brigs pharm quiz 1

Pure food and drug act of 1906

prohibited mislabeling and adulteration of drugs

Amendment (1912) to Pure Food and Drug Act

Prohibited false or fraudulent advertising claims

Food, Drug, and Cosmetic Act of 1938

requires new drugs be safe and pure, enforced by FDA.

Did not require proof of efficacy

Durham-Humphrey Act of 1952

Enabled OTC medication use

Kefauver-Harris Amendments (1962) to food, drug, and cosmetic act

Required proof of efficacy in addition to safety for drug release.

Guidelines for reporting adverse reactions, clinical testing, and advertisement of new drugs.

Response to thalidomide cases in EU

Dietary Supplement Health and Education Act of 1994

Standards for dietary supplements, prohibition of FDA review.

Requires ingredient and nutrition labeling - classifying as food supply

3 FDA requirements for medications

1. free from adulteration

2. free from mislabeling/misbranding

3. have safety and efficacy data (clinical trials)

phase I clinical trials

on healthy volunteers

phase II clinical trials

Volunteers with the illness

-dosing, adverse effects, efficacy

phase III clinical trials

double blinded, placebo-controlled

-thousands with the illness

-safety and efficacy

phase IV clinical trials

Post-marking survellence

Long-term

the FDA was established to...

protect the public from harmful medications

2 drug classes

OTC (non-legend medications)

Prescription (legend medications)

OTC medications

No rx needed

Manufacturer instruction in laymans terms and general directions

Legend (prescription) medications

Adequate directions for a healthcare professional to prescribe

-must say Rx only on bottle

data contained in package insert

PK/PD

Approved uses

Dosing

Side effects

Cautions

Monitoring

what organization regulates dietary supplements

Dietary supplement Health and Education Act (DSHEA)

No safety and efficacy demonstration

Reasons FDA can remove dietary supplements from the market

"Significant or unreasonable risk to consumers"

Adulterated

Mislabeling

Off-Label Use

Not FDA-approved use

Can't market off-label indications

Usually not covered by insurance

Example of off-label drug use

Ceftaroline - approved for skin and soft tissue infection and pnuemonia - off-label for resistant sepsis

Weight loss drugs - approved for diabetes - other benefits off-label

#1 organization overlooking controlled substance use

DEA

Schedule categories for drugs

C-I = high potential for abuse

C-V = low potential for abuse

C-I drugs

No accepted medical use

Heroin and LSD

C-II drugs definition

high potential for abuse; physical and psychological dependency

C-II drugs restrictions

eRx, signed by clinician

no strike overs

no refills

VO in emergency must follow with script in 72 hours

examples of C-II drugs

Hydromorphone

Oxycodone

Fentanyl

Morphine

Hydrocodone/APAP

C-III drugs definition

some potential for abuse; moderate psychological dependency

C-III drug examples

tylenol w/ codeine

C-IV drug definition

low potential for abuse, limited psychological and physical dependency

examples of C-IV drugs

Xanax (Alprazolam)

Ambien (zolpidem)

Tramadol

Carisoprodal

examples of C-V drugs

Lomotil

Robitussin w/ codeine

maximum time a controlled substance rx is good for

6 months regardless of refills

Important aspects of writing a C-II rx

MUST WRITE "ongoing use"

Always date, and put a "do not fill until" date

Write quantity "sixty" not "#60"

NO REFILLS EVER

No strike-out, even if initialed

what does prescription drug monitoring program do

show full rx drug use in any patient

Selecting a therapeutic objective

sets an expectation between pt and provider

Palliative - just decreases pain, no treatment

Treatment - can increase pain

Medication errors/year

180,000

costing >3.5 billion/year

medication errors of omission

-assumptions like "resume home meds"

-failure to specify strength and long-acting formulation

-lack of PRN identification

Medication errors - failure to recognize contraindications

drug-drug

drug-food

drug-disease

known organ dysfunction, like ESRD

voluntary reporting for medication errors

provides confidential feedback so providers can learn from others mistakes

mandatory reporting for medication errors

makes errors known to the public

important rx writing tips

-know allergies and pt rxn

-write out number for controlled substances

-no refills = "none"

-consider pt organ dysfunction

prescriber ID

name

degree

office address

phone #

patient ID for rx

name and address

inscription in rx

name of drug and strength

ex: amoxicillin 500mg

DAW

dispense as written, means to not sub generic

subscription - rx

instructions to pharmacist ab dose, form, and number of units to dispense

signa- rx

instructions from provider given to patient

Category A pregnancy safety description

No risk to fetus in first trimester

No evidence of risk in later trimesters

examples of Category A drugs in pregnancy

Levothyroxine

Magnesium sulfate

Category B pregnancy safety description

No risk to fetus in animal studies, but no well-controlled studies in pregnant women

Category B to pregnancy women - drug examples

HCTZ

Amox/clav

Category X pregnancy safety description

Fetal abnormalities reported, positive evidence of fetal risk in humans from animal or human studies

Risks outweigh benefits, do not use in pregnancy

Examples of category X drugs

Warfarin

Simvastatin

conscientious prescribing

patient factors

disease and drug factors

social and knowledge factors

third-party - insurance

what drugs have generic versions that can alter blood levels between types

digoxin, levothyroxin, warfarin

want to make sure these are DAW

chemical name

precise description of a drug's chemical structure

generic name

common name derived from chemical name

trade/brand name

brand name used in marketing

Pharmacodynamics looks at

receptors and binding sites

Pharmacokinetics looks at

effects of medications on the human body

what does this drug do the the body and how?

mechanism of action, therapeutic, and adverse effects

Definition of pharmacology

Study of interaction of biologically active substances in living systems

Pharmakos: medicine or drugs

logos: study

Examples of: drug + receptor = response

(Pharmacodynamics)

BP, HR, INR

change dose based on outcome

why do competitive inhibitors require a higher dose of agonist?

because they compete for receptors

covalent bonding

strongest, uncommon

irreversible

ionic bonding

powerful, helps w/ receptor binding

reversible

primary electrostatic attractor

van der waals bonding and hydrogen bonding

most common - weaker, reversible bonding

secondary attractor

Affinity

strength between drug and its receptor

example of affinity

Dilantin

-High affinity for albumin

-not much free drug in blood

-monitor free to know what is actively preventing seizures

-decreased albumin = decreased dose = decreased free drug

quantity

amount of a drug that reaches receptors

example of drug quantity

Parkinsons

Receptors must be available for binding

Low number = less dose efficacy and increased toxicity

efficacy

ability of a drug to stimulate receptor to produce pharmacological response

potency

measure of ability of a set dose to produce maximum pharmacological effect

Agonists

-affinity for activation b/c they resemble naturally occurring hormone, transmitter, or enzyme

-act longer than natural substances they mimic

-full or partial

full agonist

acts with maximal effect

partial agonist

low degree of activation

-can require more to overcome effects

beta-1-agonist

Norepinephrine

Targets the heart

Vasopressor that increases BP

beta-2-agonist

Albuterol

Targets the lungs

Partial agonist example

Buprenorphine (opioid receptors)

-less respiratory suppression makes it safer

-with pain meds like morphine, higher dose to kill pain

pharmacologic antagonist

binds w/o activating receptor, preventing activation by agonist

chemical antagonist

counters effects of another by binding agonist drug, not receptor

competitive antagonist

competes w/ agonist for binding to receptor

can be overcome by increasing agonist concentration

irreversible antagonist

binds receptor, cannot be displaced by increasing agonist concentration

beta-1-antagonist

beta-blockers that lower HR

beta-2-antagonist

Naloxone (opioid antagonist)

-in opioid OD, displaces narcotic molecules on receptors

effect of agonist + competitive antagonist

example: naloxone

decreases the effects of agonist

effect of agonist + noncompetitive agonist

lowers the effect of the agonist even more than competitive

Corticosteroid (prednisone) mechanism of action

Lipid-soluble chemical crosses plasma membrane

Acts on intracellular receptor

Insulin and monoclonal antibodies mechanism of action

signal binds extracellular transmembrane protein

activates enzymatic activity of its cytoplasmic domain

Proton pump inhibitor (nexium) and Ca channel blocker (verapamil) mechanism of action

signal binds and directly regulates opening of ion channel

beta blockers (propranolol) mechanism of action

signal binds cell surface receptor

linked to effector enzyme by G protein

second messenger system

Often activated by G-protein coupled receptor

Signaling molecule activates 3rd molecule (adenylyl cycle, guanylyl cyclase, cAMP)

examples of second messengers

Glucagon

Catecholamines

FSH and LH

PTH and TSH

Calcitonin

Ligand gated channel w/ drug example

agonist binds the channel to activate it

Benzodiazepams (xanax or avepam)

Voltage-gated channel w/ drug example

electrical impulse on cell membrane activates channel

proton pump inhibitors

enzyme drug action method

-transmembrane receptor w/ enzymatic cytosolic domains

-most add or remove phosphate group from protein

Tyrosine kinase and tyrosine phosphate

examples of enzyme methods

Carbidopa and levidopa to treat Parkinson's

Statins (HMG-CoA reductase inhibitors)

Antimetabolites method of drug action

inhibit conversion in metabolic pathway or prevents DNA synthesis and cellular division

example of antimetabolite drug method

COX-1 and 2 inhibitors (NSAIDs)

Chemo meds

Transporters other method of drug action

aid or block normal transport ions across a cell

example of transport method of drug action

Lasix - loop diuretic

stops Na, K, Cl transport in LOH