1.9.1 Introduction
Automated dispensing units (ADUs) are mechanical systems that perform operations or activities, other than compounding or administration, relative to the storage, picking, packaging, labelling, and/or giving out medicines and medical devices. They are also called automated dispensing cabinets (ADCs), automated dispensing devices (ADDs), automated dispensing machines (ADMs), automated pharmacy systems (APS), or unit-based cabinets (UBC).
Council recognises that ADUs are technology advancements that can improve speed and accuracy of medicine delivery. ADUs can assist pharmacists and licensed dispensers with phase 2 of dispensing, freeing them to focus more on patient care. The role of ADUs in the dispensing process makes it necessary for Council to exercise its ethical and legal commitment to the community by regulating ADUs in order to ensure safe delivery of pharmaceutical services.
1.9.2 Purpose
The purpose of this standard is to regulate the use of ADUs in community pharmacies, institutional pharmacies, dispensaries in primary health care clinics and medicine rooms of licensed dispensers. Minimum standards specifically relating to ADUs are thus intended to guide pharmacists and licensed dispensers on the use of ADUs. Where ADUs are utilised, all relevant legislation is applicable.
1.9.3 General considerations
| (a) |
ADUs may be installed in a pharmacy or dispensary in a primary health care clinic or medicine rooms of licensed dispensers for the purpose of assisting with phase 2 of the dispensing process in accordance with the applicable legislation. |
| (b) |
The installation and the location of the ADU must be such that medicines and medical devices are not accessed and/or received directly by the patient or his or her caregiver or agent. |
| (c) |
The Responsible Pharmacist wishing to install the ADU must apply to Council and pay the applicable fees prior to installation and operation of an ADU. |
| (d) |
The ADU may be installed in the primary healthcare clinic dispensary that complies with the minimum standards provided in Rule 1.6 of the GPP document. |
| (e) |
The ADU may be installed in the medicine room of a licensed dispenser that complies with the minimum standards provided in Rule 1.7 of the GPP document. |
| (f) |
The Responsible Pharmacist or a licensed dispenser utilising the ADU must have a contingency plan to ensure continuous supply of medicines and medical devices in an event of power or system failure. |
| (g) |
A pharmacy that operates an ADU must still comply to all relevant standards and legislation |
| 1.9.4 |
Dispensing of medicines using an ADU |
| (a) |
Phase 1 and Phase 3 of dispensing must be done by the pharmacist, pharmacy support personnel or licensed dispenser, within their scope of practice. |
| (b) |
A pharmacist, pharmacy support personnel or licensed dispenser may only operate one ADU at a time and thereby dispense one prescription at a time. |
| (c) |
The pharmacist or licensed dispenser must be accessible to respond to inquiries or requests pertaining to all medicines and medical devices dispensed from an ADU. |
| (d) |
All prescription dispensed from ADU must be signed in person by the pharmacist or licensed dispenser. |
| (e) |
All medicines and medical devices stored in the ADU must be packaged and labelled in accordance with the applicable legislation when dispensed to the patient. |
| 1.9.5 |
The stocking and management of the ADU |
The filling and or stocking of all medicines and medical devices into the ADU must be done by the pharmacist, pharmacist intern, and relevant pharmacy support personnel under the supervision of the pharmacist or licensed dispenser.
| 1.9.6 |
The responsibilities of a responsible pharmacist of a pharmacy approved to operate an ADU |
In addition to complying with the requirements of Regulation 28 of the Regulations relating to the practice of pharmacy, the responsible pharmacist must:
| (a) |
ensure that access to the medicines and medical devices in the ADU comply with the applicable legislation; |
| (b) |
ensure that only registered persons handle medicines and medical devices in the ADU; |
| (c) |
ensure that the ADU is filled/stocked accurately and in accordance with established, written policies and procedures; |
| (d) |
ensure that in the process of picking, re-packaging and packing, cross-contamination is avoided at all times; |
| (e) |
ensure that the ADU is tested prior to initial use in accordance with the manufactures' specifications to ensure that the ADU is operating properly; and |
| (f) |
ensure that the ADU is tested on a periodic basis in accordance with the manufacturers' specifications to ensure that the ADU is operating properly; |
| (g) |
assign, discontinue, or change access control of persons to the ADU in line with such person's scope of practice. |
| 1.9.7 |
Security, location, connectivity and features of an ADU |
| (a) |
The ADU must have adequate security systems and procedures, evidenced by written policies and procedures, to: |
| (i) |
prevent unauthorised access; |
| (ii) |
comply with legislation; and |
| (iii) |
prevent the illegal use or disclosure of protected health information (confidentiality). |
| (b) |
The ADU must have a procedure and physical mechanism for securing and accounting for medicines and medical devices removed from and subsequently returned to the ADU, all in accordance with the applicable legislation. |
| (c) |
The ADU must have a procedure and physical mechanism for securing and accounting for damaged or expired medicines and medical devices in accordance with the applicable legislation. |
| (a) |
A record of medicines and medical devices filled and or stocked into the ADU must be maintained and must include identification of the registered persons filling/stocking and checking for accuracy. |
| (b) |
Records must be maintained and must be readily available to Council. Over and above the requirements of Regulations 11 and 30, such records, must include but are not limited to: |
| (i) |
Identification of the persons accessing the ADU for purposes stock management; |
| (ii) |
identification of persons accessing the ADU for purposes of dispensing; |
| (iii) |
name, strength, dosage form, and quantity of the medicine and/or medical devices; |
| (iv) |
name of the patient for whom the medicine and/or medical devices were dispensed; and |
| (v) |
such additional information as the responsible pharmacist may deem necessary. |
| (c) |
All transactions involving medicines and medical devices stored in the ADU must be recorded electronically. |
| (d) |
All aspects of handling specified Schedule 5 and Schedule 6 medicines must meet the requirements of all applicable legislation. |
| 1.9.9 |
Information to be submitted in support of an application for the installation of the ADU in a pharmacy |
Documentation that must be submitted with the application for review by Council must include but is not limited to:
| (a) |
manufacturer's name and model of the ADU including type of equipment and serial numbers; |
| (b) |
a professionally drawn floor plan and site plans of the pharmacy premises indicating the location of the ADU; |
| (c) |
name and address of the pharmacy where the ADU is to be installed; |
| (d) |
description of how the ADU is used in the dispensing process. |
[Rule 1.9 inserted by Board Notice 50, GG 38511, dated 27 February 2015]
Statistics Act, 1999
