Lecture 19 Flashcards
(25 cards)
Pharmacy Permits
Three categories of pharmacies listed in Indiana:
Category I: A pharmacy that provides pharmaceutical care to the general public by dispensing of a drug or device
Category II: A pharmacy that provides inpatient care under a drug order or to an outpatient of the institution under a prescription
Category III: A pharmacy that provides closed door operations that are not open to the general public. May include traditional and nontraditional pharmacy functions.
Pharmacy permits when do they expire
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. They can also fill inpatient prescriptions in this unique circumstances:
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
Generally institutional settings (hospitals, health care facilities, nursing homes, etc.). They provide pharmaceutical care to inpatients under a drug order, however they can also fill outpatient prescriptions in this unique circumstance:
A Category II pharmacy may offer drugs or devices to specific individuals pursuant to a prescription:
1.An employee, student, or volunteer of the hospital or health system;
2.A retiree participating in a retirement or benefit program administered by the hospital;
3.An independent contractor exclusively working with the hospital;
4.A member or the hospital’s governing board; or
5.A member of the hospital’s medical staff; and
6.Any dependents of the individuals listed above
Physical Requirements of the Pharmacy
in order to be eligible for a pharmacy permit, a pharmacy must:
1.Be stationary (unless registering specifically as a mobile location)
2.Be sufficiently secure, and able to detect and deter entry when the pharmacy is closed
3.Be well lighted and ventilated and otherwise cleanly
4.Be equipped with a sink with hot and cold running water, a proper sewage outlet, and refrigeration
5.Be of sufficient size to allow for the practice of pharmacy
6.Have other equipment as required by the board to operate in compliance with state and federal law
Pharmacy Permit Application
If you want to open your own pharmacy, you must complete an application form. That form will include:
The name and occupation of the persons requesting the permit
The location of the pharmacy
Any other information the board requires (see previous slides)
Separate applications for each pharmacy must be filed
The permit holder is responsible for ensuring adequate staffing of the pharmacy
The board shall grant or deny a permit not later than 120 days after the application (and any additional information required) is submitted
After an application is approved, but before the pharmacy is open, it must submit to an inspection by a representative of the board
Pharmacist Supervision
A pharmacist may not supervise more than:
8 pharmacy interns, pharmacy technicians, or pharmacy technicians in training at any time.
No more than 3 of the 8 individuals supervised may be techs in training
Immediate and personal supervision means within reasonable visual and vocal distance of the pharmacist.
Absence of a Pharmacist
When pharmacies are licensed, usually the entire building is licensed as a pharmacy.
How does that impact stores with hours outside of the pharmacy hours?
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
Certificates of Licensure – Unlawful Acts
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.).
If you don’t follow these rules its felony, failure to display pharmacist licensure appropriately can result in penalties up to an including revocation of the licenses
Transfer of Pharmacy Ownership
Within 10 days of the change of ownership of a pharmacy, an application must be submitted to transfer the ownership. Once the new permit is issued, the old permit must be returned to the board within 10 days.
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.
If a pharmacy is to be permanently closed, the owner must:
-Notify the board at least 20 days before the transfer of any controlled substances and submit an inventory form required by the DEA to the board
-Remove all legend drugs from stock
-Submit the licensed premises to an inspection by the board
-Remove any symbols and signs alluding to pharmacy practice
-Return the pharmacy permit to the board within 10 days after all drugs and devices are removed from the premises
Transferring Prescriptions
1.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 in writing by the prescriber
-Prohibited by federal law
2.A prescription for a patient may be transferred electronically or by fax if pharmacies don’t share a common data base
3.A technician may transfer a prescription, including a verbal transfer, as delegated by the pharmacist
Electronic Controlled Substance Transfers
In 2023, the DEA noted that 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
-The prescription was electronically prescribed
-If communicated between two licensed pharmacists
-If the prescription is maintained in an electronic format
These are one-time transfers, unless the two pharmacies involved share a real-time, online database
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.
May only be transferred one time unless the two pharmacies share a real-time online database (may transfer up to the maximum refills in this case)
Transfers must be communicated directly between two licensed pharmacists
IC 25-26-13-25: The Big One
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.
Refills
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:
1.The pharmacist made every reasonable effort to obtain authorization to refill from the prescriber
2.The pharmacist believes that failure to provide a refill would be detrimental to the patient’s health
3.The original prescription authorized refill(s), but all refills were dispensed or the prescription is expired
4.The prescription was originally filled at the pharmacy where the request for refill is received, or at an affiliate sharing a real-time, online database
5.The drug is prescribed for continuous and uninterrupted use and has been taken properly by the patient
6.The pharmacist documents the required refill information, the dates and times attempts to contact the prescriber were made, and that the pharmacist dispensed a refill without prescriber authorization
7.The pharmacist notifies the original prescriber by the prescriber’s next business day
8.Refill quantity is limited to the most recent fill quantity or a 30-day supply, whichever is less
9.Max of 1 pharmacist-initiated refill for a single prescription every 6 months
10.The drug is not a controlled substance
If the prescriber notes “No Emergency Refill” on the prescription, you can’t do this.
30-day to 90-day Supply
A pharmacist may dispense up to a 90-day supply of a medication for a patient if:
1.The patient requests a supply of more than 30 days
2.The prescription is not a controlled substance
3.The prescriber does not indicate on the prescription that the quantity of the prescription may not be changed
4.The patient has completed an initial 30-day supply of the drug therapy
5.The prescription and included refills allow the pharmacist to dispense at least a 90-day supply of the medication.
Prescription Validity, Demise of Prescriber or Patient
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 pharmacist may not knowingly dispense a prescription after the demise of the patient.
Returned Medication
A medication may not be resold, reused, or redistributed after being returned to the pharmacy unless the medication:
1.Was dispensed to an individual residing in an institutional facility, a hospice program, or a county jail or department of correction facility
2.Was properly stored and securely maintained
3.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
3.Was dispensed by the same pharmacy that is accepting the return
5.Is not expired
6.Is not a controlled substance
The pharmacist may use professional judgement to determine whether to accept medication for return under this section.
Prescription Adaptation
A pharmacist, acting in good faith, exercising reasonable care, and obtaining patient consent, may:
Change the quantity, Change the dosage form of the prescription if it is in the best interest of patient care, so long as prescriber’s directions are also modified appropriately,Complete missing information 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
does not apply to controlled substances, compounded drugs, or biological products, or if the prescriber has indicated that adaptation of a prescription is not permitted
Dispensing Epinephrine and Glucagon
1.A pharmacy 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
-The person consents to a shorter expiration date
2.A pharmacist may substitute a therapeutic alternative for epinephrine products to a patient.*
*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
Immunizations
A pharmacist may administer an immunization to an individual under a drug order or prescription
A pharmacist may administer immunizations according to a protocol approved by a physician for
Influenza,Shingles, Pneumonia, Tdap, HPV, Meningitis, MMR, Varicella, Hep A, Hep B, Hib, COVID.
Immunization
A pharmacist administering vaccinations approved by a physician MUST
-Notify the physician who authorized the immunization and the PCP
-Not administer immunizations to anyone under age 11, and not for pneumonia under age 50.
-Must receive consent from the patient, or if under 18, the parent or legal guardian
Technician & Intern Immunization
In Indiana, pharmacy technicians and pharmacy interns may administer immunizations.
- must be under direct supervision by pharmacist, physician, PA, APRN, OR a registered nurse
