511 - Pharm Law - Exam Ii - Preparation Of The Prescription

Front 1

Define: "Drug Product Equivalent"

Back 1

A drug product that is designated the therapeutic equivalent of another drug product by the FDA

Front 2

What does the term "No substitutions" mean when written on the face of a prescription?

Back 2

The drug product cannot be substituted and must be filled as written

Front 3

True or False

When a prescription contains "N.S." the pharmacist is not legally allowed to substitute the drug in question

Back 3

True

Front 4

What does the term "pedigree" mean?

Back 4

Established and managed by a wholesale distributor, a pedigree tracks the path of each drug once it leaves the normal distribution channel.

This is to ensure that drugs that reach patients are not counterfeit in nature.

Front 5

What is required information for a pedigree?

Back 5

1) Name, address, phone number and, if available, e-mail of each recipient or distributor
2) Name and address of each facility from which the drug was distributed if different from above
3) Date of each distribution
4) Certification that each recipient has authenticated the pedigree
5) Name, dose, size/number of containers, lot number and name of manufacturer for each prescription drug

Front 6

How quickly must a pedigree be made available for a law enforcement officer?

Back 6

7 days

Front 7

How long must pedigree's be maintained?

Back 7

3 years

Front 8

True or False

Drugs to be purchased for sale and dispensing at a pharmacist must be purchased by the pharmacist

Back 8

True

Front 9

How many technicians can a pharmacist supervise?

Back 9

Max of 4

Front 10

How many interns can a pharmacist supervise?

Back 10

Max of 1

Front 11

What type of employees are not considered "pharmacy technicians" per state law?

Back 11

Those in ancillary positions such as:

- Clerks
- Secretaries
- Cashiers
- Delivery Persons

Front 12

True or False

A pharmacy technician can accept an oral refill renewal from a prescriber, provided there are no changes to the order

Back 12

True

Front 13

True or False

A pharmacy technician can participate in final drug utilization reviews and make independent therapeutic alternate drug selections if allowed by the pharmacist

Back 13

False

Front 14

True or False

A pharmacy technician can transfer the final prescription to the patient without consulting with the pharmacist

Back 14

False - The pharmacist has to first provide a patient consult before the transfer can be complete

Front 15

List the circumstances in which a drug product may be returned to the pharmacy

Back 15

1) When it is from an inpatient health care facility, in original containers and is not adulterated or misbranded
2) It was dispensed in error, defective, adulterated, misbranded or dispensed beyond its BUD
3) Harm could come to the pt or public
4) Item is prepackaged, is unopened and contents are not adulterated
5) From a secured institutional pt or resident health pt in which they (has multiple requirements found on another card)

Front 16

What is required for a pharmacy to take back a drug from a secured institutional patient or a resident health care patient

Back 16

1) Item was never in possession of patient
2) Item is in tamper resistant package, contains a beyond use date and lot number
3) Items are not mixed with other health items, unless it is to be repackaged and redispensed to same patient
4) Item is in original container and not adulterated or misbranded

Front 17

Define: "Automated Dispensing System"

Back 17

A mechanical system that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing or distribution of medications, and which collects, controls, and maintains all transaction information

Front 18

True or False

Baker cells and accumed machines are considered automated dispensing systems

Back 18

False - They are considered counting machines

Front 19

What is the managing pharmacist responsible for pertaining to automated dispensing systems?

Back 19

1) That it is in good working order and accurate
2) Implements an ongoing quality assurance program
3) Provides the PEB with written notice of installation or removal of system
4) Assigning, discontinuing or changing personnel access to the system
5) Assuring that access to the medications comply with state and federal laws
6) Assuring the system is stocked accurately and in accordance with established written policies and procedures

Front 20

What is required on the notice to the PEB regarding the installation or removal of an automated dispensing system?

Back 20

1) Name and address of the pharmacy
2) Initial location of the system (can be relocated without notification
3) Identification of the managing pharmacist

Front 21

What documentation is required to be maintained on-site pertaining to an automated dispensing system?

Back 21

1) Name and address of the pharmacy or inpatient health care facility where the system is being used.
2) The system manufacturer's name, model and serial number.
3) Description of how the system is used.
4) Written quality assurance procedures to determine continued appropriate use of the system.
5) Written policies and procedures for system operation, safety, security, accuracy, access and malfunction.

Front 22

What is included in the records kept by the automated dispensing system?

Back 22

1) Time and location of system accessed
2) ID of individual accessing the system
3) Type of transaction
4) Name, strength, dosage form and quantity of the drug accessed
5) Name of the patient for whom the drug was ordered
6) Such additional information as the managing pharmacist may deem necessary

Front 23

How long must records from an automated dispensing system be kept?

Back 23

5 years

Shocking, I know.

Front 24

Define: "Central Fill Pharmacy"

Back 24

A pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription

Front 25

Define: "Originating Pharmacy"

Back 25

A pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order

Front 26

True or False

A central fill pharmacy can only fill prescription for an originating pharmacy if they have the same owner

Back 26

False - They can have a legal contract in place outlining services as well

Front 27

True or False

When a central fill pharmacy fills a prescription, it has the name and address of the originating pharmacy printed on the label

Back 27

True

Front 28

True or False

Central fill pharmacies are not responsible for patient consultations

Back 28

True

Front 29

What is "The Orange Book"?

Back 29

Maintained by the FDA, this book lists therapeutically equivalent drugs and their associated classifications

Front 30

What does the letter A mean in the Orange Book?

Back 30

This means the drug in question is considered therapeutically equivalent (or bioequivalent)

Front 31

What does the letter B mean in the Orange Book?

Back 31

The drug in question is NOT bioequivalent

Front 32

What does the rating AB mean in the Orange Book?

Back 32

There were problems with the equivalency of the drug, but they have seen been resolved

Front 33

True or False

A pharmacist can never dispense a B-rated generic drug to a patient

Back 33

False - It can be dispensed, provided it is disclosed to the patient and physican

Front 34

True or False

A "returned" drug product can not be dispensed to another patient

Back 34

True