Introduction to Pharmacology Ch 2 Drug Approval and Regulation

Pharmacology for Nurses, 6e (Adams) Chapter 2 Drug Approval and Regulation 1) A pharmaceutical representative comes to the physician's office and says his company's pharmaceutical laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is the best response by the nurse? 1. "Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug." 2. "Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration (FDA)." 3. "Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from the Food and Drug Administration (FDA)." 4. "Your pharmaceutical laboratory must be involved in academic research because they are exempt from approval by the Food and Drug Administration (FDA)." Answer: 1 Explanation: 1. Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. 2. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs. 3. Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. 4. Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Page Ref: 12-13 Cognitive Level: Applying Client Need/Sub: Physiological Integrity: Pharmacological and Parenteral Therapies Standards: QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support safety and quality. | AACN Essential Competencies: V.1 Demonstrate basic knowledge of healthcare policy, finance and regulatory environments; including local, state, national, and global healthcare trends. | NLN Competencies: Quality and Safety: Policies and procedures. | Nursing/Integrated Concepts: Nursing Process: Analysis Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval process. MNL Learning Outcome: 2.2 Examine the role of the U.S. Food and Drug Administration in the process of drug approval and drug safety. 1 Copyright © 2020 Pearson Education, Inc. Downloaded by Brian Muchoki () lOMoARcPSD| 2) A nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. The nurse's primary role in this phase of the FDA review and approval is to perform tests on which of the following? 1. The population-at-large 2. Various species of animals 3. Human cells cultured in the laboratory 4. Human clients Answer: 4 Explanation: 1. Performing tests on the population-at-large is the stage of postmarketing surveillance. 2. Performing tests on various species of animals is the preclinical investigation stage. 3. Performing tests on human cells cultured in the laboratory is the preclinical investigation stage. 4. Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients with a particular disease. Page Ref: 13 Cognitive Level: Applying Client Need/Sub: Physiological Integrity: Pharmacological and Parenteral Therapies Standards: QSEN Competencies: V.B.1 Demonstrate effective use of technology and standardized practices that support safety and quality. | AACN Essential Competencies: V.4 Examine legislative and regulatory processes relevant to the provision of healthcare. | NLN Competencies: Quality and Safety: Policies and procedures. | Nursing/Integrated Concepts: Nursing Process: Implementation Learning Outcome: 2-3 Explain the four phases of approval for therapeutic and biological drugs. MNL Learning Outcome: 2.2 Examine the role of the U.S. Food and Drug Administration in the process of drug approval and drug safety. 2 Copyright © 2020 Pearson Education, Inc. Downloaded by Brian Muchoki () lOMoARcPSD| 3) A student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA). Which statement indicates the student understands how the FDA has decreased the amount of time involved in bringing a new drug to the market? 1. "The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval." 2. "Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the review/approval process." 3. "Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA) to hire more employees to increase its efficiency." 4. "Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual basis." Answer: 3 Explanation: 1. The Food and Drug Administration (FDA) is just as strict now as it always was with regard to drug approval. 2. The Food and Drug Administration (FDA) has not streamlined the review/approval process. 3. In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more employees, and operate more efficiently. 4. The Food and Drug Administration (FDA) does not require drug manufacturers to test