Pharm Block 1 Cram Flashcards
Define “Sig”
Let it be labeled (according to prescription)
What are the two safety categories of medications?
Legend- Rx
OTC
Who determines if a drug is a Legend or OTC?
Who controls/monitors drugs with abuse potentials?
FDA
DEA
Who approves a drug as safe and effective for a specific indication?
FDA
PA school grads are privileged to write prescriptions that have been approved and recommended by whom?
Pharmacy and Therapeutics Committee (P&T)
Who assigns the Trade/Brand name and Generic name?
Trade/Brand: by company/manufacturer trademark
Generic: FDA, not protected under trademark law
What is another name for a drug’s Generic name?
US Adopted Name
What are the 4 drug names/classifications a drug can fall under?
Chemical
Drug
Pharmaceutical Class
Target physiologic system
Define “Sig”
Directions for use
Schedule 2 drugs can have how many refills?
Schedule 3-5 can have how many refills?
2= 0 3-5= 5 in 6mon AFTER date on Rx
Who authorizes/controls the fact that Schedule 3-5 drugs can have 5 refills in 6mons?
DEA
4 factors that promote PT non-compliance with medications?
Asymptomatic
Frequency
Difficult directions
Side effects
Abbreviation for Aspirin
Abbreviation for Around the Clock
ASA
ATC
Abbreviation for Bone Mineral Density
Abbreviation for Bowel Movement
BMD
BM
Abbreviation for Blood Sugar Glucose
Abbreviation for Body Surface Area
BS/BG
BSA
Abbreviation for Half Normal Saline
Abbreviation for Dextrose 5% in LR
1/2NS
D5LR
Abbreviation for Dextrose 5% in NS
Abbreviation for Dextrose 5% in water
Abbreviation for Dextrose 10% in water
D5NS
D5W
D10W
Abbreviation for Hypertension
Abbreviation for Hypotension
HTN
HOTN
Abbreviation for Nausea and Vomiting
Abbreviation for Drops
N&V
Gtts
Abbreviation for Before, After, Before Meal, and After Meal
a
p
ac
pc
Abbreviation for Ointment
Abbreviation for Dispense as Written
Ung/oint
DAW
Abbreviation for Gram
Abbreviation for Microgram
gm
mcg
Abbreviation for Millequivalent
Abbreviation for Add Sufficient Quantity to Make
meq
qs
Abbreviation for Apply to Affected Areas
Abbreviation for By Nebulizer
AAA/aaa
per neb
Abbreviation for Percutaneous Endoscopic Gastronomy
PEG
Abbreviation for Rectally
Abbreviation for Vaginally
Rect/PR/pr
PV/pv
Define Adverse Drug Reaction
Unexpected, unintended/desired response to a medication
Define Medication Error
Any preventable event that may cause/lead to inappropriate medication use/PT harm while medication is still in control of HCP, PT, consumer
Define Allergic Reaction
What is required for this to happen?
Immunologic hypersensitivity as a result of unusual sensitivity to a medication
Sensitizing dose
Define Idiosyncratic Reaction
Abnormal reaction that is unique to that PT
How are adverse drug events reported?
FDA MedWatch
Who establishes the controlled substances classifications?
DoJ
DEA: Office of Diversion Control Title 21 USC Controlled Substance Act
Two examples of Class I Drugs
Two examples of Class II Drugs
LSD
Methaquolone
PCP, Cocaine
What is the limit of codeine for Class 3
What is the limit of Codeine for Class 5
Greater than 90mg (Ketamine, Anabolic Steroids)
Less than 200mg/100ml
What are the key words in the effects of Controlled Substances?
2- severe
3- Moderate/low physical, high psychological
4- limited physical/psychological
5- limited physical/psychological
What is the only drug schedule that has medical use that is accepted with restrictions?
2
1- no accepted use
3-5= accepted use
What are the limits of Schedule 2 refills/filling?
Requires original Rx signed by practitioner to be presented prior to dispensing
No limit, usually 30 day (90 day maintenance)
No time limit
No refills
How are emergency situations requiring the issuing of Class 2 meds handled?
Telephoned Rxs allowed
Pharmacist may give quantity limited to treatment amount for emergency period
Written and signed Rx must be provided w/in 7 days
What are the 3 exceptions for faxed Rxs
Class 2 compounded for direct administration
Class 2 Long Term Care Facilities
Class 2 Hospice and paid for by Medicare Title XCIII
What are the 5 FDA pregnancy categories?
A- Adequate studies show no risk to fetus
B- adequate animal studies show no harm, no adequate studies in humans
C- animal studies show adverse, no human studies, benefits may out weigh the risks
D- marketing/human studies show evidence of fetal risk, benefits may still outweigh risks
X- Risks in use outweigh benefits
What are the 3 subsections that are required to by placed on labels for pregnancy concerns?
Pregnancy
Lactation
Reproductive potential
What year/act required pharmacists/providers to have a license and pay taxes?
1914 Harrison Tax Act
What year/act was the FDA made?
1927- Food, Drug, Insecticide Administration
What year/act required drugs to be shown safe before marketing?
1938- Food, Drug, and Cosmetic Act
What year/act made a drugs use mandatory to be on a label?
1950- Alberty Food Product vs US
What year/act made defined what drugs required a prescription for dispense?
1951- Durham-Humphrey Amendment
What year/act made it a requirement for manufacturers to demonstrate safety and effectiveness of a drug prior to marketing?
1962- Kefauver-Harris Amendment
Only applicable to drugs post 1938
What year/act made it a requirement for a drug’s label to be honest and informative?
1966- Fair Packaging and Labeling Act
What year/act made it a requirement for meds to have child-proof packaging?
1970- Poison Preventing Packaging Act
What year/act made drugs fall within five specific classifications?
1970- Controlled Substance Act
What level of formulary must be carries at all full service MTFs?
What level applies only to medications of a service IF offered at a hospital?
BCF- all full service
ECF- carried if service offered
What is a list of pharmaceutical agents that are required to be on a local formulary?
Basic Core Formulary Limited services (specialty, AD only clinics) are not required to include entire BCF
What is the requirement for an MTF that chooses to have an ECF therapeutic class on the formulary?
Must have ALL ECF medications in that class on their formulary
Define Non-Formulary
Medication provided at formulary cost share IF provider supplies info showing a medical necessity
What happens during the Pre-clinical Phase of drug development?
Animal pharmacology/toxicology data collected
New Drug application submitted to FDA and In Vitro studies
Define Monograph
Package Insert
Summary of medication info required by FDA for all medications
Give six examples of drugs that do not work at the receptor level?
Osmotic diuretics Detergents Antacids Chelating agents Chemical/Physiologic Antagonists
Chemical Antagonists are AKA ?
Neutralizing antagonists
What is a Physical Antagonist?
Drugs that compete by interacting with opposing regulatory pathways
Define Down Regulation
Dec in receptor numbers from prolonged exposure to drugs
Define Desensitization
Dec receptor response to signaling molecule when agonist is exposed to same concentration
Inc drug concentration req’d to produce an effect of the same magnitude as initial exposure on smaller drug concentration
Define Supersensitivity/Hyper-Reactivity
Enhance physiologic/biochemical response from long-term exposure to receptor antagonist followed by abrupt medication stop
Define Receptor Specificity
Define Receptor Sensitivity
Drug only has one effect on all systems
Drug prefers one receptor (Inc selectivity= fewer adverse reactions)
What is the general rule of a drug between its dose and selectivity?
Inc dose=dec selectivity
What type of receptor/channel are GABA receptors?
Major inhibitors
Cl- channel
Define Non-Competitive Antagonist
Allosteric Agonist
Binds to different site on receptor, indirectly blocks agonist/reduces affinity
Can not be overcome w/ inc dose
Define Indirect Agonist
Inhibits molecules that usually terminate an action, potentiating an agonists activity
Define Irreversible Antagonist
Permanently antagonize agonist w/ covalent bonds
Reduces efficacy of agonist
Define Competitive Antagonist
Binds to same receptor as agonist, preventing binding
Reduces agonist potency, possibly efficacy
Define the Therapeutic Index
A higher index = ?
Median Toxic/Lethal Dose / Median Effective Concentration
Higher index= safer drug, less monitoring
Lab monitoring for small/narrow index drugs are monitoring what part of blood?
Plasma concentrations
Define Graded Response w/ examples
Continuous Variables- BP, enzyme activity, muscle tension
Define Quantal Response w/ examples
“All or Nothing” response
Pain, Death, Number anesthetized
Define Potency, Efficacy and Effectiveness
P= amount needed to cause a response Eff= ability to produce desired result (more important) Effective= degree of success at producing result
What are 3 factors that effect Therapeutic Drug Monitoring?
Absorption
Vol of Distribution
Clearance
When is a Loading Dose used?
When is a Maintenance Dose used?
Therapeutic plasma concentration is needed rapidly
Replacement of lost drugs from plasma
When is the Dosing Interval changed?
When is this used?
Achieve similar steady-state concentrations
Limited dosage forms
When is a Change of Dose used/preferred?
Therapeutic concentration maintenance
When is changing a Dose and Interval used?
Substantial dose adjustment or for narrow index drugs w/ target concentrations
If given more than once a day, change interval
If given once daily or less, adjust dose
A drugs dose does not change time to steady state as long as ________?
Half life remains constant
How can the magnitude of fluctuations with a steady-state be controlled?
Dosing interval
Shorter interval decreases fluctuations, longer interval increases
No interval/short interval = ______fluctuation
Long interval= ______ fluctuation
Short, infusion
More, greater fluctuation
If a drug’s dose/interval is altered, what remains that same and what changes?
Time for steady-state= same
Final steady-state plasma level= changes
If dosing interval is less than ____ half lives, accumulation will be detectable
Shorter than four 1/2 lives
What outside factor does not effect a drug’s half life?
Concentration
What is the Elimination Constant Equation
K=Cl/VD
Cl= clearance rate
VD= vol of distribution
What is the half-life equation
T1/2= 0.693/k K= elimination constant
Normal CrCl levels
Normal= 90 - 140 Men= 125 Women= 115
Cockcroft-Gualt equation has to be adjusted for PTs with what type of weight?
BMI greater than 18.5kg/m2
Re-absorption of drugs in kidneys depends on what factor?
Lipid Solubility
What causes ion trapping in kidneys?
Charged compounds not being reabsorbed
What are the two Child-Pugh Classifications
A/B= mild/moderate hepatic impairment, no dose adjustment C= severe impairment, no ER tablets, IR tab/injections are reduced by 50%
What GI pathway does grapefruit juice inhibit?
CYP3A4
Define First Order Kinetics
Proportional to concentration; Non-linear
Rate of elimination = drug concentration
Half life same regardless of concentration
Define Zero Order Kinetics
Metabolism is proportional to concentration; Linear
Concentration changes w/ time - independent of concentration
No true 1/2 life (Ethanol, Phenytoin)
What effect do “inhibitors” have on drug metabolism?
What effect do “inducers” have on drug metabolism?
How doe Prodrugs effect this?
Inhibit CYP450
Inc drug level= Inc side effect/toxicity
Induce CYP450
Dec drug level= Therapeutic Failure
Prodrug= opposite effects for both
Chirality is AKA and is used for what 3 purposes
Steroisomerism
Create new drug
Reduce side effects
Extend a PT
CYP450 is ____ dependent
Substrate
Define Phase 2 of metabolism
Synthetic
Conjugation reaction, covalent bond w/ parent
Highly polar conjugate=rapid elimination
What are the two paths within Phase 2 /Synthetic metabolism?
Glucoronidation- Benzoic acid, meprobamate, phenol, steroids
Sulfation
Define Phase 1 of metabolism
Non-Synthetic
RedOx and Hydroxylation reactions
Introduces/exposes functional group and converts parent to polar metabolite causing loss in pharmacological activity
Oxidation reactions involve what pathway and end in what type of elimination?
Conjugation reactions involve what path and end in what type of elimination?
CP450, metabolites/polar species eliminated in urine
Glucuronidation= stable products, non polar species eliminated in stool
What effect does first pass metabolism have on drugs?
This route usually applies to what type of meds?
What can it reduce/prevent?
Reduces bioavailability
Orally ingested
Limits efficacy if clearance is large
Drugs with affinity for protein binding in plasma will have what type of Volume Distribution?
Reduced
What is the Volume of Distribution equation?
Vd= F Dose / C0 F= Bioavailability D= amount of drug given C= concentration of drug in blood/plasma
In the Two Compartment Model, what organs are in the Central Compartment?
Plasma Heart Lung Liver Kidney
What are the two drug transporting blood proteins?
Albumin
Alpha1 acid glycoprotein
Plasma protein binding properties are important for what two types of drugs?
High binding
Narrow therapeutic index
What medication route has the most rapid onset?
What route bypasses first pass metabolism?
What route is most convenient but has significant first pass?
IV
Sublingual, Transdermal
Oral
What are 3 modifications to navigate around First Pass Effect?
Increase dose
Alternative route
Delayed release dose
What are 4 factors that affect passage of drugs across biologic membranes?
Lipid-aqueous partition coefficient (non/ionized)
Specific transport
Plasma binding
Perfusion rate
What two factors determine bioavailability?
Extent of absorption
First pass metabolism
Define Bioavailability
Fraction of unchanged drug reaching systemic circulation after oral administration
In the Henderson-Hasselbach equation, what do the HA and A- stand for?
HA- protonated, un-ionized form of an acid
A- ionized, unprotonated form
Low pKa = ?
High pKa = ?
Low= strong acid High= strong base
Weak acid + acid medium = ?
Weak acid + alkaline medium = ?
Shift to L, suppresses ionization
Increased ionization
Weak base + acid = ?
Weak base + alkaline medium=
Shift to L, ionization increases
Shift to R, suppresses ionization
What are 5 factors that effect pharmacokinetic parameters?
Bioavailability Volume of distribution Drug Accumulation Clearance Elimination
What is the acronym for pharmacokinetics?
What body does to drug
ADME