1. Chapter 2 The Drug Approval Process Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

2. The Drug Approval Process 2 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

3. Drug Standards and Legislation  Brief history of pharmacology  Drug standards and legislation  Drug standards United States Pharmacopeia National Formulary (USP- NF) The International Pharmacopeia  Federal legislation 1938: Food, Drug, and Cosmetic Act 1952: Durham-Humphrey Amendment to the 1938 Act 1962: Kefauver-Harris Amendment to the 1938 Act 3 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

4. Federal Legislation  The Controlled Substances Act of 1970  1978: Drug Regulation Reform Act  1992: Drug Relations Act  1997: The Food and Drug Administration Modernization Act  2003: Health Insurance Portability and Accountability (HIPAA)  2003: Pediatric Research Equity Act  2003: Medicare Prescription Drug Improvement and Modernization Act (MMA) 4 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

5. Federal Legislation  2007: Food and Drug Administration Amendments Act  2009: Family Smoking Prevention and Tobacco Control Act  2010: Patient Protection and Affordable Care Act 5 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

6. Legislation  Nurse Practice Act  Misfeasance Negligence  Nonfeasance Omission  Malfeasance Giving correct drug via wrong route 6 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

7. Canadian Drug Regulation  Controlled Drug and Substance Act  National Association of Pharmacy Regulatory Authority  Nonprescription drugs 7 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

8. Combat Counterfeiting  FDA and consumer groups  Tighter oversight of distributors  Rapid alert system  Better informed consumers  Verified Internet Pharmacy Practice Site (VIPPS) www.fda.gov/Safety/MedWatch/HowToReport/ www.fda.gov/Safety/MedWatch/HowToReport/ 8 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

9. Drug Names  Chemical names  Generic names  Brand/trade names 9 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

10. Drug Resources  American Hospital Formulary Service Drug Information  U.S. Pharmacopeia—Drug Information (USP- DI)  Medical Letter  Prescriber’s Letter  Handbook on Injectable Drugs  MedlinePlus: www.nlm.nih.gov/medlineplus/druginformation www.nlm.nih.gov/medlineplus/druginformation 10 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

11. Practice Question #1 The nurse identifies the act that provides for the privacy of patient health information as the A.Drug Regulation Reform Act. B.Drug Relations Act. C.Food and Drug Administration Modernization Act. D.Health Insurance Portability and Accountability Act. 11 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

12. Practice Question #2 If a nurse administers the wrong medication to a patient and the patient is harmed, the offense is termed A.misfeasance. B.nonfeasance. C.malfeasance. D.assault. 12 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

13. Practice Question #3 The nurse identifies the primary purpose of federal legislation in drug standards as A.preventing overcharging for drugs. B.controlling efforts in drug research. C.ensuring public safety. D.moderating effective drug usage. 13 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

14. Practice Question #4 Which situation regarding controlled substances requires the supervising RN to intervene? A.The staff keeps a separate controlled-substances record for all required information. B.Controlled substances are locked away from patients, and all staff members have keys for necessary access. C.Opioids are kept under double lock to limit access to them. D.All discarded or wasted controlled substances are countersigned. 14 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

15. Practice Question #5 A nurse administers the correct drug, but by the wrong route, and it results in the patient’s death. The legal term for this offense is A.malfeasance. B.nonfeasance. C.misfeasance. D.malpractice. 15 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.

16. Practice Question #6 A nurse is to administer a dose of furosemide (Lasix). The nurse is aware that Lasix is the ________ for the drug. A.generic name B.chemical name C.nonproprietary name D.brand name 16 Copyright © 2015, 2012, 2009, 2006, 2003, 2000, 1997, 1993 by Saunders, an imprint of Elsevier Inc.