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Preventing Medication Errors (2007) / Chapter Skim
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6 Action Agenda for the Pharmaceutical, Medical Device, and Health Information Technology Industries
Pages 266-309

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From page 266...
... As with other com ponents of the medication-use system, however, certain features of design processes and communication mechanisms warrant signifi cant improvement to better serve the health needs of consumers and the practice needs of providers and, most important, prevent medication errors. This chapter provides an action agenda for the pharmaceutical, medical device, and health information technol ogy industries that, in collaboration with appropriate government agencies, can begin to address key problems that affect the safety and quality of the medication-use system.
From page 267...
... . While a comprehensive review of the drug research and development process and recommendations for its redesign are beyond the scope of this report, certain key aspects of information generation germane to medication safety merit discussion here.
From page 268...
... 268 PREVENTING MEDICATION ERRORS globally, with its most common indication for use being prevention of cardiovascular disease in postmenopausal women. Many years after the therapy was marketed, however, both the HERS (Heart and Estrogen/ progestin Replacement study)
From page 269...
... Thus recommended doses are not specifically tailored to the needs of the individual patient. The field of clinical pharmacology needs to be invigorated.
From page 270...
... 270 PREVENTING MEDICATION ERRORS als (Califf and DeMets, 2002a,b)
From page 271...
... Open access to such data is important not only for developing clinical understand ing, but also for populating clinical knowledge and decision support systems. Disclosure of Clinical Data The current state of disclosure of the findings of clinical studies is inadequate to support safety and quality in medication use, although the situation is improving.
From page 272...
... Full disclosure of the results of all clinical trials and postmarket studies in a national registry is particularly important to fill the current knowledge gaps that affect clinical practice, patient self-management, and medication safety. The distortion of information that results from the design of postmarketing studies has been described above.
From page 273...
... Companies are concerned that if all such proprietary infor mation were required to be made broadly available to the public at the outset of clinical trials, they could not recoup their investment because competitors in the United States or abroad could copy their innovations. At the same time, industry recognizes its responsibility to do everything possible to ensure patient safety and secure the public trust.
From page 274...
... The FDA, the National Library of Medicine (NLM) , and industry should work with consumer and patient safety organizations to improve the nomenclature used in consumer materials.
From page 275...
... National Patient Safety Goals reference several look-alike/soundalike generic drug names that have contributed to 9 of 10 serious medication errors in the hospital setting (JCAHO, 2006)
From page 276...
... 276 PREVENTING MEDICATION ERRORS BOX 6-2 Examples of Major Naming, Labeling, and Packaging Problems · Brand names that look alike or sound alike -- Celebrex® (celecoxib) , Cerebryx® (fosphenytoin)
From page 277...
... Mixups resulting in medication errors can occur with either generic or brand names. In cases where the generic names are similar, the brand name can be used to differentiate products.
From page 278...
... reviews brand names for prescription and certain OTC drugs to determine the potential for naming-related medication errors (FDA, 2005b) .5 The FDA's FMEA review includes several evaluations.
From page 279...
... However, these are just recommendations and not formal requirements or standards, and compliance is inconsistent. Once a product is on the market, adjustments to naming, labeling, and packaging are made only when providers and patient safety experts exert significant effort to get problems acknowledged and accepted by industry and FDA representatives.
From page 280...
... Moreover, when the change in labeling was finally approved, the FDA would not discuss it and did not notify patient safety organizations or the public about it. This example illustrates the problems that can occur when human factors issues are not incorporated into labeling and packaging designs, and communications about problems are not transparent.
From page 281...
... The documents should address such is sues as acceptable and nonacceptable naming practices; the procedure for chang ing names, labeling, and packaging after marketing as a result of high rates of medication errors; how warnings should appear on labels; the use of suffixes to modify various dosage forms that share the same drug name; and the placement of information, such as company names and logos, that may distract readers. · The FDA should improve communication between Office of Drug Safety staff and others at all levels within the agency.
From page 282...
... about known/reported serious drug safety problems. · Industry should provide patient safety organizations (e.g., ISMP, USP)
From page 283...
... passage of the FDA's final rule requiring unit-dose packaging and bar codes for all medicines distributed to hospitals (FR, 2004)
From page 284...
... take their medication more reliably and safely and enhance their treatment outcomes. In a 2003 survey of state boards of pharmacy, two-thirds of respondents expressed their belief that unit-of-use packaging would improve efficiency, reduce errors in dispensing, improve patient compliance, and increase opportunities for patient counseling (Szeinbach et al., 2003)
From page 285...
... . The free generic samples are supplied on a trial basis for consumers who are currently using a brand name version or BOX 6-4 Safety Issues Related to the Distribution of Free Samples A number of critical medication safety and quality-of-care issues related to the distribution of product samples can contribute to errors: · Physician disregard of evidence-based guidelines · Prescribing based on samples rather than clinical appropriateness or the physician's preferred drug choice · Prescribing of products not in hospital or managed care formularies · Drug switching based on availability of samples rather than clinical need · Inability of patients to receive the benefit of pharmacy services (e.g., drug interaction checking)
From page 286...
... . Extensive studies are needed to evaluate the impact of free samples on physician and consumer behavior and patient safety and determine alternative methods of distribution.
From page 287...
... As a result, each component of the medication use-system remains compartmentalized, increasing safety risks. The lack of common drug information standards and integration of pharmacy database, decision-support, infusion, and bar code systems can have particularly devastating effects on patient safety (Patterson et al., 2002; Han et al., 2005; Koppel et al., 2005)
From page 288...
... · AHRQ should take the lead in developing user interface de signs based on the principles of cognitive and human factors and the context of the clinical environment. · AHRQ should support additional research to determine speci fications for alert mechanisms and intelligent prompting, as well as optimum designs for user interfaces.
From page 289...
... . NCVHS has designated RxNORM and NDF-RT as the core clinical drug nomenclature for electronic health records and the national health information network.
From page 290...
... The lack of common data standards among provider organizations not only prevents systems from communicating with one another, but also compromises the comparability of data from one organization to another, as well as epidemiological analysis of medication errors and ADEs in all health care settings. To remedy this problem, the NCVHS, the NLM, and the VHA need to develop a strategy for completing the development of all attributes of a comprehensive drug nomenclature.
From page 291...
... Existing and planned extensions to NDF RT (not shown) support a variety of clinical decision-support cases, such as dose adjustment based on individual pharmacogenomic characteristics.
From page 292...
... 292 product kit name Brand Packaged Product Commercial Attributes · · · drug care of authorization of Cost Plan Cost Payment Attributes · · · of weight checking checking checking route duplication on or or or Nomenclature interaction interaction cumulative and age allergy and based limits/contraindic- limits limits limits Drug for Therapeutic Drug­drug Drug Drug­food Single dose ations patient Drug­laboratory (dose contraindications) Drug­condition (dose contraindications)
From page 293...
... Rather than using an all-inclusive knowledge base to determine the alerts, the researchers used a subset of only the most clinically relevant contraindications that pertained to the ambulatory care setting. Alerts of moderate to low severity were not included.
From page 294...
... . As in the ambulatory care setting, alert rankings should reflect considerations specific to a patient's condition or provider's medical discipline (e.g., the alert ranking related to drug toxicity may be different for oncology than for nephrology)
From page 295...
... ACTION AGENDA FOR THE INDUSTRIES 295 TABLE 6-2 Sample of Alert Types, Most Common Occurrences, and Most Common Reasons for Alert Override Most Common Occurrences Most Common Reasons Alert Type of Highest Alerts for Alert Override Therapeutic · Analgesic (29%) · Transitioning from one duplication · Psychiatric (26%)
From page 296...
... One method for testing systems is to develop and test software configurations as well as train clinicians using simulation programs. The Anesthesia Patient Safety Foundation is the first medical community to adopt this technique successfully and apply it to anesthesia information management systems (AIMS)
From page 297...
... A commonly used standard that scanners can easily read will have a greater impact on patient safety than a unique symbology that few scanners are programmed to read (FR, 2004)
From page 298...
... However, many stakeholders consider the EAN/UCC standard to be inadequate for the specific applications and needs of the health care environment, especially those associated with patient safety (HIBCC, 2001)
From page 299...
... . Most important, a poorly designed user interface can even contribute to medication errors for all drug-related technologies (Patterson et al., 2002; Ash et al., 2004; Koppel et al., 2005)
From page 300...
... Although decision-support systems use standard computer monitors to display information, a significant amount of work is needed to develop optimal user interface designs that can make data capture and manipulation easier for clinicians and more accurate for patient safety. Data presentation and the user interface affect the usability of bar code medication administration systems as well.
From page 301...
... . The fragmentation of patient data also contributes to clinicians' inability to obtain at a glance a comprehensive overview of patients' medication information, as well as to degraded coordination between physicians and nurses -- one of the more noted negative side effects of bar code medication administration systems (Patterson et al., 2002)
From page 302...
... · Information-based strategies, including the development and adoption of guidelines and standards · Application of human factors to improve performance, such as the use of simulators for training · Formation of the Anesthesia Patient Safety Foundation to bring together stakeholders from different disciplines (physicians, nurses, manufacturers) · Having a leader who could serve as a champion for the cause (Leape et al., 1998; IOM, 2000)
From page 303...
... Pro ceedings of American Medical Informatics Association Symposium 2­6. Ahern MD, Kerr SJ.
From page 304...
... Presentation to the IOM Committee on Identifying and Preventing Medication Errors, March 19, 2004. Crowley WF, Sherwoo, L, Salber P, Scheinberg D, Slavkin H, Tilson H, Reece EA, Catanese V, Johnson SB, Dobs A, Genel M, Korn A, Reame N, Bonow R, Grebb J, Rimoin D
From page 305...
... 2003. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients.
From page 306...
... 2006. National Patient Safety Goals: Look-Alike/Sound-Alike Drug List.
From page 307...
... 2002. Improving patient safety by identifying side effects from introducing bar coding in medication administration.
From page 308...
... 2005. Usability Testing and the Relation of Clinical Information Systems to Patient Safety.
From page 309...
... 2002. Human factors research in anesthesia patient safety.


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