Chapter 1 Information, Sources, Regulatory Agencies, Drug Legislation, and Prescription Writing Flashcards
(24 cards)
Pharmacotherapy
The use of medications to treat different disease states
Pharmacodynamics
The study of the action of drugs on living organisms
Pharmacokinetics
The study of what the body does to a drug; the measurement of the absorption, distribution, metabolism, and excretion of the drug from the body
Pharmacy
The practice of compounding, preparing, dispensing, and counseling of patients about their medications
Toxicology
The study of the harmful effects of drugs on living tissues
Chemical name
Determined by the chemical structure of the compound
Trade name
Name company puts on drug
Generic name
Shortened version of chemical name
1914: Established regulations governing use of opium, opiates, and cocaine
1937: Marijuana laws added
Harrison Narcotic Act
Takes 12 years and 350 million from the time a drug is synthesized in the lab to its availability on product shelves. True or false?
True
Phase 1 of clinical studies
- Small and then increasing doses are
administered to a limited number of healthy human volunteers - Determines biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug
Phase 2 of clinical studies
- Larger groups of humans are given the drug
- Adverse reactions are reported to the FDA
Phase 3 of clinical studies
- Clinical evaluation involving a large number of patients who have the condition for which the drug is indicated takes place
- Safety and efficacy must be demonstrated - Dosage is determined
Phase 4 of clinical studies
- Post marketing surveillance
- Toxicity that occurs in patients taking the drug after it is released is recorded
How many schedules of controlled substances are there?
6
Packaging Inserts PI
- Chemical makeup of drug
- FDA-approved indications for use
- Contraindications
- Warnings
- Adverse reactions
- Drug interactions
- Dose and administration
- How supplied
- Draw attention to safety concerns
associated with the drug - Educates both prescriber and patient about serious safety concerns associated with the drug
Blackbox warning
Use is used outside the stated FDA
indications
Off-label use
Indicates that the FDA has
approved the drug for specific use
Labeled use
300mg and 350mg Acetaminophen are the same amounts. True or False?
True
Primary measurement system used in the pharmacy is?
Metric system
Solid drugs are dispensed by?
Weight (mg)
Liquid drugs by?
Volume (mL)
Prescription format:
- Heading
- Body
- Closing
- Substitution