Drug Regulation & Prescription Writing Flashcards
(46 cards)
What is the role of the federal government regarding drug regulation?
FDA controls what drugs may be prescribed/sold; equivalency of brand name vs generics; placement of drugs into prescription vs non-prescription
What is the role of the state government regarding drug regulation?
Control who may prescribe drugs
What are the 4 basic drug categories?
Prescription, controlled substances, OTC, dietary supplements
What distinguishes the 4 basic drug categories?
Are they evaluated for efficacy/safety; availability for prescription only; potential for abuse
What is the main goal of animal studies in the evaluation of drugs?
Determine safe dosage range for humans
Detail the basic structure of a phase 1 clinical trial.
Normal volunteers; pharmockinetic studies; determine if animal/human response differs significantly
Detail the basic structure of a phase 2 clinical trial.
Select patient pool; safety and efficacy evaluated for final dosing regimen adjustments
Detail the basic structure of a phase 3 clinical trial.
1000-6000 patients; does the drug work
The FDA can regulate what indications for drug use the manufacture can claim, what can it not regulate?
How a drug is actually used by a physician
What is an ANDA?
Abbreviated New Drug Application; submitted for generic drugs so that the manufacturer can bypass trails for an already approved drug entity
Why might low incidence of drug effects be missed in phases 1-3? What is done to monitor this risk?
Not a large enough sample size; phase 4, manufacturers must report adverse effects of their drugs on the market
Compare the pharmacological effects of generic drugs to their brand-name counterparts?
They are exactly the same
What are the categories for FDA equivalency?
Pharmaceutical; biological; therapeutic
What defines a pharmaceutical equivalent?
Drug products containing the same active ingredient(s) in same dosage formulation that are identical in strength
What is a pharmaceutical alternative?
Drug product that contains the same therapeutic moiety but different complex or dosage or strength
What is the major equivalency test required by the FDA?
Bioequivalent
What defines a bioequivalent drug product?
A pharmaceutical equivalent that displays comparable bioavailability
What does bioavailability refer to?
Rate and extent that an active ingredient is absorbed and becomes available at the site of action
How is the extent of drug absorption measured?
Area under plasma concentration time curve (AUC)
How is the rate of drug absorption estimated?
Cp max
Bioequivalent drugs are assumed to meet what other FDA equivalency test?
Therapeutic
Why are vitamins/minerals/amino acids considered distinct from herbal medications when contemplating their therapeutic use in patients?
In general, molecular entity imparting pharmacologic activity to these compounds is known; in contrast, this info is not known for the majority of herbal medications
What is a health claim?
Describes the effect a substance has on reducing the risk of or preventing a disease
What is a structure/function claim?
Describes the role of a substance intended to maintain the structure/function of the body
