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Why should we care about pharmacology as PTs?
Helps us optimize therapy sessions (ex. pain meds)
Helps us choose optimal session times (ex. after a pts sedatives wear off)
Avoid/control adverse responses
Helps us recognize side effects
What are the two main branches that form pharmacology?
Pharmacotherapeutics
Toxicology
What are the two main branches under pharmacotherapeutics?
Pharmacokinetics
Pharmacodynamics
What are the branches that fall under pharmacokinetics?
Absorption
Distribution
Elimination
What are the branches that fall under pharmacodynamics?
Systemic effects
Cellular effects
N-acetyl-p-aminophenol is an example what kind of drug nomenclature?
Chemical name
What is the drug nomenclature for the compound structure?
Chemical name
Acetaminophen, levodopa, phenobarbital, and diazepam are all examples of what drug nomenclature?
Generic name
What drug nomenclature is derived from the chemical name?
Generic name
What is the drug nomenclature that represents the official or nonprioprietary drug name?
Generic name
The trade name has to refer or be derived from the chemical or generic name. True or false?
False
Tylenol, Larodopa, Luminal, and Valium are all examples of what drug nomenclature?
Trade/brand name
What drug nomenclature should we use? Why?
Generic name because it is the easiest and the most consistent
Your pt insist that they take the brand name cold medication over the generic Walmart cold medication. Why might that be?
Because they believe that the generic name medication (Walmart in this instance) is a lower quality compared to the brand name
Which of the following correctly shows how the generic and brand name will be written in print together?
generic(Brand Name)
Generic(brand name)
Brand Name(generic)
brand name(Generic)
generic(Brand Name)
When in print, what drug name will always be in lower case, the generic name of the brand name?
The generic name
When in print, what drug name will always be in upper case, the generic name or the brand name?
Brand name
What kind of drugs are less expensive, generic or brand name?
Generic
What has to be the same between a generic and name brand drug?
Same type and amount of active ingredient
Same administration route
Same pharmacokinetic profile
Same therapetuic effects
What criteria need to be met for a drug to be considered bioequivalent?
Same type and amount of active ingredient
Same administration route
Same pharmacokinetic profile
Same therapeutic effects
Even though generic and brand name drug are bioequivalent, why might a pt respond differently to the two meds?
The different inactive ingredients may alter how the medications are absorbed by the pt
What are the roles of the FDA in relation to drug regulation?
Monitor the use of existing drugs
Assess the development of new drugs
Approve new drugs for market
What are the primary concerns of the FDA when they are looking at new, developing, and existing drugs?
Their effectiveness at treating a certain condition
Their safety
How long do in vitro studies typically last?
2 years
How long does animal testing typically last?
Roughly 2 years
How long does clinical testing typically last for a drug?
4-5 years
How many phases are there in the clinical testing portion?
3
When does a drug become an invesigational new drug (IND)?
After it completes animal testing
When a drug is going through in vitro studies and animal studies, what things are researchers primarily looking at?
Drug efficacy
Selectivity
The mechanism of the drug
How many subjects are used during phase 1 of clinical testing?
20-100
How many subjects are used during phase 2 of clinical testing?
100-200
How many subjects are used during phase 3 of clinical testing?
1000-6000
What are researchers looking at during phase 1 clinical testing?
The safety of the drug
The parmacokinetics of a drug
What are researchers looking at during phase 2 of clinical testing?
If the drug works in pts
At what phase of clinical testing is a double blind study performed?
Phase 3
After how many years of testing can a new drug application (NDA) be filled out?
8-9 years
How many years after filing a NDA does a drug patent expire?
20 years
What are some special situations where a drug is put through the drug approval process more quickly?
When the drug is being made to treat a life threatening condition and is…
Better than current options
There are no other treatments for the condition
If the drug has already been approved for one condition and is being treated for another condition
What are orphan drugs?
Drugs that are made for very rare diseases. FDA helps with funding because cost of development is so high for these drugs
What is off label prescribing?
The use of a drug to treat a condition other than what it was originally made to treat
How is off label use often found?
Via clinical observation
How do practitioners prescribe medications off label?
Based on their clinical judgement
If a pt is struggling financially, why might it not be a good idea for a practitioner to do an off label prescription?
Insurance companies often don’t pay for off label use cuz they suck
What are the differences between a prescription and a OTC?
Prescriptions are ordered and dispensed by an authorized practitioner (physician, nurse practitioner, dentist)
OTCs are purchased directly by the consumer
In regards to pharm, what are the roles of a PT?
Educate and counsel pt about purpose of meds
Reinforce proper use
Educate pts on potential benefits
Refere pt to provider if they got questions or concerns
Can PTs directly prescribe or administer OTC products?
Heck to the no
What are complimentary and alternative meds classified as by the FDA?
Dietary substances
What percentage of US adults use some form of complimentary and/or alternative meds (CAMs)?
Roughly 38%
What are some examples of CAMs?
Herbal preparations
Vitamins
Minerals
Other nutritional substances
What the heck is a complimentary medication?
A substance that is used in addition to a conventional treatment
What the heck is an alternative medication?
A substance used as a substitute for a more traditional or mainstream tx
Patient’s do not have to report CAM use to healthcare providers. True or false?
False! They should let their healthcare providers know
Since CAMs are listed as food/dietary supplements, what does that mean for their regulation?
They are not subject to the same standards for quality and purity as traditional medications
What are some potential adverse effects of CAMs?
Increase or decrease in effectiveness of real meds
Can produce their own side effects
Can damage liver since most CAMs are metabolized in the liver
What year was The Comprehensive Drug Abuse Prevention and Control Act made?
1970
What schedule drug is considered to have the highest abuse potential?
Schedule 1
How many schedules of drugs are there?
5
What drug schedule is said to have the lowest abuse potential?
Schedule 5
A drug in what schedule is not allowed to be a medical treatment?
Schedule 1
A drug in what schedule cannot be studied in research that is being funded by federal grants?
Schedule 1
What are some examples of schedule 1 drugs?
Heroin
LSD, Mescaline, Peyote
Ecstasy
Marijuana
What are some examples of schedule 2 drugs?
Morphine
Fentanyl
Amphetamine derivatives
What are some examples of schedule 3 drugs?
Codeine
Anabolic steroids
Some barbiturates
Amphetamines that aren’t schedule 2
What are some examples of schedule 4 drugs?
Certain antianxiety drugs
Certain barbiturates
Some depressants & stimulants
What are some examples of schedule 5 drugs?
Low doese opioids (like the ones in cough meds)
Anti-diarrheal
What factors are considered when deciding a drug dosage?
If the dose is large enough to allow for an adequate concentration to reach the target site
If the dose is able to produce a beneficial response
If the dose is low enough so that is will not produce any toxic effects
What is a threshold dose?
The minimal dose needed to elicit a response
What is the ceiling effect?
The point at which a drug produces its most significant response. At this point, an increase in dose will not increase the response
What does potency mean?
A dose that produces a specific response at a specific amplitude. The amount of a compound required to produce a given response
Drug A only requires 10 mg to lower BP by 25%. Drug B requries 80 mg to lower BP 25%. Which drug is more potent? Which drug is the better drug?
Drug A is more potent
Neither drug is better than the other based off this information. A more potent drug does not mean a drug is better
Does potency always equal maximum efficacy?
Nope
Drug A is able to decrease arterial pressure by 40%. Drug B is able to decrease arterial pressure by 60%. Which drug has a greater maximum efficacy?
Drug B
What are some good measures of drug safety?
Therapeutic index
Drug selectivity
Cumulative dose-response curves
Median effective dose
Therapeutic index (TI)
What does ED50 mean?
The median effective dose. The point at which 50% of the population responds to a drug in a specific manner
What does TD50 mean?
The median toxic dose. When 50% of the population exhibits the adverse effect
At what phase of clinical testing is the relationship between the dose of a drug and the occurrences of a certain response measured in a large group of people?
Phase III
What do dose response curves look at?
The percentage of a population that exhibits a specific response as a dose increases
The greater the therapeutic index value, the more dangerous the drug. True or false?
False! A greater therapeutic index value means the drug is safer
