5.5 Automated Dispensing Systems & Remote Pharmacy Operations in Georgia

Automated Dispensing Systems in Georgia

The integration of technology in pharmacy practice is heavily regulated to ensure patient safety and prevent the diversion of controlled substances. In Georgia, automated dispensing systems are primarily utilized in institutional settings (like hospitals) and long-term care facilities (like skilled nursing facilities). The Georgia Board of Pharmacy has established detailed rules for the operation, stocking, and monitoring of these systems.

Remote Automated Medication Systems (RAMS)

A Remote Automated Medication System (RAMS) is an automated device located at a facility that does not have an on-site pharmacy, which is used for the storage and dispensing of medications. In Georgia, RAMS are specifically permitted for use in Skilled Nursing Facilities (SNFs) and hospices.

Licensing and Authority

To operate a RAMS in a Georgia SNF or hospice, the managing pharmacy must be fully licensed by the Georgia State Board of Pharmacy. The pharmacy cannot be an out-of-state mail-order facility operating a RAMS in Georgia; it must have a physical, licensed presence or appropriate non-resident licensure that explicitly authorizes RAMS operation under Georgia rules.

The Pharmacist-in-Charge (PIC) of the managing pharmacy bears the ultimate responsibility for the RAMS. The PIC must ensure that the RAMS is operating correctly, that security is maintained, and that all state and federal laws are followed.

Stocking and Restocking a RAMS

The process of placing medications into a RAMS is highly restricted to prevent errors and diversion.

1. Who can stock? A RAMS may be stocked by a licensed pharmacist, a pharmacy intern, or a registered pharmacy technician.
2. Supervision and Verification: If a pharmacy technician stocks the RAMS, they must be directly supervised by a pharmacist. However, Georgia law allows for technological supervision. If the RAMS utilizes bar-coding technology or advanced electronic verification that ensures the correct drug is placed in the correct compartment, direct on-site pharmacist supervision during stocking may be bypassed, provided a pharmacist verified the medications prior to them leaving the pharmacy.
3. Medication Forms: Medications placed in a RAMS must be in unit-dose or unit-of-issue packaging. Bulk bottles are generally not permitted unless the system is specifically designed to handle and accurately dispense from bulk securely.

Dispensing from a RAMS

A RAMS must be profile-driven. This means that before a nurse or authorized caregiver at the SNF can remove a medication from the RAMS for a patient, a pharmacist at the managing pharmacy must receive the medication order, review it for clinical appropriateness (drug interactions, allergies, correct dosing), and authorize the release of the drug.

• Override Function: In a medical emergency where immediate medication access is required, the RAMS may have an override function. However, the use of this override must be strictly limited, documented, and reviewed retrospectively by a pharmacist within a specified timeframe (typically 24 hours).

Automated Dispensing Cabinets (ADCs) in Hospitals

Hospitals in Georgia frequently utilize Automated Dispensing Cabinets (e.g., Pyxis, Omnicell) on patient care units. The regulations for ADCs are similar to RAMS but are tailored for the acute care hospital environment.

Profile-Driven Requirement

Like RAMS, hospital ADCs must be profile-driven. A pharmacist must review and verify the physician's order before the ADC will allow the nurse to access the specific medication for the patient. This prospective review is a critical safety step.

Emergency Overrides in Hospitals

Hospitals require rapid access to medications in emergencies (e.g., a code blue, severe acute seizures, acute severe pain). The hospital's Pharmacy and Therapeutics (P&T) committee must establish a strict policy defining which medications are eligible for override and under what clinical circumstances.

When a nurse uses the override function:

1. They bypass the pharmacist's prospective review.
2. They must document the reason for the override.
3. A pharmacist must retrospectively review the override transaction, typically within 24 hours, to ensure the medication was appropriate and actually ordered by a physician.

Security, Discrepancies, and Inventory in ADCs

• Biometric Access: Most modern ADCs require biometric access (fingerprint) or secure passwords to ensure only authorized nursing staff can remove medications.
• Blind Counts: To prevent diversion of controlled substances, ADCs often require a "blind count." When a nurse accesses a compartment containing a controlled substance, the machine forces them to count and enter the total remaining quantity before allowing them to remove their dose. If the count is off, a discrepancy is immediately flagged for pharmacy investigation.
• Discrepancy Resolution: Any unresolved controlled substance discrepancy must be investigated by the pharmacy staff promptly and reported to the PIC and, if unresolved or indicating theft, to the GDNA.

Remote Pharmacy Operations & Order Entry

Georgia allows for remote order entry, which permits pharmacists to process prescriptions, conduct Drug Utilization Reviews (DUR), and authorize ADC/RAMS dispensing from a location other than the physical pharmacy (e.g., a centralized order entry center or even a home office).

Key Requirements for Remote Order Entry:

• The remote pharmacist must have secure, encrypted access to the pharmacy's information system.
• The remote pharmacist must be licensed in Georgia if they are processing orders for Georgia patients.
• The primary pharmacy remains responsible for the actual dispensing and physical handling of the drug.
• Remote order entry does not allow for remote dispensing (e.g., a kiosk dispensing drugs to an outpatient) without specific telepharmacy variances granted by the Board, which are strictly limited in Georgia.

MPJE Focus Areas

When studying this section for the exam, focus heavily on who is allowed to stock the machines, the requirement for profile-driven dispensing (pharmacist review first), and the stringent controls around override capabilities. Understand that the PIC is always ultimately responsible for the integrity of the automated system.