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A prescription drug manger of record can be a manager of how many pharmacies at a time?
One (exceptions can be granted)
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If a prescription drug manager wants to relinquish his role, he must notify the state board within how many days?
10 days
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May a community pharmacy use an automated filling system and do limited sterile compounding?
Yes
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What is a Class I Institutional Pharmacy?
Nursing home
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What is a general definition of a Class I institutional pharmacy (nursing home)?
- *All medicinal drugs are adminsitered from individual prescription containers to the individual patient
- *Medicinal drugs are not dispensed on premises
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Is a nursing home allowed to have a pharmacy on premises?
No - no dispensing permitted on premises.
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What type of pharmacist must be in a nursing home?
A consultant pharmacist of record
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What must a consultant pharmacist do at a nursing home?
Must provide written, on-site consultation (drug regimen review ) at least once a month
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Can a nursing home use automated filling systems?
Yes
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In regards to automated filling systems, a consultant pharmacist of record is reponsible for what duties?
- *Maintaining a record of each transaction/operation
- *Controlling access to the system
- *Maintaining policies and procedures
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What can a nursing home do while waiting for another contracted pharmacy to be able to dispense/deliver the meds?
Contract with another pharmacy to provide "starter doses"
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What type of kits must nursing homes have for residents?
Emergency kits
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Who determines the drug selection of these emergency kits?
Medical Director, Director of Nursing, and Pharmacist
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What must these kits have?
- *All contents labeled
- *Sealed
- *Written policies and procedures for use
- *Inventory log attached to kit
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When must a kit be resealed if the seal is found broken?
By next business day
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The nursing home may have controls in their emergency kit, but do they need to be DEA-registered?
No
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In an ICD/FF Intermediate Care Facility for Developmentally Disabled, up to how many controlled drugs can be included in an emergency kit (and how many doses)?
- *Up to five controlled drugs
- *Up to 3 doses of each for 60 or less beds (add'l 3 doses for each 60 beds subsequent)
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Who are allowed to inventory, replace, and reseal emergency kits for ICD/FF?
Nurses and pharmacists
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What is a Class II Institutional Pharmacy?
Hospital
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What is the definition of a Class II Institutional Pharmacy (Hospital)?
Dispensing and consultation on premises, pharmacy onsite
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In a hospital, meds must be dispensed in what type of packages?
Unit-dose
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Describe the operating hours of hospital pharmacies.
Sufficient to provide adequate and quality services
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When is a hospital pharmacy considered closed?
When no pharamcist is present and on-duty - in this case, the pharmacy must be locked
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What type of pharmacist must a hospital pharmacy have?
Consultant pharmacist of record
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Can ER doctors dispense meds for outpatient use?
Yes (inclu controlled substances)
- *Smallest duration or 24 hrs
- *Only when drug is warranted and community pharmacy services are not available
- *Records made be doc and maintained by Consultant Pharmacist
- *Must properly label drugs
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What is a modified class II institutional pharmacy?
- Pharmacies that meet requirements of class II permit, except space and equipments requirements
- Examples: primary alcholism treatment centers, free-standing ER's, rapid in/out surgical centers, certain county health programs, and correctional institutions)
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What type of pharmacist must a modified class II pharmacy have?
Consultant pharmacist that provides written, on-site consultation (drug regimen review) at least monthly
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Drugs dispensed in a modified class II IP can only be used where?
On-site
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Consultant pharmacists are responsible for providing what 2 things in a mod class II IP?
Written protocols and policy/procedure manual
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What are some examples of a Modified Class II A? Describe their formulary.
- *Methadone clinic, dialysis center
- *A limited formulary of 15 drugs or less
- *Cannot have large stock bottles of controlled substances (>100 dosages)
- *<10% of mod class II registrations
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What are some examples of a Modified Class II B? Describe formulary.
- *Surgical center
- *Bulk, or unit dose (no formulary limitations)
- *>90% of registrations
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Special-Limited Community?
- *For employees and dependents personal use
- *Patients under continuation of course of therapy
- *Patients in ER
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Special-Parenteral and enteral?
Sterile products, parenteral/enteral compounding
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Special-Closed System Pharmacy
Dispenses medical drugs, using closed delivery systems to facilities where Rx's are individually prepared for the ultimate consumer (e.g., nursing homes, jails, ALFs)
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Special-non-resident (mail-service)
Pharmacy out of state delivering a dispensed med into this state
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Special-End Stage Renal Disease?
Provides dialysis products and supplies to persons with chronic kidney failure for self-administration at person's home
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Special-Parenteral/Enteral Extended Scope
Pharmacies which compound patient specific enteral/parenteral preparations in conjunction with institutional pharmacy permits
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Special-ALF?
- *Assisted Living Facilities providing a drug delivery system using meds provided in unit-dose packaging
- *Consultant RPh must provide drug regimen review monthly at least
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Where are internet pharmacies located?
In- or out-state
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If an internet pharmacy is going to dispense controls, what 2 active registrations will it need?
Pharmacy and DEA
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Is an internet pharmacy providing services to this state is required to be registered as an Internet Pharmacy in FL?
Yes
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How long must an internet pharmacy be open?
At least 6 days a week, and 40 hrs a week
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What is required in every prescription bottle label filled by an internet pharmacy?
A toll-free number
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Does an internet pharmacist need a licensed prescription drug manager? if som does he need to be licensed in FL? And if he is relinquishing his role, he must notify the board within how many days?
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What pharmacy is requried to reigister as a non-resident pharmacy?
An out-of-state pharmacy that ships, mails, delivers, or advertises it fills RX's to FL pts
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If nonresident pharmacy is dispensing controls, what 2 registrations must it have as active?
Pharmacy license and DEA registration
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How long must a nonresident pharmacy be open?
At least 6 days a week, 40 hrs a wk
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What must a nonresident pharmacy put in each prescription bottle label?
Toll-free number
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Out-of-state pharmacies must register as what?
Special-Non-resident
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In a nuclear pharmacy, who is designated as a prescription department manager?
A FL nuclear RPh
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When the PDM of a nuclear pharmacy wants to relinquish his responsibilities, how long does he have to notify the board?
Within 10 days
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The Hot lab, storage area, and compounding and dispensing area shall be a min of how many sq ft?
150 sq ft
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Can a registered tech in a nuclear pharmacy take an oral prescription (write a new prescription)?
Yes
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When can you obtain sodium pentobarbital (w/lidocaine) for animal euthanasia?
Animal Shelter Pharmacy
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Can you transfer over a permit?
No; new owner must complete application and be BOP approved
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How often are permits renewed?
every 2 yrs
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Do you need to be a pharmacist to own/permit a pharmacy?
No
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What must occur before a permit is issued? What must you have before DEA registration?
- *An inspection
- *Need a permit before DEA registered
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You may advertise drugs and pricing, but what are the 2 exceptions?
- *No controlled substances advertising
- *No advertising ephedrine, stimulants, drugs for mental alertness, weight loss, appetitie control, energy, and non-FDA approved indications
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How often must expiration dates be checked?
every 4 months (3 times a yr) and remove immediately
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How often must you conduct Continuous Quality Improvements Program reviews?
Every 3 months (quarterly)
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How long must you maintain CQI reports?
2 years
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You must give the generic unless:
- 1) Pt requests brand
- 2) Doc says it's "medically necessary"
- 3) Drug is in negative formulary
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Are samples allowed in community pharmacy?
No
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Are samples allowed in class II IP?
Yes upon written request of prescriber
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How many permits can a pharmacy have?
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