Pharm Principles

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