Term
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Definition
| the Rx symbol, means "take vow" |
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Term
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Definition
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Term
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Definition
The dosage form and number of units (ex. 30 capsules or 5 ounces)
Historically was how to make it |
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Term
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Definition
| The directions on how to take the medicine |
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Term
| What drug often uses grains as its unit? |
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Definition
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Term
| Define dram for this class |
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Definition
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Term
| Define ounce for this class in terms of mL |
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Definition
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Term
| List the five things a prescription is required to have |
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Definition
1. Patient Name
2. Date
3. Drug name, dosage, strength
4. Sig
5. Dr's name and address |
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Term
| What does a controlled substance prescription need to have that normal ones do not? |
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Definition
1. Patient's address
2. Dr's DEA number and signature if not called in
3. Initials of pharmacist and date dispensed |
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Term
| Where does the patient's ID information go when filling a prescription? |
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Definition
| OBNDD to the PMP (prescription monitoring program) |
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Term
| Can controlled substances be called in? |
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Definition
CIII-v can, but not CII
(and of course not CI) |
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Term
| Can a pharmacist edit a prescription (adding a DEA# or give a generic instead, for example)? |
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Definition
| Yes, but it must be documented on the back of the precription |
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Term
| What can a pharmacist add to a prescription without prescriber confirmation? |
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Definition
1. Patient age/address
2. Prescriber DEA
3. Generic drug name, if used |
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Term
| What can a pharmacist add/change to a prescription with prescriber confirmation? |
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Definition
1. Drug strength
2. Drug quantity
3. Directions for use
4. Dosage form
5. Whether it is compounded |
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Term
| When do non-controlled substances prescription refills expire? |
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Definition
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Term
| When do CIII-CV substances prescription refills expire? |
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Definition
| 6 months from date, cannot be refilled more than 5 times |
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Term
| When do CII substances prescription refills expire? |
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Definition
| 30 days from date written, cannot be refilled |
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Term
| Are refills required on a prescription label? |
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Definition
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Term
| How long does it take a new drug to go to market? |
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Definition
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Term
| How much does it cost to develop a new drug? How many recoup the loss? |
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Definition
$500mil-2bil
Only 1/3 recoup development cost |
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Term
| How many new drug compounds reach the market? |
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Definition
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Term
| What are the 7 steps of drug development? |
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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 |
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Term
| Describe step 1 of drug development, Lab Research |
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Definition
| Identification of biological target and identification of chemical compound (by use of assays, computer simulations, microorganisms) |
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Term
| Describe step 2 of drug development, Animal Studies |
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Definition
Typically 2 or more species, rodent and a non-rodent
ADME: Absorption, distribution, metabolism, and excretion studies |
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Term
| Describe step 3 of drug development, IND |
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Definition
| FDA determines if it is safe to be an Investigational New Drug based on Animal Pharmacology, Manufacturing Plan, and Clinical Protocols planned |
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Term
| Describe step 4 of drug development, Human Clinical Trials |
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Definition
| 3 phases with increasing numbers, repetitive reports to FDA |
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Term
| Describe step 5 of drug development, NDA |
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Definition
| New Drug Application sent to FDA, several hundred thousand pages of data, documentations, and manufacturing plans |
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Term
| Describe step 6 of drug development, FDA Review/Approval |
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Definition
Takes about a year
Review of NDA, package insert, manufacturing plant |
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Term
| Describe step 7 of drug development, Market/Post-Marketing |
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Definition
| Additional studies, MedWatch, possible Blackbox warning/Patient Medication guides/Drug withdrawal |
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Term
| Describe phase 1 of a Human Clinical Trial |
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Definition
| 6-9 months long, emphasis on safety, healthy small group (<100) checking side effects, metabolism, and excretion |
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Term
| Describe phase 2 of a Human Clinical Trial |
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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 |
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Term
| Describe phase 3 of a Human Clinical Trial |
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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) |
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Term
| What 5 names does a drug have? |
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Definition
1. Empirical formula
2. Chemical name
3. Investigational name
4. Generic name
5. Brand name |
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Term
| Why do all drugs have a generic name but there is not always a generic available to the patient? |
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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 |
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Term
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Definition
| A 10 digit code for drug identification used to prevent mistakes and file insurance claims |
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Term
| What does the first segment on an NDC refer to? |
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Definition
| Labeler (Manufacturer or distributor) |
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Term
| What does the second segment on an NDC refer to? |
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Definition
| Product (Strength, dosage form, and formulation) |
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Term
| What does the third segment on an NDC refer to? |
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Definition
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Term
| What form is the NDC for an insurance claim? |
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Definition
| 5-4-2, add a zero in front of the segment needed to match this form |
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Term
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Definition
| Illegal, highest abuse potential, no medical use |
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Term
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Definition
| High abuse potential, may cause withdrawal, but has an accepted medical use |
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Term
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Definition
| Of increasingly less abuse potential but still controlled |
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Term
| When did pharmacies become a separate entity from other practitioners? |
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Definition
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Term
| When was the first Pharmacopeia of the US published? |
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Definition
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Term
| What was the first college of pharmacy in the US? |
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Definition
| Philadelphia College of Pharmacy |
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Term
| What was two reasons why the Philadelphia College of Pharmacy was founded? |
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Definition
1. Deterioration of the practice of pharmacy
2. Discriminatory classification by school medical faculty |
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Term
| Who was the Father of American Pharmacy? |
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Definition
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Term
| What was the primary problem with the profession of pharmacy from 1900-1950s? |
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Definition
| Surgeon general refused to recognize pharmacy as a profession, just seen as shopkeepers |
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Term
| What was the purpose of the Asheville Project |
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Definition
| Gave pharmacy a new image, mid 1990s, started patient counseling |
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Term
| What was the most important recognition of pharmacy in the 1970s? |
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Definition
| 1974- clinical role for pharmacist recognized by government |
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Term
| What year did Pharm D programs become supported by all major pharmacy organizations? |
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Definition
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Term
| Who were the first two graduates of OU Pharmacy and when did they graduate? |
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Definition
| 1896- Lemuel Dorrance, Marshall Tucker |
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Term
| How much cheaper are generics, on average, than the brand name? |
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Definition
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Term
| Do generic drugs have the same active and inactive ingredients as the brand name? |
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Definition
Same active (within 3-4% strength), possibly different inactive ingredients
Why they look different |
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Term
| What is the FDA Orange Book rating code? |
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Definition
Ratings whether two drugs are therapeutically equivalent
first letter A=Therapeutic equivalence
first letter B=Not therapeutic equivalent
AB=bioequivalent |
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Term
| Define authorized generic |
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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. |
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Term
| How do generics benefit pharmacists? |
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Definition
| The amount of pharmacy profit allowed by the insurer goes up, and patients are happier with your service |
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Term
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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. |
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Term
| What are common confusions in dispensing generic drugs? |
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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 |
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Term
| What are the requirements for internship licensure? |
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Definition
1. 50 hours of passing college credit
2. Enrollment in accredited pharmacy college
3. Expires after 5 years |
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Term
| What are the requirements for licensure examination? |
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Definition
| 1,500 hours (within program of college of pharmacy) |
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Term
| What are the requirements for intern license display? |
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Definition
| Must be conspicuously displayed in every location. Do not copy the license. |
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Term
| What is the format of a DEA number? |
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Definition
| Two letters followed by 7 numbers |
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Term
| How do you verify a DEA number? |
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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 |
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Term
| What are the three types of dispensing containers? |
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Definition
| Vials (capsules/tablets), ovals (liquid), ointment jars |
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Term
| For this class, how many grams in 1 ounce? |
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Definition
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Term
| For this class, how many grams in one pound? |
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Definition
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Term
| For this class, how many mL in one fluid ounce? |
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Definition
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Term
| For this class, how many mL in one Tbsp? |
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Definition
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Term
| For this class, how many mg in 1 grain? |
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Definition
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Term
| For this class, how many pounds in 1 kg? |
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Definition
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Term
| What information is under "Description" on a package insert? |
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Definition
| Chemical name, structure, dosage form, how to take, inactive ingredients |
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Term
| What information is under "Clinical pharmacology" on a package insert? |
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Definition
| Pharmacology (how absorbed, distributed, metabolized, excreted- ADME) |
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Term
| What information is under "Indications and usage" on a package insert? |
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Definition
| Just like it sounds, the approved indications for the drug |
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Term
| What information is under "Contraindications" on a package insert? |
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Definition
| Situations where drug should NOT be used (ex. allergies, kidney failure) |
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Term
| What information is under "Warnings" on a package insert? |
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Definition
| Serious side effects, black box warnings (doctors still prescribe, risk vs benefit) |
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Term
| What information is under "Precautions" on a package insert? |
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Definition
| Ex. take with food, do not take with alcohol (best place to learn about medicine safety) |
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Term
| List the cautions on a package insert in order from most serious to least serious |
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Definition
Contraindications, warnings, precautions
(CWP- careful with pills!) |
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Term
| What information is under "Adverse reactions" on a package insert? |
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Definition
| All side effects ever observed. Like the "warning section" but more detailed |
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Term
| What information is under "Overdose" on a package insert? |
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Definition
| Says both danger and suggests antidote/treatment |
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Term
| What information is under "Dosage and Administration" on a package insert? |
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Definition
| Just like it sounds, recommended dosages |
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Term
| What information is under "How supplied" on a package insert? |
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Definition
| Storage information, what the medicine physically looks like |
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Term
| What are three non-required components on a package insert? |
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Definition
| Animal pharmacology/toxicity, clinical studies, references |
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Term
| For this class, how many ounces in one pound? |
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Definition
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