PTCB - Practice Test Questions (Federal Requirements)

Which of these recalls would be issues by the Food and Drug Administration (FDA) for a medication that was deemed to cause temporary adverse health effects for patients that used that medication?

Class II - Recall

class II recall

Occurs when medication may cause temporary adverse health effects that are reversible if there is a small risk of serious adverse effects

class I recall

Occurs when a medication is likely to cause severe adverse effects or even death

class III recall

Occurs when a medication is not likely to cause a patient to have adverse effects

class IV recall

does not exist

How many classes of FDA recalls are there?

three (3)

What is are acceptable ways to store prescription records?

2 files: (CII) and (non-controlled + CIII-V)

2 files: (CII-V) and (non-controlled)

3 files: (CII) and (CIII-CV) and (non-controled)

What is the appropriate form to use to order controlled substances from a pharmacy supplier?

DEA 222 form

What form is used to register a retail pharmacy with the DEA?

DEA 224 form

What form is used to report the lost or theft of controlled substances?

DEA 106 form

What form is used to describe the destruction of controlled substances?

DEA 41 form

What letter at the beginning of a DEA number is used for specialists rather than practioners?

C

What digit has to be at the end of a DEA number for it to be considered valid?

6

How do you figure out if a DEA number is valid?

Step 1: Add the first, third, and fifth numbers together (2+6+8=16)

Step 2: Add the second, fourth, and sixth numbers together (4+7+9=20)

Step 3: Multiple the sum In the second step by 2 (20*2=40)

Step 4: Add the total from steps 1 and 3 together (40+16=56)

How long do prescription records need to be retained onsite by a pharmacy?

2 to 5 years, depending on the state

Under the Medicare Modernization Act of 2003, how long are prescriptions for medicare require to be retained?

10 years

According to the Combat Methamphetamine Epidemic Act of 2005 (CMEA), what is the maximum amount of pseudoephedrine a customer can purchase in a 30-day period?

9 grams

How much pseudoephedrine can a customer purchase at one time?

3.6 grams

Which of these is always true regarding Schedule II controlled substances?

-CII drugs must be ordered using a hand written DEA 22 2 form

-CII medications can be destroyed only if a DEA agent is present

-Once received, CII medications cannot be returned to the supplier

-The pharmacist in charge must verify and document the date received on all received CII medications

The pharmacist in charge must verify and document the date received on all received CII medications

How can CII medications be ordered?

with a hand-written DEA 222 form or through the Controlled Substance Ordering System (CSOS)

Is the DEA 222 form required when using an electronic system to order?

no

What needs to be documented on all transferred prescriptions for a prescription for a controlled substance (CIII-V)?

The DEA number of the transferring pharmacy

What must all transfered controlled substance prescriptions contain?

-original prescription date and dispensing date

-number of refills remaining

-the name of the transferring pharmacist

-the DEA number, name, and address of the transferring pharmacy

When purchasing products containing pseudoephedrine, what needs to be documented in the logbook (hand-written or electronic)?

the total amount of pseudoephedrine purchased

According to the CMEA of 2005, what does the logbook need to contain?

-personal information of the person purchasing the product and quantity

-strength

-date

-time of the product sale

Which of these sets the standards for keeping pharmacy employees safe while completing tasks associated with pharmacy practice?

-the Pharmacy Practice Act (PPA)

-USP (795)

-the Occupational Safety and Health Administration (OSHA)

-the Health Insurance Portability and Accountability Act (HIPPAA)

the occupational Safety and Health Administration (OSHA)

What does HIPAA relate to?

patient confidentiality

What does USP 795 focus on?

non-sterile compounding

What is the Pharmacy Practice Act (PPA)?

it governs the practice of pharmacy

Occupational Safety and Health Administration (OSHA)

standards to protect employees who work with hazardous materials. It also outlines the proper personal protective equipment needed in various pharmacy practice settings such as compounding

What is the most appropriate source of instructions on the proper way to store and handle a hazardous substance?

Safety Data Sheets (SDS)

Safety Data Sheets (SDS)

outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product. They are specific for the product listed

Which of these is true regarding the disposal of hazardous drug waste?

-it must be completely disposed of within 48 hours

-it must be store in a leakproof container

-it must be labeled "drug waste"

-it must be stored with other drug waste until disposed of properly

it must be stored in a leakproof container

Disposal of hazardous waste must be separate from the disposal of other waste, and the waste must be labeled as "hazardous drug waste." It also needs to be stored in a leakproof container that is labeled as such until disposed of safely. There is no specific time limit on when hazardous waste must be discarded as long as it is stored properly.

When a state pharmacy law and federal pharmacy law conflict, which law should be followed?

The more strict law

What is the maximum number of refills that is allowed on a Schedule III-V controlled substance prescription?

5

a controlled substance in the schedules of III-V is allowed a maximum of 5 refills, within 6 months of the date of issue

All of the following are common reasons for a medication recall except ____.

-the presence of impurities

-product mislabeling

-contamination

-expensive cost of medication

-expensive cost of medication

What is the acronym for the online controlled substance ordering platform that has largely replaced the traditional paper format?

Controlled Substance Ordering System (CSOS)

Which of the following medication is is a Schedule II controlled substance?

-Alprazolam (Xanax)

-Fentanyl (Duragesic)

-Zolpidem (Ambien)

-Buprenorphine (Butrans)

Fentanyl (Duragesic)

alprazolam & zolpidem are Schedule IV, while Buprenorphine is Schedule III

The Combat Methamphetamine Epidemic Act of 2005 places restrictions on the sale, storage, and record requirement of all of the following medications, except ____.

-phenylephrine

-ephedrine

-phenylproanolamine

-pseudoephedrine

phenylephrine

What category of controlled substance schedules carries the highest risk of abuse, misuse, and addiction?

Schedule II