1. Consumer Safety and Drug Regulations
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 Drug standards
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 Illegal (illicit) drugs
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 DEA
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