOM, which offered recommendations about how drug safety can be improved in the U.S. The science of safety describes the systematic study of the negative impact created by drugs and devices in humans at all stages of a product’s life cycle. Overall, the science of safety aims to help scientists and practitioners²⁸: 

• Understand, explain, and predict risk from exposure to medications and devices used in the delivery of healthcare 
• Understand how safety principles can be applied to improve the identification, understanding, reporting, managing, and communication of risks at all stages of the medication-use process 

There are 2 general approaches to patient safety: (1) learning from or reacting to previous mistakes or system failures; and (2) identifying latent failures that present preconditions for errors before an error occurs.^27,29 Two widely accepted approaches for assessing or predicting actual and potential risks in the medication-use process are root cause analysis (RCA) and failure mode and effects analysis (FMEA). Both processes are required components of patient safety programs in hospital settings.³⁰

Root cause analysis

RCA is a structured, retrospective approach to the investigation of safety-related incidents. The RCA approach to investigating and identifying areas of risk originated in the manufacturing and engineering sectors and is frequently used in other high-reliability organizations, such as petrochemical, nuclear power, aviation, and aerospace industries, to uncover system weaknesses and factors that contribute to workplace safety incidents.^19,31,32 An RCA that is applied in the healthcare environment utilizes a team-based approach to identify what, how, and why a safety-related incident occurred.³¹ The team may use frameworks such as Brainstorming, Pareto Analysis, the Five-Whys technique, and Fault-Tree Analysis to gather evidence and discuss and analyze the findings^31,33 (Box 1).^34-37 Once the root cause of an incident is identified, learning needs are determined and recommendations are formulated to minimize the risk of the incident recurring.³¹ An RCA should be conducted when a medication error occurs and should focus on systems and processes to determine why an error occurred; it should not focus on the individual who made the error. Some hospitals may use an abbreviated approach to evaluate some errors and a full multidisciplinary approach to evaluate serious errors.

Overall, an RCA includes multiple steps that are focused on uncovering answers to the following questions^19,38,39: What happened? What normally happens? Why did it happen? At which step did the failure occur? How can the incident be prevented from happening again? Routine steps that are involved in an RCA are listed below: 

• Step 1: Identify the incident to be analyzed
  Step 2: Organize a team to conduct the RCA
  Step 3: Study the work processes involved in the incident
  Step 4: Collect the facts related to the incident 
  Step 5: Search for causes of the incident
  Step 6: Take action
  Step 7: Evaluate the actions taken 

In practice, a healthcare professional may discover an error. When this error is brought to the attention of the respective department or manager, the person who discovered the error is often included in the team that investigates the incident. Arguably, the most important function of an RCA is to prevent a patient safety incident from happening again. An action plan and a measurement strategy must be implemented to address the root cause of the incident. Also, organizational learning and training needs must be identified and recommendations to improve patient safety must be formulated.^31,38 While an RCA is a reactive process that takes place after patient harm or an error has occurred, it likely has utility in good catches.³⁸ An RCA should provide data on the prevalence and causes of medication errors, but low levels of reporting and inadequate feedback often devalue the information that are collected.²⁷

There are a lack of well-designed patient-safety and quality-improvement resources available to healthcare professionals, which leads to myriad difficulties and hazards in the process of completing an RCA.^33,40 In addition, controlled clinical trials supporting the efficacy of the RCA framework are lacking. Some single-incident analyses have reported positive results from RCA investigations; however, evidence is limited that RCA findings lead to significant and long-lasting changes in human performance or system-wide factors.³¹ Nonetheless, RCA is still a valuable management tool that promotes the idea of learning from mistakes and moves far beyond error prevention strategies of the past, which consisted primarily of reminding professionals to be careful.³⁸ Important considerations in a patient safety investigation include the following: 

• Determine chronology. An RCA should include a detailed sequence of events. An accurate timeline is necessary to uncover what happened before, during, and after the incident under investigation.³³ 
• Understand policies and procedures and real-world conditions. Often, an RCA fails to uncover the “real world” situations that led to an event. Identifying what normally happens, in addition to the written policies and procedures, helps investigators determine the reliability of processes and how staff members skip or modify important steps to accomplish their work.³³
• Investigate risky behavior. An RCA must question how the organization manages information, environmental constraints, human resource challenges, as well as technology failures and malfunctions. Recurring identification of these issues may uncover latent system failures.^27,33
• Investigate human factors. Human error should be investigated to determine factors that influenced performance, such as task complexity, workflow, time availability, process design, experience, training, fatigue, and stress. However, an RCA that concludes “human failure” as the cause of an incident does not reveal system weakness or promote the redesign of safe systems.^27,33
• Seek outside knowledge. RCA teams must examine similar errors or incidents outside the system or in literature to learn from others’ experiences.^33,38The team should review research, case reports, regulations, practice standards, and professional guidelines and consult experts in safety and clinical practice when investigating a medication error.³³ Healthcare professionals agree that it is useful to have input from individuals removed from the incident under investigation. An independent viewpoint can offer objective answers to cause-and-effect questions. In some instances, patient input may also be valuable.³¹
• Establish cause-and-effect. All interventions that are based on RCA findings should be clearly linked to a causative factor. The action plans should directly address the root cause of the incident.³³
• Share information. While confidentiality is paramount in healthcare, sufficient information regarding errors should be shared openly with staff members who will be instrumental in implementing changes.³³
• Recommend strong strategies. “Education” and “new policies and procedures” are common recommendations after an RCA, though these are considered weak interventions.³³ Additionally, many RCAs simply recommend repeating existing policies or confirming previous recommendations.³⁹Further, strategies that rely on human performance and vigilance to prevent errors will not lead to long-lasting, system-wide change.^27,33 The most effective risk-reduction strategies involve redesigning systems to make them resistant to human error and removing incentives for skipping important steps in the medication-use process.³³

Training is needed before clinicians or staff members are able to conduct an RCA, which is a barrier to widespread utility of this patient safety instrument.¹⁹ Another challenge of an RCA is the time that is required for professionals to conduct an investigation. Therefore, the support and participation of organizational leadership is critical to the usefulness of an RCA since managers and administrators must encourage workplace transparency, sharing of concerns, and learning across the organization.³¹

Failure mode and effects analysis

While an RCA asks “Why did the system fail in the past?,” an FMEA asks “How could the system fail in the future?”²⁴ An FMEA is a structured, proactive method for prospectively evaluating a process to identify where and how it might fail and to assess the relative impacts of different failures.^23,41 The FMEA framework has been endorsed and supported by the Joint Commission,^41-43 the Institute for Healthcare Improvement, and ISMP.⁴¹ Additionally, the Joint Commission now mandates every hospital who admits patients to establish an annual, proactive program for identifying patient safety risks and reducing healthcare-related errors.²³

Similar to RCA, FMEA methodology was developed outside of the healthcare industry and is frequently used in other high-hazard industries,⁴¹ such as aviation, nuclear power, aerospace, chemical processing, automotive industries,^27,44 and engineering sectors.²³ An FMEA involves a multidisciplinary team that identifies high-risk points of care and possible failures within the healthcare delivery system by describing parts of a process that are most in need of change. The team analyzes the steps or potential failures in a process, failure modes, failure causes, and failure effects.³⁰ The team then characterizes the probability or frequency of each failure, how serious the consequences of the failure would be, and how easily the failure can be detected to quantify which failures are most in need of attention.^41,43 Definitions related to FMEA are presented in Table 3.^23,42

For optimal use in healthcare, failure mode and effect analyses that have been traditionally used in other sectors (e.g., aviation and chemical processing) require modifications to properly characterize healthcare processes. In 2001, the United States Department of Veterans Affairs introduced a modified FMEA for healthcare settings, known as the Healthcare FMEA (HFMEA). The Department of Veterans Affairs has since published its experiences with HFMEA in numerous areas, including drug ordering and instrument sterilization. Some healthcare organizations use the HFMEA and others modify existing FMEA frameworks for use in specific settings.²³ For the best use in healthcare settings, an FMEA should include the following steps^23,33: 

• Step 1: Define the topic
  Step 2: Assemble a committed team 
  Step 3: Develop a process map 
  Step 4: Conduct a risk or hazard analysis for each process and subprocess
  Step 5: Develop an action plan 
  Step 6: Follow up on the actions taken 

The first 2 steps in an FMEA are similar to the initial steps of an RCA, which include defining the topic to be investigated and assembling the investigative team. Topics or processes to be investigated are identified through departmental audits, error reports, sentinel event responses, patient and/or customer complaints, safety and environmental inspections, and previous FMEA results. The FMEA team should include a team leader, a facilitator, a technologist, a nurse, a patient representative, and a risk manager.²³ A pharmacist or pharmacy technician should be included on any FMEA team that evaluates medication- or pharmacy-related processes and procedures. The team then outlines all processes and subprocesses under review and conducts a risk analysis of each subprocess. The team identifies failure modes, estimates the severity and impact of each failure mode, and estimates the probabilities of occurrence and detection of each failure mode. A failure mode could involve staffing, equipment or environmental issues, policies and guidelines, poor communication, human error, or misplaced or missing medications, among other factors.²³

The likelihood, detectability, and severity of each failure are quantified by the FMEA team. To determine the likelihood of an error or failure occurring during a defined period of time, team members rely on data from previous adverse events, as well as personal experiences. The team uses a scale of 1 to 10 to quantify the likelihood of failure; the higher the ranking the more likely a failure is to occur.²³ The scale ranges from “failure is unlikely” (e.g., 1 incident every 5 or more years) to “very likely or inevitable” (e.g., 1 incident per day).²⁴ A failure can be detected by healthcare workers, patients, or a computer alert. If a failure is not detected, it is unlikely to be corrected and, therefore, more likely to cause harm to a patient.²³

Detectability is assessed by asking: Is the area of failure readily known or is it discovered only when a negative outcome occurs? ¹⁸ The likelihood of detection is quantified by a 10-point scale; the higher the ranking, the less likely it is that a failure will be detected.²³ The scale ranges from “almost certain the control will detect potential cause(s)”(e.g., the failure mode can be detected during the step in which it occurs) to “absolute uncertainty that the control will not detect potential cause(s) and subsequent failure mode(s) (e.g., the system cannot or will not detect the failure mode or there is no control in place to detect the failure mode).”²⁴

The severity of a failure mode is quantified by determining how severe the outcome would be should the failure occur. When considering the consequences or severity of a failure, the team must consider not only patient harm but also the effects on the operation of a hospital or department. Additionally, some failures that affect a patient may not lead to direct harm, such as procedural delays, equipment malfunctions, reduced number of patients that can be treated, and poor customer service. A 10-point scale is used to measure severity. The scale ranges from “no severity at all” (e.g., the failure would not affect the individual or system) to “moderate” (e.g., significant effect with no injury) to “major injury” and even “death.”²⁴ A lower value indicates a lower-severity failure.²³

The outcomes of an FMEA are risk priority numbers (RPNs), which combine the estimates of failure mode severity, occurrence probability, and likelihood of detection.⁴⁵ An RPN, which is also called the criticality index, is calculated by multiplying the severity rating, the probability rating, and the detectability rating for a failure mode. ^23,24,46  Failure modes with low RPNs are unlikely to affect patient outcomes and do not require immediate attention. Failure modes with the highest RPNs are prioritized for corrective action.²³ Once RPNs are calculated and high-risk processes are identified, the team must assign actions to appropriate team members, establish timelines, and implement changes that will prevent failures from occurring in the future.²³ Changes should be monitored and sustained over time, and lessons learned should be shared with others. ^23,47

Unfortunately, it is difficult to assess the outcomes of recommendations that have been implemented as the result of an FMEA because of low error-reporting rates.⁵ In addition, the reliability and validity of FMEA outcomes have been questioned because: (1) different teams can assess failures in different ways, (2) varying sources of information have been used to calculate RPNs; and (3) different personal experiences impact the reporting of such data.^41,43,48,49 The reliability and validity of an FMEA leads to skepticism about its process and findings, and little feedback is gained regarding the accuracy and precision of the FMEA as an error prevention tool.^27,41 Ideally, an FMEA should be consistent and accurate regardless of who conducts the patient safety assessment.^41,46

An FMEA has additional limitations. First, RPNs are derived from expert opinion and statistical estimates—not actual operating conditions—which is an inherent limitation of the FMEA process. Even potential risks and causes of failures are based on experts’ opinions and personal experiences, further limiting the utility of the process.²⁴ Second, the concept of multiplying ordinal scales to assign priorities to failure modes is inherently flawed as a mathematical tool.⁴¹ For example, a failure mode with high severity but low likelihood of occurrence can have the same RPN as a failure mode with low severity but high likelihood of occurrence. A failure mode with high severity, even if rare or very unlikely to occur, is unacceptable in healthcare because it can potentially increase patient morbidity and mortality. Critics, therefore, argue that an FMEA should be targeted toward high-severity failure modes regardless of how likely it is to occur.²³

FMEA is a more positive approach to problem-solving compared with an RCA since FMEA uses knowledge and competencies of healthcare professionals to assess a system rather than highlighting professional weaknesses.²³ Additionally, an FMEA is aimed at preventing errors and does not require previous bad experience or even a near-miss of an error. FMEA can also be used to assess organizational factors such as supervision, planning, communication, training, and maintenance.²⁷ Some methods have been developed to pair simulated working conditions with FMEA to proactively assess sources of “real-world” errors.²⁴ Still, FMEA is more speculative than evidence-based.⁴²

Another benefit of FMEA is that the process of the analysis facilitates the gathering of current knowledge within an organization, which allows risk information to be stored for future use.⁴⁵ The FMEA process creates a multidisciplinary map of patient care, which is valuable work in itself. However, converting these findings into actionable plans is difficult and time-consuming.^43,48,50 Large FMEAs require substantial personnel resources^5,23,43,50 and strong management support is required for a successful FMEA. FMEAs have been used successfully in several settings, including the implementation of smart IV pump technology,⁴⁷ pediatric departments and intensive care units,^11,51 antibiotic administration,⁴⁸ infection control programs,⁵¹ perioperative processes,⁴⁴ clinical imaging,²³ medical records keeping,⁴⁹ and to quantify the impact of pharmacist-provided patient care.⁵²

Because the healthcare environment is rapidly changing and requires continual attention to quality improvement, RCA and FMEA can be effective tools for quality improvement; however, they are only useful if they result in positive change. Interventions or changes that are based on these tools must be practical and realistic for implementation, and all changes should be monitored, supported, and re-evaluated.³³ Poor quality and lack of consistency in error and risk analyses limit the usefulness of patient safety instruments, as well as the opportunity to learn from errors in healthcare.²⁷ Additionally, none of the tools or techniques used to identify risks in healthcare should be used in isolation: they should be used in conjunction with other tools and methods and risks identified by any method should be valued. Such identification provides important guidance to healthcare users and practitioners, but simply identifying risks—without positive change—will negatively impact a culture of safety.⁵³

PATIENT SAFETY IS EVERYONE’S RESPONSIBILITY 

Safe medication use is a critical role of pharmacists and all pharmacy staff.⁶ Pharmacists and pharmacy technicians must be proficient in medication-related technology; delivering evidenced-based, patient-centered care; applying quality improvement approaches in their practice; and working in interdisciplinary teams.³⁰ These multimodal and multidisciplinary approaches have proved to yield long-lasting, system-wide improvements in patient safety. 

Technology plays a key role in patient safety. Computerized order entry systems, decision support software, automated dispensing, and barcode-assisted medication administration are just a few technological advances that have improved patient safety.⁸ In addition, safety alerts within prescribing and order entry software provide value to prescribers, though compliance is inconsistent.⁵⁴ These programs, as well as pharmacy order processing software, often display alerts for safety reviews and potential interactions, but these alerts are frequently bypassed before proper consideration is given to the alert. Some alerts are false-positives (not clinically relevant) and are themselves errors in drug information. These inaccuracies and inconsistencies have led to a climate in where healthcare professionals ignore alerts since so many are deemed clinically insignificant. This behavior, called “alert fatigue,” is a preventable source of error. Pharmacists, technicians, and other professionals must agree on alert management practices in order to improve prescribing and pharmacy software programs.⁵⁵

A multidisciplinary approach to healthcare and patient safety incorporates staff from different levels and areas of treatment, which facilitates communication and efficient care.⁵⁶ In most cases, healthcare professionals recognize the skills and expertise of other professionals, and patient-care recommendations by 1 member are often supported and accepted by other members of the multidisciplinary team. Such recommendations can lead to decreased adverse events, improved medication use, and enhanced patient safety.^57-59 For instance, communication during prescribing, dispensing, administration, and monitoring of drug therapy can be achieved by taking care with LASA drug pairs; avoiding unapproved abbreviations, symbols, and dose designations in medication communications; and standardizing prescribing vocabulary.⁶⁰

While most data indicate that multidisciplinary teams limit adverse events, improve outcomes, and enhance patient and employee satisfaction, this approach to healthcare delivery is not without challenges.⁵⁶ Multidisciplinary teams comprise interprofessional differences that can present barriers to investigating incidents and recommending improvements.³¹ Typically, scientists, clinicians, and healthcare professionals view concepts, issues, and errors in the frame of their own specialties.²⁸ From pharmacy’s perspective, the members of a multidisciplinary team should have at least some knowledge of pharmacology and medication safety issues.¹⁸

Patients and their caregivers are also important members of the healthcare team.^5,61 Patients are sometimes able to detect medication errors; in some settings, they are encouraged to review their own medication records. Patient involvement functions to remind staff about medication administration times, improve information exchange during shift changes and transitions of care, and to facilitate discussion with their healthcare providers. Patients are more willing to participate in safety initiatives and be an active part of their own care if they are encouraged to do so.⁶¹

CONCLUSION 

The provision of healthcare relies on a series of complex interactions among various healthcare professionals, scientists, manufacturers, patients, equipment, and technologies.^23,27 Healthcare professionals agree that patient safety will only improve when they collectively acknowledge and integrate patient safety concepts into daily practice. Unfortunately, patient safety concepts and error-reduction techniques in the workplace are not widely addressed in the education sector. Healthcare professional education does not currently match competencies to patient needs, emphasize teamwork, promote broad contextual understanding of patient safety, or develop leadership for improving health-system performance. Patient safety does not necessarily need to be taught as a stand-alone subject; rather it can be integrated into clinical teaching and student learning across all subject areas. Specifically, healthcare professionals should receive training in RCA and FMEA in order to effectively achieve patient safety goals and properly report and investigate medication errors and events.^26,30,40

Medication safety remains a global challenge and all healthcare disciplines and stakeholders should be leaders in safety initiatives that are consistent within their area of practice, experience, and expertise. Error reporting should not be a burden, and errors should be viewed as opportunities to learn and improve patient care.^62,63 Focusing only on the individual who committed the error, instead of the system weaknesses that allowed for the error, is ineffective as a long-term safety improvement strategy.²⁷ Improved communication and a team-based approach to care will help aid in the mitigation of risks and the prevention of medication errors. Additionally, mandatory medication error reporting can identify systems or processes that contribute to errors, support strategies for prevention, and provide evidence-based information that can be applied to patient safety tools, such as RCA and FMEA.⁶⁴

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