The patient is the last individual involved in the medication use process. The pharmacist–patient interface can play a significant role in catching medication errors before they occur. Unfortunately, many health care organizations do not take advantage of this key interaction. Three important factors play a role in any patient interface and often determine the outcome of error-prevention efforts. These include direct patient education, health care literacy, and patient compliance.
Community pharmacies in the United States filled 3.6 billion prescriptions in 2009, and prescription volumes continue to increase at a rate of approximately 3% per year (StateHealthFacts, 2011). This increase in prescription volume often results in a decrease in the amount of time available for direct pharmacist involvement in patient education. A 1999 study involving community pharmacies in eight states revealed that 87 percent of all patients received written information with their prescriptions. However, only 35 percent of pharmacists made any reference to the written leaflet, and only 8 percent actually reviewed it with the patient (Svarstad, 2000). Contributing to this gap in patient education is the failure to provide patients with understandable written instructions.
The second factor is patient literacy, which includes general literacy levels and health care literacy. Many people have difficulty understanding their illness or disease, proper management of disease, and their role in maintaining their health. Whether limited by knowledge, socioeconomic factors, emotional or clinical state, or cultural background, patients' level of health literacy (i.e., the ability to read, understand, and act on health care information) often is much lower than many health care providers appreciate. Examples of patients who have had difficulty reading and understanding medication directions are plentiful. For example, an elderly patient could not tell the difference between his bottle of Coumadin® (warfarin) and Celebrex® (celecoxib). A mother, who after reading the label on a bottle of acetaminophen, could not accurately state her child's dose. And a teenager who misunderstood directions for contraceptive jelly and ate it on toast every morning to prevent pregnancy.
According a report published by the American Medical Association Ad Hoc Committee on Health Literacy, more than 40 percent of patients with chronic illnesses are functionally illiterate, and almost a quarter of all adult Americans read at or below a fifth grade level. Unfortunately, medical information leaflets typically are written at or above a tenth grade reading level. Further contributing to the dilemma is the fact that an estimated three-quarters of patients throw out the medication leaflet stapled to the prescription bag without reading it, and only one-half of all patients take their medications as directed (AMA, 1999).
One reason for this lack of understanding may be that people who have difficulty reading or understanding health information are too embarrassed or ashamed to acknowledge their deficits. Instead, they are hesistant to ask questions of their health professionals and often pretend to understand instructions. In addition, low literacy is not obvious. Researchers have reported poor reading skills in some of the most poised and articulate patients (ISMP, 2011a).
Compliance is the third patient-related factor contributing to medication errors. One study found a 76 percent difference between medications patients actually are taking when compared with those recorded in their charts as prescribed. Two factors that contribute to this high rate of discrepancy include confusion that may accompany advancing age and the increase in the number of prescribed medications (Bedell et al., 2000). Another study demonstrated that patient noncompliance played a role in 33 percent of hospital admissions (McDonnell et al., 2002).
Noncompliance may be exhibited by patients in many ways, such as not having a prescription filled initially or refilled, dose omissions, taking the wrong dose, stopping a medication without the physician's advice, taking a medication incorrectly or at the wrong time, taking someone else's medication, and financial inability to purchase their medications. Patients at risk for being noncompliant include those taking more than one drug, those with a chronic condition who are on complex drug regimens that may result in bothersome side effects, those who take a drug more than once daily, and those who have a condition that produces no overt symptoms or physical impairment such as hypertension or diabetes (National Council on Patient Information and Education (NCPIE), 2002). In addition, elderly patients are more at risk owing to factors such as decrease in mental acuity and increased confusion, lack of family or caregiver support, decreased coordination and dexterity, and impaired vision (Lombardi and Kennicutt, 2001). Pharmacy managers must consider these factors in developing and providing patient education tools or methodologies.
A New Model of Accountability
Despite a growing awareness of the system-based causes of errors, many in health care are still struggling to come to terms with the role of individual accountability. Even when we seem to understand the system-based causes of errors, it's still hard to let individuals “off the hook.” We ask, “How can we hold individuals accountable for their actions without punishment?” Some have suggested that a nonpunitive approach to error reduction leads to increased carelessness as people learn that they will not be punished for their mistakes. However, another perspective is that staff awareness of safety issues, as well as their enthusiasm for changing systems and practices associated with errors, actually grows in a nonpunitive system. A nonpunitive, system-based approach to error reduction does not diminish accountability; it redefines it and directs it in a more productive manner by focusing on the most manageable component of the error: the medication-use system itself.
Typically when an error happens, only those individuals at the “sharp end” of an error (for example, pharmacists and pharmacy technicians) are held accountable. But, we must shift from this thinking and realize that accountability must be shared among all health care stakeholders. In the new patient safety model, each individual becomes accountable, not for zero errors (which is an unrealistic and unattainable expectation for any human), but for making patient safety a part of every aspect of their job. In addition, all become accountable for identifying safety problems, implementing system-based solutions, and inspiring and embracing a culture of safety.
Because we are not capable of practicing without making errors, health care practitioners should be held accountable for speaking out about patient safety issues, voluntarily reporting potential and actual errors as well as hazardous situations, and sharing personal knowledge of what went wrong when an error occurs. Also, practitioners must be empowered to ask for help when needed, consistently provide patient education, and be willing to change their practices to enhance safety.
Management should be held equally accountable for making it safe and rewarding for practitioners to openly discuss errors and patient safety issues. They must hold regular safety briefings with staff to learn about improvement needs, discuss strategic plans, and identify new potential sources of error. When practitioners recommend error prevention strategies, leaders must support them and provide the means necessary within a reasonable timeframe to implement system enhancements to improve efficiency and safety. Leaders should be held accountable for understanding and addressing barriers to safe practice such as distractions and unsafe workloads. Leaders should incorporate patient safety as a value in the organization's mission and engage the community and staff in proactive continuous quality improvement (CQI) efforts, including an annual self-assessment of patient safety. All health care personnel should be held accountable for working together as a team, not as autonomous individuals. Finally, leaders and staff alike need to review and share safety literature frequently and offer visible support to their colleagues who have been involved in errors.
This model of shared accountability spreads far beyond the walls of individual health care settings to encompass licensing, regulatory, and accrediting bodies; institutions that educate and train students and health care professionals; professional associations; governments and public policy makers; the pharmaceutical industry; medical device and technology vendors; and even the public at large. These often-overlooked participants share equal accountability for doing their part to make health care safer. For example, licensing, regulatory, and accrediting bodies should be held accountable for adopting standards related to error reduction recommendations that arise from expert analysis of adverse events and scientific research. Educators should seek out patient safety information and use it in curriculum design. Professional organizations should support local and national reporting systems and disseminate important patient safety information to their members. Companies that produce medical devices, pharmaceutical products, health care computers and software, and other health-related products should be held accountable for pre- and postmarket evaluation, continuous improvement in the design of devices and products as well as labels and packages. Purchasers of health care should provide incentives and rewards for patient safety initiatives. And all health care professionals, including pharmacists, should encourage the public to ask questions and stay informed about their care and ways to avoid errors.
The system-based model of accountability requires that all who interact with the health care system help to define its weaknesses and find ways to make it stronger. Organizational leaders and other stakeholders who simply hold the workforce accountable when an error happens are inappropriately delegating their own responsibility for patient safety. Managers must stop blaming and punishing those closest to an error, and instead accept a model of shared accountability to collectively translate our sincere concern for patient safety into effective system-based error solutions. Implementing such solutions and inspiring and embracing a culture of change to reach the goal of safety may not be easy, but is certainly necessary.
Effective Risk-Reduction Strategies
Selecting the best error-prevention strategies is not an easy task. Often, the most effective action is not obvious, and the best error prevention tools to use in each situation are not clear, even when system-based causes have been identified. In addition, pharmacists should focus their efforts on medications that may lead to harm if involved in an error. Although most medications have a wide margin of safety, a few drugs have a high risk of causing patient injury or death if they are misused. Special precautions are needed to reduce the risk of error with these “high-alert” medications. Errors with these drugs may not be more common than with other medications, but their consequences can be more devastating (ISMP, 2008).
Listed below are examples of error-prevention strategies for creating lasting system changes for safe medication use (See Table 29-1). Those listed first are considered to be “high leverage” strategies, such as constraints and forcing functions, are more powerful because they focus on changes to the system in which individuals operate. As the list descends, strategies that target system changes but rely in some part on human vigilance and memory, considered to be “low leverage” strategies, such as education and information, are presented. Strategies toward the end are familiar and often easy to implement, but rely entirely on human vigilance (ISMP, 1999; ISMP, 2006).
- Fail-safes and constraints are among the most powerful and effective error-prevention strategies. They involve true system changes in the design of products or how individuals interact within the system. In the hospital setting, one example includes removing concentrated potassium chloride for injection from all patient care areas. In this situation, a nurse could not accidentally administer this medication because it would not be available to select from stock. Another acute care example includes eliminating nursing access to the pharmacy when it is closed by establishing a carefully selected nighttime formulary and dispensing cabinet. At a community pharmacy where the pharmacy computer system is integrated with the cash register, a fail-safe would prevent the clerk from “ringing up” the prescription unless final verification by a pharmacist was noted in the system.
- Forcing functions are procedures that create a “hard stop” during a process to help ensure that important information is provided before proceeding; often referred to as a “lock and key” design. Examples outside of health care would include the inability to drive your car unless you first place your foot on the brake before shifting the car into “drive.” For example, a pharmacy order entry system that requires a weight to be entered for each patient receiving an order for a weight-based medication (e.g., heparin, enoxaparin) before it is processed, or a bar-code scanning system that does not allow final verification of a product without a positive match between the selected product and the profiled medication.
- Automation and computerization of medication-use processes and tasks can lessen human fallibility by limiting reliance solely on vigilance or memory. Examples include use of electronic prescribing software that includes clinical decision support; pharmacy computer systems that can receive prescriptions sent electronically from a prescriber's hand-held device or computer and thus eliminate transcriptions and misinterpretations; robotic prescription preparation and dispensing technology; and computer systems that provide accurate warnings related to allergies, significant drug interactions, and excessive doses.
- Standardization creates a uniform model to adhere to when performing various functions and it tends to reduce the complexity and variation of a specific process. For example, standardized processes could be created to guide the pharmacist's final verification of a medication or to enhance the safety of giving or receiving a telephoned medication order. Prescriber use of carefully designed preprinted prescription blanks or standardized order forms that contain commonly used protocols (e.g., steroid tapers, insulin regimens, weight-based heparin) or frequently prescribed medications can reduce problems with confusing or missing instructions and illegible handwriting. On its own, standardization relies on human vigilance to ensure that a process is followed; therefore, it is less effective than the strategies mentioned previously.
- Redundancies incorporate duplicate steps or add another individual to a process to force additional checks in the system. Involving two individuals in a process reduces the likelihood that both will make the same error with the same medication for the same patient. However, the potential for error still exists since the redundant step may be omitted or ignored. Examples of redundancies include use of both brand and generic names when communicating medication information or requiring independent double checks of high-alert medications before dispensing. Patient counseling is often an underutilized redundancy that can detect many errors.
- Reminders and checklists help make important information readily available. For example, using auxiliary labels to distinguish products; building look- and sound-alike alerts into order entry systems; and using preprinted prescription blanks that include prompts for important information (e.g., medication indication, allergies, patient birth date).
- Rules and policies are useful and necessary in organizations. Effective rules and policies should guide staff toward an intended positive outcome. However, some may add unnecessary complexity and may be met with resistance, even rightfully so, especially when implemented in response to an error. Because their use relies on memory, they should be used as a foundation to support more effective strategies that target system issues.
- Education and information are important tactics when combined with other strategies that strengthen the medication-use system. But, the effectiveness of these tactics relies totally on an individual's ability to remember what has been presented. Thus, on their own, they offer little leverage to prevent errors.
Table 29-1. Medication Error Reduction Strategies (ISMP, 2006) ||Download (.pdf)
Table 29-1. Medication Error Reduction Strategies (ISMP, 2006)
Fail-safes and constraints
Automation and computerization
Reminders and checklists
Rules and policies
Education and information
Suggestions to be more careful or vigilant
While each tool mentioned above can play an important role in error prevention, beware of those that, on the surface, seem to provide the easiest and fastest solution. While strategies at the bottom of the list may be used initially, we must realize that they will not be effective for long-lasting error prevention when used alone. In order to do a better job at preventing errors, we need to employ a variety of strategies that focus on the medication-use system issues and address human factors issues for those who work within that system. Since people cannot be expected to compensate for weak systems, managers should routinely evaluate the error-prevention strategies being used in their organizations. Consider if there are more powerful strategies that could be implemented to enhance medication safety.
Risk Identification Methods
All drug-dispensing procedures should be examined regularly, both proactively and retrospectively, and the potential problems as well as causes of system breakdowns must be discovered so that prevention measures can be designed. Pharmacy staff needs to communicate clearly to managers what it takes to do the job correctly in terms of personnel, training programs, facilities design, equipment, drug procedures and supplies, computer systems, and quality assurance programs. In addition, reducing medication errors requires using a number of effective risk identification methods including a nonpunitive environment and a voluntary medication error reporting system.
Currently, many pharmacies have an ineffective approach to error reduction. Often their primary means of identifying risk involves investigations that occur during the error reporting process. These investigations tend to focus their attention on the front end or active end of the error, such as the front-line practitioner. Human nature tends to assign blame to these front-line practitioners involved in medication errors. It is easier and in our nature to blame individuals and resort to familiar solutions: disciplinary action, individual remedial education, placing error information into personnel files, or developing new rules. While these actions may not seem outwardly punitive, these forms of reprimand lead to underreporting of errors. In fact, punishing individuals for errors actually can be dangerous to an organization. It inhibits open discussion about errors, creates a defensive and reactive environment, and hinders careful and unbiased consideration of the system-based root causes of errors. Pharmacies are weakened further by punitive actions, especially if the sole responsibility for safe medication practices rests on individuals rather than on strong systems that make it difficult for practitioners to make errors.
The goal of patient safety is best served with a nonpunitive environment that places more value on a variety of risk identification methods, in addition to reporting problems so that they can be remedied, rather than on pursuing the unprofitable path of disciplining employees for errors. Methods to proactively identify the potential for problems in an organization include performing FMEAs to see where breakdowns may occur, using self-assesssment tools, and using external sources of information such as reviewing the literature for errors that have taken place in other organiztions and applying the “lessons learned” and determine if your organization could experience the same problems.
Self-assessments can help organizations assess the safety of medication practices throughout the facility, identify opportunities for improvement, and possibly compare their experiences with the aggregate experiences of demographically similar hospitals (ISMP, 2011b). One key consideration when undergoing this type of process is the establishment of an interdisciplinary team that should consist of representatives from all aspects of an organization, ranging from leadership (CEO, CMO, and nurse executives), directors of pharmacy as well as front line staff including nursing, pharmacists and physicians.
It is also important for pharmacy staff not just to focus on their own internal errors but also to look at other pharmacies' errors and methods of prevention and to learn from them. Organizations such as the ISMP, TJC, and many others provide ongoing features to facilitate these reviews in publications such as Hospital Pharmacy, Pharmacy Today, and Pharmacy and Therapeutics or newsletters that report on current medication safety issues and offer recommendations for changes.
The direct observation technique, in which a trained observer accompanies the person giving medications and witnesses the preparation and administration of each dose, was developed by Barker and McConnell (1962). The observer writes down in detail what the subject does when preparing and administering the drug (Barker et al., 2002). The notes are then compared with the prescriber's orders. An error is counted if the subject did not carry out the order accurately. The error rate is the percentage of doses administered in error, and the accuracy rate is the percentage of doses accurately administered. This method has many advantages. For example, it is not affected by lack of awareness of errors, lack of willingness to report errors, faulty memory, poor communication skills, or selective perception of the subject observed. Its reliability has been established through replication over many years. A large quantity of data can be accumulated at a rate 24 times that of chart review and 456 times that of incident reports. It can detect more errors and more types of error per unit of time than other methods, and it can identify clues about the causes so that future errors can be prevented (Cohen, 2007b).
A retrospective, voluntary, confidential reporting program provides pharmacists and pharmacy technicians with the opportunity to tell the complete story without fear of retribution. The depth of information contained in these stories is critical to understanding the error. This information is critical to identification of system deficiencies that can be corrected to prevent future errors. However, successful and sustained improvement of error-prone processes cannot occur if there is little information available about factors that contribute to an error.
Many organizational factors inhibit the reporting of medication errors. Examples include inconsistent definitions of a medication error within an organization, a punitive approach to medication errors, failure to improve the medication system or address reported problems reported by staff, lack of feedback to staff, over concern with medication error rates when reporting of an error may increase a facilities “error rate”, complex reporting processes, a perception that reporting is a low priority andconcern for personal liability. A voluntary program encourages practitioners to report hazardous situations and errors that have the potential to cause serious patient harm. A confidential reporting system where everyone understands that errors will not be linked to performance appraisals is critical. Many pharmacy organizations have regular meetings where medication errors are addressed. The results of these meetings often are not shared with the front-line staff, therefore giving the impression that “nothing is being done” when errors are reported. In addition, busy practitioners tend to avoid reporting errors owing to the cumbersome nature of their organizations' reporting forms and processes. It is important to make error reporting easy, reward error reporting, and provide timely feedback to show what is being done to address problems. Consistently applying a nonpunitive approach to errors is important. If even one person is disciplined for an error, mistakes will be hidden. Employees should not be evaluated based on errors or lack of making mistakes but on positive measures that evaluate an employee's overall contribution to the organization. Armed with these tools, pharmacists can become aware of the deficiencies in their organizations and make performance-improvement changes. Without them, pharmacies can only address errors when they surface rather than at the root cause.
To be successful, medication error-reduction efforts must result in system improvements that are identified through a four-pronged analysis of errors. The first two prongs, both reactive in nature, include analysis of organization-specific errors that have caused some degree of patient harm and analysis of aggregate medication error data (e.g., trends by drugs or location of drugs involved in errors). Equally important, the other two prongs, both proactive in nature, include analysis of “close calls” (errors that have the potential to cause patient harm) and analysis of errors that have occurred in other organizations. Each prong contains valuable information about weaknesses in the system that, collectively, can lead to effective error-reduction strategies. Yet many organizations focus primarily on the first two prongs of error analysis and action. Most often proactive efforts are not given high priority. As a result, organizations may be busy “fighting fires” rather than preventing them. A “close call” should be clear evidence that a tragic event could occur. Unfortunately, too often this wakeup call is not heard. Little attention is focused on thorough analysis of errors that, fortunately, do not cause actual patient harm, especially if organizations identify errors that require analysis by a severity rating that is based on actual patient outcome. For example, a serious overdose detected before administration may not be given the same priority and analysis as a similar error that actually reached and possibly harmed the patient. Worse, some organizations fail to use errors that have occurred elsewhere as a road map for improvement in their own organization. Staff will be more comfortable discussing a serious external error than one that has occurred within its own organization. Because blame is not an issue, defensive posturing and other obstacles to effective discussion will not be present. Staff can identify possible system-based causes of the error more easily and the likelihood of a similar error in their facility and make suggestions for improvement. As improvements are made, enthusiasm builds for identifying, reporting, and analyzing errors that are actually occurring within the organization. In the end, discussion about external errors leads to more effective analysis of internal errors.
Multidisciplinary educational programs should be developed for health care personnel about medication error prevention. Because many errors happen when procedures are not followed, this is one area on which to focus through newsletters, discussions during staff meetings, and in-service training.
Lastly, organizations should report medication errors externally so that the lessons learned from these events can be shared with others to prevent future occurances in their facilities. In 1999, the IOM issued a landmark report entitled, “To Err is Human: Building a Safer Health System” that highlighted critical areas of research and activities needed to improve the safety and quality of health care delivery. One critical area of the IOM report addressed the reporting and analysis of data on adverse events.
The IOM report and its findings spotlighted a serious need to capture information that would help to improve quality and reduce harm to patients. Addressing this need, Congress passed The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). To implement the Patient Safety Act, the Department of Health and Human Services issued the Patient Safety and Quality Improvement final rule. The Patient Safety Act and the Patient Safety Rule authorize the creation of Patient Safety Organizatoins (PSOs) to improve quality and safety through the collection and analysis of data on patient events [Agency for Healthcare Research and Quality (AHRQ), 2011].
PSOs are organizations that share the goal of improving the quality and safety of health care delivery. Organizations that are eligible to become PSOs include: public or private entities, profit or not-for-profit entities, provider entities such as hospital chains, and other entities that establish special components to serve as PSOs. By providing both privilege and confidentiality, PSOs create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data, thereby improving quality by identifying and reducing the risks and hazards associated with patient care. ISMP is certified as a Patient Safety Organization (PSO) by the Agency for Health care Research and Quality, which offers the highest level of legal protection and confidentiality for medication error reporting and analysis
Reporting errors to organizations like ISMP can also inform pharmaceutical companies of labeling and packaging problems. Many pharmaceutical companies have responded to suggestions made by technicians and pharmacists. Health professionals can report all of the aforementioned close calls and actual medication errors by using the ISMP Medication Error Reporting Program (MERP). Reports are forwarded to the individual pharmaceutical company and the FDA, and ISMP provides follow-up when appropriate. Call 1-800-FAILSAFE, visit ISMP's Web site at www.ismp.org, or complete an ISMP MERP report (see Fig. 29-9).
Used with permission, Form used in reporting medication errors, preventable adverse drug reactions, close calls, or hazardous conditions to the National Medication Errors Reporting Program (ISMP MERP), operated by the Institute for Safe Medication Practices. You may submit reports to the ISMP MERP via the Internet at: www.ismp.org/merp.