Pharmacy Law Exam- Maintaining Drug Security & Integrity

1.

1 point

According to Nebraska law, how long do records of the destruction of controlled substances need to be maintained?

10 years

2 years

1 years

5 years

2.

1 point

According to federal law, a pharmacy discontinuing business must notify the DEA office at least ____ days in advance of the date on which the planned transfer will occur.

14

21

30

7

3.

1 point

How often do you need to unlock & lock a securely locked... cabinet?

Before and after each business day

Before and after each prescription

4.

1 point

APAP elixir found to be contaminated with yeast is what class of recall?

Class III

Class II

Class I

5.

1 point

An immunosuppressant drug prescribed for inpatient use may be accepted by a participant according to the Immunosuppressant Drug Repository Program Act.

True

False

6.

1 point

Any pharmacy in Nebraska may accept cancer drug returns.

True

False

7.

1 point

Halved tablets or other broken dosage forms can be returned from a long-term care facility.

True

False

8.

1 point

According to Nebraska law, the destruction of liquid controlled substances containing 50 mL or less needs to be witnessed by two individuals credentialed under the Uniform Credentialing Act.

True

False

9.

1 point

Who is responsible for all hazards of contamination or adulteration that may arise, should he/she mix returned portions of drugs to his/her shelf stocks?

Patient

Physician

Pharmacy technician

Pharmacist

10.

1 point

According the Nebraska law, the PIC of a pharmacy discontinuing business must do the following within 15 days of closing:

Sale or other disposition of legend drug, device or biological inventory

Location of all patient records including prescription files

Sale or disposition of controlled substances and controlled substances invoices and inventory records

Notify the patients that they will need to seek service elsewhere

11.

1 point

A pharmacists may charge a fee for collecting dispensed drugs or devices for disposal or from a long-term care facility.

True

False

12.

1 point

An immunosuppressant drug donated under the program shall not be resold.

True

False

13.

1 point

A Class I recall is the most serious.

True

False

14.

1 point

Which DEA form needs to be filled out if the theft or significant loss of controlled substances occurs?

Form 41

Form 222

Form 224

Form 106

15.

1 point

Health care professionals are required to report adverse reactions via MedWatch or the SAERS program.

True

False

16.

1 point

A tight container protects the contents from extraneous solids and from loss of the article.

True

False

17.

1 point

According to Federal and Nebraska law, a non-legend drug for OTC use may NOT be returned by patients.

False

True

Neither law addresses this issue

18.

1 point

Drugs, devices and biologicals can be stored in the same compartment of a refrigerator with food.

True

False

19.

1 point

There is a limit on the number of doses of immunosuppressant agents a participant can accept according to the Immunosuppressant Drug Repository Program Act.

True

False

20.

1 point

What is considered a COOL temperature storage condition?

20 to 25 C

2 to 8 C

8 to 15 C

> 8 C

21.

1 point

The calculated expiration date means the expiration date on the manufacturer's, packager's, or distributor's container or one year from the date the drug or device is repackaged, whichever is later.

True

False

22.

1 point

It is required by federal and Nebraska law to keep a perpetual record-keeping system for all Schedule II controlled substances.

True

False

23.

1 point

Under the Cancer Drug Repository Program Act, an injectable cancer drug may be accepted if it DOES have temperature requirements.

True

False

24.

1 point

According to Nebraska law, where must products containing ephedrine be stored?

Behind a counter or in a locked cabinet

In the prescription department

On the regular store shelves

25.

1 point

In Nebraska, a pharmacy can accept the return of unit-dose packages which are repackaged for a 30-day supply.

True

False

26.

1 point

According to Nebraska law, a copy of the DEA form required for theft or significant lost of controlled substances must be sent to:

Nebraska Department of Health and Human Services, Division of Public Health

Nebraska Pharmacy Inspector

Diversion Captain at the NE State Patrol Headquarters

Division of Investigation of the NE Department of Health and Human Services

DEA Office

27.

1 point

Which types of reports are the FDA seeking via MedWatch and the SAERS program?

Any serious event

Product quality issues

Any serious event associated with drug, biologic, medical device or dietary supplement

Therapeutic failures

Any serious event associated with drug, biologic, or medical device

Use errors

28.

1 point

What schedule(s) of controlled substances are required to be stored in a securely locked, substantially constructed cabinet?

I

II

II, III, IV, V

I, II, III, IV, V

29.

1 point

What are the exceptions to accepting a return from a long-term care facility?

No controlled substances may be returned

Dispensed drug must be in the original and unopened labeled container

Pharmacists must accept the return if it means the packaging system standards.

Unit dose container must be impermeable to moisture and approved by the Board of Pharmacy to be returned

30.

1 point

Which DEA form is used to document the destruction of controlled substances?

Form 224

Form 222

Form 225

Form 41

31.

1 point

APhA and the FDA do NOT agree on how to dispose of non-controlled drugs.

True

False

32.

1 point

A prescription filled and NOT picked up by the patient can be returned to stock as long as lot numbers and expiration dates are not mixed in your inventory.

True

False

33.

1 point

A Class II recall apply to products that are not likely to cause adverse health consequences.

True

False