Terms & Definitions (chapter 2) Flashcards
define select drug organization, terms, laws, and drugs (from chapter 2 - in outlook email from Joslyn)
Adulteration
The mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency.
Barbiturate
A drug derived from barbituric acid; a barbiturate acts as a central nervous system depressant. Barbiturates are often used in the treatment of seizures and as sedative and hypnotic agents
Board of pharmacy (BOP)
State board that regulates the practice of pharmacy within the state
Boxed warning
Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk for potentially dangerous side effects. It is the strongest warning the US Food and Drug Administration (FDA) can give. It is common in the pharmacy profession to call these warnings “Black Box Warnings” because of their appearance in a drug label; the warning is often enclosed in a black outlined box to draw attention to the content
Controlled substance
Any drug or other substance that is scheduled I through V and regulated by the US Drug Enforcement Administration (DEA)
Drug diversion
The intentional misuse of a drug intended for medical purposes; the DEA usually defines diversion as the recreational use of a prescription or scheduled drug. Diversion also can refer to the channeling of the prescription drug supply away from legal distribution and to the illegal street market
Drug Enforcement Administration (DEA)
Federal agency within the US Department of Justice that enforces US laws and regulations related to controlled substances
Drug utilization evaluation (DUE)
A process that ensures that prescribed drugs are used appropriately. The main desired outcome of any DUE program is an increase in medication-related efficacy and safety
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Federal act that protects patients’ rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data
Legend drug
Drug that requires a prescription for dispensing; these drugs carry the federal legend: “Federal law prohibits the dispensing of this medication without a prescription”
Medicaid Federal- and state-operated insurance program
covers health care costs and prescription drugs for low-income children, adults, and elderly and those with disabilities
Medicare Federal- and state-managed insurance program
that covers health care costs and prescription drugs for individuals older than 65, persons younger than 65 with long-term disabilities, and individuals with end-stage renal disease
Misbranding
Labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and weight
Monograph Comprehensive
information on a medication’s actions within that class of drugs. Also lists generic and trade names, ingredients, dosages, side effects, adverse effects, how the patient should take the medication, and foods or other drugs (eg, over-the-counter [OTC] medications, herbals) to avoid while taking the medication
Narcotic
Narcotic A nonspecific term used to describe a drug (such as opium) that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses causes stupor, coma, or convulsions and may lead to addiction. From the standpoint of US law, opium, opiates (derivatives of opium), and opioids, in addition to cocaine and coca leaves, are “narcotics
National Drug Code (NDC)
A 10-digit number that indicates specifics of a prescription drug or an insulin product. The NDC specifies the drug manufacturer, the drug product (drug strength, dosage form, and formulation), and the package size
National Formulary (NF)
A book of standards for certain pharmaceuticals and preparations not included in the USP; revised every 5 years, and recognized as a book of official standards by the Pure Food and Drug Act of 1906
Negligence
A legal concept that describes an action taken without the forethought that should have been taken by a reasonable person of similar competency
Occupational Safety and Health Administration (OSHA)
US government–managed agency that oversees safety in the workplace; created Safety Data Sheet (SDS) requirements
Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)
Congressional act that changed reimbursement limits and mandated drug use evaluation, pharmacy patient consultation, and educational outreach programs
Physicians’ Desk Reference (PDR)
One of the many reference books on medications; it compiles and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals
Pregnancy categories
A system used by the FDA to describe five levels of assessment of fetal effects caused by a drug; a required section of current prescription drug labeling. First introduced in 1979, the system is being reevaluated for usefulness and inclusion in the prescription label
Protected health information (PHI)
A term used to describe a patient’s personal health data. Under HIPAA, this information is protected from being shared or distributed without permission
Pure Food and Drug Act of 1906 Act
which led to the creation of the FDA and was enacted to prevent mislabeling or misbranding of medicines
Safety Data Sheet (SDS) (formerly known as MSDS sheets)
A document providing chemical product information. An SDS includes the product name, composition (chemicals in the product), hazards, toxicology, and other information about the proper steps to take with spills, accidental exposure,handling, and storage of the product. Filing of an SDS in the pharmacy or workplace is usually a requirement for meeting Occupational Safety and Health Administration (OSHA) standards
The Joint Commission (TJC)
An independent, nonprofit organization that accredits hospitals and other health care organizations in the United States. Accreditation is required to be eligible for Medicare and Medicaid payments
Tort
An act that causes harm or injury to a person intentionally or because of negligence
United States Pharmacopeia (USP)
An independent, nonprofit organization that establishes documentation on product quality standards, drug quality and information, and health care information on medications, OTC products, dietary supplements, and food ingredients to ensure that they have the appropriate purity, quality, and strength
US Drug Enforcement Administration (DEA)
Federal agency within the US Department of Justice that enforces US laws and regulations related to controlled substances
US Food and Drug Administration (FDA)
The agency within the US Department of Health and Human Services that is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive products
