Alkaloids
React with body acids to form a salt, which is ready soluble in body fluids
Glycosides
Contain a carbohydrate or sugar molecule
Gums
Mucilaginous secretions (usually polysaccharides) with the ability to attract and hold water
Oils
Insoluble in water and are classified as volatile or fixed
Volatile oils
Derived strictly from plants evaporate when exposed to air
Fixed oils
Also known as fatty oils. Derived from both animals and plants and their consistency varies with temperature
Resins
Solid or semisolid, water insoluble, organic substances of vegetable origin commonly used as laxative or causative agents
Sources of drugs
Plants, Animals, Synthetic Chemicals, and Genetically Engineered Chemicals
Pharmacogenetics
The study of how genetic variables affect the pharmacodynamics of a drug in a specific patient
Pharmacogenomics
Application of the "omics" technology for the prediction of the sensitivity or resistance of an individual patient's disease to a specific drug or group of drugs
Chemical name (of a drug)
describes the drug's atomic and molecular structure, using exact chemical nomenclature and terminology. Mostly used for chemists and biochemists.
Generic name (of a drug)
(official name) Also known as nonproprietary name. Identifies the drug's active ingredient
United States Adopted Names Council
Assigns official name to each drug and publishes them in the United States Pharmacopeia and National Formulary
Trade name (of a drug)
Also known as brand or proprietary name. Given by manufacturer. Usually easy to say and remember. Trademarked.
Chemical composition (of a drug)
Describes its chemical base
Physiologic classification (of a drug)
Describes its effect on the body systems
Therapeutic classification (of a drug)
Describes the drug by its use in therapy
United States Pharmacopeia (USP)
Source for standards of strength, quality, purity, and preparation of medicinal compounds
National Formulary (NF)
Sets national standards for drug quality
Pure Food and Drug Act of 1906
Due to unsanitary/unethical practices in meatpacking industry.
Designated USP & NF as official standards
Federal Food, Drug, and Cosmetics Act of 1938 (FFDCA)
In response to 100+ deaths due to marketing of untested drugs. Established FDA as agency for monitoring and controlling drug manufacturing and marketing and allowed FDA to prohibit marketing of any drug judged to be untested or dangerous
Kefauver-Harris Amendment
Amendment tightened controls on drug safety and stated adverse reactions and contraindications must be cited and included.
Preclinical trials
Designed to provide basic safety, bioavailability, pharmacokinetic, and initial efficacy data about the drug and are carried out in animal subjects in the laboratory setting
Clinical trials
Occur in four phases from 5-9 years
Phase I -3 before drug is marketing and IV is completed after marketing begins.
Phase I (Clinical Trials)
Introduces the drug to humans. Goal is to determine metabolic and pharmacologic actions of the drug in humans as well as adverse effects that occur with increasing doses
Phase II (Clinical Trials)
Well-controlled, closely monitored, conducted in a small cohort of several hundred people. Goal is to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition
Phase III (Clinical Trials)
Includes both controlled and uncontrolled trials. Also intended to uncover infrequent or rare adverse effects that sometimes only affects a small portion of the population. Several hundred to several thousand patient volunteers enrolled in double-blind st
Phase IV (Clinical Trials)
FDA conducts postmarketing surveillance to monitor the drug for safety and any new developments. Additional tests may be done.
Placebo response
May involve objective physiologic and biochemical changes as well as subjective complaints with disorder being treated. Occurs consistently 20-40% of patients in all studies
MedWatch
Sponsored by FDA and encourages voluntary reporting from health professionals and consumers about adverse effects from drug products or medical devices
Practioners' Reporting Network
Sponsored by USP and has four programs
1. USP Drug Product Problem Reporting Program (targets drug packaging and dedicated to problems with unclear labeling, defective packaging, poor product quality, suspected counterfeiting, product tampering)
2. USP Dr
Orphan drug
Drugs useful in the diagnosis, treatment, or prevention of rare diseases
Legend Drugs
Prescription drugs, identified by the inscription or legend on the container
Three names that a drug may be identified with
generic name
chemical name
trade or brand name