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Food and drug adminstration (FDA),
Who is responsible for approving new drugs and monitoring drugs for adverse or toxic effects
manufacturer develops a drug that has potential
invitro testings on animal and human cells
then applies for IND (INVESTIGATIONAL NEW DRUG) status
drug testing phase involes 3 phases
last 4 to 6 weeks
done on 20-100 healthy volunteers
studies focus on dosing and safety
NDA New drug application
this is submitted after phase 1, 11, and 111, are completed and the drug is found to be safe and effective
federal government has stated they are potentially harmful unless their use is under supervision of a health care professional
know as legend drugs
must be prescribed by a licensed health care provider
the prescription must contain?
name of drug
the method and times for administration
signature of a licensed health care provider
are designated by the FDA to be safe if taken as directed
no prescription required
can also be called OTC over-the-counter
are the most carefully monitored of all drugs
high potential for abuse
may cause physical or psychological dependence
a compulsive need to use a substance repeatedly to avoid mild to severe withdrawal symptoms
a compulsion to use a substance to obtain a pleasurable experience
it is the mind's dependence
controlled substance act of 1970
regulates the manufacture, distribution and dispensing of drugs that have abuse potential
controlled substances act of 1970
classified into shcedules (CI, CII, CIII, CIV, CV)
based on their potential for abuse and physical and psychological dependence
controlled substances scheduled C1
high abuse potential
not accepted in US
Heroin, marijauana, ecstasy, LSD
the prescription for controlled substances must contain?
must be in ink
cannot be filled more than 6 months after the prescription was written
cannot be refilled more than 5 times
controlled substances scheduled C11
high potential for abuse
demerol, methadone, morphine, oxycontin, amphetamines, ritalin
controlled substances scheduled C111
less potential for abuse than C11
potential for moderate abuse
serious allergic drug reaction
requires immediate medical attention
can be fatal if not treated immediately
cumulative drug effect
when the body is unable to metabolize and excrete one dose of a drug before the next is given
can occur in patient with liver or kidney disease
the time required for the body to eliminate 50% of the drug in circlulation
takes 5 to 6 half-lives to eliminate the drug completely from the body
synergistic drug reaction
two drugs working together in harmony being better then one drug working alone
additive drug reaction
the combined effect of two drugs equals the sum of the effects of each drug given alone
Which drugs interact or interferes with the action of another drug?
a genetically caused abnormal response to normal doses of a drug
due to inherited traits
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