Chapter 2 Terms & Definitions

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Act: A statutory plan passed by Congress or any legislature that is a "bill" until it is enacted and becomes law

Adulteration: The mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency.

May cause injury or illness to the consumer.

Amendment: A change in the original act or law

Barbiturate: Drug derived from barbituric acid. It acts as a central nervous system depressant. Often used in the treatment of seizures and as a

sedative and hypnotic agent.

Board of pharmacy (BOP): State board that regulates the practice of pharmacy within a state

Boxed warning: Drug warning placed in prescribing information of product that indicates a significant risk of potentially dangerous side-effects.

Strongest warning the FDA can give, found in a black box outline.

Controlled Substance: Drug or substance, scheduled I-V, regulated by the DEA.

Drug diversion: Intentional misuse of a drug intended for medical purposes, defined by the DEA as unlawful recreational use.

Drug Enforcement Administration (DEA): Federal agency within the U.S> Department of Justice that enforces U.S, laws and regulations related to

controlled substances.

Drug utilization evaluation (DUE): Process that ensures that prescribed drugs are used appropriately to increase efficacy and safety of their use.

Ethics: The values and morels used within a profession.

Food and Drug Administration (FDA): Agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive products.

Health Insurance Portability and Accountability Act of 1996: (HIPAA) A federal act that protects patient rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data.

Legend drug: Requires a prescription for dispensing.

Medicaid: Federal-and-stat- operated insurance program that covers low-income children, adults, and elderly and those with disabilities.

Medicare: Federal-and-state-managed insurance program that covers individuals 65 years and older, persons younger than 65 with long-term disabilities, and those with end-stage renal disease.

Misbranding: Labeling of a product that is false or misleading.

Monograph: Comprehensive information on a medication.

Morals: Standards concerning or relating to what is right or wrong in human behavior.

Narcotic: Term to describe a drug that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses causes stupor, coma, or convulsions that may lead to addictions.

National Drug Code (NDC): A 10-digit number that indicates specifics of a prescription drug. It specifies manufacturer, product strength and form, and package size.

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): U.S. government-managed agency that oversees safety in the workplace; created SDS sheets.

Omnibus Budget Reconciliation Act of 1990 (OBRA '90): Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational outreach programs.

Pregnancy Category: System used by the FDA to describe 5 levels of assessment of fetal effects caused by a drug. Introduced in 1979 and is being reevaluated for its usefulness.

The Joint Commission: An independent, nonprofit organization that accredits hospitals and health care organizations in the U.S. This accreditation is required to be eligible to accept Medicare and Medicaid payments.

Tort: Act that causes harm or injury to a person intentionally or because of negligence.

United States Pharmacopeia (USP): Independent, nonprofit organization that establishes documentation on product quality standards, drug quality and information, and health care information ensuring that they have the appropriate purity, quality, and strength.

United States Pharmacopeia-National Formulary (USP-NF): Publication of the USP that contains standards for medications, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

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