Flashcards in CH. 1 (Exam 1) Deck (82):
The Study of drugs and their interactions with living cells and systems?
Drugs have 3 types of names, what are they?
When studying a drug, they give the drug what type of name?
A code name
When the drug is study and developed, the company who discovered the drug gives the drug what type of name?
A Trade name
T/F Generic Name Drugs stay the same in any country, while Trade Name Drugs change names in different Countries.
T/F Trade Name Drugs is always Capitalized?
Who grants approval for drugs marketed in the U.S.?
FDA stands for what?
Food and Drug Administration
Who determines which drugs can be sold over the counter and prescription?
Who prohibits the false advertising of foods, nonprescription (OTC) drugs, and cosmetics?
Who regulates the labeling and advertising of prescription drugs?
What does FTC stand for?
Federal Trade Commision
What does DEA stand for?
Drug Enforcement Administration
Who regulates the manufacture and distribution of substances that have a potential for abuse, including opioids, stimulants, and sedatives?
What is Opioids?
The Process of New Drug Develop is done in what four stages?
Preclinical: Studies on animals
Clinical: 3 phases of clinical studies
NDA Review: Submits Application
Post-marketing Surveillance: Surveys
Tested on a small group of volunteer people, increases doses, determines biologic effects, metabolism, safe dose range in humans, and toxic effects of the drug is what stage of the Clinical Studies?
Tested on Larger groups of humans and adverse reactions are reported to the FDA during what Stage of the Clinical Studies?
Tested on a large group of pts with a condition for which the drug is indicated for, dosage of drug is determined, and where the safety/efficacy is demonstrated is what Phase of Clinical Studies?
Postmarketing surveillance, toxicity that occurs in pts taking the drug after it is released is recorded during what Phase of Clinical Studies?
What are Schedule 1 drugs?
What are Schedule 2 drugs?
What are Schedule 3 drugs?
Hydrocodone (Vicodin) mixtures
What are Schedule 4 drugs?
Dextropropoxyphene forms (Darvon)
What are Schedule 5 drugs?
Some codeine-containing cough syrups
What schedule drug has the most abusive drugs?
Schedule 1 drugs
What Schedule Drugs require a prescription?
Schedule Drugs 2-4
What Schedule Drugs must be typed or written in pen or indelible ink?
What Schedule Drug cannot be telephoned to a pharmacist?
What Schedule Drug requires new prescriptions for refills?
What Schedule Drugs may not be refilled more than five times in 6 month period?
T/F DEA number is required before one can prescribe schedule drugs?
T/F Triplicate or duplicate prescriptions my be required for Schedule 2 drugs?
What is the purpose of a Black Box Warning Label?
To draw attention to safety concerns associated with the drug. It also educates both prescriber and pt about serious safety concerns associated with the drug
With the "Labeled and Off-Label Uses" Labeled indicates what?
That the FDA has approved the drug for specific use
With the "Labeled and Off-Label Uses" Off-Label indicates what?
it is used outside the stated FDA indications
What is an Orphan Drug?
Drugs developed to treat rare medical conditions. Usually less than 200,00 ppl effected with the rare condition
Why would a drug be RECALLED?
A reasonable probability that use result in serious adverse health consequences or death
T/F You want to keep a copy of prescriptions in the pt's chart
The primary measuring system used in pharmacy is?
The Metric System
Solid drugs are dispensed by?
Weight (milligrams [mg])
Liquid drugs are dispensed by?
A teaspoon (tsp) equals how many mL (milliliters) ?
A tablespoon (tbsp) equals how many mL (milliliters)?
A dosing cup are available in what volumes with milliliters marked along the lengths?
When two formulations of a drug meet the chemical and physical standards established by regulatory agencies, is called what?
When two formulations of a drug produce similar concentrations of the drug in blood and tissues, is called what?
When two formulations of a drug have an equal therapeutic effect, is called what?
Due to which Act, pharmacists must provide patient counseling and a prospective drug utilization review (DUR) for Medicaid patients?
Omnibus Budget Reconciliation Act of 1990 (OBRA)
DUR stands for?
Drug utilization review
Three times daily
Four times daily
Which conditions must be met for a drug to be approved as a generic substitution for the patented trade name drug?
Biologically and Therapeutically Equivalent
T/F A dental hygienist must have knowledge of pharmacology to obtain health history, diagnosing diseases or conditions, handling medical emergencies and planning appointments
Which name is considered the official name of a new drug?
Metric units used in prescription writing?
Milliliter (mL) exactly 1 cubic centimeter (cc)
measurement of weight is kilogram (kg)
Various units of the metric system are based on multiple of 10
All are required on a prescription labels?
Name of the medication and its strength
Patient's name and dentist's name
Name, Address, and telephone # of the pharmacy
Direction for use
Original date and the date filled
Quantity of medication dispensed
T/F A patient must be a patient of record and have a condition for which the prescription is being prescribed is a dentist-related condition must be met before a dentist can prescribe a medication
T/F 1 liter = 1000 milliliters (ml)
Prescription format: Heading
Name, address, telephone # of (prescriber)
Name, address, age, telephone #(pt)
Date of prescription
Prescription format: body
Name of drug
Amount of dispense
Directions of use