Basics of Pharmacology

Drug development is overseen by who?

the FDA

Overall what does the FDA do?

they oversee the process of allowing drugs to be on the market

What are the three specific things that the FDA checks with drug development?

-are they reliable?

-do they do what they are supposed to do?

-are they safe?

What is important to remember with the preclinical trial of drugs?

this is not phase 1

What happens in the preclinical trial and what is the aim?

-this is when a drug is tested on animals

-the aim is to see if there is an effect on live tissue

What happens if there is an effect on live tissue in the preclinical phase?

the drug moves to phase I

What happens in phase I and who are drugs tested on?

-the drug is tested to see if there are any effects or toxicity on human tissue

-the drugs are tested on healthy men

Why are drugs in this phase not tested on women?

because the drugs might have effects on fertility

What are the main questions that are answered in phase II? (4)

-is there any benefit?

-What dose is needed?

-What are the side effects?

-What is the benefit to risk ratio?

What does benefit to risk ratio mean?

do the benefits outweigh the risk/side effects

What also is conducted in phase II?

this is when trials are going to be conducted

What happens in phase III?

-people are on these drugs longer and they might see different side effects than in earlier phases, so they are seeing if there are any unacceptable side effects

-providers are asked to prescribe the drug

When doctors are asked to prescribe drugs to their patients what are they also asked for?

doctor is asked to send data and report how their patients are doing with the drugs

What happens in phase IV?

can the drug receive FDA approval?

Explain how brand name and generic name drugs are made

brand name drugs will have patents that will eventually expire and then other companies will be able to make generic versions

What is the same and different in brand name drugs and generic name drugs?

-brand name drugs and generic name drugs both have the same active ingredients

-but they have different inactive ingredients

Do inactive ingredients have the same effect on everyone? What can happen because of this?

-no, this can have different effects on different people

-sometimes patients can only take the brand name because they have different effects with the generic name

Do hospitals usually administer brand or generic name medication? And which is more expensive?

-hospital usually administers generic medication

-brand names are more expensive

What are orphan drugs?

drugs that have been developed for very rare diseases and usually are only needed for very small limited populations

-usually very unaccessible

Why is it important to have the lot number on the drug label?

in case there is a recall

Do over the counter drugs also have to go through the FDA?

yes

What are risks of taking over the counter medications? (3)

-mask symptoms

-overdose

-interactions

What does mask symptoms mean in reference to over the counter drugs?

these drugs can mask the symptoms of symptoms that are signs for certain conditions

-ex. they could mask a chronic cough that is a sign of GERD or asthma

What does interactions mean in reference to over the counter drugs?

drugs that mix with each other and cause dangerous effects

What is something to remember when asking patients about the medications that they are taking?

patients will tell you about their prescribed medications but not over the counter medications

Caution should be used with what three things regarding drugs and pregnancy?

a drug should be used in caution for anyone who is looking to get pregnant, has just had a baby, or is currently pregnant

(fertility, breastfeeding, fetus)

What are teratogenic drugs?

drugs that can have a dangerous effect on a fetus

Generally are drugs usually safe or not safe for pregnant women?

not safe

What are controlled substances?

drugs that are highly regulated due to the risk of abuse

What are controlled substances regulated by? What do they also do?

regulated by the DEA

-also license people to prescribe these (physicians, NPs, etc.)

Controlled substances are organized through what levels?

Schedule I to V

(I is more dangerous than V)

What are schedule I drugs?

high abuse drugs that have no medical use

What are schedule II drugs?

high abuse drugs with medical use

What are schedule III drugs?

some abuse drugs with medical use

What are schedule IV drugs?

less abuse drugs with medical use

What are schedule V drugs?

limited abuse drugs with medical use

What are pharmacodynamics?

what the drug does to the body

What are different ways the drug can affect the body? (4)

-replace/substitute

-increase/stimulate

-depress/slow

-interfere

How can drugs replace/substitute?

the drug can act as a substitute or a replacement

-ex. B12 drug could be substituting the B12 in your body

What is an example of how drugs can increase/stimulate?

antidepressant can stimulate the production of some neurotransmitters

What is an example of how drugs can depress/slow?

ex. ibuprofen can be slowing down the inflammation process to decrease pain

How can drugs interfere?

they can kill or stop cells from growing

-ex. chemo or antibiotics

What are the three ways that drugs "do its job"?

receptors, enzyme, and selective toxicity

What do receptors do and what are the two types?

drugs have to connect with these and are either agonists or antagonists

What do agonists do?

speed up

What do antagonists do?

slow down

What do enzymes do?

make a chemical reaction that causes an effect

-ex. digestive enzymes can be taken and the enzyme causes a chemical reaction that is supposed to treat the wanted effect

What does selective toxicity do?

selectively kills off what the aim is

-ex. antibiotic