Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 50
Preventing Medication Errors 2 Overview of the Drug Development, Regulation, Distribution, and Use System CHAPTER SUMMARY The drug system encompasses four main stages—research and development; regulatory review; medication manufacturing, distribution, and marketing; and medication use—that each contain multiple critical control points at which quality, safety, and efficacy can be addressed, and at which breakdowns can occur. This chapter provides an overview of the major components of the drug system and the points that might lead directly or indirectly to errors as well as opportunities for learning, recovery, and improvement. As noted in two previous Institute of Medicine (IOM) reports—To Err Is Human: Building a Safer Health System (IOM, 2000) and Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001), redesigning health care to improve quality and safety requires definitive action by all stakeholder groups interacting with the health system. Applied to this report, stakeholders of the drug system associated with research, innovation, regulation, clinical practice, payment, education, legislation, and reporting should be assessed according to how well quality and safety are (or can be) achieved, among other factors. Advancing this concept requires that the disciplines of human factors engineering, organizational psychology, sociology, and informatics must become the basic sciences of quality just as molecular biology, pharmacology, and genetics are the basic sciences of medicine (Brennan et al., 2005). Quality and safety in medication use depends directly on the extent to which the principles of these
OCR for page 51
Preventing Medication Errors sciences are built into the overall drug system (Califf et al., 2002). Integrating the sciences of quality with the biomedical and health sciences will ultimately facilitate the translation of safety and quality in medication use from theory to clinical practice. As a first order of business, the points at which safety and quality can be compromised must be identified. Currently, the potential for harm is present throughout the system. Harm can be due to any number of factors, many of which are now in the national spotlight, including undisclosed harmful side effects of a drug for specific patient populations; lax follow-through on regulatory responsibility after product approval; human error in prescribing, dispensing, administering, and monitoring effects in patients; and inadequate patient activation and education. This chapter identifies the key issues of the overall drug system that affect safety and quality in medication use. Subsequent chapters in this report provide recommendations for improvement, many of which incorporate the “sciences of quality” mentioned above. STRUCTURE OF THE OVERALL DRUG SYSTEM Currently more than 10,000 prescription drugs and biologics (FDA, 1999) and more than 300,000 over-the-counter (OTC) products are on the market in the United States (RSW, 2001). In 2004, 215 prescription and 71 OTC drugs were recalled because of manufacturing and distribution problems or serious adverse reactions (FDA, 2004a). The regulatory element of the drug system evolved over the past century from being focused on regulating interstate transport and misbranded products to being built on an infrastructure with the goal of reliable standards, processes, and laws to ensure some degree of safety and efficacy in medicinal agents. The result is a sophisticated, comprehensive drug system encompassing four stages that interact with, support, and reinforce each other to varying degrees (see Figure 2-1): (1) research and development (R&D), where ideas for new drugs are conceived and candidates are clinically tested; (2) regulatory review by the Food and Drug Administration (FDA) to validate or counter the research findings and ensure proper labeling; (3) manufacture, distribution, and marketing of products that have received regulatory approval; and (4) use of medications available either through a prescription or OTC. Prescription drugs, biologics, and some OTCs follow this model. The product development and regulatory review stages are abbreviated for other OTCs and for generics. Each element of the drug system is governed by its own set of standards and methods for scientific analysis to advance the safety, quality, and efficacy of products and their use. As the chief protector of the public health, the FDA has responsibility for developing and enforcing the standards in all
OCR for page 52
Preventing Medication Errors FIGURE 2-1 Four stages of the drug system. NOTE: AADA = Abbreviated Antibiotic Drug Application; ANDA = Abbreviated New Drug Application; BLA = Biologic Licensing Application; DTC = direct to consumer; FDA = U.S. Food and Drug Administration; IND = Investigational New Drug Application; NDA = New Drug Application; OTC = over-the-counter; PBM = Pharmacy Benefits Manager.
OCR for page 53
Preventing Medication Errors areas except clinical practice, which is governed by state boards of medicine, nursing, and pharmacy; professional societies; and accreditation organizations.1 Compliance with FDA regulatory standards is the responsibility of the manufacturers who promote their products in the marketplace. Safe and effective use of medications is the responsibility of providers who prescribe the medications and patients who take them. Standards2 for each component of the drug system act as links in a chain of events that have an important bearing on the competence and effectiveness of drug therapies in medical care. The key points at which important interventions can be implemented are identified in Figure 2-1. Building safety and quality into the system starts with rational ideas for new drug products, followed by sound scientific research; reliable clinical testing; rigorous regulatory reviews; appropriate labeling; use of good manufacturing processes; proper distribution techniques; adequate supplies; ethical marketing practices; competent prescribing, dispensing, and administration of medications; and finally suitable monitoring of the patient, reporting of errors, and measurement of outcomes (Martin, 1978). If standards do not exist, are inadequate, have not been met, or are not enforced at any point along this chain, patient safety and quality of care can be compromised. For example, restriction on the publication of a drug’s side effects can affect a prescriber’s ability to choose the best drug for a patient or to identify and respond to an adverse reaction in a timely manner; lax enforcement of regulatory requirements for drug labeling can result in product confusion in a high-stress, fast-paced clinical setting; formulary restrictions can force a switch to a medication that may be less appropriate for a patient than the one initially prescribed; or the failure to document all of the medications a patient is taking (including OTCs and dietary supplements) can cause a drug–drug interaction that could have been prevented. In the first three of these examples, problems in the drug development, regulation, and distribution systems contribute to medication-use errors that should be corrected. Yet most links or components of the drug system operate in a quasi-silo state with less-than-ideal means of sharing important 1 The Center for Drug Evaluation and Research (CDER) regulates prescription (including therapeutic biologics), generic, and nonprescription drugs; the Center for Biologics Evaluation and Research (CBER) regulates the remaining biologics and blood products; and the Center for Devices and Radiological Health regulates medical devices, including those used to administer medications. The FDA’s authority, established by the Federal Food, Drug, and Cosmetic Act of 1938, has evolved steadily over the past 60 years through a series of legislative and regulatory actions to foster safety and efficacy through all stages of the drug system. 2 A set of characteristics or quantities that describes features of a product, process, service, interface, or material. The description can take many forms, such as the definition of terms; specification of design and construction; detailing of procedures; or performance criteria against which a product, process, and other factors can be measured (NRC, 1995).
OCR for page 54
Preventing Medication Errors information or responding to safety-related problems. In the last example, the problem results from an error within the medication-use system itself (e.g., insufficient information). Most often this is the case: medication errors are the result of a problem incurred during the prescribing, dispensing, administration, or monitoring phases of the medication-use system. Nevertheless, both aspects of causation—how the drug is prepared (developed, regulated, distributed) and how it is used in clinical practice or self-care—must be addressed if errors in the medication-use system are to be reduced and prevented. The remainder of this section addresses the former (research and development; regulatory review; and manufacture, distribution, and marketing). The second section of the chapter addresses medication use. Research and Development The R&D process involves more than the development of new products; it encompasses the overall generation and disclosure of high-quality data that can be used with confidence by providers and patients in medical care, by providers and technology vendors to populate knowledge bases and clinical decision-support systems, by regulators in assessing benefit/risk balances for protection of the public health, and by researchers for continued innovation and advancement of science and medicine (Califf, 2004). Issues related to study design, data quality, and disclosure can have direct bearing on the development of the medication knowledge base needed to support clinicians and pharmacists in clinical decision making and prescribing; preparation and administration of appropriate dosages; and monitoring of patient response (positive and negative) to a medication, particularly the ability to discern symptoms of disease from effects of the drug. Public availability of information from trials also is necessary to support consumers in their self-care, disease management, and medication self-management. Data quality can be compromised by poor clinical study designs, less-than-optimal methods of data analysis, and/or conflicts of interest that affect the objectivity of investigators (Califf and DeMets, 2002a,b; Strom, 2004; March et al., 2005). The failure to disclose negative study results (e.g., serious adverse side effects) can have fatal effects on patients (Bodenheimer, 2000; Moore et al., 1998). Current State of R&D Pharmaceutical R&D for new drugs and biologics aims to meet a medical need in a specified patient population by creating medications with characteristics of high activity, low toxicity, and relatively few side effects. Fundamentally, approval for marketing a drug is based on an assessment of
OCR for page 55
Preventing Medication Errors the balance of the benefit and risk of using the drug in the specified population. The ability to separate toxic and side effects from therapeutic effects on the basis of preclinical evaluation is an ongoing challenge. Sizable amounts of time and effort are spent on trying to increase this margin, but ultimately the balance of benefit and risk cannot be defined until clinical trials have been conducted in relevant populations (Martin, 1978; Califf, 2004). Trends in drug development over the past few decades have led to significant improvements in study designs, reducing the incidence of incorrect conclusions concerning dosage, efficacy, and safety while deepening understanding of how the molecular structures of potential new drugs interact with specific human cellular structures. More recent scientific discoveries in the areas of genomics, biotechnology, and informatics are expected to increase significantly the number of new molecular targets and the ability to develop medicines with greater specificity and fewer side effects (NRC, 2004), although this promise has not been realized, and the time frame for pragmatic advances remains unclear (Califf, 2004). Clinical Study Design Traditionally, the R&D process has been performed in sequential stages. After discovery of potential compounds for new medicines and preclinical testing in the laboratory and in animals for safety and biological activity against the targeted disease, the manufacturer (i.e., sponsor) submits an Investigational New Drug Application (IND) to the FDA or other international regulatory authority for review.3 The IND contains plans for clinical studies in humans (Phases I, II, and III), all data from preclinical testing, and complete structural and manufacturing information. At any time after the IND has been submitted, the sponsor may request an accelerated development and approval track (“fast track”) for drugs that promise substantial benefit over existing therapies for serious or life-threatening illnesses. Granting of fast track status is based on the case that the drug would fulfill a critical unmet health need, early evidence of the drug’s effects on a surrogate end point,4 commitments to undertake postmarket studies, and/or agreement to restrict distribution and use after approval (FDA, 1999). Most Phase I studies use healthy volunteers to test the drug’s actions, both metabolic (pharmacokinetics [PK]) and pharmacologic (pharmacody- 3 The FDA performs clinical, chemistry, toxicology, and safety reviews of the IND and, if it is accepted, makes adjustments to clinical trial parameters as needed. The IND sets the stage for the FDA’s interaction with the sponsor during clinical studies. 4 A surrogate end point is a laboratory finding or physical sign that may not, in itself, be a direct measurement of how a patient feels, functions, or survives, but nevertheless is considered likely to predict therapeutic benefit (FDA, 1999).
OCR for page 56
Preventing Medication Errors namics [PD]);5 side effects associated with increasing doses; and if possible, early evidence of efficacy (FDA, 1998). Phase II studies use a small group of patients with the condition in well-controlled circumstances to evaluate the dose that optimally affects the chosen biological target, the method of delivery (e.g., oral, intravenous), the dosing interval, and short-term side effects, and to extend the preliminary evidence of safety from Phase I (Walters, 1992; Leonard, 1994; FDA, 1998). A substantial number of drug trials are discontinued after both Phases I and II because of ineffectiveness, safety problems, or intolerable side effects. If the Phase I and II trials are successful, the sponsor may apply for Treatment IND status to provide promising drugs to patients with a life-threatening disease (e.g., AIDS) if no comparable therapy exists or the patients cannot participate in clinical studies. Phase III trials are the most critical in the determination of a drug’s approval for labeling by the FDA and international regulatory authorities. Typically, Phase III trials are structured as randomized controlled trials involving enough patients carefully selected, often across multiple sites, to obtain data on the drug’s overall benefit/risk relationship so that regulators, often guided by expert panels, can be comfortable that the balance is favorable for the defined population (Nies, 2001). While such studies typically can last from 1 to 4 years and commonly include from 1,000 to 10,000 patients, generally only a few hundred patients are treated for more than 3 to 6 months with the drug, regardless of the duration of treatment required in clinical practice. As a result, only the most profound and overt risks and side effects that occur immediately after taking a drug can be detected if the occurrence rate is 1 in 100 administrations. Risks that are medically important but delayed, less frequent than 1 in 1,000 administrations, or not evenly distributed across the population may not be revealed prior to marketing (Nies, 2001). In particular, serious adverse effects for a specific patient population (e.g., pediatric, geriatric, those with renal dysfunction or multiple comorbidities) usually will not be known, as those groups are not well represented in the trials (Lee et al., 2001; Klein et al., 2002). Accordingly, postmarket surveillance and evaluation studies (Phase IV) are often requested for further evaluation of safety issues (e.g., adverse effects) after approval. During a January 2005 meeting on drug development science sponsored by the FDA and the Association of American Medical Colleges (AAMC), participants from academia, industry, and government identified 5 Pharmacodynamics denotes the biochemical and physiological effects of a drug and the relationship between drug concentration and effect. Pharmacokinetics is the activity or fate of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion.
OCR for page 57
Preventing Medication Errors crucial problems with the current model and opportunities for improvement (AAMC, 2005). The participants found that study designs often are not tailored to the pharmacology of potential new drugs and the patient populations that will use them, and frequently are not structured to allow adequate evaluation of a broad range of doses. Each of the above factors can contribute to issues of patient safety and quality of care in the medication-use process. For example, drugs can produce very different effects in elderly patients and younger adults. The elderly are more likely to have impaired kidney and renal function, to be taking other medications, or to have other medical conditions. Few clinical studies include substantial numbers of elderly patients, however, even though the elderly are a growing proportion of the general population (FDA, 1999; Noah and Brushwood, 2000; Boyd et al., 2005). Data Quality While randomized controlled trials are considered the gold standard for assessing efficacy, they rarely provide all the information needed in clinical practice (Teutsch et al., 2005). Drugs are usually compared with a placebo, and studies frequently use surrogate or intermediate measures of efficacy, such as blood pressure, low-density lipoprotein cholesterol, or tumor shrinkage, rather than tangible patient outcomes, such as mortality, morbidity, and quality of life. Placebo-based comparisons serve regulatory requirements, leaving long-term studies comparing treatments to post-approval. Without data on health outcomes, extrapolation from the carefully selected patient populations used in clinical trials to patient populations seen in typical practice settings and from the patient population used in a trial to another patient population introduces uncertainty (Teutsch et al., 2005). A variety of leaders have voiced concern about the threat posed to scientific integrity by conflicts of interest among industry and academic researchers, private-sector investigators, and regulators (Bodenheimer, 2000; Chopra, 2003; Fontanarosa et al., 2004; Psaty et al., 2004). There is evidence that research has tended to overemphasize drug benefits while downplaying risks (Rochon et al., 1994; Rothman and Michels, 1994; Bero and Rennie, 1996; Bekelman et al., 2003). Disclosure of Results Currently, public disclosure of results through registration is required only for clinical gene-transfer trials registered with the National Institutes of Health (NIH) and studies conducted under INDs (FDA, 2004b). Nondisclosure (failure to register) of all clinical trials from start to completion and
OCR for page 58
Preventing Medication Errors BOX 2-1 Summary of Key Problems with the Research and Development Process Affecting Safety and Quality in the Medication-Use System Study designs are insufficient to generate data for the full range of knowledge needs (for example, to evaluate metabolic and pharmacologic effects and clinical outcomes in specific populations). Studies are short-term, but medication use can be long-term; thus long-term effects are unknown. Public disclosure of clinical trial results may be selective. failure to report results (both positive and negative) in a public database have left sizable gaps in the knowledge base that can affect decision making by regulators and clinicians, as well as the work of researchers and editors of medical journals (Steinbrook, 2004; IOM, 2006). (See Box 2-1 for a summary of key problems with the research and development process.) Regulatory Review Prior to marketing in the United States, all new prescription drugs (including generics), OTC drugs, and biologics are subjected to formal regulatory review and approval by the FDA’s Center for Drug Evaluation and Research (CDER). The primary objectives of the regulatory review are to evaluate a drug’s safety and effectiveness and to determine whether its benefits outweigh its risks. Regulatory review also verifies that industry has taken the appropriate measures to prepare the products properly for the market. The balance of benefit and risk is influenced significantly by intended use, and varies from drug to drug and from one patient group to another (FDA, 1999; University of Utah, 2006). For example, greater risk may be tolerated for a drug designed to treat a life-threatening illness than for one designed to treat the common cold. Likewise, lower risk may be required for drugs intended for geriatric patients, who are more likely to have renal or hepatic impairment and multiple conditions (FDA, 1994). As genomics and proteomics enable drug development to become increasingly individualized, it will be possible to establish more specific benefit and risk assessments for particular patient populations with certain clinical or genetic characteristics. This capability will necessitate reexamination of the current benefit/risk model used for regulatory approval (Califf, 2004).
OCR for page 59
Preventing Medication Errors Review of Clinical Data for New Drugs and Biologics Assessment of new drugs (i.e., new molecular entities [NMEs]) is based on the New Drug Application (NDA) or the Biologic Licensing Application (BLA)—dossiers submitted by the drug sponsor that include all data from preclinical and clinical studies on safety and efficacy, proposed labeling, and manufacturing details. A team from CDER’s Office of New Drugs reviews the dossiers; communication with the sponsor occurs throughout the process to address scientific, medical, and procedural issues. The FDA uses advisory committees of external scientific experts for advice and opinions to broaden its basis for decision making on an NDA/BLA or regulatory issue. For a drug to win approval, the FDA does not require that it be better than products already available, only that it be effective (better than nothing [i.e., placebo]) and fairly safe (Deyo, 2004). A drug is determined to be effective if it achieves a “surrogate outcome” (e.g., lowers cholesterol) without its effects on life expectancy being known. The FDA does not approve every use for which a drug may be prescribed by a clinician, only the use evaluated during its clinical trial. Postmarket Surveillance of New Drugs Some of the risks associated with a new drug are not known at the time of regulatory review because the data from clinical trials are limited in terms of patient population, study size, and/or duration. Consequently, drugs must continue to be evaluated as they are used in clinical settings to detect less frequent but significant adverse side effects, long-term effects, or effects in different patient populations. Two mechanisms are available for this purpose: (1) postmarket surveillance studies, and (2) the FDA’s adverse event reporting systems (see later in the chapter). Both approaches rely on manufacturers to collect, evaluate, and report data on their own products (Fontanarosa et al., 2004). Postmarket studies can be designed to observe a drug’s effects in a larger, more heterogeneous population over 3–4 years (Berndt et al., 2005). The FDA requires postmarket studies as a condition for approval in only two product categories—drugs granted fast track status and drugs for which the manufacturer desires a pediatric indication (Fontanarosa et al., 2004). Such studies are optional for other product categories, although strongly encouraged. Manufacturers complete fewer than half of the postmarket studies they commit to undertaking as a condition for approval (FR, 2004a; Fontanarosa et al., 2004). At the request of the FDA, the IOM Committee on Assessment of the U.S. Drug Safety System is evaluating the agency’s postmarketing surveillance. More detail on surveillance systems is given in
OCR for page 60
Preventing Medication Errors the section on adverse event reporting and surveillance systems later in the chapter. Review of Clinical Data for Generics and OTCs The FDA uses a process similar to that for NMEs to review new generic drugs and OTCs. Sponsors of generics file an Abbreviated New Drug Application (ANDA) or Abbreviated Antibiotic Drug Application (AADA) that provides information supporting equivalence to an FDA-approved brand-name drug in terms of active ingredients, dosage, safety, strength, administration, quality, performance, and intended use. Generic manufacturers are not required to replicate the extensive clinical trials of the original drug, but must demonstrate bioequivalence; this can be done by measuring bioavailability (e.g., rate and extent of absorption) of the generic in 24 to 36 healthy subjects (FDA, 1999). For OTCs the FDA has established drug monographs for each OTC product class, covering acceptable ingredients, doses, and formulations (FDA, 1998). An FDA team assesses a product’s conformance to the monograph, as well as to OTC labeling guidelines. Product Labeling After deciding to approve a drug for a specific indication, the FDA evaluates the product labeling. Labeling is a broad term that encompasses a number of materials developed by pharmaceutical companies, including the professional product label (also known as the package insert); medication guides (for drugs posing a serious public health concern); patient package inserts (with content often used in media advertisements); product packaging (which pertains to the external package labeling of the drug); and any written, printed, or graphic material used for marketing (Kenny, 2001). Professional product labels (package inserts) are developed by companies on the basis of Phase III data. They are evaluated by the FDA for compliance with federal regulations, rather than for usefulness6 to health care professionals and consumers. Medication guides and patient package inserts are written for consumers in a more user-friendly language. However, problems with the design and content of all labeling materials affect their readability, comprehensibility, and usefulness (FR, 2006; Hubal and Day, 2006). The FDA’s recently published new rule on drug labeling is an 6 The Code of Federal Regulations requires that labels describe the drug’s ingredients, structural formula, and clinical pharmacology; its indications, contraindications, warnings, and precautions; its associated adverse reactions and potential for abuse; the signs and symptoms of overdose; guidelines for proper use; and how the drug is supplied.
OCR for page 94
Preventing Medication Errors vated polio; hepatitis B; hemophilus influenzae type B (polysaccharide); hemophilus influenzae type B (conjugate); varicella; and pneumococcal conjugate (IOM, 2004c). From its establishment in 1990 through the end of 2001, VAERS had received over 128,000 reports (CDC, 1999). Gaps in scientific knowledge about the possible adverse effects of vaccines and in the capacity to evaluate such effects scientifically prompted the CDC to initiate the Vaccine Safety Datalink (VSD) project in 1990 (Medstat, 2002). This project involves partnerships with several large HMOs to conduct high-quality scientific evaluations of important safety questions related to immunization. The CDC also has a number of reporting and surveillance systems for evaluating the prevalence of adverse events in clinical settings (see Box 2-6). REFERENCES AAMC (Association of American Medical Colleges). 2005. Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia, Industry, and Government. Washington, DC: FDA. Abrams T. 2005. FDA, Division of Drug Marketing, Advertising, and Communications. Submission to the IOM Committee on Identifying and Preventing Medication Errors. Washington, DC: FDA. Allan EL, Barker KN, Malloy MJ, Heller WM. 1995. Dispensing errors and counseling in community practice. American Pharmacy NS35(12):25–33. Allinson TT, Szeinbach SL, Schneider PJ. 2005. Perceived accuracy of drug orders transmitted orally by telephone. American Journal of Health System Pharmacists 62(1):78–83. AHCA (American Health Care Association). 2002. Results of the 2001 AHCA Nursing Position Vacancy and Turnover Survey. Washington, DC: AHCA. ANA (American Nurses Association). 1998. Standards of Clinical Nursing Practice. Washington, DC: ANA. Anderson G, Knickman JR. 2001. Changing the chronic care system to meet people’s needs. Health Affairs 20(6):146–160. Angell M. 2004. The Truth About Drug Companies. New York: Random House. Armstrong EP. 2000. Electronic prescribing and monitoring are needed to improve drug use. Archives of Internal Medicine 160(18):2713–2714. Avorn J. 2004. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. New York: Vintage Books, Random House. Bates DW, Gawande AA. 2003. Improving safety with information technology. New England Journal of Medicine 348(25):2526–2534. Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, Vander Vliet M, Nemeskal R, Leape LL. 1995. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. Journal of the American Medical Association 274(1):29–34. Behrman RE. 2005. Adverse Reactions: Information in, Information out. [Online]. Available: http://www.iom.edu/CMS/3740/24155/29378.aspx [accessed February 6, 2006]. Bekelman JE, Li Y, Gross GP. 2003. Scope and impact of financial conflicts of interest in biomedical research. Journal of the American Medical Association 289(4):454–465. Berndt ER, Gottschalk AHB, Strobeck MW. 2005. Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA. Cambridge, MA: National Bureau of Economic Research.
OCR for page 95
Preventing Medication Errors Bero LA, Rennie D. 1996. Influences on the quality of published drug studies. International Journal of Technology Assessment in Health Care 12(20):209–237. Blumenthal D. 2004. Doctors and drug companies. New England Journal of Medicine 351(18):1885–1890. Bobb A, Gleason K, Husch M, Feinglass J, Yarnold PR, Noskin GA. 2004. The epidemiology of prescribing errors. Archives of Internal Medicine 164(7):785–792. Bodenheimer T. 2000. Clinical investigators and the pharmaceutical industry. New England Journal of Medicine 42(20):1540–1543. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. 2005. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: Implications for pay for performance. Journal of the American Medical Association 294(6): 716–724. Brennan TA, Gawande A, Thomas E, Studdert D. 2005. Accidental deaths, saved lives, and improved quality. New England Journal of Medicine 353(13):1405–1409. Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Goldman J, Kassirer JP, Kimball H, Naughton J, Smelser N. 2006. Health industry practices that create conflicts of interest: A policy proposal for academic medical centers. Journal of the American Medical Association 295(4):429–433. Buchanan TL, Barker KN, Gibson JT, Jiang BC, Pearson RE. 1991. Illumination and errors in dispensing. American Journal of Hospital Pharmacy 48(10):2137–2145. Budnitz D. 2005. The CDC’s National Electronic Injury Surveillance System: Cooperative Adverse Drug Event Surveillance Project. Washington, DC: IOM Committee on Identifying and Preventing Medication Errors. Budnitz DS, Pollock DA, Mendelsohn AB, Weidenbach KN, McDonald AK, Annest JL. 2005. Emergency department visits for outpatient adverse drug events: Demonstration for a national surveillance system. Annals of Emergency Medicine 45(2):197–206. Bulechek G, McCloskey J, Titler M, Denehey J. 1994. Nursing interventions used in practice. American Journal of Nursing 94(10):59–66. Burke KG, Mason DJ, Alexander M, Barnsteiner JH, Rich VL. 2005. Making medication administration safe: Report challenges nurses to lead the way. American Journal of Nursing 28(Suppl. 2):2–3. Califf RM. 2004. Defining the balance of risk and benefit in the era of genomics and proteomics. Health Affairs 23(1):77–87. Califf RM, DeMets DL. 2002a. Principles from clinical trials relevant to clinical practice: Part I. Circulation 106:1015–1021. Califf RM, DeMets DL. 2002b. Principles from clinical trials relevant to clinical practice: Part II. Circulation 106:1172–1175. Califf RM, Gibbons RJ, Brindis RG, Smith SC. 2002. Integrating quality into the cycle of therapeutic development. Journal of the American College of Cardiology 40(11):1895– 1901. Calis KA, Young LR. 2004. Clinical analysis of adverse drug reactions: A primer for clinicians. Hospital Pharmacy 39(7):697–712. Carney SL, Nair KR, Sales MA, Walsh J. 2001. Pharmaceutical industry-sponsored meetings: Good value or just a free meal? Internal Medicine Journal 31(8):488–491. Castle NG, Engberg J. 2005. Staff turnover and quality of care in nursing homes. Medical Care 43(6):616–626. CDC (Centers for Disease Control and Prevention). 1999. FDA on VAERS. [Online]. Available: http://www.cdc.gov/nip/vacsafe/concerns/hepB/fdatest.htm#Limitations [accessed January 11, 2006].
OCR for page 96
Preventing Medication Errors Chew LD, O’Young TS, Hazlet TK, Bradley KA, Maynard C, Lessler D. 2000. A physician survey of the effect of drug sample availability on physicians’ behavior. Journal of General Internal Medicine 15(7):478–483. Chimonas S, Rothman DJ. 2005. New federal guidelines for physician-pharmaceutical industry relations: The politics of policy formation. Health Affairs 24(4):949–960. Chopra SS. 2003. Industry funding of clinical trials: Benefit or bias? Journal of the American Medical Association 290(1):113–114. Christensen ML, Helms RA, Chesney RW. 1999. Is pediatric labeling really necessary? Pediatrics 104(3 Pt. 2):593–597. Chung RS, Taira DA, Noh C. 2003. Alternate financial incentives in multitiered formulary systems to improve accountability for outcomes. Journal of Managed Care Pharmacy 9(4):360–365. Classen DC, Pestotnik SL, Evans RS, Burke JP. 1991. Computerized surveillance of adverse drug events in hospital patients. Journal of the American Medical Association 266(20):2847–2851. Cohen MR. 2000. Medication Errors: Causes, Prevention, and Risk Management. Sudbury, MA: Jones and Bartlett Publishers. Cohen MR. 2005. Overview of the Institute for Safe Medication Practice and Reported Adverse Drug Events. Huntingdon Valley, PA: Institute of Safe Medication Practice. Coyle SL. 2002. Physician–industry relations: Part 1: Individual physicians. Annals of Internal Medicine 136(5):396–402. Cropper CM. 2005. Counter intelligence. BusinessWeek. [Online]. Available: http://www.businessweek.com/@@1N2NgIUQOPQ*bx0A/magazine/content/05_21/b3934126_mz070.htm [accessed June 7, 2006]. Cummings SR, Palermo L, Browner W, Marcus R, Wallace R, Pearson J, Blackwell T, Eckert S, Black D. 2000. Monitoring osteoporosis therapy with bone densitometry: Misleading changes and regression to the mean. Journal of the American Medical Association 283(10):1318–1321. D’Arcy PF. 1993. Adverse reactions and interactions with herbal medicines. Part 2. Drug interactions. Adverse Drug Reactions and Toxicological Reviews 12:147–162. Davey P, Pagliart C, Hayes A. 2002. The patient’s role in the spread and control of bacterial resistance to antibiotics. Clinical Microbiology and Infectious Disease 8(Suppl. 2):43–68. Davis NM. 1996. Performance lapses as a cause of medication errors. Hospital Pharmacy 31:1524–1527. Davis NM, Cohen MR. 1994. Ten steps for ensuring dispensing accuracy. American Pharmacy NS34(7):22–23. Dean B, Schachter M, Vincent C, Barber N. 2002. Prescribing errors in hospital inpatients: Their incidence and clinical significance. Quality Safety Health Care 11(4):340–344. Deyo RA. 2004. Gaps, tensions, and conflicts in the FDA approval process: Implications for clinical practice. Journal of the Board of Family Practice 17(2):142–149. Dick A, Keady S, Mohamed F, Brayley S, Thomson M, Lloyd BW, Heuschkel R, Afzal NA. 2003. Use of unlicensed and off-label medications in pediatric gastroenterology with a review of the commonly used formularies in the U.K. Aliment Pharmacology and Therapeutics 17:571–575. Donohue SM, Needleman SM. 1998. Potential cause of medication administration error. Anesthiology 89(3):800–803. Evans RS, Pestotnik SL, Classen DC, Bass SB, Menlove RL, Gardner RM, Burke JP. 1991. Development of a computerized adverse drug event monitor. Proceedings of the Annual Symposium on Computer Applications in Medical Care 23–27. Evans RS, Pestotnik SL, Classen DC, Horn SD, Bass SB, Burke JP. 1994. Preventing adverse drug events in hospitalized patients. The Annals of Pharmacotherapy 28(4):523–527.
OCR for page 97
Preventing Medication Errors FDA (U.S. Food and Drug Administration). 1994. Specific Requirements on Content and Format of Labeling for Human Prescription Drugs. Revision of Pediatric Use Subsection in the Labeling. Final Rule Edition. CFR Part 201 [Docket No. 92N-0165]. Rockville, MD: FDA. FDA. 1998. The CDER Handbook. Rockville, MD: U.S. Department of Health and Human Services. FDA. 1999. From Test Tube to Patient: Improving Health Through Human Drugs. Rockville, MD: FDA. FDA. 2003. FDA’s Review Process for New Drug Applications: A Management Review. Rockville, MD: U.S. Department of Health and Human Services. FDA. 2004a. 2004 Report to the Nation: Improving Public Health Through Human Drugs. Rockville, MD: FDA. FDA. 2004b. Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. Rockville, MD: FDA. Fialova D, Topinkova E, Gambassi G, Finne-Soveri H, Jomsson PV, Carpenter I, Schroll M, Onder G, Sorbye LW, Wagner C, Reissigova J, Bernabei R. 2005. Potentially inappropriate medication use among elderly home care patients in Europe. Journal of the American Medical Association 293(11):1348–1358. Fick DM, Maclean JR, Rodriguez NA, Short L, Vanden Heuvel R, Waller JL, Rogers RL. 2004. A randomized study to decrease the use of potentially inappropriate medications among community-dwelling older adults in a Southeastern managed care organization. American Journal of Managed Care 10(11):761–768. Field MJ, Grigsby J. 2002. Telemedicine and remote patient monitoring. Journal of the American Medical Association 288(4):423–425. Fields M, Peterman J. 2005. Intravenous medication safety system averts high-risk medication errors and provides actionable data. Nursing Administration Quarterly 29(1):78–87. Flynn EA, Barker KN, Gibson JT, Pearson RE, Berger BA, Smith LA. 1999. Impact of interruptions and distractions on dispensing errors in an ambulatory care pharmacy. American Journal of Health System Pharmacists 56(13):1319–1325. Flynn EA, Barker KN, Carnahan BJ. 2003. National observational study of prescription dispensing accuracy and safety in 50 pharmacies. Journal of the American Pharmaceutical Association 43(2):191–200. Fontanarosa PB, Rennie D, DeAngelis CD. 2004. Postmarketing surveillance-lack of vigilance, lack of trust. Journal of the American Medical Association 292(21):2647–2650. Forester AJ, Halil RB, Tierney MG. 2004. Pharmacist surveillance of adverse drug events. American Journal of Health System Pharmacists 61(14):1466–1472. FR (Federal Register). 2004a. Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Washington, DC: U.S. Department of Health and Human Services. FR. 2004b. Bar Code Label Requirements for Human Drug Products and Biological Products: Final Rule. Washington, DC: National Archives and Records Administration. FR. 2006. Requirements on Content and Format of Labeling for Human Drug and Biological Products and Draft Guidances and Two Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products: Final Rule and Notices. Washington, DC: National Archives and Records Administration. Frank C, Godwin M, Verma S, Kelly A, Birenbaum A, Seguin R, Anderson J. 2001. What drugs are our frail elderly patients taking? Do drugs they take or fail to take put them at increased risk of interactions and inappropriate medication use? Canadian Family Physician 47:1198–1204. Frush KS, Luo X, Hutchinson P, Higgins JN. 2004. Evaluation of a method to reduce over-the-counter medication dosing error. Archives of Pediatric Medicine 158:620–624.
OCR for page 98
Preventing Medication Errors Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. 2003. Adverse drug events in ambulatory care. New England Journal of Medicine 348(16):1556–1564. GAO (Government Accountability Office). 2004. Internet Pharmacies: Some Pose Safety Risks for Consumers. Washington, DC: GAO. Gladstone J. 1995. Drug administration errors: A study into the factors underlying the occurrence and reporting of drug errors in a district general hospital. Journal of Advanced Nursing 22:628–637. Golden AG, Preston RA, Barnett SD, Llorente M, Hamdan K, Silverman MA. 1999. Inappropriate medication prescribing in homebound older adults. Journal of the American Geriatrics Society 47(8):948–953. Goodman B. 2001. Do drug company promotions influence physician behavior? Western Journal of Medicine 174:232–233. Greengold NL, Shane R, Schneider P, Flynn E, Elashoff J, Hoying CL, Barker K, Bolton LB. 2003. The impact of dedicated medication nurses on the medication administration error rate. Archives of Internal Medicine 163(19):2359–2367. Gribetz B, Crunley SA. 1987. Underdosing of acetaminophen by parents. Pediatrics 80: 630–633. Grissinger M, Kroon L, Prenna P. 2003. Misadventures in insulin therapy: Are your members at risk? Journal of Managed Care Pharmacy 9(Suppl. 3). Groves KEM, Sketris I, Tett SE. 2003. Prescription drug samples: Does this marketing strategy counteract policies for quality use of medicines? Journal of Clinical Pharmacy and Therapeutics 28:259–271. 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. 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. American Journal of Medicine 118(3):251–258. Haley RW, Culver DH, White JW, Morgan WM, Emori TG, Munn VP, Hooton TM. 1985. The efficacy of infection surveillance and control programs in preventing nosocomial infections in U.S. hospitals. American Journal of Epidemiology 121(2):182–205. Hanlon JT, Fillenbaum GG, Schmader KE, Kuchibhatla M, Horner RD. 2000a. Inappropriate drug use among community-dwelling elderly. Pharmacotherapy 20(5): 575–582. Hanlon JT, Shrimp LA, Semla TP. 2000b. Recent advances in geriatrics: Drug-related problems in the elderly. Annals of Pharmacotherapy 34:360–365. Hartigan K. 2003. Patient education: The cornerstone of successful oral chemotherapy treatment. Clinical Journal of Oncology Nursing 7(6):21–24. Holbrook AM, Pereira JA, Labris R, McDonald H, Douketis JD, Crowther M, Wells PS. 2005. Systematic overview of warfarin and its drug and food interactions. Archives of Internal Medicine 165(10):1095–1106. Horsky J, Kuperman GJ, Patel VL. 2005. Comprehensive analysis of a medication dosing error related to CPOE. Journal of the American Medical Informatics Association 12(4): 377–382.
OCR for page 99
Preventing Medication Errors HPA (Health Policy Alternatives, Inc.). 2003. Pharmacy Benefit Managers: Tools for Managing Drug Benefit Costs, Quality, and Safety. Washington, DC: Pharmaceutical Care Management Association. The HSM Group. 2002. Acute Care Hospital Survey of RN Vacancy and Turnover Rates. Chicago, IL: American Organization of Nurse Executives. Hubal R, Day RS. 2006. Understanding the frequency and severity of side effects: Linguistic, numeric, and visual representations. In: Bickmore T, Green N, Editors. Argumentation for Consumers of Healthcare: Papers From the 2006 Spring Symposium. Technical Report SS-06-01. Menlo Park, CA: American Association of Artificial Intelligence. Husakamp HA, Deverka PA, Epstein AM, Epstein RS, McGuigan KA, Frank RG. 2003. The effect of incentive-based formularies on prescription-drug utilization and spending. New England Journal of Medicine 349(23):2224–2232. Ikesue H, Ishida M, Uchida M, Harada M, Haro T, Mishima K, Itoh Y, Kotsubo K, Yoshikawa M, Oishi R. 2004. Monitoring for potential adverse drug reactions in patients receiving chemotherapy. American Journal of Health System Pharmacy 61(22):2366– 2369. IMS Health. 2004. Total U.S. Promotional Spending by Type, 2003. [Online]. Available: http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_44304752_44889690,00.html [accessed June 7, 2006]. IOM (Institute of Medicine). 2000. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press. IOM. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press. IOM. 2002. Leadership by Example: Coordinating Government Roles in Improving Health Care Quality. Washington, DC: The National Academies Press. IOM. 2003. Priority Areas for National Action: Transforming Health Care Quality. Washington, DC: The National Academies Press. IOM. 2004a. Health Literacy: A Prescription to End Confusion. Washington, DC: The National Academies Press. IOM. 2004b. Keeping Patients Safe: Transforming the Work Environment of Nurses. The National Academies Press. IOM. 2004c. Patient Safety: Achieving a New Standard for Care. Washington, DC: The National Academies Press. IOM. 2006. Developing a Registry of Pharmacologic and Biologic Clinical Trials. Washington, DC: The National Academies Press. Jarman H, Jacobs E, Zielinski V. 2002. Medication study supports registered nurses’ competence for single checking. Internal Journal of Nursing Practice 8(6):330–335. Jenkins R, Elliott P. 2004. Stressors, burnout and social support: Nurses in acute mental health settings. Journal of Advanced Nursing 48(6):622–631. Jha AK, Kuperman GJ, Teich JM, Leape L, Shea B, Rittenberg E, Burdick E, Seger DL, Vander Vliet M, Bates DW. 1998. Identifying adverse drug events: Development of a computer-based monitor and comparison with chart review and stimulated voluntary report. Journal of the American Medical Informatics Association 5(3):305–314. Jong GW, Vulto AG, de Hoog M, Schimmel KJM, Tibboel D, van den Anker JN. 2001. A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics 108(5):1089–1093. Kastango ES. 2003. Compounding Sterile Preparations. Bethesda, MD: American Society of Health System Pharmacists. Katz D, Caplan AL, Merz JF. 2003. All gifts large and small: Toward an understanding of the ethics of pharmaceutical industry gift-giving. American Journal of Bioethics 3(3):39–46.
OCR for page 100
Preventing Medication Errors Kenny R. 2001. Introduction to Compliance with FDA Labeling and Advertising Requirements. [Online]. Available: http://www.ehcca.com/presentations/PharmaReg1/203_1.pdf [accessed June 30, 2005]. Klein DF, Thase ME, Endicott J, Adler L, Glick I, Kalai A, Leventer S, Mattes J, Ross P, Bystritsky A. 2002. Improving clinical trials. Archives of General Psychiatry 59(3):272–278. Knowlton CH, Penna RP. 2003. Pharmaceutical Care. 2nd ed. Bethesda, MD: American Society of Health System Pharmacists. 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. Kos M. 2005. Satisfaction with pharmacotherapy for approved and off-label indications: A Delphi study. Annals of Pharmacotherapy 39(4):649–654. Landon BE, Reschovsky JD, Blumenthal D. 2004. Physicians’ views of formularies: Implications for Medicare drug benefit design. Health Affairs 23(1):218–226. Leape LL. 2002. Reporting of adverse events. New England Journal of Medicine 347(20): 1633–1638. Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T, Hallisey R, Ives J, Laird N, Laffel G, Nemeskal R, Petersen L, Porter K, Servi D, Shea B, Small S, Sweitzer B, Thompson B, Vander Vleit M. 1995. Systems analysis of adverse drug events. Journal of the American Medical Association 274(1):35–43. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. 2001. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. Journal of the American Medical Association 286(6):708–713. Leonard EM. 1994. Quality assurance and the drug development process: An FDA perspective. Quality Assurance 3:178–186. Lesar TS, Briceland LL, Delcoure K, Parmalee JC, Masta-Gornic V, Pohl, H. 1990. Medication prescribing errors in a teaching hospital. Journal of the American Medical Association 263(17):2329–2334. Lesar TS, Briceland L, Stein D. 1997. Factors related to errors in medication prescribing. Journal of the American Medical Association 277(4):312–317. Levy R. 1994. The role and value of pharmaceutical marketing. Archives of Family Medicine 3:327–332. Lifshitz M, Gavrilov V, Gorodischer R. 2001. Off-label and unlicensed use of antidotes in pediatric patients. European Journal of Clinical Pharmacology 56:839–841. Livingston MG, Livingston HM. 1996. Monamine oxidase inhibitors. An update on drug interactions. Drug Safety 14(4):219–227. Loder EW, Biondi DM. 2004. Off-label prescribing of drugs in specialty headache practice. Headache 44(7):636–641. Loucks M. 2003. Department of Justice Investigations and the Pharmaceutical Industry. Washington, DC: Fourth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum. Madlon-Kay DJ, Mosch FS. 2000. Liquid medication dosing errors. Journal of Family Practice 49(8):741–744. Maguire P. 2001. Samples: Cost-Driver or Safety Net? [Online]. Available: http://www.acponline.org/journals/news/jan01/drugsamples.htm [accessed August 21, 2005]. Manasse HR, Thompson KK. 2005. Medication Safety: A Guide for Health Care Facilities. Bethesda, MD: American Society of Health System Pharmacists. Manias E, Aitken R, Dunning T. 2005. How graduate nurses use protocols to manage patients’ medications. Journal of Clinical Nursing 14:935–944. March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R. 2005. The case for practical clinical trials in psychiatry. American Journal of Psychiatry 162(5):836–846.
OCR for page 101
Preventing Medication Errors Martin EW. 1978. Hazards of Medications. Philadelphia, PA: J.B. Lippincott Company. Medstat. 2002. Implementation Planning Study for the Integration of Medical Event Reporting Input and Data Structure for Reporting to AHRQ, CDC, CMS, and FDA. Final Report: Volume 2–Appendixes. Rockville, MD: AHRQ. Moore TJ, Psaty BM, Furberg CD. 1998. Time to act on drug safety. Journal of the American Medical Association 279:1571–1573. Moynihan R. 2003. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 2: Disentanglement. British Medical Journal 326:1193–1196. Munroe DJ. 2003. Assisted living issues for nursing practice. Geriatric Nursing 24(2): 99–105. Murphy D. 2005. Pediatric Drug Development and Medication Errors. Washington, DC: IOM Committee on Identifying and Preventing Medication Errors. NABP (National Association of Boards of Pharmacy). 2004. Survey of Pharmacy Law. Mount Pleasant, IL: NAPB. NACDS (National Association of Chain Drug Stores). 1999. Pharmacy Activity Cost and Productivity Study. Alexandria, VA: NACDS. NASHP (National Academy for State Health Policy). 2006. Patient Safety Toolbox for States. [Online]. Available: http://www.pstoolbox.org/_docdisp_page.cfm?LID=6BC2AB7D-6F1E-4DF2-AD20DAE18001147B [accessed, June 7, 2006]. NCI (National Cancer Institute). 2004. Q&A: Off-Label Drugs. [Online]. Available: http://www.nci.nih.gov/clinicaltrials/learning/approval-process-for-cancer-drugs/page5 [accessed June 29, 2005]. Nicholas PK, Agius CR. 2005. Toward safer IV medication administration. American Journal of Nursing 105(3):25–30. Nies AS. 2001. Principles of therapeutics. In: Hardman JG, Limbird LE, Gilman AG, Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York: McGraw Hill. NIHCMREF (National Institute for Health Care Management and Research and Educational Foundation). 2002. Prescription Drug Expenditures in 2001: Another Year of Escalating Costs. Washington, DC: NIHCMREF. NLM (National Library of Medicine). 2005. MedlinePlus: Antidepressants, Monamine Oxidase Inhibitors (MAO) (Systemic). [Online]. Available: http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202054.html [accessed August 30, 2005]. Noah BA, Brushwood DB. 2000. Adverse drug reactions in elderly patients: Alternative approaches to postmarket surveillance. Journal of Health Law 33(3):383–454. Norrish B, Rundall T. 2001. Hospital restructuring and the work of registered nurses. Milbank Quarterly 79(1):55. NPSF (National Patient Safety Foundation). 1997. National Patient Safety Foundation at the AMA: Public Opinion of Patient Safety Issues Research Findings. Louis Harris and Associates. NRC (National Research Council). 1995. Standards, Conformity Assessment, and Trade. Washington, DC: National Academy Press. NRC. 2004. Health and Medicine: Challenges for the Chemical Sciences in the 21st Century. Washington, DC: The National Academies Press. Nunn AJ. 2003. Making medicines that children can take. Archives of Disease in Childhood 88(5):369–371. O’Shea E. 1999. Factors contributing to medication errors: A literature review. Journal of Clinical Nursing 8:496–504. Patel VL, Branch T, Arocha JF. 2002. Errors in interpreting quantities as procedures: The case of pharmaceutical labels. International Journal of Medical Informatics 65(3): 193–211.
OCR for page 102
Preventing Medication Errors Patterson ES. 2003. Addressing human factors in bar code medication administration systems. Hospital Pharmacy 38(11):S16–S17. Pedersen CA, Schneider PJ, Scheckelhoff DJ. 2003. ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2002. American Journal of Health System Pharmacists 60(1):52–68. Petersen M. 2000, November 15. Growing opposition to free drug samples. New York Times. Business. Phillips J, Beam S, Brinker A, Holquist C, Honig P, Lee LY, Pamer C. 2001. Retrospective analysis of mortalities associated with medication errors. American Journal of Health System Pharmacists 58:1835–1841. Poole SG, Dooley MJ. 2004. Off-label prescribing in oncology. Supportive Care in Cancer 12(5):302–305. PPSA (Pennsylvania Patient Safety Authority). 2006. Patient Safety Authority. [Online]. Available: http://www.psa.state.pa.us/psa/site [accessed June 7, 2006]. Presecky W. 2006, February 25. FDA joins probe after 2 infants die in Kane. Chicago Tribune. Psaty BM, Furberg CD, Ray WA, Weiss NS. 2004. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: Use of cerivastatin and risk of rhabdomyolysis. Journal of the American Medical Association 292(21):2622–2631. Ringold DJ, Santell JP, Schneider PJ. 1999. ASHP national survey of pharmacy practice in acute care settings: Dispensing and administration. American Journal of Health System Pharmacists 57(19):1759–1775. Roberts DE, Spencer MG, Burfield R, Bowden S. 2002. An analysis of dispensing errors in U.K. hospitals. Internal Journal of Pharmacy Practice 10(Supplement):R6. Rochon PA, Gurwitz JH, Simms RW, Fortin PR, Felson DT, Minaker KL, Chalmers TC. 1994. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Archives of Internal Medicine 154:157–163. Rosenthal J, Booth M. 2005. Maximizing the Use of State Adverse Event Data to Improve Patient Safety. Portland, ME: National Academy for State Health Policy. Rothman K, Michels K. 1994. The continuing unethical use of placebo controls. New England Journal of Medicine 331(6):394–398. RSW (Roper Starch Worldwide). 2001. Self-Care in the New Millennium. Washington, DC: Consumer Healthcare Products Association. Sawicki PT. 1999. A structured teaching and self-management program for patients receiving oral anticoagulation: A randomized controlled trial. Journal of the American Medical Association 281(2):145–150. Schiff GD, Klass D, Peterson J, Shah G, Bates DW. 2003. Linking laboratory and pharmacy: Opportunities for reducing errors and improving care. Archives of Internal Medicine 163(8):893–900. Schondelmeyer S. 2005. Community Pharmacy Perspectives on Preventing Medication Errors at the July 6, 2005, Meeting of the IOM Committee on Identifying and Preventing Medication Errors, Washington, DC. Schroeder K, Fahey T, Ebrahim S. 2004. How to improve adherence to blood pressure-lowering medication in ambulatory care? Archives of Internal Medicine 164(7): 722–732. Schull PD. 2005. Five Rights Still Resound. Nursing Spectrum. [Online]. Avaliable: http:// community.nursingspectrum.com/MagazineArticles/article.cfm?AID=17801 [accessed June 7, 2006]. Shrank WH, Young HN, Ettner SL, Glassman P, Asch SM, Kravitz RL. 2005. Do the incentives in 3-tiered pharmaceutical benefit plans operate as intended? Results from a physician leadership survey. American Journal of Managed Care 11(1):16–22.
OCR for page 103
Preventing Medication Errors Simaon HK, Winkle DA. 1997. Over-the-counter medications: Do parents give what they intend to give? Archives of Pediatrics and Adolescent Medicine 151(7):654–656. Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, Chan KA, Platt R, Schech SD, Ray W. 2000. Contraindicated use of cisapride: Impact of Food and Drug Administration regulatory action. Journal of the American Medical Association 284(23):3036–3039. Smetzer J. 2001. Safer medication management. Nursing Management 32(12):44–48. Smetzer J, Cohen MR. 2006. Medication Error Reporting Systems in Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association. Smith PC, Araya-Guerra R, Bublitz C, Parnes B, Dickinson LM, Van Vorst R, Westfall JM, Pace WD. 2005. Missing clinical information during primary care visits. Journal of the American Medical Association 293(5):565–571. Steinbrook R. 2004. Public registration of clinical trials. New England Journal of Medicine 351(4):315–317. Strom BL. 2004. Potential conflict of interest in the evaluation of suspected adverse drug reactions. Journal of the American Medical Association 292(21):2643–2646. Studdert DM, Mello MM, Brennan TA. 2004. Financial conflicts of interest in physicians’ relationships with the pharmaceutical industry: Self-regulation in the shadow of federal prosecution. New England Journal of Medicine 351(18):1891–1900. Suzuki K, Ohida T, Kaneita Y, Yokoyama E, Uchiyama M. 2005. Daytime sleepiness, sleep habits and occupational accidents among hospital nurses. Journal of Advanced Nursing 52(4):445–453. Svarstad BL, Bultman DC, Mount JK. 2004. Patient counseling provided in community pharmacies: Effects of state regulation, pharmacist age, and business. Journal of the American Pharmaceutical Association 44(1):22–29. Szefler SJ, Whelan GJ, Leung DY. 2006. Black box warning: Wake-up call or overreaction? Journal of Allergy and Clinical Immunology 117(1):26–29. Taira DA, Iwane KA, Chung RS. 2003. Prescription drugs: Elderly enrollee reports of financial access, receipt of free samples, and discussion of generic equivalents related to type of coverage. American Journal of Managed Care 9(4):305–312. Tamada JA, Garg S, Jovanovic L, Pitzer KR, Fermi S, Potts RO. 1999. Noninvasive glucose monitoring: Comprehensive clinical results. Journal of the American Medical Association 282(19):1839–1844. Teutsch SM, Berger ML, Weinstein MC. 2005. Comparative effectiveness: Asking the right questions, choosing the right method. Health Affairs 24(1):128–132. Thomas CP. 2003. Incentive-based formularies. New England Journal of Medicine 349(23): 2186–2188. Tokars JI, Richards C, Andrus M, Klevens M, Curtis A, Horan T, Jernigan J, Cardo D. 2004. The changing fact of surveillance for health care-associated infections. Clinical Infectious Diseases 39:1347–1352. University of Utah. 2006. Chapter 1: Testing and Marketing: Drug Development. [Online]. Available at: http://www.pharmacy.utah.edu/pharmtox/common_meds/ICM1.html [accessed June 5, 2006]. USP (U.S. Pharmacopeia). 2003. Summary of Information Submitted to MedMarx in the Year 2002. Rockville, MD: USP. USP. 2004. MedMarx 5th Anniversary Data Report: A Chartbook of 2003 Findings and Trends 1999–2003. Rockville, MD: USP. Vincent C. 2001. Clinical Risk Management: Enhancing Patient Safety. 2nd ed. London, UK: BMJ Books.
OCR for page 104
Preventing Medication Errors Wagner AK, Chan KA, Dashevsky I, Raebel MA, Andrade SE, Lafata JE, Davis RL, Gurwitz JH, Soumerai SB, Platt R. 2006. FDA drug prescribing warnings: Is the black box half empty or half full? Pharmacoepidemiology and Drug Safety 15(6):369–386. Wakefield DS, Wakefield BJ, Borders T, Uden-Holman T, Blegen M, Vaughn T. 1999. Understanding and comparing differences in reported medication administration error rates. American Journal of Medical Quality 14(2):73–80. Walls CA, Rhodes KV, Kennedy JJ. 2002. The emergency department as usual source of medical care: Estimates from the 1998 National Health Interview Survey. Academic Emergency Medicine 9(11):1140–1145. Walters PG. 1992. FDA’s new drug evaluation process: A general overview. Journal of Public Health and Dentistry 52:333–337. Watzke HH, Forberg E, Svolba G, Jimenez-Boj E, Krinninger B. 2000. A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation. Thrombosis and Haemostasis 83(5): 661–665. Wazana A. 2000. Physicians and the pharmaceutical industry: Is a gift ever just a gift? Journal of the American Medical Association 283(3):373–380. Weatherby LB, Walker AM, Fife D, Vervaet P, Klausner MA. 2001. Contraindicated medications dispensed with cisapride: Temporal trends in relation to the sending of “Dear doctor” letters. Pharmacoepidemiology and Drug Safety 10:210–218. Weatherby LB, Nordstrom BL, Fife D, Walker AM. 2002. The impact of wording in “Dear doctor” letters and in black box labels. Clinical Pharmacology and Therapeutics 72(6):735–742. Wilkes MS, Bell RA, Kravitz RL. 2000. Direct-to-consumer prescription drug advertising: Trends, impact, and implications. Health Affairs 19:110–128. Woods A, Johnson SD. 2002. Executive summary: Toward a taxonomy of nursing practice errors. Nursing Management 33(10):45–48.
Representative terms from entire chapter: