Misc Flashcards
If a physician wishes to dispense drugs that are available from local pharmacies-do they need a pharmacy license?
Yes-most likely ‘practitioners of the healing arts to sell CS” license lol
Does a physician planning to dispense medications from multiple offices need to obtain a dispensing license from each location?
No-just one
What is a limited use license?
Essentially for physicians office dispensing-waiver for square footage requirement and security system (as long as no more than 5 different topical drugs are intended for use)
What must be on physician dispensed label?
-name/address of office and patient
-date
-drug name/strength
-dosage units
A prescriber can add brand medically necessary phrase printed on Rx pad. True or false
True
Must nonresident pharmacies submit inspection reports?
yes-basically submit its respective state board inspection
If two drugs are therapeutic equivalents then they are also xxx equivalent:
Pharmaceutical and bioequivalent
FDA Class I Recall
-Reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
-immediately remove meds from inventory
-identify patients who received and contact
-advise they return for disposal
FDA class II recall
-may cause temporary or medically reversible ADR
Class III Recall
Not likely to cause ADR
What type of program may be an RN or LPN act as pharmacy tech?
opioid treatment program provided that all take home medication doses are verified by pharmacist.
-they also may be allowed to be in the pharmacy when pharmacist not there
What information must be on methadone take home dose from opioid treatment program?
-opioid program’s name
-program address/phone number
-patient name
-medication name
-physician name
-dispensing date
if liquid, dose and directions for use as single dose
only applies to methadone
How long do you have to tell patients about HIPAA breach?
60 days preferably via mail
also suggested to post on website for 90 days with phone number for them to call to find out if their information was shared
if more than 500 people affected, must tell media and HHS
SItuations HPI can be released
-if patient has written authorization
-HHS is undergoing investigation
VAERS can be reported only by HCP
false-anyone can report
VIS Requirements
-must be administered prior to administration
-must indicate in EMR the date and edition of VIS
*also name/address/title of who gave vaccine/date/manu/lot
What is your responsibility if dispensing a biosimilar?
-inform the patient prior to dispensing
-note on record and label name of product
-write SUBSTITUTED FOR
In a hospital setting when provider gives verbal for CII, how long do they have to sign physical order?
72 hours
In a hospital setting when provider gives verbal for CII, how long do they have to sign physical order?
72 hours
For unit dose dispensing system, what is required on unit dose label?
Drug name
Strength
Lot
Expiration date
How long must after hours pharmacy records be kept?
1 year
Includes date, patient name, drug info, how many doses taken, RN name
How does pharmacy notify pts of changed hours?
Sign-14 days in advance
If RN has after hours access to hospital pharmacy what must be recorded?
-date
-patient name
-drug info
-amount removed
-RN signature
SAVE FOR 1 YR
How often do pharmacies need to report to continuous quality programs?
Monthly, keep records for 12 months
How often must pharmD do review of drug therapy in LTCF
Monthly
Emergency drug kits in LTCF-how long do they have to return to pharmacy? How long does prescriber have to sign Rx?
72 hours for both
When does a nursing home need to get a CS registration?
If they are using any CS from automated dispensing system UNLESS they are solely drugs that would kept in a stat drug box/emergency
What must be on hospital unit delivery record?
Must be kept for CS at minimum.
Date, drug name/strength, quantity, unit, signature of pharmD and receiving RN
-any records of admin are kept and returned to pharmacy within 3 months
If you are doing bulk compounding, reconstituting INJ, or repackaging drugs you must keep records for how long
control records for a period of 1 year or until expiration, whatever is sooner
If a dispensing error occurs, how quickly must it be documented
72 hrs
Analysis by PIC performed within 30 days
