Tenn. Comp. R. & Regs. 1140-13-.06

Current through September 10, 2024
Section 1140-13-.06 - PHARMACIST RESPONSIBILITIES
(1) Pharmacy Operations and Security.
(a) The pharmacist-in-charge shall ensure that the central pharmacy's connection with the satellite clinic through computer, videolink, and audiolink is operational at all times that the satellite clinic is open.
(b) In the event that the computer, videolink, or audiolink connection is not operational, the pharmacist-in-charge shall ensure that the satellite clinic shall cease to operate relative to the issuance of prescriptions supplied by the central pharmacy until the links are reconnected. Whenever an interruption of data, video, or audiolink occurs between the central pharmacy and the satellite clinic, no prescription shall be dispensed, and a sign shall be posted noting the closure with an estimated time until a resumption of services can be expected.
(c) The pharmacist-in-charge shall ensure that prescriptions for controlled substances schedules I, II, III, or IV are not issued from the satellite clinic.
(d) The pharmacist-in-charge shall ensure that only the pharmacists and pharmacy technicians employed by the federally qualified health center and working in the satellite clinic shall have keys to the satellite clinic.
(e) The pharmacist-in-charge shall ensure that the security at the central pharmacy shall be performed in accordance with Tenn. Comp. R. & Regs. Rule 1140-01-.12.
(f) The pharmacist-in-charge shall ensure the security of the storage of drugs at the central pharmacy and the satellite clinic.
(g) The pharmacist-in-charge shall ensure that the prescriptions filled at the central pharmacy and stored in the satellite clinic to be issued to patients and caregivers by means of telepharmacy shall be segregated in a secure area in the pharmacy room from other medications stored in the pharmacy room that have not been filled and will not be issued through the telepharmacy program.
(h) The pharmacist-in-charge shall ensure that pharmacy technicians working at the central pharmacy are supervised by a pharmacist in accordance with Rule 1140-02-.02(8).
(i) The pharmacist-in-charge shall ensure that pharmacy technicians working at the satellite clinic shall be supervised by a pharmacist without a pharmacist being physically present.
(j) The pharmacist-in-charge may request a waiver of Tenn. Comp. R. & Regs. Rule 1140-03-.14(12) upon a showing of good cause.
(2) Verification.
(a) The pharmacist shall perform all in-process and end-process verification of the pharmacy technician's activities, including, but not limited to: checking the contents of the prescription bottle; checking the bottle label; checking the prescription; performing a drug utilization review in accordance with Tenn. Comp. R. & Regs. Rule 1140-03-.01(3); and performing patient counseling.
(3) Patient Counseling.
(a) If a pharmacist is not physically present at the satellite clinic and the patient or patient's agent is being issued a new prescription, then the pharmacist shall counsel the patient or patient's caregiver by means of telepharmacy before the prescription is issued.
(b) If a pharmacist is not physically present at the satellite clinic and the patient or patient's agent is being issued a refilled prescription, then the pharmacy technician shall offer counseling to the patient or patient's caregiver by means of telepharmacy before the prescription is issued.
(c) Pharmacists shall counsel patients in accordance with Board of Pharmacy rules whether the medication is issued from the central pharmacy or the satellite clinic.
(4) Supervision.
(a) The pharmacist-in-charge shall ensure that each individual operating as a pharmacy technician while employed by a federally qualified health center at a central pharmacy or satellite clinic is properly registered with the Board at all times.
(b) The pharmacist-in-charge or a designee of the pharmacist-in-charge shall complete an in-person inspection twice a month of the satellite clinics to ensure compliance with all applicable laws and rules relative to drugs and the practice of pharmacy outlined in the central pharmacy's policies and procedures.
(c) The pharmacists working at the federally qualified health center are not required to be physically present to verify the accuracy of all pharmacy technician functions performed at the satellite clinic while participating in this program; verification may be conducted by means of the computer link, videolink, and audiolink.
(5) Policies and Procedures.
(a) The pharmacist-in-charge shall ensure that the central pharmacy and satellite clinic have policies and procedures including, but not limited to the following:
1. when and how a pharmacy technician should contact a pharmacist to perform the issuing process;
2. how the pharmacy technician is to use the computer, videolink, and audiolink technology to communicate with the pharmacist;
3. delivery of the filled prescriptions to the satellite clinic to be issued to the patient or the patient's caregiver;
4. recordkeeping process to track the prescriptions dispensed from the central pharmacy and issued from the satellite clinic;
5. recordkeeping process to track the filled prescriptions received by the satellite clinic from the central pharmacy;
6. how to securely transport the filled prescriptions from the central pharmacy to the satellite clinic;
7. how to order prescriptions and refills for the central pharmacy;
8. how to ensure that patient counseling is performed in accordance with this chapter;
9. when and how unissued medications will be disposed of or sent back to the central pharmacy.

Tenn. Comp. R. & Regs. 1140-13-.06

Public necessity rule filed November 25, 2008; effective through May 9, 2009. New rule 1140 filed February 24, 2009; effective May 10, 2009.

Authority: Chapter 1028 of the Public Acts of 2008, § 2 and T.C.A. §§ 63-10-601 through 63-10-602. [effective July 1, 2008].