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UNITEK HAYWARD Pharmacology UPDATED Exam Questions and CORRECT Answers

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Which description best defines a medication? A) Chemical substance that requires a prescription by a health professional B) Drug used for a therapeutic effect to treat or prevent an illness C) Pharmacologic preparation used to reverse disease D) Plant, animal, or mineral substance that prevents...

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UNITEK HAYWARD Pharmacology UPDATED Exam Questions and CORRECT Answers Which description best defines a medication? A) Chemical substance that requires a prescription by a health professional B) Drug used for a therapeutic effect to treat or prevent an illness C) Pharmacologic preparation used to reverse disease D) Plant, animal, or mineral substance that prevents disease - ANS✔ B) Drug used for a therapeutic effect to treat or prevent an illness Medications are drugs used for their therapeutic effects. A therapeutic effect can be the prevention or treatment of disease. All medications do not require a prescription. Specifying a certain action is not the best definition of a medication because it i s incomplete. What is the trade name of a drug? A) The proprietary name of the drug given by a manufacturer. B) The chemical name of the drug given by its developer. C) The name given to the drug by the U.S. Food and Drug Administration (FDA). D) The name under which the drug is listed in the U.S. Pharmacopeia. - ANS✔ A) The proprietary name of the drug given by a manufacturer. The trade or brand name is the proprietary name given to the drug by its manufacturer. The same drug produced by different companies has one generic name but may have many trade names. The trade name is trademark protected and can be used only by its manuf acturer. The drug may be listed under more than one name in the Pharmacopeia. The book is used to provide standards for identity, quality, strength, and purity of substances used in healthcare practice. The trade name is not given to a drug by the FDA. The chemical name is the exact chemical constitution of the drug and the exact placing of its atoms or molecular groupings. What is the MedWatch form used for? A) Tracking numbers of prescriptions written for a specific drug B) Assessing the acceptability of the drug to individual patients C) Determining the therapeutic effectiveness of the drug D) Identifying adverse effects of a drug in the general population - ANS✔ D) Identifying adverse effects of a drug in the general population Healthcare practitioners make a significant contribution to the knowledge of drug safety by reporting adverse effects to the FDA using the MedWatch program for the voluntary reporting of adverse events and product problems. This method of identifying adver se effects of a drug in the general population is part of the postmarketing surveillance phase of drug development. More than 200,000 MedWatch forms are filed with the FDA annually. MedWatch is not designed to track the numbers of prescriptions written for a specific drug; is not a program involved in determining the therapeutic effectiveness of a drug; and is not involved in assessing the acceptability of a drug to individual patients. Which statement about drug names is correct? A) Drugs are listed by their chemical names in the U.S. Pharmacopeia. B) A drug may have multiple proprietary names. C) The generic name is a trademarked name. D) The official name must be used on all prescriptions. - ANS✔ B) A drug may have multiple proprietary names. The proprietary name of a drug is a trade or brand name and is followed by the symbol ®. Each manufacturer of a drug can register a proprietary name that can be used only by that company. Thus a drug produced by more than one manufacturer can have multiple proprietary names but only one generic name. Drugs are listed by their official names in the U.S. Pharmacopeia. Generic names are not trademarked. Prescriptions can be written using generic or trade names. How do Schedule II drugs differ from Schedule V drugs? A) Schedule V drugs have greater risk for toxicity. B) Schedule II drugs have less potential for abuse. C) Schedule V drugs lack accepted safety measures for use. D) Schedule II drugs are more likely to cause dependence. - ANS✔ D) Schedule II drugs are more likely to cause dependence. Schedule II drugs have a high potential for abuse that may lead to severe psychological or physical dependence. Schedule II drugs have more, not less, potential for abuse than Schedule V drugs. Schedule II and Schedule V drugs have accepted guidelines for safe use. Drugs in both schedules are not differentiated based on toxicity. There may be drugs in each schedule that have high or low toxicity. Which legislation was written to require companies to determine the safety of medications before marketing? A) The Federal Food, Drug, and Cosmetic Act of 1938 B) Durham Humphrey Amendment of 1952 C) The Kefauver Harris Drug Amendment of 1962 D) Controlled Substance Act of 1970 - ANS✔ A) The Federal Food, Drug, and Cosmetic Act of 1938 The Federal Food, Drug, and Cosmetic Act of 1938 (passed on June 25, 1938, and amended in 1952 and 1962) requires the FDA to determine the safety of drugs before marketing and to ensure that certain labeling specifications and standards in advertising are met in the marketing of products. Manufacturers are required to submit new drug applications to the FDA for review of safety studies before products can be released. The Durham Humphrey Amendment of 1952 was passed to tighten control over prescription drug s by restricting the refilling of prescriptions. The Kefauver Harris Drug Amendment of 1962 was brought about by the thalidomide tragedy. The amendment provides greater control and surveillance of the distribution and clinical testing of investigational dr ugs, and requires that a product be proven safe and effective before release for sale. The Controlled Substance Act of 1970 was passed by Congress to improve the administration and regulation of manufacturing, distributing, and dispensing of drugs that hav e been found necessary to be controlled. Which legislation was enacted to stimulate development and availability of drugs to treat rare diseases? A) The Orphan Drug Act B) The Fast Tracking rules C) The Controlled Drugs and Substance Act of 1997 D) The Food and Drug Act of 1979 - ANS✔ A) The Orphan Drug Act The medicines that are developed for rare conditions are known as orphan drugs, because the manufacturers have been unable to recover the costs of the research due to the very limited use of the final product. Because no companies were willing to "adopt" t he disease to complete extensive research to develop products for treatment, the diseases became known as health orphans. In 1983, Congress passed the Orphan Drug Act to stimulate the development and

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