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What is the number 1 rule of medicine? |
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Definition
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Factors to consider when prescribing. |
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Definition
pharmacoeconomics patient's age education diseases and what stage care givers ALL products taken |
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What is in over 600 products, and should be considered when prescribing? |
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In 1937, what medicine was tested for taste and fragrance (but not toxicity) that lead to deaths of many patients and the passing of the "Food, Drug and Cosmetic Act" in 1938? |
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Definition
Elixir Sulfanilamide-a flavored antibiotic syrup |
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What does the Durham-Humphrey Amendment of 1951 require? |
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Definition
prescription drugs can only be given under the care of a physician |
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What does the Kefauver-Harris Amendment of 1962 require? |
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Definition
drugs must be shown to be both safe and effective |
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What drug was used for morning sickness in Europe, but resulted in babies born with limb deformities? |
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Definition
Thalidomide -today used to treat multiple myeloma |
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What drug was made to bring blood pressure down in the lab, but is now used as Rogaine? |
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Definition
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What is the drug name? proprietary name? |
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Definition
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What is the difference between the FDA and the DSHEA (Dietary Supplement Health Education Act)? |
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Definition
FDA approves legend and OTC drugs through rigorous testing to be proven safe and effective.
DSHEA releases products without rigorous testing (or FDA approval) such as cosmetics and dietary supplements |
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Definition
any item that federal law prohibits dispensing without a prescription -categorized into schedules based on their actual or relative potential for abuse |
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What is the criteria for a schedule 1 drug and what are some examples? |
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Definition
-highest potential for abuse -not for medical treatment in U.S. (considered unsafe for medical use)
examples:heroin, LSD, Mescaline, Peyote, PCP |
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What is a lethal dose of tylenol? How many people admitted to the hospital last year for tylenol overdose? |
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Definition
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Term
What is the criteria for a schedule 2 drug and what are some examples? |
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Definition
-high potential for abuse -used for medical treatments in US, but with severe restrictions -abuse may result in severe physical or psychic dependence -PAs cannot prescribe -not refillable, need separate script for refill
examples: marijuana, opiates (Oxycontin, Kadian, methadone,fentanyl), amphetamine, methamphetamine, methylphenidate, pentobarbital |
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What is the criteria for a schedule 3 drug and what are some examples? |
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Definition
-potential for abuse is less than 1 and 2 -abuse may lead to low-moderate physical dependence or high psychological dependence -most used by US -refillable
examples: testosterone, Lortab, Norco, codeine, ketamine, Suboxone, Tylenol #3 |
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What is the criteria for a schedule 4 drug and what are some examples? |
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Definition
-low potential for abuse compared to 3 -abuse may lead to limited physical or psychological dependence compared to 3
examples: benzodiazepines, phentermine, Ambien, Midrin, Lunesta Provigil, Darvocet, Sonata |
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What is the criteria for a schedule 5 drug and what are some examples? |
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Definition
-low potential for abuse compared to 4 -limited physical and psychological dependence relative to 4
examples: codeine (Robitussin AC), diphenoxylate/ atropine (Lomotil), Lyrica |
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What drug is overprescribed for pain? for antibacterial? |
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Definition
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Term
What are the common state laws for PAs to prescribe? |
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Definition
-Physician's name on Rx pad (co-signature) -restriction to formulary (exclusionary) -controlled substances (excludes C-2) -restriction by practice setting -required practice guidelines/protocols -continuing medical education |
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Term
How does the DEA describe a controlled (scheduled) substance? |
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Definition
a controlled substance is 'abusable' |
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Term
What has to be on a PAs prescription pad? |
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Definition
name (of supervising physician and PA) address telephone number
FYI: PAs name should appear on the prescription lable |
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Term
What are the Rx requirements for legend drugs? |
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Definition
-date of issuance -name of prescriber and supervising physician -name of patient -name of drug, strength, dosage form -quantity prescribed in numeral and letters -directions for use -refill instructions -prescriber signature -DAW (dispense as written), if desired |
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Term
What do Medicaid and Medicare require of prescription pads? |
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Definition
that they be tamper resistant |
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Term
What are the control requirements? (policies and procedures used to monitor and minimize operational risks) |
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Definition
-state by state -legend drug requirements -patient name and address -prescriber's name, address and DEA # |
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Term
What are the rules for faxing a schedule 3,4 or 5 prescription? |
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Definition
-must be from prescriber or prescriber's agent -any other source is information only |
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Term
What are the rules for faxing a schedule 2 prescription? |
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Definition
-must be signed by prescriber -prescriber must indicate that the patient is terminally ill or in a long term facility -allows prescriber to fill prescription 10 x in 60 days -'titrate to comfort' allows fusion pharmacy to adjust patient's medication without further physician orders |
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Term
What are the time limits on a C3 & C4 prescription? |
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Definition
-6 mos from date of prescription issue
example: tylenol #3 and xanax |
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Term
What are the time limits on a C5 prescription? |
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Definition
federal law: no time limit -TN regulation: 1 yr from date of prescription issue
example: Lomotil |
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Term
How should you write sig codes (directions to the patient)? |
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Definition
-start with a command (take, place, insert, unwrap...) -note dosage number and form/unit -add command modifier (by mouth, per rectum) -follow with dosing frequency (twice daily, every 4-6 hours) -finish with frequency modifier (as needed for pain, with food) |
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twice daily 3 x daily 4 x daily every other day |
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Definition
every 4 hours every 4-6 hours |
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at bedtime in the evening in the morning |
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acetyl salicylic acid (aspirin) |
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Definition
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Definition
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What are the pregnancy categories, and what do they mean |
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Definition
A-pretty safe for pregnant pt B-kinda safe C-quesitonable, not in humans D-don't use if pregnant X-never use if pregnant or could be pregnant! |
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Term
Make sure to look over the 'do not use' list |
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Definition
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Term
What are 4 vitamins that can be toxic an how? |
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Definition
A,D,K and E -they are fat soluble and can be built up |
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Term
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Definition
relative amount and rate at which the drug reaches the general circulation |
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Term
What administration of drugs is considered 100% bioavailable? |
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Definition
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Term
What is pharmacokinetics? |
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Definition
what the body does to a drug via -distribution -metabolism -elimination |
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Term
In what ways can a drug respond to the body according to pharmacoknetics? |
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Definition
-pharmacologically -therapeutically -toxically |
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Term
What is first pass effect? |
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Definition
immediately following drug absorption, passage of a drug via the hepatic portal vein to the live where metabolism of a drug takes place -amount of drug that reaches circulation can be much less than what was initially administered due to metabolism |
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Term
What drug must be activated by the liver? |
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Definition
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Term
What is pharmacodynamics? |
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Definition
what the drug does to the body. -physiologic effects of a drug -MOA- mechanism of action of a drug |
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Term
What can affect drug absorption? |
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Definition
-route/site of administration -mechanism of absorption -prodrugs -absorption-based DDIs (drug-drug interactions) |
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Term
Administration can either be parenteral or enteral (by mouth), what are the four types of parenteral administration? |
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Definition
-intramuscular (IM) -intrathecal (IT) -intravenous/intraaterial (IV/ IA) -subcutaneous (SubQ, SC) |
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Term
Which form of administration is the safest, most common, most economical, and most convenient? |
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Definition
enteral (PO) may be swallowed or sublingual great for GI disease
examples: capsules, tablets |
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Term
What does sublingual administration avoid? |
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Definition
first-pass effect by bypassing the stomach directly into the bloodstream |
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Term
What are some topical routes of administration via the mucous membranes? |
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Definition
buccal/sublingual (SL) Intraaural/ auricular/ otic (AD, AS, AU) Intranasal intraocular/ opthalmic (OD, OS, OU) Intrauterine (IU) Intravaginal Pulmonary/ Inhalation (Inh.) (Ano) Rectal (PR) |
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Term
What are some issues with PO? |
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Definition
absorption -patient may not be compliant -extensive first pass effects |
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Term
What is the absorption pattern of IM injection? |
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Definition
-prompt with aqueous solutions -slow with repository or depot preparations (drug is in a non-aqueous vehicle and may precipitate at the site of injection. (for sustained release) -75-100% bioavailable |
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Term
What can IM injection be used with? |
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Definition
-moderate volumes -oily vehicles -some irritants -depot injections (sustained release) |
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Term
What is the disadvantage of IM injection? |
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Definition
-breaking skin barrier -get different variation of bioavailability due to different types of muscles |
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Term
What is the absorption pattern of IT injections? |
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Definition
-very prompt -provides fast and effective spinal block of pain perception -allows for maximizing the drug concentration in the CNS |
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Term
What are some limitations and precautions of IT injections? |
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Definition
-limited volumes possible -issues relating to dural puncture |
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Term
What are some examples of IT injections? |
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Definition
epidural (bupivacaine or Marcaine) fentanyl (Sublimaze) |
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Term
What are some examples of IM injections? |
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Definition
Haldol (slow release, for longer patient compliance) |
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Term
What is the absorption pattern for IV/IA drug administration? |
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Definition
-circumvents need for cross membrane absorption to get drug directly into circulation -immediate-almost immediate -100% bioavailability -best for emergency use -can be used with larger volumes and irritants (when diluted) -can be used for larger peptides and proteins |
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Term
What are the limitations of IV/IA administration? |
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Definition
-not for poorly solule or insoluble agents -only oily vehicles -usually require slow administration -increased risk of adverse events -stability limited -NO GOING BACK |
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Term
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Definition
a pharmacologically inactive compound that is converted into an active drug by metabolic biotransformation |
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Term
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Definition
-increase solubility -prolong release -biostability- keep the drug from being destroyed |
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Term
How is bioavailability determined? |
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Definition
comparing plasma levels of a drug after a particular route of administration (compare oral to injected which is 100%) |
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Term
What is volume of distribution (V subscript d)? |
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Definition
fluid volume that is required to keep the drug in the body at the same concentration measured in the plasma/blood
-useful to compare the distribution of a drug with the volumes of the water compartments of the body
-COMPARES AMOUNT OF DRUG IN THE BODY TO CONCENTRATION (C) OF DRUG IN THE BLOOD/PLASMA |
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Term
What are the 3 water compartments of the body? |
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Definition
plasma, ECF, total body water (ICF) -drugs do not always go to just one compartment, sometimes administer themselves among all 3 contributing to the apparent distribution volume |
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Term
So what does Vd mean for drug half life? |
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Definition
-if the Vd for a drug is large, most of drug is in the extraplasmic space and is unavailable to excretory organs -any factor that increases Vd, increases the half life, extending the duration of the action of the drug |
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Term
How does a drug become sequestered to the ECF? |
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Definition
By binding to plasma proteins when Vd is exceptionally large |
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Term
How is total body water divided up in a 70 kg individual? |
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Definition
4 L-plasma 10 L- interstitial 28 L- intracellular |
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Term
How does metabolism primarily occur? |
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Definition
-via the liver, blood, intestines |
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Term
What are some influencing factors of metabolism? |
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Definition
age, disease state, drug therapy, genetic factors (pharmacogenetics) |
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Term
What does phase I of metabolism entail? |
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Definition
converts lipophilic molecules into mor polar molecules by introducing functional groups such as OH or NH3. -This may decrease, increase or leave the drug's pharmacologic ability unaltered |
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Term
What is the CYP enzyme and what drug did he want us to know is a red flag with relation to this enzyme and why? |
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Definition
-CYP is an enzyme in the liver and GI tract involved in phase I of metabolism. -a DDI with Warfarin is a red flag, because is an anticoagulant and could make you bleed to death |
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Term
What does phase II of metabolism consist of? |
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Definition
conjugation reactions, drugs are then excreted by the kidney or into the bile. |
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Term
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Definition
mutagenesis or carcinogenecity -is organ specific -excretion does not occur properly |
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Term
What is the primary excretory route of a drug? secondary? |
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Definition
-liver -kidneys/urine, bile/feces, lungs/exhalation |
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Term
What is excreted by the kidneys/urine? |
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Definition
primary route for water soluble drugs and metabolites |
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Term
What is excreted by the bile/feces? |
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Definition
-lipid-soluble (and less water-soluble) drugs and metabolites |
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Term
What is excreted by lungs and exhalation? |
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Definition
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Term
What is zero order rate reaction with regards to excretion of the drug? |
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Definition
-independent of the concentration |
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Term
What is first order rate reaction with regards to excretion of the drug? |
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Definition
-dependent on the concentration -loss of the drug is directly proportional to the concentration remaining with respect to time |
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Term
What is the volume of distribution? (Vd again) |
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Definition
relates the amount of drug in the body to concentration of the drug in the blood plasma? |
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Term
What is the equation for Vd? |
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Definition
Vd=dose/ Cp0 Cp0=concentration of the drug in the blood/plasma |
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Term
How many liters of fluid are in the human body? |
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Definition
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Term
What describes how a drug is distributed in the body? |
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Definition
Vd -not a real physical quantity -high Vd means the drug is distributed well -low Vd means the drug probably stayed within the vascular compartment |
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Term
What cannot be attained unless a loading dose is given? |
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Definition
therapeutic levels -is a single dose administered to reach steady state condition instantly |
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Term
What is the maintenance dose? |
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Definition
-dose administered every dosing interval to maintain the steady state condition. |
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Term
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Definition
= (METABOLISM + EXCRETION)/ PLASMA (DRUG) proportionality constant describing the relationship bw a substance's rate of elimination at a time and it's corresponding concentration in an appropriate fluid at that time. |
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Term
What is the time at which the mass of an unchanged drug becomes half of the initial mass as soon as the equilibrium is established after administering a dose? |
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Definition
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Term
What can change half life? |
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Definition
-organ function (kidneys for example) |
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Term
Why do you want to maintain the half life of a drug? |
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Definition
To get to the steady state |
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Term
What is steady state condition? |
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Definition
when, under a given dosage regimen, the amount of drug administered or absorbed is equal to the amount of drug eliminated. |
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Term
What must a pt be to follow a steady state drug plan? |
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Definition
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Term
Why does Gentamyocin (an antibiotic) have red flags during renal disease? |
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Definition
-never excretes with renal problems -can lead to more serious problems such as ototoxicity |
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Term
What is the therapeutic window? |
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Definition
range of drug doses that elicits a therapeutic response without unacceptable side effects |
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Term
What is the therapeutic window for Amitripyline? When is it toxic? lethal? |
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Definition
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Term
During receptor binding, what is the role of an agonist? antagonist? |
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Definition
-drug or endogenous mlcl that binds and stabilizes a receptor in the active state -inhibits the action of an agonist but has no effect in absence of an agonist |
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Term
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Definition
strength the amount of drug needed to produce an effect |
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Term
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Definition
effectiveness ability of a drug to produce its intended effect |
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Term
Which has greater efficacy at eliminating salt and water through urine, furosemide or chlorothiazide? |
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Definition
furosemide, because it eliminates much more salt and water than chlorothiazide |
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Term
What is ED50? TD50? LD50? |
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Definition
-dose that elicits a response in 50 % of the population -dose that is toxic to 50 % of the population -dose that is lethal to 50 % of the population |
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Term
Why is dosing important in infants? |
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Definition
-immature hepatic and renal function -dose based on body weight or body surface area |
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Term
Why is dosing important in geriatric pts? |
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Definition
organs are not what they used to be -C.O. falls 1%/ year from 20-80 -GFR falls progressively until 80 (@80 is only half what it was at age 20) |
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Term
What's an example of a transport protein? |
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Definition
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Term
What are some inhibitors of PGP? |
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Definition
-Cyclosporine A (Sandimmune, Neorak) -Quinidine (Quinadex, Quindaglute) -Ca channel blockers -Azole antifungals -Macrolide antibiotics |
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Term
What effects does the interaction of quinidine and loperimide have on PGP? (in the CNS) |
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Definition
quinidine blocks PGP-mediated efflux from the CNS--> increased loperamide levels within CNS and opoid toxicity (respiratory depression) |
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Term
What effects does quinidine interacting with digoxin have on the GI? |
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Definition
quinidine blocks PGP-mediated renal alimination of digoxin--> higher levels of digoxin in the body |
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Term
What are some inducers of PGP? |
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Definition
-Rifampin, phenobarbital, St. John's wort |
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Term
How does the DDI of St. john's Wort and Lanoxin work? |
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Definition
St. John's Wort can decrease the rate of Lanoxin(digoxin) absorption -results in a lower drug concentration in the serum which could make you non-therapeutic |
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Term
What name of a drug should you use with both patients and other professional to eliminate confusion? |
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Definition
generic -brand name will be generic soon anyways |
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Term
"A response to a drug is noxious and unintended and occurs at doses normally used for man for prophylaxis, dx or therapy of a dx or for the modification of physiologic fxn" What is this the definition of and who gave this definition?? |
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Definition
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Term
What is the incidence of an adverse drug reaction (ADR) and how many of those were hospitalized? |
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Definition
28% 3-6.7% (770,000 US annually costing $5.6 billion) |
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Term
What is an example of an ADR? |
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Definition
-buffalo hump after years of steroid use |
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Term
Who are the most at risk for ADRs? |
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Definition
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Term
What do you need to do when an ADR occurs? |
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Definition
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Term
What is an additional effect, desirable or undesirable, of a drug that is not the primary purpose of giving the drug? |
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Definition
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Term
What do enzymes such as P-450 do? |
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Definition
-metabolize many enodgenous compounds -biotransformation of exogenous substances -may need to increase or decrease drugs due to this NZ |
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Term
Where does the P-450 NZ operate? |
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Definition
-throughout the whole body, but concentrates in the liver, intestine and lungs |
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Term
various other NZs throughout the body needed for drug metabolism that are isozymes of P450 |
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Definition
CYP3A4, CYP2D6 etc. don't need to memorize these, just know what they are. |
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Term
How do you figure out if a person has a metabolism NZ for a drug? when? |
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Definition
run a panel -for new pts and very toxic drugs |
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Term
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Definition
the actions of two drugs working together -one helps the other simultaneously for an affect that neither could produce alone. |
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Term
What is an example of desirable synergism? |
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Definition
simvastatin lowers cholesterol gemfibrozil lowers high tirglycerides so, small amts together high lipid levels can be treated more affectively |
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Term
What is an example of undesirable synergism? |
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Definition
sedatives and barbituates together can depress the CNS to dengerous levels |
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Term
Potentiation is the action of two drugs in which one _______ or _______ the effect of the other |
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Definition
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Term
What is an example of desirable potentiation? |
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Definition
-probenecid (anti gout drug) builds up a high level of some penicillins in the blood. -probenecid potentiates the affect of penicillin by slowing down the excretion rate of the antibiotic |
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Term
What is an example of undesirable potentiation? |
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Definition
imipramine (antidepressant) given with cimetidine may result in toxic effects |
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Term
Antagonism is the _________ action of two drugs in which one decreases or cancels out the effects of the other |
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Definition
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Term
What is an example of desirable antagonism? |
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Definition
naloxone cancels out the effects of drug overdose by narcotics |
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Term
What is an undesirable antagonism? |
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Definition
antacids taken with tetracycline -alter pH from chelates and prevent adsorption of tetracycline |
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Term
Do you abruptly stop the use of a drug that took a long time to have an effect on the body? |
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Definition
no- gradually stop (every other day) (smaller doses) |
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Term
If a drug crosses the BBB, what does it cause? |
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Definition
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Term
What are the 5 unexpected rxns to a drug? |
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Definition
-teratogenic -idiosyncratic -paradoxical -tolerance -dependence |
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Term
Teratogenic effects occurs when a drug is administered to the ______ causing the development of physical defects in a ______. This is why drugs have_______. |
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Definition
-mother -fetus -FDA pregnancy categories |
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Term
When a person has a unique, unusual and unexpected response to a drug, it is considered_________. When the person has the opposite effect of what is expected, it is considered__________. |
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Definition
-idiosyncratic -paradoxical |
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Term
What is tolerance? What should you do to achieve the desired affect? |
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Definition
-decreased response to a drug that develops after repeated doses are given. -dosage must be increased or the drug must be replaced |
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Term
When hydrocodone and APAP are taken together does tolerance eventually occur? |
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Definition
not exactly, the two together do ruin the liver though and the drug can eventually not be processed. |
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Term
What is the acquired need for a drug that may produce psychological / physical symptoms of withdrawal when drug is discontinued? |
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Definition
dependence psychological dependence- anxiety is only symptom physical- cells actually need the drug (retching, nausea, pain, tremors and sweating) |
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Term
What is FDA Med Watch for? |
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Definition
VOLUNTARY reporting of adverse event, product problems and product use errors |
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Term
Which phase of drug approval pathway are healthcare providers in? |
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Definition
4- post marketing surveillance -report whatever happens so other people won't be affected |
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Term
What would be the 2 variables of getting rid of a drug? What about the 2 variables to get to a steady state? |
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Definition
-Metabolism and Excretion -Absorption and distribution |
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