| 1.11.1 |
Introduction and background |
Council embraces the use of innovation and technology to improve access to pharmaceutical services. Council is aware of the shortage of human resources in pharmacy and high burden of disease in this country that warrants the profession employing alternative methods of delivery of pharmaceutical services in the public sector.
Pharmacies in the public sector may use the Remote Automated Dispensing Unit (RADU) for purposes of dispensing medicine and devices for long term therapy (Chronic) in order to improve access to medicines and to alleviate the patient burden on public facilities.
| 1.11.2 |
Definitions of terms |
Remote Automated Dispensing Unit (RADU) - refers to an automated dispensing unit that is remotely operated from a pharmacy to dispense medicines and medical devices for long term therapy (chronic medicine).
The purpose of this standard is to regulate the dispensing of medicines and medical devices for long term therapy (chronic medicine) through the use of a RADU to improve access to medicines.
| 1.11.4 |
General considerations |
| (a) |
A pharmacy owner or the responsible pharmacist intending to install a RADU must apply to Council for approval of an installation of a RADU on the form provided by Council and pay the applicable fees, prior to operating a RADU. |
| (b) |
A pharmacy may use a RADU for the purposes of dispensing of medicines and medical devices for long term therapy (chronic medicine). |
| (c) |
In the case where a RADU is used to dispense a prescription with no repeats, the copy of the prescription must be retained by the unit. |
| (d) |
The responsible pharmacist or the pharmacist may only operate a RADU at the location identified by the applicant for the purpose of inspection by Council. |
| (e) |
The responsible pharmacist of the pharmacy approved to operate a RADU must: |
| (i) |
have a procedure and a mechanism for securing and accounting for damaged or expired, returned and recalled medicines and medical devices at the RADU; |
| (ii) |
develop and maintain all policies and procedures regarding the usage of RADU; |
| (iii) |
ensure that adequate systems and procedures relating to the use of the RADU for supply and dispensing of medicines are in place and that there is compliance with such systems and procedures. |
| (f) |
Only registered pharmacy personnel may have access to the RADU for the purpose of stock management, dispensing medicines and medical devices. |
| 1.11.5 |
Dispensing of medicines using a RADU |
| (a) |
Phase 1 and 3 of the dispensing processes must be performed only by a pharmacist through the audio-visual interface, at the time of dispensing. |
| (b) |
A pharmacist may only dispense one prescription at a time, when using a RADU. |
| (c) |
All prescriptions dispensed from a RADU must be signed by the pharmacist. |
| (d) |
All medicines and medical devices dispensed at or by a RADU must be labelled in accordance with the requirements of Regulation 8(4) of the General Regulations published in terms of the Medicines and Related Substances Act 101 of 1965 and must include the address of the RADU and pharmacy approved to operate the RADU. The reason for the additional requirement for address of the RADU is to identify the RADU from which the medicine/s were dispensed. |
| (e) |
If a patient refuses the dispensed medicine by a RADU, the medicine must be locked in a secure cabinet in the RADU and may not be dispensed until checked by a pharmacist or pharmacy support personnel for quality assurance purposes. |
| (f) |
A pharmacist must be accessible to respond to all enquiries and or requests from a patient when utilising the RADU. |
| (g) |
If the RADU is not operational on a 24-hour basis, a designated pharmacist(s) must be available for the emergency supply of pharmaceutical services. |
| (h) |
Contact details of the pharmacist-on-duty must be displayed visibly at the RADU. |
| (i) |
Operational hours must be displayed visibly at the RADU. |
| 1.11.6 |
The responsibilities of a responsible pharmacist of the pharmacy approved by Council to operate a RADU |
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 the RADU is operated in compliance with all relevant legislation; |
| (b) |
ensure that the pharmacy offering dispensing services through a RADU is appropriately staffed; |
| (c) |
provide proof to Council, in the form of an assessment certificate from the internet service provider (ISP), that there is adequate connectivity to facilitate communication between the patients and the pharmacist operating the RADU; |
| (d) |
assure the integrity of the medicines dispensed from a RADU; |
| (e) |
ensure that there is proper stock control and that only registered pharmacy personnel may stock the RADU; |
| (f) |
ensure that pharmacy personnel who operate the RADU are trained on the operation of the RADU such training must be documented; |
| (g) |
ensure that written policies and procedures are developed specific to RADU: |
| (i) |
ensure the safe and effective dispensing of medicines and medical devices; |
| (ii) |
ensure that the RADU is operating safely, accurately, and securely; and |
| (iii) |
define conditions for access to the RADU and medicines contained in the unit, as well as policies that assign, discontinue, or change access to the RADU and medicines; |
| (h) |
ensure that only pharmacists or pharmacy support personnel have access to the medicines in the RADU and any person not registered with Council who needs access to the RADU to provide technical support must be accompanied by a registered person. |
| (a) |
Records of prescriptions filled at the RADU must be maintained at the pharmacy which operates the RADU; and |
| (b) |
Records must be available for inspection at all times and must include the following: |
| (i) |
all medicines dispensed at the RADU; |
| (ii) |
all inventory movement at the RADU; |
| (iii) |
a policy and procedure manual in respect of the operation of the RADU; |
| (iv) |
service and maintenance records of the RADU; |
| (v) |
records of individuals accessing the system; |
| (vi) |
audio-visual recordings of transactions; |
| (vii) |
continuous temperature monitoring records; |
| (viii) |
type of transaction; |
| (ix) |
prescriptions dispensed; |
| (x) |
who loaded the stock; |
| (xi) |
all records must be kept in accordance with applicable legislation. |
| 1.11.8 |
Security, location, connectivity and features of a RADU |
A RADU must:
| (a) |
be well secured to prevent unauthorised access at all times and entry must be limited to authorised personnel only; |
| (b) |
be located in a place that ensures safety, privacy and confidentiality; |
| (c) |
ensure that medicines are secured at all times; |
| (d) |
be connected via computer with a secure live video and audio link; |
| (e) |
not be operated if there is no audio-visual link; |
| (f) |
have the ability to record all transactions; |
| (g) |
have a back-up system or generator to ensure continuity of service; |
| (h) |
have at least the following features: |
| (i) |
technology that effectively identifies the specific product; |
| (ii) |
technology that confirms the correctness of the medicine to be dispensed; |
| (iii) |
technology to print and affix labels; |
| (iv) |
a video and audio component (monitor) that allows the patient to have a 'face-to-face' consultation with the pharmacist. (hardware to facilitate the audio-visual link). |
| 1.11.9 |
Documentation and information displayed conspicuously at the RADU |
| (a) |
Copies of the license and/or recording/registration certificate of the pharmacy operating the RADU. |
| (b) |
The original certificate of approval issued by Council to operate a RADU. |
| (c) |
A copy of the registration certificate of the responsible pharmacist. |
| (d) |
Contact details of the pharmacy operating the RADU. |
| 1.11.10 |
Information to be submitted in support of an application for installation and operation of a RADU |
Documentation as to the type of equipment, serial numbers, content, policies and procedures, must be submitted with an application for review by Council. Such documentation must include but not limited to:
| (a) |
a professionally drawn floor plan of the RADU and site plans indicating the location of the RADU; |
| (b) |
name and address of the location where the RADU is being used; |
| (c) |
manufacturer's name and model and or unique identifier of the machine. |
[Rule 1.11 inserted by Board Notice 193, GG 40522, dated 23 December 2016, and numbered accordingly for ease of reference]
Statistics Act, 1999
