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B Chapter 2 Vocab

QuestionAnswer
Act A statutory plan passed by congress or any legislative that is called a bill until it is enacted and becomes law
Adulteration The mishandling of medication that can lead to contamination/impurity, falsification of contents, or loss of drug quality or potency can cause harm to the consumer
Amendment A change to the original act or law
Barbiturate A drug derived from barbituric acid it acts as a central nervous system depressant and are often employed in the treatment of seizures and as a sedative or hypnotic agent
Board of Pharmacy (BOP) state board that regulates the practice of pharmacy within a state
Boxed Warning Drug warning that is placed in the package insert or prescribing information indicating significant risk or potential side effects of a drug. also referred to as the "black box" in pharmacy the strongest warning the FDA can give
Controlled Substance any drug or other substance that is schedule I-V and regulated by the (DEA) Drug Enforcement Administration
Drug division The intentional misuse of a drug intended for medical purposes the DEA usually defines it as the recreational use of a prescription or scheduled drug. also refers to moving them from legal cannels to the streets.
Drug Enforcement Administration (DEA) A federal agency within the U.S. department of justice that enforces U.S. laws and regulations related to controlled substances
Drug Facts and Comparisons Reference book found in pharmacies that contains detailed information on medications
drug utilization evaluation/review (DUE) or (DUR) A process employed to ensure that prescribed drugs are utilized appropriately the main desire of the group is an increase in medication-related safety and efficiency
Food and Drug Administration (FDA) The agency within the U.S. human and health services responsible for assuring the safety security and efficiency of human and veterinary drugs, cosmetics, radioactive agents, medical devices, the national food supply, and biologic agents
Health Insurance Portability and Accountability Act of 1996 (HIPPA) Federal act for protecting patients rights and establishing national standards for electronic health care communication and ensuring the security and privacy of health data
Legend drug a drug that requires a prescription to dispense
Material Safety Data Sheet (MSDS) A document that includes product name, composition, hazards, toxicology, and other information regarding the proper steps to take with spills accidental exposure handling and storage of a chemical product and is an OSHA requirement in most pharmacies
Medicaid Federal and state operated insurance program that covers health care cost and prescription drugs for low-income children adults elderly and those with disability's
Medicare federal and state managed insurance program that covers heath care cost for individuals older than 65 or younger for those with end stage renal failure of disability's if long term
Misbranding Labeling of a product that is false or misleading information must include directions for use safe and unsafe dosages manufacturer packer or distributor quantity and weight
Monograph Comprehensive information on a medications actions within that class of drugs also a list of generic and trade names ingredient dosages side effects adverse effects and how the patient should take the medication and for and drugs to avoid while taking
Narcotic A non-specific term used to describe a drug that in moderate doses dulls the senses relieves pain and induces profound sleep but in excess doses causes stupor coma or convulsions and can lead to addiction exp: opium and cocaine
National Drug Code (NDC) A 10 digit number that indicates a specific prescription drug or an insulin product it specifies the drug manufacturer product strength form and formulation along with package size
Negligence a legal concept referring to the taking of an action without the forethought that a reasonable person of similar competency would have taken
Occupational Safety and Health Administration (OSHA) U.S. government managed agency that oversees safety in the workplace
Omnibus Budget Reconciliation Act of 1990 (OBRA '90) Congressional act that changed the reimbursement limits and mandated drugs utilization evaluation pharmacy patient consultation and educational outreach programs
over-the-counter (OTC) Medication that can be purchased without a prescription AKA non-legend drugs
Physician's Desk Reference one of many of the many reference books on medications compiles select manufacturer provide package inserts and prescribing information useful to healthcare professionals
Pregnancy Category a system in use by the FDA to describe five levels of assessment of the fetal effects caused by a drug a required section of prescribing information introduced in 1979 currently under reevaluation to determine usefulness and inclustion in the drug label
Protected Health Information (PHI) a term used to describe a patient's personal health data that's is protected under HIPPA so that it cant be shared with a distributer with out permission or the patient
The Joint Commission (TJC) an independent nonprofit organization that accredits hospitals and other health care organizations in the United States and accreditation is required to be able to accept Medicare and Medicaid payment
Tort To cause harm or injury to a person intentionally or because of negligence
United States Pharmacopeia (USP) An independent nonprofit organization that establishes documentation on drug/product quality standards quality and health care info on medications OTC products dietary supplements and food ingredients to ensure proper strength purity and quality
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
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