Pharmacy Operation
At the state level, the board of pharmacy may offer certain specialty pharmacist licenses such as
Nuclear pharmacist
Consultant pharmacist
Clinical Pharmacist ( mid level practitioner with prescriptive authority)
license is restricted for a specified period of time is
probation
license is inactivated may be reinstated after conditions are met
suspension
license is taken away by licensing agent
revocation
individual agrees to voluntarily gives up licensure under the pressure to avoid penalties or criminal charges
surrender
license that lapsed was suspended or revoked is returned to active status authorizing practice as defined by that license
reinstatement
The state board or regulatory agencies financially sponsor state rehabilitation programs. Only requires desire to seek help. an a leniency be granted to licensee who voluntarily enrolls in the program
yes leniency may be granted to a licensee
What are required as part of licensing application when opening, running and maintaining a pharmacy?
physical address of pharmacy
classification of pharmacy ( community, hospital, specialty)
name and license number of PIC
Application fee payable to licensing agency
NPI for the pharmacy
state require licensing agency or board of pharmacy to inspect pharmacy during application process and periodically thereafter T/F
T
After licensure pharmacy will have to renew the license usually annually or biennially by submission of a renewal application and fee
Do the following groups have to be licensed?
out of state or non resident pharmacies
wholesalers
manufactures/repackager
distributers
third party logistics
yes
After obtaining a state license or permit, a facility or prescriber must register with DEA. After initial approval, the DEA will send a registration renewal notice to registrant ______ days prior to expiration.
60
An out of state pharmacy can perform centralized or shared services for another pharmacy such as dispesnisng, DUR etc Should patients be notified?
Patients should be notified if another pharmacy fills their prescription
T/F All pharmacies that dispense controlled substances must have a valid DEA registration unless exempt meet PDMP requirements when applicable
T
Specialty pharmacies : NABP recongnizes what type of pharmacy as specilaties that usually requires board certification or other training
Nuclear and radiologic pharmacies
must be present all the times in the pharmacies
for radioactive material must have caution radioactive material on container
Pharmacy Inspection and space and equipment page 37
equipment
libraries
what are some of the documents can be kept int he pharmacy?
every state permit electronic with exception of few
current copy of state laws and regulation
drug information resource and references
if compounding then USP chp 797,
radiopharmaceutical for nuclear pharmacy
Pharmacy access by non pharmacist personnel should be kept at a minimum and entry of non- pharmacy staff will be at the discretion of pharmacist: T/F
True
Renaming, relocating, closing a pharmacy:
A change of business name, closure or relocation of pharmacy will require notification to the sate board within set limit such as _____ or within ____
immediately or within 30 days
the DEA will require change of address notice for registrant when schedule drugs are moving location such as with relocation
true
All pharmacies must publicly display or have readily available all licenses of the licensed personnel T/F
T
Patient records relating to prescriptions and pharmacy operations can be stored how?
In a hard copy or electronic format or in a combination of two
What are some of the records that must be kept by pharmacies include are
Patient profile ( with included information pt name, address, hone number, DOB, gender, drugs, any other information)
Dispensing record for each rx
receipt for all drugs purchased and received by the pharmacy
compounding log
DEA Form 222
Logbook for OTC sales of ephedrine or pseudoephedrine
Instituitional Pharmacy:
Is a licensed nurse authorized to restock automated dispensing systems with verification technology such as barcode scanning?
yes when a pharmacy is NOT physically attached
Absence of pharmacist in the hospital.
A supply of drugs should be located outside of the pharmacy such as night cabinets or ADSs.
True or False ; For emergencies, the PIC may grant pharmacy access for authorized individuals
True
each facility must designate authorized individuals who can access the locked cabinets and or the pharmacy
Emergency kits
What drugs in general can be contained in these kits?
controlle dan dnon controlled as long ass pharmacy supplying the controlled drugs can complies with state and federal regulations
Emergency kits
Pharmacist ( or designated person) has what responsibilities for Emergency kits
seal and store kits in a secure location that only allows for authorized access
expiration date must be the earliest expiration date of any drug within the
when kit expires pharmacist must replace expired drug and update expiration date
drug should be removed in pursuatant to chart order
True/False: It is not necessary for the pharmacist to be notified anytime when emergency kit is opened
False
must be notified. Pharmacy will then restock and reseal the emergency kit
what are the 3 required things required on emergency kit label
drug name strenght and quantity
expiration date of contents
NAT of supplying pharmacy ( name address telephone)
ADS in LTCF
Can ADS in LTCF contain both controlled and non controlled?
yes
FYI examples of ADS are pyxis , omnicell
Are drugs stored in the ADS considered LTCF stock or pharmacy stock?
pharmacy stock but before they are dispensed!
What other registration requirement does the pharmacy stocking meds in LTCF ADS need to have?
pharmacy needs a separate DEA registration
Telepharmacy
A patient brings Rx to remote sites staffed by technicians and nurses. What are the duties of the central pharmacist?
supervisies workflow over teleconferencing system
verifies prescription transmitted from rural site
Rx label and packaged are dispensed from ads at remote site
pharmacist counsels patient through real time video
page 42 skipped
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Any drug that is not kept under proper storage conditions is considered
a) misbranded
b) adultered
adultered must be removed placed i separate area and disposed
finish page 44-49
b