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Preventing Medication Errors 4 Action Agenda to Support the Consumer–Provider Partnership CHAPTER SUMMARY A key step in improving the safety of the medication-use process is establishing a consumer–provider partnership. The consumer of health care—the patient—is the person with the greatest stake in identifying and preventing medication errors. The chapter addresses ways in which both consumers and providers (including physicians, nurses, and pharmacists) can strengthen the consumer– patient partnership. There are also many areas for improvement in consumer-oriented drug information. According to a 2004 survey by the Kaiser Family Foundation, 48 percent of Americans are concerned about the safety of the medical care they and their families receive, and 55 percent are dissatisfied with the quality of the nation’s health care—up from 44 percent who expressed this view in a survey conducted 4 years ago (KFF, 2004). Results of other national and international surveys indicate that 34 to 40 percent of individuals have experienced a medical error themselves or know of a family member or friend who has (CMWF 2005; NPSF, 1997). A National Patient Safety Foundation survey found that among those who had personally experienced an error, 40 percent of the errors were due to mistakes in diagnosis and wrong treatments. Medication errors accounted for 28 percent of the errors, while 22 percent were the result of mistakes during surgery. In a six-country survey by the Commonwealth Fund, 28 to 32 percent of patients in
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Preventing Medication Errors each country said treatment risks had not been completely explained during their hospital stay. In addition, 55 to 64 percent of patients said physicians had not always reviewed all their medications during the past year, and 47 to 69 percent stated that physicians did not always explain the side effects of medications (CMWF, 2005). Usually, people are not told about an error unless injury or death occurs. In a nationally representative survey of hospital risk managers, the vast majority reported that their hospital’s practice was to disclose harm at least some of the time, although only one-third of hospitals actually had board-approved policies for doing so in place (Lamb et al., 2003). More than half of respondents stated that they would always disclose a death or serious injury; when presented with actual clinical scenarios, however, respondents revealed they were much less likely to disclose preventable harm than to disclose nonpreventable harm of comparable severity. In a 2004 survey by the Premier Safety Institute, no respondents indicated that disclosures of errors causing serious or short-term harm were never given; 57 percent said such errors were frequently disclosed to patients or families, while 37 percent said such disclosures were always made (PSI, 2004). The following is an example of a medication error that resulted in a fatality: Eighteen-month-old Josie King was admitted to the hospital for first- and second-degree burns received when she climbed into a hot tub. She spent 10 days in the pediatric intensive care unit, with her mother being vigilant as to the details of her care. Josie was recovering and was transferred to an intermediate care floor for a few more days. After her central line was removed, however, her condition worsened. Although her mother expressed concern about Josie’s new symptoms, which at one point included sucking avidly on a wet washcloth, those concerns were not addressed by the shift nurses. Moreover, despite a doctor’s order that no narcotics be administered to the child, and over the objections of her mother, Josie received a narcotic pain medication 2 days before she was to go home. She then experienced cardiac arrest. In retrospect, the child’s symptoms reflected progressive dehydration. Josie’s mother is among the many individuals, parents, and surrogates whose voices are often ignored by providers (JKF, 2002). The following are examples of medication errors with the potential to result in death or serious harm: A child with leukemia was discharged from the hospital with a nasogastric tube in place for intermittent enteral feeding. While readmitted for chemotherapy, he developed an infection and had a peripherally inserted central catheter (PICC) emplaced for the administration of antibiotics. He recovered from the infection and was discharged. Shortly thereafter, the
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Preventing Medication Errors PICC line clotted. His mother called the home care nurse. When the nurse arrived, she found that the mother was about to use a syringe of ginger ale to clear the PICC line and prevented a serious error. Having been taught to clear the child’s feeding tube with ginger ale, the mother thought the same could be done with the PICC line. She is just one example of the many caretakers who do not receive adequate discharge counseling (Cohen, 2000). A middle-aged man with newly developed asthma was prescribed an inhaler, but was not responding to treatment. During a follow-up visit, he described how he was using the inhaler. He would squirt two puffs in the air and breathe deeply for 15 minutes. He said he’d been instructed to do this by his doctor, who had picked up an inhaler, held it in the air, and released two puffs to demonstrate its use. The doctor had given the man no further instructions. The man had not read the instructions on the package because he was functionally illiterate. He is an example of the millions of Americans who do not receive adequate medication instructions and have difficulty with basic reading and writing (Cohen, 2000). Each of the above cases illustrates the potentially lethal consequences of inadequate and ineffective interactions between consumers (patients or surrogates) and providers. The cases underscore the most common complaint about providers—they fail to take the time to listen and to explain. Some communication problems have been attributed to the fact that many health care providers focus on diseases and their management rather than on people, their lives, and their health issues (Lewin at al., 2005). Other issues concern the lack of understanding and respect for patients’ rights to be informed and to play an active role in their and their family members’ care. Unfortunately, such circumstances are commonplace (Annas, 2004; KFF, 2004; CMWF, 2005). Care delivered without good communication and follow-through on patient rights is provider-centric when in truth, consumers want and increasingly expect care that is patient-centered (Cleary, 1993). The Institute for Healthcare Improvement’s program on Patient and Family Voices has identified key aspects of patient-centered care desired by consumers (see Box 4-1). FOUNDATION FOR IMPROVEMENT Improving safety and quality in the medication-use system requires a shift from the conventional approach to care toward a patient-centered model based on consumer–provider partnership and communication. The foundation for this change has several elements discussed in this chapter. First, all participants in the health care delivery system need to acquire a thorough understanding of what patient-centered care really entails in terms of both the consumer–provider relationship and the culture of the health
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Preventing Medication Errors BOX 4-1 Patients’ Expectations of Their Providers To be listened to, taken seriously, and respected as a care partner. To have family/caregivers treated the same. To participate in decision making at the level they choose. To always be told the truth. To have things explained fully and clearly. To receive an explanation and apology if things go wrong. To have information communicated to the entire care team. To have care promptly and impeccably documented. To have these records made available if requested. For care to be coordinated among all members of the health care team across settings. To be supported emotionally as well as physically. To receive high-quality, safe care. SOURCE: IHI, 2005. care organization. Second, consumers need to be empowered to play an active role in their care through the establishment of patient rights that are ensured at all points along the medication-use continuum, enhancing the presence, power, and participation of consumers in their relationships with providers. Third, certain basic, definitive actions can be taken to minimize and prevent medication errors and other safety issues; for example, the consumer can carry a medication list, and the provider can regularly practice medication reconcilation. Fourth, participants in the health care delivery system should seek to understand and address barriers to patient-centered care, patient–provider communication, and consumer medication self-management. Finally, resources need to be developed to support partnership, communication, and self-management. The first two of these elements are discussed below; the others are addressed in the remainder of the chapter. Understanding Patient-Centered Care Understanding patient-centered care is critical to quality and safety in medication use. Patient-centered care is an approach that adopts perspective of patients—what matters to them, what affects them either positively or negatively, and their experience of illness (Gerteis et al., 1993). The aim is to see people in their biopsychosocial entirety, understanding the whole person, sharing power and responsibility, and drawing attention to
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Preventing Medication Errors patients’ individual identities (Armstrong, 1982; Stewart, 1995; Stewart et al., 1995; Mead and Bower, 2000). The approach recognizes that important aspects of the patient’s experience have just as much to do with the quality of care delivery during interactions with medical staff as the actual medical care itself (Frampton et al., 2003). It focuses attention on the heart of the patient–provider relationship—communication during each clinical encounter, whether a consultation, intervention, or simple exchange. Patient-centered care that embodies both effective communication and technical skill is necessary to achieve safety and quality of care (Griffin et al., 2004). Although a number of definitions have been presented in the academic and clinical literature (Frampton et al., 2003; Lewin et al., 2005), the Committee on Identifying and Preventing Medication Errors uses the multifaceted definition developed by Gerteis and colleagues (1993) and espoused in previous Institute of Medicine (IOM) reports. This definition encompasses seven primary dimensions of patient-centered care, as described in Box 4-2: (1) respect for patients’ values, preferences, and expressed needs; (2) coordination and integration of care; (3) information, communication, and education; (4) physical comfort; (5) emotional support and alleviation of fear and anxiety; (6) involvement of family and friends; and (7) transition and continuity. Effective, patient-centered communication along these dimensions supports a more collaborative consumer– provider relationship whereby the joint definition of problems, treatment goals, and management strategies can be accomplished (Von Korff et al., 1997; Wolpert and Anderson, 2001). This collaboration, in turn, can lead to improved patient satisfaction, engagement in decision making, participation in prevention activities (Flach et al., 2004), better self-management of chronic conditions (Heisler et al., 2002), and adherence to medication regimens (Safran et al., 1998). Even though the benefits of patient-centered communication are well understood, they have not been well implemented across health care settings, institutions, and practices (IOM, 2001). In today’s health care system, such communication is sometimes sacrificed as a result of the intrusion of business into clinical practice, the pressures of limited time for office visits, the culture of medicalization, and the often all-consuming focus on technology (Teutsch, 2003). There is a misconception that supportive interactions require more staff or more time and are therefore more costly (Frampton et al., 2003). This is not necessarily the case. Rather, it could be argued that negative interactions (e.g., alienating patients, being unresponsive to their needs, or limiting their sense of control) can be very costly in terms of lost patient revenues, poor health outcomes, and, in some cases, increased likelihood of litigation (Frampton et al., 2003). For example, insufficient communication about medications can lead to nonadherence
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Preventing Medication Errors BOX 4-2 Dimensions of Patient-Centered Care Respect for patients’ values, preferences, and expressed needs. Respecting patients’ individuality and restoring their autonomy entails: paying attention to the impact that their condition or treatment has on their quality of life or subjective sense of well-being; involvement in decision making; being treated with dignity and respect, and sensitivity to their cultural values; and meeting their expectations and needs for autonomy. Coordination and integration of care. Understanding patients’ feeling of vulnerability and powerlessness in the face of illness and their need for competent and caring staff to coordinate and integrate clinical care effectively, including ancillary and support services, and “front-line” patient care. Information, communication, and education. Respecting patients’ need for information on clinical status, progress, and prognosis delivered accurately in a manner they understand; information on processes of care, how alternative treatments might affect their subjective well-being and clinical status, and information about the reasoning behind clinical decisions. Physical comfort. Providing the most basic elements of physical comfort includes staff who listen and are attentive to patients’ complaints about pain, help them with activities of daily living, and keep them clean and comfortable in an environment that is reasonably pleasant. Emotional support and alleviation of fear and anxiety. Understanding that the emotions experienced in relation to illness may be as debilitating as the physical effects, and attending to and alleviating their fear and anxiety over clinical status, treatment, and prognosis; over the impact of the illness on self and family; and over the financial impact of the illness. Involvement of family and friends. Accommodating patients’ wishes for involvement or noninvolvement of family and friends relative to emotional support and decision making, and providing support and resources to family or friends who are caregiving in both immediate and extended term. Transition and continuity. Addressing patients’ concerns about their ability to care for themselves away from the clinical setting, their need to receive adequate information about their medications, dietary or other treatment regimens, and danger signals to look out for; their need for information about the plans made and services coordinated for continuing care and treatment; and their need for information to access clinical, social, physical, and financial support on a continuing basis if needed. SOURCE: Gerteis et al., 1993.
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Preventing Medication Errors and increased hospitalization (DiMatteo, 2004). Conversely, good communication can obviate the need for extensive discussions about the medication regimen with every patient during every visit. Methods for incorporating patient-centered communication about medications into day-to-day clinical practice can be drawn from the Chronic Care Model (as well as others employed to develop consumers’ self-management skills). The Chronic Illness Care Breakthrough Series Collaboratives established by the Institute for Healthcare Improvement and Associates in Process Improvement developed a five-component model of key steps to patient-centered self-management support (Glasgow et al., 2002) (see Figure 4-1). It is designed to organize evidence-based intervention components into an integrated and understandable iterative process appropriate for incorporation into busy primary care practices. The five components are as follows: (1) current self-management beliefs and behaviors are assessed, with feedback for both providers and patients; (2) the feedback prompts collaborative goal setting between patients and provider(s); (3) a personal action plan for self-management is developed; (4) initial self-management goals are refined and informed through the identification of anticipated barriers to and supports for the achievement FIGURE 4-1 The Chronic Care Model: Key steps to patient-centered, self-management support. SOURCE: Glasgow et al., 2002.
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Preventing Medication Errors of those goals and a better understanding of the patient’s perspective and the social environment in which self-management must be conducted; and (5) individually tailored strategies and problem-solving approaches are developed to enhance self-efficacy and provide patients with strategies for overcoming the barriers identified (Glasgow et al., 2002). These steps are repeated in an iterative, ongoing, flexible way at future encounters. Glasgow and colleagues (2002) believe this model is different from that used in most health care settings in that it is patient-centered, individualized, and self-correcting, and encompasses the overall care of a patient’s health conditions rather than being an isolated activity. Self-management education programs have been found to improve patient health outcomes (IOM, 2003). For example, a study that investigated the effects of self-management education and regular practitioner review for adults with asthma demonstrated a statistically significant reduction in the proportion of subjects reporting hospitalizations and emergency room visits, unscheduled physician visits, days lost from work, and episodes of nocturnal asthma (Gibson et al., 2000). The above steps outlined for chronic care could easily be adapted to patient-centered care for improved medication self-management. In fact, Svarstad and colleagues (1999) developed a brief medication questionnaire for patients as a means of identifying those who need assistance with their medications, assessing their concerns, evaluating new ways to assist them, and monitoring their progress (including adherence). Additional research could be undertaken to develop methods for adapting the components of the Chronic Care Model to general medication self-management and the resources required to support patients and providers in a patient-centered, collaborative partnership. Empowering Consumers in Their Health Care The second critical element of the foundation for improving the safety and quality of the medication-use process through an emphasis on patient-centered care is the empowerment of consumers as equal partners in their health care. Equalizing and empowering consumers in their relationship with their providers requires assurance of their rights as patients in all health care settings. Embracing a set of basic patient rights that are endorsed and enforced by health care provider, accreditation, and regulatory organizations to support patient-centered medication management, informed decision making, and prevention of errors is necessary to improve the safety of medication use and the quality of care overall. As seen in the examples quoted earlier, patient rights are not important only in the abstract; they can literally save lives (Annas, 2004).
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Preventing Medication Errors Many rights that empower consumers and protect them from harm have been instituted through codes, regulations, and laws governing informed consent prior to receipt of a medication, treatment, or procedure during an experimental clinical study or during clinical care. Informed consent is the fundamental ethical and legal doctrine that protects patients’ rights to personal autonomy and bodily self-determination (Ridley, 2001). Where informed consent is relevant, the physician is required to discuss and disclose the following (AMA, 1998): Patient’s diagnosis, if known Nature and purpose of a proposed medication, treatment, or procedure Risks and benefits of a proposed medication, treatment, or procedure Alternatives (including medication options), regardless of their cost or the extent to which they are covered by health insurance Risks and benefits of an alternative medication, treatment, or procedure Risks and benefits of not receiving or undergoing a treatment or procedure Patients are also entitled to the opportunity to ask questions so they can elicit a better understanding of their treatment plan (medication or procedure) before proceeding with or refusing a proposed medical intervention. Regulations of the U.S. Food and Drug Administration (FDA) govern informed consent requirements for participation in clinical trials. Vulnerable populations—children, pregnant women, those with mental illnesses, those of reduced competency, and prisoners—are given special consideration and, in some cases, extra protection by the federal government (Getz and Borfitz, 2002). As part of licensing, certification, and regulatory authority, state medical boards govern informed consent requirements in hospitals and ambulatory practice. Informed consent provisions are based on the American Medical Association’s Code of Medical Ethics and standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). While most state laws regarding informed consent are written for hospital care, precedent set by extensive case law applies these provisions equally to ambulatory care. In the realities of clinical practice, however, consumers are often not adequately informed to participate as partners in their care. For example, many aspects of medication therapy that should be discussed as fully as in an informed consent discussion are not. Often lacking is discussion of contraindications, side effects, adverse reactions, how to distinguish side effects and adverse reactions from the symptoms of disease, and what to do about them (Kerzman et al., 2005; Safran, 2003). Not all patients need a full discussion at every clinical encounter, especially if they are familiar with their medication(s), but such discussion should be recognized as a patient’s fundamental right. This raises another
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Preventing Medication Errors core issue: a formal set of patient rights applicable in all health care settings has never been instituted at the federal or state level. Federal legislative attempts in the 1990s to pass a comprehensive patient bill of rights that would apply to health care services did not succeed, with the exception of consumers’ right to sue their insurance payer for denial of benefits. Health care provider and accreditation organizations have, however, been leaders in promulgating statements of patient rights. For example, the American Hospital Association recently recrafted its 1992 Patient’s Bill of Rights to include principles of the patient care partnership, a model that represents a shift to patient-centered care. Those principles state what patients can expect during a hospital stay in terms of the hospital environment, participation in their care, protection of privacy, discharge preparation, and help with billing. JCAHO evaluates compliance with standards for ethics, rights, and responsibilities in hospital and ambulatory care settings. The purpose of these standards is to ensure that care, treatment, and services are provided in a way that respects and fosters patient dignity, autonomy, positive self-regard, civil rights, and involvement (JCAHO, 2005). Consideration is given to patients’ abilities and resources; their cultural, psychosocial, and spiritual values; the relevant demands of their environment; and their wishes regarding the involvement of family members in their care. Other efforts to raise awareness of patient rights include those of the Tavistock Group—a group of experts representing health care stakeholders that developed a set of shared ethical principles to guide decision making in an integrated health care delivery system (Smith et al., 1999). Certain states have instituted a patient bill of rights, but provisions are not comprehensive, nor do they cover all health care settings (see Table 4-1 for examples). While these efforts are steps in the direction of patient-centered care and patient rights, they do not go far enough. The committee believes that establishment of a basic set of patient rights—presented in Box 4-3—is essential to achieve patient-centered care, consumer activation and partnership, and improvements in safety and quality. Many but not all of these rights are established broadly in the U.S. Constitution (Amendments I and XIV1) and have been articulated by the courts through common law. Nonetheless, they remain difficult to enforce for patients and providers alike, especially for sick individuals (Annas, 2004). One important point listed in Box 4-3 that is not specifically provided for in the law is the right to be told 1 Freedom of religion under the First Amendment allows citizens to make decisions according to their religious beliefs, including medical decisions regarding treatment. Due process under the Fourteenth Amendment as applied to health care ensures that citizens retain their right to life, liberty, and equal protection; meaning self determination and civil rights (patient rights).
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Preventing Medication Errors TABLE 4-1 Examples of State Patient Rights Statutes State Provision Providers/Facilities Covered Alaska Patient Medical Rights Alaska Stat. § 47.30.825 (2006) Mental health facilities California Patients’ Bill of Rights Cal. Health & Safety Code § 1599 (2006) Nursing homes Florida Patient’s Bill of Rights and Responsibilities Fla. Stat. § 381.026 Medical doctors, osteopaths, podiatrists, hospitals, and other health care facilities Maryland Patient Bill of Rights Md. HEALTH-GENERAL Code Ann. § 19-342 Hospitals Massachusetts Patients’ Bill of Rights Annotated Laws of Michigan, ch. 111, § 70E (2005) Hospitals, clinics, nursing homes Mississippi Patients Rights Miss. Code Ann. § 41-21-102 Mental health facilities BOX 4-3 Improving Medication Safety: Actions for Nurses Establish safe work environments for medication preparation, administration, and documentation; for instance, reduce distractions and provide appropriate lighting. Maintain a culture of rigorous commitment to principles of safety in medication administration (for instance, the five rights of medication safety and cross-checks with colleagues, where appropriate). Remove barriers to and facilitate the involvement of patient surrogates in checking the administration and monitoring the effects of medications wherever and whenever they are administered. Foster a commitment to patients’ rights as coproducers of their care. Develop aids for patient (or surrogate) self-management support. Enhance communication skills and team training so as to be prepared and confident in questioning medication orders and evaluating patient responses to drugs. Actively advocate for the development, testing, and safe implementation of electronic health records. Work to improve systems that address the most common near misses in the work environment. Realize they are part of a system and do their part to evaluate the efficacy of new safety systems and technology. Contribute to the development and implementation of error reporting systems, and support a culture that values accurate reporting of medication errors.
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Representative terms from entire chapter: