The South African Pharmacy Council received a number of requests from pharmacists for guidance on the safe use of Unit Dose Dispensers during the dispensing of medicines to patients.
The Minimum standard for unit dose dispensing (UDD) was developed and published for comment on 31 August 2018, as Board Notice 99, as an additional standard in the Rules relating to good pharmacy practice in accordance with section 35A(b)(ii). The Minimum standards are intended to guide pharmacists and pharmacy support personnel on the use of Unit Dose Containers (UDC) and the legal requirements to be taken into consideration when dispensing or re-dispensing medicines in a container as individual unit doses.
Stakeholders ranging from independent pharmacists, members representing various pharmacies in public and private health facilities, to institutions involved in the use of UDD, submitted comments and were invited to present their comments to a task team appointed by Council.
During the presentation of the comments it became apparent that there is confusion concerning this minimum standard and what it is addressing; some stakeholders confused Unit Dose Dispensing with pre-packing. For that reason, the task team re-looked at the standard and revised the key definition.
Unit dose dispensing (UDD) is defined as a process where individual doses of different medicines are dispensed or re-dispensed into a container (UDC; see fig 1), ready for administration to patients, involving a manual or an automated system and that includes but is not restricted to other international definitions e.g. the multi-compartment system.
Unit dose container (UDC) – is a container used for the dispensing or re-dispensing of medicines according to its administration time for a specific patient and/or a caregiver to administer and that includes but is not restricted to other international definitions e.g. multi-compartment compliance aids.
The standard further details specific consideration for those pharmacists who wish to provide services using the UDD. These include:
- The clinical needs and supportive care of the patient who has consented to receive their medication dispensed in the UDD;
- The factors to be taken into consideration when determining the suitability of medicines for dispensing in UDC;
- The general guideline pertaining to solid dosage forms that should NOT be dispensed into a UDC (the list is not comprehensive and should be elaborated on based on the professional discretion of the UDD pharmacist);
- The quality control system that must be in place to check and control the quality of the procedures and end results relating to the dispensing or re-dispensing of medicines into a UDC;
- Compliance with Regulation 10(6) of the General Regulations published in terms of the Medicines Act in terms of the labelling requirements and additional requirements for labelling to ensure patient safety; and
- Records that must be kept for each UDC prepared for a patient as well as the information to be provided to patients on the disposal of unused medicines.
Pharmacists and/or pharmacy support personnel must ensure that they have adequate knowledge of UDD techniques and UDCs, and must be able to demonstrate the use of UDCs if patients require it. The UDD pharmacist remains responsible for any decision to dispense medicines into UDCs.
The use of UDD is optional and not compulsory for use by all patients. Council has finalised the standard and approved it to be published for implementation.