SSA Questions Flashcards

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1
Q

When a pharmacy site WITHIN TN opens what needs to be done, referring to site licenses?

A

ex: Pharmacy practice site, manufacturer, wholesaler, outsourcing facility, oxygen supplier

-need to submit application 30 days before opening

-need an inspection before opening

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2
Q

What does a practice site OUTSIDE of TN seeking for site licensure in TN need to have?

A

-current license from where they are located
-the pharmacist in charge is licensed in TN
-access to a pharmacist by a toll-free phone

-records of Rx dispensed to patients in TN
-must comply with counseling, profiling, and review requirements of TN (even if your site is not in TN)

-if engaged in sterile products: need sterile prep modifier registration (except for wholesaler)

-if compounding: need to provide evidence of inspection performed within the last 12 months wherever you are located

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3
Q

What must the recipient of a transfer Rx record?
***

A

-name, address, and original serial number from the original pharmacy
-name of the transferor
-all information constituting an order (all info that you need to have on an original Rx)
->pharmacist initial, date, and record the amount that was dispensed
->Serial number

-DEA number if it is a controlled substance

-transferee (receiver pharmacist) informs the patients that the original Rx has been canceled from the pharmacy from which it was obtained

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4
Q

What are the standards of the Pharmacy Department?

A

what a pharmacy need to have

-consultation area offering sufficient privacy to the patient
-Area not less than 180 square feet
-physical barrier preventing access and pilferage (theft)
-access restricted to pharmacist, interns and techs (and others allowed by PIC, even a manager (not pharmacist cant be there w/o the PIC allows it)

-in in a larger establishment (like grocery store):
->need to be open during the same time as the larger store unless the pharmacy can be closed from floor to ceiling
->need to be under supervision of the pharmacist at all time (if the pharmacist goes to the bathroom, they have to close the pharmacy - not seen in practice)

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5
Q

What are the requirements for electronic orders?
Can an E-Rx date be used as the original?

A

-only from a prescriber (or agent, nurse) to the pharmacist or an area in a pharmacy under direct supervision of the pharmacist

-has to include:
Prescriber phone (to verify the Rx)
Date and time
Pharmacy name
electronic signature (+ agent signature if they send it)

-the electronic data is considered the original

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6
Q

What should be on a Dispensing label in TN, based on the Rules of the Board?
OUTPATIENT

A

-Name, address, phone of pharmacy
-Prescriber name
-Patient name
-Serial number
-Name of product

-Directions
-Advisory label

-Original date and refill date
-Expiration date

-make accommodations for visually impaired patients
-rules don’t apply to institutional/LTC pharmacies
-applies to assisted-living facilities (since the patient is in possession of the drug)

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7
Q

Repackaging inpatient setting

A

when packaging into a unit dose container need:

-Name, strength, drug quantity
-Manufactures Name, Lot or control number
-expiration date
-advisory label

-may assign a batch number that contains all the info when scanned (bv ot enough space on the container)

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8
Q

What needs to be documented when using a controlled substance from a floor stock?

A

Drug:
Name, strength, and dosage form

Administered: date, time, and quantity/dose

ID: patient, prescriber, and personnel who is administering

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9
Q

What should be on the record of destructed controlled drugs in an institutional setting?

A

-Drug: name, strength, dosage form, and quantity
-Destruction: date, method, and ID of witness
-ID of the patient
-kept for 2 years

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10
Q

What needs to be on the label of radioactive drugs?

!!! ***

A

-in addition to the requirements of non-radioactive drugs
-labeled on the immediate outer container

-Standard radiation symbol
-“Caution – Radioactive Material”
-Radionuclide
-Chemical Form
-Amount of radioactive material, in millicuries or microcuries
-Volume, if liquid
-Calibration time (the time when the drug was calibrated)
-Expiration time (usual short half-lives)
-Pharmacy name, address, telephone number

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11
Q

What should be on the label of the immediate container of a radioactive drug?

!!! ***

A

-the immediate container may be the syringe that is kept in the lead shield

-Standard radiation symbol
-“Caution – Radioactive Material”
-Drug name
-Rx order number

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12
Q

What equipment is required in a nuclear pharmacy?

A

-Vertical laminar flow hood
-Dose calibrator
-Refrigerator
-Room Monitor
-Portable survey monitor (measures radioactivity in the room)
-Scintillation counter (measures radioactivity)
-Microscope
-Other BRH required equipment

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13
Q

What training information for sterile compounding needs to be recorded?

A

-Person being trained
-Date of training or eval
-Description of topics covered
-Signature of trainer/evaluator and PIC/designee

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14
Q

What needs to be on the label of a sterile compounded product?

OUTPATIENT

A

-Patient name
-Prescriber name
-Pharmacy name, address, phone
-Directions for use

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15
Q

What needs to be on the label of a sterile compounded product?
***
ALL labels ???

A

-Healthcare entity name (in place of patient name)
-Pharmacist ID
-Intern/tech ID if applicable
-Name of drug added
-Amount of drug added
-Expiration time/BUD
-Date of compounding
-Appropriate auxiliary label(s)

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16
Q

What should be on the label of dispensed hazardous drugs?
***

A

a distinctive warning label and caution statement

17
Q

What must a manufacturer and a sterile manufacturer provide to the Board?
***
Dont need to memorize

A

manufacturer:
-results of the FDA inspection
-proof of FDA registration

sterile manufacturer:
-current products manufactured, wholesale, distributed
-provide sterility potency testing contacts (report who is doing the testing)

18
Q

Patient identifier
***

A

-patient’s full name
-address including zip code
-date of birth
-SSN or alternative identification number (see below)

19
Q

What are the alternative identification numbers?
***

A

-driving license number
-Telephone number

->if they dont have them: 000-00-0000
->if they refuse to provide them: 999-99-9999

-if someone is picking it up for the patient use the same order:
SSN -> DLN -> phone number, 000-00-0000 -> 999-99-9999

20
Q

What must be provided to the patient when dispensing hormonal contraceptives under a CPA?

A

TDH self-screening risk assessment tool

-review the assessment tool with the patient
-dispense the med
-counsel
-provide PPI (patient package info and CMI (consumer medication info)
-tell the patient to see PCP
-provide a list of PCPs

-repeat after 12 months

21
Q

What are the factors that make a drug an OTC product?
***
!!!

A

-the patient has to be able to self-diagnose
-self-treat
-self-monitor/manage

The Label has to be
-easy to read
-easy to understand
-of minimum size font

22
Q

What must be in the Drug Facts Panel?
***
!!!

A

-active ingredient
-inactive ingredients

-purpose
-use (indication)

-warnings
-direction

-other pertinent information/miscellaneous: storage etc.
-contact of the manufacturer (if there are Questions?)

23
Q

Professional OTC labeling
***

A

-Additional labeling specifically for healthcare professionals
-FDA doesn’t allow it on OTC labeling
-does not contain adequate direction of use

-OTC products used for the specific condition that was diagnosed by the doctor (not self-treated anymore -> doesn’t meet the criteria of OTC)

-pharmacist should not provide it to patients unless requested

24
Q

What are the 3 ways to switch from Rx to OTC based on the Durham Humphrey Amendment?
***

A

-the manufacturer requests the switch by submitting a NDA (new drug application) or SNDA (supplemental new drug application) - MOST OFTEN

-the manufacturer or other parties (anyone) can request through a citizen petition

-FDA may add or amend an OTC monograph