Victoria Jo | Key Terms: Pharmacy Law, Ethics, and Regulatory Agencies

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. Adulteration may cause injury or illness to the consumer

Amendment

A change in an original act or law

Barbiturate

A drug derived from barbituric acid; a barbituate 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 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

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

Ethics

The values and morals used within a profession

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 that 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 wit 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 drug class. 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, OTC medications, herbals) to avoid while taking the medication

Morals

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

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 drugs 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 1906

Negligence

A legal concept that describes an action taken without forethought that should have been taken by responsible person 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.

Over the counter (OTC)

Describes medication that can be purchased without a prescription; non legend medications

Physicians' Desk Reference (PDR)

One of many reference books on medications; it compiles and publishes select manufacturer-provided package inserts and prescribing information useful for health professionals.

Pregnancy categories

A term 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 re evaluated for usefulness and inclusion in the prescription label.

Protected health information (PHI)

A term used to describe a patient's personal health daya. Under HIPAA, this information is protected from being shared or distributed without permission

Pure Food and Drug Act of 1906

Act that led to the creation of the FDA and was enacted to prevent mislabeling or misbranding of medicines.

Safety Data Sheet (SDS) (formerly known as the 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 proper steps to take with spills, accidental exposure, handling, and storage of the product. Filing of an SDS in the pharmacy or work place is usually a requirement for meeting occupational Safety and Health Administration (OSHA) standards.

The joint Commision (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

United States Pharmacopeia-National Formulary (USP-NF)

A publication of the USP that contains standards for medications, dosage forms, drug substances, excipients, medical devices, and dietary supplements

US Drug Enforcement Administration (DEA)

Federal agency within the US Department of Justice that enforces US laws and regulations 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