Inspection Findings from 2023

The PSI inspects pharmacies to assess compliance with the Pharmacy Act 2007 and other pharmacy and medicines legislation, in the interests of the health and safety of the public. Here we highlight a number of compliance issues noted at inspections during 2023.

1. Patient Consultation Areas

An appropriate patient consultation area must be available within the pharmacy premises so a pharmacist can discuss matters with a patient or carer in private relating to the patient’s medicine and/or facilitate other pharmacy services. At some inspection visits, it has been noted that these areas are not being used solely for patient consultations/services and are being used as a storage area for items such as retail stock and medicines or as a staff area for breaks. Please be reminded that it is inappropriate to use the consultation area for additional functions or as a storage area for items not related to consultations and pharmacy services.

Additionally, it has been observed at inspections that sharps bins containing used sharps and patient records are being stored in the patient consultation area and are not being stored in a secure manner. Please ensure the sharps bin and all patient records relating to consultations are kept in locked cupboards in the patient consultation area or in the dispensary, under the personal control of the pharmacist.

Guidelines on Patient Consultation Areas in Retail Pharmacy Businesses are available for review to ensure that legal requirements and standards expected for a patient consultation area are met

2. Storage of Pharmacy-only Medicines in a Retail Pharmacy Business

It has been noted at some inspection visits that non-prescription pharmacy only medicines are accessible for self-selection by members of the public in the following areas:

  • in the public pharmacy area. 
  • behind the medicines counter, where a fixed barrier is not in place to restrict access to the area. 
  • on shelving adjacent to the fixed barrier, which is still accessible to the public.

It is the responsibility of pharmacy owners and superintendent pharmacists to review their storage arrangements to ensure that compliance with these legislative provisions is achieved. 

Regulation 5(1)(a) of the Regulation of Retail Pharmacy Businesses Regulations 2008 (as amended) states that pharmacy-only medicines “are stored in a part of the premises to which the public does not have access”. If a member of the public is able to self-select (i.e. physically access / pick up) a pharmacy-only medicine from a publicly accessible part of the pharmacy, then it is the view of the PSI that the medicine is not stored in a part of the premises to which the public does not have access.

It is recommended that regular reviews are conducted to ensure pharmacy only medicines are not accessible to the public and that training is provided to relevant staff in relation to medicine categorisation. All pharmacy staff can check the ‘latest list of pharmacy only medicinal products not subject to medical prescription’ and ‘latest list of general sales product information’ on the Health Products Regulatory Authority’s website.

The following pharmacy medicines are commonly noted at inspections as being accessible to the public for self-selection: Galfer® preparations, Ferrograd® preparations, Magnesium Verla® Sachets, Nicorette Invisi Extra Strength 25mg/16 hours transdermal patches, Voltarol® preparations, Diclac® preparations, and Daktarin® preparations.

Further information is provided in the PSI regulatory notice on the Storage of Pharmacy-only Medicines in a Retail Pharmacy Business.

3. Error and Incident Record keeping

At all routine pharmacy inspections, PSI Quality Assessors review medication error management records in place at the pharmacy. This review includes checking that the pharmacy has policies and procedures to assist all members of staff in dealing with and learning from medication errors, as well as that records of medication errors and near misses are maintained at the pharmacy.

It has been noted at some inspection visits that comprehensive records of medication errors are not being maintained on an ongoing basis. In particular, records do not outline the corrective action and preventative action that has taken place to ensure appropriate action is taken to safeguard the health of the patient and to minimise the risk of future mistakes taking place.

The maintenance and review of error records and near miss logs as part of an error management system will facilitate the identification of any patterns or repeated errors, help identify learning needs and the consequent re-training of staff and contribute to the continuous review of the policies and procedures of the pharmacy.

Further information including record templates is provided in the Inspectors' Advice on Medication Error Management which may be useful when reviewing your error management processes.

4. Temperature record keeping

It has been noted at some inspection visits that temperature records are not always maintained consistently.

In order to ensure the continued therapeutic effectiveness of medicines supplied to patients, strict adherence to the manufacturers' recommended storage conditions must be observed. Medicines requiring storage between 2 and 8°C must be stored in a pharmaceutical grade refrigerator, and room temperature should be less than 25°C. The maximum and minimum temperatures of the dispensary and the refrigerator should be recorded at least once daily in a log. The refrigerator should have adequate capacity to allow for organised, well-spaced storage of all medicinal products. There should be a written procedure outlining temperature monitoring and the action to be taken if temperatures fall outside the range. The PSI Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business may assist you in your review of storage conditions.

5. Storage of controlled drug medicines

At all routine pharmacy inspections, the PSI Quality Assessors review the storage of controlled drug (CD) medicines in the pharmacy i.e. Schedule 2 CDs (CD2) and Schedule 3 CDs (CD3). In some inspections, it has been observed that CDs are not always stored in the controlled drugs safe as per legislation. The following examples were noted as CD storage compliance issues at inspections:

  • Dispensed CD medicines awaiting collection stored outside of the CD safe and placed in the prescription collection area.
  • Expired CD medicines, non-confirming CD medicines and/or patient returned CD medicines awaiting destruction stored outside of the CD safe. 
  • CD medicines stored outside of the CD safe because of inadequate CD safe capacity.

All CD2s and CD3s must be stored in the CD safe. This includes Methadone preparations. Expired or non-conforming (e.g. damaged) Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock, and clearly labelled ‘CDs for destruction'. Patient-returned CDs should be promptly destroyed. While awaiting destruction, patient-returned Schedule 2 and 3 CDs should be stored in the CD safe, segregated from ‘live’ stock and clearly labelled ‘Patient-returned CDs for destruction'.

A review of the capacity of the CD Safe should be conducted by pharmacy owners and superintendent pharmacists if the above storage requirements cannot be maintained in order to ensure that all CD2 and CD3 medicines can be securely stored at all times under the supervision of a pharmacist. 

Further information