PCTB Exam

Cream

Oil-in-water emulsion

Ointment

water-in-oil exmulsion

micropump

a system of 5,000 to 10,000 microparticles contained within a tablet or capsule; each microparticle is released in the stomach and is able to deliver a drug over an extended period of time

solution

a homogenous liquid dosage form containing one or more solutes dissolved in a solvent

suspension

A dispersion containing an insoluble solid in a liquid

-azepam

Benzodiazepine anxiolytic (temazepam)

-pidem

Sedative/Hypnotic (zolpidem)

-plon

nonbenzodiazepine anxiolytic (zaleplon)

-bactam

beta-lactamase

cef-

Cephalosporins

-cillin

penicillins

-conazole

Miconazole-type antifungal

-cycline

Tetracyclines

-ezolid

oxazolidone antibiotics

-oxacin

quinolones

-vir

antivirals

-mycin

macrolides

-arone

Antiarrhythmics (amiodarone)

-azosin

prazosin-type antihypertensive (terazosin)

-dralazine

Hydrazine-phthalazine-type antihypertensive

-olol

beta blocker

-pril

ACE inhibitor

-sartan

Angiotensin II Receptor Antagonist

-teplase

plasminogen activator

-vastatin

antihyperlipidemics

-astine

H1 receptor (Azelastine)

-onide

Corticosteroid (Budesonide)

-formin

hypoglycemic (metformin)

-glinide

Meglitinide (repaglinide)

-gliptin

dipeptidyl peptidase-4 inhibitor (saxagliptin)

-glitazone

Thiazolidene derivative (rosiglitazone)

-prazole

Antiulcer (omeprazole)

-setron

Serotonin (5-HT3) antagonist (ondansetron)

-tidine

H2 receptor antagonists/acid neutralzer (famotidine)

-ac

anti-inflammatory agents/acetic acid (diclofenac)

-caine

local anesthetic (lidocaine)

-coxib

cox 2 inhibitor (celecoxib)

-dronate

Biphosphonates (alendronate)

-icam

antiinflammatory/ isoxicam type (meloxicam)

-ast

antiasthmatics/antiallergics (montelukast)

-(a)tadine

H1 receptor antagonists (loratadine derivatives)/(loratidine)

-terol

Bronchodilator (albuterol)

-afil

PDE inhibitor (sildanifil)

-steride

testosterone reductase inhibitor (dutasteride)

Which act:

-prohibits interstate commerce of misbranded and adultered drugs, foods, drinks

-focus on purity, not safety

-did not protect false therapeutic claims

-legislation did not require manufacture labels to list ingredients, directions, warnings, or safety

Pure Food and Drug Act of 1906

Which act:

-was hastened in 1937 due to 1000 deaths from sulfa-based elixirs

-required drug labeling to include directions, warnings, and safety

- provides mandates for premarketing approval of all drugs

Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938

Prescription Drug Label requirements:

-highlights

-limitations statement

-product name and initial FDA approval date

-boxed warning

-recent major changes

-indications and usage

-dosage and administration

-dosage form and strength

-contra.

-warnings and precautions

-adverse reactions

-drug interactions

-use in specialized pop.

-patient counseling info.

What is an adultered product?

a drug that fails to conform to compendial standards of quality, strength, or purity

The form that allows pharmacies to dispense controlled substances

DEA 224 form

The form that renews the ability to dispense controlled substances

DEA 224a form

The form to order schedule 2 drugs

DEA form 222

Which copy of DEA form 222 should the pharmacy keep?

copy 3

Which copy of DEA form 222 is kept by the supplier?

copy 1

which copy of DEA form 222 is fowarded to DEA?

copy 2

How long should schedule II drugs be maintained?

2 years

How long should schedule 3,4,5 be maintained?

2 years

Can schedule II's be ordered over the phone?

NO

Can schedule 3 and 4 be ordered over the phone?

YES

How do you calculate a DEA number?

example: AB1234563

-add 1st, 3rd, and 5th

-then add 2nd, 4th, and 6th. multiply by 2

-add the sum of lines 1 and 2

-The last digit in the DEA should be the same # as last # in answer

Do you use DEA #'s for non-controlled prescriptions?

NO

How many times can schedule 3/4 drugs be refilled?

5 times within 6 months

What does the pharmacist write on the transfer prescription?

-original date of prescription

-# of refills

-original dispensing date

-# of refills remaining

-name, address, and DEA #

- receiving pharmacist name

-name, address, and DEA # of pharmacy where prescription was originally filled

Form to return control substances

DEA 222

Form to destroy outdated or damaged controlled substances

DEA 41

upon theft of a medication, the pharmacy must notify the DEA and local police department and fill out:

DEA form 106

what law made childproof containers?

Poison Prevention Packaging Act (PPPA) of 1970

What is the Omnibus Budget Reconciliation Act (OBRA) of 1990?

This imposes counseling obligations, check DUR, and record keeping mandates on pharmacists

Does the state target Medicaid patients for OBRA 1990?

Yes it is targeted, but it is also required for non-medicaid patients.

What does HIPAA stand for?

Health Insurance Portability and Accountability Act

What is the Isotretinoin safety and risk management act of 2004?

This implemented iPLEDGE to reduce spontaneous abortions, and fetal abnormalities from accutane

How long is a prescription for Accutane?

-30 days

-must be filled and picked up within 7 day window

What is the sale restriction on Ephedrine, pseudophedrine, and phenylpropanolamine?

3.6g/day and 9g/month

What is a Risk Evaluation and Mitigation Strategy (REMS)?

encourages safe and effective medication use based on teratogenicity, abuse potential, and necessity. FDA may require manufacturers to submit to REMS upon drug approval.

What does OSHA do?

requires employees to be protected hazardous chemicals through hand-washing and the use of personal protective equipment (gowns,gloves, goggles, feet/hair cover, and masks)

When would a person use nonpowdered gloves?

when handling hazardous drugs and waste

When would a person use non-latex gloves?

when preparers or patients are allergic to latex

How should counting trays and spatulas be disinfected?

with 70% isopropyl alcohol

What is a Class I recall?

-involves violative products that are likely to cause serious adverse health consequences or death

-EX: label mix-up on a life-saving medication

What is a Class II recall?

-involves violative products that may cause temporary health issues or where the probability of serious adverse health consequences is remote

-EX: the presence of small particles in a medication container

What is a Class III recall?

-involves violative products that are not likely to cause adverse health consequences

-EX: leaking package

What is an FDA market withdrawal?

a withdrawal issued for a product that has a minor violation that would not warrant legal action

what is an FDA medical device safety alert?

A recall that is issued fro a medical device that may present an unreasonable risk of substantial harm

What is the american drug index?

-info on composition, strength, dosage form, schedule, and usage

-immunological info

-charts and comparative info

-drug container and storage requirements

what is a drug facts and comparisons?

comprehensive info on 22,000 Rx and 6,000 OTC products

-drugs are divided by therapeutic or pharm groups

-treatment guidelines

FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

-identifies FDA's approved drug products on the basis of safety and efficacy

-contains therapeutic equivalency evaluations for prescription products

Handbook on Injectable Drugs

-a collection of monographs on commercially available parenteral drugs

-Info on prep,stability, storage, administration, and compatibility

Physician's Desk Reference

-Compilation of medication package inserts providing information on drug mechanisms, drug interactions, contraindications, side effects, and warnings

-Updated annually

-Tablet identifier catalog

Remington's The Science and Practice of Pharmacy

Covers 8 distinct topics, including orientation, pharmaceutics, pharmaceutical chemistry, testing/analysis/control, pharmacokinetics and pharmacodynamics, pharmaceutical and medicinal agents, pharmaceutical manufacturing, and pharmacy practice

United States Pharmacopeia drug information Volume 1 (USP-DI Vol 1) Drug info for health care proffessional

-Label and off-label uses for more than 11,000 drugs

-Drug monographs with info including indication, dosing, dosage form, pharmacology/pharmicokinetics, adverse effects, and patient counseling tips

United States Pharmacopeia... Vol 2

-Presented in layman terms for easy reading

-simplified drug monographs with info on proper drug use, precautions, side effects, and special considerations

United States Pharmacopeia-national Formulary (USP-NF)

-the official compendium of drug info form the US pharmacopeial convention

-presents official monographs of info about drug substances and dosage forms, pharmacuetical ingredients, and drug standards and specifications

What is: The process of mixing and preparing drug components to meet a patient's need

Extemporaneous compounding

What is sterile compounding?

- used for intravenous solutions, parenteral nutrition, ophthalmic formulations,

What is non-sterile compounding?

- used for tablets, capsules, creams, ointments, suspensions, suppositories, transdermal applications, and troches

Would suspensions be sterile or non-sterile compounding?

non-sterile

Who sets standards for product safety and purity?

(USP) United States Pharmacopeial Convention

Disposal of pharmaceutical waste must meet state and federal guidelines according to:

US Environmental Protection Agency

vials should be used no more than ____ hours after the initial needle puncture

6 hours

Would you store an open ampule?

NO

What is the beyond- use date of a multi-dose vial such as insulin injection after opening?

28 days