EXAM 3 lecture 19 Flashcards
Pharmacy permit expirations
Pharmacy Permits expire every two years on December 31st of odd-numbered years, renewal is similar to the pharmacist renewal process.
Category I Pharmacies
They provide drugs or devices to outpatients under a prescription
A Category I pharmacy may offer drugs or devices to:
- A long term care facility
- A health facility
- An assisted living facility
Category II Pharmacies
They provide pharmaceutical care to inpatients under a drug order
A Category II pharmacy may offer drugs or devices to specific individuals pursuant to a prescription:
- an employee, student, volunteer of hospital/health system
- a retiree in a benefit program
- an independent contractor
- a member of hospital board
- a member of hospital staff
Any dependents above
Physical requirement of the pharmacy
- be stationary
- be sufficiently secure (detect and deter entry when pharmacy is closed)
- be well lit and ventilated
- be equipped with a sink with hot and cold running water, a proper sewage outlet, and refrigeration
- be sufficient size to allow for practice
- have equipment required by board to operate with state and federal law
Pharmacy Permit Application
Application form requirements:
- Name and occupation of persons requesting the permit
- The location of the pharmacy
- Any other information the board requires
Permit ensures adequate staffing
After an application is approved, but before pharmacy opens – it must submit to an inspection by board representative
Pharmacist Supervision
Requires reasonable and vocal distance of the pharmacist
May not supervise more than:
- 8 interns, techs or techs-in-training at once
- no more than 3 of 8 may be techs in training
A category I or category III pharmacy may request to be open to the general public without a pharmacist on duty if:
- They obtain approval from the board
- They securely lock all legend drugs and other merchandise which can only be dispensed by the pharmacist
- They prominently display a 20” x 30” sign stating: Prescription Department Closed, No Pharmacist on Duty
- Only a pharmacist has access to the secured area
You cannot practice pharmacy without a pharmacist license, and without a pharmacy permit
- Inappropriate display of either of these items, or practice without these appropriate licensure and permit, is grounds for a violation
- You can’t even use words in a title which might cause the public to believe that pharmacy is being practiced (pharmacy, pharmacist, apothecary, drugs, etc.).
Transfer of pharmacy ownership
- Within 10 days of the change of ownership of a pharmacy, an application must be submitted to transfer the ownership
- If the new owner moves the pharmacy, an application for a permit for the new location must be filed.
Temporary & Permanent Pharmacy Closure
If a pharmacy will be closed for 5 days or more, the permit holder must notify the board of the closure and secure drugs as directed by the board
Transferring Prescriptions
- Upon request of a patient, a pharmacy shall transfer to another pharmacy a prescription for a patient (including C-II), that the pharmacy has received but not filled unless prohibited by law or writing prescriber
- A prescription for a patient may be transferred electronically or by fax if pharmacies don’t share a common data base
- A technician may transfer a prescription, including a verbal transfer, as delegated by the pharmacist
Electronic Controlled Substance Transfers
Electronic prescriptions may be transferred to another pharmacy, even if they have never been filled. This applies to all schedules, and is allowed if:
- Allowed by state law
- Prescription was electronically prescribed
- If communicated between two licensed pharmacists
- If the prescription is maintained in an electronic format
Non-electronic Controlled Substance Transfers
Any non-electronic transfers are limited to C-III, C-IV, and C-V prescriptions
- These prescriptions must have been filled at least once before being eligible to be transferred.
Original Prescription Maintenance
All original prescriptions shall be organized, maintained and accessible at the pharmacy for at least two years.
They must be available for inspection to any member of the board or agent of the board.
A prescription may not be refilled:
without written, electronically transmitted, or oral authorization of a licensed practitioner
A prescription may be refilled by a pharmacist without written, electronically transmitted, or oral authorization of a licensed practitioner if the following conditions are met:
- RPh made reasonable effort to obtain authorization
- RPh believes failure would be detrimental to the patient’s health
- The original prescription authorized refills, but it is expired
- Rx was originally filled at pharmacy where the request was received
- Rx is prescribed for continuous use
- RPh documents the info like time dates to contact prescriber
- RPh notifies the original prescriber by next business day
- Max 1 RPh-initiated refill for a single Rx every 6 months
- Drug is not CS
IF prescriber writes “No emergeny refill” this cannot occur
A pharmacist may dispense up to a 90-day supply of a medication for a patient if:
- The patient requests a supply of more than 30 days
- The prescription is not a controlled substance
- The prescriber does not indicate on the prescription that the quantity of the prescription may not be changed
- The patient has completed an initial 30-day supply of the drug therapy
- The prescription and included refills allow the pharmacist to dispense at least a 90-day supply of the medication.
Prescription Validity
A prescription is valid for not more than 1 year after the original date of issue
A pharmacist may not knowingly dispense a prescription after the demise of the prescriber, unless the pharmacist judges it to be in the best interest of the patient’s health.
A medication may not be resold, reused, or redistributed after being returned to the pharmacy unless the medication:
the pharmacist may use their professional judgement
- Was dispensed to an individual residing in an institutional facility, a hospice program, or a county jail or department of correction facility
- Was properly stored and securely maintained
- Is returned unopened and was dispensed either in the manufacturer’s original container, or in a multiple dose blister container or unit dose package supplied by the dispenser
- Was dispensed by the same pharmacy that is accepting the return
- Is not expired
- Is not a controlled substance
A pharmacist, acting in good faith, exercising reasonable care, and obtaining patient consent may
change the quantity of medication prescribed if:
- The prescribed quantity is incorrect package size
- The change quantity is related to a change in dosage form
- The change quantity reflects the intended day supply
Change the dosage form of the prescription if in the best interest of the patient
Complete missing info on a prescription if there is sufficient evidence to support the change
Extend a maintenance drug for the limited quantity necessary to coordinate a patient’s refills in a medication synchronization program
A pharmacist may not dispense epinephrine or glucagon to a person unless
The product has an expiration date of not less than 12 months from the date dispensed
A pharmacist may substitute a therapeutic alternative for epinephrine products to a patient.
TRUE
*Note that this is not generic substitution, this is changing to a different chemical
structure in the same therapeutic class with the same expected therapeutic
effects and adverse reactions
Pharmacists may also dispense epinephrine pursuant to a standing order, so
long as…
the individual has completed a training and can administer the drug to
patients experiencing anaphylaxis
A pharmacist administering an immunization must:
- Notify the physician who authorized the immunization
- Not administer immunization to anyone under 11, and not for pneumonia under age 50
- Must receive consent from the patient, or if <18 their parent/guardian
A pharmacist may admin immunization according to a protocol approved by a physician for
Influenza
Shings
Pneumonia
TDap
HPV
Meningitis
MMR
Varicella
HEPA + B
Hib
COVID