Week 1 Flashcards by Yuko Porter

What is the perfect drug? 6

Effectively treats
Rapid response
Produce no adverse effects
Infrequently
Inexpensive
Not interact with other meds

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What are the common medication errors?
That will make pt harm

Wrong drug
Overdosage
Wrong Route
Monitoring Error

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Source of drug
Plant
a) Willow tress
b) Ephedra sinica
c) Opium Poppy

Most drugs come from plants

a) Aspirin
b) ephedrine, ephedra5
c) laudanum, opium 1%

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Source of drug
Animal
a) cows and pigs
b) horses
c) cow stomach
d) anchovies, sardines
e) diphtheria, tetanus

Insulin
Conjugated estrogens
Pepsin
Fish oil
Antitoxin sera

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Source of drug
Microbes
a) Penicillium molds
b) lactobacillus family

Penicillin
Dextran

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Source of drug
Synthetic

Naturally available

Aspirin
Antihistamines
Anesthetics
Fentanyl

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Source of drug
Semi-Synthetic
a) Hydromorphone and Heroin from?
b) Ampicillin from?

taken from something and changed to get fewer side effects or to get the desired effect
a) Morphine
b) Penicillin

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Source of drug
Biosynthetic
a) From yeast?
b) From bacteria?

a) Hepatitis B vaccine
b) Recombinant insulin

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What is tertiary Literature?

Summarized
Evaluates or interprets primary sources

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What is Secondary Literature?

Databases use to search for primary literature

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What is Primary Literature?

Clinical research studies
Provide the most recent information
Require longer time commitment

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Drug laws
Pure food and drug act 1906

Protect the public from mislabeled drugs and food
Required to list if 1 of 11 dangerous and or addicting drugs

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Drug laws
Food drug and cosmetic act 1938

Test for harmful effects
Drag labels must be accurate and complete

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Durham-Humphrey Amendment (1952)

Specified how prescription drugs can be ordered and dispensed

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Drug laws
Kefauver-Harris Amendment (1962)

Required proof of both safety and efficacy prior to approve
Permitted generic versions of drugs initially marketed from 1938-1962

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Drug approve process
Phase 1

Initial pharmacologic evaluation
Small # of normal /healthy/unafflicted volunteers
1.5 years

Drug approve process
Phase 2

Limited controlled evaluation
(tested on patients with disease)
Determines clinical effectiveness, drug safety, and establishes the safe/effective dose

2 years

Drug approve process
Phase 3

Extended clinical evaluation
Determination of Clinical effectiveness
and safe/effective dose
3.5 years

Generic drug approval
Same active ingredients, dosage, form, strength and route

Pharmaceutical Equivalence

Generic drug approval
Rate and extent of absorption
What factors and must lie within?

Bioequivalence
AUC
C max
T max
Must lie within 80 to 125%(-20 to +25%)

Texas Controlled Substances Act
Classifies controlled substances according to?

Their abuse potentials

Prescriptions are electronically transmitted to?

DPS
Texas Department of Public Safety

Identify prescribers who may be inappropriately
prescribing controlled substances
Identify potential abusers
Identify diversion

Schedule 1 medication

High abuse potential
No accepted medical use
May lead to sever dependance
Heroin
Marijuana
LSD

Schedule 2 medication

Accepted medical use
High abuse potential
May lead to sever dependance
Must be written on an official prescription form
No refills

Oxycodone
Cocaine
Morphine

Schedule 3 medication

Accepted medical use low/moderate physical dependance Written or oral prescription High psychological dependance 6 months of refills Acetaminophen Steroid

Schedule 4 medication

Accepted medical use Written or oral prescription 6 months of refills

Schedule 5 medication

Accepted medical use May or may not require prescription

Where drugs do come from?

Plants Animals Microbes Synthetic Semi-Synthetic Biosynthetic

What are a) C max b) T max c) AUC

a) The amount of drugs that get into the bloodstream b) How long it take for drug to take effect c) Result of time and concentration, used to determine equivalence

Differentiate between t generic and trade name?

brand name drug refers to the name giving by the producing company generic drug refers to a drug produced after the active ingredient of the brand name drug

Drug laws Drug Price Competition and Patent Term Restoration Act(1984)

Established the approval pathway for generic drug products

What is an ANDA?

After 5 years generic companies can submit an ANDA to get their generic drug approved Drug must be able to display pharmaceutical equivalence and bioequivalence

What is an NDA?

New Drug Application (NDA) Must go through the FDA drug approval process (3 phases) then submit an NDA drug application to the FDA

Chemical name of drug?

Expresses the chemical makeup of the drug Ex: N-(4 hydroxyphenyl) acetamide

Generic name of drug?

Actual name of the drug (common name) Each drug has 1 generic name Tells us the drug category Ex: acetaminophen, ibuprofen

Trade name/Brand name of drug?

Name the drug is marketed under (several names) Each drug can have multiple names Has the “R” symbol behind name

What are the advantages and disadvantages of the drug information references? Package insert/drug label

Advantages: FDA required and approved Great for warnings, contraindications, side effects Disadvantages: Not good for indications (since almost all drugs have more than one use other than what the FDA approves the drug for)