HOSA Pharmacology

-approve new drugs to be sold in the US -process New Drug Applications (NDA) -regulate package inserts -regulate drug advertising -issue recalls -federal agency

-federal agency -enforce the CSA ( controlled substances act) -track controlled substances manufactured and sold -investigates all violations involving controlled substances -set the DEA Sch. Definitions -issue DEA numbers

-regulate licensing of pharmacists -regulate licensing of pharmacy technicians -set state laws/ requirements -outline the operating guidelines in the pharmacy -investigate violations of the operating guidelines -determine state regulated controlled substances -state agency

-watches over healthcare organizations -third party auditors/ regulators for insurance providers

-no accepted medical use -extremely high potential for abuse -high potential for psychological and physical dependency -ex. weed, heroin, mdma

-does have medical use -high potential for abuse -relative potential for psychological and physical dependency -ex. oxycodone, codeine, retalin -no refillls allowed -cannot be "called in" or transmitted electronically unless it is an absolute emergency

-does have medical use -moderate abuse potential exits -ex. vicodin and tylenol w/ codeine

-abuse potential exists -ex. ambien, darvocet, lorazepam

-lowest abuse potential -ex. cough medicine w/ codeine or anti-diarrheas

-must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors

-add the 1st, 3rd, and 5th digits -add the 2nd, 4th, and 6th digits. double it -add the two totals together. the second digit is the check digit -preceded by two letters: first letter represents the type of practice or institution the DEA number is issued to, the second letter represents the first letter of the practitioner's last name

-tells pharm techs how to dispense it -also printed on the prescription it is dispensed in but translated into regular words for the patient

no expiration

6 months

12 months

no refills allowed

-up to 5, but only 5 times -if a patient can only afford 50 at a time then they will only get 250 total

up to 12 months worth

-date of prescription issue -patient's name and address -practitioner's name, address, and phone number -drug name -drug strength -dosage form and instructions -exact quantity prescribed -complete directions for use -number of refills authorized -a valid DEA number

-must be manually signed by the practitioner. no exceptions -may not be faxed or called in, except for a valid emergency -may not have any refills

would be used in a case where there is a probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequence is remote

may be used in a situation in which use of a violative product is not likely to cause adverse health consequence, but has violated some FDA regulation

appropriate when a product has a minor violation that would be not subject to FDA legal action. the manufacture must remove the product from distribution markets or correct the violation. "a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal"

used only for medical apparatus equipment. this is when a medical device may present an unreasonable risk of substantial harm. in some cases, these situation also are considered recalls.

pre-clinical (animal) testing

-review of pre-clinical trial results -determination of safety to use on humans -authorization to ship across state lines

-involves 25-100 volunteers -safety tolerated dosage determined -identification of major side effects -emphasis on safety and maximum tolerated dosages

-involves 100-300 volunteers -emphasis on the drug effect against what it's designed to treat -effets compared with similar patients receiving different treatments

-involves 300-3000 volunteers -emphasis on the drugs overall effect -effects compared with patients taking placebos -study of different population and different dosages -testing the drug in combination with other drugs -final phase before presenting to FDA for approval

-ongoing/post approval trials -health-care professionals to report any adverse findings -lasts eternally, as long as the drug is on the market

-can usually take 12-15 years -patent only last 20 years from the time the application for patent was filled

-known as the Pure Food and Drug Act -provided authority for federal inspection of meat products and prohibited the sale of adulterated foods -required that "secret elixirs" containing ingredients like: cocaine, heroin, morphine and alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages -replaced by the Federal Food, Drug and Cosmetic Act of 1938

-known as the Harrison Narcotic Act -provided authority for the IRS to collect taxes on Opiates thru tax stamps -required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS -emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction

-known as FDCA 1938 -replaced the Food and Drug act of 1906 -provided better clarification about misbranding definitions -provided better clarification about adulteration definitions -gave the FDA authority to require adequate testing of new drugs for safety

-created a distinction between "OTC" and "Legend Drugs" -required legend drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription." -emphasis on this act was to insure safety through qualified medical supervision

-known as the "Drug Efficacy Amendment" -required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval -required drug advertising to be more closely regulated and disclose accurate information about side effects

-predecessor agency of the DEA -BNDD merged into the DEA in 1973

-known as the CSA -completely replaced the Harrison Act -required the use of DEA numbers -required comprehensive record keeping and transaction tracking -enforced the DEA under the US Dept of Justice

-also known as the PPPA -designed to reduce the risk of children ingesting dangerous substances -required locking caps on most prescription

-enacted to regulate the OTC sales of pseudoephedrine -identity and address of each purchaser to be kept for two years -daily sales of regulated products not exceed 3.6 grams -30 day purchase limit not to exceed 9 grams -30 day purchase via mail order not to exceed 7.5 grams

-used to identify legend drugs -part of the drug listing act of 1972

-identifies the drug's manufacturer -number is unique to the maker or re-packager of the product

-identifies the product -number unique to the formulation and strength of the product

-identifies the packaging -unique to the size and quantity of the product

every

every hours

every morning

every evening

every bedtime

every day

every other day

every week

every month

every __ hours

every __ hours

twice a day

three a day

four a day

times __ days

3 times a day

with

before a meal

after a meal

at bedtime

as needed

as directed

of each

quantity sufficient

drop

right eye

left eye

both eyes

right ear

left ear

both ears

by mouth/oral

sub-lingual

naso gastic

cheek/gum

rectally

vaginally

suppositiory

tablet

capsule

intramuscular

sub-cutaneous

intravenous

intra cardiac

injection

immediately

-given orally and pass through the GI tract to be absorbed into the bloodstream and metabolized by the liver -includes oral, naso-gastric, and rectal routes

-injected or placed into the body tissues and do not pass through the liver before entering the bloodstream -can include injections, topical and inhalation reoutes -generally refers to injection

-usually in the form of solution or powders -mixed with a sterile diluent to render an injectable solution

-applied to the skin surface or a mucous membrane

-to form a tablet, the drug is combined with fillers and is them compressed into a hard pellet -available in fast acting, slow released, control released, enteric coated, film coated, sublingual, chewable and other formulations -sublingual tablets are placed under the tongue, wafers are placed on the tongue and buccal tablets are placed between the cheek and gum

-to form a capsule, the drug is contained in a cylindrically shaped shell

-an oval shaped tablet

-drug is mixed with, but not completely dissolved into a liquid -needs to be shaken before administration in order to suspend the drug particles evenly

-contain a high concentration of sucrose or sugar to sweeten, for ease of use