Chapter 1 Flashcards
Pharmaco
Drug, medicine
Logy
Study of
Pharmacology
The study of drugs and their interactions with living cells and systems
What are the types of names for a drug?
Chemical name
Code name
Trade name
Generic name
Which name is always capitalized?
Trade name
Which name is not capitalized?
Generic name
What are requirements for drug substitution?
Chemically equivalent
Biologically equivalent
Therapeutically equivalent
Chemically equivalent
Two formulations of a drug meet the chemical and physical standards established by regulatory agencies
Biologically equivalent
Two formulations of a drug produce similar concentrations of the drug in blood and tissues
Therapeutically equivalent
Two formulations of a drug have an equal therapeutic effect
What are the Federal Regulations and Regulatory Agencies
Harrison Narcotic Act U.S. Food and Drug Administration (FDA) Federal Trade Commission (FTC) Drug Enforcement Administration (DEA) Omnibus Budget Reconciliation Act (OBRA)
Harrison Narcotic Act
Established regulations governing the use of opium, opiates, and cocaine; Marijuana added later.
Food and Drug Administration (FDA)
Approval for drugs marketed in U.S.
Quality control in drug manufacturing plants
Determines which drugs can be sold prescribiton/OTC
Regulates advertising and labeling
What is the FDA part of
U.S. Department of Health and Human Services (DHHS)
Federal Trade Commission (FTC)
Regulates the trade practices of drug companies
Prohibits the false advertising of foods, OTC drugs, and cosmetics
Drug Enforcement Administration (DEA)
Administers the Controlled Substances Act
Regulates the manufacturing and distribution of substances that have a potention for abuse
Omnibus Budget Reconciliation Act
Pharmacists must provide patient counseling and a prospective drug utilization
What is the DEA part of?
Department of Justice
Phase 1 of clinical studies
Small groups of people with increasing doses administered to healthy human volunteers
Determines biologic effects (metabolism, safe dose, toxic effects)
Phase 2 of clinical studies
Larger groups of humans
Adverse reactions are reported to FDA
Phase 3 of clinical studies
Drug given to larger amount of people who have the condition for which the drug is indicated
Safety and efficacy must be demonstrated
Dosage is determined
Phase 4 of clinical studies
Postmarketing surveiliance
Toxicity that occurs in patients taking the drug after it is released is recorded
This is required for prescribing drugs
DEA number
Schedule II-IV drugs
Must require a prescription
These type of schedule drugs must be typed or written in pen or indelible ink
Schedule II
Prescriptions cannot be telephoned to pharmacist
Schedule II
Prescriptions require a new written prescription for refill
Scheule II
Schedule III-IV drugs may not be..
Refilled more than five times in 6-month period
What is the most abusive class of scheduled drugs
I
What is the least abusive class of scheduled drugs
V
Schedule I
Heroin, LSD, hallucinogens
Schedule II
Oxycodone, morphine, amphetamine, secobarbital
Schedule III
Codeine (Tylenol 3) and hydrocodone (Vicodin) mixtures
Schedule IV
Dextropropoxyphene forms (Darvon), diazepam (Valium)
Schedule V
Some codeine-containing cough syrups
Purpose of Black Box warning
To draw attention to safety concerns associated with the drug
Labeled uses
Indicates that the FDA has approved the drug for specific use
Off-label use
Is use outside the stated FDA indications
Orphan Drugs
Drugs developed to treat rare medical conditions
What is involved in the prescription format
Heading Body RX Closing Subsitution
Heading of a prescription
Prescribers name, address, telephone #
Patients name, address, age, telephone #
Date of prescription
Body of a prescription
RX sympol
Drug name and dose size or concentration
Directions to patient - Sig:
RX of a prescription
Drug name # mg table
Disp: # ___
Sig:
Closing of a prescription
Prescribers signature
DEA number, if required
Refill instructions
Substitution of a prescription
Permitted
Not permitted
bid
Twice a day
-
c
With
cap
capsule
d
day
disp
dispense
gm
gram
h
hour
hs
at bedtime
-
p
after
pc
after meals
PO
by mouth
prn
as required, if needed
q
every
qid
4 times a day
-
s
without
sig
write (label)
tab
Tablet
tid
3 times daily
