Battery- is causing physical harm to another person. (p. 27) Brand Name- is a name given by the manufacturer. (p. 22) Broken Contract- are the simplest form of torts. It is a broken promise to do or not to do an act. Chain Pharmacy- is a pharmacy that has multiple outlets located regionally or nationally, and is usually owned by a corporation. (p. 8) Chemical Name- describes a drug’s chemical composition and is the official name of a drug that describes the exact chemical formula of the drug. (p.22)
Child-Resistant Container- is a container that cannot be opened by 80 percent of children younger than five years old, but can be opened by 90 percent of adults. (p. 21) Compounding Pharmacy- is a specialized pharmacy wherein the pharmacist and/or pharmacy technician compounds or prepares medication mixtures that are customized specifically for the unique healthcare needs of the patient. (p. 8) Controlled Substance- is defined as a drug with a potential for abuse or addiction. (p 20) Defendant- is the party being sued.
(p. 26) Drug Enforcement Administration (DEA)- is a federal regulatory body that operates under the judicial branch of government. It is responsible for enforcing laws relating to the acquisition, storage, dispensing, and documentation of controlled substances. (p 25) Drug-Utilization Review (DUR)- is a review of a patient profile to ensure that medications dispensed to a patient in the past were correct. It also requires that the patient profile be reviewed prior to the filling of each prescription. (p.23) Ethics- are a system of moral standards of conduct and behavior for a person, group, or a profession. (p. 18)
Food and Drug Administration (FDA)- is a federal agency that was established to protect public health by regulating the safety and efficacy of food, dietary supplements, drugs, medical devices, biologics, tobacco products, and cosmetics. (p. 24) Formulary- is a list of drugs that have been recommended for use by physicians and pharmacists. (p. 10) Franchise Pharmacy- is a combination of a retail chain and an independent pharmacy.
(p. 9) Generic Name- is the non-proprietary name. (p. 22) Health-Maintenance Organization (HMO)- provides care that is focused on keeping patients healthy or managing chronic diseases in an effort to decrease hospitalizations and emergency-room visits. (p. 10) Home Health Care- is the delivery of medical, nursing, and pharmaceutical services to patients at home. (p. 16) Home Infusion Pharmacy- is one that specializes in parenteral mixtures, such as chemotherapy, antibiotics, nutrition and feeding supplies.
Hospital Pharmacy- is an institutional pharmacy that provides services to patients and healthcare professionals in the hospital. (p. 9) Independent Pharmacy- is a pharmacy that is owned and operated by a private owner or owners. (p. 8) Institutional Pharmacy- can broadly be defined as a facility that provides pharmaceutical-care services to patients in an institutional facility or organized healthcare system. (p. 9) Law- is a rule that represents the minimum level of acceptable standards. (p. 17) Legend Drugs- are drugs that are not considered safe for use without medical supervision.
(p. 19) Libel- is written communication of false statements against another individual. (p. 27) Long-Term-Care Facility- provides a broad range of services for patients requiring a longer length of stay. (p. 10) Long-Term-Care Pharmacy- dispenses medications, sterile intravenous preparations, and nutritional products to patients in nursing homes, assisted-living facilities, and hospice programs. (p. 10) Mail-Order Pharmacy- is closed-door, centralized pharmacy operation that dispenses a large number of prescriptions, which are mailed directly to the patient.
(p. 9) Malpractice- is negligence in meeting the standard of care. (p. 27) Managed-Care Organizations- is an organization that controls the financing and delivery of healthcare serviced for those who are involve in a specific healthcare plan. (p. 10) National Association of Boards of Pharmacy (NABP)- is the professional association that helps to develop uniform standards for all state boards of pharmacy. (p. 12) Negligence- is conduct that falls below the standards of behavior established by law. (p.27)
Nuclear Pharmacy- is a specialty practice of pharmacy that promotes health through the safe and effective use of radioactive drugs for diagnosis and therapy. (p. 10) Over-the-Counter (OTC) Drugs- can be legally obtained without a prescription and are generally safe for use without medical supervision. (p. 19)
Parenteral- are mixtures administered by a needle or catheter into one or more layers of the skin. (p. 9) Pharmacist- is a licensed professional trained to prepare and dispense medications, proved drug information, and monitor response to therapy. (p.4) Pharmacognosy- is the study of the medicinal properties of natural products from plant and animal sources and minerals. (p. 7) Pharmacology- is the study of drugs, their properties, and their mechanisms of action. (p. 7)
Pharmacy Technicians- is a paraprofessional who can assist in all daily activities, under the direct supervision of a licensed pharmacist, that do not require the professional judgment of a pharmacist. (p. 8) Plaintiff- is the person or party filing the case. (p. 26) Point-of-Service (POS) Plan- is a type of managed healthcare plan that is a hybrid of an HMO and PPO.
It is called a POS plan because each time a member seeks medical care, he or she must decide which option—HMO or PPO—to choose. (p. 11) Preferred Provider Organization (PPO) Plan- is similar to an HMO plan in that is has a preferred provider network, but patients do not need to see a primary care physician for a referral to a specialist. PPOs generally offer financial incentives to use network providers. (p. 11)
Primary Care Physician- is a “gatekeeper” who controls access to health care and costs. (p.10) Professional Standard- is a code of conduct or practice that professionals in a discipline would follow or carry out in a given circumstance. (p. 18)
Regulation- is a written rule or established guideline that exists to carry out a federal or state law. (p. 18) Retail Pharmacy- is any independent, chain, or franchise pharmacy that dispenses prescription drugs to outpatients; also known as a community pharmacy or drug store. (p. 8)
Slander- is verbal communication of false statements against another individual. (p.27) Standard of Care- is the level of performance that is expected of a healthcare worker in carrying out his or her professional duties. (p. 27) State Boards of Pharmacy- are regulatory bodies that oversee pharmacy activities in each individual state. (p. 26) Tort- is defined as causing personal injury intentionally or because of negligence. (p. 26) United States Pharmacopeia (USP)- is a non-governmental, independent scientific organization that sets standards for all over-the-counter and prescription medications and other healthcare products manufactured or sold in the United States.
(p. 27) USP-NF-is a compendium containing standards set by the USP for medicines, dosage forms, drug substances, excipients, dietary supplements, inert ingredients, and medical devices. (p. 28) Additional Information a. ) Greek physician, Hippocrates is known as the “Father of Medicine”. b. ) Another Greek physician, Galen is considered to be the “Father of Pharmacy”. c. ) 1. ) Traditional Era (1920s)—Era in which the pharmacy profession focused on preparing, compounding, and dispensing drugs from natural sources, such as plants.
2. ) Scientific Era (1940s-1950s)—Era in which the pharmacy profession focused on the development and testing of drugs and their effects on the human body. 3. ) Clinical Era (1960s)—Era in which pharmacy profession focused not only on the traditional roles of compounding and dispensing, but also provided drug information to patients and physicians. 4. ) Pharmaceutical Care Era (1990s-Present)—Era that has expanded the role of the pharmacist to include responsibility for appropriate medication use. d. )
1.) Constitutional Law- is derived from the Constitution and the Bill of Rights. 2. ) Legislative Law- is drawn from the U. S. Congress and state legislatures. 3. ) Administrative Law- is derived from the president or state governor. 4. ) Common Law- is drawn from the judicial branch of the government. e. ) Pure Food and Drug Act (1906)- was the first federal law regulating drugs. Prevented the manufacture, sale or distribution of inaccurately labeled food and drugs across state lines and required that labels not contain false information of a drug’s strength and purity.
f. ) Food, Drug, and Cosmetic Act (FD&C) (1938)- called for the creations of the Food and Drug Administration (FDA) and required all drug manufacturers to file a New Drug Application (NDA) to provide evidence of a drug’s safety before any drug could be approved for the market. g. ) Durham-Humphrey Amendment (1951)- was an amendment to the FD&C Act that established clear criteria for the classification of prescription or nonprescription over-the-counter medications.
h.) Kefauver-Harris Amendment (1963)-required that all medications be pure, safe, and effective for use in humans. It also required all drug manufacturers to file an investigation new drug application (INDA) before starting a clinical trial in humans or submitting a NDA. i. ) Comprehensive Drug Abuse Prevention and Control Act (1970)- aka Controlled Substances Act (CSA), required the pharmaceutical industry to keep records and implement security measures for certain medications. It was created to prevent and control drug abuse.j. )
Poison Prevention Packaging Act (PPPA) (1970)- established standards for child-resistant packaging to prevent accidental childhood poisonings. k. ) Drug Listing Act (1972)- assigns a unique drug code to each medication known as the National Drug Code (NDC). It consists of 11 characters: first five- identify the manufacturer or distributer of the drug; next four- identify the product, strength, and dosage form of the medication; last two- identify the packaging size and type.
l. ) Orphan Drug Act (1983)- was enacted to stimulate the development of drugs for rare diseases. m. ) Waxman-Hatch Act (1984)- aka the Drug Price Competition and Patent-Term Restoration Act, ensured that brand-name drug manufacturers would have patent protection and a period of marketing exclusivity to enable them to recoup their investments in the development of valuable new drugs, as well as provide and incentive for new drugs to reach the marketplace. n.
) Prescription Drug Marketing Act (PDMA) (1987)- was designed to increase safeguard to prevent the introduction and retail sale of substandard, ineffective, and counterfeit drugs in the U. S. supply chain. o. ) Anabolic Steroid Control Act (1990)- classified anabolic steroids (illegally used by athletes) as Schedule III controlled substances, increasing the penalty for the illegal distribution of these drugs. p. ) Omnibus Budget Reconciliation Act (OBRA) (1990)- requires that pharmacies that fill prescriptions for Medicaid obtain, record, and maintain basic patient information. q.)
Health Insurance Portability and Accountability Act (HIPAA) (1996)- was implemented to improve continuity and portability when transferring health-insurance coverage from one employer to another; also sought patient confidentiality under Medicare and Medicaid. r. )
Food and Drug Administration Modernization Act (1997)- focused on reforming the regulation of food, medical products, and cosmetics. It wanted more evidence for new drugs and their function and put “Rx only” on drug labels. s. ) Medicare Prescription Drug, Improvement, and Modernization Act (2003)- gives all people who receive Medicare benefits the option for prescription-drug coverage under the Medicare Part D plan. t. ).
Combat Methamphetamine Epidemic Act (2005)- was enacted to reduce the availability of drugs used to illegally produce methamphetamine and to stop the use of methamphetamine. Set limits on the quantity of drugs containing pseudoephedrine, phenylpropanolamine, and ephedrine purchased during a 30-day period. u. ) Occupational Safety and Health Administration (OSHA)- is the main federal agency responsible for the enforcement of regulation relating to the safety and health of workers.