EXCPT EXAM

Pure Food and Drug Act (1906)

Prohibits interstate commerce of misbranded and adulterated drugs and foods.

Misbranded

a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading

Adulterated

a drug product that fails to meet quality, strength, or purity standards

Federal Food, Drug, and Cosmetic Act of 1938

Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application before marketing them.

This act essentially created the FDA and started a new system of drug regulation.

If the FDA does not take any action within 60 days, the drug is automatically approved. (Note: the Kefauver-Harris Amendment of 1962 invalidated this aspect of the Act.)

Durham-Humphrey Amendment of 1951

defines two categories for drug products: legend drugs (prescription-only) and OTC medication

Kefauver-Harris Amendment of 1962

requires drug manufacturers to scientifically prove a medication is not only save but effective

Controlled substances act (CSA) (1970)

federal drug policy that regulates the manufacture, importation, possession, use and distribution of controlled substances

controlled substances have 5 schedules

I , II, III, IV, V

drugs are places in their prespectivee schedules based on

medical use and potential for abuse or dependence

legend drugs

only dispensed with a proper prescription

Schedule I drugs

Have high potential for abuse with no accepted medical use

Schedule II drugs

- Drugs have high potential for abuse

- Drugs have currently accepted medical uses

Schedule II drugs examples

Most ADHD medications (Adderall, Ritalin, methamphetamines)

oxycodone, codeine, morphine, methylphenidate

Schedule III Substances

moderate to low potential for physical dependence but potential for psychological dependence

Schedule IV Controlled Substances (anxiety, sleep)

lower potential for abuse but can still lead to addiction.

EX) benzo's, carisoprodol, tramadol, and zolpidem

Schedule V

Lowest potential for abuse

cough, nerve pain

Non-controlled prescription drugs

expire one year after date written

C-II

no refills, new prescription needed for each fill

C-III - IV drugs

5 refills or refills for up to six months from date issuance- whichever comes first

C-II partial fill

remainder must be filled within 72 hours

C-II cannot be transferred

True

C-III-V transferred

one time between two pharmacies

Drugs need to be stored at room temp of

20 to 25 C

68 to 77 F

Macrolide allergy cannot take

Azithromycin

Medication for cough

antitussive

Medication for pain

analgesics

Brand sertraline

Zoloft

Brand metoprolol

Lopressor, Toprol XL

Suspension

small particles that don't dissolve

Elixer

contains alcohol warning drowsiness

Emulsion

mix of two that dont mix oil and water

Not required on repackaged unit doses

NDC

Omeprazole (PPI)

prilosec

Esomeprazole (PPI)

Nexium

Proton Pump Inhibitor

A specific type of medication that reduces stomach acid

anticouagulant

Warfarin, eliquis, herparin, xarelto

DEA Form 222

Order form for CI and CII substances. Must be kept for 2 years.

DEA Form 41

reporting distruction

DEA form 104

Reporting pharmacy closure or surrender of pharmacy permit

DEA form 106

report of theft or loss of controlled substances

DEA form 224

Application for New Registration

1 gram

1000 milligrams

30 ml

1 oz

15 mL

1 tablespoon

5 mL

1 teaspoon

What drug does not require special handling

Medrol

What counteracts antipsychotic meds

Benzotropine

When does a Laminar Flow Hood should be cleaned?

beginning of each shift

TJC (The Joint Commission)

organization that establishes "standards of Care in hospitals & long term care

Angiotensin II Antagonist

avapro, cozaar, diovan (NOT Beta blockers)

subcutaneous- under the skin

45 degree angle

Intramuscular (IM)

90 degree angle entrance

Uses 20 to 23 gauge needles

What type of Balance weighs less than 120 grams

Class A

Intradermal (ID)

10-15 degree angle

Each individual unit dose package must contain

drug name and strength, expiration date, and lot number

Celoxib brand name

Celebrex

Simvastatin

Zocor

Atorvastatin

Lipitor

Rosuvastatin

Crestor

Refrigeration storage

36 to 46 F (2 to 8 C)

ac

before meals

pc

after meals

APAP

Acetaminophen (Tylenol)

Benadryl

diphenhydramine (antihistamine)

What drug agency requires access to safety data sheets when handling chemotherapy medications?

OSHA (occupational safety and health administration)

A patient presents to the pharmacy that she recently lose her job. Which of the following provides temporary insurance coverage?

COBRA

What OTC can increase blood pressure?

pseudoephedrine

prevents blood clots

Anticoagulant

tall man lettering

Uppercase letters used within a drug name to highlight differences between look-alike drug names

Buccal

cheek/gum

Furosemide is used for

congestive heart failure, pulmonary edema, hypertension

auxillary label for reconstituted medication is ?

shake well

auxillary label for ciprofloxican

?????????

controlled medication with no medical use

schedule I

ss

half

os

left eye

od

right eye

ou

both eyes

ad

right ear

au

both ears

as

left ear

pr

rectally

ophthalmic

eye

Otic

ear

tamper-resistant

Packaged to make it clear whether the product has been opened since packaged

tamper-resistant prescriptions

CMS requires all written prescriptions must meet requirements

- one or more features to prevent unauthorized copying

-one or more features to prevent erasure or modification

-one or more features to prevent the use of counterfeit prescription forms

NSAIDs

anti-inflammatory drugs: pain, fever, inflammation

ibuprofen, naproxen, diclofenac (voltaren)

Narcan

Counteracts Morphine - opioid narcotics.

black box warning

A type of warning that appears in a drug's prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug.

betadine

A brand of povidone-iodine solution used as an antiseptic

Antiviral

Acyclovir (Zovirax)

Vertical laminar flow hood

Used to prepare chemotherapy drugs

Maxalt (Rizatriptan)

anti migraine meds

DEA

responsible for enforcing the controlled substance act

Potentiation

one drug that enhances or prolongs the effects of another drug

sildenifil and nitroglycerin both increase blood flow leading to severe hypotension

unit dose package

drug name, strength, expiration date, and lot number

ACE inhibitors should not be taken with

Potassium Diuretics

A drug that dose not require blood work

sulfasalazine

vitamin deficiency causes rickets

vitamin d

Inventory for Controlled Substance's is performed ?

every 2 years