Chapter 1

1. Chapter 1 Consumer Safety and Drug Regulations

2. Introduction • Health care practitioners: • Inform patients with knowledgeable answers about medications • Have a serious, responsible attitude about all aspects of drug therapy

3. Drug Laws • 1900s in the United States • Laws were passed with regard to the dispensing of drugs • Drug standards • Set to assure consumers that they are getting what they pay for • All preparations with the same drug name must be of uniform strength, quality, and purity

4. Drug Laws ( cont’d.) • Drug preparations • Drug companies must not add other active ingredients or varying amounts of chemicals • Illegal (illicit) drugs • Lack of enforcement of drug standards poses consumer danger • No controls on quality can lead to deaths from overdose

5. Drug Laws ( cont’d.) • Three major acts • 1906 Pure Food and Drug Act • 1938 Federal Food, Drug, and Cosmetic Act and Amendments Of 1951 and 1962 • 1970 Controlled Substances Act

6. 1906 Pure Food and Drug Act • First attempt to establish consumer protection in drug and food manufacture • Required drugs to meet minimal standards of strength, purity, and quality • Demanded labeling for preparations containing dangerous ingredients • Established United States Pharmacopeia (USP) and National Formulary (NF)

7. 1938 Federal Food, Drug, and Cosmetic Act • Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmetics • Example: “Warning” labels must be present on certain preparations • “May cause drowsiness,” “may cause nervousness,” “may be habit-forming,” etc.

8. 1970 Controlled Substances Act • Established the Drug Enforcement Administration (DEA) • Set tighter controls on depressants, stimulants, psychedelics, narcotics, and anabolic steroids • Provided guidelines for five schedules of controlled substances • Refer to Table 1-1.

9. Additional Drug Legislation • The 1983 Orphan Drug Act • Gives financial incentives to develop medications for diseases that affect a small number of people • Omnibus Budget Reconciliation Act (OBRA) of 1990 • Mandates that OTC drugs be documented as part of a medical record • Mandates that pharmacists provide drug use review and patient counseling

10. FDA and DEA • Food and Drug Administration (FDA) • Oversees drug testing before release • Inspects plants where foods, drugs, medical devices or cosmetics are made • Reviews new drug applications and petitions for food additives • Investigates and removes unsafe drugs from the market • Ensures proper labeling of foods, cosmetics, and drugs

11. FDA and DEA (cont’d.) • Drug Enforcement Administration (DEA) • Created as the need for better control of addictive drugs became urgent • Handles all the needs and safety controls for the more dangerous drugs

12. FDA and DEA (cont’d.) • Specific areas of control • FDA • Concerned with general safety standards in the production of drugs, foods, and cosmetics • Responsible for the approval and removal of products on the market • DEA • Concerned with controlled substances only • Enforces laws against drug activities • Monitors need for changing the schedules of abused drugs

13. Health Care Practitioners and the Law • Guidelines for those who dispense medications • Keep a current drug reference source available at all times • Keep controlled substances locked securely • Locked safety box in a locked cupboard • Conceal and secure prescription pads • Properly destroy expired drugs and old records

14. Health Care Practitioners and the Law (cont’d.) • Keep accurate records of each controlled substance dispensed, received, or destroyed during past two years • Keep up-to-date with current FDA news, DEA activities, and registration renewals • Establish a working rapport with a pharmacist • If you work in an office, maintain a professional rapport with pharmaceutical representatives