4 Providers should only accept low-value gifts, such as pens & pads of paper, from the pharmaceutical ADV Pharm | TextBook | StudyGuide 7
. representative. 12. Under new U.S. Food & Drug Administration labeling, Pregnancy Categories will be: 1 . Strengthened with a new coding such as C+ or C- to discern when a drug is more or less toxic to the fetus 2 . Changed to incorporate a pregnancy risk summary & clinical considerations on the drug label 3 . Eliminated, & replaced with a link to the National Library of Medicine TOXNET Web site for in-depth information regarding pregnancy concerns 4 . Clarified to include information such as safe dosages in each trimester of pregnancy Chapter 4. Legal & Professional Issues in Prescribing 1. The U.S. Food & Drug Administration regulates: 1 . Prescribing of drugs by MDs & NPs 2 . The official labeling for all prescription & over-the-counter drugs 3 . Off-label recommendations for prescribing 4 . Pharmaceutical educational offerings 2. The U.S. Food & 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. An Investigational New Drug is filed with the U.S. Food & 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 4. Phase IV clinical trials in the United States are also known as: 1 . Human bioavailability trials 2 . Postmarketing research 3 . Human safety & efficacy studies 4 . The last stage of animal trials before the human trials begin 5. Off-label prescribing is: 1 . Regulated by the U.S. Food & 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 6. The U.S. Drug Enforcement Administration: 1 . Registers manufacturers & prescribers of controlled substances 2 . Regulates NP prescribing at the state level ADV Pharm | TextBook | StudyGuide 8
3 . Sanctions providers who prescribe drugs off-label 4 . Provides prescribers with a number they can use for insurance billing 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 3 . Keeping any pre-signed prescription pads in a locked drawer in the clinic 4 .
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