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Introduction to Clinical Pharmacology
Pharm. Chapter 1
86
Pharmacology
Graduate
01/07/2013

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Cards

Term
What is Pharmacology?
Definition
the study of drugs
Term
What does pharmacology study in relation to how drugs work in the body?
Definition
looks at interactions with cells, tissues, and other organisms
Term
What are two ways in which drugs work to create physiological changes within the body?
Definition
-stimulating responses
-depressing an existing response
Term
What counts as a drug?
Definition
anything that goes into the body that takes effect
Term
What are some examples of drugs? (6)
Definition
-OTC drugs
-herbal(ginko, garlic)
-vitamin
-mineral
-protein
-prescriptions
Term
What is pharmacokinetics?
Definition
properties of drugs within the body(how they work)
Term
What ypes of materials should dentist offices include for reference materials?
Definition
printed and computer based materials
Term
How often must printed reference materials be updated? What are the two types?
Definition
updated frequently
-reference format and explanation based
Term
What is good about computer-based references?
Definition
more easily used and frequently updated
Term
What is something to ask about drugs?
Definition
do the benefits outweigh the risks
Term
What are the three types of drug names?
Definition
1.experimental names
2.brand/trade name
3.generic name
Term
What is the experimental name?
Definition
start with first few letters of company, followed by number
Term
What is the brand/trade name?
Definition
chosen by the company, ex: tylenol
Term
What is the generic name?
Definition
gives information about which category the drug falls into, choosen by US adopted name council
Term
Is the generic or brand name capitalized?
Definition
Brand/trade name is capitalized, generic name is not(Ex- Tylenol(brand), acetemonphen(generic))
Term
Are generic drugs better than brand drugs and vice versa?
Definition
fillers in brand compared to generic drug could be different and cause reaction so some people can't take a generic of a medication or a certain brand
Term
When is chemical equivalence?
Definition
when generic and brand name drugs have the same chemical structure
Term
What is biological equivalence?
Definition
generic and brand name drugs cause the same contradictions in the body
Term
What is therapeutic equivalence?
Definition
clinical trials establish that generic and brand name drugs are equally effective at treating the condition
Term
When must therapeutic equivalence be established?
Definition
before the generic is approved for sale
Term
Who regulates the efficacy of drugs coming to the market and gives marketing approval?
Definition
FDA
Term
Who determines if a drug will be OTC or prescription, and the labeling of drugs?
Definition
FDA
Term
Who regulates trade practices and advertising? (how drugs are desribed, etc in commericals)
Definition
Federal Trade Commission(FTC)
Term
Who regulated manufacturing and distribution of drugs that may be abused?
Definition
Drug enforcement administration(DEA)
Term
What is the first clinical trial before phase I? What is it performed on?
Definition
preclinical trial, done on cells, animals, NOT humans. A lot of these drugs don't make it to the market
Term
How long do preclinical trials usually last?
Definition
about 4 and 1/2 years
Term
What happens in Phase I clinical trials?
Definition
FDA approved, done on healthy humans who do not have the condition the medicine is designed to treat, simply to test safety of product
Term
How many patients are tested in Phase I and how long does it last?
Definition
about 15-30 and a couple of months
Term
Who is tested in phase II?
Definition
people with the disorder the medicine was created for, but this trial is more about looking for side effects than helping with the issue
Term
About how many people are involved in phase II?
Definition
fewer than 100 patients
Term
How long does phase II last?
Definition
at least a year
Term
Who is tested in phase III?
Definition
patients with the disorder, this trial is used to see if the drug actually works for what it is supposed to and this trial is also used to determine if this drug is better than what is already available
Term
How many people are tested in phase III and how long does it last?
Definition
100's-1000's of people and it lasts years
Term
WHat occurs during the FDA approval phase?
Definition
the drug is being approved fr the market by the FDA
Term
How long does FDA approval take?
Definition
about 1 and 1/2 years
Term
What has to happen before a drug moves on the a new phase in clinical trials?
Definition
the FDA has to approve every stage
Term
What is an adverse reaction?
Definition
problems that a drug causes at normal doses
Term
What are two things that drugs create at usual therapeutic doses?
Definition
therapeutic an side effects
Term
Are side effects life threatening?
Definition
they could range anywhere from simply annoying to life threatening
Term
What are the top two classes of drugs that cause adverse drug reactions?
Definition
Anesthetics, sedatives

and

Antibiotics, antifungals
Term
Example of brand vs generic name
Definition
brand- Tylenol
generic-acetaminophen
Term
What are used to determine common ADR's in new drugs?
Definition
clinical trials
Term
Who are ADR's reported to after drugs are commercially available and who reports them?
Definition
they are reported to the FDA, health practitioners and consumers report ADR's
Term
Who determines if a drug stays on the market?
Definition
FDA
Term
What are some categories of adverse reactions? (8)
Definition
1.side effects
2.toxic reactions
3.allergic reactions
4.idiosyncratic reactions
5.mutagenic effects
6.teratogenic effects
7.interfering with natural defense reactions
8.drug interactions
Term
Are side effects predictable? Are they dose-related? What do they act on?
Definition
side effects are predictable, dose-related, and they act on nontargeted organs
Term
What is a toxic reaction?
Definition
the drug works too much on the target organ or tissue
Term
Are toxic reactions predictable? Dose related? Act on target organs?
Definition
they are predictable, dose related, at on target organs, they are extensions of pharmacologic effects
Term
Are allergic reactions predictable? Are they dose-related?
Definition
allergic reactions are NOT predictable or dose-related
Term
When are side effects more common?
Definition
at higher doses and when excretion pathways are compromised(when kidneys and liver does not work well)
Term
What are therapeutic effects?
Definition
when the drug works on the target organ/tissues
Term
What are toxic effects?
Definition
occurs when pharmacologial effects on the target organ are experienced to an extent that they cause damage
Term
Why do toxic effects occur?
Definition
occurs due to sensitivity of the patient to the drug, also when excretion pathways are compromised or dur to genetic predisposition
Term
What are pharmacogenomics?
Definition
looking at someone's enzyme profile to determine what they metabolize at certain rates
Term
What is an allergic reaction?
Definition
hypersensitivity to drug, immune system responds to the drug as if it were a dangerous antigen
Term
What can a allergic reaction cause?
Definition
anaphylaxis or other effects
Term
What is the type I drug allergy?
Definition
-IgE antibodies
-causes anaphylactic shock, asthma, and dermatitis
-this is the most dangerous type of allergy but also most rare
Term
What is a Type II allergy?
Definition
-IgG/IgM antibodies
-causes anemias(an immune system response against blood cells)
Term
What is a Type III allergy?
Definition
-IgG antibodies
-most delayed reaction
-causes serum sickness(blood vessels, arthritis, kidney issues, etc)
Term
What is a Type IV allergy?
Definition
-T lymohocyte mediated
-causes inflammatory reactions
-localized reactions like rash, goes away quickly
Term
What are idiosyncratic differences?
Definition
genetic variations in the way people metabolize drugs
Term
What can idiosyncratic differences be associated with? Are they predictable?
Definition
may be associated with different ethic groups, sometimes there is no way to tell whether it will occur
Term
What do metagenic effects cause?
Definition
damage to DNA, may cause disorders within the person taking the medication(cancers)
Term
Are mutagenic effects heritable?
Definition
if it effects the gametes
Term
What are teratogenic effects?
Definition
caused by drug exposure to developing fetus in a pregnant woman
Term
When is a drug rated category C?
Definition
if the drug appears safe but there is not enough information to prove it
Term
What must you always ask a woman of childbearing age before deciding on drug treatment?
Definition
if they are pregnant
Term
What are the categories of drugs for pregnancy(teratogenic effects)
Definition
A, B, C, D, X
Term
What is category A?
Definition
no known danger after sufficient human studies have been performed

*safest*
Term
What is category B?
Definition
No known danger after animal studies, sufficient human studies have not yet been performed
Term
What is category C?
Definition
animal studies show teratogenic effects, sufficient human studies have not yet been performed

**most common**
Term
What is category D?
Definition
human studies show potential teratogenic effects but benefit to the mother may outweigh the risk to the fetus
Term
What is category X?
Definition
human studies show definite teratogenic effects, no situation in which benefit to the mother outweighs the risk to the fetus
Term
Treatment with certain drugs can cause what after dental procedures?
Definition
can make a patient more susceptible to infection
Term
Some drugs are BLANK immunosuppresants, other are BLANK
Definition
permanent, temporary
Term
When do drug interactions occur?
Definition
when one substance alters the effect of a drug, could be another drug or even a food
Term
When do drug interactions often happen?
Definition
when the drugs share a pharmacokinetic pathway
Term
Are drug interactions harmful?
Definition
most often harmful, but they may be beneficial
Term
What does drug absorption and distribution depend on? (3)
Definition
-the route of drug administration
-the distribution at the administration site
-chemical properties of the drug
Term
What are the two ways that drugs can be administered?
Definition
Enteral(directly into GI tract) or parenteral(bypasses GI tract)
Term
How are enteral drugs administered?
Definition
orally(most common) or rectal/vaginally (least common)
Term
How are parenteral drugs administered?
Definition
injected(most common), inhaled, topical, pumps/implants
Term
Are pills and tablets efficient?
Definition
some of the least efficient mechanisms for drug distribution into the body, but are simple to the administer
Term
What happens to pills/tablets when you swallow them?
Definition
-stomach breaks down the outside coating
-then it breaks apart medication
-it then needs to diffuse throughout the stomach and GI tract
-it is then absorbed into the GI tract
Term
How can injected drugs be administered?
Definition
intravenous, intramuscular, subcutaneous, intradermal, inteathecal, or intraperitoneal
Term
What are two things that effect the absorption of a drug administered by injection?
Definition
the blood flow to the tissue where it is injected, the solubility of the drug
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