LA MPJE Flashcards
Can marijuana pharmacies advertise?
- Not to the public! Can advertise directly to practitioners
- allowed to have 2 signs on outside of bldg, max 1600 sq. inches
Re-use of prescription vials
Ok for glass, no allowed for plastic
Who needs a CDS?
Every person/entity who does or proposes to manufacture, distribute, prescribe, or dispense controlled substances
All rx records should be kept for how long?
- 2 years
- up to 10 years if medicare (federal) involved
How long is PTC registration good for?
- 2 years, non renewable
- if a PTC leaves training program, the license dies. If they return to program, license can be re-activated, but original 2 year expiration remains
how does a pharmacist qualify to be PIC?
- active LA pharmacist license
- have been a pharmacist at least two years, in any state
- complete and notarize PIC affidavit
How many EDK permits may one pharmacy have?
Unlimited, but remember the PIC of the provider pharmacy is still responsible for all EDKs
Who keeps the pieces of the 222 triplicate?
Copy 1 - Supplier
Copy 2 - DEA
Copy 3 - purchaser
What is floor stock used for?
For first dose and as needed doses only
A pharmacy must be open at least ___ hrs per week
10 hrs
Process of a drug becoming scheduled
- Secretary of HHS recommends, AG considers and decides
- If the UN passes a rule, then the HHS Sec must consider scheduling
What products have NDCs?
All Rx-only products must have an NDC, although it doesn’t have to appear on the label. NDC not required for non-Rx
Generic drugs can deviate ___% from their reference product
-20% to +20%
Partial filling C-II’s for reasons other than inventory
- ok for LTCF or terminally ill pts…must be written on rx
- each partial fill must be noted on original script, or kept electronically
- must fill entire amt within 60 days
BUD of compounded prescriptions (in absence of stability data)
- Aqueous solutions: 14 days at cold temperature
- Nonaqueous solutions: 25% of time left or 6 mos
- For all others: duration of therapy, with max of 30 days
Anti-tampering requirements
An indicator that provides visible, enduring evidence that a package has been opened and potentially tampered
what are automated medication systems (AMS)?
- mechanical systems that store/package/deliver meds
- require their own permit (and CDSL if appl)
- must be in a licensed hospital or healthcare area
- may be profile- or non-profile driven
When do AMS permits expire?
Annually on June 30th
When can prescribers fax C-IIs?
- LTCF residents
- Hospice-enrolled patients
- Home infusion pharmacies
Pharmacy technician certificates expire every ____
annually, on June 30th
documenting C-IIs when a central fill will fill it
-retail pharmacist writes “Central fill” on hard copy along with name, address, DEA # of pharmacy
Can patients return prescriptions?
Prescriptions may not legally be returned, exchanged, or redispensed once they have left the pharmacy premises. Especially for controls
what is telepharmacy?
- a means of reaching patients in rural areas without easy access to prescription
- allows for off-site dispensing by a pharmacy machine
Executive director
- a pharmacist who is not a member of the board
- handles a lot of functions/operations of BOP
Requests for non-safety caps
- Prescriber can make one-time exclusion to PPA
- Pharmacist can make no exclusion
- Patient can make a single or blanked exclusion
Expiration vs BUD dating for drugs
- expiration is based on drug chemical stability, established by manufacture
- BUD is prescription-patient specific
General qualifications to be pharmacy technician candidate (PTC)
- at least 18 yo
- HS graduate, or have GED
- proof of professional eligibility (training program, experience, and/or PTCB)
interlocutory
- summary hearing
- has quick turnaround
- used when there is a clear danger to the public
Allowed qty of controlled substances in an EDK
8 x 8 rule
-up to 8 unique controlled meds, up to 8 doses of each drug
For a C-II, what elements can a pharmacist never change/add?
- Patient’s name
- Drug’s name (except for generic subsitution)
- Date of issue
- Prescriber signature
Can you advertise your pharmacy?
Yes!
- but no advertising of controlled drugs
- currently ok to advertise compounding
Can practitioners prescribe narcotic drugs for detox/maintenance?
- Generally no, can only administer such drugs
- however they can prescribe Subutex/Suboxone for this purpose
Can techs compound high risk sterile products?
YES!
This is a new change, mentioned in the Jan 2018 BOP newsletter. Note that PTCs still cannot do high risk though
T/F: Do out-of-state manufacturers and distributors need a CDS license?
Yes, if transporting inside LA
Tylenol with codeine is schedule ____
C-III
T/F: Transfers of C-IIs between central fill/retail pharmacy require a 222 form
False, they are exempt
inventory of drug cabinet
- perpetual inventory of all controlled drugs stored
- PIC is responsible for conducting inventory
Special regulations: ipecac syrup
- warning saying for emergency use only
- no more than 30 mL per bottle
When are you allowed to substitute generic for brand?
- when prescriber did not write/mark DAW
- patient provides informed consent
- generic is cost saving
if paid by medicare/medicaid, wording must be “Brand (medically) necessary” to apply
Additional labeling requirements for veterinary prescriptions
- Client name and patient species
- “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”
Inventory requirements for PSE
Every two years, however pharmacies are excluded
Anabolic steroids are schedule ____
C-III
what special requirements exists to be licensed as a nuclear pharmacy?
- have LA Radioactive Material License
- have nuclear PIC
- have dispensing, receiving, and storage areas
What “perks” do active duty military and their spouses receive?
- applications are marked priority
- may receive a speak work pass, valid for 120 days
A pharmacy may be considered a distributor of CDSs when ______
- 5% or more of your dosage units sold during a calendar year are CDS
- you are then a distributor and must register as one
receiving verbal prescription orders
- can be done by pharmacist, intern, tech
- must be written down immediately, or pharmacist can input it directly into computer
- sign/initial transfer, + pharmacist if necessary
- only pharmacists can do controls
naloxone dispensing
- ok to dispense to person who is not expected to need it
- pharmacists can enter into non-patient specific standing order with physician to prescribe it
Can a pharmacist dispense CDS in a clinic/amb care setting?
No. Pharmacists’ CDS dispensing authority is limited to being at a physical pharmacy. Physicians, nurses, and vets can dispense in clinic settings with their CDS license
display of permits in pharmacy
required for pharmacy, not personnel
When should you do a CDS inventory?
- annually
- when old PIC leaves and when new PIC starts
- theft or substantial loss of CDS
- permanent closure of pharmacy
Z drugs are schedule ____
C-IV
Do out-of-state pharmacists dispensing to patients in LA need to be licensed pharmacists in LA?
No – not unless they are PIC of an out of state pharmacy. Only the PIC needs to have a LA pharmacist license
How do out of state pharmacies meet counseling requirements?
By providing a toll-free number for call pharmacy. Must be on every bottleq
How many attempts can you have to pass the NAPLEX/MPJE?
three
Thalidomide REMS
STEPS
- pharmacy must register
- requires written Rx’s
- patient must be on birth control
- max 28 DS
When do DME permits expire?
annually on August 31
Bioequivalent
- Having the same rate and extent of absorption as a reference product
- Aka pharmaceutical equivalent
Can hospitals have off-site pharmacies for inpatient services?
Yes, provided there is always a pharmacist on call for emergencies
Under the supervision of a pharmacist, interns can do anything a pharmacist can do, except:
- present himself as a pharmacist
- sign/initial any document that must be signed/initialed by a pharmacist
- independently supervise techs
BOP members
17 total
- 2 from each district
- 1 consumer representative
T/F: a new permit is required when a pharmacy changes location
Depends.
If in “reasonably close proximity” to the old location, can keep same permit and just notify board of address change.
If farther, old permit must be cancelled and new one obtained
Who is responsible for proper prescribing of CDS?
The prescribing practitioner bears most of the liability, but the pharmacist has a corresponding liability
qualifications to apply for a MJ pharmacy permit
- no political contribution within last 2 yrs to any statewide elected official
- they or family have not service on BOP in last 2 yrs
- must have 100,000 escrow acct during building of pharmacy
What kinds of drugs may be donated to a penal pharmacy?
- Non-controlled, non-expired drugs
- PIC is responsible for ensuring drugs are good
expiration of pharmacy intern license
- one year after EXPECTED graduation date
- or once the intern is licensed as a pharmacist
- foreign grads have 2 yr licenses
What is a special event pharmacy?
- meant for short term events
- permits are valid for 30 days, with single renewal of add’l 30 days allowed
standing committees
permanent BOP committees
-executive, regulatory revision, reciprocity, impairments, violations, reinstatement
physical space requirements of a pharmacy
- total > 300 sq ft
- work counter > 24 sq ft
- aisles > 30” wide
how to dispose of CDS
- complete DEA 41 and submit to Special Agent
- agent will advise to either transfer to a licensed person for disposal, deliver to DEA, destroy in presence of agent, etc
How often must a drug cabinet be inspected?
- every 30 days, plus or minus 5 days
- done by “the pharmacy” (so not nec. PIC)
T/F: Prescribers must keep records of CDSs prescribed.
False, only must record CDSs that were dispensed, not if they were prescribed or administered
-unless they are prescribing for detox/addiction tx
pharmacy intern licenses for foreign grads expire _____ after the date of issue
2 years
How long are intern hours good for?
Intern hours expire two years after the intern license expires
If a patient is prescribed ibuprofen 800 mg, can you tell the patient to just take 4 OTC tablets per dose instead?
No.
These preparations have not been tested for bioequivalence, and you cannot truly make that recommendation to a patient
What can you do with CIII-V drugs upon permanent closure?
- can give to another pharmacy
- can return to wholesaler
- can destroy (form 41)
What are remote processing services?
- processing of order or Rx by one pharmacy on behalf of another
- includes all components of the dispensing process except for final transfer
pharmacist interns can accumulate up to ___ hrs/week
50
Selling needles/syringes without a prescription
- Allowable.
- Pharmacist is the one with the authorization to sell, but tech/clerk can conduct the actual transaction
- Must be stored securely so customers cannot grab off the shelf
Form for destruction of controlled substances
- DEA Form 41
- Witnessed by at least two HCPs, or an LEO
When must pharmacy permit (and CDS, if appl) applications be completed?
-At least 30 days prior to intended opening
A DEA registration expires after _____
-36 months (3 yrs)
how long is a special work pass valid for?
120 days
security of EDK
- stored within a secure enclosure at the facility
- tamper evident ability
What is a drug cabinet?
- NOT an ADS
- for use when a pharmacist unavailable
- intended for emergency use
notification requirements for change of PIC
- permit holder notifies board within 10 days of old PIC leaving, must name a new PIC during this time
- new PIC must notify board within 10 days of old one leaving
T/F: Pharmacists must register on the BOP’s imz registry
true
Techs need ___ CE hrs to renew their licenses
10 hrs, must be appropriate for tech level (not pharmacist)
Class 100 environment
“think clean room”
employee requirements of MJ pharmacy
- min age 18
- interns, techs, and pharmacist must all have TM designation and access to PMP
- no tech candidates allowed
Storage requirements for 222 forms
- kept separately from other information
- maintained for at least two years
Diphenoxylate with atropine is schedule ____
C-V
Who owns a prescription during its lifetime?
Prior to filling, owned by patient. After filling, owned by pharmacy. Patients can only receive copies from that point onward
T/F: Pharmacists can fill prescriptions from internet-based physicians
False, there is no valid patient-physician relationship
T/F: impaired pharmacists may not practice pharmacy
False. They may practice so long as they pose no danger to the public. (not sure how often this is the case with addicted RPhs, though)
For a C-II, what elements can a pharmacist add/alter after consulting with prescriber?
- Drug strength
- Quantity prescribed
- Directions for us
appointment process for board members
- nomination ballots go out > 60 day prior to vacancy
- nominees can be nominated by residents of their district
- ballots counted publicly, top 3 names go to gov. for selection
Can you fill prescriptions for CSs written by a foreign prescriber?
No, per federal rules
labeling requirements for drugs dispensed by hospital pharmacy for use within the facility
- name and location of patient
- name/strength of drug
- dose to be administered
- if compounded or sterile, BUD, who made it, who verified it
Who is responsible for maintaining EDKs?
The PIC of the provider pharmacy, who also serves as the “PIC” of the EDK
You are preparing unit-dose packages using a stock bottle. What is the appropriate BUD?
- 25% of remaining shelf-life, up to one year
- customized patient med packs are limited to 60 days
Promethazine with codeine is schedule _____
C-V
When accruing intern hrs for future pharmacist licensure, what qualifications must the supervising pharmacist have?
- must have been practicing as a pharmacist in his jurisdiction at least two years before the intern begins accruing hrs
- no probation/restriction during the time hours are reported
What qualifies as a quorum for the BOP?
simple majority (9 members)
Requirements for pharmacist license display
- must be on display at primary practice site
- you do NOT have to have a copy/ID card on you at any time, even if practicing elsewhere
Oral C-II prescriptions
- limited quantity for emergency periods only
- prescriber must send written form to pharmacy within 7 days
telepharmacies must have no other pharmacies within ____ miles of them
20 miles
How much time does a supplier have to complete an order from a 222 form?
Must be completed within 60 days. May be partially filled in the meantime
qualifications to be pharmacy technician
- 18 years old, HS diploma or GED
- completion of training program, OR obtain 600 hrs of practical experience
- pass exam (PTCB)