MODULE 4: MEDICATION SAFETY BY DEXTER JOHN F. BUSTAMANTE, RPH Scope of the Safety Problem •Safety is an implied minimum standard in providing health care. Yet many Americans are harmed as a result of medical error. Scope of the Safety Problem •Research in the area of medication safety and error prevention has identified some serious concerns for patients and care providers. •As health care delivery systems become more complex, it is evident that the opportunities for error abounds. •A national, concerted effort by health professionals, organizations, purchasers, and regulators will be required to deal with this complex issue. •Reports published indicate that errors involving medications are responsible for an immense burden of patient injury, suffering, and death. Scope of the Safety Problem Current research has identified some issues, previously only discussed behind closed doors, regarding the scope and seriousness of the problem of medication errors: • The costs of medication-related morbidity and mortality are high. • Many medication errors are preventable, and physicians, nurses, and pharmacists can play a vital role in diminishing medication errors. • The medication use process is highly complex, problem-prone, and requires a systematic approach for improvement. Scope of the Safety Problem •Additional studies frame the issue of medication-related errors in other settings by identifying errors in prescribing and dispensing of prescriptions in an outpatient environment. •There is evidence that ADEs account for a sizable number of admissions to inpatient facilities; however, it is unknown how many of these ADEs are directly associated with error. •One study found that between 3% and 11% of hospital admissions were attributable to ADEs. Scope of the Safety Problem •Appropriate medication use is a complex process involving multiple organizations and professions from various disciplines combined with a working knowledge of medications, access to accurate and complete patient information and integration of interrelated decisions over a period of time. •The growing complexity of science and technology requires health care providers to know more, manage more, monitor more, and involve more care providers than every before. Scope of the Safety Problem •Health care systems have traditionally operated under the assumption that if care providers are well educated and follow well-developed policies, procedures, or guidelines, errors will not happen. •Errors reoccur despite the best educational and planning efforts. •To understand what is or is not known about medication-related adverse events, common definitions must be established and understood. Scope of the Safety Problem •Organizations must come to a common understanding regarding medication errors, reporting requirements, and risks to capture and act upon error potential within their own medication use systems. UNDERSTANDING THE ERROR •Adverse Drug Event (ADE): There are two types of ADEs: (1) those caused by errors and (2) those that occur despite proper usage of a medication. If an ADE is caused by an error, it is by definition, preventable. •Nonpreventable ADEs (injury, but no error) are called adverse drug reactions. •Preventable Adverse Drug Event: An injury due to an error in the use of a drug (including failure to use). UNDERSTANDING THE ERROR •Potential Adverse Drug Event (PADE): A potential ADE is a serious medication error—one that has the potential to cause an ADE, but did not, either by luck (eg, the patient was not allergic to the drug despite a note in the record stating so) or because it was intercepted •Adverse Drug Reaction (ADR): an ADR does not result from an error. UNDERSTANDING THE ERROR These definitions provide the following insights regarding adverse events and medication use: • Medication errors are considered preventable while adverse drug reactions are generally are not. • If an error occurs, but is intercepted by someone in the process, it might not result in an adverse event. These potential adverse events are often referred to as near misses. • Capturing information regarding near misses could yield vital information regarding system performance. UNDERSTANDING THE ERROR •Research indicates that perhaps one of the best ways to address the problem of adverse drug events and medication errors is to recognize that inherent risk exists with use of medications in patient care. •Health care professionals are human and can make mistakes. Yet, during training and practice, they are immersed in an environment where there is no room for error. •Reporting an error is often viewed as professional failure or negligence and is followed by sanction or punishment of the individuals involved UNDERSTANDING THE ERROR •A zero error standard is demanded in health care. •Increased patient complexity and decreased numbers of health care staff contribute to potential error. •Because errors are thought to be preventable, examining what happened when an error occurs is the natural response, a means to develop future prevention strategies. •Unfortunately, in many organizations, the response to error targets the people rather than the system involved in the production of an error. TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL IOM’s Chasm offers four recommendations for a tiered strategy: • Establish a national focus on patient safety by creating a center for patient safety within the Agency for Healthcare Research and Quality (AHRQ) • Identify and learn from errors by establishing nationwide mandatory and voluntary reporting systems • Raise standards and expectations for improvement in safety through the actions of oversight organizations, group purchasers, and professional groups • Create safety systems inside health care organizations through the implementation of safe practices at the delivery level TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL •Medical safety research, including research on medication safety, has focused on identification, quantification, and exploration of causal pathways of error, as well as well as the concept of safety culture and the structure that supports a safety culture. •In relative isolation, researchers have studied medical and surgical staff, interdisciplinary teams and specialty practice to discern what characteristics enhance safety. TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL •How structures and strategies of care delivery at the microsystem level affect performance and outcomes holds a promise for vast improvement opportunity. •Additional research will be needed to develop and test better ways to prevent errors and improve safety at the microsystem level–the sharp end–of health care organizations. TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL •The microsystems concept is based on systems theory and the work of Deming, Senge, Wheatley, and others who applied systems thinking to concepts of organizational development, improvement, and leadership. •Microsystems are defined as small, organized groups of providers and staff caring for defined populations of patients TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL •Focus on the microsystem offers the potential for greater standardization of common activities, while still offering needed customization of care for individual patients. •An increased use and analysis of information and medical evidence to support daily work is a key component of improvement efforts at the microsystem level. •Constant measurement and feedback of data to providers and patients offers the infrastructure and information flow that supports shared learning, understanding, and improvement of process, performance, and outcome. TARGETING MEDICATION SAFETY AT THE MICROSYSTEM LEVEL •Open dialog, collaborative teamwork and multifunctional/multidisciplinary cooperation, respect, and caring are the hallmark of a highly reliable microsystem of care. •Learning within and among microsystems offers an unsurpassed opportunity to identify and spread best practices. •The results of interactions between patients, staff, and support processes produce results–clinical, economic, health status, and satisfaction outcomes—that combine to represent a relative value. CLINICAL MICROSYSTEM 10 SUCCESS CHARACTERISTICS LEADERSHIP •Organizational support is provided by the larger organization through recognition, information, and resources to legitimize the work of the microsystem. •Staff focus includes attention to hiring the right people for the job, actively integrating new staff into work roles as well as the culture, and aligning competencies with the work. •Education and training is the ongoing responsibility of the microsystem. There is a team-based approach to training and recognition that continuing education and development of competencies aligning with work roles is recognized as vital for success. CLINICAL MICROSYSTEM 10 SUCCESS CHARACTERISTICS STAFF •Education and training is the ongoing responsibility of the microsystem. There is a team-based approach to training and recognition that continuing education and development of competencies aligning with work roles is recognized as vital for success. •Interdependence is established and maintained through: • the development of trusting and collaborative relationships of staff based on willingness to help others on the team, understand and appreciate complementary roles and a belief that all contribute individually to a shared purpose. • The team is multidisciplinary, and there is respect for each role on the team. CLINICAL MICROSYSTEM 10 SUCCESS CHARACTERISTICS PATIENT •Patient focus is a primary concern, meeting all patient needs through caring, listening, educating, and in response to special requests. •Community and market focus should be understood and served by microsystem. The relationship, how the microsystem serves the community, and how the community is a resource to the microsystem must actively connect patients to all available resources to meet their needs. •A focus on excellence, partnerships, and innovative collaboration should be part of the individual microsystem and organizational outreach plan. CLINICAL MICROSYSTEM 10 SUCCESS CHARACTERISTICS PERFORMANCE •Performance results should focus on achieving high quality outcomes, reducing costs, streamlining care delivery processes, using feedback effectively, promoting positive competition, and establishing useful dialog about current practice performance and future goals for improvement. •Process improvement must be supported by resources. Within the microsystem and organization, an atmosphere for learning and redesign is supported by a plan for continuous system and practice monitoring, use of benchmarking, change assessment, and an empowered staff focusing on innovation and improvement. CLINICAL MICROSYSTEM 10 SUCCESS CHARACTERISTICS •Information and information technology IS THE CONNECTOR of staff to patients, staff to staff, needs with actions to meet needs. •Technology can facilitate effective communication and both formal and informal channels must be used to keep everyone informed all the time to assure that learning and knowledge is linked to patient care. •Communication, with reliance on technology and redundancy of communication channels keep everyone on the team informed, facilitate open dialog and keeps all team members in the loop on important topics and issues, with information access at the point of need. UNDERSTANDING MEDICATION USE PROCESS •Medication use complication and errors can occur in all patient care settings; no patient care arena is immune ORGANIZATIONAL ISSUES •Health care organizations tend to make the same medication mistakes over and over because members tend to accuse individual employees rather than consider the real root cause of the error, a faulty system. •Implementing new strategies will require a profound change in the way health care does business. •A new framework for guiding organizations will be needed to transition health systems to better meet patient needs. •A variety of factors can influence individual and team performance. Of growing concern are the effects of burnout, stress, and fatigue ORGANIZATIONAL ISSUES Highlights methods to guide these transitions and help organizations remain focused on the true agenda: SAFER CARE FOR PATIENTS. • Redesign care practices based on best practice • Use information technologies to improve access to clinical information and support decisionmaking • Develop effective teams • Incorporate new knowledge and skills management • Coordinate care across patient conditions, services and settings over time • Incorporate performance and outcomes measures for improvement and accountability ORGANIZATIONAL ISSUES SOME DISTINCT OBSERVATIONS AND CONCLUSIONS HAVE BEEN MADE AS A RESULT OF THESE ADVERSE EVENT STUDIES: • ADEs are common, more common than previously recognized • ADEs resulting from error are preventable • For each preventable error, three more near misses occur • Ordering and administration of medications are most likely to be identified as error prone • Costs of ADEs are significant and include injury, malpractice, additional care and work and overall damage to organization ORGANIZATIONAL ISSUES SOME DISTINCT OBSERVATIONS AND CONCLUSIONS HAVE BEEN MADE AS A RESULT OF THESE ADVERSE EVENT STUDIES: • Organizational redesign is needed • There are costs for implementing safe systems; but the costs of inaction are much higher • Error reduction strategies will require a systems oriented approach • Many errors that are preventable are also often not reported; organizations must identify methods for health care providers to report and engage in prevention activities. Safety Culture •Culture is based on values. It reflects the vision and mission of the organization, as well as the goals that are set and the strategies that it employs to reach its goals. •Leaders and top management must set the tone and expectation for the culture in the beliefs, values and actions that define expectations. •Communication from the top down must be credible, consistent, and relevant to be received and acted upon by workers, without any perception of hypocrisy. Safety Culture •The perceived messages must resonate with workers, build in intensity toward a consensus and belief system. •Reward systems must be aligned to support and reinforce the culture concept. •Promotions, salary adjustment, approval, and reinforcement mechanisms should all flow in the direction of individuals acting on and supporting the culture, values, and beliefs, to avoid saying one thing, only to do another. LINKING SAFETY & PERFORMANCE IMPROVEMENT •A fine balance of integrating a wide range of strategies, identifying how staff implement and use these strategies and measuring their effects are necessary. •Literature documents some serious quality problems. There is a gap, for some a chasm, between services that should be provided based on current professional knowledge, technology, and services that patients actually receive. •This wake-up call for health care has inspired many organizations to rededicate their focus on identifying, measuring, and implementing performance improvement strategies to strive for better care services. PERFORMANCE IMPROVEMENT PROCESS •It is essential that health systems identify the changes most likely to result in a sustainable improvement. •One particular model for improvement, the Plan-Do-Study-Act learning cycle, has been advocated for use by health care systems to improve processes affecting patient care. •This model has a demonstrated framework for a variety of system contexts including health care and can be used alone or in conjunction with other change models that are utilized within a health care system to accelerate improvement efforts. •The model was initially by Thomas Nolan and his colleagues at Associates in Process Improvement. • The Plan-Do-Study-Act (PDSA) process is dependent upon the work of a team that has an interest in evaluating a change and has knowledge of what the current process is and is capable of being. PDSA CYCLE The model has two parts. First a series of three questions must be answered. 1. What is the aim of the change initiative? ◦ Health system should clearly identify, in numerical or specific terms 2. How will the health system know if the change has resulted in the desired improvement? ◦ Identify clear, objective measurements are crucial to improve process. Health systems should identify quantitatively measures to determine if the change resulted in an actual improvement. 3. What changes should be made to result in the improvement? • the goal is to identify a change or series of changes to be tested in a real world setting to find out if the change improves care as the aim has described. PDSA CYCLE •Second, use of a learning cycle, referred to as the PDSA cycle is used to test and implement the identified change. •This cycle is really based on a systematic, trial and learning approach. •The PDSA is a shorthand way of describing how a change is tried, observed, and then evaluated for future modification. The completion of a PDSA cycle leads directly to a next cycle. •The team learns from the test, identifies what works or doesn’t, and then determines what should be kept, changed, or abandoned for improvement. The challenges of each step of the PDSA process are as highlighted below: PDSA CYCLE STEP 1 PLAN: THE TEAM SHOULD STATE THE OBJECTIVE OF THE PDSA CYCLE. •How will the change be tested? Who will be involved? What will be measured? Where will these observations be made? What data will be collected? How will training occur? •This is the greatest challenge of the change initiative and the most time consuming, but it clearly sets the context and framework for the team to evaluate the change. PDSA CYCLE •Step 2 DO: This is the phase where the test or change is actually carried out. Documentation of the observations and findings begin at this stage. Data collection is occurring •Step 3 STUDY: At this point, evaluation of the data occurs. The team needs to compare the findings of the change initiative to the predictions made. A summary of learnings and findings must be provided. PDSA CYCLE •Step 4 ACT: At this point, analysis of findings is complete and the team needs to determine what modifications are necessary, what gains should be held and what new knowledge has been identified. •Improving patient safety is a complex undertaking. •Organizing a team of individuals with diverse skills, characteristics, and knowledge is an essential first step. •Deciding who should be on the team begins with a focus on the strategic initiative. The overall plan for the organizational safety initiative includes three steps that allow the organization to determine the aim or goal of whatever it is trying to accomplish. •These steps include: • Developing a strategy, Analyzing organizational capabilities, Developing an action plan TOOLS TO IDENTIFY, CONTROL, CONTAIN OR MITIGATE RISK •When adverse events occur, health systems must identify the causes of the event, the interrelationship of these causes, and implement improvement or redesign efforts to eliminate causes of error. •Since errors are thought to be preventable, organizations must also identify methods to design or redesign systems proactively. •These proactive efforts are aimed to prevent, or at least minimize, the likelihood that failures occur and also protect patients from the effects of failures when they do occur. BARRIERS ASSOCIATED WITH SAFETY MOVEMENT •Organizations have not adequately defined the process, the scope of collection, and members of the health care team do not understand why there is a need to collect and discuss the data. •Additionally, data collection and discussion about medication errors or adverse events are often fragmented. •Pharmacy might collect and discuss some of the data, while nursing may be responsible for other parts and risk management or QA may get involved for other issues. BARRIERS ASSOCIATED WITH SAFETY MOVEMENT •Having a plan and an organizational understanding of the aim regarding safety improvement is essential. •Many parts of the health care team contribute to the use of medications within the organization. •All members within the organization must be aware of the importance of medication use safety, mindful of the potential for error and their role in averting it and what the organization has in place to assure that safety is a priority. BARRIERS ASSOCIATED WITH SAFETY MOVEMENT •Integration of all data and associated knowledge regarding medication use is needed. •The integration of existing data, including ADR, medication error, pharmacy/nursing interventions, and medication interaction data, into one organization-wide database is the key to an effective ADE quality management program. •The overall impact of the database could be measured by examining the impact that the reduced incidence of ADEs has on health outcomes: clinical, economic, patient satisfaction, and health status outcomes. BARRIERS ASSOCIATED WITH SAFETY MOVEMENT Specific goals for adverse event improvement activities generally include: • Increase documentation • Aggregate data effectively • Organizational education and training regarding prevention and detection • Use data to improve the medication use system BARRIERS ASSOCIATED WITH SAFETY MOVEMENT • Minimize patient risk • Maximize health outcomes • Create an open and honest environment where there is a focus on system improvement and reporting • Remove focus on individual and punitive process • Meet regulatory standards BARRIERS ASSOCIATED WITH SAFETY MOVEMENT •Many groups have identified methods to improve the safety of the medication use process. •National and local groups have strategies to share and stories to tell. •It is important to learn and replicate best practice and build on the success of others. THANK YOU!
