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Automated Dispensing Device ("device") means a mechanical device that delivers controlled substances or medical devices, other than by administration, and uses automated data processing technology to:
Pharmacist-in-Charge means the Director of Pharmacy or Pharmacist Manager of Record or a pharmacist so designated by one of the above. The Pharmacist-in-Charge is responsible for the establishment and enforcement of the policies and procedures regarding the use of automated dispensing devices.
Pharmacist Designee means a pharmacy intern or pharmacy technician who is designated by the pharmacist to prepare, deliver and store controlled substances and medical devices in an automated dispensing device.
The use of automated dispensing devices requires that adequate and appropriate policies and procedures and quality assurance programs are in place prior to implementation to ensure safety, accuracy, security, and patient confidentiality.
The Pharmacist-in-Charge must provide prior written notice of installation or removal of an automated dispensing device to the Board of Registration in Pharmacy [The Board] and the Department of Public Health, Drug Control Program [DCP] which shall include but not be limited to:
Detailed specific documentation relating to the use of the automated dispensing device such as policies and procedures must be maintained on-site in the pharmacy and be readily retrievable upon request. The submission of documentation to the Board and DCP shall not be considered as part of an approval process or an endorsement for the use of any particular automated device.
The pharmacy policy and procedures shall include, but not be limited to, the following:
Requirement for loading verification/count verification: At the time of loading any controlled substance in Schedules II - V into the automated dispensing machine the Pharmacist-in-Charge or pharmacist designee must verify that the inventory in the compartment being loaded is correct.When an automated dispensing device is loaded by a pharmacist designee, a mechanism must be in place to verify that the device has been properly loaded. Verification documentation must include a co-signature recording the delivery and should include the name of the nurse accepting the delivery. All records must be maintained for not less than two years and must be readily retrievable upon request. Any discrepancy must be recorded on the delivery record and reported immediately to the Pharmacist-in-Charge. The Pharmacist-in-Charge and nurse supervisor or physician are responsible for the reconciliation of the discrepancy.
Requirements for review of drug order: In compliance with applicable regulations, a pharmacist shall review medication orders, prior to removal of any controlled substances from an automated dispensing device. Exceptions include: Labor and Delivery, the Operating Room, the Emergency Department and when patient care could be seriously compromised. In such cases, medication orders for controlled substances in Schedules II-VI must be reviewed by a pharmacist within 24 hours after removal. The automated dispensing device must be capable of producing, for the pharmacist, a record of the patient's profile as maintained by the pharmacy. An approved list of controlled substances that may be accessed without pharmacist review must be approved by the Pharmacy and Therapeutics Committee of the facility. The Pharmacist-in-Charge must monitor the appropriateness of use of the override function by reviewing all override reports and the incident/event within 24 hours.
Requirements for records and/or electronic data maintained by an automated dispensing device:
Requirement for reporting a loss: In the event that a loss is identified, the Pharmacist-in-Charge must report the loss to the Board of Registration in Pharmacy within 7 days, pursuant to 247 CMR 6.02 (10), and the Department of Public Health immediately by telephone upon discovery in accordance with 105 CMR 700.005.
The Pharmacist-in-Charge must control, authorize and monitor the access to the automated dispensing device. The Pharmacist-in-Charge must incorporate these access requirements into the policies and procedures manual, which shall include:
The automated dispensing device shall be used only for the furnishing of controlled substances for immediate administration to inpatients and outpatients of the health care facility.
Inventory count for controlled substances in Schedules II through V, stored in dedicated compartments, must be verified by licensed staff (RN, LPN, CRNA, NP, Anesthesiologist) accessing the automated dispensing device prior to removing any controlled substance.
These guidelines apply to the furnishing of controlled substances for administration purposes for patients pursuant to a valid order.
Any controlled substance removed from the automated dispensing device but not administered to the patient must be returned to the automated dispensing device return bin if the item is unopened, remains in its original manufacturers' unit dose packaging and has not been exposed to conditions that might affect its efficacy (e.g. heat, humidity). In such cases, the controlled substance may be redispensed by the Pharmacist-in-Charge. Pre-filled syringes may not be returned to the automated dispensing device and must be destroyed by two licensed staff and documented accordingly.
The facility must have written policies and procedures that assures the automated dispensing device is in good working order, accurately dispenses the correct strength, dosage form and quantity prescribed, while maintaining appropriate recordkeeping. In addition, written policies and procedures must include requirements that any malfunction of the automated dispensing device be reported immediately to the Pharmacist-in-Charge.
The Automated dispensing device must provide a mechanism for the securing and accounting for disposal of controlled substances in accordance with state and federal laws.
If a controlled substance is removed from the automated dispensing device and requires disposal, accountability must be maintained at all times. Disposal must be conducted by two licensed staff and documentation in the automated dispensing device must effectively reflect the destruction process, pursuant to the health care facility's written policies and procedures.