Pharmacology: Chapter 1

What are the online resources for drug information?

1. Mosby's dental drug reference

2. Lexicomp

3. Epocrates app

4. mayoclinic website

5. FDA website

What is the harrison narcotic act about?

established regulations governing the use of opium, opiates & cocaine

- including marajuna at a later date

When was the US FDA founded?

1906

What does FDA regulate? theres 4

1. Grants drug approval

2. Sets quality control standards in drug manufacturing plants

3. determines which drugs can be sold by prescription and over-the-counter

4. Regulates labeling and advertising of prescription drugs

what is chemical names?

usually only one name

- unique codes

what are generic name and example

- only one name

ex: ibuprofen

what are trade names & examples

- multiple (brand) names depending on company selling it

ex: Motrin, Advil

What are the common trade names for ibuprofen?

Advil, Motrin

what does it mean for a drug substitution to be chemically equivalent

two formulations of a drug meet the chemical and physical standards established by regulatory agencies

what does it mean for a drug substitution to be biologically equivalent

two formulations of a drug produce similar concentrations of the drug, blood, & tissues

what does it mean for a drug substitution to be therapeutically equivalent

two formulations of a drug have an equal therapeutic effect

what information does the "package insert" contain? name4

- chemical make up of drug

- FDA approved indications for use

- contraindications

- warning/adverse reactions

- drug interactions

- dose and administration

- how supplied

describe phase 1 of clinical trials

small and then increasing doses are mixed to a limited number of healthy human volunteers to determine safety

describe phase 2 of clinical trial

larger groups of humans are given the drug to test effectiveness

describe phase 3 of clinical trial

clinical evaluation involving a large number of patients who have the condition for which the drug is indicated

& dosage is determined

describe phase 4 of clinical trial

post marketing surveillance

what are scheduled drugs? 3 things

- " controlled substances"

- drugs with abuse potential (addiction)

- usually psychoactive drugs

give some examples of schedule I drugs and define

illegal street drugs; nor prescribed

- heroin, LSD, hallucinogens, marijuana

give some examples of schedule II drugs and define

prescriptions must be written in person with no refills for a max of 30 days

- oxycodone, morphine, amphetamine, secobarbital

What is a "Black Box Warning" in the prescribing information (package insert) for an FDA approved drug? and why doesit exist

required by FDA to draw attention to specific, serious safety concerns associated with the drug

- potentially fatal, life-threatening, or disabling adverse effects

what are "labeled" uses of drugs

indicates that the FDA has approved the drug for specific use (disease or condition)

what are "off-label" uses of drugs

and an example

- use outside the stated FDA indications whether that be for a different condition or different dosage of the medication

ex: taking a breast cancer treating medication for infertility

When a dentists writes a prescription for a drug, what types of information go on the prescription? name 4

- National Provider Identifier (NPI)

- Patient name

- Date of prescription

- Age if patient is under 12 or over 60

- Drug name and dosage

- whether or not substitutions are allowed

- DEA number (when required)

When is the DEA number required for a prescription?

for scheduled drugs (II-V) only