Pharm exam 1: Section 1

safety, appropriateness, effectiveness • is the regimen easy? • Will pt follow regimen? • Does regimen have least amount of side effects?

regulate whether drug can be on the market; regulate if off label use is ok

Anyone using electronic prescribing system needs NPI #

lab and animal studies

small safety study with healthy people 20-80 people

Safety study People with illness that med will be used for 100-300 people Determine side effects

Determines effectiveness of drug and side effects Trial is double blind with placebo People with illness for meds use 1k-3k people

Approved or rejected If approved - med is marketed

long term monitoring of drug side effects post marketing studies

FDA determines potential for drug to cause addiction and dependency (physiologic or psychological)

High potential for abuse, no therapeutics use Ex: heroin, lsd, cocaine, marijuana

Valid for medical use High potential for abuse No prescription refills Must write number of pills prescribed on paper prescription with signature Ex: methadone, opioids

Potential for abuse, moderate to low risk for dependence Prescription refills 5 times over 6 months Ex: Percocet, Vicodin Must write number of pills prescribed on paper prescription with signature

Low potential for abuse unless used everyday Physiologic dependence possible Ex: anti-anxiety medication, non-narcotic pain meds

Lowest potential for abuse Ex: cough medicine with codeine, antitussives, antidiarrheals

Determines what drugs are required to be scheduled

Generic can be made and marketed when patent expires for brand medication Generic must undergo clinical trials Generic must be similar in how well they work to brand Must be within close percentage of bioequivalence of brand Safe because of oversight

Not regulated, may be counterfeit May be different dose or have different ingredients Unsafe

Sold as food, no FDA approval required Ex: St. Johns Wort interferes with many meds Fox glove is digitalis

Contaminate environment if not disposed via community drug take back program Can put meds in cat litter and dispose in closed container

States, not federal government Board of nursing with some medical board Cert and license determine scope of practice 22 states and DC allow APN to prescribe independently

Collect data and assess pt (med hx, sx hx, allergies, hx and physical exam) Formulate differential dx Select appropriate therapy (don’t duplicate therapy, cost effective therapy) Patient education: therapeutic effects, side effects, how to deal with adverse drug reactions, how to deal with adverse reactions, readable instructions, easily understood language, pharmacy preference)

Lack of knowledge: prescriber must educate pt, if unfamiliar with pt medical issue, refer Lack of communication Illegible, incomplete, or wrong medication use Lack of allergy medication Overuse, underuse, misuse, inadequate history If don’t know meds pt is taking, look it up

Name and title Practice address and phone License (state) and NPI # DEA # if a controlled substance (print and sign prescription) Billing medicare needs NPI #