Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Hart13 ppt ch03 2012

279 views

Published on

Published in: Education, Health & Medicine
  • Be the first to comment

Hart13 ppt ch03 2012

  1. 1. Chapter 3 Drug Products and Their Regulations© 2011 McGraw-Hill Higher Education. All rights reserved.
  2. 2. Chapter 3: Regulation & Legislation  What is being targeted?  Certain substances  Recreational use  Medicinal use  Who is doing the regulating?  U.S. Department of Agriculture/FDA  U.S. Treasury Department  Motives  Public safety concerns?  Revenue & trade status?  Impact© 2011 McGraw-Hill Higher Education. All rights reserved.
  3. 3. Reformism  Current laws trace back to two pieces of legislation from the early 1900s  Racist fears about deviant behavior, including drug misuse, played a role in the development of drug regulation  Laws were developed to regulate undesirable behaviors© 2011 McGraw-Hill Higher Education. All rights reserved.
  4. 4. 3 Issues Leading to Legislation  Fraud in patent medicines that were sold directly to the public  False therapeutic claims  Habit-forming drug content  Collier’s magazine series: Great American Fraud  Opium  Sale of opium by merchants  Reactions  Cocaine  Availability led to concerns of overuse  Concerns of crime© 2011 McGraw-Hill Higher Education. All rights reserved.
  5. 5. Two Bureaus, Two Types of Regulation  The Pure Food and Drugs Act (1906)  U.S. Department of Agriculture  Goal: drugs are pure and honestly labeled  Foundation for modern laws  Harrison Act (1914)  U.S. Treasury Department  Goal: taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers  Question of motives© 2011 McGraw-Hill Higher Education. All rights reserved.
  6. 6. From 1906 Act: Regulation of Pharmaceuticals 1. Purity  The contents of the product must be accurately listed on the label  FDA encouraged voluntary cooperation and compliance 2. Safety  Originally—no legal requirement that medications be safe  1938 Food, Drug, and Cosmetic Act required pre-market testing for toxicity  Companies required to submit a New Drug Application (NDA) to the FDA  Directions must be included  Adequate instructions for consumer OR  Drug can be used only with physician prescription© 2011 McGraw-Hill Higher Education. All rights reserved.
  7. 7. Regulation of Pharmaceuticals 3. Effectiveness  1962 Kefauver-Harris Amendments  Pre-approval required before human testing  Advertising for prescription drugs must include information about adverse reactions  Every new drug must be demonstrated to be effective for the illnesses mentioned on label  Steps  Preclinical research and development  Clinical research and development  Permission to market© 2011 McGraw-Hill Higher Education. All rights reserved.
  8. 8. From 1914 Act: Registration & Taxation  Early enforcement  Dr. Webb  1919 Volstead act & Bureau of Prohibition  Prohibited sale of alcohol  Penalties for production  18th Amendment: Prohibition – 1920  Repealed in 1933 by the 21st Amendment© 2011 McGraw-Hill Higher Education. All rights reserved.
  9. 9. Comprehensive Drug Abuse Prevention and Control Act of 1970  Replaced or updated all previous laws  Drugs controlled by the Act are under federal jurisdiction  Prevention and treatment funding increased  Direct control of drugs, not control through taxation, is the goal  Enforcement separated from scientific and medical decisions© 2011 McGraw-Hill Higher Education. All rights reserved.
  10. 10. Comprehensive Drug Abuse Prevention and Control Act of 1970  Drug Schedules  I – No medical use; high potential for abuse  II – Medical use; high potential for abuse  III – Medical use; moderate potential for abuse  IV – Medical use; mild potential for abuse  V – Medical use; low potential for abuse  Penalties for illegal manufacture, distribution or possession were assigned by category  Rules for prescribing physicians  Amendments  1984  1986  1988  2010© 2011 McGraw-Hill Higher Education. All rights reserved.
  11. 11. Impact of Drug Enforcement  Early enforcement  Prison vs. rehabilitation  Punishment seemed not to be working  “Narcotic farms”  Current issues  Bureau of Narcotics (Treasury Department)  “Drug Czar”  Mandatory minimum sentences (1951)  1956 Narcotic Drug Control Act toughened penalties  DEA formed  State vs. federal law  Drug screening© 2011 McGraw-Hill Higher Education. All rights reserved.
  12. 12. Impact of Drug Enforcement  Budget  Other costs  Cost of prison population  Crimes committed to purchase drugs  Corruption in law enforcement  Conflicting international policy goals  Loss of individual freedom  Effectiveness of control?© 2011 McGraw-Hill Higher Education. All rights reserved.

×