Dispensing Requirements Flashcards
CLIA protocol (Test and Treat COVID, UTI, Flu, etc) age limit?
Must be 18 years or older
How many times can CIII-V be transferred?
Once but chains can transfer up to maximum refills
CS transfers can be communicated between interns orally. True or false?
False
CII-V how long to report to PMP?
24 hours or next business day (whichever comes later)
Can tech enter PMP?
Yes! But every pharmacist must register.
Can you disclose PMP info to patient?
No
Automated counting/dispensing systems expiration dispensing
Dispense lot expiring soonest.
What must automated counting/dispensing systems maintain in records?
-Bin filling record
-lot number
-fill date
-exp date
-pharmd verificaiton
Label requirements for dispensed drugs
-name/address of pharmacy
-date of filling
-name of pt
-name of prescriber
-sig
-rx number
-drug name/quantity/strength
Can compounding drugs be kept ‘for office use’?
No
How long do you have to return opened pharmacy kits to pharmacy?
72 hrs
Define adulteration
Purity, quality or strength issues
Define misbranding
Misleading labeling or label lacking required information
Can hospitals have samples?
Yes but prescribers must dispense to patients and physician must place order in writing for themselves
What % can pharmacy distribute without having to register as distributor?
5% of gross annual drug sales
OTC Label Requirements (in order)
active ingredients, including amount of active ingredients in each dosage unit
purpose of product
indication
specific warnings
side effects
directions for use
lot number
pregnancy/BF warnings
Questions, call x
inactive ingredients
Wording for dietary supplements
Can: health claims, structure/function claims, nutrient
Cannot: treat, prevent, alleviate
Repackaged OTC products are subject to FD&C act. True or false?
True
Max pseudoephedrine without Rx
3.6 g per day or 9 g per 30 days
Storage of pseudoephedrine
Behind counter or locked in cabinet inaccessible to public
What must you bring to buy Sudafed?
Government issued photo ID and sign that they understand limits and penalties
What happens if you don’t keep Sudafed records for 2 years?
Class 1 misdemeanor
CS Scripts Must be electronic unless
-prescriber is dispensing directly to patient
-prescription is for someone in a hospital, assisted living, nursing home or residential health facility
-receiving services from hospice or outpatient dialysis facility
-electronic difficulties (must write this in medical record)
-dispensed on federal property (must write in medical record)
-vet rx
-research protocol
-
Vet Rx CS Stipulations
-cannot prescribe for human use
-can be written or oral rx
-Rx: date, signature, name address of owner, species of animal, name/address/dea number of prescriber
In the setting of drugs repackaged with automated counting device, what is the protocol in setting of drug recall?
If a lot added in the past 3 months is implicated, all drugs should be removed and not used for patient care. Exceptions include-bin can recognize what needs to be removed, bin is empty
How many days supply can be given via unit dose dispensing system in hospitals/LTCFs?
7 days if licensed; 72 hours f unlicensed
How long must hospital EMS kit records be kept?
1 year; except for CS which is 2 years
Can you repackage already dispensed medications from a different pharmacy?
Yes if patient at LTCF to put into unit dose. Must keep records
How many doses allowed per blister for ephedrine products?
2
Recordkeeping requirements for ephedrine products
-name of purchaser
-address of purchaser
-date/time of sale
-amount of product sold
remember need to present a government issued ID and sign log book
Rules for having an emergency kit with CS in non DEA registered LTCF:
-where they get drugs from is DEA registered
-security safeguards
-LTCF and supplier keep records of CS in kit
-notice that could have state revocation, denial or suspension if these rules are not followed
How long does a pharmacy have to inform patient of HIPAA breach?
60 days
What is difference between restricted and non restricted manufacturer?
-non restricted can do rx drugs
-restricted only non rx and can make gas for medical use
PMP reporting requirements
-pt name and address and dob
-CS quantity
-date of dispense
-prescriber and pharm ID number
-method of payment
FDA can require a medication guide in which of the following scenarios
-will prevent ADRs
-drug has serious risks which patient should be aware of
-adherence is crucial
A hard-copy prescription must be written in ink, or individually typed/printed (true or false)
true
pharmacist may not provide refills on C-II through C-V controlled substances without the prescriber’s authorization (true or false)
true
What are exceptions to 1 medication rx per prescription?
-hospitalized pt
-LTCF
-hospice
-home infusion
-govt organizations such as jails, DOH, etc.
What are exceptions to physicians offices needing to obtain a dispensing license from BOP?
-dispense manufacturer samples
-medical emergency
-when pharmaceutical services are not available
Emergency kits in LTCF-can a CS be dispensed without prescription?
No BUT you can give verbal!!!
CSOS can be used for CII only. True or false?
False-can be used for CII-V
If you deny to fill a written rx, what must you write on back?
“Declined”
Name/address/telephone number of the pharmacy
Date
Signature
Return to stock drug exp date
1 year from dispense or manufacturer date, whatever is earlier
Drugs in compliance packaging must have what on each label
-date/time drugs should be taken
-name of drug within
-MAIN packaging label shall contain all required elements for outpatient prescription label and a physical description of drug
Examples of misbranding
label not having name/place of business of manufacturer, quantity of contents in terms of weight/measure/numerical count, drug name
Delivery of prescription drugs by mail must include what in shipment
-written notice alerting the consumer that under certain circumstances chemical degradation can occur
-toll free number to respond to consumer questions for chemical degradation
Where must prescriptions awaiting delivery be kept?
secured area outside of prescription department, not accessible to the public
If dispensing meds while pharmacist is on duty what records must be kept?
patient name
rx number
date
signature of person receiving
keep records for 1 year
