Exam 2: Week 5 Wednesday (medications) Flashcards
Definition of Pharmacotherapeutics
area of pharmacology that refers to the use of specific drugs to prevent, treat, or diagnose a disease
Definition of Pharmacokinetics
the study of how the body deals with the drug in terms of the way it is absorbed, distributed, and eliminated
Definition of Pharmacodynamics
the analysis of what the drug does to the body, including the mechanism by which the drug exerts its effect
Definition of Pharmacogenetics
the branch of pharmacology concerned with the effect of genetic factors on reactions to drugs.
What is the difference between a chemical name and a generic name?
- Chemical name refers to specific compound’s structure (typically long and cumbersome)
- Generic name tends to be shorter and often derived from chemical name.
Two alternative ways the generic name can be thought of
- official
- nonproprietary
List of steps for having a drug approved
- Animal studies
- Human Clinical Trials phase I
- Human Clinical Trials phase II
- Human Clinical Trials phase III
*Postmarketing surveillance
What is bioequivalence?
If 2 products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
*This does not always occur and sometimes people react differently to a generic drug compared to brand name drug.
When referring to a medication, what is the ideal drug name to use?
generic
Brand (or Trade) names can often be confusing and sound like other drugs used for very different purposes
Something to ask or check if patient complains of not feeling quite right or having increased side effects to their medication
Did they change their medication from brand name to generic.
What does Human Clinical Trials Phase I typically involve?
Usually a small group of healthy volunteers (20-80 people)
What does Human Clinical Trials Phase II typically involve?
Usually a small group of people with the targeted pathology (200-300 people)
What does Human Clinical Trials Phase III typically involve?
Usually a much larger group of people with the targeted pathology (several hundred - several thousand people)
Common drug that gets expedited through the drug approval process
flu vaccine
What is postmarketing Surveillance?
drug is monitored for side effects after released.
If substantial or severe adverse effects reported, drug can be pulled off the market
What is a black box warning?
- strictest warning in the labeling of prescription drugs by FDA
- when there is reasonable evidence of an association of a serious hazard with the drug.
EX: Clindamycin- antibiotic that flushes out all of intestinal flora
What is an orphan drug?
- a drug that remains commercially undeveloped owing to limited potential for profitability.
- Usually under 200,00 people in the US with that disease.
- Because there is limited demand, FDA will fund production of orphan drug.
Off label medication?
approved medications used for something other than their intended indications.
Ex; Neurotin- anti-seizure medication also used to treat pain and has been used as an anti-psychotic
Who assumes liability for off label medication?
prescribing doctor
benefits and disadvantages of OTC meds
Benefits
- Do not need to see a doctor to get them
- safety is reasonable- typically reduced in half to accommodate for consumer error
- clinical effectiveness proven dosage
Disadvantages
- Dr. not there to tell consumer how to use them
- insurance typically does not pay for OTC meds leading to potentially more out of pocket cost
Why would a physician need a DEA license?
Augments prescription writing privileges to include schedled medications.
What are schedule I drugs?
drugs with highest potential for abuse and not used for therapeutic use
Ex: LSD, heroin
What are schedule II drugs?
drugs approved for specific therapeutic purposes but still have high potential for abuse and addiction
Ex: morphine, fentanyl
What are schedule III drugs?
drugs have mild to moderate risk for physical and/or psychological dependence
Ex: anabolic steroids, codeine
What are schedule IV drugs?
drugs supposedly have lower potential for abuse and dependence
Ex: phenobarbitol
What are schedule V drugs?
drugs with lowest risk for dependence and abuse
Ex: some cough medications, antidiarrheal preparations
What is a dose-response curve?
provides info about the dosage range over which the drug is effective, as well as the peak response that can be expected from that drug.
What is the threshold dose and where is it located on the dose-response curve?
- min dose of drug that will produce a detectable degree of any given effect
- At the very beginning of the curve
What is the ceiling effect and where is it located on the dose-response curve?
- point at which there is no further increase in the response to a drug- maximal efficacy of drug is reached.
- located at highest point and end point of dose-response curve.