Adams,Pharmacology for Nurses: A Pathophysiologic Approach,54/EChapter 2

Question:1 Type: MCSA The 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)." Correct Answer: 1 Rationale 1: Any pharmaceutical laboratory must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Rationale 2: Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs. Rationale 3: Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Rationale 4: Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Global Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs. Cognitive Level: Applying Client Need: Physiological Integrity Client Need Sub: Pharmacological and Parenteral Therapies 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 health care. NLN Competencies: Quality and Safety: Policies and procedures. Nursing/Integrated Concepts: Nursing Process: Implementation Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the drug approval process. MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 13 Question 2 Type: MCSA The nurse is employed by the Food and Drug Administration (FDA) and is involved in clinical investigation. What is the primary role of the nurse in this phase of the review and approval process by the FDA? 1. To perform tests on the population-at-large 2. To perform tests on various species of animals 3. To perform tests on human cells cultured in the laboratory 4. To perform tests on human clients Correct Answer: 4 Rationale 1: Performing tests on the population-at-large is the stage of post-marketing surveillance. Rationale 2: Performing tests on various species of animals is the preclinical investigation stage. Rationale 3: Performing tests on human cells cultured in the laboratory is the preclinical investigation stage. Rationale 4: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients with a particular disease. Global Rationale: Clinical investigation includes performing tests on healthy volunteers, and later, on selected clients with a particular disease. Performing tests on human cells cultured in the laboratory is the preclinical investigation stage. Performing tests on the population-at-large is the stage of post-marketing surveillance. Performing tests on various species of animals is the preclinical investigation stage. Cognitive Level: Applying Client Need: Physiological Integrity Client Need Sub: Pharmacological and Parenteral Therapies 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 health care. NLN Competencies: Quality and Safety: Policies and procedures. Nursing/Integrated Concepts: Nursing Process: Implementation Learning Outcome: 2-5 Identify the nurse’s role in the drug approval process and in maintaining safety practices. MNL Learning Outcome: 1.1.1 Apply basic concepts related to pharmacology. Page Number: 13 Question 3 Type: MCSA The student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA). What has the student learned about 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. Correct Answer: 3 Rationale 1: The Food and Drug Administration (FDA) is just as strict now as it always was with regard to drug approval. Rationale 2: Th