Exam 1 Flashcards
Chemicals that affect living processes.
drugs
study of drugs and their interactions with living systems
pharmacology
study of drugs in humans
clinical pharmacology
medical use of drugs to diagnose, treat, or prevent disease
therapeutics/pharmacotherapeutics
Name the three most important properties of the ideal drug.
effectiveness, safety, selectivity
Name some of the additional properties of an effective drug
reversible action, predictability, ease of administration, freedom from interactions, low cost, chemical stability, simple generic name
What is the therapeutic objective of drug therapy?
to provide the maximum benefit with the minimum harm
What are the 6 rights?
right drug, right patient, right dose, right route, right time, right documentation
Why is it important for nurses to know pharm?
minimize adverse effects, patient education, proper dosage and administration, prn decisions, manage toxicity
This legislation required drugs to be free of adulterants, did nothing for safety or effectiveness.
Federal Pure Food and Drug Act of 1906
Required that all new drugs undergo testing for toxicity and that the FDA reviewed these tests for safety before drug hits the market.
Food, Drug, and Cosmetic Act (1938)
Required that all drugs be tested for effectiveness before hitting the market, also set rigorous procedure for testing new drugs before FDA approval.
Harris-Kefauver Amendments to the Food, Drug, and Cosmetic Act (1962)
Set rules for the manufacture and distribution of drugs considered to have the potential for abuse. Schedule 1 most abuse, Schedule 5 the least.
Controlled Substances Act (1970)
FDA takes too long to review drug applications, for $500k the process is sped up with additional reviewers and a stricter timetable.
Prescription Drug User Fee Act (1992) PDUFA
Includes drugs for other serious life threatening illnesses in the accelerated program, must notify patients 6 mos. in advance if stop manufacturing drug, clinical trial database will be established for drugs treating serious life threatening illnesses, drug companies can provide info for off label use of drugs, research must include women
Food and Drug Administration and Modernization Act (FDAMA) (1997)
Offers a 6 month patent extension for drug companies who evaluate a drug already on the market for its safety, efficacy, and dosage in children.
Best Pharmaceuticals for Children Act (BPCA) (2002)
The FDA can require drug companies to conduct pediatric clinical trials on meds that might be used on children.
Pediatric Research Equity Act (PREA) (2003)
FDA can require postmarketing safety studies, changes in a drugs label to include new safety info, and restrict distribution of drugs based on safety concerns. FDA also created an active postmarketing risk surveillance system.
FDA Amendments Act (FDAAA) (2007)
Legislation resulted from Tragedy where >100 ppl died d/t new med that contained an antibiotic (sulfanilimide) and a solvent (diethylene glycol) aka antifreeze.
Food, Drug, and Cosmetic Act (1938)
Legislation resulted from the European thalidomide tragedy where moms took the drug that didn’t absolutely need it. Babies born with defects - phocomelia - malformation/absence of limbs.
Harris-Kefauver Amendments to the Food, Drug, and Cosmetic Act (1962)
This legislation Came about due to the rise of cancer and AIDs and the need for meds to treat them. The drug risks are much less known this way.
Prescription Drug User Fee Act (1992) PDUFA
a substance given to a group to compare to an experimental group, could be a placebo with no effect or an already existing drug.
control
- subjects are assigned randomly to the control or experimental group to prevent allocation bias.
random
study in which the subjects don’t know if they are in the control group or the experimental group.
single blind study