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Preventing Medication Errors 5 Action Agenda for Health Care Organizations CHAPTER SUMMARY Health care providers need to develop safer medication-use systems. This chapter presents the committee’s recommendation for systemic changes in three settings—inpatient, nursing home, and outpatient—and in care transitions. Recognizing that systemic change takes time, the committee proposes ways in which individual physicians, pharmacists, and nurses can improve medication safety in the short term. In addition, health care providers must acknowledge that the work of making medication use safer is never finished. Thus the chapter provides guidance on ways to monitor for medication errors. This chapter presents the committee’s recommendation for systemic changes aimed at improving the safety of medication use. These recommendations are directed at providers in three settings—inpatient, nursing home, and outpatient—as well as in care transitions, which can be especially problematic with respect to the risk of medication errors. In formulating its recommendations, the committee bore in mind the diversity of each of these settings; for example, the outpatient setting encompasses ambulatory care, home care, community pharmacies, care in schools, and assisted living. Overall, the committee believes patients should be involved in their medication-related care in all settings, with the extent of their autonomy being determined by their preferences and capacity. The committee’s recommendation is intended to apply to all of the
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Preventing Medication Errors above settings, although the way it is implemented will vary by setting, as will the medication-use systems and the errors and adverse drug events (ADEs) that may occur. In the inpatient setting, for example, major safety issues include medication selection and administration (Bates et al., 1995a). By contrast, in nursing homes and the outpatient setting, monitoring is especially important (Gandhi et al., 2003; Gurwitz et al., 2000, 2003). In all settings, access to patient-specific and reference information is central to delivering safe medication-related care. Actions identified by the committee that can be taken to improve medication safety by individual prescribers are summarized in Box 5-1, by individual pharmacists in Box 5-2, and by individual nurses in Box 5-3. The committee’s recommendation for systemic changes across health care settings is then presented. The remainder of the chapter provides a detailed discussion of the specifics of this recommendation. Many of the actions for providers listed in Boxes 5-1 to 5-3 are recommended by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Quality Forum (NQF). Since 2003, JCAHO has set annual National Patient Safety Goals (JCAHO, 2005) and included a survey of compliance with the requirements as part of the accreditation process. Many of the National Patient Safety Goals relate to medications (see Box 5-4). The Agency for Healthcare Research and Quality (AHRQ) requested that the NQF use an expert consensus process to define a list of best safety practices. The resulting NQF report, Safe Practices for Better Healthcare, listed 30 practices that should be universally adopted in applicable care settings, 13 of which involve the use of medications (see Box 5-5), and another 27 practices (15 of which are medication-related) that should receive high priority for additional research (NQF, 2003). A number of additional key points should be emphasized. First, having a safety culture is pivotal to improving medication safety. To institute a safety culture, senior management must devote adequate attention to safety and provide sufficient resources to quality improvement and safety teams. Senior management must also authorize resources to invest in technologies that have been demonstrated to be effective but are not yet widely implemented in most organizations, such as computerized provider order entry (CPOE) and electronic health records. It has become increasingly clear that the introduction of any of these technologies requires close attention to business processes and ongoing maintenance. A number of studies have shown that these tools can have unintended and adverse consequences, and that avoiding such consequences requires addressing business and cultural issues. Improvements in the safe use of medications need to be implemented within the context of an overall quality improvement program, specifically
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Preventing Medication Errors BOX 5-1 Improving Medication Safety: Actions for Prescribers Reconcile medications at transition points, e.g., admission, discharge, transfer. (All) Make routine the reconciliation of medication changes with the pharmacy record. (NH/AL, Out) Avoid verbal orders except in urgent situations and emergencies. (In) Be aware of other medications the patient is taking when prescribing. (NH/AL) Keep an accurate medication list (including over-the-counter and complementary and alternative medications). (Out) Ask patients to bring their medications in periodically. (Out) Ask about allergies when prescribing a new medication. (Out) Inform the patient of indications for all medications. (Out) Ask regularly whether patients are taking their medications, including as-needed drugs, as nonadherence may signal issues other than knowledge deficits, practical barriers, or attitudinal factors. (Out) Ask the primary pharmacy about the patient’s refill history. (Out) Consider that new complaints may represent side effects of medications. (NH/AL) Explain common or significant side effects when prescribing. (Out) Ask regularly about side effects or adverse drug events (ADEs). (All) Prescribe electronically when possible. (All) Use readback with verbal orders when feasible. (All) Avoid abbreviations. (All) Include patient age and weight when applicable. (All) Work as a team with pharmacists and nurses. (In) Work as a team with consultant pharmacists and nurses. (NH/AL) Work as team with the primary pharmacist and nurses. (Out) Adhere to Class I clinical indications and guidelines. (All) Use special caution with high-risk medications (All), especially warfarin. (NH/AL) Exercise particular caution in high-risk situations—when stressed, sleep-deprived, angry, or supervising inexperienced personnel. (All) Consult electronic or other reference sources for questions. (All) Report errors and ADEs. (All) Include medications when transferring patients between providers. (In) Standardize and improve transfers between covering physicians and other providers. (NH/AL) Standardize communication about prescriptions within the practice; standardize and improve handoffs to the primary pharmacist. (Out) Actively monitor the patient for response to medication therapy, and use validated instruments when possible. (Out) Minimize the use of free samples; when dispensing free samples, apply standards similar to those a pharmacy would use. (Out) NOTE: All = all prescribers; In = inpatient prescriber; NH/AL = nursing home/assisted living prescriber; Out = outpatient prescriber.
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Preventing Medication Errors BOX 5-2 Improving Medication Safety: Actions for Individual Pharmacists Monitor the medication safety literature and other resources regularly for information related to medication errors, and take action to ensure that similar errors will be avoided in the local practice setting. (Amb and Hosp) Develop, implement, and follow a medication error avoidance plan. (Amb) As part of this plan, establish a routine procedure for double-checking filled prescriptions waiting to be picked up and verifying the accurate entry of data on new prescriptions into computer systems. (Amb) Monitor error frequencies, and correct system problems associated with errors. (Amb and Hosp) Use the show-and-tell counseling method to detect and correct dispensing errors; this should include verification of patient identity. (Amb) Educate consumers regarding error prevention techniques and resources (e.g., websites such as http://www.ismp.org, http://www.safemedication.com, and http://www.ahrq.gov). (Amb) Pharmacy managers designate a medication safety officer with responsibility for improving the safety of prescription filling processes. (Amb) Advocate for a medication safety officer with responsibility for improving medication safety throughout the hospital. (Hosp) Create a safe work environment by optimizing lighting levels, using a magnifying lens or resizable scanned prescription for viewing prescription slips, minimizing distractions, and arranging drug storage areas to call attention to drugs with a high potential for errors leading to patient harm. (Amb) Create a safe work environment by optimizing lighting levels and minimizing distractions and interruptions. (Hosp) Advocate for a statewide medication safety coalition, to include the state board of pharmacy, pharmacy organizations, practitioners, and consumers. (Amb and Hosp) Report errors and near misses to both internal and external medication error reporting programs or systems to help others learn how to avoid similar problems. (Amb and Hosp) Request resources needed to promote accurate prescription dispensing (clinical decision support, bar code verification technology, time for counseling patients). (Amb) Be assertive in requesting resources needed to promote accurate medication processing and dispensing (clinical decision support, bar code verification technology). (Hosp) Actively pursue a tiered system of clinical alerts that can facilitate better response to serious medication safety issues (e.g., suppress trivial warnings and retain those with a high probability of patient risk). (Amb and Hosp) Evaluate and continuously monitor new technologies (e.g., automated prescription filling machines) regarding the risk of introducing medication errors. (Amb) Evaluate and continuously monitor new technologies (e.g., infusion pumps, automated medication dispensing machines) regarding the risk of introducing medication errors. (Hosp)
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Preventing Medication Errors Regularly make targeted follow-up calls to patients (e.g., those with asthma, chronic pain, hypertension) to assess how they are faring with new medications, learn about any side effects or potential ADEs, and ensure that medications are being taken properly. (Amb) Work with nurses to make regular targeted follow-up calls to discharged patients (e.g., those with asthma, chronic pain, hypertension) or use mailed questionnaires to assess how these patients are faring with prescribed medications, learn about any side effects or potential ADEs, ensure that medications are being taken properly, and answer any questions patients may have. NOTE: Amb = ambulatory care pharmacist; Hosp = hospital pharmacist. BOX 5-3 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 crosschecks 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. Actively participate in or lead evaluations of 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. BOX 5-4 National Patient Safety Goals of the Joint Commission on Accreditation of Healthcare Organizations Relating to Medication Use Goal 1: Improve the accuracy of patient identification 1A. Use at least two patient identifiers (neither to be the patient’s room number) whenever administering medications or blood products, taking blood samples
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Preventing Medication Errors and other specimens for clinical testing, or providing any other treatments or procedures. 1B. Prior to the start of any invasive procedure, conduct a final verification process to confirm the correct patient, procedure, site, and availability of appropriate documents. This verification process uses active—not passive—communication techniques. Goal 2: Improve the effectiveness of communication among caregivers 2A. For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the order or test result “read-back” the complete order or test result. 2B. Standardize a list of abbreviations, acronyms, and symbols that are not to be used throughout the organization. 2C. Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values. 2E. Implement a standardized approach to “hand off” communications, including an opportunity to ask and respond to questions. Goal 3: Improve the safety of using medications 3B. Standardize and limit the number of drug concentrations available in the organization. 3C. Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs. 3D. Label all medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions on and off the sterile field in perioperative and other procedural settings. Goal 8: Accurately and completely reconcile medications across the continuum of care 8A. Implement a process for obtaining and documenting a complete list of the patient’s current medications upon the patient’s admission to the organization and with the involvement of the patient. This process includes a comparison of the medications the organization provides to those on the list. 8B. A complete list of the patient’s medications is communicated to the next provider of service when it refers or transfers a patient to another setting, service, practitioner or level of care within or outside the organization. Goal 13: Encourage the active involvement of patients and their families in the patient’s care as a patient safety strategy Define and communicate the means for patients to report concerns about safety and encourage them to do so. SOURCE: JCAHO, 2005.
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Preventing Medication Errors BOX 5-5 The National Quality Forum’s Safe Practices for Better Health Care Among the 30 safe practices identified by the NQF consensus report, the following 13 relate to medication use: 1. Create a health care culture of safety. 3. Specify an explicit protocol to be used to ensure an adequate level of nursing based on the institution’s usual patient mix and the experience and training of its nursing staff. 5. Pharmacists should actively participate in the medication-use process, including at a minimum, being available for consultation with prescribers on medication ordering, interpretation and review of medication orders, preparation of medications, dispensing of medications, and administration and monitoring of medications. 6. Verbal orders should be recorded whenever possible and read back to the prescriber—i.e., a health care provider receiving a verbal order should read or repeat back the information that the prescriber conveys in order to verify the accuracy of what was heard. 7. Use only standardized abbreviations and dose designations. 8. Patient care summaries or other similar records should not be prepared from memory. 9. Ensure that care information, especially changes in orders and new diagnostic information, is transmitted in a timely and clearly understandable form to all of the patient’s current health care providers who need that information to provide care. 12. Implement a computerized prescriber order entry system. 25. Decontaminate hands with either a hygienic hand rub or by washing with disinfectant soap prior to and after direct contact with the patient or objects immediately around the patient. 27. Keep workspaces where medications are prepared clean, orderly, well lit, and free of clutter, distraction, and noise. 28. Standardize the methods for labeling, packaging, and storing medications. 29. Identify all “high alert” drugs (e.g., intravenous adrenergic agonists and antagonists, chemotherapy agents, anticoagulants and antithrombotics, concentrated parenteral electrolytes, general anesthetics, neuromuscular blockers, insulin and oral hypoglycemics, narcotics and opiates. 30. Dispense medications in unit-dose or, when appropriate, unit-of-use form, whenever possible. SOURCE: NQF, 2003. within the clinical unit—a small group of clinicians and staff working together with a shared clinical purpose to provide care for a defined set of patients (Mohr and Batalden, 2002). Research on highly effective clinical units has indicated that they share a number of characteristics (Mohr and Batalden, 2002). Such units (1) integrate information within the care deliv-
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Preventing Medication Errors ery process (often with technology playing a key role); (2) monitor processes and outcomes routinely to assess the quality of care delivered; (3) provide care through multidisciplinary teams sharing information among providers and patients; (4) make resources available for quality improvement, including staff training; and (5) work within a larger management environment that is supportive of quality improvement. The application of these ideas at LDS Hospital, Salt Lake City, Utah, led to reduced ADE rates and postoperative deep wound and organ space infection rates (IOM, 2004). Similarly, application of these principles in intensive care units (ICUs) has led to reductions in medication errors in patient transfer orders using medication reconciliation (Pronovost et al., 2003a) and to reduced ICU lengths of stay using a one-page daily goals form to improve the effectiveness of communication among the care team (Pronovost et al., 2003b). The committee also believes that all organizations in all settings need to monitor rates of medication errors and ADEs more effectively. Most organizations have focused solely on spontaneous reporting, which is necessary but not sufficient. While spontaneous reporting has and will continue to produce highly valuable information, especially at the regional and national levels, internal improvement at the organizational level requires ongoing measurement of meaningful rates. Observation is valuable for assessing administration. In addition, it will increasingly be possible to detect errors and ADEs through computerized monitoring, and such monitoring produces much more reliable information about rates of errors and ADEs in the patient population than does spontaneous reporting. Recommendation 3: All health care organizations should immediately make complete patient-information and decision-support tools available to clinicians and patients. Health care systems should capture information on medication safety and use this information to improve the safety of their care delivery systems. Health care organizations should implement the appropriate systems to enable providers to: Have access to comprehensive reference information concerning medications and related health data. Communicate patient-specific medication-related information in an interoperable format. Assess the safety of medication use through active monitoring and use these monitoring data to inform the implementation of prevention strategies. Write prescriptions electronically by 2010. Also by 2010, all pharmacies should be able to receive prescriptions electronically.
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Preventing Medication Errors By 2008, all prescribers should have plans in place to implement electronic prescribing. Subject prescriptions to evidence-based, current clinical decision support. Have the appropriate competencies for each step of the medication-use process. Make effective use of well-designed technologies, which will vary by setting. ACCESS TO POINT-OF-CARE REFERENCE INFORMATION Providers should have access to comprehensive reference information concerning medications and related health data. A number of studies have examined the information needs of practicing clinicians (Covell et al., 1985; Gorman, 1995; Gorman and Helfand, 1995; Ely et al., 1999, 2005; Shablinsky et al., 1999). These studies have found that patient care generates a large number of clinical questions, regardless of the provider’s specialty. Covell and colleagues (1985) found that internal medicine physicians, both generalists and primary care, generated approximately two clinical questions for every three patients seen. Gorman (1995) found that physicians asked slightly over one question per two patients (Gorman, 1995), while Barrie and Ward (1997) found they asked just over one question per five patients. Much less is known about the information needs of providers other than physicians, but it is reasonable to assume that nurses, pharmacists, and others have frequent needs for clinical information. It should be noted that research indicates nurses prefer to gain knowledge from personal experience and interactions with coworkers and patients rather than from journal articles, textbooks, or research resources (Thompson et al., 2001; Estabrooks et al., 2005). Most investigators have found that the majority of the questions raised by clinicians during patient care go unanswered1 (Covell et al., 1985; Gorman, 1995; Ely et al., 1999). Moreover, when clinicians do seek further information, they spend, on average, only 2 minutes doing so. By contrast, one study found that trained librarians took an average of more than 10 minutes to find answers to well-formulated clinical questions all focused on a single illness (Giuse et al., 1994). The clinical impacts of the decision not 1 Examples related to medications are: “This patient is already on a maximal dose of the most potent statin. Which secondary drug—niacin, ezetimibe, or a fibrate—has the greatest impact on stroke and myocardial infarction?” and “This patient is not doing well on valproic acid for controlling bipolar symptoms. Would it be better to add an atypical antipsychotic or switch to another primary medication?”
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Preventing Medication Errors to seek further information have not been rigorously evaluated, though it is reasonable to assume that such impacts do occur. Remaining current, even in highly focused areas, has become extremely difficult for clinicians (Giuse et al., 1994). Thirty years ago, it was estimated that there were 1 million facts in the core body of general knowledge in internal medicine (Pauker et al., 1976). This number has likely increased significantly since that time. Nonetheless, most clinicians still rely primarily on memory and clinical experience. Despite the widespread availability of data through the World Wide Web, little improvement in knowledge management has been documented over the past decade (Covell et al., 1985; Gorman, 1995; Ely et al., 2005). Even when clinicians have access to electronic databases, the process of seeking information from these sources is typically so time-consuming as to be impractical in many patient care settings (Alper et al., 2001). With the continuing expansion of medical information, this situation is unlikely to improve without new approaches to knowledge management (Smith, 1996). The decision to initiate a clinical intervention requires the synthesis of a wide array of data, resulting at a minimum in a probable diagnosis and logical therapeutic options. Medications are the most common options offered (Woodwell and Cherry, 2004). The continuing availability of new pharmacotherapeutic options creates an ongoing need for new knowledge to ensure safe prescribing. Appropriate and safe pharmacotherapy demands not only knowledge of the medication itself, but also appropriate decision making prior to the start of therapy, an understanding of how the medication may interact with coexisting illnesses and medications, and knowledge of requirements for monitoring for success and side effects. Dealing with all these variables requires an extraordinary degree of information synthesis (Smith, 1996). Not surprisingly, then, practicing clinicians indicate a need for highly synthesized and abridged information (Grandage et al., 2002). Access to the Clinical Knowledge Base Given that the knowledge base and decision processes are often unique to a particular care setting, clinicians require knowledge gathered from studies conducted in appropriate settings with appropriate patient populations and in a particular stage of the care process (Oxman et al., 1993). The concept of just-in-time information, a given in many businesses, has developed in medicine over the past decade in response to this challenge (Ebell, 1999; Ely, 2001). Practicing clinicians also require information that has been critically analyzed, typically combining the results of a number of studies and presented in clinically relevant form (Smith, 1996; Grandage et al., 2002). The past two decades have seen a shift from teaching individual clinicians how to evaluate the medical literature (Oxman et al., 1993) to
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Preventing Medication Errors answering clinical questions through larger, organized approaches, best exemplified by the Cochrane Collaboration (The Cochrane Library, 2004), national task forces on prevention (CTFPHC, 2005; DHHS, 2005), and the Family Physicians Inquiries Network (FPIN, 2005), as well as numerous commercial endeavors. Most of these approaches are focused on interpretation and analysis of the medical literature; far fewer focus as well on the ability to search for and deliver the knowledge in a rapid and reproducible fashion. Yet both of these aspects of the process are critical if improved care and safety are to be realized. There are two methods of delivering information to practicing clinicians—the passive lookup of information and the proactive interactive search for information. The Cochrane Collaborative is an example of a passive lookup information source. The collaborative has established a quality standard for creating critically reviewed clinical answers. The reviews are available through several channels, including the Internet, local intranets, and programs available on handheld devices (CC, 2005). A number of organizations are now designing ways to produce answers for busy clinicians (Epocrates, 2005; FPIN, 2005; JFP, 2005), including databases with tags for rapid searches and multiple delivery methods. Applications of this type are typically available in both web versions and versions that can be run on personal digital assistants (PDAs) (Ebell et al., 2002; Beattie, 2003; Lu et al., 2003; Barrett et al., 2004; Taylor, 2005). The current lack of Internet access from the bedside or examination room of most care locations in the United States has helped fuel PDA-based approaches to clinical information management (Rothschild et al., 2002). The rapid growth of PDA computing capabilities has spurred major advances in health information programs (Galt et al., 2005). The ability to update information daily, offer robust search capabilities, and imbed clinical algorithms in these programs enhances their utility for clinicians who are facile and regular users. Nonetheless, the stand-alone nature of these systems renders them but an intermediate step in the quest for robust knowledge management systems for health care providers. Even with the enhanced compilation of clinical information and the improved databases and search engines of current knowledge management systems, applications that require the active engagement of a clinician will not be used as often as they should be. Full clinical decision support requires systems that support hyperlinks from data within an electronic health record (EHR) to information repositories (Kamel Boulos et al., 2002; Maviglia et al., 2005). Existing systems provide primarily links to static data, such as greater information on a laboratory test or drug monograph information. With improved capabilities for structured data capture, EHRs could facilitate the review of diagnostic features and testing, as well as choices among therapeutic options during patient care, through embedded
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Preventing Medication Errors Certification Commission on Health Information Technology, which will be certifying electronic prescribing applications if they are part of EHRs. It is also useful to pilot the CPOE in a limited setting prior to full implementation to identify and rectify any problems. During the implementation period, it is best to include as many order sets as possible at the outset and to provide intensive support to all users so that any problems can be rapidly addressed. After implementation, use of the CPOE system must undergo a continuous quality improvement process (Bates, 2005) with frequent evaluation to determine whether the system is functioning as intended, and new errors that are introduced must be tracked and addressed. The clinical processes involved are complex. Errors and problems will continue to occur. Sufficient resources must be available to analyze problems and implement process improvements. Several models of successful quality improvement in clinical units have been documented (IOM, 2004; Batalden et al., 2003; Pronovost et al., 2002). The above practices apply for any clinical decision support system as well. Care Transitions Data increasingly suggest that care transitions are associated with high levels of risk (Forster et al., 2003), especially for ADEs (Forster et al., 2005). Many of these ADEs are due in part to the changes in medication that are made at the time of admission or discharge. Thorough reconciliation of medications is crucial in these situations (Rozich et al., 2004), but difficult to achieve. Technology can assist in this process. In addition, outreach to patients who have recently been discharged will likely be necessary, and it appears likely that technology such as telemedicine and personal health records can be used to leverage this outreach. Conclusions In the future, it is inevitable that technologies will serve as increasingly important tools for improving medication safety in all settings, though the specific technologies involved will differ by setting. For inpatients, the core challenge appears to be accurately delivering the appropriate and intended medications. Outside the hospital, improving the safety and efficacy of prescribing is essential, together with improving monitoring and communication. In all settings, safety culture is pivotal, and there are many things that individual providers can do to that end, though achieving high levels of safety will demand that providers have tools appropriate for their setting. These tools must be implemented well, and all carry the potential for unintended consequences.
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