Study Guides for Week 1 and 2 Flashcards
Phase 1 clinical trial (copy from other deck)
first time used in humans
Goals:
- to find highest dose of new treatment that can be given safely without causing severe side effects
- help to decide on best way to give new treatment
- to determine what the drug does to the body and what the body does with the drug
*first few people get very low dose and are monitored closely – volunteers are usually young, healthy males
What is critical concentration?
The amount of drug that is needed to cause a therapeutic effect
What is pharmacogenomics?
The study of how a person’s unique genetic makeup (genome) influences his or her response to medications
What is the primary and secondary response of a medication?
the “primary response” refers to the intended therapeutic effect of a drug, meaning the desired beneficial action it is supposed to have, while the “secondary response” refers to any additional effects, whether beneficial or harmful, that occur alongside the primary effect, often called side effects.
Symptoms of hypokalemia
- typically do not occur until levels below 3.0
- decreased bowel sounds
- fatigue
- anorexia
- nausea
- vomiting
- muscle weakness
- leg cramps
- decreased bowel motility
- paresthesia
- arrhythmias
Explain which medications are best distributed across the blood-brain barrier
High lipid soluble medications are more likely to get across the BBB and reach the CNS
- non-lipid soluble drugs can NOT cross BBB
What does blood urea nitrogen (BUN) measure? (cant find this in ppt just adding stuff from another resource)
It is a normal waste product resulting from the breakdown of proteins
Increased levels can indicate a kidney problem and be toxic in the body
What is loading dose?
Some medication take a long time to reach critical concentration, and if effect needed quickly, then loading dose given to reach critical concentration
- is a higher dose than usually used for treatment
- “jumpstart”
What is creatinine? (cant find this in ppt just adding stuff from another resource)
End product of muscle metabolism solely filtered from the blood via glomerulus
Normal levels: 0.6-1.2 mg/dl
What is dynamic equilibrium?
The actual concentration that makes it to the body
Depends on:
- absorption from site of entry
- distribution to the active site
- biotransformation (metabolism in the liver)
- excretion from the body
Schedule 2
has high potential for abuse that may lead to severe psychological or physical dependence
has a currently accepted medical use in treatment in US
– OR currently accepted medical use with severe restrictions
examples: morphine, cocaine, fentanyl, hydromorphone, oxycontin, PCP, methadone, Adderall
What are orphan drugs?
Orphan drugs are medications developed specific to treat a rare condition (small population of people; usually 1000 or less)
What is the definition of tonicity? How does it relate to body fluids?
Tonicity is the concentration (amount) of solutes in solution compared with blood steam
Isotonic, hypertonic, hypotonic solutions
How are medications excreted?
Kidneys are the major organ involved in drug excretion (drugs made water soluble for excretion)
- glomerular filtration
Other meds need active transport and will exchange an acid/HCO3 to do so - affects acid-base of urine
Also occurs via:
- skin
- lungs
- feces
- saliva
- bile
What are Parkinson-like side effects?
Dopamine levels are affected directly or indirectly
Symptoms:
- akinesia
- dyskinesia (spasms)
- muscle tremors)
- drooling
- change in gait
- rigidity
- restlessness
Ex: anti-psychotics, neuroleptics, lithium, HTN meds
Identify 3-5 roles that the kidneys play in the body
Kidneys are the major organ involved in drug excretion
kidneys regulate concentrations of most substances in the body by filtering plasma and then reabsorbing needed substances back into the vascular system
what we don’t need is excreted
removal of waste
regulation of blood pressure
regulation of electrolytes
acid-base balance
reabsorption of amino acids, glucose, and water
RBC, hormone, and enzyme production
Causes of hyperkalemia
Increased intake, certain medications, cell injuries, intravascular hemolysis, insulin deficiency, DKA, renal disease, metabolic acidosis
Schedule 4
low potential for abusive relative to drugs in schedule 3
has a currently accepted medical use in treatment in US
abuse may lead to limited physical or psychological dependence relative to schedule 3
Examples: benzodiazepines and tramadol
clinical trial phase 3
- typically done on about 3000 participants
- evaluates how this medication works in comparison to existing medications for the same condition
- look at new indications (can it be used for other illnesses)
– look at new formulations (different routes)
– look at other patient populations (cancer, autoimmune, etc) - drug companies can apply for FDA approval upon the completion of the phase 3 trial
- fast tracking like with COVID
What does isotonic, hypotonic and hypertonic mean? Give examples
Isotonic: same tonicity as the blood
- no fluid shifts and no change in cell size
- volume expander and to maintain access
- NSS, LR
Hypertonic: higher concentration than blood
- 5% dextrose in 0.9% NS, 5% dextrose in LR
Hypotonic: lower concentration than blood
- 0.45% NSS
Identify 3-5 adolescent concerns related to medications
- must monitor for drug toxicity
- need to have safe drug calculations
- ordered in mg/kg
- slower rate of absorption than adults
- decreased protein binding to drugs (low albumin)
- decreased renal blood flow before 9 months
Explain the factors which may interfere with metabolism
Liver and kidneys (renal or hepatic impairment)
- first pass effect
- hepatic enzyme system
– inducers (increases metabolism)
– inhibitors (decreases metabolism) - liver not working: proper metabolism will not occur
schedule 1 controlled substances
- highest potential for abuse
- has no currently accepted medical use in treatment in US
- lack of accepted safety for use of drug under medical supervision
- examples: heroin, LSD, ecstasy, marijuana (now state regulated but federally still not allowed)
What is the important of liver function tests?
Simple blood draws; done to monitor liver function to ensure the medication can be metabolized properly
AST: can be elevated in many body systems beside the liver
ALT: only elevated when liver is inflamed
What is the difference between an agonist and antagonist medication?
Agonists: occupy and activate receptors (full and partial)
Antagonists: occupy receptors, but do not stimulate them; keep the agonist from occupying the same spot and producing a response
What is the importance of high alert drugs?
These are medications that have the highest risk of causing patient harm
includes chemotherapy, insulin, opioids, potassium (IV), parenteral nutrition, anticoagulants, and look-alike/sound-alike drugs
What is a medication reconciliation?
- Medication reconciliation is performed at admission, discharge, every home visit and at each clinic visit. It is done to prevent medication errors, drug interactions and multiple prescriptions of the same medication
- Compare the orders to what the patient believes they are taking
- include meds, OTC, herbals, supplements, vitamins
Differentiate between different controlled substance schedules
(copy from other deck)
Explain how the FDA communicate safety of medication in pregnant and breastfeeding women?
Categories A, B, C, D, and X (do not take X is pregnant)
New pregnancy-risk categories (PLLR)
Newest: written out information for pregnancy implications and breast-feeding considerations
Clinical trial phase 2
Studies those who have the disease:
- group of 25-100 participants with the same disease
- usually participants get the same dose (some studies randomly assign people to different treatment groups)
- groups may get different doses or get treatment in different ways - assessing best balance of safety and response
- may be done at major medical centers, community hospitals, or physician’s office
- continue to gather new information about side effects
What are the 4 main ways medications affect the body?
Replace or act as a substitute for missing chemicals (Ex. insulin)
Increase or stimulate certain cellular activities (Ex. beta agonists)
Depress or slow down certain activities (Ex. beta blockers)
Interfere with the functioning of foreign cells like microorganisms or neoplasms (Ex. antibiotics or chemo)
What are the types of skin rashes seen with medication administration?
Steven Johnson Syndrome
What happens when potassium levels are too low? Too high? Causes? Symptoms?
Normal levels: 3.5-5.5 meq/L
Hypokalemia: less than 3.5 meq/L
Hyperkalemia: more than 5.5 meq/L
What are the different phases of the clinical trials for development of a medication?
pre-clinical trial; phase 1; phase 2; phase 3; phase 4
schedule 2 controlled substances
- has high potential for abuse that may lead to severe psychological or physical dependence
- has a currently accepted medical use in treatment in US
– OR currently accepted medical use with severe restrictions - examples: morphine, cocaine, fentanyl, hydromorphone, oxycontin, PCP, methadone, Adderall
Explain factors which affect absorption of medication through the GI tract?
Barriers:
- presence of food or drugs
- acidity of stomach: food in stomach increases the acidity and stomach empties slower so drug exposed to acid longer
- blood flow to the GI tract
- length of time in stomach
other factors:
- intestinal interference
- pain and stress response:
– decreased blood flow to GI tract (better blood flow allows better absorption)
– ANS response
- heavy high fat response
Identify 3-5 concerns related to adherence and the older adult
- polypharmacy
- difficult to keep a regular schedule
- decreased vision, hearing, memory impairment, and decreased dexterity
- economics
- asymptomatic diseases
- adverse reactions