Glossary of Terms and Acronyms
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
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).
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.
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
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
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
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
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
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
IND Investigational New Drug Application
INR international normalized ratio
IOM Institute of Medicine
ISMP Institute for Safe Medication Practices
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
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
MHA Massachusetts Hospital Association
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
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
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
PDA personal digital assistant
PHR personal health record
PhRMA Pharmaceutical Research and Manufacturers of America
PICC peripherally inserted central catheter
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
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.