Part II
Moving Toward a Patient-Centered, Integrated Medication-Use System

TRANSFORMING THE MEDICATION-USE SYSTEM

Medication safety as a strategic goal and core value of health care is essential at all levels of the health care system—that of patient/consumer in terms of both self-management and relationship–partnership with the provider; that of provider microsystems (e.g., small units of care); that of systems, products, and stakeholders that support the consumer, the consumer–provider relationship, and provider microsystems; and that of the environment, which includes research, regulatory, and legal factors important to the function of each of the other levels and the system as a whole (Leape et al., 1998). From this perspective, medication safety becomes everyone’s responsibility. All individuals, departments, committees, teams, and services apply safety principles in their work (CIHSP, 2001). Management provides necessary resources, incentives, and rewards for optimal safety performance. There is openness, including with patients and families, regarding errors and problems. Safety decisions are made by those in the best position to protect the patient, regardless of rank or hierarchy (CIHSP, 2001). At the heart of all care is patient- and family-centeredness encompassing the qualities of compassion; empathy; and responsiveness to the needs, values, and expressed preferences of the individual (IOM, 2001). This new system, then, is different in attitude, culture, design, and operation (Christopherson, 2004) from the health care system whose deficiencies were highlighted in the Quality Chasm report (IOM, 2001).



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Preventing Medication Errors Part II Moving Toward a Patient-Centered, Integrated Medication-Use System TRANSFORMING THE MEDICATION-USE SYSTEM Medication safety as a strategic goal and core value of health care is essential at all levels of the health care system—that of patient/consumer in terms of both self-management and relationship–partnership with the provider; that of provider microsystems (e.g., small units of care); that of systems, products, and stakeholders that support the consumer, the consumer–provider relationship, and provider microsystems; and that of the environment, which includes research, regulatory, and legal factors important to the function of each of the other levels and the system as a whole (Leape et al., 1998). From this perspective, medication safety becomes everyone’s responsibility. All individuals, departments, committees, teams, and services apply safety principles in their work (CIHSP, 2001). Management provides necessary resources, incentives, and rewards for optimal safety performance. There is openness, including with patients and families, regarding errors and problems. Safety decisions are made by those in the best position to protect the patient, regardless of rank or hierarchy (CIHSP, 2001). At the heart of all care is patient- and family-centeredness encompassing the qualities of compassion; empathy; and responsiveness to the needs, values, and expressed preferences of the individual (IOM, 2001). This new system, then, is different in attitude, culture, design, and operation (Christopherson, 2004) from the health care system whose deficiencies were highlighted in the Quality Chasm report (IOM, 2001).

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Preventing Medication Errors Given these deficiencies, the Quality Chasm report called for profound changes and a paradigm shift away from a paternalistic, provider-centric system. The report outlined 10 new rules to guide the transition to a health care system that would better meet patients’ needs (IOM, 2001, p. 8–9): Care based on continuous healing relationships. Patients should receive care whenever they need it and in many forms, not just face-to-face visits. This rule implies that the health care system should be responsive at all times (24 hours a day, every day) and that access to care should be provided over the Internet, by telephone, and by other means in addition to face-to-face visits. Customization based on patient needs and values. The system of care should be designed to meet the most common types of needs, but have the capability to respond to individual patient choices and preferences. The patient as the source of control. Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over health care decisions that affect them. The health system should be able to accommodate differences in patient preferences and encourage shared decision making. Shared knowledge and the free flow of information. Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information. Evidence-based decision making. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place. Safety as a system property. Patients should be safe from injury caused by the care system. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors. The need for transparency. The health care system should make information available to patients and their families that allows them to make informed decisions when selecting a health plan, hospital, or clinical practice, or choosing among alternative treatments. This should include information describing the system’s performance on safety, evidence-based practice, and patient satisfaction. Anticipation of needs. The health system should anticipate patient needs, rather than simply reacting to events. Continuous decrease in waste. The health system should not waste resources or patient time. Cooperation among clinicians. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.

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Preventing Medication Errors These rules serve as the basis for the discussion of medication safety and quality improvement in this report. Applying these rules, the committee developed a new vision of a patient-centered, integrated medication-use system. This model, outlined in Table II-1, is intended to engender new expectations and actions on the part of those involved at all levels of the system by conceptualizing important factors that influence the current and the envisioned, safe state. More in-depth discussion of specific actions that can be taken to achieve the safe state is presented in Chapters 4 through 8. TABLE II-1 Transforming the Medication-Use System: Where We Are and Where We Want to Be Reality: Where We Generally Are Vision: Where We Want to Be Patient and Community Experiences The health system is provider-centric and provider-directed. The health system is patient-centered; patients are listened to and respected as informed, engaged full partners and the source of control. The patient experience is highly variable; minimum expectations are not consistently met. Specific patient rights and expectations are honored across the health system and applied specifically and consistently to the medication-use process. Providers focus on patient medications in the context of an encounter. Patient health and satisfaction are the focus, optimized through self-care, self-management, and the continuum of care. Self-management issues include nonadherence, knowledge deficits, practical barriers, and attitudinal barriers. Through supportive interventions, education, patient contracts, and behavioral change, patients are skilled in managing wellness, along with their acute, chronic, and disability needs. Families and caregivers are not generally recognized or supported. Families and caregivers are encouraged to be full participants in care. Patients, families, providers, and pharmacies lack a single accurate patient medication record. Each patient has a single electronic medication record. The patient, all providers, and pharmacies work from this record. All medications are reconciled against this record. Over-the-counter (OTC) drugs and dietary supplements are not considered medications for purposes of the medication record. Medications, OTCs, and dietary supplements are part of the medication record and patient care.

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Preventing Medication Errors Reality: Where We Generally Are Vision: Where We Want to Be Medication education is not a high priority, nor is it provided according to literacy levels. Education is a priority, with verbal counseling and materials the patient can understand, and with sensitivity to culture and lifestyle. Medication instructions are variable, presented with too much information, difficult to read, and inadequate. Medication instructions are standardized, focused, comprehensive, and useful, and designed to maximize safety. Staffing levels prevent providers from giving careful care, making respectful inquiries, and educating the patient. Staffing calculations and expectations allow for careful care, respectful inquiries, and patient education. The patient’s medication experience is one of fragile processes, inconsistency, defects, and waste. The medication-use process produces for the patient consistently high reliability and performance. Patients are unclear about where to go for additional medication information and answers to questions. Providers and pharmacies provide around-the-clock telephone and Internet resources to answer medication questions. Patients are unclear on expectations for reporting complications and on how to report and resolve complications when they occur. Clinicians provide appropriate instructions and encouragement to patients for reporting of adverse side effects. Resources to address complications from prescriptions are available around the clock. Patients do not receive clear explanations on what to do if an adverse event or unanticipated medication outcome occurs. After experiencing an adverse event or unanticipated medication outcome, patients, as well as families as appropriate, receive support, with their concerns addressed. Patients feel distanced from health care staff and organizations and get few answers when a medication error occurs. Patients, and families as appropriate, receive truth and support, being told what happened, why, what to expect, and what is being done to prevent a recurrence, as well as a statement of regret or apology. Patients lack mechanisms to report medication errors for accountability or learning purposes. Reporting systems with multiple options capture reports of medication errors from patients and families. Patients do not experience a system that is organized for care across multiple settings or during care transitions. The system is patient-centered, with active support across transitions of care. In partnership with the patient, a clinician is responsible for coordination of care, and in this case, medication management.

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Preventing Medication Errors Reality: Where We Generally Are Vision: Where We Want to Be Patients on chronic therapy may not be subject to appropriate monitoring for toxicities and side effects. Patients receive appropriate monitoring (laboratory tests) to detect any harm resulting from chronic administration of medications. Requests for renewals of medications are cumbersome and unreconciled. Patients have easy access to telephone and Internet-based prescription renewals with concurrent reconciliation. Patients are dependent on clinicians for medication safety alerts. Safety alerts are communicated directly to patients, and follow-up measures are taken. Organizational and Microsystem-Based Medication-Use Processes Professional autonomy drives variability. Medications are customized to patient needs and values. Medication safety is an individual responsibility. Medication safety is a system property. Safety can be overridden by volume and time pressures. Providing safe care is always the highest priority. Secrecy is necessary. Transparency is necessary. Staffing is based on historical trends and budgetary considerations. Staffing is based on workload and the complexity of patients needs. Medication orders are largely paper-based. Medication orders are computer-based, with decision support. The safety of medication orders depends on the vigilance of the ordering physician, nurses, pharmacists, and others. Systems to validate the total medication management plan are not in place or not consistently used. Patients may be taking medications no longer needed or therapeutic duplications, or may not be taking medications on an optimum administration schedule. All clinicians have immediate access to complete patient information and point-of-care reference information. The ordering process is guided by medication knowledge bases and other decision-support tools. Reconciliation is ongoing. In addition to being reviewed at the time of each prescribing event, a patient’s medication regimen is reviewed at least every X months to minimize therapeutic duplications, drug interactions, unnecessary treatments, and the like. Medication communications are unstructured and often oral. Medication communications are interdisciplinary and structured and include the patient.

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Preventing Medication Errors Reality: Where We Generally Are Vision: Where We Want to Be Orders called into pharmacies are oral and error-prone. All prescriptions are written and received in pharmacies electronically (e-prescribing), with appropriate decision support available in pharmacy computer systems. The medication administration record is typically paper-based, incomplete, and broadly inaccessible. A single electronic medication administration record is broadly accessible. The incidence of near-misses, adverse drug events, and medication errors is generally unknown by setting. All settings know their specific incidence of near-misses, adverse drug events, and medication errors through improved monitoring. Learning with regard to medication errors, when it does occur, is limited to a single setting. There is dissemination and diffusion of organizational learning from errors, with reporting to national agencies. Reports of medication errors lead to punitive responses. Reporting stimulates learning in a fair and just culture. The impact of medication management on health outcomes is unknown. Studies are conducted of medication management’s impact on outcomes, by setting, both individually and collectively. Processes supporting medication management have evolved over time, with multiple steps and high complexity. The medication management process is carefully designed, using principles and tools such as lean reliability and six-sigma, to produce reliable results 100 percent of the time. Medication management improvement activities are focused on pharmacy quality assurance. Medication management quality improvement activities are interdisciplinary and systemwide, and include the patient’s experience. The focus of care coordination and medication management is on transitions into and out of one setting. Care coordination embraces the whole experience of medication care. Medication selection may be driven by cost rather than by optimization of therapy. The approach to health care expenses and decisions to treat is holistic, based on what is best for the patient. The focus of medication management is cost reduction. The focus of medication management is waste reduction.

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Preventing Medication Errors Reality: Where We Generally Are Vision: Where We Want to Be Environmental Context for Medication-Use Processes Patients experience disjointed care, with confusing/contradictory medication management. Medication treatment management programs are supported with incremental funding. Adoption of electronic medical records and e-prescribing continues to be slow. Financial incentives and baseline e-prescribing standards rapidly accelerate adoption. Commercial pharmacy quality assurance and improvement activities are voluntary and inconsistent. Medication management/pharmacy quality assurance and quality improvement are mandatory in all settings. Medication safety education is fragmented and inconsistently delivered to the interdisciplinary team. Stakeholders develop and disseminate standardized interdisciplinary medication education safety programs. Direct-to-consumer marketing can result in misleading claims about the effectiveness of medications. Clinicians and patients have the information they need to make informed decisions about medications. Manufacturers agree to curb claims in their advertising. Medication information resources are scattered and disjointed. Consumer-based resource centers for medication and safety information are widely distributed. Drug naming, labeling, and information sheet development are complex and confusing and lead to errors. A focused research agenda is aimed at determining what strategies and tactics can improve understanding and reduce errors. The legal environment discourages transparency, reporting, and learning, as well as appropriate responses to claims. All components of the medication-use system, including the patient, consider the current legal and claims system fair and just. Some adverse medication events with harm are unavoidable—“the cost of doing business.” A concerted effort is made to reduce, minimize, or mitigate harm by reconsidering current treatment plans, dosing levels, and/ or use of adjunctive therapy. NOTE: This table is organized around the chain of effect in improving health care quality as identified by Berwick (2002).

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Preventing Medication Errors MAKING THE VISION A REALITY: AN OVERVIEW OF THE REMAINDER OF THE REPORT The committee believes a key step in improving the safety of the medication-use process is establishing a strong patient–provider partnership. Chapter 4 provides guidance on ways for both patient and the provider to strengthen this partnership. In addition, the chapter recommends ways of improving the information infrastructure available to the patient. Chapter 5 contains the committee’s recommendations on short- and long-term system changes that health care organizations can make in the medication-use process in three settings—the inpatient, nursing home, and outpatient—and in care transitions. Pharmaceutical, medical device, and health information technology companies represent the chief product-related industry sectors of the medication-use system. Chapter 6 provides an action agenda for design improvements to the information products and medical devices produced by these industries, focused on improving medication safety. The committee uncovered enormous gaps in the knowledge base regarding medication errors. In Chapter 7, the committee proposes an applied research agenda for the safe use of medications across all care settings, covering research methodologies, incidence rates, costs of medication errors, reporting systems, and testing of error prevention strategies. Finally, health care delivery is shaped by legislators, regulators, accreditators, and payers. Chapter 8 proposes ways for these stakeholders to motivate the adoption of practices and technologies that can reduce medication errors, and to ensure that professionals have the competencies required to deliver medications safely. REFERENCES Berwick DM. 2002. A user’s manual for the IOM’s “Quality Chasm” report. Health Affairs (Millwood) 21(3):80–90. Christopherson G. 2004. Person-Centered Health. Notes: Draft document provided to IOM staff. CIHSP (California Institute for Health System Performance). 2001. A Compendium of Suggested Practices for Preventing and Reducing Medication Errors. Sacramento, CA: CIHSP. IOM (Institute of Medicine). 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press. Leape LL, Kabcenell A, Berwick DM, Roessner J. 1998. Breakthrough Series Guide: Reducing Adverse Drug Events. Boston, MA: Institute for Healthcare Improvement.