Louisiana MPJE

Does NOT

LA _____ (does/does not) have a conscious objective law allowing you to refuse to fill a script

5 years; 10 years; 2 years

Prescription Storage:

-FDCA: may be audited for up to ____ years

-Medicare: may be audited for up to ____ years

-LA: most for _____ years after final refill

1. Patient name

2. Prescription # (serial)

3. Date written/dispensed

4. Directions for use

5. Name of Prescriber

6. Name & address of pharmacy

7. Cautionary statements

Prescription Label Requirements * 7 items *

5 years

NDC may be recycled after ___ years of NON-Use

2 years

To follow GMP, FDA inspects manufacturer's facilities usually every ____ years

1. Name & Address of Manufacturer

2. Established name of product

3. 'Net' quantity

4. Weight of each active ingredient

5. Federal legend

6. if not oral, specific route

7. Storage req

8. Control or Lot #

9. Expiration date established by manufacturer

Manufacturers Label Requirements * 9 items *

60 days

Customized patient med-paks are limited to _____ days

1. 14 days

2. 35 days

Non-Sterile Aqueous BUD:

1. Non-Preserved = _____ days & store in fridge

2. Preserved = ____ days

1. 90 days

2. 180 days

Non-Sterile Non-Aqueous BUD:

1. Oral liquids = _____ days

2. Preserved = ____ days

1. 6 months

2. 14 days

3. 30 days

BUD in the Absence of Stability Data:

1. Non-Aqueous liquids = time left or _____ months

2. Aqueous solutions = ____ days at cold temp

3. All others = duration of therapy or max of ____ days

6 years; 24 hours

Transaction Statement (provides tracking or all handlers of the med):

-Must be stored for a minimum of ___ years

-Must be produced within ____ hours when requested

Form 3911

What FDA form is required to be generated if a product is found to be illegitimate? (NOT required if only suspected to be illegitimate)

6 years

HIPPA forms must be kept for ____ years

1. Prescribers name, Licensure designation, address, telephone # (DEA if controlled)

2. Patients name (DEA if controlled)

3. Date prescription issued

4. Name of drug/device, strength/quantity

5. Directions for use

6. Signature of prescriber

7. Refill instructions

Prescription Requirements * 7 items *

1. 4 x 5 inches & printed signature line

2. Prescriber's name, license type, address, telephone number, & DEA if controlled (must be clear which Dr. wrote it, if multiple Dr.'s on script)

3. No more than 4 scripts per page

4. DAW check box

5. Number of refills slot, if any

6. Must have a manual signature (real legal signature)

Physical Prescription Requirements * 6 items *

NO more than close of business the next day *Even for unfilled, non-controlled medications

When does a prescription have to be transferred to another pharmacy upon request of the patient?

-Yes! As long as pt consent for it & prescriber has not noted on RX to NOT adapt it

-Change quantity, dosage form, or add information missing from RX or chart order (note in pt chart)

May a pharmacist alter a script without contacting the prescriber?

-Pharmacist, Intern, or Technician

-Must be written down IMMEDIATELY Pharmacist by enter it directly into the computer

-Must be initialed/signed by person taking it & by pharmacist if not a pharmacist

Who can receive a verbal prescription by phone?

BMN = Brand Medically Necessary

If Dr. wants a brand name and pt has Medicaid/Medicare, Rx must state ________

-Pharmacist/designee must notify prescriber within 5 days of dispensing

-Must include specific product including manufacturer & name of product

-Only notify on future refills if you switch product again

What needs to be done if pharmacist switches products that is a biosimilar?

1 year

How long is a prescription valid for with non-controlled, C-5, medical devices, medical gas, or medical equipment?

-Emergency supply of up to a 30 day supply can be given IF prescriber is unavailable (office closed/hurricane damage *NOT just unable to return calls)

-30 day supply does not apply to multiple dose unit of use containers (1 inhaler = give the full 90 day supply)

If a pt needs a medication, but is out of refills, what can be done?

-NON-controlled: between 2 pharmacy personnel

-Controlled: between 2 pharmacists Record each others DEA #

-Original & transferred scripts kept for 2 years after last refill

What must be done to transfer prescriptions between pharmacies?

Giver: Invalidate script. Record on script: name & address of pharmacy, name of pharmacist giving & taking, date of transfer

Taker: Indicate script is transferred. Record: Full name & address of script, drug name/strength/dosage form/directions for use/script #, Name & address of prescriber, Date of original script/refill #/first date of fill, # of refills left & where & when they occured, Pharmacy's name, address, & rx number

What info must I record when I transfer a NON-controlled script?

90 days

C-2 scripts are valid for _____ days

6 months

C-3 - 4 are valid for ____ months

1. Pharmacy info: name/addresss/telephone #

2. Prescriber name

3. Pharmacist name or initials

4. Prescription info: date dispensed/drug name/drug strength/directions for use/cautionary auxiliary labels/script #

5. Patient name

Prescription Label Requirements * 5 items *

1. Drug name (generic/brand)

2. Dosage form

3. Strength

4. Quantity

5. Name of manufacturer

6. Lot or batch #

7. Date of prepackaging

8. Pharmacist's initials

9. USP date of expiration

Prepackaged Drug Label Requirements * 9 items *

Prior

Board must be notified ______ to starting compounding

1. Practical / academic training in the field

2. ONE hour of CE annually

3. Provide additional training & document when & how training occurred (Name of person getting trained, Date of training/evaluation, topics covered, signature of person training & trained

What training is required to make sterile compounds?

1. Formula used

2. Lot number

3. Estimated BUD based on pharmacist judgement or acceptable data

Compounded Drug Label Requirements * 3 items *

1. Section eliminates the ability for a compounder to do this. Federal law sees these as outsourcing facility

2. Also if a product is not available from a wholesaler, you can compound it: if discontinued, on a list of drug shortages maintained by the FDA, or temporarily unavailable

3. Less than 10% strength differences between a commercial product is not enough

May I compound a product & sell it to a physicians office?

1. Must be sent directly to vet office, NO MIDDLE MAN

2. Emergency access ONLY, not as a long term solution

3. No more than 5% per month total amount of drug products dispensed may be done this way

4. Rule will NOT protect you IF Federal law is amended to prohibit this practice

Requirements for selling Veterinarian Administered Compounds?

1. Pharmacy name, address, phone #

2. Veterinarian's name

3. Name of preparation

4. Strength & concentration

5. Lot #

6. BUD

7. Special storage requirements

8. ID # by pharmacy

9. Name or initials of pharmacist making final check

Veterinarian Compounded Drug Label Requirements * 9 items *

1. Pharmacy/Pharmacist may enter in a non-patient specific agreement with a provider (Valid for ONE year)

2. Must show pt techniques to recognize overdose, how to store & administer, emergency follow-up

3. NON-pharmacies can give away & NOT charge for it

4. Pharmacist must attach a copy of standing order to invoice/sales receipt, & keep record where other transaction records are kept

Naloxone & Opioid Antagonists regulations

Form 223a

*Form 223 is the actual license hanging on the wall

DEA form for requesting reprints of lost DEA licenses

36 months; LAST; 30 days

-DEA registration expires ____ months after last renewal

-Expires on the _____ day of the month

-Late license renewal may occur up to _____ days after expiration

-Form must be signed by registrant or designee (power of attorney)

14 days

Transfer of Business:

-Registrant must notify the DEA at least ____ days in advance

1. Warehouses

2. Practitioner's office (if drugs are not stored there)

3. Common carriers (Fedex)

DEA Registration is not needed for:

1. Military Physicians

2. Physicians in training (Residents will have an extra 5 digits on end of DEA)

3. Law enforcement

4. End user

5. During times of crisis or emergency

Exempt Officials from DEA Registration:

NOT required; self-certify

-To sell Scheduled Listed Chemical Products (SLCPs) registration with the DEA is _______

-Must ______ that they meet requirements of Federal Government

C-2

In Louisiana, Carisoprodal (Soma) is a C- ____