Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-14-3 - General Requirements3.1. Any other rule notwithstanding, a pharmacy may outsource a prescription drug order filling, excluding prescription drug orders for Schedule II controlled substances listed in West Virginia Code § 60A-2-206, to another pharmacy via central prescription filling provided the pharmacies: 3.1.a. Have the same owner; or3.1.b. Have entered into a written contract or agreement which outlines the services to be provided and responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations, and include confidentiality of patient information; and3.1.c. Share a common electronic file or have appropriate technology or interface to allow secure access to sufficient information necessary or required to fill or process a prescription drug order.3.2. The pharmacist in charge of the central fill pharmacy shall assure that:3.2.a. The pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication through the delivery process; and3.2.b. The filled prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.3.3. The filling, processing, and delivering of a drug order by a central fill pharmacy for an originating or delivering pharmacy pursuant to this series is not to be considered a drug order transfer or a wholesale distribution.3.4. Any filled prescription which was not picked up by or actually delivered to the patient must be put into the originating or delivering pharmacy's inventory.3.5. Prior to outsourcing the filling of a prescription to a central fill pharmacy, the originating or delivering pharmacy must notify patients that their prescription may be outsourced to a central fill pharmacy and provide the name and address of the central fill pharmacy. Such notice may be provided through a one-time written notice to the patient or through the use of a sign in the pharmacy.3.6. The originating or delivering pharmacy is responsible for making the offer to counsel to the patient or patient's agent picking up the prescription on behalf of the patient.3.7. Pharmacies that perform central prescription filling shall create operating policies and procedures. The policies and procedures must include: 3.7.a. an audit trail that records and documents the central prescription filling process and the individuals accountable at each step in the process for complying with Federal and State laws and regulations including recordkeeping; and3.7.b. provisions for dispensing prescription drug orders when the filled order is not received from the central fill pharmacy, or the patient or patient's representative comes into the originating or delivering pharmacy before the order is received from the central fill pharmacy. The standard of care must not be altered by the pharmacies' central fill program. Ultimately the patient's therapy cannot be unreasonably delayed.3.8. The prescription label of a centrally filled prescription shall display the name and address of the originating or delivering pharmacy and may include the name of the central fill pharmacy, as well as all other information required by Rule § 15-1-22.3.9. Each pharmacy engaging in central prescription filling shall be jointly responsible for: 3.9.a. Maintaining manual or electronic records that identify, individually for each drug order processed, the name, initials, or other unique identifier of each pharmacist, intern or pharmacy technician who took part in the central prescription filling functions performed at that pharmacy;3.9.b. Maintaining manual or electronic records that identify, individually for each drug order filled or dispensed, the name, initials, or other unique identifier of each pharmacist, pharmacy intern, pharmacy technician, and pharmacy technician trainee who took part in the filling and dispensing functions performed at that pharmacy;3.9.c. Maintaining a mechanism for tracking the drug order during each step of the processing and filling procedures performed at the pharmacy. The central fill pharmacy must keep a record of the date the filled prescription was delivered to the originating or delivering pharmacy and the method of delivery (i.e., private, common or contract carrier). The originating or delivering pharmacy must keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (i.e. private, common or contract carrier) and the name of the originating or delivering pharmacy employee accepting delivery;3.9.d. Providing for adequate security to protect the confidentiality and integrity of patient information; and3.9.e. Providing for inspection of any required record or information within 72 hours of any request by the Board or its designee.