This bill requires the department of health ("department") to authorize an approved pharmacy to receive specialty medication for inspection and restock and re-dispense unopened, unused, and unexpired specialty medication. As used in this bill, "specialty medication'' means a prescription drug that is used to treat (i) cancer or the side effects of cancer, (ii) the side effects of a prescription drug that is used to treat cancer, or (iii) diseases of blood and blood components.
This bill authorizes a specialty medication that was delivered to a healthcare facility where the patient receives treatment to be returned to an approved pharmacy only if such return is made by a provider at the healthcare facility and the specialty medication has not been in the possession of the patient and has not left the healthcare facility.
This bill requires a pharmacist in an approved pharmacy to inspect a specialty medication that has been returned before such medication can be restocked or re-dispensed, subject to the following conditions:
(1) If the pharmacist determines that the specialty medication has been altered, mislabeled, stored improperly, or expired and is beyond its use date, then the pharmacist must immediately discard the specialty medication;
(2) If the pharmacist determines that the specialty medication is unused, in its original, unopened tamper-evident packaging, and is not required to be discarded pursuant to (1) above, then the pharmacist may restock the specialty medication; and
(3) If the pharmacist determines that the specialty medication is in single-unit dose packaging that is unopened and undisturbed, then the pharmacist may restock the specialty medication.
REIMBURSEMENT OR CREDIT GIVEN
This bill provides that if the specialty medication is eligible to be restocked, then the approved pharmacy must reimburse or credit the entity that paid for the specialty medication, including TennCare, for such specialty medication returned to the approved pharmacy. An approved pharmacy must maintain a record of a credit or reimbursement that contains the (i) name and address of the healthcare provider that returned the specialty medication, (ii) name and address of the healthcare facility from which the specialty medication was received, (iii) amount of the credit or reimbursement, (iv) date the credit or reimbursement was issued, (v) name of the pharmacist issuing the credit or reimbursement, (vi) name of the person or entity to whom the credit or reimbursement was issued, (vii) date the specialty medication was dispensed, (viii) unique identification number assigned to the specialty medication by the pharmacy, and (ix) name, strength, and quantity of the specialty medication.
After the approved pharmacy has issued a credit or reimbursement, this bill authorizes the approved pharmacy to re-dispense the unopened and unused specialty medication.
LIABILITY
This bill requires a drug manufacturer to have active commercial general liability insurance to cover claims of injury, death, or loss to a person or property for matters related to the acceptance, restocking, or re-dispensing of a prescription drug manufactured by the drug manufacturer that is returned under this bill. Additionally, a person not subject to such a requirement, acting reasonably and in good faith, is immune from civil liability and criminal prosecution for injury to or the death of an individual to whom a returned prescription drug is re-dispensed under this bill and is exempt from disciplinary action related to the person's acts or omissions related to the acceptance, restocking, or re-dispensing of a returned prescription drug under this bill.
RULEMAKING
This bill requires the department to promulgate rules to establish procedures that ensure proper safety and management of specialty medication received and maintained by an approved pharmacy.
ON APRIL 10, 2024, THE SENATE ADOPTED AMENDMENT #2 AND PASSED SENATE BILL 2139, AS AMENDED.
AMENDMENT #2 rewrites the bill to, instead, do the following:
(1) Authorize the board of pharmacy to register any mechanical or electronic systems that operate solely on the premises of a hematology or oncology clinic in this state and that perform the storage, control, and dispensing of commercially-available drug products pursuant to a valid patient-specific prescription, as part of the operations of a licensed pharmacy. The pharmacy responsible for the operations of the mechanical or electronic system must maintain the collection, control, and maintenance of all transaction information and the security, control, and accountability for such commercially-available drug products;
(2) Prohibits controlled substances and compounded drug products from being stocked or placed inside such mechanical or electronic system;
(3) Prohibits the mechanical or electronic system from engaging in the administration of any drug product;
(4) Authorizes only a physician, a nurse, and a pharmacist or pharmacy technician licensed in this state to have access to the mechanical or electronic system as an agent of the patient;
(5) Requires the mechanical or electronic system to be stocked only by a pharmacist or a pharmacy intern or pharmacy technician acting under the supervision of a pharmacist;
(6) Requires the mechanical or electronic system to be nonmobile in nature and must be placed in a secure location behind a locked door at the hematology or oncology clinic;
(7) Requires each patient who receives a commercially-available drug product pursuant to a valid patient-specific prescription from the mechanical or electronic system to receive counseling in accordance with the rules of the board of pharmacy; and
(8) Requires the board to establish fees necessary to carry out the bill.