Week 1 Ch 1: Information Sources, Regulatory Agencies, Drug Legislation and Prescription Writing

chemically equivalent

2 formulations of a drug meet the chemical and physical standards

biologically equivalent

2 formulations of a drug produce similar concentrations of the drug in the blood and tissues

therapeutically equivalent

2 formulations of a drug have equal therapeutic effects in a clinical trial

phase 1

small and the increasing doses given to limited healthy human volunteers; determines safety

phase 2

larger group of humans are given the drug; determines effectiveness, any adverse reactions are reported to FDA

phase 3

group of patients with the condition the drug is for; determines safety, efficacy and dosage

phase 4

post marketing surveillance; toxicity of drug reported after released, removed off shelves if so

package inserts (PI)

literature about the drug between manufacturer and FDA; provides information of chemical makeup of the drug; FDA-approved for use, contraindications, warnings, adverse reactions, drug interactions, dose and administration, how it is supplied

black box warning

FDA requires manufacture to display this in PI; draws attention to warnings for both prescriber and patient; for serious safety concerns

labelled and off label uses

FDA uses of drugs for specific indications, listed on PI; any usage outside of the labeled indications; pharmacists cannot discuss or provide literature to prescribers

orphan drugs

developed to treat rare medical conditions

drug recall

done if there is reasonable probability that their use will have serious adverse health effect and/or death

prescription writing

an order for a specific medication for a specific patient at a particular time, with appropriate instructions for how the patient is to use the prescribed medication