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Pharmacy Practice Exam 1
Exam Information Through Oct 14th
84
Pharmacology
Graduate
09/02/2011

Additional Pharmacology Flashcards

 


 

Cards

Term
Define Superscription
Definition
the Rx symbol, means "take vow"
Term
Define inscription
Definition
The name of the drug
Term
Define subscription
Definition
The dosage form and number of units (ex. 30 capsules or 5 ounces)
Historically was how to make it
Term
Define signa
Definition
The directions on how to take the medicine
Term
What drug often uses grains as its unit?
Definition
Aspirin
Term
Define dram for this class
Definition
5mL or one teaspoon
Term
Define ounce for this class in terms of mL
Definition
30mL
Term
List the five things a prescription is required to have
Definition
1. Patient Name
2. Date
3. Drug name, dosage, strength
4. Sig
5. Dr's name and address
Term
What does a controlled substance prescription need to have that normal ones do not?
Definition
1. Patient's address
2. Dr's DEA number and signature if not called in
3. Initials of pharmacist and date dispensed
Term
Where does the patient's ID information go when filling a prescription?
Definition
OBNDD to the PMP (prescription monitoring program)
Term
Can controlled substances be called in?
Definition
CIII-v can, but not CII

(and of course not CI)
Term
Can a pharmacist edit a prescription (adding a DEA# or give a generic instead, for example)?
Definition
Yes, but it must be documented on the back of the precription
Term
What can a pharmacist add to a prescription without prescriber confirmation?
Definition
1. Patient age/address
2. Prescriber DEA
3. Generic drug name, if used
Term
What can a pharmacist add/change to a prescription with prescriber confirmation?
Definition
1. Drug strength
2. Drug quantity
3. Directions for use
4. Dosage form
5. Whether it is compounded
Term
When do non-controlled substances prescription refills expire?
Definition
One year from date
Term
When do CIII-CV substances prescription refills expire?
Definition
6 months from date, cannot be refilled more than 5 times
Term
When do CII substances prescription refills expire?
Definition
30 days from date written, cannot be refilled
Term
Are refills required on a prescription label?
Definition
No, but helpful
Term
How long does it take a new drug to go to market?
Definition
2-12 years, average 8.5
Term
How much does it cost to develop a new drug? How many recoup the loss?
Definition
$500mil-2bil

Only 1/3 recoup development cost
Term
How many new drug compounds reach the market?
Definition
1/10,000
Term
What are the 7 steps of drug development?
Definition
1. Lab research in vitro
2. Animal studies
3. Investigational New Drug status by FDA
4. Human Clinical Trials
5. New Drug Application submitted to FDA
6. FDA Review/Approval
7. Market/Post-Marketing
Term
Describe step 1 of drug development, Lab Research
Definition
Identification of biological target and identification of chemical compound (by use of assays, computer simulations, microorganisms)
Term
Describe step 2 of drug development, Animal Studies
Definition
Typically 2 or more species, rodent and a non-rodent

ADME: Absorption, distribution, metabolism, and excretion studies
Term
Describe step 3 of drug development, IND
Definition
FDA determines if it is safe to be an Investigational New Drug based on Animal Pharmacology, Manufacturing Plan, and Clinical Protocols planned
Term
Describe step 4 of drug development, Human Clinical Trials
Definition
3 phases with increasing numbers, repetitive reports to FDA
Term
Describe step 5 of drug development, NDA
Definition
New Drug Application sent to FDA, several hundred thousand pages of data, documentations, and manufacturing plans
Term
Describe step 6 of drug development, FDA Review/Approval
Definition
Takes about a year

Review of NDA, package insert, manufacturing plant
Term
Describe step 7 of drug development, Market/Post-Marketing
Definition
Additional studies, MedWatch, possible Blackbox warning/Patient Medication guides/Drug withdrawal
Term
Describe phase 1 of a Human Clinical Trial
Definition
6-9 months long, emphasis on safety, healthy small group (<100) checking side effects, metabolism, and excretion
Term
Describe phase 2 of a Human Clinical Trial
Definition
6 months-3 years

Emphasis on efectiveness(efficacy
People with the condition (100-300) and hopefully otherwise good health, placebo controlled, establish min/max dosing
Term
Describe phase 3 of a Human Clinical Trial
Definition
1-4 years, expanded trials allow extrapolation

Emphasis on Safety/efficacy/dosage/interactions/effects/toxicities

1,000s of patients with condition, specific trials (ex. old vs young, lactating women, renal insufficiency)
Term
What 5 names does a drug have?
Definition
1. Empirical formula
2. Chemical name
3. Investigational name
4. Generic name
5. Brand name
Term
Why do all drugs have a generic name but there is not always a generic available to the patient?
Definition
There's a generic name given that describes properties of the drug when it comes out, but a generic brand isn't available until the patent runs out
Term
Define NDC
Definition
A 10 digit code for drug identification used to prevent mistakes and file insurance claims
Term
What does the first segment on an NDC refer to?
Definition
Labeler (Manufacturer or distributor)
Term
What does the second segment on an NDC refer to?
Definition
Product (Strength, dosage form, and formulation)
Term
What does the third segment on an NDC refer to?
Definition
Package (size)
Term
What form is the NDC for an insurance claim?
Definition
5-4-2, add a zero in front of the segment needed to match this form
Term
Describe C1 drugs
Definition
Illegal, highest abuse potential, no medical use
Term
Describe CII drugs
Definition
High abuse potential, may cause withdrawal, but has an accepted medical use
Term
Describe CIII-CV drugs
Definition
Of increasingly less abuse potential but still controlled
Term
When did pharmacies become a separate entity from other practitioners?
Definition
The middle ages
Term
When was the first Pharmacopeia of the US published?
Definition
1820
Term
What was the first college of pharmacy in the US?
Definition
Philadelphia College of Pharmacy
Term
What was two reasons why the Philadelphia College of Pharmacy was founded?
Definition
1. Deterioration of the practice of pharmacy
2. Discriminatory classification by school medical faculty
Term
Who was the Father of American Pharmacy?
Definition
William Procter Jr.
Term
What was the primary problem with the profession of pharmacy from 1900-1950s?
Definition
Surgeon general refused to recognize pharmacy as a profession, just seen as shopkeepers
Term
What was the purpose of the Asheville Project
Definition
Gave pharmacy a new image, mid 1990s, started patient counseling
Term
What was the most important recognition of pharmacy in the 1970s?
Definition
1974- clinical role for pharmacist recognized by government
Term
What year did Pharm D programs become supported by all major pharmacy organizations?
Definition
1992
Term
Who were the first two graduates of OU Pharmacy and when did they graduate?
Definition
1896- Lemuel Dorrance, Marshall Tucker
Term
How much cheaper are generics, on average, than the brand name?
Definition
$50 cheaper
Term
Do generic drugs have the same active and inactive ingredients as the brand name?
Definition
Same active (within 3-4% strength), possibly different inactive ingredients

Why they look different
Term
What is the FDA Orange Book rating code?
Definition
Ratings whether two drugs are therapeutically equivalent

first letter A=Therapeutic equivalence
first letter B=Not therapeutic equivalent
AB=bioequivalent
Term
Define authorized generic
Definition
An actual brand-name drug product relabeled and marketed under a generic brand name, about 50% of generics sold. Look exactly the same as the brand.
Term
How do generics benefit pharmacists?
Definition
The amount of pharmacy profit allowed by the insurer goes up, and patients are happier with your service
Term
Define DAW code
Definition
Dispense As Written

What you would enter in the computer if dispensing a brand name when a generic is available. The code tells why.
Term
What are common confusions in dispensing generic drugs?
Definition
1. Different forms of generics are available that all have same brand name (ex. extended vs sustained release Wellbutrin)

2. Multiple brand and generics are available but only some are equivalent
Term
What are the requirements for internship licensure?
Definition
1. 50 hours of passing college credit
2. Enrollment in accredited pharmacy college
3. Expires after 5 years
Term
What are the requirements for licensure examination?
Definition
1,500 hours (within program of college of pharmacy)
Term
What are the requirements for intern license display?
Definition
Must be conspicuously displayed in every location. Do not copy the license.
Term
What is the format of a DEA number?
Definition
Two letters followed by 7 numbers
Term
How do you verify a DEA number?
Definition
A) Add first, third, and fifth number
B) Add second, fourth, and sixth and multiply by 2
C) Add (A) and (B) and the last digit of this sum will equal the seventh digit
Term
What are the three types of dispensing containers?
Definition
Vials (capsules/tablets), ovals (liquid), ointment jars
Term
For this class, how many grams in 1 ounce?
Definition
30g=1oz
Term
For this class, how many grams in one pound?
Definition
480g=1 lb
Term
For this class, how many mL in one fluid ounce?
Definition
30mL=1oz
Term
For this class, how many mL in one Tbsp?
Definition
15mL=1Tbsp
Term
For this class, how many mg in 1 grain?
Definition
60mg=1gr
Term
For this class, how many pounds in 1 kg?
Definition
2.2lb=1kg
Term
What information is under "Description" on a package insert?
Definition
Chemical name, structure, dosage form, how to take, inactive ingredients
Term
What information is under "Clinical pharmacology" on a package insert?
Definition
Pharmacology (how absorbed, distributed, metabolized, excreted- ADME)
Term
What information is under "Indications and usage" on a package insert?
Definition
Just like it sounds, the approved indications for the drug
Term
What information is under "Contraindications" on a package insert?
Definition
Situations where drug should NOT be used (ex. allergies, kidney failure)
Term
What information is under "Warnings" on a package insert?
Definition
Serious side effects, black box warnings (doctors still prescribe, risk vs benefit)
Term
What information is under "Precautions" on a package insert?
Definition
Ex. take with food, do not take with alcohol (best place to learn about medicine safety)
Term
List the cautions on a package insert in order from most serious to least serious
Definition
Contraindications, warnings, precautions

(CWP- careful with pills!)
Term
What information is under "Adverse reactions" on a package insert?
Definition
All side effects ever observed. Like the "warning section" but more detailed
Term
What information is under "Overdose" on a package insert?
Definition
Says both danger and suggests antidote/treatment
Term
What information is under "Dosage and Administration" on a package insert?
Definition
Just like it sounds, recommended dosages
Term
What information is under "How supplied" on a package insert?
Definition
Storage information, what the medicine physically looks like
Term
What are three non-required components on a package insert?
Definition
Animal pharmacology/toxicity, clinical studies, references
Term
For this class, how many ounces in one pound?
Definition
16oz=1 lb
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