Ch. 11 etc Flashcards
Who can have a pharmacy permit?
Individuals, corporations or partnerships
How long is a pharmacy permit valid?
All expire on Dec 31st
What are the physical requirements of a pharmacy?
Well-lit Ventilated Climate controlled Safely enclosed structure Restricted area Electronic record keeping Sufficient space Sink with hot and cold water Security system
Who can have access to the pharmacy?
Pharmacists must lock doors when dept is closed. Emergency access is kept outside of the pharmacy and it must be logged if used by a non-pharmacist
What references are required to be in a pharmacy?
LABOP laws and regulations (printed)
Current and appropriate references for pharmacy practice (online or printed)
What are the rights of the PIC?
Circumvention -> they have the right to be the final decision maker
What are the responsibilities of a PIC?
Permit application Authority and accountability Policy and procedure manual Records Recall D/C and outdated meds Must be present in pharmacy =/> 20 hours per week
When must the board be notified if a new PIC is named?
Within 30 days of the old one leaving and name new pic within 10 days of old leaving
If an old pic who voluntarily leaves role, when must they notify the board?
within 10 days prior to leaving role unless replaced sooner
What do you need to be a PIC?
An affidavit of responsibility
2 years of experience being a pharmacist
What are the requirements for a pharmacy being open?
Open for at least 10 hours per week
Hours must be posted in a visible place
Pharmacists must always be there if pharmacy open
When is a rest break required?
> /= 6 hours
Can a pharmacy be open without a pharmacist
Yes, if the pharmacist remains on site, is available for emergencies, and believes the pharmacy is safe
CPT or intern must be present
How long are the breaks for a pharmacist?
No more then two 30 minute breaks per 12 hours
What happens if a pharmacist must leave?
The pharmacy must close, a sign must be posted
What can you NOT advertise?
No controlled substances
Untrue claims
Prescription pads with advertising info
How long should records be kept for if medicare is involved (feds)
10 years
Is there a required prior authorization form?
Yes, in louisiana all insurances must use the LA approved PA form.
What do you need to open up a pharmacy?
CDS, Pharmacy and Applications signed by a PIC within 30 days prior to opening
What should be public notice when closing a pharmacy?
Let the public know in > 10 days prior
Closure date
When and where scripts are transferred
Statement that transfers can go anywhere
What should be board notice when closing a pharmacy?
Let the board know prior >10 days
Closure date
Name of transferring pharmacy
Where are the drugs going?
Do CIII-CV need forms when you close?
No, only CIIs
When do you need a new license based on change of ownership?
Sale of pharmacy, death of sole proprietor, addition or deletion of partners, bankruptcy, 50% ownership change
If you are moving nearby what should you do?
Notify board, submit to an inspection
If you are moving further what should you do?
Forfeit old license, get a new one. Submit to an inspection
An employed or contracted pharmacist may access a system off site as long as:
Pharmacy has established controls to confidential records.
Pharmacists does not receive written rxs
No part of the pharmacy’s dispensing system info is duplicated
How often should hospital pharmacies maintain their inventories of CI and CIIs?
perpetially
Labels on a prescription drug order must include:
Name and location of patient, drug name and strength, dose
When should drug cabinets be used?
When a pharmacist is not available
When do pharmacists dispense to out patients?
Discharge from hospital
Research related patient
Employee of hospital
What is an automated medication system?
Remote dispensing system- bidirectional audio visual tech
What pharmacies do not have to register the AMS?
Facility that already has a CDSL
Hospital or institutional facility licensed by the state department of health
Within detention or correctional facility
A remote dispensing system can be placed in a healthcare setting that the PIC is okay with
If a pharmacy is in the same building
How to get, maintain, and when do you lose the license for an AMS?
Application must be on paper (no faxes)
Registration is tied to pharmacy and location. Changes must be made known to board.
Renewal is yearly (June 30th)
What happens when a pharmacy stops using the AMS?
Notify the BOP within 10 days. You may not transfer ownership.
What must a PIC do for the AMS?
Ensure its working well Establish a QA program Give access Ensure it's properly stocked Retain records for 2 years Document temp
When should medication orders be reviewed?
Prospectively
How long should records for the AMS be maintained for?
1 year
What data should be recorded for the AMS?
Identity of system accessed ID of person accessing Type of transaction Name or ID of pt Name, strength, dosage form, and quantity of drug ID of person restocking meds
Who can restock the AMS?
A licensed pharmacy person. Non-pharmacist must be supervised by a pharmacist
What does the board consider an institution?
Nursing home Rehab center Drug abuse treatment center Family planning clinic Penal institution Athletic facility
What is a drug cabinet?
Medication storage outside of a pharmacy.
Usually for emergency use and can only be used when the pharmacy is closed.
Who decides what goes in a drug cabinet?
PIC
What goes in a drug cabinet?
Quantities needed for acute issues
How is accountability held for drug cabinets?
A valid medical order must be provided for every med taken out.
Must be inspected every 30 days by the pharmacy
Who does not need an EDK permit?
Hospital or have an institutional pharmacy permit
How do you apply for an EDK permit?
Provider pharmacy applies and may have unlimited number of EDK permits
Who is responsible for all EDKs?
PIC
How is accountability held for EDKs?
Who prescribed and administered
Resident name, drug info, time and date of administration
How often must EDKs be inspected?
every 30 days
Are you allowed to have controls in EDKs?
Yes but no more than 8 units of 8 diff CDSs
What kind of inventory must a drug abuse treatment center pharmacy have?
perpetual inventory for everything
Do pharmacies serving prisons have to have a permit?
Yes
What if a penal permit expires?
Complete an application form
If expired for < 1 year: Approval by board’s admin personnel
If expired for > 1 year - < 5 years: Approval by member of board
If expired for > 5 years: Approval from full board and hearing
What kinds of drugs can be donated?
Anything but CS
No expired drugs
What is a nuclear pharmacy?
handles radiopharmaceuticals
What are the requirements to be licensed as a nuclear pharmacy?
Must have LA radioactive Material license
Must have nuclear PIC
Must have dispensing, receiving, and storage area
Must have appropriate equipment, plumbing, and supplies
How many hours of CE are required for nuclear pharmacists?
Must obtain 5 hours of CE yearly in applications and procedures specific to nuclear (this is apart of the 15 total. hours)
What are the labeling requirements for the immediate container?
Radiation symbol Caution Prescription control number Name of radionuclide Amount of radioactive material
What are the labeling requirements for the outer container?
Radiation symbol Caution Name of radionuclide Chemical form Amount Liquid vol Calibration time and date
Who can be a charitable pharmacy?
Must be a charitable org
Do you need a permit to give out free drugs?
YEs if you are a pharmacy
What are the requirements for an oos pharmacy?
Have a PIC licensed in LA
The PIC must be licensed in LA and home state
How do OOS pharmacies provide counseling?
Through a toll free number that should be on every bottle
When does a DMSE permit expire?
Aug 31st every year
How long is a short term pharmacy good for?
30 days
How long is a short term pharmacy good for?
30 days
A single container of marijuana may contain how much?
1 month supply
Producer labeling of marijuana must include?
Batch/lot number Potency of THC and CBD in mg Net weight Product exp Any caution statements
Who is not allowed to work at a dispensary?
Anyone without a TM designation and no access to PMP and no tech candidates
How long must you have your license before getting the TM designation?
2 years
Who can dispense marijuana
Only pharmacist
Who can sell marijuana?
Pharmacist, tech, intern
Who can destroy weed?
PIC with one witness documenting
What are the drugs of concern?
Butalbital
Naloxone
Promethazine liq
Gabapentin
When are pmps reported?
ASAP
By the end of the next business day of dispensing
What form of prescription for MJ is not allowed?
oral form
What is the Louisiana Medical Marijuana Tracking System (LMMTS)?
is a “seed-to-sale” information system designed to capture and manage data from multiple stakeholders in the production and distribution of medical marijuana products
Requests for marijuana products shall expire ___________ after the date of issue, unless a shorter period of time is indicated by the physician.
1 year
What is the max day supply for MJ?
90 days
Who appoints where MJ can be produced?
LDAF (Louisiana Department of Agriculture and Forestry)
The pharmacist shall not dispense any marijuana product that does not bear the producer label required by the __________.
LDAF (Louisiana Department of Agriculture and Forestry)
