Understanding Drug Therapy, Classifications, and Regulations in Pharmacology, Exams of Pharmacology

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Chapter 1: Introduction to Pharmacology pharmacology - _______ is the study of drugs (chemicals) that alter functions of living organisms. drug therapy - _______ also called pharmacotherapy, is the use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes. medications - drugs given for therapeutic purposes are called ______. prototypes - individual drugs that represent groups of drugs are called ____ Phaarmacoeconomics - _____involves the cost of drug therapy, which include the costs of purchasing, dispensing, storage, and administration; laboratory and other theses used to monitor patient responses; and losses due to expiration. generic name - often indicates the drug group trade or brand name - name designated and patented by the manufacturer food, drug, and cosmetic act of 1938 - regulates the manufacture, distribution, advertising, and labeling of drugs Durham-Humphrey Amedment - Designates drugs that must be prescribed by a licensed physician or nurse practitioner and dispensed by a pharmacist Controlled substances act - regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids A --> C --> B --> D - Sequencing Since 1962, newly developed drugs have been extensively tested before being marketed for general use. Clinical trials are conducted in four phases, which are given below in random order. Write the correct sequence in which they are performed in the boxes provided. A. A few doss are given to a certain number of healthy volunteers to determine safe dosages, routs of administration, absorption, metabolism, excretion, and toxcity. B. Studies help to determine whether the potential benefits of the drug outweigh the risks. C. A few doses are given to a certain number of sbjects who have the disease or symptom of the which the drug is being studies, and responses are compared with those of healthy subjects. D. The FDA evaluates the data from the first three phases for drug safety and effectiveness, allows the drug to be marketed for general use, and requires manufacturers to continue monitoring the drugs effects. Drugs with local effects, such as sunscreen lotions and local anesthetics, act mainly at the site of application - Medications may be given for local effects. Give an example of a drug that exhibits its effects locally, and identify the action of the medication. b. eliminate pain c. improve ability to function in activities of ADLs d. decrease dependence on drugs e. increase longevity -therapeutic uses - Drugs are classified according to what features? a. name b. therapeutic sues c. side effects d. actions -conditions for which the medication is used. - what do the names of therapeutic classifications usually reflect a. actions of the medication b. conditions for which the medication is used. c. possible adverse reactions to the medications d. possible generic names for the medication. -by generic or trade name - How may drugs be prescribed and dispensed? a. by generic name only b. by trade name only c. by prescription d. by generic or trade name -the drug may not be manufactured by other companies until the patent expires. - Once a drug is patented, what statement is true? a. the drug may be manufactured by other companies. b. the drug may be manufactured by other companies under a generic name. c. the drug may not be manufactured by other companies until the patent expires. d. the drug may be marketed by other companies. that drugs marketed for therapeutic purposes are safe and effective - The main goal of current drug laws and standards is to ensure what? a. that drugs are available to all, regardless of cost b. that drugs marketed for therapeutic purposes are safe and effective c. that drugs are cost-effective d. that drugs are patented -Increased standardized chemical characteristics - less allergenic - limited use for treatment of disease - What are the advantages of using a synthetic drug? Select all that apply. a. Increased standardized chemical characteristics b. produced by cloning c. less allergenic d. limited use for treatment of disease Manufacture and distribution of narcotics - What does the Comprehensive Drug Abuse Prevention and Control Act regulate? a. Classifications of narcotics b. Acceptable diagnoses for prescription for narcotics c. Manufacture and distribution of narcotics d. abuse of narcotics -storing controlled substances in locked containers. -recording prescribed controlled substances on medication administration records -maintaining an accurate inventory of narcotics - What are nurses responsible for? Select all that apply. a. storing controlled substances in locked containers. b. reporting discrepancies in the narcotic inventory to the physician. c. recording prescribed controlled substances on medication administration records d. maintaining an accurate inventory of narcotics e. administering controlled substances when the prescribed analgesic is not effective. - keep accurate records of all transactions -be registered with the DEA =provide for secure storage of controlled substances - People and companies that are legally empowered to handle controlled substances must do what? -people may choose an OTC that interacts with another medication - What is a major disadvantage of using OTC medications? a. causes increased visits to the health care practitioner. b. consumers resist the effort to learn more about their condition. c. people may choose an OTC that interacts with another medication d. lack of autonomy test the drugs with animals - Since 1962, newly developed drugs have been extensively tested before being marketed for general use. What do drug companies do to test drugs initially? a. Test the drugs with animals. b. Test the drugs on volunteers. c. Test the drugs with humans. d. Test the drugs in a controlled laboratory experiment. C-II - A nurse is preparing to administer morphine. The nurse understands that this drug is categorized as which schedule of a controlled substance? a) C-II b) C-III c) C-IV d) C-V insulin - Which of the following drugs may be derived from an animal source? a) Digitalis b) Morphine c) Insulin d) Opium Health care providers report adverse effects to FDA. - One of the phases of drug development is the post-marketing surveillance phase. Which one of the following activities is carried out during this phase? a) In vitro tests are performed using human cells. b) Health care providers report adverse effects to FDA. c) The drug is given to patients with the disease. d) Healthy volunteers are involved in the test. the effect of the drug on the body - Which of the following best describes the focus of pharmacotherapeutics? a) The biological effect of a drug b) The effect of the drug on the body c) Proper method for drug administration d) How the body processes drugs for elimination Faster absorption of the drug because of greater surface area. - The nurse knows that application of a topical drug on an infant's skin may result in what drug response? a) Faster absorption of the drug because of greater surface area. b) Greater concentration of drug in the infant's tissues, due to decreased body water content. c) Increased serum levels of drugs caused by decreased renal mass and glomerular filtration rate. d) Delayed and decreased metabolism of the drug caused by decreased blood flow to the liver. After taking this medication for a while, your mind, not your body, will desire the effect of this medication." - A client has been prescribed a medication that has the potential to cause psychological dependency. How will the nurse best explain this possible situation to the client? a) "After taking this medication for a while, your mind, not your body, will desire the effect of this medication." b) "You may notice while taking this drug that you will require larger and larger doses to achieve the same effect." c) "If you take this medication for longer than three days you will have withdrawal symptoms when you stop taking it." d) "If you take this medication repeatedly, you will develop physical symptoms if you stop taking it." C-V - A nurse is preparing to administer a cough syrup containing codeine to a client. The nurse understands that this drug would be classified as which schedule of a controlled substance? a) C-II b) C-V c) C-IV d) C-III • They may be administered at a lower dosage than the prescription. • They may require additional clinical trials to determine the safety and effectiveness of the OTC use. • They may be used for different indications than the original prescription medication. - Choice Multiple question - Select all answer choices that apply. Kefauver-Harris Act Controlled Substance Act Orphan Drug Act - Question: The following laws were important legislative efforts affecting the clinical use of drugs. Place the events in their proper sequence from earliest to latest. 1. Durham-Humphrey Amendment 2. Kefauver-Harris Act 3. Federal Food, Drug, and Cosmetic Act 4. Orphan Drug Act 5. Controlled Substance Act 6. Pure Food and Drug Act skin - The nurse is administering medications and knows that there is a longer distribution time when the drug is intended for what area? a) Kidney b) Heart c) Liver d) Skin Kefauver-Harris Act of 1962 - Regulatory control over drug testing and evaluation by the FDA resulted from which legislation? a) Durham-Humphrey Amendment of 1951 b) Kefauver-Harris Act of 1962 c) Pure Food and Drug Act of 1906 d) Federal Food, Drug, and Cosmetic Act of 1938 Phase I study - A nurse is reading an article about drug development. The article reports that the drug has been tested on laboratory animals and is now ready for the next phase. The nurse identifies this next step as which of the following? a) Preclinical trial b) Phase I study c) Phase II study d) Phase III study • 6-week-old client with pertussis • Client 88 years of age with a skin infection • Client 55 years of age with chronic renal failure - Choice Multiple question - Select all answer choices that apply. When caring for a group of clients the nurse will monitor which clients for effects related to impaired drug excretion? Select all that apply. a) client 43 years of age with a deep vein thrombosis b) Client 18 years of age with appendicitis c) 6-week-old client with pertussis d) Client 88 years of age with a skin infection e) Client 55 years of age with chronic renal failure Kefauver-Harris Act of 1962 - Which of the following legislative acts allowed the FDA to tighten control over the quality of drugs, and required that safety and efficacy standards be established? a) Federal Food, Drug, and Cosmetic Act of 1938 b) Kefauver-Harris Act of 1962 c) Durham-Humphrey Amendment of 1951 d) Pure Food and Drug Act of 1906 • The chemical type of the drug's active ingredient. • The way the drug is used to treat a specific condition. - A drug may be classified by which of the following? Select all that apply. a) The trade name of the drug. b) The nonproprietary name of the drug. c) The chemical type of the drug's active ingredient. d) The generic name of the drug. e) The way the drug is used to treat a specific condition. Lortab and Tylenol with Codeine. - Examples of schedule 3 drugs include: a) Valium and Phenobarbital. b) Chloral Hydrate and Percodan. c) Morphine and Methadone. d) Lortab and Tylenol with Codeine. Enforcement of control of substances with high abuse potential - After teaching a group of students about the responsibilities of the Food and Drug Administration (FDA) related to drugs, the instructor determines that the students need additional teaching when they identify which of the following as a major responsibility? a) Enforcement of standards for testing drug toxicity b) Assignment of a pregnancy category for each new drug b) "The generic name describes the molecular structure of the drug." c) "The generic name is the drug name registered by the manufacturer." d) "The generic name is the official name given by the U.S. Food and Drug Administration." Conditions for which the medication is used - What do the names of therapeutic classifications usually reflect? a) Actions of the medication b) Conditions for which the medication is used c) Possible generic names for the medication d) Possible adverse reactions to the medications Ferrous sulfate (iron) - A group of students are reviewing information about the natural sources of drugs. The students demonstrate understanding of the information when they identify which of the following as a drug derived from inorganic compounds? a) Thyroid hormone b) Ferrous sulfate (iron) c) Castor oil d) Codeine Bioassay - A nurse is assured that medications being administered meet standards of strength by animal response to specified doses. What is this type of response testing on animals termed? a) Bioassay b) Artificial testing c) Chemical analysis d) Live testing • Effects on body systems • Therapeutic uses • Chemical characteristics - Choice Multiple question - Select all answer choices that apply. Which of the following are ways that drugs are classified? Select all that apply. a) Chemical characteristics b) Method of manufacture c) Therapeutic uses d) Dosage e) Effects on body systems • Prescription • Nonprescription • Controlled substance - Choice Multiple question - Select all answer choices that apply. The Food and Drug Administration assigns newly approved drugs to which of the following categories? Select all that apply. a) Noncontrolled substance b) Controlled substance c) Prescription d) Nonprescription e) Nutraceuticals Phase IV - A drug has been approved by the Food and Drug Administration. Which of the following would occur next? a) Phase II study b) Phase III study c) Phase IV study d) Phase I study work around - A nurse is preparing to administer medications at a facility that requires nurses to log on a computer and take out one patient's medications at a time. The nurse is feeling rushed, and instead logs in once and takes out medications for all three patients under care. What would Quality and Safety Education for Nurses (QSEN) term this type of behavior? a) Cutting corners b) Safe care c) Professional behavior d) Work around Phase I - A nurse is reading an article about drug development. The article reports that the drug has been tested on laboratory animals and is now ready for the next phase. The nurse identifies this next step as which of the following? a) Phase III study b) Phase I study c) Phase II study d) Preclinical trial preclinical trial - During which stage of drug development is the drug tested on laboratory animals? e) Dispensing genetic engineering - After studying the various sources of drugs, a group of students demonstrate a need for additional study when they identify which of the following as an example of a synthetic source for a drug? a) Animals b) Plants c) Genetic engineering d) Inorganic compounds Conditions for which the medication is used - What do the names of therapeutic classifications usually reflect? a) Possible adverse reactions to the medications b) Actions of the medication c) Possible generic names for the medication d) Conditions for which the medication is used • First-pass effect • Active transport • Half-life • Biotransformation - Choice Multiple question - Select all answer choices that apply. What are the elements of the pharmacokinetic phase of drug activity? Select all that apply. a) Half-life b) Active transport c) Alterations in cellular environment d) First-pass effect e) Biotransformation