NJ MPJE Flashcards
How long do you have to keep DEA form 222 copies (original copy is kept by the supplier)
2 Years
Can you FAX a completed DEA form 222
No, you have to Mail it
How often does a pharmacy have to do an inventory of their controlled substances
Every 2 years
Who keeps the original DEA Form 222 and who keeps the Copy of the DEA form 222
Supplier = Original Form
Purchaser = Makes a copy of the Form and keeps for 2 years
Can a Pharmacy store their DEA Form 222 copies off-site?
No, the forms must be kept on the site that is registered with the DEA and the files must be kept separate (can be kept separately in an online format as well)
Other than doing a Controlled Substance Inventory every 2 years - What other circumstances would require an CS inventory to be done?
- Change in the Pharmacist-In-Charge
- If a Pharmacy is going out of business and transferring the CS inventory
How long do Controlled Substance Inventory Record need to be kept for?
2 years
How long does a DEA Registration last? (Manufacturers, Physicians, Pharmacies, Distributors)?
3 years
Who is responsible for assigning generic (nonproprietary) names to all active drug ingredients in the United States
United States Adopted Name (USAN)
What forms are needed to be completed with the FDA and State Authority when trying to obtain approval for a narcotic treatment program?
From FDA-2632
Form FDA-2633
How many times can you transfer a C-III-V prescription?
Is there an exception to this?
ONCE
Yes, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
How many refills can you have a C-II
0
Can you fax a C-II Rx
Yes, but only for pain management (C-II) for the following:
1. Hospice
2. LTC
3. Compounded for Direct Administration (Parenteral, IV, IM, SC, intraspinal infusion)
How many refills for C-III and C-IV
5 refills (6 months)
Can a pharmacist substitute a biological product if the provider did not indicate DAW
Yes, as long as the substitution is interchangeable or therapeuticaly equivalent per the FDA purple book
What are the books for?
1. orange
2. pink
3. purple
4. red
5. yellow
- therapeutic equivalent
- vaccines/preventable disease
- biologics
- drug pricing
- International travel
Can a pharmacist change the formulation?
yes
How long after changing the formulation of a dispensed medication must the RPh notify the provider?
48 hours
What 3 things can the provider NOT change on a C-II Rx
- The name of the drug (excludes brand/generic),
- the name of the patient,
- the provider signature
What can the pharmacist add WITHOUT consulting the provider
- Patient’s Address (IF MISSING)
- Patient DOB
- Correct patient name spelling
What can the pharmacist change with consult with the provider
- DEA number if it was omitted
- Date issued
- Patient Address (IF Incorrect)
If a med is therapeutically equivalent what letter will the Orange Book show?
“A”
DEA # - what letter does it start with for the following:
- Full Practitioner
- Mid-level Practitioner
- Full practitioner w/ Buprenorphine privileges
- A, B, F
- M
- X
Can a NJ RPh administer naloxone?
No
How many days does a patient have to fill a controlled substance prescription?
30 days
How many refills for a C-V
Can be filled as prescribed by provider
Can you partial fill a C-II?
Yes, if they are unable to supply the full quantity
Can also do a partial C-II for LTC and Terminally Ill - need to note this on the RX - These are valid for 60 days from the issue date.
- How long after doing a partial fill of a C-II must the remaining amount be dispensed in retail?
- LTC or terminally ill?
- 72 hours
- 60 days
Can you partial fill a CIII-V?
yes - each partial fill is recorded as a refill
How long does a CIII-V prescription last?
6 months
What do all personnel working at any pharmacy practice site need on their ID Tag?
Who is an exception?
- First Name, Last Initial and Job Title
- anyone doing sterile compounding
How long are prescription valid for Medical Marijuana in NJ
Prescriptions for dispensing are valid within one year from the date written
What is the max amount of Marijuana that can be dispensed in a 30 day period?
Are there any exceptions?
3 Ounces (84 Grams) can be dispensed in a 30 day period for 18 months
Exception: No limit for terminally ill or hospice patients
Can a APN use the words “PRN” or “use as directed” on prescriptions?
No
What providers can prescribe Marijuana (if registered)?
Physicians, Psychiatrist, Physician Assisstant
Can an Optometrist prescribe C-II’s?
Only Hydrocodone Products
Can NP’s and PA’s prescribed C-II-V?
Yes, with collaborating physician
How often should protocols for Collaborative Practice Agreements be reviewed?
Yearly
Can an Optometrist use PRN or use as directed on a prescriptions?
No
How often do pharmacies have to renew with the NJ Drug Unit
Yearly
How long is a Prescription for a non-controlled valid for?
1 year from written date
Does the Physician have to be the one who submits the electronic RX?
No - the electronic Rx must be transmitted by the prescriber OR their authorized agent (full name and title)
How long do prescription records need to be stored?
5 years
How long should prescription records > 1 year old be retrieved? (New Jersey - Specific)
within 2 weeks
*NOTE: Federal is 30 days, NJ is more strict
How long should prescription records < 1 year old be retrieved? (New Jersey Specific)
within 1 business day
*NOTE: Federal is 30 days, NJ is more strict
Can a PIC be ad PIC at multiple pharmacies?
No, can only be a PIC at one pharmacy
How many hours does a PIC need to work each week?
35
How long can a pharmacy operate without a PIC?
30 days
How many hours can an intern work each week?
45
How long can a pharmacy remain temporary closed before they have to get approval from the BOP
48 hours
How long before a permanent change to pharmacy hours must the BOP be notified?
30 days
How often do pharmacies have to have their weights and automatic counting devices, scales, balances inspected?
every 12 months y the Department of Weight and Measures
How often do Out-of-State Pharmacies need to register with the NJ BOP
Yearly
What are the limits on C-V substances dispensed to an individual before the RPh needs to obtain written/oral confirmation from physician for continued use
MORE than 5 times within 12 months (6th dispense)
What is the limit of ephedrine that a person can purchase per day? per 30 days? via delivery per 30 days?
- 3.6 GM per day
- 9 GM per 30 days
- 7.5 GM via delivery per 30 days
Pharmacists do not need to put a purchase of pseudoephedrine in the log book if the quantity sold is what amount?
individual sales of package with 60 mg or less
Re-importation of medications is only legal if performed by?
The original Manufacturer (for the purpose of emergency medical care)
what are the 3 T’s of the Transaction Report that the Drug Supply Chain Security Act requires manufacturers to provide to pharmacies for each product sold
Transaction History
Transaction Information
Transaction Statement
Orphan Drug if it is for rare diseases or conditions affcting how many people?
Less than 200,000 People
Scheduling controlled substances at the federal level is performed by the
U.S Attorney General (head of the DOJ)
“Federal Law Prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” must be on the label of what Controlled Substances (e.g I-V)
II-IV
(Remember, V can be given OTC)
What is an outsourcing facility
Also known as a 503B Facility - permitted to compound sterile products without receiving patient-specific prescriptions or med orders
What USP Chapter is used for
1. Sterile Compounding
2. Non-Sterile Compounding
3. Safe Handling of Hazardous Drugs
- USP-797
- USP-795
- USP-800
What class of Controlled Substance are anabolic steroids?
C-III
How often do LTC RPh’s need to conduct as Drug Regimen Review for LTC Patients
at least once a month
Where must a pharmacist report administration of vaccines for inclusion in the patient’s registry?
New Jersey Immunization Information System (NJIIS)
If a patient requests a COPY of a previous prescription from > 1 year ago - how long does the pharmacist have to give the patient the Copy?
If < 1 year ago?
- 72 hours
- 24 hours
Need to have “COPY - FOR INFORMATION ONLY” on copy
How many interns can a Preceptor have
ONE
