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chapter2
| Question | Answer |
|---|---|
| accreditation | the status achieved by a hospital, community college, college, or university that meets quality standards and fulfills the requirements designated by the accrediting organization |
| adulterated product | a product that differs in drug strength, quality, and purity |
| anabolic steroid | a synthetic, performance-enhancing drug that mimics the human hormone testosterone; due to abuse by athletes, this drug has been reclassified by the DEA as a controlled substance |
| brand name | the name under which the manufacturer markets a drug; also known as the trade name |
| burden of proof | the obligation of a person or party filing a lawsuit to provide evidence in order to prove a case |
| child-resistant container | a medication container with a special lid that cannot be opened by 80% of children under age 5 but can be opened by 90% of adults; a container designed to prevent child access in order to reduce the number of accidental poisonings |
| civil law | the areas of the law that concern U.S. citizens and the crimes they commit against one another |
| common law | the system of precedents established by decisions in cases throughout legal history |
| controlled substance | a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried |
| Controlled Substances Act (CSA) | laws created to combat and control drug abuse |
| defendant | one who defends against accusations brought forward in a lawsuit |
| Drug Enforcement Administration (DEA) | the branch of the U.S. Justice Department that is responsible for regulating the sale and use of drugs with abuse potential |
| ethics | standards of behavior that all professionals are encouraged to follow |
| Food and Drug Administration (FDA) | the agency of the federal government that is responsible for ensuring the safety and efficacy of food and drugs prepared for the market |
| four Ds of negligence | four areas of negligence, which include duty, dereliction, damages, and direct cause. |
| generic name | a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol |
| law | a rule that is designed to protect the public and is usually enforced through local, state, or federal governments |
| law of agency and contracts | the general principle that allows an employee to enter into contracts on the employer's behalf |
| legend drug | a drug that requires a prescription; labeled “Rx only” on medication stock bottle |
| licensure | the process by which a state board grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimum degree of necessary competency. |
| malpractice | a form of negligence in which the standard of care was not met and was a direct cause of injury |
| misbranded product | a product whose label includes false statements about the identity or ingredients of the container’s contents |
| National Association of Boards of Pharmacy (NABP) | an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams |
| National Drug Code (NDC) | a 10- or 11-character code that is assigned by the FDA to each drug product; each code is unique and identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging |
| negligence | a tort for not providing the minimum standard of care |
| new drug application (NDA) | the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States |
| Occupational Safety and Health Administration (OSHA) | an agency of the Department of Labor whose primary mission is to ensure the safety and health of U.S. workers by setting and enforcing regulations and standards |
| orphan drug | a medication approved by the FDA to treat rare diseases |
| patent drug | another name for an over-the-counter (OTC) medication |
| plaintiff | one who files a lawsuit for the courts to decide |
| professional standards | guidelines of acceptable behavior and performance established by professional associations |
| reasonable doubt | the standard of proof or evidence that the plaintiff must provide in a case involving crimes against the local, state, or federal government |
| reciprocation | the administrative process for relicensure of pharmacists in another state |
| registration | the process of being enrolled on a list created by the state board of pharmacy; most state boards require pharmacy technicians to register with their state of practice |
| regulation | a written rule and procedure that exists to carry out a law of the state or federal government |
| regulatory law | the system of rules and regulations established by governmental bodies |
| schedule | a listing of controlled substances categorized by the DEA according to their potential for abuse and physical or psychological dependence |
| standard | a set of criteria to measure product quality or professional performance against a norm |
| standard of care | the usual and customary level of practice in the community |
| state boards of pharmacy | governing bodies responsible for the regulation of the practice of pharmacy within the state |
| statutory law | a law passed by a legislative body at either the federal, state, or local level |
| tort | the legal term for personal injuries that one citizen commits against another in a lawsuit |
| United States Pharmacopeia (USP) | the independent, scientific organization responsible for setting official quality standards for all drugs sold in the United States as well as standards for practice |
| United States Pharmacopeia-National Formulary (USP-NF) | a book that contains U.S. standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements |
| USP–NF General Chapter (795) | a chapter of the United States Pharmacopeia that contains national standards for pharmacies formulating nonsterile preparations |
| USP–NF General Chapter (797) | a chapter of the United States Pharmacopeia that contains national standards for pharmacies formulating sterile preparations |
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