Chemical

generic

trade

shorter name derived from the chemical name- nonpropriety

actual drug- active ingredient

- a copy of a brand name drug whose patent has expired

-during a patent period (20 years) only the original manufacturer can market the patented drug

-after the patent expeires any company can market the drug-usually marketed under the generic NAME

-Cost $$$

-brand name drugs may cost up to 4 times more than a generic drug

-large portion of cost of brand name drug covers the high cost of research and development

-generic manufacturers do not have to duplicate the cost of research and marketing conducted by the original manufacturer

generic drug usually marketed under generic name which usually indicates the active ingredients

-brand-name does not indicate active ingedients

OTC

prescription

controlled substances (scheduled)

-Do not require prescription

-contains less drug per dose when compared to corresponding prescription drug

-Aleve-200mg OTC

-Naproxen-250 or 500 mg- prescription

-often marketed as combination products (tylenol cold) that include several ingredients

-requires a physician to write and pharmacist to fill it

-greater potential for adverse effects (side effects, drug interactions, allergies, etc)

-should only be used for restricted periods of time

-greater potential for abuse than prescription drugs

-greater restriction in storage, distribution, and record keeping

schedule I- highest potential for abuse

Schedule V- lowest potential for abuse

-most narcotic pain presciptions and anabolic steroids are scheduel III

Drug enforcement agency or the department of justice is responsible for 

-manufacturing 

-distribution

-dispensing of controlled substances

-Enters the body by way of the alimentary canal or digestive system

-oral 

-sublingual- just sits there and disolves

-Rectal- cream or pill

-Pathway other than through the alimentary canal or digestive system

-usually allows drug to be delivered directly to target tissue

-inhalation

-injection

-topical or transdermal application

-oral

-injection

-intranasal

-oral inhalation

-sublingual- under tongue

-buccul-inside cheek or directly on gum

-rectal

-opthalmic- eye

-Otic- ear

-topical- skin

-intravenous-kicks in instantly

-inhalation

-sublingual absorption

-drugs administered orally may require 30 min before relief provided

-liquids or powders dissolved in water will act more quickly than tablets or capsules

-housed within the department of health and human services

-responsible for the review and approval of all new drugs before they can be made available to the public

-before applying for drug approval, manufacturer must do preclinical testing

-3-6 years

-laboratory and animal testing to determine specific biological activity of drug

-begin clinical trials- studies involving human subjects)

-phase I clinical trials

-small number (80-100) of health volunteer subjects over a 1-2 year period 

-pruose: to check how the body handles the drug and confirm safe dosages

-phase II-

-moderate number(100-300) of actual patients over 2-3 year period to determine effectiveness and short-term side effects of drug interaction

-phase III- large number(1000-3000) of actual patients over  3-4 year period to determine effectiveness and short-term side effects or drug interactions of new drug compared to another therapy

Step 3 of drug approval

-submit a new drug application

-approval of NDA allows physicians to prescribe the new drug

-continuous monitoring of the drug in the general populations of patients

-adverse effects

-longterm effects

-phase IV studies to compare new drug to other therapies