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)
Can you fill out-of-state controls?
For CII-III opioids:
- If you can access PMP for that state, yes, with no add’l restrictions
- If not, then you can only fill 10 DS…unless rx is marked cancer pain or terminally ill
For other controls:
Yes, no restrictions
Can an pharmacist/intern with a lapsed license work as a tech/PTC?
No. They are not qualified to apply for tech/PTC
Pregnancy categories
A - Good studies in humans B - Animal studies show no risk C - No or bad animal studies D - documented risk to fetus X - fetal risk outweighs any maternal benefit
What individuals are exempt from DEA registration?
- military physicians (use service ID)
- physicians in training (use institution’s DEA with unique suffix)
- LEOs
- End users (patient)
- During official crisis/emergency
Requirements to permanently close a pharmacy
- public notice at least 10 days out
- board notice at least 10 days out – when, who’s getting the rx transfers, who’s getting the drugs?
purpose of Collaborative Drug Therapy Management
-allows a pharmacist to coordinate with a physician to care for the physician’s patients
Can a pharmacy be open without a pharmacist?
- Yes, if the pharmacist remains on site and is available for emergencies
- Tech or intern must remain present
- RPh can have max 2 30-min breaks per 12 hrs
- breaks < 5 min don’t count
storage of controlled substances
may be stored in a locked, substantial cabinet, or dispersed along with non-controls
What info is not req’d on prescription labeling per federal rules?
- name/strength of drug
- Mfr and lot number
requirements for technicians working at a telepharmacy site
- must have at least two yrs as a certified technician
- are included in the remote pharmacist’s tech ratio
Buprenorphine is schedule ____
C-III
When do pharmacists licenses expire?
December 31 of each year
How long is a pharmacy permit valid?
All permits expire Dec 31
Storage of drugs within the EDK
- must meet the storage requirements of each individual drug
- specific drugs may be stored outside of actual EDK if necessary (ie refrigerator), must document this
Technical aspects of a fax machine receiving prescriptions
- Must be located in the pharmacy
- must use non-fading paper with non-fading ink
Isotretinoin REMS
iPledge
- 2 forms of contraceptive with monthly pregnancy tests
- Rx must be dispensed within 28 days of visit to MDO
Patents last ___ years
17 years (but 12 for biologics)
- can extend another 6 mos for peds, or 1 yr to lifetime for orphan drugs
- First generic drug gest 6 mos exclusivity
Dronabinol is schedule ___
C-III
procedure for public comments at BOP meetings
- at beginning of meeting
- max 3 min/person, max 30 min per meeting
Is there a maximum day supply for C-IIs?
- No limit per federal law
- But max is generally accepted as 90 days
- LA practitioner can write 3 rx’s for total 90DS, with them spaced out with DNF until dates
PSE/ephedrine limits
3.6 g base per day
9 g base per 30 days
7.5 g per 30 days for mail orders
pharmacist:intern ratio
1: 1
- However if interns are part of COP-associated rotation, 3:1
Partial filling C-IIs due to being out of stock
- okay for any patient
- pt must return and p/u remainder within 72 hrs of initial fill, or lose the remaining
To approve a generic drug, its mfr must file a _____ which proves the drug is ________
- must file an ANDA
- proving the drug is bioequivalent to its reference (not safe or effective)
profile-driven vs non-provile driven
Profile-driven essentially means it is attached to specific patients/orders, and a pharmacist reviews meds before access is allowed by floor staff
What conditions need to be met to give “loaners”
- medication necessary for pt health, but out of refills/expired
- physician is unavailable
- max 72 hr supply, although you can exceed that for unbreakable products like an inhaler
Form 224 must be signed by ________
The registrant (owner of the pharmacy). NOT the PIC
When is a pharmacist considered absent?
- When the pharmacist is off-site (short on-site breaks are not considered absences)
- the prescription dept must close if pharmacist is absent
How often must PIC be present at pharmacy?
- at least 20 hrs per week
- if site open < 20 hrs per week, then at least 50% of normal business hrs
Can a pharmacist administer medications?
-Yes, if the physician writes and authority to administer (AA) rx
requirements for CDS license
-have appropriate Louisiana professional license/permit (MD, DDS, pharmacy permit, etc)
How often must an EDK be inspected?
- every 30 days, plus or minus 5 days
- done by provider pharmacy, not nec. PIC
how many hrs of pharmacist CE are required each year?
- 15 hrs/yr, if 3 of those hours are live
- 20 hrs/yr otherwise
What can medical psychologists prescribe?
non-opioid CII to CVs. Note they cannot dispense, only prescribe
THC variance allowed in marijuana
15% allowed variance
-If labeled 10 mg THC, must be be between 8.5 and 11.5 mg
How many telepharmacies may a central pharmacy have?
maximum of 2
How to get professional eligibility to become PTC
- enrollment in approved technician training program
- pass exam + completion of high school/GED
- be licensed as tech in another state at least 1 year + have passed exam
Are you allowed to compound drugs withdrawn/removed from market?
Yes, but not if the drugs were withdrawn due to safety concerns (most)
What requirements are there if you want to keep your rx record electronic?
- records must be searchable
- must be kept for at least two years after LAST refill
- backup must be done daily
T/F: a patient may issue a blanket waiver to deny counseling forever
False
How many intern hrs must an intern have to become licenses as pharmacist?
- 1740 hrs, of which 1500 must be practical experience (under qualified pharmacist providing pharmacy primary care)
- graduates of approved COPs automatically receive 1740 hrs
Can you dispense a CDS written for “office use”
No
What can you do with C-II drugs upon permanent closure?
either
- return to wholesaler via 222
- destroy or turn into DEA via form 41
Can you compound a product and sell it to a physician’s office?
No. Previously was ok per LA law, but federal law considers this “outsourcing” and must be registered as an outsourcing facility
What must be included on an inventory?
- drug name, strength, formulation
- number of unopened containers x qty of each container
- number of units of each open bottle
Who is eligible to get meds from a penal pharmacy?
- offenders residing in the penal institution
- offenders in another penal institution
If you discover a significant loss of CDS then later recover it, should you still report the loss?
Yes — check LABOP rules 2737
T/F: hospitals can dispense to both inpatients and outpatient under the same permit
False
- hospital outpatient dispensing requires separate permit
- outpatient cannot acquire drugs through the hospital permit
- maintain completely separate drug inventories
Benzodiazepenes are schedule ____
C-IV
Examples of what the board consider an ‘institution’?
NOT a hospital
- nursing home
- rehab center
- drug abuse treatment center
- family planning clinic
- penal institution
- athletic facility
How to report theft or significant loss of CDS
- Notify NOLA office of DEA and Board of pharmacy within ONE business day
- Submit Form 106 to DEA (does not have to be done within 1 day if you need to investigate, but notification MUST still be sent)
Dextromethorphan restrictions
- Must be at least 18 to purchase OTC
- provide positive ID
A patient is interested in taking St. John’s Wort but requires a liquid formulation. Could you compound this for her?
Probably not. FDA frowns on compounding using ingredients from non-FDA approved mfrs. Since this SJW is likely an OTC herbal company, they would not qualify
what can pharmacists in a CDTM do?
- monitor/modify specific drug therapy
- collect/review patient history
- obtain/review vital signs
- order/evaluate lab work
- counsel on specific diseases/conditions
Allowed inactive ingredients
- “anything goes” for PO
- sterile products cannot have any added colors. Inert gasses are allowed
T/F: anytime the spare/emergency key to the pharmacy is used, the person using it must document it in the log book
False. Only non-pharmacists have to document in the log book
what non-controls are considered “drugs of concern” on the PMP
- butalbital + 325 mg or more APAP
- naloxone
off-site satellite pharmacy
- a separate, smaller pharmacy at the same address as the primary “provider” pharmacy
- requires separate application
A lot where tablets were improperly pressed and falling apart would likely result in a Class (I/II/III) recall.
Class III
special requirements to be a nuclear pharmacist?
- must be listen on a LA radioactive material license
- must obtain 5 CE yearly specific to nuclear pharmacy
T/F: remote processor pharmacies can store medications
No, their function is in data processing only? No physical transfer of prescription products
Who signs an application/renewal for pharmacy permit?
PIC and the owner of the pharmacy
how often must a PIC visit/inspect a telepharmacy site?
every 30 days
Kefauver-Harris
1962 amendment to FDCA.
Required extensive pre-clinical trials before allowing human trials.
Who reports a CDS loss/theft when a central pharmacy loses it?
Whoever is contracted with the courier
Can institutional pharmacies dispense to patients that are outpatients/not directly treating?
No, institutional pharmacies are focused wholly on the patients of that institution. (No employees)
what controls can NPs prescribe?
- CIIs for attention deficit only
- CIII-Vs
What is considered “positive ID”?
- Essentially two-step authentication.
- a private password, PLUS
- either manual signature on rx, magnetic card reader, bar code reader, biometrics, or a register for RPh to sign
qualifications for BOP pharmacist members
- LA resident at least 6 mos
- currently licensed in LA and active in pharmacy
- 5 yrs LA pharmacy experience
- no felons or hx board probation
Carisoprodol is schedule ___
C-II (federally C-IV)
Mailing prescriptions
Okay per USPS. Meds cannot be considered “poison” or an “alcoholic beverage”.
(UPS/FedEx also ok)
Who needs a community pharmacy permit?
Individuals/entities who operate a pharmacy and dispense prescription drugs to patients in Louisiana
tampering
intentionally tainting a consumer product, including its labeling, container, or contents
A CDS license expires after ____
1 year
A manufacturer labeling a bottle of simvastatin 40 mg as simvastatin 20 mg instead would likely cause a Class (I/II/III) recall.
Class II
Can pharmacists treat minors under a CDTM?
Generally not allowed to treat patietns < 18 yo. Allowed for smoking and imz
Substituting biosimilar for brand
- must notify prescriber within 5 days of dispensing the name and mfr of dispensed product
- only required on initial fill, unless you switch products
Who is exempt from CDS licensure?
- employees of a licensed company – except sales reps
- researchers
- people who possess CDS pursuant to a valid rx
How are controlled prescription records stored in the pharmacy?
3 options: -CII, CIII-V, legend -CII-V, legend -CII, CIII-V with legend (if CIII-V are combined with any group, they must be stamped with red C stamp)
restrictions when dispensing to institutionalized patients
- max 34 DS or 100 dosage units (whichever less)
- end user cannot possess medication
Emergency scheduling
- AG can put a substance n schedule I only
- valid for 1 yr, can extend add’l 6 mos
Special regulations: mineral oil
Label must have warning saying it cannot be used in infants, and not to lay down after taking
Durham-Humphrey
1951 amendment to the FDCA.
Created Rx vs OTC classes
Can hospitals with on-site pharmacies use remote processing so they don’t have to employ pharmacists?
Not really, this is not the intent of the law.
- Hosps with 100+ occupied beds must have at least one on duty RPh at all times.
- ok to have no on-site RPh is < 100 occupied beds and using remote processing
Who applies for an EDK?
The provider pharmacy, NOT the facility where the EDK will be (LTCF, etc)
Records requested by the board for inspection must be provided within _____
72 hrs
-potentially sooner if board inspector requires it
When are exact inventory counts required?
- for all C-I and C-IIs
- for CIII-V when bottle size > 1,000
Butalbital with APAP or ASA is schedule ____
C-III
T/F: Institutions do not need permits for any EDKs
Depends!
- If institution has an institutional pharmacy permit, no.
- Otherwise, yes it must have a permit
Inventory requirements for controls for hospital pharmacies
- CI-II must have perpetual inventory
- annual inventory of all controls
requirements for pharmacist providing CDTM
- active pharmacist license
- must register with board
- no hx of license suspension, restriction, etc.
EDK permits
- required if if EDK is not at a hospital or at a facility with an institutional pharmacy permit
- separate permit required for each EDK
- applied for by the provider pharmacy
- permit expires annually on July 1
When is codeine C-V?
- max 200 mg per 100 mL
- combined with other non-controlled ingredients
T/F: pharmacists are allowed to let nurses counsel patients on their behalf
True, in hospital/institutional settings
Can scanned prescriptions be considered originals?
- yes, except for C-IIs
- if scanning, hard copy can be kept for only one year
what controls can PAs prescribe?
CII-V to the extent delegated by supervising physician
How many members serve on each committee?
At least 3 members. In the case of the executive committee, it is the officers
what is a drug abuse treatment center? (DATC)
-an inpatient or outpatient clinic where patients are treated for abuse issues
Form required for pharmacy to register for DEA license
Form 224
How many marijuana pharmacies does LA allow?
- maximum of 10 pharmacies
- 1 per each of nine “health” regions, with an add’l 10 that can be issued if need is present
What happens after an EDK is opened?
- facility notifies pharmacist within 24 hrs
- staff will do shift counts on controlled substances until the pharmacist comes to reseal EDK
minimum age to be licensed as pharmacist
21
Requirements for a pharmacist to administer meds (vaccines)?
- complete an approved course (usually APhA course)
- BLS certification
- provide docs of completion to BOP
- display certificate
- 1 hr CE in field per year
Prior to filling for a pt, the pharmacist must make a reasonable attempt to obtain what info from pt?
- name, address, telephone number
- DOB/age, gender
- allergies, disease states
- list of all current meds
What can you dispense for outpatient detox treatment?
- FDA-approved CIII-V drugs (only Suboxone/subutex meets this req)
- methadone for detox cannot be filled by pharmacy
Board decisions on hearings
- due within 30 days of hearing
- goes into effect 11 days after respondent receives notice of decision, unless respondent appeals
What qualifies as childsafe packaging
No more than 20% of children can open package, while no fewer than 10% of adults are unable to open package
How long should CDS records be stored?
At least 2 years
tech:pharmacist ratios
-3:1, including up to 1 one PTC
Per FDCA, prescriptions may be audited for up to ___ years
Up to 5 years. Note that it is unusual to be audited under FDCA
Who can prescribe controlled substances?
- Independent practitioners: physicians, dentists, vets
- Midlevels if done per protocol
- Therapeutic optometrists
- Medical psychologists, but NOT narcotics
when must interns submit their applications?
prior to the end of their first semester of pharmacy school
how much THC is allowed is marijuana packaging?
- max 10 mg per dosage form
- if multidose, max 100 mg
- no single container can container > 30 day supply
violations committee
- one of BOP committees
- decides type of hearing appropriate for violations
If a bottle of warfarin 5 mg was labeled 3 mg by the mfr, this would likely cause a Class (I/II/III) recall.
Class I
Marijuana grown from somewhere besides the source approved by LDAF is considered _______
Adulterated and misbranded
Inventories of controlled substances are required every _____
Every year
- Federal law says every 2 yrs, but state is more strict
- LA allows non-pharmacies to do inventory every other yr
How long should your copies of 222 forms be retained?
At least two years
Can community pharmacies enlist the services of remote processor pharmacies?
No – restricted to hospital only
May an intern administer vaccines?
Yes, as long as both the intern and pharmacist are certfied for imz/BLS
What references must be kept in a pharmacy?
- printed copies of LaBOP laws and regs
- access to current references on pharmacology, drugs interxns, dosing/toxicity, counseling
Up to ___ prescriptions can be written on a single paper
four
Classes of recalls
Class I - potential for serious illness/death
Class II - potential for reversible AE, death highly unlikely
Class III - not likely to cause AEs
Partial filling of C-II
- can be done if OOS, must be fulfilled within 72 hrs
- can be done for terminally ill or LTCF pts, must be fulfilled within 60 days of first fill
- remember – still no refills
What can PTCs not do that techs can?
- receive verbal intial rx orders
- give/receive verbal transfers
- compound high risk sterile products
an application to become a pharmacist is valid for _____
1 yr after submission
Do partial fills count toward the 5 allowed refills for a CIII-V?
No, the DEA has clarified that they do not count.
informal hearing
- info used here cannot be used at later hearings
- attending members must recuse themselves from future hearings
- the charge may ‘die’ here
Who is a remote dispenser?
- a LA-permitted pharmacy who provides centralized dispensing service for another permitted pharmacy in LA
- the “central fill site” ie not the one that patients will pick up their scripts from
Pregabalin is schedule ___
C-V
board member terms
- six year terms, staggered
- terms begin July 1
- except for consumer member, who serves “at pleasure of the gov”
OBRA 90 requirements
- Drug use review
- Counseling for patients reimbursed by federal policy
- Patient medication histories
Do physicians practicing at multiple sites need multiple CDS licenses?
Depends.
- if only prescribing, one CDS will cover the prescriber’s activities
- if dispensing, administering, etc. each site needs a CDS
Is a DEA registration needed for a practitioner’s office?
No, unless controls are stored there. (Double check this…wouldn’t most offices have some controls on hand?)
“Usable” marijuana exludes what components?
Does not include seeds, stalks, or roots
What are valid MJ “prescriptions”?
- written rx
- escribed rx
- emergency CII-like phone orders are allowable
Under what circumstances can a hospital pharmacy dispense to outpatients?
- to hospital outpatient for personal use on hospital premises
- for take-home use to extend for limited/reasonable time tx that was begun as inpatient
- to hospital’s employees/students for their personal use or for the their dependents
What form do you use to order additional 222 forms?
DEA 222a
A prescription must be at least ____ in size
4 x 5 inches
How long must you keep privacy-related forms per HIPAA?
6 years
required questions to ask potential pharmacy employees
- convicted of felony within 5 yrs?
- convicted of misdemeanor within 2 yrs?
- knowingly used drugs illegally within 3 yrs?
DATC pharmacies do inventory how often?
perpetual
Clozaril REMS
Clozaril National Registry
- “No blood, no drug”
- Weekly CBC x 6 mos, QOW CBC x 6 mos, then monthly CBC
Loaning CDSs to another pharmacy
- allowable, but remember the 5% rules
- if CII, must fill out a 222 with you as the distributor
when does an AMS permit expire?
Annually on JUne 30
For a C-II, what elements can a pharmacist add without consulting prescriber
- Patient’s address
- Drug dosage form
- Prescriber’s DEA
NDCs can be recycled after ______
after 5 years of non-use
Products excluded from PPA
- products intended for emergency use (nitrates)
- products commonly prepackaged (Zpak, birth control, etc)
- these are not blanket exclusions, any excluded products have to be specifically stated in the rules
Who is authorized to prescribe in LA?
Physicians, PAs, NPs, therapeutic optometrists, dentists, veterinarians
What must pharmacy do when pharmacist is absent?
Must close!
-post 8.5x11” sign saying “Prescription dept closed” in 1” lettering
How to dispose of MJ
- mix with at least 50% non-marijuana waste, ground up
- must be done by PIC and one witness
Compounding personnel require ___ annual CEs related to compounding
One hour
special allowances during a State of Emergency
- emergency RFs allowed in affected parishes for essential therapies
- max 30 DS
- write “emergency prescription” on hard copy
- non-LA pharmacists may work in affected parishes
counseling on naloxone
- physician required to train caregiver when prescribing
- under standing order, pharmacist must educate on recognizing opioid o/d, storage/administration, and emergency follow up
How often is the Board required to meet?
At least once every 12 mos. Typically meets more often
Quality control program for clean room
- certify clean room at least every 6 mos
- test samples of finished products
rules for late renewal of expired CDS license
pay registration + late fees
-if exp < 1 yr, admin assistant may review
-if exp 1-5 yrs, one board member may review
if exp > 5 yrs, full board hearing req’d
what is an emergency drug kit?
- a kit containing emergency drugs that meet an immediate need of an LTCF paitent
- intended for one-time use. Once accessed, the pharmacy will restock it, re-lock it and return it to original area
Do warehouses housing controls need a DEA registration?
No, only the seller needs it
placehold for info about LINKS because idk what it is
n
Regulation of off-label use
- “discouraged” by FDA
- mfr is allowed to distribute research on off-label usage
- mfr is not liable for harm occurring secondary to off-label use
T/F: for legal purposes, off-site pharmacy sites contracting with a hospital are considered themselves a hospital pharmacy
False!
Storage of drugs unfit to be dispensed (misbranded, adulterated, recalled, expired, etc)
- Must be stored outside of the pharmacy
- Expired drugs however are allowed to be stored within the pharmacy, as long as they are in a separate space
