Week 5 HW

A key responsibility when dispensing controlled substances is maintaining accurate:

dispensing records

Protected health info (PHI) includes any health info that could reasonably identify a patient

True

Sales of products containing ephedrine and pseudoephedrine are restricted to reduce:

ilicit methamphetamine production

T or F: HIPAA is a federal law that governs the privacy of protected health info.

True

Food and Drugs Act

Outlaws tainted and mislabeled drugs

Food, Drug, Cosmetic Act

Requires drugs to be proven safe prior to marketing

Durham-Humphrey Amendment

Defines drugs that cannot be used safely without medical supervision

Kefauver-Harris Drug Amendments

Requires manufacturers to prove drugs are effective prior to marketing

Tamper-Resistant Packaging Regulations

Makes it a crime to tamper with packaged products and requires tamper-proof packaging

Hatch-Waxman Act

Allowed FDA to approve generic versions of brand name drugs without repeating research to prove safety and efficacy

Combat Methamphetamine Epidemic Act

Limits retail sale of pseudoephedrine to “behind the pharmacy counter”

Sherley Amendment

Outlaws labeling drugs with fake medical claims meant to trick the buyer

Generic substitution allows a pharmacist to:

dispense a therapeutically equivalent drug

Pharmacy technicians support patient privacy by:

discarding patient info in a secure manner

All of the following statements concerning pharamcy technicians and their scope of practice are true except

licensed pharm techs must perform tasks with the supervision of a pahramcist

A legend drug is a drug that requires a prescription to be dispensed

true

All of the following statements about the sale of pseudoephedrine products are true except:

The Combat Methamphetamine Epidemic Act of 2005 excludes common cough, cold, and allergy combination products

state prescription drug monitoring programs (PDMPs) are designed primaryl to

identify potential diversion and abuse of controlled substances

HIPAA allows the use and disclosure of protected health info for dispensing prescriptions, patient treatment, billing for pharmacy services, and managing patient care

True

Which of the following statements about brand name and generic drugs is true?

1. ) Generic manufactureres need to demonstrate bioequivalence to the brand name.

2. ) Generic drugs must look identical to brand name drug

3. Research must be repeated to show that the generic drug is safe and effective

4. Generic manufactureres have different manufacturing, quality, and labeling standards than brand name manufactureres

Controlled substances are schedules based on potential for abuse or addiction and therapeutic use

True