Module 1 Big Test

Pure Food and Drug Act

-Enforced by USDA

-Disclosure of certain dangerous/ addictive ingredients

-additional federal protections were needed

-Concerned with drug PURITY and correct labeling

Federal Food, Drug, and Cosmetic Act

-Enforced by FDA

-Medications being SAFE and pure

-Medications must be approved before being sold

-Expanded FDA authority

Duram-Humphrey Amendment

-Enforced by FDA

-All products must have adequate instructions for use

-Permitted prescriptions to be written/ called in from the doctor

-Distinction between OTC and Rx

-"Caution: Federal law prohibits dispensing without a prescription" or "Rx Only"

Kefauver-Harris Amendment

-Enforced by the FDA

-Manufacturers provide proof of the purity, safety, and effectiveness of their drugs before approval

-Clinical research + Informed consent

-Proof of EFFECTIVENESS

Controlled Substances Act

-Enforced by DEA

-Established 5 schedules

-Requires use of DEA numbers

-Controlled substance regulations

Poison Prevention Packaging Act

-Enforced by CPSC

-Child resistant packaging for many meds

-Certain meds and packaging are exempt

-Protect children from poisoning, doesn't mean childPROOF

Drug Listing Act and NDC

-Enforced by the FDA

-Drug listing requirements associated with the nation drug code

-Medications assigned with 10 digit ID (NDC)

OBRA '90

-Enforced by state/federal government

-Pharmacists to keep records of all medications used by medicaid patients

-Pharmacists counsel all patients

-Drug utilization review

-Helps identify medication related problems before dispensing

Anabolic steroid control act

-Enforced by DEA

-Classified anabolic steroids as schedule 3 (C-3) under federal law

-Regulations related to registration, security, labeling, packaging, inventory, etc.

-To minimize misuse of anabolic steroids

Medicare Modernization Act

-Enforced by CMS

-Medication therapy management (MTM)

-Medicare Part D prescription drug coverage

-Provides prescription drug coverage through approved private plans

Combat Methamphetamine Epidemic Act

-Enforced by DEA

-Sales must be documented in a log book or approved electronic system

-Purchases require ID

-Regulates sales of certain products including, ephedrine, pseudoephedrine

Drug Supply Chain Security Act

-Enforced by the FDA

-Report to the FDA any illegitimate or adultered drug that are discovered in the supply chain

-Preventing counterfeit, stolen, contaminated, or recalled drug products from

-Track and Trace

-Prevent certain drugs from entering the marker

FDA Amendments Act and REMS

-Enforced by FDA

-Risk evaluation and mitigation strategies

-Manage risks with certain medications

-ex. istretinoin (iPledge program)

-Some REMS programs require additional steps before a medication can be dispensed

FDA

-Food and Drug Administration

-Approves new Rx and OTC meds

-issues boxed warning

-Oversees drug recalls and medwatch

-Drug labeling, effectiveness, safety, quality

-Evaluates vaccine safety

DEA

- Drug enforcement administration

- Controlled substance act

- controlled substance schedule (C-I - C-V)

-DEA numbers

-record keeping, diversion

State board of pharmacy

-Oversees practice of pharmacy in each state

-licenses state pharmacies and professionals

-Can revoke suspend or place license on probation

-Determines scope of practice

-Investigate complaints

NABP

-National Association of Boards of pharmacy

-NAPLEX

-Supports state boards

-Offers programs to support safe pharmacy

-Prove accreditation

USP

-United States pharmacopeia

-standard setting organization

-OTC and Rx standards

USP-NF Chapter 795

Non sterile Compounding

USP-NF Chapter 797

Sterile Compounding

USP-NF Chapter 800

Hazardous drug handling

TJC

-The Joint Commision

-Non-profit

-Accredits health care organizations

-Focus on patient safety

ISMP

-Institution for Safe medication practices

-Non-profit

-Entire mission is to prevent medication errors

-Has a list of error prone abbreviations to avoid

CMS

-Centers for medicare and medicaid

-Assigns NPI

-Federal agency under US HHP

-Medicare and medicaid

-HIPAA guidelines

OSHA

-Occupational safety and health administration

-Federal agency

-Makes sure work places are safe

Orange Book

-Therapuetic equivalence

-Rated by safety, effectiveness, bioequivalence

-ALL pharmacies must have a copy

-think "oranges to oranges"

Red book

-Think "blood money"

- All about average costs of medications.

Bioequivalence

When two drugs work the same way at delivering a medication in the bloodstream. For example, Aripriprazole is Abilify because they work in the same fashion.

Bioavailability

The amount of the active ingredient enetering in the bloodstream.

USP-NF

-Sterile compounding standards

-list of standards set by USP

Handbook of non prescription Drugs

-injectables

-helpful for patients

-lists safety and effectiveness along with guides for administration/dosing

Physicians desk reference

-Brand/generic information with color photos

-Over 4,000 Rx and OTC medication with colored photos

-info on use, class, safety and interactions

Lexicomp online, AHFS-PI, MicroMedX

-Interactions and dosing

-Encyclopedia of medivations

-comparing groups or individual drugs by dosing, interactions, warnings, indications, etc.

Manufacturer package insert

-Written by manufacturer

-gives pharmacist all the info that can't fit on the label or bottle

-indications, Contraindications, warnings, dosage, administration

-required in all prescription medications

Patient Package Insert

-Manufacturer w/ FDA approval

-Required for some meds, for example Oral contraceptives

-Lot of similar info as MPI, but in less medical terms for the patient to understand

FDA Medication Guide

-FDA

-Requires these for certain drug types that have serious AE

-They help patients make decisions about the medications and prevent adverse effects

In window/ Drop-off

-New prescriptions

-Technician greets patients

-Free of signs, displays

Out window/pickup

-Completing sales transactions

-Patient signs forms/checks etc.

-Kept uncluttered to write forms/checks

Counseling area

-Pharmacists counsel patients

-protecting patient privacy

-Out of way to allow the counseling to be private

To-be entered section

-Holds prescription forms

-Patients picking up prescriptions

-Organized by wait time

To be filled section

-rack or filing system

-prepared by pick up time

-Place patients in the store ahead of scheduled ahead

Staging section

-Label, Oh Rx order, Stock bottles of med to dispense

-Keep it organized

-Only one med at a time

-near dispensing area

Data entry Area

-next to in window

-technician enters patient profile

-To be entered, to be filled and staging

Dispensing Area

-Counting, pouring and packaging meds

-Clean off trays using isopropyl alchohol between meds

-Avoid contamination

Pickup Area

-Finished prescriptions in basket/bin

-organized by patient last name

-Out window

Administration area

-paperwork

-pharmacy techs check in orders from suppliers

Compounding area/ clean room

-Sterile products prepared

-compounding non sterile products

-Sterile

What do we use to clean counting trays?

Isopropyl alcohol

Pharmacodynamics

What medications do to the body

Pharmacokinetics

What a body does to the drug (ADME)

Can a technician order DME?

Yes

DME

Durable medication equipment

What does ADM help with?

Safety, Reduce labor costs, inventory

Can a pharmacy tech explain how to use a medication?

No only a RPh

Can a pharmacy tech verify?

No only a RPh

Can a pharmacy technician administer immunizations?

Depends on state

(If yes or no question, select No.)

Clecoin Info

Clindamycin, Lincosamide ABX, treats bacterial infections (acne). Patients must take with a full glass of water to prevent C difficile associated diarrhea and colitis.

Aspirin important warning

-Dont use in children .... Reyes syndrome

ADME stands for....

Absorption, Distribution, Metabolism, Excretion