Applied Research Agenda for Safe Medication Use
In this chapter, the committee proposes an applied research agenda for the safe use of medications across all care settings. This agenda, based on gaps in the medication error knowledge base, encompasses research methodologies, incidence rates, costs of medication errors, reporting systems, and testing of error prevention strategies.
In developing the recommendations presented in this chapter, the committee reviewed the literature on the incidence and costs of medication errors and on error prevention strategies. From this review, the committee identified important methodological issues and gaps in the medication error knowledge base. Overall, the committee believes the emphasis of research on safe medication use should gradually shift away from incidence rates, the current focus, to error prevention strategies. The committee believes the nation should invest about $100 million in research addressing medication safety, starting at $50 million per year.
Recommendation 6: The Agency for Healthcare Research and Quality (AHRQ) should take the lead, working with other government agencies such as the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Library of Medicine (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.
Researchers use a variety of definitions for medication errors, near misses, and adverse drug events (ADEs). There is a clear need to standardize terminology and measures for these phenomena if the field is going to advance.
Much of the literature reviewed by the committee failed to specify in sufficient detail the definition of a medication error used in the study. When detail was given, the definitions varied widely. Studies of medication errors in pediatric populations illustrate the problem: in one study, the definition of a medication dosing error was any dose greater than 10 percent over the recommended dose, while in another study, the definition was any dose greater than 10 times the recommended dose. In another set of studies examining the entire medication delivery system, some research teams did not include as errors events that were detected before they reached the patient, whereas other researchers counted these events as errors. As another example, some studies counted an order that was lacking a prescriber’s signature as a medication error; although this is clearly an error, the potential for harm to patients is substantially different from that resulting from orders with dosage errors. If the definitions of medication errors and their subtypes are not standardized, and outcome data are not collected in a manner that permits assessment of the potential for harm, it is difficult to compare incidence rates across studies and to identify areas of high priority for intervention. The existing variations also result in a broad range of reported frequency and severity of errors.
To address this issue, the committee recommends that an international consensus conference be held to define the terms medication error, near miss, and ADE, as well as the subtypes of these terms, and to identify the practical applications of these definitions in various care settings. This conference could be similar to a session organized by the American College of Chest Physicians/Society of Critical Care Medicine in August 1991 to agree on a set of definitions that could be applied to patients with sepsis and its sequelae (Bone et al., 1992). The definitions introduced as a result of this conference have been widely used in practice and have served as the foundation for inclusion criteria for many clinical trials of therapeutic interventions (Levy et al., 2003). This uniform set of definitions has also made it
much easier to compare results from different sepsis studies and to better understand the various syndromes.
ROLE OF THE PATIENT AND FAMILY
The public at large needs to develop a healthy respect for the risks as well as the benefits of medications. For example, one study revealed that patient-level errors are associated with about 20 percent of ADEs in the ambulatory setting among the elderly (Gurwitz et al., 2003). Engaging the patient as an active participant in decisions about and monitoring of medication use is critically important. Thus the committee recommends pursuit of a research agenda aimed at delineating effective strategies for involving patients and their families in the prevention, early detection, and mitigation of harm due to medication errors (IOM, 2004), with particular focus on the following topics:
Determining how best to present information to patients to facilitate their understanding of medication use and safety, including the development of a consumer-friendly nomenclature for representing this information.
Developing improved systems for supporting patients in identifying and eliminating barriers to following the prescribed medication regimen, or in seeking advice before altering the regimen in response to drug side effects or barriers to administration.
Developing improved systems for supporting surrogates’ roles in safe medication use when patients are receiving medications from professionals and are unable (too ill, disabled, or cognitively impaired) to monitor the administration of or their response to the drugs.
Developing standard approaches to the maintenance of personal medication lists and investigating the effects of these lists on the effectiveness of safety strategies, such as medication reconciliation.
Developing strategies to inform ambulatory patients of clinically significant abnormal test results, including the use of computerized patient notification of such results.
Exploring the effectiveness of patient self-monitoring devices, such as home finger-stick devices and nomograms to self-adjust wafarin dosages.
The committee believes medication self-management can be enhanced with tools available through personal health records. In this regard, 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 consumer-oriented information tech-
nologies by incorporating basic information tools for consumers’ medication self-management.
MEDICATION SAFETY RESEARCH: INCIDENCE, COSTS, AND PREVENTION STRATEGIES
The committee examined the literature on incidence rates of medication errors. Despite the considerable research on incidence that has already taken place in certain areas, the committee believes much more such research needs to be carried out. In particular, it is important to characterize incidence rates by type and severity. Incidence rates are important for gauging the scope of the problem, for setting priorities for prevention strategies, and for measuring the impact of such strategies. The types of research required are described below for the hospital, nursing home, and ambulatory care settings; for pediatric and psychiatric care; and for the use of over-the-counter (OTC) and complementary and alternative medications.
Medication error rates in hospitals have been relatively well researched. Thus the committee believes measurement of error rates in this care setting, with the exception of rates for specific populations (pediatric and psychiatric patients; see below), is not a priority for research. As indicated in Chapter 5, methods for detecting errors and ADEs can increasingly be built into electronic health records and other information systems, enabling better estimation of incidence rates for some types of errors and ADEs on an ongoing basis. Furthermore, these systems may be able to identify ADEs early enough in many situations to mitigate harm. However, research aimed at improving and standardizing these methods is a high priority.
Nursing Home Care
The long-term care arena is in need of a broad research agenda, including incidence data and the characterization of high-risk errors. There are more than 1.6 million residents of nursing homes in the United States. Levels of medication use are particularly high in these facilities, and patients are at particular risk for ADEs (Gurwitz et al., 2000, 2005). Recent studies have not focused specifically on medication errors, but have indicated that as many as half of all ADEs in the nursing home setting may be preventable. Nursing home residents taking antipsychotic medications,
anticoagulants, and diuretics are at greatest risk for experiencing a preventable ADE. Nursing home residents may also be especially vulnerable to medication errors as they move between different settings of care, such as from the ambulatory setting to the nursing home, and back and forth to the hospital during episodes of acute illness.
In the ambulatory setting, the best-understood aspects of medication error rates are prescribing errors in ambulatory primary care clinics and dispensing errors in community pharmacies. There is some understanding of the incidence of ADEs in ambulatory care and self-care errors. There is limited understanding of incidence rates in care transition situations, medication administration and monitoring in ambulatory care, mail order pharmacy, and school care (Forster et al., 2003). Little information exists as well concerning medication errors associated with prescribing in ambulatory specialty clinics. Specialty clinicians typically prescribe a limited set of medications (for example, chemotherapeutic agents). Nonetheless, specialists often work with incomplete medication data on patients that are referred or transitioning between settings—situations known to increase the risk of errors (Fernald et al., 2004).
New studies should focus especially on error incidence rates associated with care transitions, medication administration in ambulatory care, monitoring of medications in ambulatory care, mail order pharmacy, and school care. In addition, not enough is known about what happens between the time a prescription is filled and the time the patient is supposed to take a particular dose of the medication at a particular time. Such research is difficult for multiple reasons, although technological approaches using smart pill bottles and bioassays can be used. However, the very act of intrusive observation raises questions about the generalizability of results obtained with these approaches.
Despite extensive work on medication errors in the hospital setting, the committee found only a handful of studies on medication errors in pediatric patients in the emergency department, ambulatory care, and home environments, all of which are critical targets for future research. The home environment in particular should be a high priority given the growing reliance on home care for increasingly complex medical conditions. All three of the existing studies involving home medication administration (Li et al., 2000; McErlean et al., 2001; Goldman and Scolnik, 2004) focused narrowly on the administration of antipyretics. These studies estimated significant rates
of medication errors by parents and guardians. A preliminary report also indicates high rates of prescribing errors in outpatient pediatric clinics (McPhillips et al., 2005b).
The committee found only two studies of medication errors in psychiatry (Senst et al., 2001; Grasso et al., 2003). The committee found no studies of psychiatric care that used an independent audit to identify medication errors and then examine a potential causal link between errors and clinical harm. The committee believes medication errors in inpatient and outpatient psychiatry require more study.
Psychiatrist professional organizations have only recently identified medication errors as a patient safety and quality concern. The American Psychiatric Association (APA) first convened its Task Force on Patient Safety in 2002 (Herzog et al., 2003). ADEs were identified as one of four priority areas. The recommendations of the task force were approved by the board of trustees in November 2002 and by the assembly executive committee in January 2003, leading to the inception of the APA Committee on Patient Safety (Herzog et al., 2003).
The committee believes psychiatrists and other mental health professionals should join with their medical and surgical colleagues to speak a common language regarding the detection, reporting, and management of medication errors and ADEs. Broader incorporation of such terminology might also enable a more objective comparison of quality among psychiatric hospitals.
Apart from the three highly specialized studies on the administration of antipyretics mentioned in the above discussion of pediatric care, the committee found no studies on incidence rates of medication errors arising from use of OTC drugs. Yet there is a growing literature on OTC drug–disease issues and OTC drug–drug interactions (see Box 3-2 in Chapter 3).
Further, a growing number of OTC drugs are being approved, including some that formerly had prescription status. From 1995 to 2004, there were 84 new approvals or prescription-to-OTC switches, an average of 8.4 per year (CDER, 2005). Looking to the future, it is likely that completely new categories of OTC drugs will become available in the United States. In 2004, the United Kingdom approved the first low-dose statin as an OTC drug, provided that a pharmacist reviews the purchase (Bellingham, 2004)—this even though statins do have drug–drug interactions, and it is difficult for patients to monitor either their effectiveness or
their toxicity. This decision came 4 years after failed attempts in the United States to achieve OTC status for low-dose statins (Mitka, 2004). Against this background, the committee believes the time is right for a major study on the use of OTC drugs and the epidemiology of associated medication errors and ADEs, as well as drug–drug and drug–disease interactions.
Complementary and Alternative Medications
An emerging literature suggests that complementary and alternative medications have the potential for adverse interactions with prescription drugs (D’Arcy, 1993; Calis and Young, 2004). The Institute of Medicine’s (IOM) recent report Complementary and Alternative Medicine (IOM, 2005) recommended that the National Institutes of Health and other public agencies provide the support necessary to develop and implement a sentinel surveillance system (comprising selected sites collecting and reporting data on patterns of use of these and conventional medications), practice-based research networks,1 and complementary and alternative medication research centers to facilitate the work of the networks (by collecting and analyzing information from national surveys, identifying important questions, designing studies, coordinating data collection and analysis, and providing training in research and other areas). The IOM report also recommended that the National Institutes of Health and other public or private agencies sponsor quantitative and qualitative research to examine adverse events associated with complementary and alternative medications and their interactions with conventional treatments. The committee endorses both of these recommendations.
There have been few micro-level studies of the costs of medication errors. Most of these studies have estimated either the extra hospital costs of an ADE occurring while the patient is in the hospital or the costs of hospital admissions attributable to earlier ADEs. Two of these studies are now quite dated: one used data from 1990–1993 (Classen et al., 1997) and the other data from 1993 (Bates et al., 1997). Apart from one study relating to ambulatory care (Field et al., 2005), all of the studies related to hospital care. Clearly there are large gaps in our understanding of the costs of
medication errors. A better understanding of these costs is important for a number of reasons, including informing decisions about investments in technological interventions designed to reduce the risk of medication errors. Accordingly, the committee recommends that additional studies be carried out on these costs in hospitals, nursing homes, and ambulatory care. These studies should include (1) the costs of medication errors in pediatric and psychiatric care, (2) the costs of errors associated with OTC and complementary and alternative medications, (3) the costs of the failure to receive drugs that should have been prescribed, and (4) the costs of over-utilization of drugs (for example, antibiotics). Moreover, some of these studies should examine not just additional health care costs relating to medication errors, but also the economic and social costs borne by patients and their families.
The committee acknowledges that it is not possible to put forward a fully comprehensive set of corrective medication error strategies. The area best understood is the incidence of medication errors and preventable ADEs in various care settings where significant problems and their causes have been identified. More research is needed to evaluate the impact of system problems in the research and development, regulatory review, and distribution/ marketing stages on the incidence of errors in the use of medications and the impact of the underutilization of medications.
As suggested above, the primary focus of research on medication errors should be on informing, developing, and then testing prevention strategies. In the next sections, the committee outlines suggestions for further research on such strategies for hospital care, nursing home care, ambulatory care, pediatric care, psychiatric care, and care transitions.
As reported in Chapter 3, the universe of preventable ADEs is a minority of total ADEs. Although most of the development of error prevention strategies to date has been focused on the ADEs that are known to be preventable today, it will likely be possible in the future to prevent many events currently considered nonpreventable. In particular, better tools for detecting drug sensitivities and the use of pharmacogenomics offer great promise in this regard (Gandhi et al., 2005). In addition, innovations in the way compounds are constructed or delivered may result in a safer drug administration process.
Finally, further cost/benefit studies of all prevention strategies are urgently needed. Most such studies carried out to date have involved hospitals and a limited number of decision-support tools. Particularly needed are studies of vendor-based systems, a broad range of decision-support tools, and care settings other than hospitals. The aim should be to identify a
group of high-impact interventions in each care setting that can be implemented first.
For the most part, interventions that appear to have the strongest evidence are consistently incorporated into recommended best practices for reducing medication error rates, such as the National Quality Forum’s (NQF) Safe Practices for Better Healthcare (NQF, 2003). Computerized provider order entry (CPOE) is almost universally recommended, as is incorporating clinical pharmacists into the inpatient medical team during daily rounds and creating specialized protocols for high-alert medications. Other strategies for which the evidence is not as strong but that are commonly recommended include standardizing prescription writing, limiting oral orders, improving medication error identification systems, adopting system-based approaches to reducing medication errors, promoting a culture of safety, implementing bar coding, and using unit dosing.
Bar coding and smart pumps are widely recommended interventions for which more rigorous testing appears warranted. In addition, there is a need to investigate nontechnical strategies that address human factors, such as techniques for combating fatigue (e.g., adequate staffing of professionals involved in medication use); elimination of redundancies (e.g., identifying when double-checks add value in decreasing errors); echoing and readback; the use of reminders, constraints, and color differentiation; and systematic approaches that couple continuous surveillance of error reports/alerts and review of good-practice guidance from internal and external sources with proactive prevention strategies.
Beyond the validation of individual approaches to error reduction, the next steps in research on prevention strategies for hospital care should focus on evaluation of the following:
How to make a business case for investment in error prevention strategies. CPOE, bar coding, and smart pumps are expensive applications and have to compete with other investments for a health care organization’s limited resources. Financial models for the benefits of CPOE are beginning to emerge (Kaushal et al., 2006).
How to select an individual application, such as CPOE, bar coding, and smart pumps. Tools are needed to evaluate applications in the way they present information to users, their effectiveness at intercepting medication errors, and the quality of the information provided through decision-support tools. Leapfrog has begun to develop a tool to evaluate hospital CPOE systems with decision support (Kilbridge et al., 2006).
How to implement individual approaches, such as CPOE, bar coding, and smart pumps. Implementation problems with electronic prescribing systems and unintended consequences arising from the implementation of such systems have been well documented (Ash et al., 2004; Han et al., 2005; Berger and Kichak, 2004; Koppel et al., 2005; Fernando et al., 2004). Guidance manuals are needed to help all stakeholders implement these systems successfully. In particular, more research is needed to understand the specific challenges that exist for institutions of different sizes and different staffing models (Kuperman and Gibson, 2003).
How to link the various individual applications (CPOE, bar coding, and smart pumps) together and with electronic health records and the patient’s personal health record. A better understanding is needed of how to ensure that data can pass seamlessly from one application to another, and that the data are interpreted in a consistent way across all applications.
New approaches to improve the safety of transitions between providers and patient care units, and especially as the patient leaves the hospital. Most current prevention strategies are applied in one particular care setting. Transitions from one provider to another are error prone (Forster et al., 2003). Applications need to be developed that can keep all a patient’s providers (inpatient and outpatient prescribers, pharmacists) up to date when any one of the prescribers or the patient changes the patient’s medication or the pharmacist learns that the patient has failed to fill a particular prescription.
Nursing Home Care
Although CPOE with clinical decision support has been implemented successfully in many acute care hospitals, there are few descriptions of its use in the long-term care setting (Rochon et al., 2005). Use of the technology in nursing homes poses many challenges, and its effectiveness in preventing medication errors and ADEs in this setting needs to be assessed. The impact of staffing levels on medication errors and preventable ADEs in the nursing home setting also has not been adequately studied, nor have deficiencies in communication between nursing home staff and the clinicians accountable for prescribing medications.
Many approaches to medication safety derive from the inpatient setting, and it is not clear to what extent these approaches are transferable to the ambulatory setting. For example, instruments used to assess the safety climate for the ambulatory setting lag far behind those for the inpatient setting (Nieva and Sorra, 2003). Tools for such assessment for a full range
of ambulatory institutions need to be developed. Even the effect of electronic prescribing on medication safety in the ambulatory setting has not been well studied; the same is true of the impact of providing different levels of decision support. Effectiveness studies of the most promising error prevention strategies are needed, with priority given to electronic prescribing with clinical decision support and collaborative care approaches involving physicians, nurses, and pharmacists, and with patient self-education/counseling.
The majority of patient–pharmacy interactions on a day-to-day basis involve prescription refills. There is a need for studies targeting safe practices in this area. Also needing study are the effects of time demands on clinicians in the ambulatory setting on safety in general and on medication safety in particular.
Standardization of recommended doses for children is essential to enable providers, researchers, and developers of technological prescribing solutions to speak a common language as to what doses are considered acceptable (that is, not errors) for children (McPhillips et al., 2005a,b). Despite the push for CPOE and electronic prescribing, the lack of uniformity on standard pediatric doses is at least part of the reason for the usual absence of pediatric-specific dosing tables powering most commercially available CPOE tools. Because of the inability to build such dosage rules into computerized prescribing tools, children cannot reap the full benefit of information technology in the medication delivery process.
In the home environment, research is needed on standardization of concentrations and dosing spoons, syringes, and other tools used by parents and guardians, similar to the efforts now under way to standardize and limit the number of concentrations used within institutions.
Most of the research to date on pediatric medication errors has been skewed toward prescribing errors. The committee’s review of data from error reporting systems revealed that dispensing and administering are as error prone as prescribing. In contrast with the medication-use process for adults, the steps of dispensing and administering in pediatric populations depend much more heavily on manual compounding of liquid medications and administration to patients who are unable to perform their own medication safety checks. Understanding the unique risks for children in these two steps is critical to determining which interventions will eliminate or mitigate these risks.
Many potential approaches to error reduction are relatively inexpensive and are supported by common sense based on knowledge of human factors. Such approaches include representation of pediatric care on for-
mulary committees, appropriate and competent pharmacy and nursing personnel who are knowledgeable about pediatric medication dosages and regimens, policies on oral orders, and clear and accurate medication labeling.
In Chapter 3, it was noted that no study has been carried out to evaluate the efficacy of any prevention strategy for medication errors in psychiatric care. Nevertheless, there are several promising strategies of relevance to psychiatric care that do not involve automation and thus could be evaluated immediately:
The use of medication ordering protocols for drugs that have a narrow therapeutic index and/or might be unsafe to initiate or resume without laboratory data (for example, lithium carbonate, clozapine, carbamazepine, valproic acid).
The use of unit-dose distribution systems in which medications are individually prepackaged and delivered in the exact dose to the point of administration.
Access to drug information at the time of prescribing through inclusion of a clinical pharmacist in rounds, along with immediate drug database access using personal digital assistants (PDAs).
Orientation and periodic education of nurses and physicians regarding the prescribing, transcribing, dispensing, and administration processes.
Better patient education in the use of medications.
A number of computerized interventions also appear to have the potential to decrease medication error rates in the psychiatric inpatient setting. Among these are CPOE, bar coding linked to computerized medication administration records, automated dispensing devices, and pharmacy dispensing robotics (Bates and Gawande, 2003). Outside the hospital, tools that can help patients track what medications they have actually taken may be especially beneficial in the psychiatric population.
As noted elsewhere in this report, the available data indicate that care transitions between institutions and primary or home care pose a high level of risk (Fernald et al., 2004) because medication regimens are frequently altered at these times. Research is needed on ways to improve communication between these components of the medication-use system. All concerned need to acknowledge the problem and evaluate a variety of approaches to
error reduction. Specific areas for research include (1) improved methods for helping patients and providers create and maintain accurate and up-to-date medication lists, (2) a better understanding of the benefits and risks of systems that incentivize or require patients to obtain medications from multiple sources (e.g., local and mail order pharmacies, free samples from prescribers), (3) a better understanding of the impact of the use of formularies on medication safety, (4) an improved understanding of the impact of changes in health insurance coverage leading to interruptions in medication use, (5) a better understanding of the impact of changes in formularies leading to changes in medication use and the disruptions they can cause, and (6) an improved understanding of the impact of payer regulations that mandate frequent refills within tight time frames.
The need for improved information transfer between prescribing clinicians and dispensing pharmacies/pharmacists also needs to be studied. The Continuity of Care Record (CCR) and Regional Health Information Organizations are important initiatives aimed at addressing this problem. The CCR is a standard specification developed jointly by the American Society for Testing Materials (ASTM) International, the Massachusetts Medical Society, the Health Information Management and Systems Society, the American Academy of Family Physicians, the American Academy of Pediatrics, and others (Tessier, 2005) and published in early 2006 (ASTM, 2006). It is intended to foster and improve continuity of patient care, to reduce medical errors, and to ensure at least a minimum standard of health information transportability when a patient is referred or transferred to or otherwise seen by another provider. The next step is for vendors to incorporate the CCR standard in their products.
Regional Health Information Organizations represent state and other regional groups seeking to harmonize the privacy and business rules for health information exchange (DHHS, 2005). More than 100 regional projects are under way, funded by the federal government. Several other projects are being supported by private industry or funded at the state level. The CCR and Regional Health Information Organizations could be highly complementary if appropriately combined, with one providing an improved standard for transmission of data and the other the means for rapid transmission to the point of care. Such developments should be supported and evaluated for their impact on the safety and quality of medication use.
IDENTIFICATION METHODS: DATA TRIGGERS
The IOM’s report on patient safety (IOM, 2004) recommended research aimed at developing and evaluating various methods for using data-driven triggers to detect ADEs and other high-risk events (e.g., nosocomial infections, patient falls). The committee endorses this recommendation and
believes the focus of such research should be on developing efficient, robust tools for computerized monitoring that would allow all organizations to monitor routinely for ADEs. Ultimately, it may be practical to mandate such monitoring. To this end, research is needed on improving, across all settings, the utility and reliability of computerized detection (e.g., eliminating alert fatigue; see Chapter 6); also needed are testing and validation specific to the site of care (Field et al., 2004).
In the ambulatory setting, medication monitoring, particularly for ADEs, is virtually nonexistent. Research is needed on what data sources are necessary for a robust background monitoring system in the ambulatory environment, such as the systems used for inpatients at Brigham and Women’s Hospital in Boston, Massachusetts, and LDS Hospital in Salt Lake City, Utah. Development and testing of such systems would be a major step forward in medication safety in the ambulatory setting, particularly if facilitated by the incorporation of electronic health records and electronic prescribing.
International comparison studies provide valuable benchmarking data concerning safe medication practices. These studies help challenge paradigms and encourage thinking beyond the traditional views concerning just what constitutes safe medication practice. An example of such a study is one undertaken in a hospital in the United States and a hospital in the United Kingdom (Dean et al., 1995). The medication error rate in the U.S. hospital was 6.9 percent, higher than the 3.0 percent rate observed in the U.K. hospital. The committee believes this study was very useful, but acknowledges that such studies are challenging to conduct.
The committee suggests that more international sharing of ideas on medication safety would be highly beneficial and recommends that more international studies be carried out to evaluate different medication systems and their effects on the rates of medication errors and ADEs. An important prerequisite is that researchers carrying out such international studies need to adopt common taxonomies for describing errors. In this context, the World Health Organization is taking a lead role (WHO, 2005). In addition, international studies should use multiple error detection methods.
CROSS-INDUSTRY SAFETY STUDIES
Many industries face safety challenges. Industries such as aviation, nuclear power, and chemical manufacturing have implemented successful safety strategies and continue to achieve advances in this regard. These industries have addressed safety issues of relevance to health care, generally
and medication safety in particular, such as introducing a culture of safety, implementing computerized error detection and prevention systems, standardizing procedures, reducing errors at care transitions, and developing human–computer interfaces. It is likely that many of the lessons learned in these industries will be relevant to health care delivery. As a consequence, the committee believes workshops and studies should take place regularly so that safety experts in health care can share experiences with safety experts in other industries.
The committee endorses the recommendation in the IOM’s patient safety report (IOM, 2004) that the Agency for Healthcare Research and Quality develop a standard (or common) event taxonomy for data storage and analysis. Specifically, this event taxonomy should address near misses and ADEs, cover errors of both omission and commission, and include hazardous conditions. The report format should include both standardized data elements and free-text narratives.
The committee views the work of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in this area as an important development. JCAHO has taken a leadership role (Chang et al., 2005) by developing a Patient Safety Event Taxonomy (NQF, 2005), which was endorsed by the NQF in August 2005 (see also Chapter 8).
The committee also endorses the recommendation of the IOM’s patient safety report that further studies on the cost/benefit of reporting systems be undertaken. In particular, there is a need for in-depth studies of the value of various reporting systems with regard to learning about errors and new problems, gaining knowledge from the reports, communicating guidance, and changing care delivery processes.
Ash JS, Berg M, Coiera E. 2004. Some unintended consequences of information technology in health care: The nature of patient care information system-related errors. Journal of the American Medical Informatics Association 11(2):104–112.
ASTM (American Society for Testing Materials). 2006. Continuity of Care Record Is Developed by ASTM International Health Care Informatics Committee. [Online]. Available: http://188.8.131.52/viewnews.aspx?newsID=772 [accessed April 18, 2006].
Bates DW, Gawande AA. 2003. Improving safety with information technology. New England Journal of Medicine 348(25):2526–2534.
Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, Small SD, Sweitzer BJ, Leape L. 1997. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. Journal of the American Medical Association 277(4):307–311.
Bellingham C. 2004. OTC statin may change pharmacy for ever. The Pharmaceutical Journal 273:43.
Berger RG, Kichak JP. 2004. Computerized physician order entry: Helpful or harmful? Journal of the American Medical Informatics Association 11(2):100–103.
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. 1992. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 101(6):1644–1655.
Calis KA, Young LR. 2004. Clinical analysis of adverse drug reactions: A primer for clinicians. Hospital Pharmacy 39(7):697–712.
CDER (Center for Drug Evaluation and Research). 2005. 2004 Report to the Nation: Improving Public Health Through Human Drugs. Washington, DC: U.S. Department of Health and Human Services.
Chang A, Schyve PM, Croteau DJ, O’Leary DS, Loeb JM. 2005. The JCAHO patient safety event taxonomy: A standardized terminology and classification schema for near misses and adverse events. International Journal for Quality in Health Care 17(2):95–105.
Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. 1997. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. Journal of the American Medical Association 277(4):301–306.
D’Arcy PF. 1993. Adverse reactions and interactions with herbal medicines. Part 2. Drug interactions. Adverse Drug Reactions and Toxicological Reviews 12:147–162.
Dean BS, Allan EL, Barber ND, Barker KN. 1995. Comparison of medication errors in an American and a British hospital. American Journal of Health-System Pharmacy 52(22): 2543–2549.
DHHS (U.S. Department of Health and Human Services). 2005. Regional Health Information Organizations (RHIOs). [Online]. Available: http://www.hhs.gov/healthit/rhio.html [accessed October 9, 2005].
Fernald DH, Pace WD, Harris DM, West DR, Main DS, Westfall JM. 2004. Event reporting to a primary care patient safety reporting system: A report from the ASIPS Collaborative. Annals of Family Medicine 2(4):327–332.
Fernando B, Savelyich BSP, Avery AJ, Sheikh A, Bainbridge M, Horsfield P, Teasdale S. 2004. Prescribing safety features of general practice computer systems: Evaluation using simulated test cases. British Medical Journal 328(7449):1171–1172.
Field TS, Gurwitz JH, Harrold LR, Rothschild JM, Debellis K, Seger AC, Fish LS, Garber L, Kelleher M, Bates DW. 2004. Strategies for detecting adverse drug events among older persons in the ambulatory setting. Journal of the American Medical Informatics Association 11(6):492–498.
Field TS, Gilman BH, Subramanian S, Fuller JC, Bates DW, Gurwitz JH. 2005. The costs associated with adverse drug events among older adults in the ambulatory setting. Medical Care 43(12):1171–1176.
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. 2003. The incidence and severity of adverse events affecting patients after discharge from the hospital. Annals of Internal Medicine 138(3):161–167.
Gandhi TK, Bartel SB, Shulman LN, Verrier D, Burdick E, Cleary A, Rothschild JM, Leape LL, Bates DW. 2005. Medication safety in the ambulatory chemotherapy setting. Cancer 104(11):2477–2483.
Goldman RD, Scolnik D. 2004. Underdosing of acetaminophen by parents and emergency department utilization. Pediatric Emergency Care 20(2):89–93.
Grasso BC, Genest R, Jordan CW, Bates DW. 2003. Use of chart and record reviews to detect medication errors in a state psychiatric hospital. Psychiatric Services (Washington, D.C.) 54(5):677–681.
Gurwitz JH, Field TS, Avorn J, McCormick D, Jain S, Eckler M, Benser M, Edmondson AC, Bates DW. 2000. Incidence and preventability of adverse drug events in nursing homes. The American Journal of Medicine 109(2):87–94.
Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. 2003. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. Journal of the American Medical Association 289(9):1107–1116.
Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR, Cadoret C, Lee M, White K, LaPrino J, Mainard JF, DeFlorio M, Gavendo L, Auger J, Bates DW. 2005. The incidence of adverse drug events in two large academic long-term care facilities. The American Journal of Medicine 118(3):251–258.
Han YY, Carcillo JA, Venkataraman ST, Clark RSB, Watson RS, Nguyen TC, Bayir H, Orr RA. 2005. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 116(5):1506–1512.
Herzog, A, Shore, MF, Beale, RR, Padrino, SL, Vogel, AV. 2003. Patient Safety and Psychiatry: Recommendations to the Board of Trustees of the American Psychiatric Association. [Online]. Available: www.psych.org/edu/other_res/lib_archives/archives/tfr/tfr200301. pdf [accessed September 30, 2005].
IOM (Institute of Medicine). 2004. Patient Safety: Achieving a New Standard for Care. Washington, DC: The National Academies Press.
IOM. 2005. Complementary and Alternative Medicines in the United States. Washington, DC: The National Academies Press.
Kaushal R, Jha AK, Franz C, Shetty KD, Jaggi T, Glaser J, Middleton B, Kuperman GJ, Khorasani R, Tanasijevic M, Bates DW. 2006. Return on investment for a computerized physician order entry system. Journal of the American Medical Informatics Association 13(3):261–266.
Kilbridge PM, Welebob EM, Classen DC. 2006. Development of the Leapfrog methodology for evaluating hospital implemented inpatient computerized physician order entry systems. Quality and Safety in Health Care 15(2):81–84.
Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. 2005. Role of computerized physician order entry systems in facilitating medication errors. Journal of the American Medical Association 293(10):1197–1203.
Kuperman G, Gibson RF. 2003. Computer physician order entry: Benefits, costs, and issues. Annals of Internal Medicine 139(1):31–39.
Levy MM, Mitchell PF, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G. 2003. 2001 SCCM/ESICM/ACCP/ATS/SIS international sepsis definitions conference. Critical Care Medicine 31(4):1250–1256.
Li SF, Lacher B, Crain EF. 2000. Acetaminophen and ibuprofen dosing by parents. Pediatric Emergency Care 16(6):394–397.
McErlean MA, Bartfield JM, Kennedy DA, Gilman EA, Stram RL, Raccio-Robak N. 2001. Home antipyretic use in children brought to the emergency department. Pediatric Emergency Care 17(4):249–251.
McPhillips H, Stille C, Smith D, Pearson J, Stull J, Hecht J, Miller M, Davis R. 2005a. Methodological challenges in describing medication dosing errors in children. In: Henriksen K, Battles J, Marks E, Lewin DI, eds. Advances in Patient Safety: From Research to Implementation. Vol. 2, Concepts and Methodology. Rockville, MD: Agency for Healthcare Research and Quality.
McPhillips HA, Stille CJ, Smith D, Hecht J, Pearson J, Stull J, Debellis K, Andrade S, Miller MR, Kaushal R, Gurwitz J, Davis RL. 2005b. Potential medication dosing errors in outpatient pediatrics. The Journal of Pediatrics 147(6):761–767.
Mitka M. 2004. Are OTC statins ready for prime time? Journal of the American Medical Association 293(3):317–318.
Nieva VF, Sorra J. 2003. Safety culture assessment: A tool for improving patient safety in healthcare organizations. Quality & Safety in Health Care 12(Suppl. 2):7–23.
NQF (National Quality Forum). 2003. Safe Practices for Better Healthcare: A Consensus Report. Washington, DC: NQF.
NQF. 2005. National Quality Forum Endorses Voluntary Consensus Standard for Standardizing a Patient Safety Taxonomy. August 3, 2005. [Online]. Available: http://www. qualityforum.org/news/home.htm [accessed November 26, 2005].
Rochon PA, Field TS, Bates DW, Lee M, Gavendo L, Erramuspe-Mainard J, Judge J, Gurwitz JH. 2005. Computerized physician order entry with clinical decision support in the long-term care setting: Insights from the Baycrest Centre for Geriatric Care. Journal of the American Geriatrics Society 53(10):1780–1789.
Senst BL, Achusim LE, Genest RP, Consentino LA, Ford CC, Little JA, Raybon SJ, Bates DW. 2001. Practical approach to determining costs and frequency of adverse drug events in a health care network. American Journal of Health-System Pharmacy 58(12):1126–1132.
Tessier C. 2005. Overview of the Continuity of Care Record. [Online]. Available: http:// www.astm.org/COMMIT/E31_CCR0305.ppt#256,1 [accessed October 9, 2005].
WHO (World Health Organization). 2005. Project to Develop the International Patient Safety Event Taxonomy: Report of the WHO World Alliance for Patient Safety Drafting Group, Vancouver, October, 2005. Geneva, Switzerland: WHO.