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CH 2 Terms & Def
Pharmacy Law, Ethics, and Regulatory Agencies
| Question | Answer |
|---|---|
| ACT | A statutory plan passed by congress or any legislature that is a bill until it is enacted and becomes law |
| Adulteration | 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 consumer |
| Amendment | A change in an original act or law |
| 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 acts as a sedative and hypnotic agent |
| 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. strongest warning FDA can give; Black Box Warnings |
| Controlled Substance | Any drug or substance that is scheduled 1 - 5 and regulated by the DEA (US Drug Enforcement administration) |
| Drug Diversion | The intentional misuse of a drug intended for medical purposes; Recreational use of prescription scheduled drug; Channeling drug supply to 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 efficiency and safety |
| Ethics | The values and morals used within a profession |
| Health Insurance Portability and Accountability Act of 1996 (HIPAA) | Federal act that protects patient's 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 manages insurance program that covers health care costs and prescription drugs for individuals over the age of 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 medications actions within a class of drugs. Lists generic and trade names, ingredients, dosages, side effects, etx |
| Morals | Standards concerning or relating to what is right and what is wrong in human behavior |
| Narcotic | A nonspecific term used to describe a drug (ex: Opium) that in moderate doses dulls the senses, relieves pain, and induces a profound sleep but in excess causes stupor, coma, convulsions and addiction |
| National Drug Code (NDC) | 10 digit number that indicates specifics the drug manufacturer, the drug product, 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 the 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) | Medication that can be purchased without a prescription; non-legend drugs |
| 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 the 5 levels of assessment of fetal effects caused by a drug; a required section of current prescription drug labeling. 1979 |
| Protected Health Information (PHI) | A term used to describe a patient's personal health data. Under HIPAA this info is protected from being shared 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 MSDS Sheets; Document providing chemical product information. An SDS includes product name, composition, hazards, toxicology, and other info about the proper steps to take with spills, exposure, handling, and storage. Usually required by OSHA |
| The Joint Commission (TJC) | Independent, nonprofit organization that accredits hospitals and other health care organizations in the US. 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) | 1820; Independent, nonprofit org that establishes documentation on product quality standards, drug quality and information, and health care information on medications, OTC, dietary supplements, and food ingredients to ensure appropriate purity, etc |
| 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 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, efficiency, and security of human and vet drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive |
| Drug Supply Chain Security Act (DSCSA ) | 2016 - outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US |
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