Definitions

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:

  1. provide effective storage and security of controlled substances contained in the device;
  2. limit access to authorized individuals;
  3. record the identity of all personnel who access the controlled substances stored within the device;
  4. provide documentation of storage and removal of contents;
  5. provide ongoing documentation that monitors the proper delivery of controlled substances to ensure patient safety; and
  6. comply with Massachusetts General Laws and regulations of the Department of Public Health and the Board of Registration in Pharmacy.

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.

Health Care Facility with On Site Pharmacy

General

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.

Notification To The Board and Department

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:

  1. Written notification mut be sent to the DCP and the Board within 30 days of the anticipated change;
  2. The name and address of the health care facility;
  3. The location of the automated dispensing device;
  4. Manufacturer's name and model of automated dispensing device; and
  5. A brief description of how and why the device is going to be used.

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.

Labeling/Packaging

The pharmacy policy and procedures shall include, but not be limited to, the following:

  1. Packaging requirements: controlled substances that are stored in an automated dispensing device must be in the manufacturer's sealed, original packaging or repackaged in accordance with professional practice standards for extemporaneous packaging if the device is limited to an individual dosage.
  2. Requirements for delivery record: a record of all the controlled substances that are delivered to the automated dispensing device must be generated by the pharmacy prior to loading in the machine. This record must identify the following:
  1. name of controlled substance;
  2. dosage form;
  3. strength;
  4. quantity;
  5. identification of automated dispensing device to which controlled substances are delivered; and
  6. name of pharmacist or pharmacist designee loading the controlled substances.

Filling/Stocking

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.

Record Keeping

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:

  1. All events involving the automated dispensing device must be recorded electronically;
  2. A review of patient activity involving controlled substances must be conducted at least every 24 hours by nursing management;
  3. Records must be maintained by the pharmacy for not less than two years and must be readily available to the Department of Public Health and the Board of Registration in Pharmacy upon request. Such records shall include:
  1. location of system accessed;
  2. identification of the individual accessing the automated dispensing device;
  3. type of transaction;
  4. name, strength, dosage form, and quantity of the controlled substance accessed;
  5. name or other identifier of the patient for whom the controlled substance was ordered; and
  6. such additional information as the Pharmacist-in-Charge may deem necessary.

Drug Loss

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.

Access

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:

  1. Requirement for access: Each individual authorized by the Pharmacist-in-Charge must have a unique password that enables him or her to access the automated dispensing device. The Pharmacist-in-Charge must maintain a list of all persons who have access, and the limits of that access; must be able to stop or change access at any time; and is responsible for documenting any unauthorized entry into the automated dispensing device;
  2. Requirement for temporary access codes: The Pharmacist-in-Charge may issue temporary access codes for persons who work on a per diem basis at the health care facility. These temporary access codes will be valid for a period not to exceed the anticipated period of employment, but in no case to exceed seven (7) days. In the event that the facility permits agency staff to utilize the automated dispensing machine, the access code should be limited to a 24 hour period;
  3. Following the termination or resignation of any employee with access to the automated dispensing device, the Pharmacist-in-Charge must delete that individuals' access code from the device within 24 hours after the employee leaves the facility;
  4. Requirement for withdrawal of controlled substances or medical devices: Authorization to withdraw any controlled substance or medical device from an automated dispensing device must be limited to persons authorized to prescribe, administer or dispense controlled substances pursuant to M.G.L. c. 94C;
  5. The Pharmacist-in-Charge must conduct reviews of user access reports at least quarterly; and
  6. The Pharmacist-in-Charge must ensure that personnel with access to the automated dispensing device are adequately trained in the use of the device.

Administration of Controlled Substances

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.

Maintenance

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.

Disposal of Controlled Substance

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.


This information is provided by the Division of Health Professions Licensure within the Department of Public Health.