24 Del. Admin. Code §§ 2500-16.0
Current through Register Vol. 27, No. 12, June 1, 2024
Section 2500-16.0 - Automated Delivery Devices16.1 Definitions - Words and terms defined in Title 24, Section 2502 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within Section 16.0, shall have the following meaning, unless the context clearly indicates otherwise: "Authorized agent" is as defined in subsection 8.1.
"Automated delivery device" or "device" means a mechanical device used exclusively for the storage and delivery to patients of prescriptions that have been processed and verified by a licensed pharmacist.
"Delivery" is defined in subsection 5.1.
16.2 Automated delivery devices may be utilized by licensed pharmacies and shall comply with the following provisions: 16.2.1 Devices may only include refilled prescription medication for which counseling is not required under subsection 5.3.16.2.2 Devices may include all prescriptive medication except schedule II controlled substances.16.2.3 Devices shall include Board-approved means of patient identification, identification of persons authorized to pick up medication other than the patient, and identification of pharmacy personnel who place medication into the device.16.2.4 Devices shall electronically record all delivery transactions and such records shall be readily available for inspection for at least three years. Such records shall include, but are not limited to, the following for all transactions: the identity of pharmacy personnel who place medication into the device; the identity of the patient or authorized person who picks up the medication; the type, date, and time of the transaction; and the name, strength, dosage, form, and quantity of the drug delivered. The Board and pharmacist-in-charge may require additional information at their discretion.16.2.5 Devices may operate during any store hours at the pharmacy's discretion.16.2.6 A Delaware-licensed pharmacist shall be immediately available in-person for consultation when the device is in service and the pharmacy is open. A Delaware-licensed pharmacist shall be immediately available telephonically via a toll-free number when the device is in service and the pharmacy is closed. Pharmacists providing telephonic consultation shall have access to the same patient information as would be available to a pharmacist conducting an in-person consultation.16.2.7 The following information shall be posted in the vicinity of the device:16.2.7.1 Pharmacy hours of operation,16.2.7.2 Device hours of operation, and16.2.7.3 Consultation availability, i.e. in-person during pharmacy hours and telephonically after-hours, including the toll-free number for after-hours consultation.16.2.8 The device shall be attached to the pharmacy department area in a manner acceptable to the Board.16.2.9 All delivery devices shall be reviewed, inspected, and approved by the Board or its authorized agent prior to installation.16.2.10 Patients using the device must have opted to use the device and signed a written consent form demonstrating their informed consent and intention to do so.16.2.11 Written policies and procedures shall be maintained and available for inspection. Written policies and procedures shall be acceptable to the Board and shall include, but are not limited to, the following topics:16.2.11.1 Maintaining the security of the device and the medications it contains.16.2.11.2 A list of medications appropriate and approved for storage in the device; a list of the criteria used to determine the appropriate medications, with explanations when necessary; and a list of patient qualifications for device usage.16.2.11.3 Patient orientation of device usage, including being informed of which medications may and may not be delivered via the device.16.2.11.4 Pharmacy personnel training and responsibilities pertaining to device operations and maintenance.16.3 The Pharmacist-in-Charge shall have the sole responsibility to:16.3.1 assign, discontinue, or change access to the system; and16.3.2 ensure that access to the medications comply with state and federal regulations.24 Del. Admin. Code §§ 2500-16.0
11 DE Reg. 689 (11/01/07)
21 DE Reg. 989 (6/1/2018) (Final)