Principles of Pharm Flashcards
What is Pharmacotherapeutics?
Drugs used to prevent, treat, or diagnose a disease
-composed of 2 components: pharmacodynamics and pharmacokinetics
What is Pharmacokinetics?
The study of how a drug is absorbed, distributed, or eliminated from the body
What is Pharmacodynamics?
The analysis of what a drug does to the body at the systemic and cellular levels
-what the effect the drug has on the body
-the effect of the substance on biological substances
What are the 3 different names a single drug can have?
- Chemical: the compound the drug is made of
ex: propionic acid - Generic: official name
ex: ibuprofen) - Trade or Brand: assigned by the pharmaceutical company the drug was manufactured from
ex: Celebrex
Why use the generic named drug over the brand named drug?
Generic drugs are often substituted for a brand name drug because they are cheaper. However, they need to be tested to ensure the 2 drugs are equal (same amount of active ingredients, same absorption, and same metabolism). Even if the drugs are equal, some patients have more side effects or different reactions to the generic drug.
Phases of drug testing on humans
Phase 1: tested on 10-100 healthy subjects
-pharmacokinetic parameters established
Phase 2: tested on 50-500 subjects with the specific disease
-clinical benefits and range of toxicities determined
Phase 3: tested on several hundred to thousand subjects
-safety and efficacy established
**typically takes 4-6 years of testing to gather all data
Drug Approval Process
- testing on animals
- testing on humans (Phases 1-3)-
- if animal and human testing meets expectations, an application is submitted to the FDA for approval - which can take 3+ years
- label made IF approved by FDA
- marketing of the drug (Phase 4)- monitoring the safety of the new drug (no fixed duration)
*time from filing for a new drug for approval to when marketing begins can be 5+ years
What is the lifetime of a patent?
In the US a patent lasts 20 years in which only the owner of the patent can manufacture the drug. After the 20 years, any company has the ability to make said drug without paying license fees to the original owner
What is Off-Label Prescribing?
Physicians can prescribe drugs for reasons other than what that drug is originally intended for
Example: Gabapentin which is used for seizures can also be effective in pain management
The Controlled Substances Act
Places drugs in specific categories based on their likelihood of addiction of abuse. Restrictions exist for how often a patient can refill their prescriptions to prevent abuse.
Categories: schedule I, schedule II, schedule III, schedule IV, schedule V
What does is the Dose-Response Curve? What is threshold and ceiling effect?
Provides information about the dosage range where the drug is effective
-threshold dose: minimum dose to cause cellular changes
-ceiling effect: any doses above this level will not result in any further changes
What is Potency?
The amount of drug needed to produce a given effect
-the more potent a drug, the less of that drug is needed to achieve the desired therapeutic effect
Example: if drug A produces a desired effect at a much lower dosage compared to drug B, then drug A is more potent.
Median Effective Dose
The concentration of the drug at which 50% of the population responds to it in the expected manner
Example: 50% of people who take a pain killer experience absence of pain
Median Toxic Dose
The dose at which 50% of the population exhibits the specific adverse effect
Median Lethal Dose
The dose that causes death in 50% of the animals it was tested on
Therapeutic Index (TI)
This is an indicator of a drug’s safety and it is determined by the median effective dose and the toxic dose (TI= toxic dose/median effective dose)
-the higher the TI, the safer the drug because it indicates that it takes a higher dose of the drug to evoke a toxic response
-blood levels should be monitored for drugs with low TI values to ensure there is no toxicity occurring
Example: OTC drugs have a higher TI than prescription drugs
Examples of Different TI Values
-Tylenol: 27
-Demerol (narcotic analgesic): 8
-Valium (sedative): 3
-Chemotherapy Drugs: 1
**the low TI of cancer drugs is accepted because some of the toxic effects of the drug outweigh the risk of not taking the meds
Enteral Administration
A form of taking a drug which involves the GI system
Examples:
-oral
-sublingual
-bucal
-rectal
Parenteral Administration
A form of taking a drug that does not involve the GI system
Examples:
-inhalation
-injection
-topical
-transdermal
What is the most common enteral method?
Orally- swallowing the drug where it is absorbed from the GI lumen- typically absorbed within the small intestine and transported to the liver, then taken to their action site
What must a drug be for it to be effectively absorbed within the GI tract?
Must be lipid soluble so it can pass through the GI mucosa and into the bloodstream. If it is not lipid soluble there will be poor absorption and it will be eliminated from the body