Medication Errors Course Goal Patient safety has become a major national concern and is due in part to the landmark publication in 1999 of the Institute of Medicine's report To Err is Human: Building a Safer Health System that illuminated the risks of medical care in the United States. Because of their widespread use, a significant portion of these concerns involve medications. This course is designed for pharmacists practicing in various settings in the healthcare industry. Through this study of medication errors, root cause analysis, error prevention strategies, and patient safety initiatives, pharmacists will recognize their role in the national effort to reduce medical errors, particularly those involving medications, and become aware of methods to achieve this. Objectives At the completion of this program the participant will be able to: 1. Discuss medication errors, their impact, and factors contributing to their occurrence. 2. Explain the role of an organization and the professional in the identification, reporting, monitoring and reduction of medication errors. 3. Recognize error-prone situations. 4. Discuss patient safety practices to improve patient outcomes. 5. Identify medication safety needs of special populations. 6. Describe the processes of Root Cause Analysis and Failure Mode and Effects Analysis. Introduction For those of us in healthcare, medical errors are nothing new. The possibility of their existence and their consequences were introduced to us early in our professional education and long before our licensure. Their reality became clear to us from the outset of our professional practices. We know that errors can and do occur at various levels and with diverse significance and outcomes. While our genuine desire to avoid them is consistent, our response to them at the many levels of the health care industry is not. Too often nothing really changes. Mistakes are superficially addressed with contributing procedures and systems left unaltered thus leaving the stage set for the next incident. Frequently, individuals contributing to an error may not even be aware of their role in it. More often, individuals are unjustly singled out to receive blame for matters beyond their control. A cycle of inaction, or nonproductive action, prevails. In November, 1999, a landmark report by the Institute of Medicine (IOM) initiated an unprecedented effort to break this cycle. Sobering statistics propelled its recommendations. It declared that it is simply unacceptable for patients to be harmed by the same system that is supposed to offer healing and comfort. Effects of the report were widespread, evoking reaction from the public, from regulatory and governmental agencies, as well as from all segments of the healthcare industry. In the period following its publication its initiatives continue; some high-risk activities have been identified; processes have been researched and modified; monitoring and reporting is evolving. Where this will take us is yet to be seen. As practicing healthcare professionals it is apparent that we have a long way to go. Activities on the front lines of healthcare delivery frequently conflict with those discussed, labeled, and acted on by public authorities. The primary goal of this program, as previously stated, is to help address this conflict. It is intended to make participants aware of the magnitude of the problem and of the many-leveled activities needed to resolve it. It emphasizes the importance of the individual's personal role in the issue, and it describes how they can effectively contribute to its resolution. Why is it important? Statistics The occurrence of medical errors and their associated costs are poorly understood by most. The reasons are many. They include an environment of secrecy characterized by absent reporting and documentation, as well as by a diluted perception of the problem. A disaster involving an aircraft that immediately claims the lives of 200 persons has a more emphatic impact on the public and safety officials than does 200 deaths attributable to medical errors that occur over a greater geographical area and longer period of time. Knowledge of the latter are slow to emerge and difficult to discover. Clearer definition of the problem surfaced with the IOM report To Err Is Human which estimates that 44,000 to 98,000 people die in hospitals each year as the result of medical errors and that as many as 7,000 of those fatalities are due to medication errors.1 While these numbers are impressive, they are likely to be a significant underestimation of the problem. First, the two studies from which the statistics are extracted are believed to offer conservative figures because they were limited to injuries of a specified level of harm, they required a high threshold to determine whether an adverse event was preventable or negligent, and they included only those errors documented in patient records.2 Second, these statistics represent errors in hospitals only. More recently, Barker and colleagues observed a persistence of the problem in defining 19% of doses administered in health care facilities to be in error and 7% rated as potentially harmful.3 Since the IOM To Err is Human report, others in the health care industry outside of hospitals have sought to define and characterize the problem of medical errors in their specific settings. Flynn and colleagues evaluated prescription dispensing accuracy and safety in various outpatient pharmacies.4 They determined there were 4 errors in every 250 prescriptions dispensed (1.6%). This could be extrapolated to 51.5 million errors in the 3 billion prescriptions filled annually. Of these, 3.3 million were characterized as potentially clinically important or having the potential to lead to patient harm or discomfort. The costs associated with these mistakes are also enormous. They extend from the affected individuals to society as a whole. Not only do they result in higher overall health care expenses, but they also cause lost productivity, disability, and increased costs of personal care. Costs associated with adverse drug events (ADEs) in hospitalized patients that were determined to be preventable exceeded $5000 per case and when extrapolated in a case-control study by Bates and colleagues amounted to over $2 billion nationally per year.5 This cost reflects only a portion of the problem and does not address that associated with drug use in other vulnerable settings such as ambulatory, home, or long-term care. What are medication errors? Some health professionals view medication errors simply as an infraction of one of the "five rights": "right patient, right drug, right dose, right route, and right time." This, however, is an over simplification. 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 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."6 It is important to note that this definition encompasses near misses, a feature that can help identify processes and events before they affect an actual patient. Because medications are used extensively in hospitalized patients and outpatients they are a common type of medical error. Preventable adverse drug events at two tertiary care hospitals were identified, and of these 56% were attributed to error in ordering, 34% in administering, 6% in transcription, and 4% involved dispensing errors.7 Another study showed physicians lack of knowledge about the drug or about the patient to be the main reason for dosage errors.8 When risk factors for preventable adverse drug reactions in patients admitted to medical and surgical units at two hospitals were investigated, few could be identified, which suggested to the authors that improving medication systems would be more effective than acting on patient specific factors.9 Medications are used in a variety of settings. Additionally, multiple professionals and organizations are involved in the use process which includes prescribing, dispensing, administering, monitoring, and systems and management control (Table 1). With errors occurring at any of these steps, multiple interventions on many fronts are necessary to prevent them. Studies have characterized and quantified problematic aspects of the various components of the medication use process and, as previously stated, many factors contributing to errors with medications have been identified. Why do they occur? Causes of medication errors have been identified and classified by many authors. Cohen in his text on medication errors utilizes six categories commonly observed by the Institute for Safe Medication Practices (ISMP) to provide an overview of causes.10 They are 1) failed communication, 2) poor drug distribution practices, 3) dose miscalculations, 4) problems related to drugs and drug devices, 5) incorrect drug administration, and 6) lack of patient education. Failed Communication Failed communication involves both the written and the spoken form. Written failures typically result from illegible or incomplete orders. They commonly involve the use of unfamiliar abbreviations, antiquated systems of measure, and zeros and decimal points positioned such that if the decimal point is obscured by lines on forms or distorted by transmission devices (i.e. faxes, copy machines) the amount is altered. Verbal miscommunication can stem from variation in enunciation and pronunciation, and confusion over drugs with similar sounding names and doses. Additionally, if verbal communication is not promptly reduced to writing, problems associated with recall are introduced. This category of error can be expanded to include deficiencies in knowledge and in faulty interaction with other services. If pertinent information about the patient and the drug is not readily available during the process of ordering a medication, one can consider a failure of communicating this crucial information to have taken place. This would include difficulties in sharing or presenting information from any participant in the medication use process that is required by others to complete their tasks safely and appropriately. A common and not so obvious example of failed communication is the existence and use of erroneous patient profile databases that communicate inaccurate crucial information such as patient weight, height, drug allergies, and medication use. Poor Drug Distribution Practices Redundancies and fail-safes in various procedures serve to identify irregularities or errors prior to the completion of a process. If designed and utilized properly, errors in drug distribution (dispensing, or retrieval) and verification of related crucial information (allergies, doses, etc.) can be identified before they endanger patient safety. Errors from poor drug distribution practices also include mistakes originating from confusion of drugs with similarities such as name, use, strength, or package appearance when they are stored or stocked in close proximity to each other. Realistically, this category could be identified as "poor medication use practices" in that the presence and use of adequate checks and fail-safes at all of the steps of the process should exist. When properly positioned, redundancies and fail-safes should reveal issues such as allergies or incorrect doses at the time of the order and well before access to the drug is even attempted. Dose Miscalculations Dose miscalculations are particularly common with pediatric patients and intravenous medications. In these instances computations are typically more complex. Error risk increases when these calculations are done by individuals having a poor reference or understanding of what is "normal" or "usual" for that size or age of patient, or particular medication. These errors may involve mistaking for whom the order is intended, e.g. John Sr. versus John Jr. or a 3 "mo" versus 3 "yr" patient. Dose miscalculations can happen outside of the dispensing and administration functions in the medication use process. Dosing errors frequently occur at the ordering stage. In a previously mentioned study, the physician's lack of knowledge about the drug or about the patient was identified as the main reason for dosage errors.8 Problems Related to Drugs and Drug Devices Labeling and packaging, both extemporaneous and commercial, have lead to serious medication errors when there is failure to clearly communicate contents or directions. Small print shaded so that it fades into a vial or its contents, or relabeled bulk items that cover identifying, use, or storage information are common occurrences of this problem. Software, such as that used in some pharmacies to calculate complex solution ingredients (i.e. cardioplegia solutions, parenteral nutrition), that is difficult to use and introduces too many variables or units of measure (mcg, mg, G, Kg, mMol, mEq, etc.) can contribute to medication errors. Compounding devices that allow reagent confusion or infusion pumps that are difficult to program or dont protect against free flow are additional examples of errors in this category. Incorrect Drug Administration These mistakes involve wrong patient drug administration and any imaginable confusion in route of administration, e.g. topical preparations given orally, oral preparations given intravenously, suspensions intended for IM injection given intravenously, etc. Misidentification of the patient or confusion with their medication administration record may result in this type of error. Lack of Patient Education Mistaken or inappropriate use of a medication can be the result of inadequate understanding or insufficient information provided by health professionals. Education for select medications of warning signs from excess or toxic manifestations can mitigate some medication misadventures. Teaching a patient to check their pulse before taking digoxin, or informing them of signs indicating excessive anticoagulation are examples here. As with many other functions, increased knowledge by the end user of medications or medical devices, be they nurse, physician, or patient, offers additional redundancies and enforcement at a very crucial step. Contributing Factors A common response to a medication error is to isolate a human "cause" and assert blame. This generally involves identifying a failing party, and if the result of the mistake is particularly bad, doling out an appropriate punishment. The recipient of both blame and punishment is usually the one closest to the event. Two major faults exist with such a response. First, most errors occur as a result of "a chain of events set in motion by faulty system design that either induces errors or makes them difficult to detect."8 Focusing on the individual(s) closest to the mistake is frequently a superficial response that does not address system flaws or contributing factors that allowed the error in the first place, a situation that sets the stage for repetition. Second, physicians, nurses, pharmacists, and all other health professionals, being human, make mistakes. These mistakes occur despite how much we care, how hard we work, and how much we know. Consequently, systems that rely on error-free performance by humans are likely to fail. To understand how we humans contribute to error we must appreciate the differences between active and latent errors. "Active errors occur at the level of the frontline operator, and their effects are felt almost immediately. Latent errors tend to be removed from the direct control of the operator and include things such as poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations".11 The differences are demonstrated by the following example. Pharmacist RPH enters a physician order for "clopidogrel 75mg po QD" into the hospital computer system. In doing so the quantity is miskeyed resulting in seven 75mg tablets being dispensed and a dose of 525mg po QD printing on the computer generated medication administration record. An example of an active error is the erroneous entry into the computer system resulting in an overdose of a medication. Latent error in this example would include the software design that allowed the dose entry without notifying the operator that it was outside of the usual range and the absence of steps required by the operator to acknowledge this intent. How would you evaluate and respond to this example? Many would focus on the individual and his or her need for additional training and revision of work habits. How effective is such a response in a complex system with many employees each capable of miskeying an order entry? This example offers insight into other differences and consequences between active and latent errors. Latent errors are often unrecognized, and they can contribute to many different active errors. People tend to adapt and work around design defects, which allow flaws to become acceptable. This creates a particularly dangerous situation because warning signals are not recognized. For these reasons latent errors are felt to pose the greatest threat to safety in complex systems such as those typically found in health care. System Contribution Charles Perrow, in his analysis of the Three Mile Island nuclear accident, identified how systems can cause or prevent accidents.12 He characterized systems according to their complexity and whether they are coupled loosely or tightly. Complex systems have multiple components that interact, often in unexpected or invisible ways. Specialization, interdependency, and complex communication involving multiple feedback loops characterize them. Coupling is a mechanical term and refers to the slack or buffer between two items or steps in a process. Tightly coupled systems have more time-dependent processes and sequences and are less flexible in how things can be accomplished. Complexity can cause accidents through confusion. Tight coupling lends to quick paced events and makes interception of errors or quick recovery from a mishap difficult. Some have classified health care systems as complex and tightly coupled, and thus prone to accidents.13 Additionally, health care systems can be variable in size, scope, and membership, making them difficult to analyze and understand. System contribution is most important to latent errors. Identifying and fixing latent errors has enduring effects that contribute to the safety of the system. The Human Element Reasons why people make errors have been studied for many years. Cognitive psychologists have explored the way people think. Human-factor specialists have analyzed the interrelationships between humans, the tools they use, and the environment in which they live and work.14 They have applied their findings to improve system and process design. Human mental function occurs in two basic modes, automatic and problem-solving. Each mode has unique errors associated with it.15 Automatic mode, as its label implies functions quickly and requires little conscious effort. This mode draws on one's accumulated learning of situation recognition and response. Errors while in automatic mode are called "slips" and are typically due to distraction and breaks in attention at critical moments. Problem-solving mode requires greater concentration because information must be gathered, processed through comparison to stored knowledge, and then applied to some decision rule. Consequently, problem-solving processes are slower, sequential, demanding, and difficult to sustain. Errors in this mode are referred to as "mistakes". They result from selecting the wrong rule or misapplying the correct rule. Various factors influence mistakes and affect our ability to solve problems. These factors include insufficient knowledge, pattern matching, biased memory, the availability heuristic, confirmation bias, and overconfidence. Lack of sufficient knowledge leaves us with no programmed solution, particularly in an unfamiliar situation, e.g. refilling a methotrexate prescription used for rheumatoid arthritis by a patient that has failing kidneys which leads to accumulation and bone marrow toxicity. Pattern matching involves discovering patterns in situations so that previously thought out responses can be applied, e.g. recognizing a particular drug's dose to be usual or customary for an adult, but failing to realize that it was intended for a 30 pound toddler. Biased memory results from over generalizing and assuming that patterns have universal applicability, e.g. not verifying a potential allergy problem with the physician by assuming Dr. Always wants this patient with a history of severe penicillin allergy to get cefazolin pre-operatively because he always says to do so when he is asked about allergies. The availability heuristic is the tendency to use the first information that comes to mind, e.g. grabbing the "amber" vial to administer a diuretic without realizing you had grabbed a similar appearing multiple dose vial of epinephrine. Confirmation bias involves selection of data that supports the initial thinking and discards that which contradicts or fails to support it, e.g. the label says XYZ, so it must be XYZ even though it doesn't look like XYZ or smell like XYZ. Overconfidence is the tendency to favor the chosen action and evidence that supports it, e.g. expecting a 2gm/250ml NS infusion and 1gm/100ml bolus of procainamide to be prepared after handing the IV technician three 1gm vials of procainamide injection, 1-250ml bag NS, and 1-100ml bag NS and stating "we need a procainamide bolus and drip stat" without realizing all 3 grams were put in the 100ml bag. Factors that decrease attention or create distraction can cause errors in both automatic and problem solving activities.15 These factors may be physiological, psychological, or environmental. Fatigue, illness, loss of sleep, alcohol, and drugs are examples of physiological factors. Psychological factors include various emotional states and distraction from other activities. These can be triggered by external factors such as overwork, interpersonal relations, or other forms of stress. Environmental factors such as temperature, noise level, lighting, and visual activity can cause distraction. Many of these are accepted as a normal part of existing or just how things are without linking them as factors that might cause an error. The cause of error can have many dimensions, can be quite complex, and can result from the convergence of many contributing factors. As with other complex industries, safe healthcare has many requirements such as: good managerial decisions, reliable, functional, and well-maintained equipment; a skilled and knowledgeable workforce; reasonable work schedules and well-designed jobs; and clear guidance on desired and undesired performance. These requirements have been labeled preconditions and their absence or insufficiency can be viewed as latent failures embedded in a system, which through interaction of the system and the production process, can contribute to many unsafe acts.11 Improving Patient Safety - What is being done? Actions to define and correct medication errors existed prior to the IOM report. In 1995, the United States Pharmacopoeia (USP) advocated the formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), an independent body comprised of 25 national and international organizations, to address medication error reporting and prevention.16 The 1998 report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry identified medical errors as one of the four major challenges facing the nation to improve health care quality. As recommended by this report, the Quality Interagency Coordination Task Force (QuIC) was established to coordinate quality activities in federal health care programs, the largest purchaser and provider of health care services in the country. The QuIC includes the Departments of Health and Human Services, Labor, Veterans Affairs, Commerce, and Defense; the Coast Guard; the Bureau of Prisons; the Office of Management and Budget; the Federal Trade Commission; and the Office of Personnel Management. The QuIC is charged with coordinating the overall federal response to the IOM's report on medical errors. Federal government activities extended to the private sector with President Clinton's December 1999 memorandum requiring the more than 300 private health plans participating in the Federal Employee Health Benefits program to institute patient safety initiatives. Additionally, federal agencies administering health plans were to evaluate and, where feasible, implement the latest error reduction techniques.17 Health providers are experiencing greater scrutiny and demand for safety improvement by the many oversight organizations, group purchasers, and professional groups. This responds to one of the recommendations by the IOM in its To Err Is Human report as a means to increase external pressure on providers to improve patient safety.1 Government officials at the state level are also interested. Twenty states require some form of medical error reporting. As an example, Florida requires reporting of mistakes that lead to serious patient injuries, such as life-threatening situations and epidemic outbreaks. Another class of reports involves serious adverse events, such as wrongful deaths, brain injuries, wrong limb removals, and incorrect surgeries.18 Additionally, the 2000 Florida Legislature created the Commission on Excellence in Health Care to facilitate the development of a comprehensive statewide strategy for improving health care delivery systems through meaningful reporting standards, data collection and review, and quality measurement. As a further demonstration of their intent to advance this process, legislation (456.013) was passed in 2001 requiring 2 hours of continuing education study on medical errors by all healthcare professionals to qualify for initial Florida licensure and biennial renewal. Other states have subsequently followed with similar requirements. Clearly there is no single or best way to improve patient safety. It is a complex problem that in many ways remains ill defined and, for a variety of reasons, resistant to change. The existence of these qualities was apparent in the IOM's 1999 report and tended to drive its recommendations. The standards set by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and recommendations from the IOM have served as the most influential guidelines directing change for improved patient safety in health care today. Issues and actions identified by them have set the direction for related activities by regulatory, professional, and organizational groups. It is especially important that front line health care participants know and understand these activities because it is at their level where the ultimate goal of improved patient safety is realized. 1999 IOM Recommendations The 1999 IOM recommendations for initiating the move to improve patient safety addressed the following four general areas: * create a national center to oversee and direct medical safety efforts * mandatory and voluntary error reporting * safety performance standards for health care professionals * safe practices at the delivery level Currently, the Center for Quality Improvement and Patient Safety (CQuIPS) is the primary group within the Agency for Healthcare Research and Quality (AHRQ) serving as a sustainable national driving force for patient safety. The Center is charged with conducting and supporting research on patient safety and health care quality issues, developing and disseminating reports and information, and collaborating with stakeholders to implement evidence-based practices.19 The call, initiated by the 1999 IOM recommendations and continued today, was for current knowledge on how to prevent errors to be identified and acted upon, and efforts to improve our understanding and develop other solutions to be intensified. The expectation of increased reporting is to identify errors and learn from them. This sounds simple, but in reality it is a complex and highly emotional subject that continues to be the focus of significant discussion. Because of reporting deficiencies we probably don't have an accurate grasp of the magnitude of the problem of patient safety. Nevertheless, for those errors we do know about we have failed to consistently bring about an effective resolution because of the way we evaluate and react to them. Through its recommendations the committee attempted to create an environment that encourages error identification, evaluation of their causes, and, finally, action to prevent future occurrences. To accomplish this task a national standardized method of reporting certain errors is to be mandated, and related information (type of errors, analysis, and resolution) is to be shared with the states. Recently, the IOM has provided a report describing a detailed plan to facilitate the development of data standards applicable to the collection, coding, and classification of patient safety information.20 It has also recommended legislation to protect peer review data related to patient safety and quality improvement. With less serious situations it advocates control of legal discoverability to make the environment more conducive for organizations to identify, analyze and report errors. IOM recommendations included establishing performance standards and safety expectations for health care organizations and professionals. Many groups, including regulators, accreditors, public and private purchasers, and professional societies were solicited to encourage this. Perhaps the most obvious response to this recommendation for many of us, are activities within our specific organizations to comply with new safety related JCAHO standards. In an attempt to extend the emphasis on safety to the delivery level, IOM recommendations called for implementation of specific programs in health care organizations and specified clearly defined executive responsibility. To health professionals, particularly those affiliated with hospitals, this recommendation is the most apparent because it spells out comprehensive safety related activities for organizations and the professionals affiliated with them. Its requirements include patient safety programs, non-punitive systems for reporting and analyzing errors, incorporation of well-understood safety principles, and the establishment of interdisciplinary team training programs for providers utilizing proven methods. Additionally, it states that health care organizations should implement proven medication safety practices. The Joint Commission has adopted standards that mirror these requirements. These, coupled with the Commission's Sentinel Event Policy, have stimulated patient safety activity within healthcare organizations so as not to jeopardize their accreditation. JCAHO The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the nations predominate standards-setting and accrediting body in health care, has taken an active role in addressing medical errors. It began tracking sentinel events in 1995. A sentinel event is any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.21 Serious injuries specifically include a loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Sentinel event data is used to trend safety concerns and is shared by the Commission to educate other participants. The intent of the Sentinel Event Policy is to address patient safety issues within the healthcare industry by (1) identifying significant medical errors, (2) performing root cause analysis to understand their causes, (3) making changes to reduce future occurrences, and (4) evaluating the effectiveness of those changes. Such activities compose "lessons learned" and are shared for the benefit of all. The Joint Commission produces and distributes a newsletter, Sentinel Event Alert, which informs organizations of sentinel events and how they can be prevented. Reporting to the Joint Commission is voluntary and is encouraged to expand its data base. The policy, however, identifies some functions by organizations responding to sentinel events as being subject to review by the Joint Commission. This means that for certain events the organization is required to perform a suitable root cause analysis, make revisions to prevent future occurrences, and demonstrate plans for evaluating the effectiveness of those changes. Continued accreditation requires that this be done within 45 days of the known occurrence of the event. The Joint Commission advises participants on methods to protect confidentiality and limit the risk of legal exposure of documents related to this process. JCAHO has established multiple standards addressing patient safety in health care organizations in its chapters on Leadership, Improving Organization Performance, Management of Information, Education, Continuum of Care, and Management of Human Resources.22 Leadership's role in patient safety is specifically addressed and it is made accountable for all related activities. Leadership is responsible for integrating and coordinating all patient safety efforts. In 2002 JCAHO streamlined its patient safety requirements of accredited facilities by establishing a select list labeled National Patient Safety Goals (NPSGs). Each year an individual goal may be retained, expanded, or replaced by a new priority. The requirements are based on scientific evidence when it is available. In its absence, expert consensus and data from JCAHO's Sentinel Event Database provide the basis for the requirements. National Patient Safety Goals that apply to medication safety for 2004 and those for 2005 are listed in Table 2.23,24 The NPSGs for 2005 list specific requirements for the various types of health care settings, i.e. ambulatory care and surgery centers, office-based surgery, assisted living facilities, behavioral health care settings, critical access hospitals, disease-specific care program, home health care, hospitals, nursing homes, and laboratories. Improving Medication Use Safety - Error Reduction Strategies Opportunities at All Levels The alarming estimates of harm previously described have evoked action at many levels, including policy makers, regulators, third party payers, professional groups, and the public. The current lists of groups and their activities designed to address medical errors is enormous. Under the Federal Department of Health and Human Services alone there are over 13 agencies, departments, programs, and systems involved with this issue.25 Also responding are multiple national, not-for-profit public service organizations such as the National Patient Safety Foundation (NPSF), National Forum for Health Care Quality Measurement and Reporting (Quality Forum), U.S. Pharmacopeia (USP), Society for Healthcare Consumer Advocacy (SHCA), Institute for Safe Medication Practices (ISMP) and scores of health professional organizations.26 In April of 2004 the formation of SOS Rx, a Senior Outpatient Safety coalition operated by the National Consumers League, was announced.27 SOS Rx's mission addresses patients outside of healthcare organizations and strives to make the use of medications safer for outpatients. Senior citizens, a population at high risk for medication errors, are a primary focus of this organization. With the assistance of more than 60 groups, including consumer and patient safety organizations, professional and employer groups, and government, the coalition's aim is to change consumers' behavior through education, and advocate institutional changes within the health care system. Initially, it is overwhelming to comprehend the scope of existing related activities directed toward increasing patient safety. Nevertheless, through reporting and research, medical error reduction efforts are proceeding everywhere with a renewed commitment to implement what is currently known to increase safety and participation, and to further define problems and their resolution. It is important to realize that this is a very dynamic and ongoing process. Remedies to minimize one error might introduce new opportunities for other errors. In a complex and ever changing system, such as our current healthcare environment, vigilance for their existence and awareness for methods to evaluate will be required to maintain movement in the direction of safety. Front line personnel are in a unique position to observe system irregularities and potential problems before statistics indicating a problem accumulate and are presented to managers to address. Defining the Problem Acknowledging an irregularity through error reporting and then adequately analyzing it for contributing factors is necessary to define a given problem. This process is applicable to all types and categories of errors. The authors acknowledge that formal reporting and analysis would be difficult in every situation. The pharmacist, however, is encouraged to bring to their work environment at least a modified approach to these functions. Errors and near misses need to be communicated to supervisory personnel and co-workers. These are signals of potential future patient harm and awareness of them initiates the process of evaluating for causes. From what we have learned thus far, the obvious or most superficially identified cause is usually not the most important or only reason for an error. Application of some of the techniques used to look beyond the surface will more accurately define the situation and contribute to lasting resolution. Reporting Reporting is a method of discovering preventable adverse outcomes that can then be studied to prevent (or at least minimize) their recurrence. It is the initial step to learning from one's mistakes. Reports can be submitted within an organization (internal) or to an outside agency (external). The appropriate use of two types of reporting, mandatory or voluntary, are deemed necessary for a safe healthcare environment. Mandatory reporting typically focuses on serious faults in performance and serves to promote provider accountability. Providers seek to maintain performance so as to avoid unwanted publicity and possible fines or other disciplinary action. Mandatory reporting also addresses public issues of safety and the public's "right to know" by disclosing serious inadequacies of organizations or professionals. Voluntary reporting is generally done in response to errors that result in minor or no injury, and the information generated is used to alter processes and systems to improve safety. The Institute of Medicine expressed deficiencies with both types in its 1999 report.1 Participation was low and resources necessary to subsequently interpret and act on the information were inadequate. More than one-third of the states impose mandatory reporting of certain medical errors. However, the information they gather is not consistent in terminology or form and consequently is difficult to use by others. The IOM recommended a national mandatory reporting system utilizing standardized information so as to maximize the availability and the quality of this crucial information. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) has established a standard taxonomy of medication errors to be used in the tracking of errors involving medications. This taxonomy standardizes the language and structure of medication error-related data to optimize its use across various systems.6 The ability to identify rare but serious errors improves with standardized information generated by a larger population of participants. Providers are experiencing increased pressure to improve on processes of reporting since many, including the IOM, are encouraging scrutiny of this information by purchasers of healthcare services. Voluntary reporting is one of the most significant safety related functions that delivery-level health professionals can participate in. It is vital to identifying system flaws that contribute to errors. As previously mentioned, system problems that contribute to error are particularly harmful because they are difficult to recognize, and because they can combine with a multitude of events to cause more errors. The JCAHO encourages voluntary reporting through its sentinel event policy and its various standards pertaining to patient safety. As a pharmacist, regardless of practice setting or function, ask yourself the following questions: * Do you feel your organizations error rate related to medications or the medication use process is accurate? * How do you respond when you discover an error (follow organizations procedure, document, ignore, etc.)? * Is this response uniform or do you differ action based on your evaluation of error significance? * When you report an error do you feel it will result in: a) an improvement to a system or process that will make the error less likely to be repeated, or b) someone getting into trouble? Usual answers to these questions quickly identify common barriers to reporting. We tend to blame individuals, often for things beyond their control. And we are often irregular about preparing reports, because, for a variety of reasons, we may choose not to do so. Selective treatment of errors may leave multiple "unimportant or no harm done" errors unaddressed without revealing shared system or organization problems that might result in more serious error. Authorities are aware of these obstacles. They acknowledge that we have much to learn about errors, why they occur, and how to prevent them. More exhaustive reporting, particularly at the delivery-level, is necessary. To encourage this, the adoption of non-punitive reporting systems with protection from legal discoverability is being advocated. These matters are evolving issues that will take some time to be achieved. Before subordinates will become less reluctant to accept reporting of errors leaders will need to demonstrate a departure from the culture of blame by acknowledging that systems contribute to error, and they must engage in efforts to improve these systems. Some have advocated educating health professionals on human performance and error so as to assist with altering our views on mistakes and our willingness to discuss them.28 Other issues affecting reporting include the ease of doing so and the time requirement. Reporting frequently involves completing forms that are cumbersome and time-consuming. Personnel shortages, costs, and other negative factors are unlikely to change drastically in the foreseeable future making the adoption of adequate reporting a daunting task. The Joint Commission designates an organizations leadership as accountable for establishing an environment that facilitates voluntary reporting. The burden cannot rest entirely there, however. Practitioners at every level need to understand that the principle goal of reporting is to improve patient safety; they must view it as a professional responsibility to encourage and facilitate it. Action on errors and potential errors can not proceed until they are identified and communicated. The FDA's MedWatch program, NCC MERP, and the USP-ISMP Medication Errors Reporting Program (MERP) are external reporting mechanisms useful to pharmacists. Through the MedWatch program, healthcare professionals and consumers may utilize FDA Form 3500 for voluntary reporting of adverse events associated with FDA-regulated products. Reports can be submitted online at: http://www.fda.gov/medwatch/report/hcp.htm or by telephone at 1-800-FDA-1088. Medication errors can be reported to the NCC MERP at 1-800-233-7767. MERP provides system cause analysis of errors reported through it. Another source of medication error reports originating in hospitals is available by subscription from the United States Pharmacopeia which maintains MEDMARX, an anonymous national medication error reporting database. Error Analysis To learn from past mistakes an effective analysis of all contributing factors must follow the error identification. The importance of this function is underscored by the JCAHO's mandate for organizations to complete a thorough and credible root cause analysis (RCA) (1) any time a sentinel event occurs and (2) in response to "critical effects" identified during Failure Mode and Effects Analysis (FMEA) used in an organization's required, ongoing, proactive program for identifying risks to patients' safety and reducing medical/healthcare errors (Standard LD.5.2). Critical effects are defined as possible serious effects on the patient from failure or undesirable variation in a process.22 In FMEA, processes are evaluated, ideally in the planning phase, to determine potential effects on patient safety when things don't go as planned or processes don't adhere to design or intent. Here the goal is to identify potential serious errors prior to their occurrence. Healthcare professionals routinely conduct intensive analyses of physical disease by exploring the condition at a cellular, molecular, and/or chemical level to understand the root cause of the condition. In the review of medical errors, intensive root cause analysis is a process by which the reasons underlying the occurrence are identified. Through this "cellular level" scrutiny of the medical error modifications are made so that reoccurrence can be prevented. It is based on the premise and philosophy of the National Patient Safety Foundation that most errors result from faulty systems rather than human error, and that people are in essence set up by them to make errors for which they are not truly responsible. In RCA, a team of representatives investigates an accident or mistake following a process that assumes the root cause to be an accumulation of smaller events.29 These events are dissected to discover (Figure 1): (1) the main reason an accident occurs (its proximate cause); (2) systematic problems that might lead to other mistakes (common causes); (3) contributors that could not have been foreseen or prevented (special causes); and (4) areas where the accident could have been avoided had things been done differently (risk points). Various methods and materials are available to advise and facilitate conducting an effective RCA. RCA has been used successfully for over thirty years in other settings, such as the nuclear and aviation industries. Certain barriers to application in the healthcare environment, however, have been identified. These include inadequate staff, insufficient time, fear of retribution, and stopping the analysis too soon.30 Leaders, care givers, and facilitators all have necessary roles in this process and must be represented for effective analysis. Time for proper evaluation is similarly crucial so that efforts don't stop with the most apparent or obvious causes. Both of these commodities, people and time, are scarce and thinly stretched in contemporary healthcare settings. Justification for these efforts (beyond being required to do so) is better patient care, more time-efficient processes, and the avoidance of costly mistakes. Fear of retribution applies to everyone in healthcare. Staff members are reluctant to participate in reporting because of the fear of self-incrimination when their actual performance varies from written policy or procedure. This poses a challenge to administrators and the facilitators to promote an environment that emphasizes the objective of preventing a future occurrence rather than asserting blame. Risk managers, administrators and individual licensed practitioners share a wariness of discussing and documenting mistakes because they fear possible legal action. The JCAHO sentinel event policy has been described as a "lawsuit kit for attorneys".31 However, JCAHO offers advice on how to minimize discoverability of these activities but admits that none are foolproof. Legislative protection has been suggested and recommended by the IOM but is currently not a reality. One method for avoiding or diminishing the fear of retribution is through evaluation of near misses, errors that have the potential to cause patient harm, or errors that have occurred outside of one's organization.32 Through studying these one can compare systems within their organization to arrive at a clearer understanding of system-based causes of errors and then devise proactive error reduction strategies in a non-punitive environment. An understanding of this intensive analysis and fact-finding process will provide the professional with further tools to view and evaluate processes and errors in individual work settings. In addition to the assessment of obvious system problems with simplistic solutions, the RCA arms the professional with detailed data for ongoing improvement. Regardless of whether you have the opportunity to participate in RCA or not, it is important that the reader understand how complex error can be. The bottle or label mix up in a retail work setting or mistake in intravenous antibiotic dilution in an institutional setting may signal system problems that if left unacknowledged might play a role in a future serious medication error. Healthcare professionals must learn to look beyond the surface of these matters to truly understand medication errors. Learning from other's mistakes can be extended to the analysis of medication errors. A novel source for this information is introduced by an analysis of medication-related malpractice insurance company claims by Rothschild et al.33 These claims provided detailed event information, including verbal depositions with information not always found in the medical record, that can be used to identify system and human factor failures. Error reporting and analysis directly impacts the previously mentioned common medication error causes. This process illuminates specific contributing acts, drugs, processes or functions to more fully define these causes so that productive corrective action can follow. Recognizing Error Prone Situations High Risk Situations: Populations and Processes Identification of high risk situations can come from various sources. Knowledge of reasons for errors related to human and system frailties have been considered previously and should enable practitioners to identify some situations prone to error. Human factors, such as stress or fatigue, can interfere with cognition. System inadequacies such as insufficient staffing, computer downtime or other technology failure can inject variability in processes or diminish capabilities. These and similar situations should clearly signal potential for mistakes and alert practitioners to take special measures. These might include seeking a second opinion from a co-worker, avoiding fatigue by delegating tasks, prioritizing activities, or utilizing additional reference materials. All personnel can elevate concerns for patient safety by identifying and acknowledging such situations. Other high risk circumstances are identified by organizations such as the JCAHO and ISMP that have collated data of common errors and risks. This information is disseminated via their respective web sites or through their respective publications, Sentinel Event Alert (http://www.jcaho.org/about+us/news+letters/sentinel+event+alert/) and ISMP Medication Safety Alerts (http://www.ismp.org), which, because of the large number of their contributors are capable of providing details of unusual occurring accidents along with information on how to resolve or avoid them. Knowledge of these events allows involved parties to respond to the increased error potential. The reader is encouraged to actively seek and review this information to identify the potential for error in their personal work habits and practice setting processes. Administrators can work to modify procedures and resources to minimize system contribution, and delivery-level personnel, through their awareness of the increased need for patient safety, can alter work habits. The JCAHO has mandated accredited organizations' participation in specific functions related to the handling of certain medications categorized as high risk. This requirement is part of the 2004 and 2005 National Patient Safety Goals. The list of high risk medications was compiled by the ISMP from error reports submitted to the USP-ISMP Medication Errors Reporting Program (available @ http://www.ismp.org; Table 3). It contains drugs that are not necessarily more prone to error, but those with a narrow therapeutic index or those where an error in use is more likely to harm a patient.34 Specific requirements are imposed on the availability of concentrated electrolytes in patient care areas in addition to offering more general guidelines affecting the safe use of medications. JCAHO has also addressed communication issues associated with heightened risk for error in its National Patient Safety Goals. These include verbal or telephone orders, and the use of abbreviations, acronyms and symbols. In their directives, procedures for receiving verbal or telephone orders, or telephonic reporting of critical test results must include verification by a complete "read-back". The impact of this procedural requirement in a clinical laboratory setting has been described. Errors detected and corrected by this method were determined to occur in 3.5% of the outgoing calls and the time required for requesting the information to be repeated and to do so averaged 12.8 seconds per call.35 Abbreviations, acronyms and symbols used in an organization are to be standardized and must also include a list of those NOT to be used. In 2004 JCAHO specified a "minimum list" noting abbreviations that should not be used and then allowed each organization to select a specified number of other abbreviations to add to their do not use list. (Table 4).23 The Goal addressing communication is expanded in 2005 to include the timely reporting of critical test results. Errors occur when patients are misidentified. To assist with the potentially "risky" process of patient identification the JCAHO has mandated a NPSG requiring the use of two patient-specific identifiers when administering medications or blood products, or when taking blood samples and other specimens for clinical testing.23 Currently, various methods of communicating (verbal, pictures, armbands, etc.) patient-specific identifiers (name, birthday, social security number, telephone number, etc.) are utilized, but indicators tend to support the eventual use of bar code technology for patient identification and for matching their treatments to them. In Flynn and colleagues observational study on prescription dispensing, the inspection process was the task most frequently associated with error.4 Table 5 lists error prevention techniques used in some of the pharmacies included in the study, some of which address the process of inspection. The authors revealed an important fact pertaining to these activities. They are not always effective. Many techniques will need to evolve for greater efficacy and some may actually give rise to new and different potential for error. As stated previously, patient safety related activities are very dynamic, a quality we must continually be mindful of. Certain populations are at elevated risk for mistakes with medication. For example, errors (particularly dosing errors) occur more frequently for children.36,37 The American Academy of Pediatrics has issued a policy statement on preventing medication errors in the inpatient setting. Recommendations identify guidelines, actions, education and communication directed toward the system, prescriber, pharmacy and nursing. Of their recommendations, some are general in nature and reflect the tone and content of medication safety recommendations of other groups. Others are unique to this population and are summarized in Table 6. This table reinforces the multi-faceted nature of error associated with medication use and the need for action on many fronts to improve the safety of the process. The risk of medication error also appears to increase for patients who are administered multiple drugs.38 The elderly are particularly susceptible to medication errors due to physiologic changes and their use of multiple medications needed to treat increased chronic medical conditions.39 In the USP's Fourth Annual Report on Medication Errors in U.S. Hospitals it was revealed that more than one-third of hospital medication errors involve elderly patients. Notable characteristics of errors in this population include:40 * The majority (55 percent) of fatal hospital medication errors reported involved seniors. * Of medication errors causing harm to seniors, 9.6 percent were prescribing errors, 7 percent wrong route (e.g. tube feeding given intravenously), 6.5 percent wrong administration technique (e.g. failure to dilute concentrated medications). * Omission errors (43%), improper dose/quantity errors (18%), and unauthorized drug errors (11%) were the most common medication errors among those aged 65 and over. Awareness of the increased potential for error with these populations should alter system and individual processes. This might include verification of all pediatric patients' weight prior to filling their prescription or establishing an additional step to verify that all prescriptions are present and filled correctly for those presenting multiple prescriptions. By identifying error prone situations and employing modifications to make them safer, it is easy to see how these actions and remedies might impact the majority of previously defined causes of medication errors. Verification of verbal orders and restrictions on abbreviations use addresses these communication issues. Drug distribution practices can be altered to treat identified high risk medications and populations differently to ensure greater patient safety. Verification of weight-based pediatric and chemotherapy doses can reduce errors involving dose miscalculations. Problems associated with drug and drug devices are more likely to emerge, be identified, and ultimately disseminated to the masses by sources with access to large error data bases. Correct patient identification and treatment matching will reduce incidences of incorrect drug administration. Education resources can be channeled to address error prone situations. Patient Safety Practice Modifications By implementing practices with proven track records patient safety can be significantly affected. The Agency for Healthcare Research and Quality (AHRQ), and the University of California at San Francisco-Stanford University Evidence-based Practice Center (EPC), evaluated and rated safety practices based on evidence in the literature.41 Most opportunities were clinical in nature and dealt with acute severe illness due to the focus of existing research and availability of the data it generates. Table 7 is a partial listing of the top 10 of 73 practices reviewed. This information lists patient safety practices that could potentially be influenced or facilitated by pharmacists in acute care centers. The AHRQ and EPC identified and rated other patient safety practices that appear promising but require further research. The following practices which rated most highly and could relate to pharmacists include: 41 * Improved perioperative glucose control to decrease perioperative infections. * Computerized physician order entry with computerized decision support systems to decrease medication errors and adverse events primarily due to the drug ordering process. * Limitations placed on antibiotic use to prevent hospital acquired infections due to antibiotic-resistant organisms. * Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperative infections. * Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk. * Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and post-surgical patients. * Use of analgesics in the patient with an acutely painful abdomen without compromising diagnostic accuracy. * Improved handwashing compliance (via education/behavior change; sink technology and placement; or the use of antimicrobial washing substances). Technology Computerization in healthcare organizations has grown exponentially over the last decade. It has brought with it new challenges and concerns. Issues regarding the confidentiality of medical records, the training of reticent staff, and the ever-changing technology have prompted healthcare administrators to review policies and procedures, to add information technology staff, and to provide for ongoing training of all personnel. Computerization technology will play an important role in diminishing medical errors. One application currently available and in broad use is the computer generated medication administration record (MAR). This tool introduces consistency and increased legibility to this important document. In addition to the trade name and administration directions, other information (common side effects, food-drug interactions, monitoring parameters, etc.) can be easily incorporated to assist the care provider in the safe administration of the drug. A non-paper computerized form of this process can incorporate "live" information such as current laboratory information to screen for problems that might be associated with administration of a drug. Some helpful technology is seeing little use, however. Computerized physician order entry (CPOE) is one such example. It appears that less than 7% of the hospitals in the United States avail themselves of this technology.42 CPOE systems eliminate a common trigger of medication errors - handwriting. It also provides prompts for the full name of the medication, the strength/concentration, dose, route, and frequency or rate. When integrated with "live" patient specific data, such as laboratory values, current weight, or current medication use, new orders can be screened for appropriateness and warnings initiated immediately at the beginning of the ordering process. Utilizing both the MAR and the CPOE can eliminate common transcription errors and allow for cumulative dose checking for PRN medications.43 Computerized clinical decision support systems, when used in conjunction with CPOE, can further aid in safe medication practices. Clinical decision support systems can check the ordered drug with patient characteristics, such as weight, allergies, the use of other drugs, and laboratory values.44,45 In one study it was determined that the use of a CPOE system with a basic decision support system led to a 64% reduction in all medication errors in an adult hospital. An 83% drop occurred when a more advanced decision support system was utilized.44 Other technology that is being studied for its impact on patient safety includes bar coding systems, robots, "smart" intravenous devices to reduce the likelihood of overdoses, and computerized discharge prescriptions and instructions to eliminate communication errors. Standardization Standardization promotes the consistency of patient care processes that should be sought at all levels within the healthcare environment. Critical pathways and practice guidelines lead healthcare professionals in the delivery of "best practices". Standardized times of administration of medications allows for efficient, consistent, and possibly interruption-free batching of medication administration. It also allows the coordination of other therapeutic interventions, such as rehabilitation visits, laboratory collections, and special testing. Standardized infusion concentrations pare down variability that may contribute to error. Standardizing equipment allows for reinforcement of use features through repetition, ease of training, and more efficient biomedical servicing capabilities. Studies have shown that standardization of equipment, guidelines, and protocols have dramatically reduced error rates. Errors attributable to anesthesia were reduced from 25-50 per million to 5.4 per million through just such standardization.46 Recognizing the value of standardization, the American Academy of Pediatrics recommends the standardization of equipment (scales, infusion pumps, etc.), measurement systems (Kg exclusively), and order sheets that systematically request crucial patient demographics (weight, allergies, contact numbers of prescriber, etc.) in their policy statement on preventing medication errors.37 The JCAHO embraces the importance of standardization in their National Patient Safety Goals.23,24 The requirement for adopting standardized lists of abbreviations, acronyms, and symbols that should and should not be used in organizations impacts communications contribution to error. Communication of crucial information to the providers of health services will be enhanced by the requirement (to be implemented by January 2006) calling for a complete list of the patient's current medications (standard information) to be available and communicated upon patient transfer within or outside an organization. To improve the safety of using medications, organizations are requested to standardize and limit the number of drug concentrations they have available to limit the variables that can create confusion in calculation and recognition. Health organizations are aware of patient groups at risk for misadventures with medications (e.g. oral anticoagulants, cardiac glycosides), or others that realize better outcomes when they are knowledgeable of their medications used in chronic illness (e.g. asthma, diabetes). Standardizing patient groups to receive education on specific medications or disease management can assist in achieving desired outcomes and decreasing problems related to medications. Education Staff training is crucial in reducing medical errors. Training that improves knowledge and proficiency in expected tasks adds to the previously identified desirable precondition of a "skilled and knowledgeable workforce". Education that includes potential pitfalls and consequences of incorrect use elevates the issue of error and the vigilance for employee recognition of it. Administrators can generate support for error reduction performance by adopting an organization-wide educational campaign that teaches workers how to identify the causes for medical errors when they occur. Understanding that the pediatric population is at increased risk for medication related errors, the American Academy of Pediatrics has recommended that a program educating hospital and medical staff on the medication use process in children be developed. This program is to include calculating, prescribing, preparing, and administering medications for children. Education of the general public is also needed to increase awareness of the consumer's role in providing safe medical care. Responsibility for solving the medical error problem does not lie solely with healthcare professionals. Patients, their families, and their lay advisers must also become active members of the patient's healthcare team. Healthcare organizations should support consumer education by using different venues to communicate how consumers must share in preventing errors. The AHRQ has developed patient fact sheets that advocate consumer actions such as:47 1. Informing all health care providers about all medicines and pseudomedicines that are being taken, including prescriptions, over-the-counter medications, dietary supplements, vitamins and herbal products. 2. Informing all health care providers about any allergies and adverse reactions to medications. 3. Reading all prescriptions written by the physician to ensure that the pharmacist will be able to properly dispense it. 4. Asking for information about prescribed medicines in laymens terms. 5. In healthcare facilities, asking whether the direct care providers have washed their hands. 6. Asking the provider to explain the treatment plan. 7. Asking questions about any other pertinent concerns. 8. Finding out who is in charge of their care. 9. Asking for test results. The JCAHO parallels these suggestions and directs accredited organizations to educate patients about the patients' own responsibilities for preventing errors. (PF.3.7). These include at least the following: 1. Providing information 2. Asking questions 3. Following instructions 4. Accepting consequences 5. Following rules and regulations Education leads to empowerment - of both the professional and the lay public. When individuals are empowered they become involved and energetic in error prevention efforts. So what is next? Performance Improvement During the 1990s many health organizations took to heart the teachings of business quality leaders by looking for ways to improve their complex systems. The JCAHO recognized the benefit of such improvement efforts and mandated them in their standards. While many methods exist, the FOCUS-PDCA performance improvement method is referred to here in order to explore the state of the performance improvement initiative on a national basis, and how this initiative may be driven down to the front-line worker. F -Find a process improvement opportunity In 1998 the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry brought a national awareness to the issues associated with hospital safety. The IOM further focused on this issue through its study published in 1999. The JCAHO is now mandating that patient safety programs be established in accredited organizations. From a promulgation of the national studies and statistics, and an overall healthcare organization awareness campaign, the individual healthcare professional and technologist is beginning to recognize the importance of these efforts. O Organize a team that understands the process As a result of the federal mandate the QuIC Task Force was established to focus on this problem in federal health care programs. Many organizations (practice specialties, regulatory, consumer, etc.) are directing team efforts to combat medical errors. The JCAHO requires a designated manager and organization-wide participation. Healthcare organizations are challenged to pull teams together that represent the wide variety of personnel, skills, and tasks associated with high risk and problem-prone activities that may lead to medical errors. C Clarify the current knowledge of the process The IOM's To Err is Human report presents the most thorough data to the date of this publication defining the extent and severity of medical errors. Individual healthcare organizations also maintain within their own unique environments a myriad of statistics and reports that can help elucidate the extent of this problem. Utilizing these existing data and honing their systems to accumulate additional data will assist organizations in identifying best practices by comparing their systems and processes to other local, regional and national numbers. By sharing this information with the practice community the organization can measure its relative effectiveness and set a suitable benchmark for achievement. U Uncover the root cause of variation/poor outcome The JCAHO requires that organizations conduct root-cause analysis for all their sentinel events and some processes identified in their proactive risk reduction efforts so that through intensive study of the error they will gain a heightened understanding of the factors contributing to it. National studies have categorized types of preventable errors, but it is up to individual healthcare organizations to truly understand in their own case what leads to an adverse event. S Select a process improvement National reports recognize multiple proven interventions and system improvements to minimize medical errors. A few have been mentioned in this program. The simple adoption of a new system or the purchase of new technology however, cannot guarantee improvements. Any proposed improvement must stem from the RCA, the scope of care within the organization, the patient populations, and the organizations commitment to positive change. PDCA - Plan, Do, Check, Act System improvements range from the mundane and inexpensive to the cutting-edge technology that is often accompanied with a high price tag. Whatever system improvement is proposed, its initiation must be carefully planned and implemented. Continuous monitoring must be conducted to ensure that improvement is being made and that it can be sustained. This is a time consuming task but a rewarding one. Only through this type of systematic study and improvement, and through the participation of all those involved with healthcare systems in the United States (including the consumer), can the cycle of medical errors be interrupted. Conclusion Using broad strokes this program has provided information about a very serious and complex national concern. Pharmacists are essential participants and are central to its resolution. Through additional study of best practices, by using analysis methodologies, and by improving systems, the pharmacist will join with the practice community to provide the safest patient care possible.