Pharmacy Technician Certification Exam

Front 1

What is the Pure Food and Drug Act of 1906?

Back 1

A law to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs.

Front 2

Food, Drug, and Cosmetic Act of 1938 (FDCA 1938)

Back 2

The U.S. Food and Drug Administration (FDA) created under FDCA 1938 requiring all new drug applications be filed with the FDA.
-Clearly defines adulteration and misbranding of drugs and food products.

Front 3

What is the Durham-Humphrey Act of 1951?

Back 3

Requires all products to have adequate directions for use unless they contain the federal legend "Federal law prohibits dispensing without a prescription."
-Separates drugs into legend and nonlegend (OTC)
-OTC drugs do not require a legend, but a legend drug does.
-Prescription medications require the supervision of the physician.
-Allows verbal prescriptions over the telephone.
-Allows refills to be called in from a physician's office.

Front 4

What is the Kefauver-Harris Amendment of 1962?

Back 4

Requires all medications in the U.S. to be pure, safe, and effective.

Front 5

What is the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Back 5

-Creation of the Drug Enforcement Agency (DEA) under the supervision of the Department of Justice.
-Controlled substances are placed in one of five schedules (categories) based on a potential for abuse and accepted medical use in the U.S.

Front 6

What is a Schedule I drug?

Back 6

-No medical use
-Extremely high potential for abuse.
Ex: Cocaine, methamphetamine, Ecstasy, Hashish, Heroin, LSD, Mescaline, "Roofies"

Front 7

What is a Schedule II drug?

Back 7

-Has medical use but high abuse potential with severe psychological or physical dependency.
-Ex: Adderall, Codeine, Dilaudid, Morphine Sulfate, Ritalin

Front 8

What is a Schedule III drug?

Back 8

-Has accepted medical use
-Abuse potential less than Schedule I & II drugs.

Front 9

What is a Schedule IV drug?

Back 9

-Abuse potential less than Schedule III drugs, but may lead to limited psychological or physical dependence.

Front 10

What is a Schedule V drug?

Back 10

-Abuse potential less than Schedule IV drugs.
-Includes exempt narcotics.

Front 11

What is the Drug Enforcement Agency Registration?

Back 11

-Every facility that dispenses controlled substances must be registered with the DEA.
-Registration is done by submitting a DEA Form 224. This must be renewed every 3 years.

Front 12

Ordering and Receipt of Schedule II drugs

Back 12

Schedule II drugs are ordered by filling out a DEA form 222.
This form must be signed by the individual in whose name the DEA registration is listed.
-DEA Form 222 valid only for 60 days.
-This form must be completed with a typewriter, pen, or indelible pencil.
-A maximum of 10 different items per form and only one item per line is permitted.
-The number of packages must be recorded and the form must be dated and signed by the pharmacist.
-The invoice, in addition to the completed DEA Form 222, must be retained in a secure location in the pharmacy for a min. of 2 years.

Front 13

How may Schedule III, IV, and V drugs be ordered?

Back 13

In any method (written, faxed, or verbal)

Front 14

What procedures must be followed after receipt of Schedule III to V drugs?

Back 14

The invoice or packing slip must be dated, signed, and stamped with a red C, and retained in a secure location in the pharmacy for a min. of two years.

Front 15

How long do DEA records need to be maintained?

Back 15

A minimum of two years and they must be "readily retrievable."
-They must be provided to a DEA rep. within 72 hours after request.

Front 16

How long do defective forms need to be kept?

Back 16

2 years and be readily retrievable

Front 17

What is the initial inventory?

Back 17

The initial inventory is a complete and accurate inventory of all the controlled substances before the opening of the first day of business for a pharmacy.

Front 18

What is a biennial inventory?

Back 18

A biennial inventory is taken every two years after the initial inventory is taken.
-An exact count of Schedule II drugs is taken and an estimate of Schedule III to V drugs.
-Records must be kept for a minimum of 2 years.

Front 19

What is a perpetual inventory?

Back 19

A perpetual inventory shows controlled substances received by the facility, supplied to other locations, returned to the pharmacy, and dispensed to patients.
-It shows the actual number of units of a drug at a particular moment in time.

Front 20

What requirement is necessary before a pharmacy is able to return controlled substances?

Back 20

They must be registered with the DEA.
-The DEA Form 222 is the official doc. for the transfer of Schedule II meds.
-Controlled substances cannot be returned from long-term care facilities because these facilities do not have a DEA number.

Front 21

What procedure must be followed for the destruction of outdated or damaged controlled substances?

Back 21

A DEA Form 41 must be submitted to the DEA, indicating the name, strength, and quantities of controlled substances, the date of destruction, method of destruction, and the witnesses present for the destruction.
-A retail pharmacy may submit one DEA Form 41 per year.

Front 22

What procedure must be followed in the case of the theft of a control substance?

Back 22

-The pharmacy must notify the nearest DEA diversion office, notify local police, and complete a DEA Form 106.
-The original copy of the DEA Form 106 must be sent to the DEA office and the pharmacy must retain one for its records.

Front 23

Filling of Schedule II Drug Prescriptions

Back 23

For Schedule II drugs, prescription can either be handwritten or computer generated but must be signed in ink by the physician with no allowable refills.
-A partial filling is allowed if the remaining quantity is available to the patient within 72 hours.
-A new prescription must be issued by the prescriber if additional quantities are to be provided after 72 hours.
-The pharmacist should notify the physician if the balance cannot be provided to the patient.

Front 24

Under what circumstances can an oral prescription be issued to a pharmacy?

Back 24

1. The pharmacist must make a good attempt to identify the physician.
2. The prescription is limited to a quantity to treat the patient during this period.
3. The pharmacist must convert the order into writing.
4. The physician must write a prescription for this emergency quantity and the pharmacy must receive it within 7 days of the oral order.

Front 25

Can a pharmacy accept a faxed Schedule II drug prescription for patients in a long-term care facility?

Back 25

Yes, the pharmacy may accept this.
-A partial filling of Schedule II prescriptions for residents in a long-term care facility or patients diagnosed with a terminal illness is permitted. These prescriptions may be filled partially for up to 60 days from the date of issue of the prescription, unless the prescription is discontinued sooner.
-A notation must be made on the prescription such as "long-term care facility patient" or "terminally ill patient."

Front 26

Filling of Schedule III to V drugs

Back 26

-A prescription may be handwritten or computer generated but it must be signed by the physician in ink.
-The physician's office may telephone or may fax one, depending on the state law.
-A patient may receive up to five refills within 6 months of the date the prescription was written if authorized.
-Partial fillings are permitted as long as refills are indicated on the prescription.
-Refills do not exceed the total quantity prescribed by the physician.
-No partial filling occurs after 6 months of the original date of the prescription.

Front 27

Exempt Narcotics

Back 27

Certain cough and antidiarrheal prescription items can be purchased by an individual, if permitted by state law.
-The quantity must not exceed the quantity established by the law and the purchaser must be 18 years old.
-The purchaser must complete the Exempt Narcotic Book with the date purchased, name of purchaser, address of purchaser, name of product, and quantity purchased, price of transaction, and pharmacist's signature.
-There is a limit of one container in a 48-hour period.