INTRODUCTION

Adverse outcomes in health care has been a prevalent topic gaining considerable attention in the past two decades. While pockets of research in medical errors were developing prior to 2000, the Institute of Medicine's report, To Err Is Human: Building a Safer Health System, released in late 1999, served as a catalyst for additional research in the causes of medical errors and methods to prevent adverse outcomes in health care. This report estimated that 44,000 to 98,000 people die each year due to medical errors. Additionally, this report stated that medication errors alone, whether occurring within or outside of the hospital, were estimated to account for over 7,000 deaths annually.¹ Based on more recent reports, approximately 200,000 Americans die from preventable medical errors and millions may experience errors that result in other unfavorable outcomes. In 2008, medical errors alone cost the United States $19.5 billion dollars.² Most of the literature to date has focused on work in the hospital setting, as it is, for the most part, a closed and controlled environment. Other settings are less well researched, although studies in nursing homes and ambulatory settings have shown significant opportunities for improvement. Reports of adverse drug events in the outpatient setting range from three to 50 adverse drug events per 1,000 adult patients.³ It is clear that medication safety, and the broader category of patient safety, represents a serious concern for patients and health care providers regardless of the setting.

While many health care professionals have roles in the medication use process, pharmacists and pharmacy technicians play a pivotal role in ensuring the safe use of medication. Pharmacists’ provision of accurate drug information and identification of potential medication-related adverse effects is of vital importance. All providers involved in the medication use process need a sound understanding of the risks for error and the ability to identify the underlying causes of medication errors. Taking responsibility for implementing steps to prevent such occurrences and minimize adverse outcomes is vital to safe medication use. This manuscript will describe various methods to identify errors, classify the different types of errors and patient outcomes, and outline the steps necessary to implement an event reporting system.

MEDICATION MISADVENTURE

The term medication misadventure is an overarching term that includes medication errors, adverse drug events, and adverse drug reactions. The American Society of Health-System Pharmacists (ASHP) defines a medication misadventure as an inherent risk when medication therapy is indicated that is created through either omission or commission by the administration of a medication during which a patient may be harmed. This medication misadventure may be attributable to error (human or system), immunologic response, or idiosyncratic response and is always unexpected or undesirable to the patient and the health professional. Adverse drug events involve harm to the patient and are defined as any injury caused by a medication and encompasses all adverse drug reactions, including allergic and idiosyncratic reactions, as well as medication errors that result in harm to a patient. Adverse drug reactions refer to any unexpected, unintended, undesired, or excessive response to a medication. These reactions may require medication discontinuation, dose modification, admission to a healthcare facility, or result in temporary or permanent injury or death.⁴  Medication errors can lead to adverse drug events or adverse drug reactions depending on the details of the clinical scenario.

The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP), has developed a detailed definition of what constitutes a medication error as follows: “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”⁵ Medication errors can be caused by errors in the planning (deciding what to do—which drug and/or what dose) or execution stages (completing the task that was decided on—administering the drug to the wrong patient). Medication errors include errors of omission (missed dose or appropriate medication not prescribed) or commission (wrong drug given) and do not necessarily have to cause the patient harm. All these factors become important when considering what to report as a medication error.

While there are standard definitions for medication errors, there may be significant differences in the interpretation, reporting rates, and severity ranking between institutions. There are common questions that arise when reporting medication errors such as, “Was it an error if it did not reach the patient?” “What constitutes minimal, moderate or severe harm?” “What is considered preventable?” For example, one institution may determine that an error has occurred when a dose is not received by a patient within 30 minutes of the scheduled time, where another may permit a longer time period after the scheduled administration time. Some institutions may not report an inappropriately written prescription if that error is caught by a clinician before the medication reaches the patient. Should pharmacist’s interventions related to inappropriate orders by prescribers be documented and counted as prescribing errors? According to most definitions, this would count as a prescribing error. These are all valid questions and variations make it difficult to compare data from one institution to another. Therefore, it is best practice for an institution to have a standardized process to account for these varying questions and make certain all medication errors are appropriately documented.

IDENTIFYING MEDICATION ERRORS

It is important that a systematic approach to the identification and assessment of errors and adverse events be utilized in order to identify trends and opportunities for improvement. This should involve several methods which contain prospective and retrospective methods of identifying errors and risks when possible since just a fraction of medication errors are detected by any one method used to identify them.⁶ Many methods of identifying errors in health care exist, including voluntary reporting, direct observation, chart review, trigger identification, and computerized monitoring. These methods are described below.

Voluntary Reporting

A voluntary reporting system is the most common method of identification of errors and events. Many institutions include an anonymous option for both those who detect or commit the error and this risk-free system may increase the likelihood of having the error reported. On the pro side voluntary reporting is the least labor-intensive option however, since the risk must be recognized to be reported many errors are never detected. This method only identifies approximately 1 out of 20 errors when compared to other identification methods. On a national level, voluntary reporting provides a good way to identify emerging problems that may only occur on a small-scale or in individual institutions. Some examples of national voluntary reporting programs include the FDA’s MedWatch and the sentinel-event-reporting system of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).⁶

Direct Observation

The direct-observation method uses trained observers to watch the real-time administration of medications. Notes from the observations are compared with prescribers’ orders to determine if an error has occurred. Results with this method have shown to be more valid and reliable versus self-reporting. This is limited to the identification of errors that occur during the administration phase of the medication use process and it typically samples a selected time period on a selected unit, limiting the extrapolation to other time periods or patient care areas. Errors that usually are never discovered or go unrecognized are often identified using this method.⁷ A study that compared the efficacy and cost of direct observation, chart review and incident report review showed the data collected by direct observation detected administration errors at a much higher rate and more accurately than either of the other two methods. However, direct observation was more expensive per examined dose because of the normal delays involved in medication administration sessions and the special training required for data collectors.⁸

Chart Review

Chart review identification of medication errors involves training staff to review charts looking for cues or data elements that signify an error or event has occurred. This method is generally not practical outside of a research environment as a consistent method to report medication errors. It relies on practitioners to document events when identified, which may lead to an underestimation of the true occurrence. In a study comparing chart review, voluntary reporting, and a computer-based monitoring strategy results showed that chart review detected more adverse drug events versus the other systems but was considerably more labor intensive. The computerstrategy required 11 person-hours per week to execute, whereas chart review required 55 person-hours per week and voluntary report strategy required 5 hours per week.⁹

ADE Trigger Tool

Promoted by the Institute for Healthcare Improvement (IHI), this tool is an augmented chart review method that uses automated systems to identify alerts or triggers that have been shown to correlate with potential adverse drug events. The triggers are cues that a patient may have experienced an error and/or adverse event. Example triggers include the use of reversal agents (e.g., flumazenil, naloxone, phytonadione), abnormal lab values (e.g., partial thromboplastin time (PTT), international normalized ratio (INR), serum creatine, low blood glucose), over-sedation, rash, or abrupt medication discontinuation. When these triggers are identified, it is suspected that the patient may have experienced a medication error. The patient's chart is then reviewed for evidence of error and/or level of harm and data is collected and collated to determine potential causes. For example, reviewing the charts of patients who experience hypoglycemia may reveal errors, such as incorrect insulin dosing if the patient was fasting for surgery. The tool provides instructions for conducting a retrospective review of patient records and instructions for measuring the number and degree of harmful medication events. Use of the trigger tool requires minimal capital expense, it can be introduced rapidly with focused training sessions, and is reproducible across a broad spectrum of healthcare systems and institutions.¹⁰

As a result of the need to capture data that would reduce harm to patients, Congress passed The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The act authorized the creation of a nationwide network of Patient Safety Organizations (PSOs) to improve safety and quality through the collection and analysis of data on patient events. The Patient Safety Act provides a venue for institutions to report information related to errors and events with the goal of collating the information and determining the underlying risks across similar types of events. The act provides confidentiality and privilege protection to organizations and assures that information about an error that is provided to the authorized PSO is kept confidential. The privilege protections limit or forbid the use of protected information in criminal, civil, and other proceedings.¹² It is recommended that hospitals, ambulatory centers, and other organizations join a PSO and commit to reporting data related to adverse outcomes. Overall, this process enables the collation of larger quantities of data that can be analyzed in order to provide broad scale education from errors and events.

CLASSIFICATION OF ERROR TYPES

There have been many taxonomies of errors developed by various groups, including the World Health Organization (WHO), The Joint Commission (TJC), American Society of Health System Pharmacists (ASHP), and others. As a result of the development of PSOs, a common taxonomy and language was developed to enable health care providers to collect and submit standardized information related to safety events. These standard event reporting forms are called Common Formats which define standardized data elements associated with errors and events that are to be collected and reported to the PSO. The scope of Common Formats applies to all patient safety concerns including events reaching the patient (with or without harm), near-miss events that do not reach the patient, and unsafe conditions that have the potential to cause an error or event. The Agency for Healthcare Research and Quality (AHRQ) has developed “Common Formats” for three settings of care including hospitals, community pharmacies and nursing homes and they are likely to become the standard for reporting.¹³. Consistency with the use of terminology within institutions will allow for ease of contribution to the national data pool, leading to improved overall health outcomes. The Common Formats specifies two distinct classification systems when reporting a medication error or adverse event which include event type and stage of error.¹³ The following event types have been defined for medication errors (Table 1). 

The second classification section of the medication Common Formats report asks at what stage the incorrect action was discovered (regardless of where or when the incorrect action originated) with the following choices.¹³

• Purchasing
• Storing
• Prescribing
• Transcribing
• Preparing
• Dispensing
• Administering to patient (including verifying medication)
• Monitoring

Other contributing factors are gathered in the PSO reporting process such as variables related to the environment, technology/equipment factors, workflow, staffing/scheduling etc.¹³ Medication errors are not mutually exclusive as multiple types of errors may occur during a single administration of a drug and a single adverse patient outcome may be the result of more than one type of error.¹¹ As the use of Common Formats grows, individual health care organizations are encouraged to adopt these classifications in order to develop a standard taxonomy over time.

CLASIFICATION OF PATIENT OUTCOMES

Although the classification of errors or events frequently is based on type, most are also classified by the patient outcome related to the error or event. Since most national reporting systems request information regarding the outcome of a medication error it is important for institutions to monitor both the types of errors that occur and the outcomes even in cases where no harm occurred. The NCCMERP developed a medication error index that serves to categorize errors based on the severity or outcome of the error. This index is divided into four main categories and nine subcategories and is described below.¹⁴

No error

• Category A: Circumstances or events that have the capacity to cause error

Error, no harm

• Category B: An error occurred but the error did not reach the patient
• Category C: An error occurred that reached the patient but did not cause harm
• Category D: An error occurred that reached the patient, resulted in the need for increased patient monitoring and/or needed an intervention but caused no harm

Error, harm

• Category E: An error occurred that resulted in the need for intervention and caused temporary harm
• Category F: An error occurred that resulted in initial or prolonged hospitalization and caused temporary harm
• Category G: An error occurred that resulted in permanent harm
• Category H: An error occurred that resulted in a near-death event

Error, death

• Category I: An error occurred resulting in death

Institutions may choose to use information about outcomes to focus their error prevention efforts on the types of errors resulting in the most serious outcomes. However, examining near-miss events can be as valuable in preventing future errors as focusing on serious outcomes. These near-miss events may give clues to underlying process issues that require attention before they cause harm to a patient. As resources permit it is important to analyze all types of medication related errors to promote the best possible standard of care.

IMPLEMENTING AN EVENT REPORTING SYSTEM

The Joint Commission and ASHP standards can be used as a basis for starting an error reporting program. In addition to the standards, the pharmacy and medical literature contain abundant examples of successful programs. The following steps are a compilation of TJC and ASHP standards. ^15,16

1. Utilize standardized definitions and classifications for errors and events. The definitions and classifications that the Common Formats developed in preparation for external reporting to PSOs will likely become the standard.
2. Assign responsibility for the error review program within the pharmacy and throughout other key departments, a multidisciplinary approach is an essential factor. In order to ensure overall success, a medication safety leader, preferably a pharmacist, should lead the medication safety efforts throughout the organization.
3. Develop forms or online methods for data collection and reporting to serve as the voluntary reporting component of the program. Electronic reporting can often be designed such that medication errors are reviewed by key team members to confirm severity of the event and gather additional information as needed in order to determine whether additional analysis is appropriate. Make sure staff members understand that those who report human errors and at-risk behaviors will not be punished so that the organization can learn and make improvements.
4. Provide feedback to reporters and individual units that discuss their errors as well as those of others, along with steps taken to prevent them. Providing feedback is very important to assure that those reporting feel that the identified errors are reviewed and methods to prevent recurrence are developed and implemented.
5. Develop policies and procedures for determining which errors and events are reported to national organizations.
6. Establish mechanisms for regular screening and identification of potential medication errors and adverse drug events to supplement voluntary reporting. Other event detection methods, such as trigger tools, chart review, data from technology, and direct observation, should be considered to complement error-reporting efforts. These mechanisms should include retrospective reviews, concurrent monitoring, as well as prospective planning for high-risk groups.
7. Routinely review medication errors for trends. Report all findings to the pharmacy and therapeutics committee and other hospital or organization quality and safety committees.
8. Develop strategies for decreasing the incidence of medication errors and adverse events utilizing the data collected through the various identification and reporting systems. Use caution in aggregating data by error types or other surface level classifications. The key is getting to the causes of the errors—not just the fact that the errors occurred. Seek to discover the why behind the error, as these are the issues that need to be resolved.

After creating your own internal process, it is important to review national resources that identify errors in other organizations. It is likely that your institution is experiencing similar risks. Look at your own processes and implement additional risk reduction strategies where warranted. Collaboration between institutions and national data facilitates identification of preventative methods.

TYPES OF SAFETY EVENT ANALYSES

Once the data is collected, thorough analysis is a key activity to support learning from errors to prevent recurrence. Analyzing near-miss events and errors reaching the patient but causing little to no harm can be very valuable learning experiences. The causes of these events are often the same errors that lead to serious harm. Institutions can review them in aggregate to determine if there are common themes or causes that may warrant further investigation and process changes. Medication errors that cause harm to patients, ranging from minor harm to death are what many facilities investigate to better understand the causes. It is helpful to use a root cause analysis or failure mode effect analysis to further investigations.

Root Cause Analysis (RCA)

The goal of the RCA is to investigate the event in such detail that the true root cause(s) of the event are identified. The RCA should focus on the systems of care, not on the individuals.¹⁷ Table 2 defines three different methods that can be used to perform this type of analysis.

It is remarkably easy to be imprecise about causes in the RCA. A valid approach encourages precision and clarity when developing causal statements by applying the Five Rules of Causation. These rules originated from David Marx's work on aircraft maintenance safety and are highlighted below.¹⁸

• Clearly shows the cause-and-effect relationship
• Uses specific and accurate descriptors for what occurred, rather than negative or vague words
• Human errors must have a preceding cause
• Violations of procedure are not root causes, they must have a preceding cause
• Failure to act is only causal when there is a duty to act

To better understand how to use the RCA let’s work through an example. Suppose an elderly patient with a history of heart failure comes into the ER with difficulty breathing and a cough. He has a delayed diagnosis of pneumonia. There is a delay in receiving the antibiotic after it was ordered putting the patient at an increased risk of complications.

Failure Mode and Effects Analysis (FMEA)

While RCA is a retrospective process, the use of FMEA is a prospective process. This analysis recognizes that most accidents arise when failures in multiple layers of defense line up in exactly the right way to allow harm to reach a patient. To perform the FEMA, a team takes an issue that has been identified as a potentially risky process and examines the ways in which the process or product might fail. This analysis can be done prior to implementation of a new process or technology to increase the awareness of how the implementation might fail and take adequate steps to avoid failures. In the FMEA, each step of the process is outlined, the team brainstorms all the ways in which the process could fail and defines the effect of each potential failure to the end user (often the patient). An estimation (on a 10-point scale) is made of the likelihood of the failure, the severity of the potential failure, and the probability that the failure will be detected. A criticality index is calculated and those failure modes with the highest scores are prioritized as important steps for which barriers are developed. This analysis can help prioritize among the potentially large number of targets for improvement since it is designed to provide a rank order of process steps for improvement based on their risk of causing harm via failure. Use of FMEAs will sometimes be required by state and national regulatory agencies as part of a healthcare provider's accreditation process.¹⁷

Once the cause is identified an action plan should be developed with the intent of preventing the recurrence with certainty. Risk reduction strategies such as reeducating the department, asking staff to be more careful, and developing or editing a policy and procedure have been the norm for years. These tasks require more reliance on humans to remember to perform the correct task and are thus considered weaker risk reduction strategies. It is now recognized that to prevent recurrence some change in the process is usually necessary. The concepts of mistake-proofing, standardization, and forcing functions are important considerations in the development of risk reduction strategies. These strategies are considered stronger since they rely less on humans to remember to perform the task correctly. Taking an action that physically prevents something from happening is the most effective method of preventing an inadvertent action.¹⁷ Table 4 lists some examples of strong versus weak risk management strategies. Regardless of which type of analysis is used, the key in preventing a recurrence is monitoring the action plan to ensure that it is implemented in a timely and effective manner. Measures need to be revisited to assess the implementation and effectiveness of the action plan.

BEST PRACTICES FOR ERROR PREVENTION

There are many resources that identify best practice error prevention strategies.

In particular, the Institute for Safe Medication Practices promotes a publication of a Quarterly Action Agenda that describes known risks and errors and describes recommendations for risk reduction strategy implementation. The Institute for Healthcare Improvement sponsors campaigns to reduce harm to patients, virtual training programs, safety toolkits, and various quality improvement worksheets. The reader is encouraged to visit each organizations’ website to learn more specific details related to the various resources (Table 5). The Joint Commission’s National Patient Safety Goals are recommendations updated annually related to safe medication use. They are divided into the type of health care provided (e.g., hospital, home care, ambulatory care, behavioral health care, etc.).¹⁹

Along with the tools and resources that are available from the national organizations the following are some specific recommendations that may be helpful to consider when implementing error prevention strategies.

Carefully implement new technology

There have been many advances in technology and information systems available within health care such as barcoding technology, smart pumps, automated dispensing technologies, and more. These all have the potential to provide great value, however, the implementation of these new technologies should be done cautiously. Unintended consequences may occur when a new technology is implemented, and a new problem develops as a result of the technology. An FMEA can be utilized prior to new technology implementation to brainstorm what could go wrong and develop strategies and educational tools to prevent deviations from the desired outcome. A recent study indicated that clinicians prefer technological advances in their practice sites to be implemented according to criteria that guarantee the quality of clinical care and adequate management of the technology to ensure its continuity.²⁰ It is always recommended that the end-user be involved in the selection process of these technologies since they interact with the products daily.

Use quality improvement to improve safety

While it is not necessary to conduct a randomized controlled trial with every intervention to improve safety, it is valuable to develop measures, gather baseline data, and reassess to show improvement. The Plan-Do-Study-Act (PDSA) cycle is one structured method to lead teams through the quality improvement process. This process involves a planning stage in which a problem statement and implementation strategy is developed based on gaps identified within a process (plan), the strategy is implemented (do), the results are analyzed (study), and any refinements are made to the plan (act). These cycles repeat until a reliable and efficient process is finalized.²¹

Evaluate environmental contributions

Numerous workplace factors may contribute to performance lapses and medication errors. . Examples include low lighting, high levels of noise, high temperatures, and stressful work environments are examples. Distractions and interruptions as part of the workflow should also be evaluated and minimized.

Wisely choose the team

When choosing any type of team whether it be to identify errors, implement an adverse event reporting system, analyze the error, or perform quality improvement it is critical to identify the best people. To work efficiently teams, need diversity in skill sets, experience and knowledge. Having an open mind to consider other perspectives and yet provide constructive feedback is crucial to a quality team member. In some cases, it may be favorable to include patients or other family members. The team may alter their thinking and priorities and allow the process to become more patient-centered.²²

Establish redundancies

Since humans are susceptible to error, it is recommended that redundancy be a part of processes. This allows an error caused by a slip or lapse to be caught downstream before it reaches a patient. Be sure to define exactly what is meant by an independent double check. One person should do the calculations and document the results. Then a second person, without reviewing the work of the first person, should complete the same calculations and then compare the answers for consistency. This is important to avoid confirmation bias (seeing what you expect rather than what is actually there). For maximal effectiveness, independent double checks should be limited to assure they are completed appropriately. It is recommended that independent double checks be limited to the following situations below.²³

• Situations that involve high-alert medications, such as chemotherapy, insulin, opiates, and anticoagulants
• Complex processes (compounding, calculating doses)
• High-risk patient populations (children/adolescents; elderly or pregnant patients; patients with severe congestive heart failure; patients with known renal impairment or liver disease)

CONCLUSION

Providing for safe medication use is paramount to the safety of all patients. Diligent efforts to identify errors utilizing several methods, analyzing and determining the root causes and contributing factors, and devising systems that support humans and prevent expected errors are all a part of developing a culture of safety. Involving staff on the front line when reviewing safety events and developing action plans to prevent recurrence is important to the development of an effective action plan. Garnering support and confidence that once errors are identified, leadership is committed to improving the processes is of critical value to the detection of errors by creating a culture of learning and support as opposed to blame and punishment. Teamwork and mutual respect are vital parts of making safety a core value in health care delivery.

REFERENCES

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23. Grissinger M. The virtues of independent double checks: they really are worth your time! P&T. 2006:31:9.

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