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Pharm > Fundamentals > Flashcards

Fundamentals Flashcards

1
Q
  • Effectively __, __, or __ the patients condition
  • Produces a __, __ response
  • Produces no __ effects
  • Can be taken __, usually by mouth
  • Can be taken __, usually once a day for a short period of time
  • Is __ and __ accessible
  • Is __ eliminated by the body after it produces its beneficial effect
  • Does not __ with other medications
A
  • treats, prevents or cures
  • rapid, predictable
  • adverse
  • conveniently
  • infrequently
  • inexpensive,easily
  • quickly
  • interact
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2
Q

Most common med error?

A

wrong drug

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3
Q

SSRI

A

Sliding scale regular insulin

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4
Q

4 dosing errors

A

trailing 0, naked decimal, name/dose run together, large doses without comma

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5
Q

Sources of drug info

A

package insert = drug label

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6
Q

Package insert info includes

A
  • trade/generic name
  • description
  • pharmacology/moa
  • contraindications
  • warnings
  • adverse rxn/se’s
  • OD info
  • storage
  • how supplied
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7
Q

Selected References

A
  • American Hospital Formulary Service – Drug Information
  • United States Pharmacopoeia Dispensing Information (USPDI)
  • Physicians’ Desk Reference (PDR)
  • The Cochrane Library
  • Drugs in Pregnancy and Lactation
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8
Q

On-Line Resources

A 
Micromedex
Clinical Pharmacology
Lexi-Comp
Natural Medicines
DailyMed
Drugs@FDA
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9
Q

No drug laws before..

A

1906

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10
Q

Pure food and drug act

A
  • 1906
  • no adulterated/mislabled
  • disclose any of 11 dangerous/addictive ingredients
  • no false/misleading claims about curative properties on package
  • covered interstate commerce only
  • US Pharmacopoeia and National Formulary as standards
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11
Q

Shirley Amendment

A
  • 1912

- no fraudulent therapeutic claims

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12
Q

Food, Drug and Cosmetic Act

A
  • 1938
  • mfg must test for harmful effects
  • labels accurate and complete
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13
Q

Durham-Humphrey Amendment

A
  • 1952

- how rx drugs ordered and dispensed

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14
Q

Kefauver-Harris Amentdment

A
  • 1962
  • req proof of safety and efficacy for approval
  • generics for 1938-1962 ok
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15
Q

Phase I

A
  • initial pharm eval

- small number normal volunteers

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16
Q

Phase II

A
  • limited, controlled eval
  • increasing dose
  • pts w/disease
  • effectiveness and se’s
17
Q

Phase III

A
  • Investigational new drug
  • extended clinical eval
  • objectives: determine effectiveness, safety, dosing
18
Q

NDA

A

New Drug Application

-after phase III

19
Q

Patent vs. Market Exclusivity

A

Patent granted by Patent and Trademark Office
-Good for 20 years (in general)

Market exclusivity granted by the FDA at the time of approval

  • New chemical: 5 years
  • Orphan drug: 7 years
20
Q

Product Extension

A
  • desvenlafaxine = active metabolite
  • levocetirizine = active enantiomer
  • Simcor = combo drugs
21
Q

All prescription drugs are approved by the FDA?

A

False

22
Q

Marketed Unapproved Drugs

A
  • Wrap-Up Drugs
  • -On the market before 1938
  • DESI Drugs
  • -Refers to drugs subject to safety only ”approval” (1938- 1962)
  • -Falsely claimed GRASE or grandfathered
  • Post 1962 drugs that were never approved
23
Q

Drug Price Competition and Patent Term Restoration Act

A
  • 1984
  • abbreviated application
  • 5 yr market exclusivity for pioneer drugs (extended for new indications, dosage forms/regimens)
  • generics could be approved for drugs introduced after 1962
24
Q

Generic Drug Approval Criteria

A
  • Pharmaceutical Equivalence
  • -Same active ingredients, dosage form, strength, route
  • -May differ in shape, scoring, excipients
  • Bioequivalence - 80-125%
  • -Rate and extent of absorption are not significantly different from pioneer drug
  • -AUC, Cmax, Tmax
25
Q

Branded Generics

A
  • Novel dosage form of off-patent drugs
  • -OxyContin® (oxycodone)
  • Give a generic drug a trade name
  • -Levo-T® (levothyroxine)
26
Q

Authorized Generics

A

Generic drugs manufactured or licensed by brand manufacturer

-Used to counter the 180 day “first generic” advantage

27
Q

Approved FDA equivalence

A

“Orange Book”

28
Q

Controlled Substances Act

A
  • 1970

- according to abuse potential

29
Q

Schedule I

A
  • High abuse potential
  • No accepted medical use
  • Research protocol only
  • May lead to severe dependence
  • Heroin, Marijuana, LSD, Mescaline, Peyote, Psilocybin
30
Q

Schedule II

A
  • High abuse potential
  • Accepted medical use
  • May lead to severe dependence
  • Written prescription, no refills
  • Morphine, meperidine, cocaine, secobarbital, dextroamphetamine
31
Q

Schedule III

A
  • Less abuse potential than I & II
  • Accepted medical use
  • Low/moderate physical dependence, high psychological dependence
  • Written or oral prescription, 6 months of refills
  • APAP w/codeine, anabolic steroids, ketamine
32
Q

Schedule IV

A
  • Less abuse potential than III
  • Accepted medical use
  • Limited dependence
  • Written or oral prescription, 6 months of refills
  • Phenobarbital, Diazepam, Carisoprodol
33
Q

Schedule V

A

-Less abuse potential than IV
-Accepted medical use
-Limited dependence
-May or may not require prescription
Codeine in limited quantities, Ezogabine (Potiga®)

34
Q

Types of Drugs

A
  • Legend/prescription
  • OTC
  • BTC
  • Dietary Supplements
35
Q

Prescription Drugs

A
  • defined federally
  • clinicians prescribe
  • rules govern ordering, dist and admin
36
Q

OTC

A
  • condition can be self-dx
  • tx efficacy/tox easily assessed by consumer
  • NDA
37
Q

Rx-to-OTC Switch

A
  • Vaginal antifungals
  • NSAIDs
  • Non-Sedating Antihistamines
  • Nicotine Replacement
  • H2RAs and PPIs
  • Emergency Contraception
  • Nasal steroids
  • Oxytrol®
  • Statins?
38
Q

Behind the Counter

A
  • Schedule V Drugs
  • -Some states (not Texas)
  • -Codeine cough syrup
  • Combat Methamphetamine Epidemic Act of 2005
  • -Requires ID and log books to buy pseudoephedrine
  • Insulin (regular and NPH)
39
Q

Dietary Supplements/Herbals

A
  • Governed by the Dietary Supplement Health and Education Act
  • Includes plant parts, extracts and essential oils
  • Considered safe until proven unsafe
  • Not required to test ingredients in clinical trials
  • Cannot make claims to treat disease
  • -“boost immune system”
  • -“aids digestion”
  • -“improves heart health”
  • -“increases energy”

Pharm (7 decks)

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