ProCert has awarded certification in the amount of 1 Continuing Competence Units (CCUs) to this activity. CCUs are a unit of relative value of an activity based on its evaluation against a rigorous and comprehensive set of standards representing the quality of an activity. The CCU determination is a valuation applying many factors including, but not limited to, duration of the activity. No conclusion should be drawn that CCUs correlate to time (e.g. hours).
The purpose of this course is to enable the learner to understand and apply principle of process improvement, the influence of human factors in errors, how to identify situations where errors commonly occur, and how to apply strategies for prevention.
Audience ARNP, CNA, CRNA, CNS, RDN, EO, HHA, LPN, LVN, MW, PT, PTA, RN, and RT. All professions included in the audience will benefit from this course of Evidence Based strategies in preventing medical errors in all practice settings.
After completing this course, the learner will be able to:
Over the past fifty years, a variety of approaches have been tried to reduce medical errors, with only limited success (Chassin, 2011). “The Institute of Medicine estimates that, on average, hospitalized patients are subject to at least one medication error per day (Radley, et.al. 2013, pg. 2).” Based on literature review, deaths associated with preventable harm to patients were estimated at more than 400,000 per year (James, 2013). John James, PhD (2013. Pg. 2) president of the Joint Commission, feels the following are the contributing factors to preventable medical errors:
Medical care in the United States is technically complex at the individual provider level, at the system level, and at the national level. The amount of new knowledge generated each year by clinical research that applies directly to patient care can easily overwhelm the individual physician trying to optimize the care of his patients. Furthermore, the lack of a well-integrated and comprehensive continuing education system in the health professions is a major contributing factor to knowledge and performance deficiencies at the individual and system level. Guidelines for physicians to optimize patient care are quickly out of date and can be biased by those who write the guidelines. At the system level, hospitals struggle with staffing issues, making suitable technology available for patient care, and executing effective handoffs between shifts and also between inpatient and outpatient care. Increased production demands in cost-driven institutions may increase the risk of preventable adverse events (PAEs). The United States trails behind other developed nations in implementing electronic medical records for its citizens. Hence, the information a physician needs to optimize care of a patient is often unavailable.
At the national level, our country is distinguished for its patchwork of medical care subsystems that can require patients to bounce around in a complex maze of providers as they seek effective and affordable care. Because of increased production demands, providers may be expected to give care in suboptimal working conditions, with decreased staff, and a shortage of physicians, which leads to fatigue and burnout. It should be no surprise that PAEs that harm patients are frighteningly common in this highly technical, rapidly changing, and poorly integrated industry.
Medical errors increase expenses in additional patient care and in litigation. Serious medical errors are devastating to the patient, family, and staff.
The severe consequence of medical errors is one reason that healthcare is a highly regulated business. All healthcare organizations have to be licensed. They also have to meet industry standards, building and safety codes, Federal statutes, and state statutes.
Healthcare organizations are subject to inspection for compliance with statutes, regulations, and industry standards. Inspections can be scheduled or unscheduled. Scheduled inspections are conducted periodically. Unscheduled inspections can be conducted randomly, or they can be conducted for cause, like a patient complaint. One of the most well know inspection agencies for hospitals is the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). It is an independent organization, meaning that JCAHO is neither a government agency nor does it have a financial interested in any healthcare organization. If a healthcare organization meets industry standards, JCAHO accredits that organization.
Healthcare organizations must determine an individual's qualifications and ability to do the job. This involves checking education, license, experience, and credentials before an employee is hired. At least annually, staff performance is evaluated. Competency, continued licensure, and continuing education should also be checked at least annually. For licensed independent practitioners, like physicians and nurse practitioners, that process is called credentialing and privileging.
Healthcare organizations have ongoing programs to identify, correct and prevent medical errors. PI is a way to systematically monitor, analyze, and improve an organization’s performance and outcomes. PI should improve an organization’s performance by reducing factors that contribute to unanticipated adverse events and outcomes. Unanticipated adverse events and outcomes can be caused by poorly designed systems, system failures, or errors. Decreasing unanticipated adverse events and outcomes requires an environment where patients, families, staff, and leaders can identify and manage risks to safety. Such an environment encourages the following:
The following are other concepts related to PI. Continuous Quality Improvement (CQI) is an approach that ensures that organizations always look for ways to improve processes and practices. Total Quality Management (TQM) is a management system that encompasses quality planning, quality control, and quality improvement. Six Sigma, lean management, and change management are performance improvement methodologies that are a systematic approach to dissecting complex safety problems and implementation of effective solution (Chassin, 2011).
These programs are slightly different from PI, but you may hear the terms used interchangeably.
High Reliability is an ongoing quality improvement process that is used in highly technical industries where there is a high risk. The concept of high reliability involves a safety culture of collective mindfulness that everyone who works in these organizations is acutely aware that even small failures in safety protocols or processes can lead to catastrophic adverse outcomes. Therefore, everyone in these organizations is always searching for the smallest indication that the environment or a key safety process has changed in some way that might lead to failure (Chassin, 2011). Once a deficiency is identified, it is eliminated by improving the processes. There are three Requirements for Achieving High Reliability:
Quality Control (QC) is an ongoing, systematic measurement to determine compliance and accuracy. It is required for some equipment or measurement tests. Examples are checking the high and low control limits on a glucometer or the temperature of the medication refrigerator. QC is often a component of, or is mentioned in relationship to PI.
Risk Management (RM) is a program that is focused on eliminating or minimizing the effects of accidental losses to an organization. RM works closely with and sometimes overlaps functions with PI. The Risk Managers are involved with risk financing, through insurance companies to minimize financial losses. They usually investigate serious medical errors, institute damage control, and consult with legal council as needed.
Incident reports are an important source of information for a Risk Manager. Aggregate data from incident reports is statistically analyzed to identify areas of risk and exposure. Risk control techniques are then applied to those areas of focus. The usual techniques are avoidance, transfer, prevention, reduction, segregation, and duplication.
Avoidance is a technique that eliminates the possibility of a loss. This is also known as a forcing function. This technique involves designing equipment or processes to make it impossible to use it incorrectly. Examples are stocking only one concentration of a medication or removing concentrated Potassium Chloride from floor stock. These functions are effective, but can be inconvenient and time-consuming for personnel.
The Pharmacy recently changed the medication stock available on the unit. Concentrated Potassium Chloride (KCL) was removed from floor stock restricting access on the unit to one premixed KCL dosage. This change is time-consuming for staff who need to administer a nonstandard concentration of KCL and will delay administration of the medications since the different concentration has to be ordered from the pharmacy.
Errors in mixing concentrated KCL can cause significant morbidity or mortality for the patient. Because of the significant risk to the patient, applying avoidance of KCL mixing errors justifies the administration delays and consumption of staff’s time.
Transfer is the process of negotiating with insurance companies to transfer the financial burden of a loss. This technique assumes that the loss cannot be prevented so we must be insured against those times when it happens.
Loss prevention reduces the probability or frequency of a loss but does not eliminate the chance of loss, nor does it reduce the severity of that loss. This is also known as a constraint function. This means that equipment or a process is designed to make it difficult to use it incorrectly.
|Case Study: 2|
The hospital changes policy to limiting verbal orders to only emergency situations in limited specialty units. This change is not well received by the staff and the practitioners because of the time involved and delay in treatment implementation.
Verbal orders are a significant opportunity for human errors in communication. Reducing the frequency of verbal orders is loss prevention of errors that might be made by less experienced or distracted personnel.
Loss reduction focuses on reducing the severity of damage. For example, frequent monitoring instituted for conscious sedation procedures does not reduce the risk of the sedation being too deep. However, it allows early intervention to reverse the sedation and provide adequate oxygenation.
Segregation means that a process is totally separated from the rest of a clinical setting to reduce or eliminate errors. For example, changing the medication administration system so the pharmacist fills the order and administers the medication to a patient. This eliminates the potential error at the point the pharmacy usually hands off the medication to nursing. However, as with most segregation techniques, it is too expensive and impractical.
Duplication means that there is a backup. For instance, having employees cross-trained. That way, someone is available to perform a job when the person who normally performs that job is unexpectedly unavailable.
JCAHO (2007, pg 1) defines a sentinel event as:
The following events are considered a sentinel event, even if the outcome is not death or major permanent loss of function: suicide; unanticipated death of a full term infant; infant abduction or discharge to the wrong family; rape; hemolytic transfusion reaction; and surgery on the wrong patient or wrong body part (JCAHO, 2007). A near miss is a potential error that fails to cause injury by chance or because it is stopped before it occurs. The natural course of the patient's illness or underlying condition is not considered a sentinel event.
JCAHO requires accredited organizations to identify and respond appropriately to sentinel events. Appropriate response includes conducting a timely and thorough investigation, implementing improvements to reduce risk, and monitoring the effectiveness of the improvements. Healthcare organizations are encouraged to report sentinel events to JCAHO. The information from these reports is evaluated and published in the Sentinel Event Alert. It includes aggregate data, specific examples, and strategies for prevention. The Sentinel Event Alert is available on the Internet here.
JCAHO requires the use of root cause analysis (RCA) to investigate the processes and systems that contribute to a sentinel event. RCA is a tool that helps identify and clarify the bottom line factors that precipitate an error or near miss. RCA focuses on systems and processes, not on individual performance.
The RCA process repeatedly digs deeper into an issue by asking “Why” questions until no additional logical answers can be identified. A team of people representing the areas that are involved in an event is brought together to do this analysis. The team begins with a standardized template called an Ishikawa diagram. (Figure 1) This template is also known as a fish bone diagram or cause and effect diagram.
Figure 1, Ishikawa Diagram. The major headings are suggested and can be changed.
The team selects major headings for the diagram that will include categories of possible causes. The headings should be as independent from each other as possible to avoid confusion. The team identifies the potential factors that would cause the problem. These are written along the major branches of the diagram. For each cause listed, the team asks “why?” Those reasons are written down as smaller branches on the diagram. The rule of thumb is to ask “why” five times. When you reach a point where there is no additional logical answer to the question “why,” you have reached what is called a root cause.
Once the Ishikawa diagram is complete, the underlying causes of the event are summarized. Changes that could be made in systems and processes that would reduce the risk of similar adverse events are suggested.
One type of cause is special cause found in clinical processes. Special cause is a factor that is intermittently and unpredictably. This causes a variation that is not inherent in the system. An example is a patient has an allergic reaction to a medication that they have successfully taken in the past. The other type of cause is common cause in organization’s process. Common cause is a factor that results from variation that is inherent in the process or system. RCA seeks to identify potential areas for improvement in a process or system that might help reduce the risk of occurrence of an event. An example is allowing only premixed Potassium Chloride solutions on the nursing unit will prevent the possibility of making an error in the dilution.
RCA has a limitation, which is known as the blinder effect. That is the tendency for the team to look only at one part of the process that led to the event, instead of the entire process.
By nature, humans are fallible. It is unreasonable to expect an error-free performance by humans. Human beings have limited mental and information-processing capabilities. Excessive levels of stress or fatigue have a negative impact on performance (ACSQC, 2004).
Every day we all face thousands of interactions with machines, systems, and each other. The vast majority of those interactions goes smoothly and unnoticed. A few interactions that force us to work outside of routine and intuition are simple annoyances with which we have learned to live. Occasionally, one of those interactions leads to an unintended result, an error. While humans can rapidly adapt to impediments blocking their path, and develop compensatory workarounds, these short-term solutions often introduce new risks. Human factors science offers a better understanding of the causes of errors, the workarounds already in place, and solutions which are less likely to have negative, unintended consequences.
Human error has been implicated in 60 to 80 percent of accidents that occur in complex systems. Accidents due solely to environmental and mechanical factors have been greatly reduced over the last several years; however, those attributable to human error continue to be a problem.
Healthcare has traditionally regarded error as a moral failing. This places an unsustainable burden of perfection on clinicians (ACSQC, 2004). This attitude impedes efforts to identify errors their frequency, their effects, and how to best protect patients (ACSQC, 2004).
Solutions reached by trial and error or workarounds might simply shift the risk elsewhere. While “fixed by common sense” may often be sufficient, common sense can also benefit from science and engineering.
Human factors science discovers and applies information about human behavior, abilities, limitations, and other characteristics to the design of tools, machines, systems, tasks, jobs, and environments for productive, safe, comfortable, and effective human use. Human factors science is not just applying checklists and guidelines, not just using oneself as the model for designing things, and it is not just common sense.
Human factors engineering uses systems analysis. Humans are considered a critical system component. Human factors analysis focuses on human operators to determine what they are required to do. It combines the scientific methodology familiar to clinicians to explore the causes of error with an engineering approach of task analysis. Human factors analysis goes further than Root Cause Analysis (RCA). This methodology includes:
British Psychologist Professor James Reason (1990) developed a model of human error based on the premise that adverse outcomes are the result of a combination of factors of systemic issues such as resource availability, organizational policies and procedures, and human functional errors. Reason’s model is called the Swiss cheese model because every layer of defense against errors has it holes; the more layers, the smaller the risk of causing harm (ACSQC, 2004). There is less chance of the holes lining up to allow an error to occur.
Breakdown of a productive system
Reason’s Model Inputs
Reason (1990) said that "we cannot change the human condition, but we can change the conditions under which humans work." Using his model it is easier to understand that errors reflect problems at the practical level and the systemic level. A safe reporting system is used to ensure system integrity is monitored (ACSQC, 2004).
The human cognitive process is how we remember, think, develop and use motor skills to perform activities individually, in teams and within organizational systems.
The impact of design on human factors has four different types of interactions and a wide variety of applications. The science applies an understanding of theories of physical, cultural, and psychological factors to the reduction in flawed behavior.
Interaction with machines and objects is the most studied area of human factors problems. Most human errors related to human/machine interactions are due to either the condition or training of the operator, bad design of the machine interface, or both. A bad design is one that does not conform to intuitive application. Design flaws can lead to the incorrect use of equipment. Speed, stress, and fatigue increase the likelihood that bad design will lead to error.
Negative impacts of the work environment exist even with the best designed objects and machines. Human factors problems are encountered, stemming from the physical world around us. Physical space, layout, temperature, light, air quality, noise levels, and visual distractions can all interfere with or alter the ability to perform an activity. When these factors become obstacles they can manifest as inconveniences or can be harmful. Fatigue from loss of sleep, circadian rhythm changes, and muscular effort expenditure has been identified as one of the major contributors to errors.
As creatures of habit, humans often seek to “workaround” a new system in order to maintain an old mindset. For example, to help technicians correctly assemble devices with multiple components, matching barcodes were encoded on adjoining components. By swiping each piece, correct assembly was assured. However, reviewers discovered that the procedure was frustrating for some users who, as a workaround, put matching copies of the bar coding on a paper and scanned the paper instead of the equipment pieces, enabling incorrect assembly. Nurses, too, have found that it is easier to scan the patient label from the medication administration sheet rather than taking the medication cart with a scanner to the patient bedside to scan the patient identification band on the patient’s wrist.
When a system problem is solved in isolation and without consideration of how it might affect the rest of the system, unintended consequences can undo the benefit of the fix. An example of this is a computerized forcing function programmed into a hospital medication system to prevent the over-administration of potassium. This inadvertently prevented the administration of high doses when they were needed. A solution can exacerbate existing minor problems or actually create new opportunities for errors. This is the unintended consequence. Piloting and field testing solutions help identify these “downstream consequences.”
Human factors problems related to practice environment tend to be more transient than design problems. Lighting, noise, temperature, even physical space, can change from one patient encounter to the next. If the healthcare provider works in multiple practice settings, the opportunity for environmentally-related problems are equally multiplied. Other issues may include things like:
In a variety of clinical services, care is provided through changing teams of providers over various timeframes and supported by many administrative personnel. Each person acts in his or her capacity to attend to the patient’s needs through his or her own professional and personal lens of mental model. Inadequate communication can lead to misalignment of mental models. Interactions among teams and entire systems of healthcare providers are an important area of human factors study. Inadequate communication was the second most frequent risk management issue identified in claims made from 1996 to 2000. Handoffs, passing on information or responsibility are a particular patient safety problem area.
Mental models are a deeply ingrained assumption, generalization, or even pictures/images that influence how we understand the world and how we take action. When two people have different mental models of the same situation or process, they are at risk of misinterpreting each other’s directions or intentions.
Teams of people working together need to share a common understanding of what needs to be done and how; for example, the same mental model. Teams need efficient communication that is remembered at least long enough for the recipient to take proper action as a result.
Human factors apply wherever humans work. In healthcare, work environments are hazardous. Instruments are potential weapons; drugs are a potential poison; and every worker is a potential killer (ACSQC, 2004). The following are human factors problem areas in healthcare:
Accept human factors problems as an inevitable, although manageable, part of everyday practice. Shift from a punitive to a creative frame of mind that seeks out and identifies the underlying system failures. Efficient, routine identification of human factors need to be part of every practice, as well as routine investigation of all human factors problems that cause injuries.
Not all design flaws in healthcare environments are obvious hazards. One of the most subtle mistakes is failure to realize that the best-motivated and most highly-trained professionals are potentially lethal agents (ACSQC, 2004). Fatigue management in healthcare is a big challenge. Fatigue resulting from an inadequate amount of sleep or insufficient quality of sleep over an extended period can lead to a number of problems, including (JCAHO, 2011, pg. 1):
Contributing factors to fatigue and risks to patients include (JCAHO, 2011, pg. 2):
Shift length and work schedules have a significant effect on healthcare providers’ quantity and quality of sleep and, consequently, on their job performance, as well as on the safety of their patients and their individual safety. This fact has been borne out in numerous studies. Findings from a groundbreaking 2004 study of 393 nurses over more than 5,300 shifts – the first in a series of studies of nurse fatigue and patient safety – showed that nurses who work shifts of 12.5 hours or longer are three times more likely to make an error in patient care. Additional studies show that longer shift length increased the risk of errors and close calls and was associated with decreased vigilance and that nurses suffer higher rates of occupational injury when working shifts in excess of 12 hours. Still, while the dangers of extended work hours (more than 12 hours) are well known, the healthcare industry has been slow to adopt changes, particularly with regard to nursing.
Recommended actions (JCAHO, 2011, pg. 3):
Everyone needs some stress; otherwise life would be dull and unexciting. Stress adds flavor, challenge, and opportunity to life. It has also been said that stress is a good motivator, but working when over-stressed, irritated, upset, or shaken will substantially alter one’s judgment and can compromise patient safety. Too much stress can seriously affect physical and mental well-being. The angry healthcare provider is aggressive, offensive, and careless, and as a result, is dangerous. Stressful conditions involving personal or business life will cause distractions that can interfere with the provision of safe patient care. They should be recognized and addressed as negative influences on workplace habits.
The clinician should evaluate his or her state of mind before providing patient care such as medication administration. Providing patient care takes a clear and focused mind, uncluttered by thoughts of aggravation and distress. The healthcare provider with a wandering mind caused by any one of the aforementioned effects has a decreased awareness of the subtle changes in patient status, a slower reaction time, and an overall lack of concentration. The ability to anticipate complications and to determine appropriate responses is also adversely affected. A major challenge in this stress filled world of today is to use stress in a positive way and prevent it from becoming distress.
The emotionally distressed healthcare provider is more apt to make a medical error than is the rested, clear-headed provider. It should be made clear that tired, disturbed, or cluttered minds decrease critical thinking ability. When disturbed by emotions, the healthcare provider is not concentrating on what they are doing; he or she is concentrating on what has him or her upset. This could manifest in increased risk taking behavior such as taking shortcuts, failing to follow policy, and not paying attention to the details. Unsafe behaviors can contribute to increased risk of medical error.
With severe emotional distress, an individual could turn to substance use or abuse to hide emotional pain. Combined with heavy workloads, this increases the likelihood of error. With the increased risk-taking behavior, aggression could result. The clinician is then labeled as “difficult to work with.” Unchecked emotions can lead to aggressive behavior and disciplinary action. The emotionally distressed mind is not capable of rational function or critical thinking required to provide safe patient care. Managers need to recognize the emotionally distressed clinician.
Standards of practice and hospital policies are instituted and established for patient safety. Policy may not specifically cover special situations; but, most clinicians agree there is a need for policies and standards of practice. Unsupervised and uncontrolled practice would lead to chaos. Some healthcare providers despise the increase in the number of “rules.” They stress the negative side of policies rather than the goal for increased patient safety. It must be understood that policies and standards of care can benefit them and should be supported and followed.
Patient safety focus by the following groups has increased the number of policies and standards of practice that decrease medical errors.
Healthcare providers should be aware that circumstances and attitude changes could dramatically affect practice habits. Some attitudes that predispose to risk taking behavior and increase the risk of errors are:
Design work to minimize the requirements for particularly fallible human functions such as short-term memory and tasks requiring prolonged attention. For instance, don’t rely on memory to retrieve a laboratory test result or the time a medication is due. Systemizing these tasks reduces memory related errors.
Reduce reliance on memory for high-risk procedures, or multi-step processes, by using checklists. Review checklists to ensure appropriateness and avoid increasing error through workarounds that make more errors. While surgical areas generally use preoperative checklists already, it may be wise to use checklists in handoff situations as well. Couple brief, useful protocols with procedures developed by the healthcare teams who provide the services. Standardize color match items that are used together to prevent slips such as clinicians combining items that should not be used together. Pre-package component items into kits.
As the volume of information increases, you need creative ways for making it more readily available, displaying it where clinicians need it when it is needed. Making information available at the point of care will make a significant impact on error reduction. Many medication-related claims are the result of clinicians making decisions about treatment without having all of the appropriate information available. Create forms to promote accurate documentation and electronic ticklers for tracking test results. Block avenues to workarounds that cut out important transmission of information.
Complexity increases the opportunity for errors. Where possible, critical tasks should be structured so that errors cannot be made. The reliability of a system can be improved by perfecting its parts and handoffs, but reducing complexity is even more powerful.
Adverse drug events (ADEs) are a serious public health problem. It is estimated that (CDC, 2012 pg1):
The numbers of adverse drug events will likely grow due to (CDC, 2012, pg. 1):
Nurses are most likely to be blamed for medication errors because they are involved at the administration point. However, medication errors are complex and are rarely the result of one person’s actions. The medication system in hospitals is complicated. There are multiple steps and many individuals involved. Every time a document or medication changes hands, there is an increased potential for error.
Administering medication is a crucial nursing responsibility. To ensure safe and effective drug therapy, the nurse must be familiar with indications, usual dosages, and intended effects of drugs. Remember the 5 rights: right patient, right drug, right dose, right route, and right time. Each patient must be assessed before administration and medication should be delayed or withheld if indicated.
One study found adherence by nurses to standard medication administration practice was very low. This adherence is reported below as ratios per item.
Only 45•6% of nurses verified the amount of medication indicated on the vial at least once for at least one-second. In addition, only 6•5% read the name of the patient from the wristband. Administering the medication at the correct time guideline was observed 41•0% of the time. The guideline regarding hand washing before external and oral medications was followed only 4•5% of the time, although this figure was much higher for intravenous medications at 96•6%. Overall, among 31 categories regarding drug administration, 17•2 (± 3•6) items per person were followed, whereas 5•7 (± 1•2) items per person were violated… We found key instances in which nurses did not follow the guidelines, including many from the Five Rights. About one in four elements were violated overall. (Jeongeun, et.al. 2013).
Nurses’ medication error interception practices¬ are associated with lower rates of medication errors. One study defines these interceptive practices as (INQRI, 2012):
The types of medication errors include: prescribing, omission, wrong time, unauthorized drug, improper dose, wrong drug preparation, wrong administration techniques, deteriorated drugs, improper monitoring and compliance, product errors, process errors and human errors. Areas that are particularly error prone are:
Handwritten and manually transcribed physician orders leave a lot of opportunity for errors. A computerized physician order entry, in which the physician must enter all orders by computer, eliminates handwriting and transcription errors. It also makes it possible to automatically check doses, drug-drug interactions, allergies and significant patient characteristics, like allergies and impaired renal function.
Meta-analysis of the research revealed that computerized physician order entry decreases the likelihood of error on that order by 48% (95% CI 41% to 55%). Given this effect size, and the degree of adoption of computerized order entry and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ~17.4 million medication errors averted in the USA in 1 year (Radley, et.al. 2013).
A computerized order entry system presents its own set of problems. There is a significant expense that smaller facilities may not be able to afford. Cost prohibitions or lack of space may limit the number of PCs to the point that practitioners have long wait times for computer access. It seems slow and inconvenient at times. In addition, physicians who are less computer savvy may be resistant to change.
A listing and resource for confusing drug names (look alike/sound alike) can be found at the following website.
Studies have shown that the majority of medication errors resulting in death or serious injury were caused by a list of specific medications.
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization devoted entirely to medication error prevention and safe medication use. ISMP represents over 35 years of experience in helping healthcare practitioners keep patients safe, and continues to lead efforts to improve the medication use process. The organization is known and respected worldwide as the premier resource for impartial, timely, and accurate medication safety information.
|High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies like improving access to information about these drugs; limiting access to high-alert medications; using auxiliary labels and automated alerts; standardizing the ordering, storage, preparation, and administration of these products; and employing redundancies such as automated or independent double checks when necessary. (Note: manual independent double-checks are not always the optimal error-reduction strategy and may not be practical for all of the medications on the list).|
|Based on error reports submitted to the ISMP National Medication Errors Reporting Program, reports of harmful errors in the literature, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high-alert medications. During October 2011-February 2012, 772 practitioners responded to an ISMP survey designed to identify which medications were most frequently considered high-alert drugs by individuals and organizations. Further, to assure relevance and completeness, the clinical staff at ISMP, members of our advisory board, and safety experts throughout the US were asked to review the potential list. This list of drugs and drug categories reflects the collective thinking of all who provided input.|
|adrenergic agonists, IV (e.g., EPINEPHrine, phenylephrine, norepinephrine)|
|adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol)|
|anesthetic agents, general, inhaled and IV (e.g., propofol, ketamine)|
|antiarrhythmics, IV (e.g., lidocaine, amiodarone)|
|antithrombotic agents, including:
|chemotherapeutic agents, parenteral and oral|
|dextrose, hypertonic, 20% or greater<|
|dialysis solutions, peritoneal and hemodialysis|
|epidural or intrathecal medications|
|inotropic medications, IV (e.g., digoxin, milrinone)|
|insulin, subcutaneous and IV|
|liposomal forms of drugs (e.g., liposomal amphotericin B) and conventional counterparts (e.g., amphotericin B desoxycholate)|
|moderate sedation agents, IV (e.g., dexmedetomidine, midazolam)|
|moderate sedation agents, oral, for children (e.g., chloral hydrate)|
|neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)|
|parenteral nutrition preparations|
|radiocontrast agents, IV|
|sterile water for injection, inhalation, and irrigation
(excluding pour bottles) in containers of 100 mL or more
|sodium chloride for injection, hypertonic, greater than 0.9% concentration|
|epoprostenol (Flolan), IV|
|magnesium sulfate injection|
|methotrexate, oral, non-oncologic use|
|nitroprusside sodium for injection|
|potassium chloride for injection concentrate|
|potassium phosphates injection|
|vasopressin, IV or intraosseous|
|ISMP List of High-Alert Medications in
Community/Ambulatory Healthcare (ISMP, 2013, pg. 1)
High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors and minimize harm. This may include strategies like providing mandatory patient education; improving access to information about these drugs; using auxiliary labels and automated alerts; employing automated or independent double checks when necessary; and standardizing the prescribing, storage, dispensing, and administration of these products
|Based on error reports submitted to the ISMP Medication Errors Reporting Program (ISMP MERP), reports of harmful errors in the literature, and input from practitioners and safety experts, ISMP created a list of potential high alert medications. During June-August 2006, 463 practitioners responded to an ISMP survey designed to identify which medications were most frequently considered high alert drugs by individuals and organizations. In 2008, the preliminary list and survey data as well as data about preventable adverse drug events from the ISMP MERP, the Pennsylvania Patient Safety Reporting System, the FDA MedWatch database, databases from participating pharmacies, public litigation data, literature review, and a small focus group of ambulatory care pharmacists and medication safety experts were evaluated as part of a research study funded by an Agency for Healthcare Research and Quality (AHRQ) grant. This list of drugs and drug categories reflects the collective thinking of all who provided input. This list was created as part of the AHRQ funded project "Using risk models to identify and prioritize outpatient high alert medications" (Grant # 1P20HS01710701).|
|antiretroviral agents (e.g., efavirenz, lamiVUDine, raltegravir, ritonavir, combination antiretroviral products)|
|chemotherapeutic agents, oral (excluding hormonal agents) (e.g., cyclophosphamide, mercaptopurine, temozolomide)|
|hypoglycemic agents, oral|
|immunosuppressant agents (e.g., azaTHIOprine, cycloSPORINE, tacrolimus)|
|insulin, all formulations|
|opioids, all formulations|
|pediatric liquid medications that require measurement|
|pregnancy category X drugs (e.g., bosentan, ISOtretinoin)|
|chloral hydrate liquid, for sedation of children|
|heparin, including unfractionated and low molecular weight heparin|
|methotrexate, non-oncologic use|
|midazolam liquid, for sedation of children|
The following are drug specific strategies for prevention of medication errors (JCAHO, 2007).
Opiates and Narcotics:
Injectable Potassium Chloride (KCL) (or Phosphate):
Sodium Chloride Solutions Concentration above 0.9%:
The anticoagulants most commonly used and most frequently involved in medication error are unfractionated heparin, warfarin and enoxaparin (JCAHO, September 08). Contributing factors to medication error with the use of anticoagulants include (JCAHO, September 08, pg 1):
Risk reduction strategies (JCAHO, September 08, pg 1):
Other JCAHO recommendations (JCAHO, September, pg 1):
For all anticoagulants:
Patient weight is the basis for calculating a lot of dosing of pediatric medications. Therefore an accurate weight should be done before administering any weight based medications, except in emergencies. The kilogram should be the standard for all pediatric weights. Pediatric patients are more prone to medication errors and more likely to be harmed from medication errors because (JCAHO, April 2008, pg 1):
JCAHO (April 2008, pg 1) recommends the following pediatric-specific strategies for reducing medication errors:
Ensure full pharmacy oversight—as well as the involvement of other appropriate staff—in the verifying, dispensing and administering of both neonatal and pediatric medications.
Use technology judiciously.
The types of infusion pump errors seen are the use of pumps that do not protect from free–flow of fluids to the patient, the wrong drug concentration, or the wrong rate is set.
Free-flow of fluids occurs when the infusate flows freely, under the force of gravity, without being controlled by the infusion pump. Infusion pump tubing needs a built in, anti-free-flow mechanism. This prevents gravity free-flow by closing off the tubing to prohibit flow when the administration set is removed from the pump. If an infusion pump does not have free-flow protection, devices that attach to the administration set are available. However, they are not recommended, because the mechanisms are packaged separately and must be manually attached to a set. Clinicians may forget to use the mechanism or may accidentally remove them.
Training and education are important in the prevention of infusion pump administration errors. Be sure to in-service staff who may not be administering medication, but may be handling the infusion pumps, such as aides, radiology technicians and transporters. Another concern is that patients, family members or visitors may mishandle pumps.
Key bump errors can cause errors in the volume or infusion rate. These should be double checked after entry and before starting the pump. Having a second nurse check calculations and settings for infusion pumps when high-alert drugs are used is recommended.
Medication reconciliation is done to avoid medication errors. Hand-off situations are prone to errors. Errors can be omission, duplication, contraindications, prescription errors and administration errors. Therefore, the process should be done every time a patient has a hand off (transition in care). A hand-off includes change in setting, service, practitioner, or level of care (JCAHO, January 2006). Medication reconciliation has five steps (JCAHO, January, 2006, pg 1):
When the patient has difficulty with the instructions, someone must be designated and taught about the patient’s medications.
Risk reduction strategies include (JCAHO, January, 2006, pg 1):
Place the reconciling form in a consistent, highly visible location within the patient chart (easily accessible by clinicians writing orders).
JCAHO recommendations include (JCAHO, January, 2006, pg 1):
Medical errors are fostered by intimidating and disruptive behaviors. Left unchecked, these behaviors lead to increased turnover, interfere with communication, and interfere with teamwork. "It is important that organizations recognize that it is the behaviors that threaten patient safety, irrespective of who engages in them" (JCAHO, July 08, pg 1).
Most healthcare providers have experienced or witnessed intimidating or disruptive behaviors. One survey reported that "40 percent of clinicians have kept quiet or remained passive during patient care events rather than question a known intimidator" (JCAHO, July 08, pg 1). Intimidating and disruptive behaviors include active and passive behavior such as (JCAHO, July 08, pg 1):
When manifested by health care professionals in positions of power, these behaviors include (JCAHO, July 08, pg 1):
Disruptive behaviors are often not address because the behavior is not reported. There is fear of retaliation, the stigma of whistle blowing, and reluctance to confront an intimidator. In one survey, almost 39 % of physician acknowledged that physicians who generate high revenue are treated more leniently concerning behavior problems (JCAHO, July 08).
January 1, 2009, JCAHO implemented a new Leadership standard (LD.03.01.01) that addresses disruptive and inappropriate behaviors in two elements of performance (JCAHO, July 08, pg 1):
Misconnection of tubing can lead to patient deaths. Causative factors include (JCAHO, April, 06, pg 1):
Error reduction recommendations include (JCAHO, April, 06, pg 1):
Health information technology and converging technologies have been found to contribute to medical errors. Care must be taken when implementing new technology. Contributing factors include (JCAHO, December 08, pg 1):
Recommended actions include (JCAHO, 12/08, pg. 1):
Alarm-equipped devices are essential to providing safe care to patients in many health care settings. The number of alarm signals per day can reach several hundred, depending on the unit. "It is estimated that between 85 and 99 percent of alarm signals do not require clinical intervention, such as when alarm conditions are set too tight; default settings are not adjusted for the individual patient or for the patient population; ECG electrodes have dried out; or sensors are mispositioned (JCAHO, 201, pg. 1)." Therefore, staff become desensitized or immune to the sounds, and are overwhelmed by information. This is called alarm fatigue.
Major contributing factors to sentinel events involving medical device alarms were (JCAHO, 2013, pg. 2):
Factors that contribute to alarm-related sentinel events include (JCAHO, 2013, pg. 2):
Recommended actions include: (JCAHO, 2013, pg.3)
JCAHO has made patient safety a priority and is seeking to promote specific improvements in patient safety. The mechanism for doing this is the use of National Patient Safety Goals (NPSGs) as a major focus for accreditation visits. The NPSGs highlight problematic areas and seek system wide solutions and are being updated annually. The following is the link to NPSGs.
Hold the ctrl button and right click on the name of the list to be taken to the website.
NPSG Program Links
The following are the 2013 Hospital National Patient Safety Goals (JCAHO, 2013).
Identify patients correctly
Improve staff communication
Use medicines safely
Identify patient safety risks
Prevent mistakes in surgery
Do Not Use Abbreviations are also a focus of JCAHO accreditation visits. The following is a link to the JCAHO Facts about Do Not Use Abbreviations.
Healthcare professionals have a responsibility to be knowledgeable about the PI process and to participate as opportunity presents. Healthcare professionals also have a responsibility to be aware of clinical situation that are prone to error, and to participate in procedures to prevent those errors.
Systems redesign to prevent all such errors should be based on a balanced utilization of evidenced-based technology, training, on-going education, standards of practice and best practices, keeping in mind each human’s inherent cognitive and physical limitations.
Human factors lead to medical errors. Human factors errors can be reduced through the application of scientific method. Human errors are inevitable within healthcare settings. Human factors analysis needs to be part of every medical error investigation.
Australian Council for Safety and Quality in Healthcare Council (2004) Setting the Human Factor Standards for Healthcare: Do Lessons from Aviation Apply?
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