Week 1 - Ch 1,2 Flashcards
Any non food chemical substance that affects the mind or body
Drug
The study of drugs and their interactions with living organisms
Pharmacology
Chemical substances that do not have a preventative, diagnostic, or therapeutic use.
Drug
Drug deliberately administer for its medicinal value as a preventative, diagnostic, or therapeutic agent.
Medicine
Three general areas of medical use for drugs
Prevent disease, diagnose disease, treat symptoms/conditions/diseases
Preparation of drugs in the 1800’s
Chemists developed techniques to extract and isolate pure substances from crude drug preparations
Preparation of drugs in the 1900’s
The extractions and preparation of drugs was a time consuming process that utilized test tubes, filters, and Bunsen burners. Pharmacists at that time actually prepares the drugs the dispensed.
The Food and Drugs Act of 1906
The first federal drug law
1912 Amendment to The Food and Drugs Act
Required the accurate labeling of drugs to prevent substitution or mislabeling of ingredients
The Food, Drug, and Cosmetic Act of 1938
FDA can remove a product without fraud for the best interest of the people
Durham-Humphrey Amendment (1951)
Defined prescription drugs as those drugs that could only be given to patients under the care of a physician.
Kefauver-Harris Amendment (1962)
Required drugs to be shown to be both safe and effective before being marketed. It also required manufacturers to report adverse effects from new drugs.
1988
The FDA was moved under the federal Dept of Health and Human Services.
Dietary Supplements and Health Education Act (1994)
Allowed the FDA to set up guidelines for the manufacturers of herbal products and dietary supplements
FDA Modernization Act (1997)
Gave the FDA the authority to accelerate the approval process for certain types of drugs
Emergency Treatment Investigation New Drug (IND) Application
Allows physicians to prescribe some investigational drugs even before they are officially approved for marketing, these drugs are for life threatening diseases a for which no alternative therapy exists
Health Insurance Portability and Accountability Act of 1996
All healthcare settings must provide patients with a statement that verifies that their health record, including all drug information, is kept secure and is only released to authorized inquiries from other healthcare providers, insurance companies, or healthcare monitoring organizations.
Patent medications and associated problems
First drugs marketed to consumers. Usually associated with outrageous claims and not baked by science.
Scheduled drugs
Potentially addictive drugs divided into 5 categories based on their potential for physical or psychological dependence
Schedule drugs were first regulated by this act
The Harrison Narcotics Act of 1914