NSG 6005 WEEK 10 QUESTION AND ACCURATE ANSWERS A+ RATED COMPLETE PASS
Chapter 4. Legal and Professional Issues in Prescribing
1. An Investigational New Drug is filed with the U.S. Food and Drug Administration
NSG 6005 WEEK 10 QUESTION AND ACCURATE ANSWERS A+ RATED COMPLETE PASS Chapter 4. Legal and Professional Issues in Prescribing 1. An Investigational New Drug is filed with the U.S. Food and Drug Administration: 1. When the manufacturer has completed phase III trials 2. When a new drug is discovered 3. Prior to animal testing of any new drug entity 4. Prior to human testing of any new drug entity 2.The U.S. Food and Drug Administration approval is required for: 1. Medical devices, including artificial joints 2. Over -the-counter vitamins 3. Herbal products, such as St John’s wort 4. Dietary supplements, such as Ensure 3. The U.S. Food and Drug Administration regulates: 1. Prescribing of drugs by MDs and NPs 2. The official labeling for all prescription and over-the-counter drugs 3. Off-label recommendations for prescribing 4. Pharmaceutical educational offerings 4. Phase IV clinical trials in the United States are also known as: 1. Human bioavailability trials 2. Postmarketing research 3. Human safety and efficacy studies 4. The last stage of animal trials before the human trials begin 5. The U.S. Drug Enforcement Administration: 1. Registers manufacturers and prescribers of controlled substances 2. Regulates NP prescribing at the state level 3. Sanctions providers who prescribe drugs off-label 4. Provides prescribers with a number they can use for insurance billing 6. Off-label prescribing is: 1. Regulated by the U.S. Food and Drug Administration 2. Illegal by NPs in all states (provinces) 3. Legal if there is scientific evidence for the use 4. Regulated by the Drug Enforcement Administration 7. Drugs that are designated Schedule II by the U.S. Drug Enforcement Administration: 1. Are known teratogens during pregnancy 2. May not be refilled; a new prescription must be written 3. Have a low abuse potential 4. May be dispensed without a prescription unless regulated by the state 8. Precautions that should be taken when prescribing controlled substances include: 1. Faxing the prescription for a Schedule II drug directly to the pharmacy 2. Using tamper -proof paper for all prescriptions written for controlled drugs
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