Exam (elaborations)
UNITEK HAYWARD Pharmacology | Quiz 1 | Chapters 1, 2, 3 | Latest Update Already Passed
- Course
- Institution
UNITEK HAYWARD Pharmacology | Quiz 1 | Chapters 1, 2, 3 | Latest Update Already Passed
[Show more]
Content preview
UNITEK HAYWARD Pharmacology | Quiz 1 | Chapters 1, 2, 3 | Latest Update Already Passed 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 - (correct answer) -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 is incomplete. What is the trade name of a drug? A) The proprietary name of the drug given by a manufactur er. 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. - (correct answer) -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 manufacturer. 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 - (correct answer) -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 adverse 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 . - (correct answer) -B) A drug may have multi ple 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 manufac turer 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. - (correct answer) -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 Amendm ent of 1962 D) Controlled Substance Act of 1970 - (correct answer) -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 drugs 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 drugs, 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 have 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 - (correct answer) -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" the 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 market availability of products that are used for the treatment of rare diseases. The Orphan Drug Act provides research grant s, protocol development assistance by the FDA, special tax credits for the cost of clinical trials, and 7 years of exclusive marketing rights after the product has been approved. The Food and Drug Act of 1979 empowered Health Canada to protect the public from foreseeable risks relating to the manufacture and sale of drugs. The Fast Tracking rules allow investigational drugs to receive highest priority for review with the FDA. The Controlled Drugs and Substance Act of 1997 established the requirements for control and sale of narcotics and substances of abuse in Canada. Which stage of new drug development involves giving the medication to large numbers of individuals with the disorder that the medication intends to treat? A) Developmental stage —Phase 2 B) Postmarketing surveillance stage C) Developmental stage —Phase 1 D) Developmental stage —Phase 3 - (correct answer) -D) Developmental stage —Phase 3 If phase 1 trials are successful, the drug is moved to phase 2, which involves a smaller population of patients who have the condition that the drug is designed to treat. Studies at various dosages are conducted to determine the success rate and safety of a drug for its intended use. If successful, the drug is advanced to phase 3 trials, in which larger patient
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Wisdoms. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75632 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now