Clayton's Basic Pharmacology for Nurses: Chapter 1 2023 test bank with verified questions and answers

deals with the study of drugs and their actions on living organisms pharmacology examples of therapeutic methods include the following: - drug therapy - diet therapy - physiotherapy - psychological therapy therapy which focuses on treatment with drugs drug therapy therapy which focuses on treatment with diet diet therapy therapy which focuses on treatment with natural physical forces (e.g. water, light, heat) physiotherapy therapy which focuses on the identification of stressors and methods that can be used to reduce or eliminate stress psychological therapy chemical substances that have an effect on living organisms drugs therapeutic drugs, used for the prevention or treatment of diseases medicines each drug has 3 names: - chemical name - generic name - brand name describes the drug's chemical composition and molecular structure chemical name non-proprietary name, given by the US Adopted Names Council, considered the official name and the one listed by the FDA generic name proprietary name, drug has a registered trademark, use of the name is restricted by the drug's patent owner (usually the manufacturer) trademark/brand name drugs may be classified by a variety of methods according to: - the body system they affect - their therapeutic use or clinical indication - their physiologic or chemical action drugs which require an order by a health professional who is licensed to prescribe drugs prescription drugs drugs which are sold without a prescription in a pharmacy or in the health section of department or grocery strores nonprescription/over the counter (OTC) drugs drugs or chemical substances used for nontherapeutic purposes; obtained illegally or have not been approved for use by the FDA illegal drugs a biologic product that is close in structure and function to an existing approved biologic product biosimilar drug __________________ provides a legal basis for drug treatments and protects the consumer from false claims made by the drug manufacturer legislation the two amendments to the Federal Good, Drug, and Cosmetic Act of 1938 - The Durham Humphrey Amendment of 1951 - The Kefauver-Harris Drug Amendment of 1962 amendment which divides medicines into prescription and nonprescription (OTC) categories based on safety The Durham Humphrey Amendment amendment which provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven both safe and effective before release for sale; result of the thalidomide tragedy The Kefauver-Harris Drug Amendment act passed by Congress in 1970, composite law designed to improve the administration and regulation of the manufacturing, distribution, and dispensing of drugs that require control by the government because of their high incidence of abuse Controlled Substances Act the basic structure of the Controlled Substances Act consists of ___ classifications, or __________________, of controlled substances - 5 - schedules schedule ___ drugs have a very high potential for abuse, are not currently accepted for medical use in the US, and lack of accepted safety for use under medical supervision I lysergic acid diethylamide, peyote, heroin, and hashish are all examples of which schedule of drugs schedule I schedule ___ drugs have a high potential for abuse, are currently accepted for medical use in the US, have abuse potential that may lead to severe psychological of physical dependence, and do not come with refills II amphetamines, morphine, hydrocodone/acetaminophen (Vicodin, Lortab, Norco), methadone, oxycodone/aspirin (Percodan), methylphenidate (Ritalin), and amphetamin/dextroamphetamine (Adderall) are all examples of which schedule of drugs schedule II schedule ___ drugs have a high potential for abuse, are currently accepted for medical use in the US, have abuse potential which may lead to moderate or low physical dependence or high psychological dependence, and which have a prescriptions which outdate in 6 months with no more that 5 refills within that month III aspirin/codeine (Empirin with codeine), apirin/butalbital/caffeine (Fiorinal), acetaminophen/codeine (Tylenol with codeine) are all examples of which schedule of drugs schedule III schedule ___ drugs have a low potential for abuse compared with drugs in previous class, are currently accepted for medical use in the US, have abuse potential that may lead to limited physical or psychological dependence, and which have a prescription which outdates in 6 months with no more than 5 refills IV phenobarbital, chlordiazepoxide, diazepam, flurazepam, and temazepam are all examples for which schedule of drugs schedule IV schedule ___ drugs have low potential for abuse, are currently accepted for medical use in the US, have an abuse potential of limited physcial or psychological dependence liability compared with other classes, prescription may not be required, and which have a prescription which outdates in 6 months with no more than 5 refills V atropine/diphenoxylate (Lomotil, Virtussin AC) is an example of which schedule of drugs schedule V organization developed to enforce the Controlled Substances Act, gather intelligence, train officers, and conduct research in the area of dangerous drugs and drugs of abuse Drug Enforcement Administration (DEA) nurses may not have controlled substances in their possession unless the following conditions are met: - the nurse is giving them to a patient under an order from a healthcare provider - the nurse is a patient for whom a healthcare provider has prescribed scheduled drugs - the nurse is the official custodian of a limited supply of controlled substances on a unit or for a department of the hospital it currently takes an average of ___ to ___ years and more than $2 billion in research and development costs to bring a single new drug to market 8 to 15 the Food, Drug, and Cosmetic Act of 1938 charged the FDA with the responsibility of ________________ new drugs regulating rules and regulations evolved by the FDA divide new drug development into 4 stages: - preclinical research and development - clinical research and development - New Drug Application (NDA) review - postmarketing surveillance phase of new drug development which begins with the discovery, synthesis, and purification of the drug; the goal of this stage is to use laboratory studies to determine whether the experimental drug has therapeutic value and whether the drug appears to be safe in animals perclinical research phase only about ___% of the chemicals tested in the preclinical phase advance to the clinical testing phase 20% phase of new drug development in which humans are first tested clinical research and development stage phase of the clinical research and development stage in which studies determine an experimental drug's pharmacologic properties, such as its pharmacokinetics, metabolism, safe dosage range, potential for toxicity at a certain dosage, and safe routes of administration phase 1 phase of the clinical research and development stage in which a smaller population of patients who have the condition that the drug is designed to treat experiment with various dosages to determine success and rate safety of the drugs intended use phase 2 phase of the clinical research and development stage in which a larger patient population is used to ensure the statistical significance of the results phase 3 procedure used by the FDA to expedite the development and approval of drugs for the treatment of life-threatening illnesses through rules which allow certain INDs to receive the highest priority for review within the agency fast tracking process used by the FDA to expedite the development and approval of drugs for the treatment of life-threatening illness by conducting studies alongside principal controlled clinical trials but without a concurrent control group parallel tracking if safety concerns are identified after a drug is approved for marketing the FDA issues a ________________________________ to the package insert of the product black box warning medicines which are developed to treat rare diseases and illness (ex: cystic fibrosis, Hansen's disease, sickle cell anemia, blepharospasm, infant botulism, etc.) orphan drugs term used to describe individuals with rare diseases which manufacturers/companies do not research drug therapies for because of inability to recover the cost for reasearch health orphans