Exam 1 Flashcards
What is pharmacotherapeutics?
The use of drugs for the purpose of disease prevention, diagnosis and treatment
What are therapeutic effects?
The beneficial responses to medication treatment
What are adverse effects?
The serious side effects resulting from taking a medication
What are teratogens?
Drugs that cause birth defects
What is the minimal effective concentration definition?
The amount of drug required to produce a therapeutic effect
What is a toxic concentration?
The amount of drug that results in serious adverse effects
T/F Preclinical trials are not regulated by the FDA.
True
T/F Preclinical trials are tested on animals or human microbial cells.
True
When do FDA regulations begin on drug approval?
When humans become involved as test subjects
What happens in Phase I of clinical trials?
The volunteers are all healthy.
What happens in Phase II of clinical trials?
There is a larger number of volunteers who have the specific disease for the drug being tested.
What happens in Phase III of clinical trials?
The trials are wide scale, patient’s have multiple issues and they monitor drug interactions.
What happens in Phase IV of clinical trials?
The drug is in the public and adverse effects are reported.
How long does it take for a drug to get approved for use?
12 years
What is Category X?
a drug that has demonstrated fetal abnormalities or adverse responses
What is pharmacokinetics?
How the body responds to a drug
What are the four phases of pharmacokinetics?
Absorption, distribution, metabolism, excretion
What happens in the absorption phase?
The drug is absorbed and starts going places
What happens in the distribution phase?
The drug travels to where it needs to go in the body
What is the metabolism phase?
the speed at which your body breaks down and excretes a drug
What happens in the excretion phase?
The speed at which your body rids the drug from your system
What happens in the excretion phase?
The speed at which your body rids the drug from your system
What is the primary factor that determines the onset and intensity of drug action?
Absorption
Which routes do not go through the 1st pass effect?
Sublingual and buccal
What is the 1st pass effect?
Where the drug concentration is greatly reduced before reaching systemic circulation
What kind of tablet takes longer to absorb?
enteric coated
What needs to be monitored in order to make sure the body can metabolize drugs?
liver function
Where is the primary site of excretion in the body?
the neys
What are some considerations for a drug with a narrow therapeutic index?
Mo
What are some considerations for a drug with a narrow therapeutic index?
Monitor via labs, random serum drug levels, peak and trough
What is a peak?
When the drug is highest in the body
What is a trough?
The point where the drug serum level is lowest in the body
What are factors influencing drug effects?
Weight, age, biological sex, pathologic, genetic, psychological, immunological factors and physiological factors
What weight are drug recommended doses based off of?
150 lbs
How can age affect drug effects?
Children metabolize drugs differently; metabolism can be faster or slower. Older adults may take longer to metabolize and have more CNS effects
How can biological sex affect drug effects?
Men have more vascular muscle and women have more fat cells
What are 3 common drug classes that cause adverse effects?
Opioids, diuretics and anticoagulants
Where is the site of drug metabolism?
The liver
T/F Drugs with a narrow therapeutic index are more likely to cause serious consequences.
True
T/F Dietary supplements are controlled and tested by the FDA.
False
The Dietary Supplement Health and Education Act of 94 states that
Medical claims cannot be on bottle however symptoms can.
What are DMARDS?
Disease Modifying Antirheumatic Drugs
T/F Early start of DMARDS reduces chances of long term complications.
True
T/F DMARDS take several months to reach max therapeutic effects; patients will take an NSAID with DMARD.
True
What are the prototypes of DMARDS I?
Methotrexate and hydroxychloroquine
DMARDS are antimetabolite drugs, which means _____
they interfere with folic acid
An adverse effect of DMARDS I is putting you at risk for ___ blood cells
low
DMARDS I are contraindicated in those with visual field damage (methotrexate) because
they can cause more field damage.
T/F A woman of childbearing age needs to be on contraception when taking DMARDS I because it is a category X medication.
True
T/F You cannot take DMARDS I & II together.
False; you can take these together.
What is the MOA of DMARDS II?
The primary action for RA is immunosuppression
T/F DMARDS II are tumor necrosis factor antagonists.
True
T/F Discontinue DMARDS II if a rash appears, this could be Steven Johnson’s syndrome.
True
What are the major reactions of DMARDS II?
Increased risk of infection, injection site reactions, severe skin reactions.