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Preventing Medication Errors B Glossary of Terms and Acronyms TERMS ACE inhibitor. Angiotensin-converting enzyme inhibitor. Adverse drug event. Any injury due to medication (Bates et al., 1995b). Adverse event. An event that results in unintended harm to the patient due to an act of commission or omission rather than the underlying disease or condition of the patient (IOM, 2004). Ambulatory care. For the purposes of this study, care given in (1) the ambulatory clinic, (2) the community pharmacy, (3) the home care setting, (4) the self-care setting, or (5) the school setting. Biologics (including vaccines, blood, and blood products). A subset of drug products. Biologics are distinguished from other drugs by their manufacturing process—biological as opposed to chemical. Clinician. An individual who uses a recognized scientific knowledge base and has the authority to deliver health care services to patients (IOM, 1996). The term encompasses prescribers, nurses, and pharmacists. Dietary supplement. A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the dietary intake; or a concentrate, metabolite, constituent, extract or combination of any ingredient described above (Dietary Supplement Health and Education Act of 1994 [P.L. 103-147]). Drug. A substance that is recognized by an official pharmacopoeia or formulary; intended for use in the diagnosis, cure, mitigation, treatment, or
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Preventing Medication Errors prevention of disease; intended to affect the structure or any function of the body (other than food); intended for use as a component of a medicine but not a device or a component, or a part or accessory of a device (FDA, 2004). Drugs are divided into those that require a prescription and those that do not. Nonprescription drugs are usually called “over-the-counter” (OTC) drugs (see below). Error. The failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning). An error may be an act of commission or an act of omission (IOM, 2004). Formulary. A schedule of prescription drugs that will be paid for by a health insurance plan and dispensed through participating pharmacies. A formulary can be an important safety tool since it can eliminate (for example, in hospitals) the use of drug products considered to be unsafe. Hand-off. The process of moving patients and their information from one provider or site to another. Health care professional. See clinician. Managed Care Organization. A health care provider that attempts to manage the access, cost, and quality of health care. Medication. See drug. Medication error. Any error occurring in the medication-use process (Bates et al., 1995a). Medication therapy management. A service or group of services that optimize therapeutic outcomes for individual patients to help ensure that the goals of drug therapy are achieved. These services can be provided in conjunction with or independently of the provision of a medication product by pharmacists or other qualified health care providers. Nonformulary drug. A medication that has a preferred alternative listed in the drug formulary. Off-label use. The Food and Drug Administration (FDA) permits the prescribing of approved medications for other than their intended indications. This practice is known as off-label use. Orphan drug. A product that is used in the diagnosis or treatment of diseases or conditions that are considered rare in the United States. OTC (“over-the-counter”) drug. A drug sold without a prescription. The product’s potential for misuse and abuse is low, consumers are successfully able to use it for self-diagnosable conditions, it can be adequately labeled for ease and accuracy of use, and oversight by health practitioners is not needed to ensure its safe and effective use (FDA, 2005). Potential adverse drug event (ADE). An event in which an error occurred but did not cause injury (for example, the error was intercepted before the patient was affected, or the patient received a wrong dose, but no harm occurred) (Gandhi et al., 2000).
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Preventing Medication Errors Practicing clinician. See clinician. Practitioner. See clinician. Preventable adverse drug event (ADE). An adverse drug event arising because of an error. Primary care. The provision health care services by clinicians who are accountable for addressing a large majority of a patient’s health care needs, developing a sustained partnership with patients, and practicing in the context of family and community (IOM, 1996). Provider. See clinician. Reconciliation. Comparison of the medications a person is taking in one care setting with those being provided in another setting. ACRONYMS AADA Abbreviated Antibiotic Drug Application AAFP American Academy of Family Physicians AAMC Association of American Medical Colleges ACE angiotensin converting enzyme ACGME Accreditation Council on Graduate Medical Education ADE adverse drug event ADWE adverse drug withdrawal event AFB American Foundation for the Blind AGS American Geriatrics Society AHA American Hospital Association AHCA American Health Care Association AHRQ Agency for Healthcare Research and Quality ALLHAT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial AMA American Medical Association ANDA Abbreviated New Drug Application ANSI American National Standards Institute APA American Psychiatric Association ASHP American Society of Health-System Pharmacists ASTM American Society for Testing and Materials BLA Biologic Licensing Application BTE Bridges to Excellence CC Cochrane Collaboration CCR Continuity of Care Record CDC Centers for Disease Control and Prevention CDER Center for Drug Evaluation and Research, Food and Drug Administration
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Preventing Medication Errors CDSS clinical decision support system CERTS Centers for Education and Research on Therapeutics CGMP Current Good Manufacturing Practices CME continuing medical education CMS Centers for Medicare and Medicaid Services CMWF The Commonwealth Fund CoSI Commission for Systemic Interoperability COX-2 cyclooxygenase-2 CPOE computerized provider (physician) order entry CTFPHC Canadian Task Force on Preventive Health Care DCRI Duke Clinical Research Institute DDMAC Division of Drug Marketing, Advertising and Communications, Food and Drug Administration DHA Australian Department of Health and Ageing DHHS Department of Health and Human Services dl deciliter DMETS Division of Medication Errors and Technical Support, Food and Drug Administration DTC direct-to-consumer EAN/UCC European Article Number/Uniform Code Council eHI eHealth Initiative EHR electronic health record FACCT Foundation for Accountability FDA U.S. Food and Drug Administration FMEA failure modes and effects analysis FPIN Family Physicians Inquiries Network FR Federal Register GAO U.S. Government Accountability Office GMP Good Manufacturing Practices GRAM Geriatric Risk Assessment MedGuide H2 histamine-2 HEDIS Health Plan Employer Data and Information Set HHS (Department of) Health and Human Services HI Harris Interactive HIBCC Health Industry Business Communications Council HIRO Hospital Incident Reporting Ontology HL7 Health Level 7
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Preventing Medication Errors HMO health maintenance organization HOPE Health Outcomes and PharmacoEconomic HPA Health Policy Alternatives, Inc. HRSA Health Resources and Services Administration ICU intensive care unit IHI Institute for Healthcare Improvement IM intramuscularly IND Investigational New Drug Application INR international normalized ratio IOM Institute of Medicine ISMP Institute for Safe Medication Practices IV intravenous JAMIA Journal of the American Informatics Association JCAHO Joint Commission on Accreditation of Healthcare Organizations JFP Journal of Family Practice JKF Josie King Foundation KFF Kaiser Family Foundation kg kilogram LDL low-density lipoprotein m2 square meter MAO monamine oxidase MAR medication administration record MBRP Massachusetts Board of Registration in Pharmacy MCPME Massachusetts Coalition for the Prevention of Medical Errors MDS Minimum Data Set MERP Medication Error Reporting Program mg milligrams MHA Massachusetts Hospital Association ml milliliters MMA Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108-173) MoA mechanism(s) of action NABP National Association of Boards of Pharmacy NACDS National Association of Chain Drug Stores
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Preventing Medication Errors NCCAM National Center for Complementary and Alternative Medicine NCCMERP National Coordinating Council for Medication Error Reporting and Prevention NCHM National Center for Health Marketing NCHS National Center for Health Statistics NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education NCQA National Committee for Quality Assurance NCVHS National Committee on Vital and Health Statistics NDA New Drug Application NDF-RT National Drug File Reference Terminology NEISS-CADES National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance NHS National Health Service NICHQ National Initiative for Children’s Healthcare Quality NIH National Institutes of Health NIHCMREF National Institute for Health Care Management and Research and Educational Foundation NIMH National Institute of Mental Health NLM National Library of Medicine NMBP New Mexico Board of Pharmacy NME new molecular entity NPSF National Patient Safety Foundation NQF National Quality Forum NRC National Research Council NSAID nonsteroidal anti-inflammatory drug OBRA Omnibus Budget Reconciliation Act OIG Office of Inspector General OSCAR Online Survey Certification and Reporting OTC over-the-counter PACE Program of All-Inclusive Care for the Elederly PBM Pharmacy Benefits Manager PCA patient-controlled analgesia PCM pharmaceutical case management PCSEPMBBR President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research PD pharmacodynamics PDA personal digital assistant PHR personal health record PhRMA Pharmaceutical Research and Manufacturers of America
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Preventing Medication Errors PICC peripherally inserted central catheter PK pharmacokinetics PMS Pathways for Medication Safety POCA Phonetic Orthographic Computer Analysis POL Physician Office Link PPAG Pediatric Pharmacy Advocacy Group PSET Patient Safety Event Taxonomy PSI Premier Safety Institute QSHC Quality and Safety in Healthcare R&D research and development RFID radio frequency identification RHIO Regional Health Information Organization RoA route of administration RSW Roper Starch Worldwide RWJF The Robert Wood Johnson Foundation SAGE Systematic Assessment of Geriatric drug use via Epidemiology SPL Structured Product Label TGA Therapeutic Goods Administration UNC University of North Carolina USAN United States Adopted Name Council USP U.S. Pharmacopeia USP-ISMP MERP United States Pharmacopeia-Institute for Safe Medication Practices Medication Errors Reporting Program VA (Department of) Veterans Affairs VAERS Vaccine Adverse Event Reporting System VHA Veterans Health Administration VistA Veterans Health Information Systems and Technology Architecture VSD Vaccine Safety Datalink WHI Women’s Health Initiative WHO World Health Organization
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Preventing Medication Errors REFERENCES Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. 1995a. Relationship between medication errors and adverse drug events. Journal of General Internal Medicine 10(4): 100–205. 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. 1995b. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. Journal of the American Medical Association 274:29–34. FDA (U.S. Food and Drug Administration). 2004. Drugs @ FDA: Glossary of Terms. [Online]. Available: http://www.fda.gov/cder/drugsatfda/glossary.htm [accessed June 7, 2005]. FDA. 2005. Office of Nonprescription Drugs. [Online]. Available: http://www.fda.gov/cder/ offices/otc/default.htm [accessed June 7, 2005]. Gandhi TK, Seger DL, Bates DW. 2000. Identifying drug safety issues: From research to practice. International Journal for Quality in Health Care 12(1):69–76. IOM (Institute of Medicine). 1996. Primary Care: America’s Health in a New Era. Washington, DC: National Academy Press. IOM. 2004. Patient Safety: Achieving a New Standard for Care. Washington, DC: The National Academies Press.
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