The use of medications is ubiquitous. In any given week, more than four of five U.S. adults take at least one medication (prescription or over-the-counter [OTC] drug, vitamin/mineral, or herbal supplement), and almost a third take at least five different medications.1 Errors can occur with any of these products at any point in the medication-use process and in any care setting. The frequency of medication errors and preventable medication-related injuries represents a very serious cause for concern.
The Centers for Medicare and Medicaid Services sponsored this study by the Institute of Medicine (IOM) with the aim of developing a national agenda for reducing medication errors based on estimates of the incidence of such errors and evidence on the efficacy of various prevention strategies. The study focused on the safe, effective, and appropriate use of medications in the major components of the medication-use system, addressing the use of prescription drugs, OTC drugs, and complementary and alternative medications, in a wide range of care settings—hospital, long-term, and community.
The committee estimates that on average, a hospital patient is subject to at least one medication error per day, with considerable
variation in error rates across facilities. The few existing studies of the costs associated with medication errors are limited to the health care costs incurred by preventable injuries, and these are substantial.
At least a quarter of all medication-related injuries are preventable. Many efficacious error prevention strategies are available, especially for hospital care; examples are electronic prescribing and clinical decision-support systems that check dosages and monitor for harmful drug–drug interactions. This report provides guidance on how to implement error prevention strategies in hospitals, long-term care, and ambulatory care.
Establishing and maintaining a strong provider–patient partnership is a key approach for reducing medication errors. The report outlines how such a partnership can be achieved and what roles providers, patients, and third parties must play. For example, consumers should maintain careful records of their medications, providers should review a patient’s list of medications at each encounter and at times of transition between care settings (e.g., hospital to outpatient care), and the federal government should seek ways to improve the quality of pharmacy leaflets and medication-related information on the Internet for consumers.
Health care providers in all settings should seek to create high-reliability organizations that constantly improve the safety and quality of medication use. To this end, they should implement active internal monitoring programs so that progress toward improved medication safety can be accurately demonstrated. The report offers guidance on appropriate monitoring systems for each major care setting.
In carrying out this study, the IOM committee identified enormous gaps in the knowledge base with regard to medication errors. Current methods for generating and communicating information about medications are inadequate and contribute to the incidence of errors. Likewise, incidence rates of medication errors in many care settings, the costs of such errors, and the efficacy of prevention strategies are not well understood. The report proposes a research agenda to address these and other knowledge gaps.
The Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System (IOM, 2000) accelerated existing efforts to prevent medication errors and improve the quality of health care, efforts that are just now gaining acceptance as a discipline requiring investment in individuals who specialize in error prevention and quality improvement. Against this background, at the urging of the Senate Finance Committee, the United States
Scope of the Study
Congress, through the Medicare Modernization Act of 2003 (Section 107(c)), mandated the Centers for Medicare and Medicaid Services to sponsor the Institute of Medicine to carry out a study:
Congress directed the Centers for Medicare and Medicaid Services (CMS) to contract with the IOM for a study to formulate a national agenda for reducing medication errors by developing estimates of the incidence of such errors and determining the efficacy of prevention strategies (see Box S-1).
THE LEVEL AND CONSEQUENCES OF MEDICATION ERRORS ARE UNACCEPTABLE
Rates of Errors and Preventable Harmful Events Are High
The frequency of medication errors and preventable adverse drug events (ADEs) (defined in Box S-2) is a very serious cause for concern. In
Error: The failure of a planned action to be completed as intended (error of execution) or the use of a wrong plan to achieve an aim (error of planning). An error may be an act of commission or an act of omission (IOM, 2004).
Medication error: Any error occurring in the medication-use process (Bates et al., 1995a). Examples include wrong dosage prescribed, wrong dosage administered for a prescribed medication, or failure to give (by the provider) or take (by the patient) a medication.
Adverse drug event: Any injury due to medication (Bates et al., 1995b). Examples include a wrong dosage leading to injury (e.g., rash, confusion, or loss of function) or an allergic reaction occurring in a patient not known to be allergic to a given medication.
hospitals, errors are common during all steps of the medication-use process—procuring the drug, prescribing, dispensing, administering, and monitoring the patient’s response. In hospitals, they occur most frequently at the prescribing and administration stages.
Published error rates depend on the intensity and specifics of the error detection methods used. In particular, some methods are better suited to certain stages of the medication-use process. Detection methods addressing all stages but not including direct observation of administration found a rate of 0.1 prescribing errors per patient per day in a study of hospital pediatric units (Kaushal et al., 2001) and a rate of 0.3 prescribing errors per patient per day in a study of hospital medical units (Bates et al., 1995a). A major study using direct observation of administration (Barker et al., 2002) carried out at 36 different health care facilities found an administration error rate of 11 percent, excluding doses administered outside the scheduled time (“wrong-time” errors). Since a hospital patient receives on average at least ten medication doses per day, this figure suggests that on average, a hospital patient is subject to one administration error per day. Further, since prescribing and administration errors account for about three-fourths of medication errors (Leape et al., 1995), the committee conservatively estimates that on average, a hospital patient is subject to at least one medication error per day. Substantial variations in error rates are found, however. For the 36 facilities in the study mentioned above, the administration error rate (excluding wrong-time errors) ranged from 0 to 26 percent, with a median value of 8.3 percent (Barker et al., 2002).
A preventable ADE is a serious type of medication error. ADEs, defined as any injury due to medication (Bates et al., 1995b), are common in
hospitals, nursing homes, and the outpatient setting. ADEs associated with a medication error are considered preventable. The committee estimates that at least 1.5 million preventable ADEs occur each year in the United States:
Hospital care—Classen and colleagues (1997) projected 380,000 preventable ADEs occurring annually, and Bates and colleagues (1995b) 450,000. These are likely underestimates given the higher preventable ADE rate of another study using more comprehensive ADE identification methods (Jha et al., 1998).
Long-term care—Gurwitz and colleagues (2005) projected 800,000 preventable ADEs, again likely an underestimate given the higher ADE rates of other studies.
Ambulatory care—Among outpatient Medicare patients alone, Gurwitz and colleagues (2003) projected 530,000 preventable ADEs. Their approach was conservative, however, because it did not involve direct contact with patients, which yields much higher rates (Gandhi et al., 2003).
The above data exclude errors of omission—failure to prescribe medications for which there is an evidence base for the ability to reduce morbidity and mortality. With respect to such errors, the committee found well-documented evidence of inadequate treatments for acute coronary syndromes, heart failure, chronic coronary disease, and atrial fibrillation, as well as inadequate antibiotic and thrombosis prophylaxis in hospitals.
Morbidity Due to Medication Errors Is Costly
Current understanding of the costs of medication errors is highly incomplete. Most of what is known relates to additional health care costs associated with preventable ADEs, which represent the injuries caused by errors.
For hospital care, there is one estimate of the extra costs of inpatient care for a preventable ADE incurred while in the hospital—$5,857 (Bates et al., 1997). This figure excludes health care costs outside the hospital and was derived from 1993 cost data. Assuming conservatively an annual incidence of 400,000 in-hospital preventable ADEs, each incurring extra hospital costs of $5,857, yields an annual cost of $2.3 billion in 1993 dollars or $3.5 billion in 2006 dollars.
For long-term care, as noted earlier, Gurwitz and colleagues (2005) projected an annual incidence of 800,000 preventable ADEs. However, there is no estimate of the associated health care costs for this group of preventable ADEs.
For ambulatory care, the best estimate derives from a study (Field et al., 2005) that calculateed the annual cost of preventable ADEs for all Medi-
care enrollees aged 65 and older. The cost in 2000 per preventable ADE was estimated at $1,983, while national annual costs were estimated at $887 million.
In addition to the likelihood of underestimation, the above estimates are characterized by some important omissions. First, the costs of some highly common medication errors, such as drug use without a medically valid indication and failure to receive drugs that should have been prescribed, were excluded from the Medicare study of ambulatory ADEs (Field et al., 2005). Moreover, the costs of morbidity and mortality arising from the failure of patients to comply with prescribed medication regimens were not assessed. Second, all the studies omitted some important costs: lost earnings, costs of not being able to carry out household duties (lost household production), and compensation for pain and suffering. Third, few data are available for any setting regarding the costs of medication errors that do not result in harm. While no injury is involved, these errors often create extra work, and the costs involved may be substantial.
Effective Error Prevention Strategies Are Available
According to most studies, at least a quarter of all harmful ADEs are preventable. Moreover, many efficacious error prevention strategies are available, especially for hospital care. In the hospital setting, there is good evidence for the effectiveness of computerized order entry with clinical decision-support systems (Bates et al., 1998), for clinical decision-support systems themselves (Evans et al., 1994), and for pharmacist participation on hospital rounds (Leape et al., 1999). Bar coding and smart intravenous (IV) pumps show promise for the hospital setting, but their efficacy has not yet been clearly demonstrated.
Interventions consisting of educational visits appear to hold promise for improving prescribing practices and patient outcomes in nursing homes. Involving pharmacists in the management of medications in nursing homes and ambulatory care also shows promise, but requires additional study. This intervention has been most successful to date in populations with certain conditions, such as diabetes.
IMPROVED PROVIDER–PATIENT COMMUNICATION IS VITAL
Achieving the patient-centered model of care envisioned in the IOM report Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001) will require a paradigm shift away from a paternalistic, provider-centric model of care. Consumers (and their surrogates) should be empowered as partners in their care, with appropriate communication, information, and resources in place to support them. For medication safety,
consumers and providers (including physicians, nurses, and pharmacists) should know and act on patients’ rights, providers should engage in meaningful communication about the safe and effective use of medications at multiple points in the medication-use process, and government and other participants should improve consumer-oriented written and electronic information resources.
Patient rights are the foundation for the safe and ethical use of medications (see Box S-3). Ignoring these rights can have lethal consequences. Millions of Americans take prescription drugs each year without being fully informed by their providers about associated risks, contraindications, and side effects. When clinically significant medication errors do occur, they usually are not disclosed to patients or their surrogates unless injury or death results.
Many but not all patient rights relating to medical care have been established broadly in the U.S. Constitution (Amendments I and XIV) and articulated by the courts through common law. Certain states have instituted a patient bill of rights relating to particular providers or care settings. One important point not specifically addressed by these laws is the right for a patient to be told when an adverse event occurs. Establishing a comprehensive set of patient rights in one document would facilitate patient and
Patients have the right to:
provider understanding and exercise of these rights and improve the safety and quality of medication use.
Actions for Consumers
For sound medication management, providers and consumers2 should maintain an up-to-date record of medications being administered, including prescription medications, over-the-counter (OTC) drugs, and dietary supplements, as well as all known drug and/or food allergies. Such records are especially important for patients who have chronic conditions, see multiple providers, or take multiple medications.
By becoming more informed and engaged, consumers (and their surrogates) may decrease the probability of experiencing a medication error (Cohen, 2000). Such actions can range from the simple and routine, such as double-checking their prescription when dropping it off and picking it up from the pharmacy, to the more involved, such as forming an active partnership with providers in managing their health care. When using OTC medications, herbal remedies, and dietary supplements, consumers should seek the information they need to make informed decisions. When obtaining medical care, consumers should ask questions and insist on answers from providers to guide their decision making based on their personal values and preferences. They should ensure that their provider explains their medication regimen clearly and speak up if they do not understand. In addition, they should ensure that providers give them written information about their medications, as well as tell them where to obtain information from other sources. Finally, consumers should communicate with their providers if they experience any unexpected changes in the way they feel after initiating a new medication. Some specific actions consumers can take are outlined in Box S-4.
Actions for Providers
Providers can take several specific actions to improve medication safety (see Box S-5). First, they can verify the patient’s current medication list for appropriateness at each encounter, and they can ensure that this list is accurate at times of transition between care settings. They can educate their patients about the medication regimen, understanding that patients need different kinds of information at different times and for different purposes. Providers can also respect patients’ wishes and inform them of
Consumer Actions to Enhance Medication Safety
Ambulatory Care/Outpatient Clinic
Hospital Inpatient (Patient or Surrogate)
Issues for Discussion with Patients by Providers (Physicians, Nurses, and Pharmacists)
their rights, including the right to have a surrogate present and involved in their medication management whenever they are unable to monitor their own medication use.
When communicating about medication errors that occur with the potential for or actual harm, providers can tell patients how the error may affect their health and what is being done to correct it. The vast majority of patients want and expect to be told about errors, particularly those that cause them harm.
Barriers Experienced by Consumers and Providers
In the current system, a number of barriers affect the ability of consumers to engage in safe and effective use of medications and the ability of providers to change their day-to-day practices to support new consumer-oriented activities (Cohen, 2000). These barriers include (1) knowledge deficits, such as patients lacking sufficient education about their medications and providers lacking the latest pharmacological knowledge about particular drugs; (2) practical barriers, such as patients being unable to pay for their medications and providers having to operate burdensome prescribing arrangements required by payers; and (3) attitudinal factors, such as patients and providers having different cultural norms and beliefs about the use of medications. These barriers often result in errors, such as taking the wrong dose, taking a medication at the wrong time, or taking someone else’s medication. Many of these barriers can be overcome by improved consumer-oriented drug information, efforts on the part of providers to respond to the challenges faced by their patients, and actions by health care organizations to adopt a culture of safety and make more extensive use of information technology.
Recommendation 1: To improve the quality and safety of the medication-use process, specific measures should be instituted to strengthen patients’ capacities for sound medication self-management. Specifically:
Patients’ rights regarding safety and quality in health care and medication use should be formalized at the state and/or federal levels and ensured at every point of care.
Patients (or their surrogates) should maintain an active list of all prescription drugs, over-the-counter drugs, and dietary supplements they are taking; the reasons for taking them; and any known drug allergies. Every provider involved in the medication-use process for a patient should have access to this list.
Providers should take definitive action to educate patients (or their surrogates) about the safe and effective use of medications. They should provide information about side effects, contraindications, and how to handle adverse reactions, as well as where to obtain additional objective, high-quality information.
Consultation on their medications should be available to patients at key points in the medication-use process (during clinical decision making in ambulatory and inpatient care, at hospital discharge, and at the pharmacy).
Actions for Government and Other Stakeholders
Consumers should be able to obtain high-quality information about medications not only from their providers, but also from the pharmacy and Internet and community-based resources. However, these resources need significant improvement in two overarching areas.
First, current materials (e.g., pharmacy information sheets [leaflets], Internet-based information) are inadequately designed to facilitate consumers’ ability to read, comprehend, and act on medication information. Pharmacy leaflets are the source of such information most relied upon by consumers. Yet a number of studies have revealed the inadequate quality of these leaflets, as well as their variable quality from one pharmacy to another and from one drug to another (Svarstad and Mount, 2001). Internet-based health information has proliferated over the last decade, providing consumers with immediate access to valuable resources such as medical journals and libraries, but most consumers are unfamiliar with how to access this information since it usually does not figure prominently during online searches. Rather, consumers are directed to a multitude of other sources of information with differing standards for the content provided.
The federal government should develop mechanisms for improving pharmacy leaflets and the quality of Internet information for consumers.
Second, there is a need for additional resources beyond pharmacy leaflets and Internet information that can be provided on a national scale. In particular, a national drug information telephone helpline and community-based health resource centers should be developed to promote consumer education. Further, communication networks already in place, such as those associated with the public health infrastructure (e.g., the Centers for Disease Control and Prevention’s National Center for Health Marketing) and consumer networks should be used for broad dissemination of national medication safety initiatives.
Recommendation 2: Government agencies (i.e., the Agency for Healthcare Research and Quality [AHRQ], the Centers for Medicare and Medicaid Services [CMS], the Food and Drug Administration [FDA], and the National Library of Medicine [NLM]) should enhance the resource base for consumer-oriented drug information and medication self-management support. Such efforts require standardization of pharmacy medication information leaflets, improvement of online medication resources, establishment of a national drug information telephone helpline, the development of personal health records, and the formulation of a national plan for the dissemination of medication safety information.
Pharmacy medication information leaflets should be standardized to a format designed for readability, comprehensibility, and usefulness to consumers. The leaflets should be made available to consumers in a manner that accommodates their individual needs, such as those associated with variations in literacy, language, age, and visual acuity.
The NLM should be designated as the chief agency responsible for Internet health information resources for consumers. Drug information should be provided through a consumers’ version of the DailyMed program, with links to the NLM’s Medline Plus program for general health and additional drug information.
CMS, the FDA, and the NLM, working together, should undertake a full evaluation of various methods for building and funding a national network of drug information helplines.
CMS, the FDA, and the NLM should collaborate to confirm a minimum dataset for personal health records and develop requirements for vendor self-certification of compliance. Vendors should take the initiative to improve the use and functionality of personal health records by incorporating basic tools to support consumers’ medication self-management.
A national plan should be developed for widespread distribution and promotion of medication safety information. Health care provider, community-based, consumer, and government organizations should serve as the foundation for such efforts.
ELECTRONIC PRESCRIBING AND MONITORING FOR ERRORS IN ALL CARE SETTINGS ARE ESSENTIAL
Safe medication use requires that clinicians synthesize several types of information, including knowledge of the medication itself, as well as understanding of how it may interact with coexisting illnesses and medications and how its use might be monitored. Several electronic supports can help providers absorb and apply the necessary information.
Access to Automated Point-of-Care Reference Information
The underlying knowledge base is constantly changing, creating a situation in which it is almost impossible for health care providers to have current knowledge of every medication they prescribe. Clinicians therefore need access to critical syntheses of the evidence base. The Cochrane Collaboration (CC, 2005) is one such resource. In addition, many software applications now being developed provide decision support for prescribing clinicians (Epocrates, 2005). Applications of this type are typically available via the Internet or on personal digital assistants (PDAs). All prescribers should use point-of-care reference information.
Paper-based prescribing is associated with high error rates (Kaushal et al., 2003). Having all pharmacies receive prescriptions electronically would result in fewer errors than occur with current paper or oral approaches (Bates, 2001). Electronic prescribing is safer (Bates et al., 1998) because it eliminates handwriting and ensures that the key fields (for example, drug name, dose, route, and frequency) include meaningful data. More important, as noted above, computerization enables the delivery of clinical decision support (Evans et al., 1998), including checks for allergies, drug–drug interactions, overly high doses, and clinical conditions, as well as suggestions for appropriate dosages given the patient’s level of renal function and age. It should be noted that recent studies have identified implementation problems and the unintended occurrence of new types of errors with these computerized approaches (for example, pharmacy inventory displays of available drug doses being mistaken for the usual or minimally effective doses). Avoiding these problems requires addressing business and cultural
issues before such strategies are implemented and aggressively solving technological problems during the implementation process. Regulatory issues must also be addressed for electronic transmission of prescriptions to be practical.
Effective Use of Well-Designed Technologies
To deliver safe drug care, health care organizations should make effective use of well-designed technologies, which will vary by setting. Although the evidence for this assertion is strongest in the inpatient setting (AHRQ, 2005), the use of technology will undoubtedly lead to major improvements in all settings. In acute care, technologies should target prescribing by including computerized provider order entry with clinical decision support. Administration is also a particularly vulnerable stage in the medication-use process, and several technologies are likely to be especially important in this stage. These include electronic medication administration records, which can improve documentation of what medications have been given and when, as well as machine-readable identification, such as bar coding, and smart IV infusion pumps. All these technologies should be linked electronically.
In nursing homes, computerized prescribing with decision support will likely be important, although there has been little research on its efficacy (Gurwitz et al., 2005). Moreover, implementation of computerized prescribing in this setting will be challenging since most nursing homes have very limited resources.
Some evidence suggests that computerized prescribing will be important in the outpatient setting as well (Gandhi et al., 2003), although it may not yield significant safety benefits without added decision support. Equally important are likely to be approaches that improve communication between patients and providers.
Communication of Patient-Specific Medication-Related Information
The delivery of care often involves moving the locus of care among sites and providers. These “handoffs” are fraught with errors. One strategy for reducing errors during these care transitions is to reconcile medication orders between transition points, especially between care settings such as hospital and outpatient, but also between points within organizations, such as the intensive care unit and a general care unit. This reconciliation involves comparing what a patient is taking in one setting with what is being provided in another to avoid errors of transcription and omission, duplication of therapy, and drug–drug and drug–disease interactions. This process typically reveals many discrepancies (Pronovost et al., 2003).
Reconciliation is facilitated when medication data are transmitted electronically among providers, with confirmation by the patient. Three important steps are required. First, a complete and accurate medication list must be compiled. Second, the data must be structured into components such as the medication name, dose, route, frequency, duration, start date, and so on. Third, these data must be formatted in a way that allows disparate computer systems to understand both their structure and content.
The power of interoperable health care data was demonstrated after the devastation of Hurricane Katrina. Pharmacy chains were able to make patients’ medication lists available quickly to care providers, and states with immunizations registries were able to retrieve immunization records, enabling the enrollment of children in new schools.
Monitoring for Errors
All health care provider groups should seek to be high-reliability organizations preoccupied with the possibility of failure (Reason, 2000). They should implement active internal monitoring programs so that progress toward improved medication safety can be accurately demonstrated. Voluntary internal reporting systems have recognized limitations for evaluating the true frequency of medication errors and ADEs (Flynn et al., 2002). Error detection methods that complement such systems should be used in all care settings. These include computerized detection of ADEs, observation of medication passes in hospitals to assess administration errors, and audits of filled prescriptions in community pharmacies to monitor dispensing errors.
Many external programs exist to which patients and providers can report a medication error or hazardous situation (IOM, 2004). Voluntary practitioner reporting to an external program will continue to be important, as it is often the only way practitioners can effect change outside their organizations. Errors need to be reported and analyzed if improvements in care are to be achieved.
Adopting a Safety Culture
Patient safety can best be achieved through the adoption of a culture of safety—an organizational commitment to continually seeking to improve safety. To achieve a safety culture, senior management of health care organizations must devote sufficient attention to safety, as well as make sufficient resources available for quality improvement and safety teams (IOM, 2004). Senior management must also authorize the investment of resources in technologies that have been demonstrated to be effective but are not yet widely implemented in most organizations, such as computerized provider order entry systems and electronic health records. It has become increas-
ingly clear that the introduction of any of these technologies requires close attention to business processes and ongoing maintenance. As noted above, studies have shown that these tools can have unintended and adverse consequences, and that avoiding these consequences requires addressing both business and cultural issues.
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. 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.
ENORMOUS KNOWLEDGE DEFICITS MUST BE ADDRESSED
Current methods for generating and communicating information about medications are inadequate and contribute to a growing rate of medication errors. Likewise, error incidence rates, costs to the health system, and prevention strategies are not well understood. As a result, there are enormous gaps in the knowledge required to implement a safe medication-use system.
Risk/Benefit Information for Prescription Drugs
Being able to determine whether a medication error has been made depends on knowing the correct dose of the drug for that patient at that time and whether the indication for that drug is correct in comparison with alternative approaches to treatment. Over the past several decades, however, drug evaluations have not been sufficiently comprehensive. As a result, the balance of risk and benefit for a drug frequently is not known for a given population. Such gaps in therapeutic knowledge often result in devastating effects on clinical practice and patient health, as exemplified by adverse events involving hormone replacement therapy, cyclooxygenase-2 (COX-2) inhibitors, and nonsteroidal anti-inflammatory drugs that resulted in increased morbidity and mortality.
These issues are magnified in specific patient populations. For example, the majority of prescriptions written for children are off label—not based on empirical demonstration of safety and efficacy. Among those over age 80, the fastest-growing segment of the population, almost nothing is known about the balance of risks and benefits. Patients with renal dysfunction are another large and growing group for whom more comprehensive studies are needed. And patients with multiple comorbidities are typically excluded from premarketing clinical trials, yet many of the major problems with drug toxicity have occurred in those taking multiple medications because of multiple diseases. Thus the numbers and types of patients for whom clinical outcomes are measured must be greatly increased to elucidate the proper dosing of drugs in individuals and within subgroups.
Of critical concern is the need for transparency through the publication of clinical studies in a national repository to advance medication safety, error prevention, and public knowledge. Such a repository should include postmarket studies. The goal of such studies is to generate new data about a drug’s effects in the population; often, however, these studies place insufficient emphasis on safety information. There is a need for comprehensive redesign and expansion of the mechanisms for undertaking clinical studies to improve understanding of the risks and benefits of drug therapies, prevent errors and ADEs, and meet the health needs of the population.
Communication of Drug Information
How information about a drug is communicated to providers and consumers can directly affect the frequency of medication errors and ADEs (see Box S-6). Drug information is communicated through labeling and packaging, marketing practices, and advertisements. Poorly designed materials and inadequate representation of the risks and benefits to providers and consumers have led to many errors, including inappropriate prescribing;
Drug Naming, Labeling, and Packaging Problems
confusion among products, affecting dispensing and administration; and compromised ability to monitor the effects of drugs adequately.
In particular, drug names that look or sound alike increase the risk of medication errors. Abbreviations, acronyms, certain dose designations, and other symbols used for labeling also have caused errors. Even the layout and presentation of drug information on the drug container or package label can be visually confusing, particularly if it is designed for marketing rather than clinical purposes.
Unit-of-use packaging—containers that provide enough medication for a particular period, such as blister packs containing 30 individually wrapped doses—is not widely employed in the United States but is used extensively elsewhere. This form of packaging brings important safety and usage benefits. The committee believes the expanded implementation of unit-of-use packaging in this country warrants further investigation.
Another issue related to medication safety is the common practice of providers offering free samples of prescription drugs to patients to start them on their medications quickly, to adjust prescribed doses before the full prescription is filled, and to offset medication costs for indigent and underinsured patients. However, there has been growing unease about the way free samples are distributed. In particular, concern exists about the resulting lack of documentation of medication use and the bypassing of standard prescribing and dispensing services, which incorporate drug-interaction checking and pharmacy counseling services. There is a need for resarch on the impact of differing sample distribution methods on medication safety.
Recommendation 4: Enhancing the safety and quality of the medication-use process and reducing errors requires improved methods for labeling drug products and communicating medication information to providers and consumers. For such improve-
ments to occur, materials should be designed according to designated standards to meet the needs of the end user. Industry, AHRQ, the FDA, and others as appropriate (e.g., U.S. Pharmacopeia, Institute for Safe Medication Practices) should work together to undertake the following actions to address labeling, packaging, and the distribution of free samples:
The FDA should develop two guidance documents for industry: one for drug naming and another for labeling and packaging. The FDA and industry should collaborate to develop (1) a common drug nomenclature that standardizes abbreviations, acronyms, and terms to the extent possible, and (2) methods of applying failure modes and effects analysis to labeling and packaging.
Additional study of optimum designs for all drug labeling and information sheets to reflect human and cognitive factors should be undertaken. Methods for testing and measuring the effects of these materials on providers and consumers should also be established, including methods for field testing of the materials. The FDA, the NLM, and industry should work with consumer and patient safety organizations to improve the nomenclature used in consumer materials.
The FDA, the pharmaceutical industry, and other stakeholders should collaborate to develop a strategy for expanding unit-of-use packaging for consumers to new therapeutic areas. Studies should be undertaken to evaluate different unit-of-use packaging and design approaches that will best support various consumer groups in their medication self-management.
AHRQ should fund studies to evaluate the impact of free samples on overall patient safety, provider prescribing practices, and consumer behavior (e.g., adherence to the medication regimen), as well as alternative methods of distribution that can improve safety, quality, and effectiveness.
Health Information Technology
Realization of the full benefits of many health information technologies (such as decision-support systems, smart IV pumps, bar code administration systems, and pharmacy database systems) is hampered by the lack of common data standards for system integration and well-designed interfaces for end users.
Problems with data standards for drug information are threefold. First, there is no complete, standardized set of terms, concepts, and codes to represent drug information. Second, there is no standardized method for
presenting safety alerts according to severity and/or clinical importance. Instead, providers are sometimes inundated with too many alerts, which can result in “alert fatigue.” Third, many systems lack intelligent mechanisms for relating patient-specific data to allowable overrides, such as those associated with a particular patient and drug allergy alert or duplicate therapy request.
The ability of clinicians to use health information technologies successfully depends on how well the technologies have been designed at the level of human-machine interaction (i.e., the user interface). Displaying information in a cluttered, illogical, or confusing manner leads to decreased user performance and satisfaction. Moreover, a poorly designed user interface can contribute to medication errors. Addressing user interface issues requires greater attention to the cognitive and social factors influencing clinicians in their daily workflow and interaction with technologies (van Bemmel and Musen, 1997).
Recommendation 5: Industry and government should collaborate to establish standards affecting drug-related health information technologies. Specifically:
The NLM should take the lead in developing a common drug nomenclature for use in all clinical information technology systems, based on standards for the national health information infrastructure.
AHRQ should take the lead in organizing mechanisms for safety alerts according to severity, frequency, and clinical importance to improve clinical value and acceptance.
AHRQ should take the lead in developing intelligent prompting mechanisms specific to a patient’s unique characteristics and needs; provider prescribing, ordering, and error patterns; and evidence-based best-practice guidelines.
AHRQ should take the lead in developing user interface designs based on the principles of cognitive and human factors and the context of the clinical environment.
AHRQ should support additional research to determine specifications for alert mechanisms and intelligent prompting, as well as optimum designs for user interfaces.
Research on Medication Errors: Incidence Rates, Costs, and Prevention Strategies
In reviewing the research literature, the committee concluded that large gaps exist in our understanding of medication error incidence rates, costs,
and prevention strategies. The committee believes the nation should invest about $100 million annually in the research proposed below.
The primary focus of research on medication errors in the next decade should be prevention strategies, recognizing that to plan an error prevention study, it is essential to be able to measure the baseline rate of errors. Evidence on the efficacy of prevention strategies for improving medication safety is badly needed in a number of settings, including care transitions, ambulatory care (particularly home care, self-care, and medication use in schools), pediatric care, psychiatric care, and the use of OTC and complementary and alternative medications. For hospitals, key areas are further investigation of some prevention strategies (particularly bar coding and smart IV pumps) and how to integrate electronic health records with computerized provider order entry, clinical decision support, bar coding, and smart IV pumps.
Overall, most data on medication error incidence rates come from the inpatient setting, but the magnitude of the problem is likely to be greater outside the hospital. Areas of priority for research on medication error and ADE incidence rates are care transitions, specialty ambulatory clinics, psychiatric care, the administering of medications in schools, and the use of OTC and complementary and alternative medications. Much more research is needed as well on the patient’s role in the prevention of errors, specifically, what systems provide the most cost-effective support for safe and effective medication self-management or for surrogate participation in medication use when a patient is unable to self-manage.
Most studies of the costs of medication errors relate to hospitals, and some report data more than 10 years old (Bates et al., 1997). A better understanding of the costs and consequences of medication errors in all care settings is needed to help inform decisions about investing in medication error prevention strategies.
Recommendation 6: AHRQ should take the lead, working with other government agencies such as CMS, the FDA, and the NLM, in coordinating a broad research agenda on the safe and appropriate use of medications across all care settings, and Congress should allocate the funds necessary to carry out this agenda. This agenda should encompass research methodologies, incidence rates by type and severity, costs of medication errors, reporting systems, and in particular, further testing of error prevention strategies.
OVERSIGHT, REGULATION, AND PAYMENT
Improving medication safety will require key changes in oversight, regulation, and payment. Accordingly, the following recommendation is addressed to the stakeholders that shape the environment in which care is
delivered, including legislators, regulators, accreditors, payers, and patient safety organizations.3
Recommendation 7: Oversight and regulatory organizations and payers should use legislation, regulation, accreditation, and payment mechanisms and the media to motivate the adoption of practices and technologies that can reduce medication errors, as well as to ensure that professionals have the competencies required to deliver medications safely.
Payers and purchasers should continue to motivate improvement in the medication-use process through explicit financial incentives.
CMS should evaluate a variety of strategies for delivering medication therapy management.
Regulators, accreditors, and legislators should set minimum functionality standards for error prevention technologies.
States should enact legislation consistent with and complementary to the Medicare Modernization Act’s electronic prescribing provisions and remove existing barriers to such prescribing.
All state boards of pharmacy should undertake quality improvement initiatives related to community pharmacy practice.
Medication error reporting should be promoted more aggressively by all stakeholders (with a single national taxonomy used for data storage and analysis).
Accreditation bodies responsible for the oversight of professional education should require more training in improving medication management practices and clinical pharmacology.
The American people expect safe medication care. In this report, the committee proposes an ambitious agenda for making the use of medications safer. This agenda requires that all stakeholders—patients, care providers, payers, industry, and government, working together—commit to preventing medication errors. Given that a large proportion of injurious drug events are preventable, this proposed agenda should deliver early and measurable benefits.
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