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34 Cards in this Set

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Define: "Drug Product Equivalent"
A drug product that is designated the therapeutic equivalent of another drug product by the FDA
What does the term "No substitutions" mean when written on the face of a prescription?
The drug product cannot be substituted and must be filled as written
True or False

When a prescription contains "N.S." the pharmacist is not legally allowed to substitute the drug in question
True
What does the term "pedigree" mean?
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.
What is required information for a pedigree?
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
How quickly must a pedigree be made available for a law enforcement officer?
7 days
How long must pedigree's be maintained?
3 years
True or False

Drugs to be purchased for sale and dispensing at a pharmacist must be purchased by the pharmacist
True
How many technicians can a pharmacist supervise?
Max of 4
How many interns can a pharmacist supervise?
Max of 1
What type of employees are not considered "pharmacy technicians" per state law?
Those in ancillary positions such as:

- Clerks
- Secretaries
- Cashiers
- Delivery Persons
True or False

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

A pharmacy technician can transfer the final prescription to the patient without consulting with the pharmacist
False - The pharmacist has to first provide a patient consult before the transfer can be complete
List the circumstances in which a drug product may be returned to the pharmacy
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)
What is required for a pharmacy to take back a drug from a secured institutional patient or a resident health care patient
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
Define: "Automated Dispensing System"
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
True or False

Baker cells and accumed machines are considered automated dispensing systems
False - They are considered counting machines
What is the managing pharmacist responsible for pertaining to automated dispensing systems?
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
What is required on the notice to the PEB regarding the installation or removal of an automated dispensing system?
1) Name and address of the pharmacy
2) Initial location of the system (can be relocated without notification
3) Identification of the managing pharmacist
What documentation is required to be maintained on-site pertaining to an automated dispensing system?
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.
What is included in the records kept by the automated dispensing system?
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
How long must records from an automated dispensing system be kept?
5 years

Shocking, I know.
Define: "Central Fill Pharmacy"
A pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription
Define: "Originating Pharmacy"
A pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order
True or False

A central fill pharmacy can only fill prescription for an originating pharmacy if they have the same owner
False - They can have a legal contract in place outlining services as well
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
True
True or False

Central fill pharmacies are not responsible for patient consultations
True
What is "The Orange Book"?
Maintained by the FDA, this book lists therapeutically equivalent drugs and their associated classifications
What does the letter A mean in the Orange Book?
This means the drug in question is considered therapeutically equivalent (or bioequivalent)
What does the letter B mean in the Orange Book?
The drug in question is NOT bioequivalent
What does the rating AB mean in the Orange Book?
There were problems with the equivalency of the drug, but they have seen been resolved
True or False

A pharmacist can never dispense a B-rated generic drug to a patient
False - It can be dispensed, provided it is disclosed to the patient and physican
True or False

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