Dispensing Requirements Flashcards

1
Q

CLIA protocol (Test and Treat COVID, UTI, Flu, etc) age limit?

A

Must be 18 years or older

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2
Q

How many times can CIII-V be transferred?

A

Once but chains can transfer up to maximum refills

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3
Q

CS transfers can be communicated between interns orally. True or false?

A

False

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4
Q

CII-V how long to report to PMP?

A

24 hours or next business day (whichever comes later)

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5
Q

Can tech enter PMP?

A

Yes! But every pharmacist must register.

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6
Q

Can you disclose PMP info to patient?

A

No

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7
Q

Automated counting/dispensing systems expiration dispensing

A

Dispense lot expiring soonest.

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8
Q

What must automated counting/dispensing systems maintain in records?

A

-Bin filling record
-lot number
-fill date
-exp date
-pharmd verificaiton

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9
Q

Label requirements for dispensed drugs

A

-name/address of pharmacy
-date of filling
-name of pt
-name of prescriber
-sig
-rx number
-drug name/quantity/strength

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10
Q

Can compounding drugs be kept ‘for office use’?

A

No

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11
Q

How long do you have to return opened pharmacy kits to pharmacy?

A

72 hrs

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12
Q

Define adulteration

A

Purity, quality or strength issues

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13
Q

Define misbranding

A

Misleading labeling or label lacking required information

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14
Q

Can hospitals have samples?

A

Yes but prescribers must dispense to patients and physician must place order in writing for themselves

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15
Q

What % can pharmacy distribute without having to register as distributor?

A

5% of gross annual drug sales

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16
Q

OTC Label Requirements (in order)

A

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

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17
Q

Wording for dietary supplements

A

Can: health claims, structure/function claims, nutrient
Cannot: treat, prevent, alleviate

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18
Q

Repackaged OTC products are subject to FD&C act. True or false?

A

True

19
Q

Max pseudoephedrine without Rx

A

3.6 g per day or 9 g per 30 days

20
Q

Storage of pseudoephedrine

A

Behind counter or locked in cabinet inaccessible to public

21
Q

What must you bring to buy Sudafed?

A

Government issued photo ID and sign that they understand limits and penalties

22
Q

What happens if you don’t keep Sudafed records for 2 years?

A

Class 1 misdemeanor

23
Q

CS Scripts Must be electronic unless

A

-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
-

24
Q

Vet Rx CS Stipulations

A

-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

25
Q

In the setting of drugs repackaged with automated counting device, what is the protocol in setting of drug recall?

A

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

26
Q

How many days supply can be given via unit dose dispensing system in hospitals/LTCFs?

A

7 days if licensed; 72 hours f unlicensed

27
Q

How long must hospital EMS kit records be kept?

A

1 year; except for CS which is 2 years

28
Q

Can you repackage already dispensed medications from a different pharmacy?

A

Yes if patient at LTCF to put into unit dose. Must keep records

29
Q

How many doses allowed per blister for ephedrine products?

A

2

30
Q

Recordkeeping requirements for ephedrine products

A

-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

31
Q

Rules for having an emergency kit with CS in non DEA registered LTCF:

A

-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

32
Q

How long does a pharmacy have to inform patient of HIPAA breach?

A

60 days

33
Q

What is difference between restricted and non restricted manufacturer?

A

-non restricted can do rx drugs
-restricted only non rx and can make gas for medical use

34
Q

PMP reporting requirements

A

-pt name and address and dob
-CS quantity
-date of dispense
-prescriber and pharm ID number
-method of payment

35
Q

FDA can require a medication guide in which of the following scenarios

A

-will prevent ADRs
-drug has serious risks which patient should be aware of
-adherence is crucial

36
Q

A hard-copy prescription must be written in ink, or individually typed/printed (true or false)

A

true

37
Q

pharmacist may not provide refills on C-II through C-V controlled substances without the prescriber’s authorization (true or false)

A

true

38
Q

What are exceptions to 1 medication rx per prescription?

A

-hospitalized pt
-LTCF
-hospice
-home infusion
-govt organizations such as jails, DOH, etc.

39
Q

What are exceptions to physicians offices needing to obtain a dispensing license from BOP?

A

-dispense manufacturer samples
-medical emergency
-when pharmaceutical services are not available

40
Q

Emergency kits in LTCF-can a CS be dispensed without prescription?

A

No BUT you can give verbal!!!

41
Q

CSOS can be used for CII only. True or false?

A

False-can be used for CII-V

42
Q

If you deny to fill a written rx, what must you write on back?

A

“Declined”
Name/address/telephone number of the pharmacy
Date
Signature

43
Q

Return to stock drug exp date

A

1 year from dispense or manufacturer date, whatever is earlier