Consumer Safety and Drug Regulations Chapter 1 Consumer Safety and Drug Regulations

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

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

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

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

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)

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.

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.

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

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

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

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

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

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