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Flashcards in Chapter 1 Deck (63):
1

Pharmaco

Drug, medicine

2

Logy

Study of

3

Pharmacology

The study of drugs and their interactions with living cells and systems

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What are the types of names for a drug?

Chemical name
Code name
Trade name
Generic name

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Which name is always capitalized?

Trade name

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Which name is not capitalized?

Generic name

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What are requirements for drug substitution?

Chemically equivalent
Biologically equivalent
Therapeutically equivalent

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Chemically equivalent

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

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Biologically equivalent

Two formulations of a drug produce similar concentrations of the drug in blood and tissues

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Therapeutically equivalent

Two formulations of a drug have an equal therapeutic effect

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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)

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Harrison Narcotic Act

Established regulations governing the use of opium, opiates, and cocaine; Marijuana added later.

13

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

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What is the FDA part of

U.S. Department of Health and Human Services (DHHS)

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Federal Trade Commission (FTC)

Regulates the trade practices of drug companies
Prohibits the false advertising of foods, OTC drugs, and cosmetics

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Drug Enforcement Administration (DEA)

Administers the Controlled Substances Act
Regulates the manufacturing and distribution of substances that have a potention for abuse

17

Omnibus Budget Reconciliation Act

Pharmacists must provide patient counseling and a prospective drug utilization

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What is the DEA part of?

Department of Justice

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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)

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Phase 2 of clinical studies

Larger groups of humans
Adverse reactions are reported to FDA

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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

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Phase 4 of clinical studies

Postmarketing surveiliance
Toxicity that occurs in patients taking the drug after it is released is recorded

23

This is required for prescribing drugs

DEA number

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Schedule II-IV drugs

Must require a prescription

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These type of schedule drugs must be typed or written in pen or indelible ink

Schedule II

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Prescriptions cannot be telephoned to pharmacist

Schedule II

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Prescriptions require a new written prescription for refill

Scheule II

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Schedule III-IV drugs may not be..

Refilled more than five times in 6-month period

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What is the most abusive class of scheduled drugs

I

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What is the least abusive class of scheduled drugs

V

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Schedule I

Heroin, LSD, hallucinogens

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Schedule II

Oxycodone, morphine, amphetamine, secobarbital

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Schedule III

Codeine (Tylenol 3) and hydrocodone (Vicodin) mixtures

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Schedule IV

Dextropropoxyphene forms (Darvon), diazepam (Valium)

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Schedule V

Some codeine-containing cough syrups

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Purpose of Black Box warning

To draw attention to safety concerns associated with the drug

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Labeled uses

Indicates that the FDA has approved the drug for specific use

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Off-label use

Is use outside the stated FDA indications

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Orphan Drugs

Drugs developed to treat rare medical conditions

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What is involved in the prescription format

Heading
Body
RX
Closing
Subsitution

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Heading of a prescription

Prescribers name, address, telephone #
Patients name, address, age, telephone #
Date of prescription

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Body of a prescription

RX sympol
Drug name and dose size or concentration
Directions to patient - Sig:

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RX of a prescription

Drug name # mg table
Disp: # ___
Sig:

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Closing of a prescription

Prescribers signature
DEA number, if required
Refill instructions

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Substitution of a prescription

Permitted
Not permitted

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bid

Twice a day

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-
c

With

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cap

capsule

49

d

day

50

disp

dispense

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gm

gram

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h

hour

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hs

at bedtime

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-
p

after

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pc

after meals

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PO

by mouth

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prn

as required, if needed

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q

every

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qid

4 times a day

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-
s

without

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sig

write (label)

62

tab

Tablet

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tid

3 times daily