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Pharmacy inspections

Inspection reports and learning from inspections

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Weaknesses in monitoring and review mechanisms and non-compliance with SOPs

Pharmacy type


Pharmacy context

This is a community pharmacy located in an affluent area in the centre of a city. It serves its local population which is varied and includes tourists. The pharmacy opens 6 days a week. The pharmacy sells a range of over-the-counter medicines, dispenses NHS prescriptions and supplies medicines in multi-compartment medicine devices for people to use living in their own homes.

Relevant standards

  • 1.1 - The risks associated with providing pharmacy services are identified and managed
  • 1.2 - The safety and quality of pharmacy services are regularly reviewed and monitored

Why this is poor practice

There are no procedures in place to record and learn from dispensing incidents and near misses are very infrequently recorded and the pharmacy team cannot demonstrate any learning from these. The Standard operating procedures (SOPs) that were in place for some dispensary tasks were not followed, including that for Monitored dosage system (MDS) trays.

What the shortcomings are

No dispensing errors had been recorded and the team could not demonstrate any learning from previous errors. There were no written procedures in place to process dispensing errors. The pharmacy team were unfamiliar with the process fpr recording near misses. There were 3 near misses recorded in 3 months but they were incorrectly assigned as dispensing errors on the patient medical record system. Monitored dosage system trays were pre-assembled based on what medicine the patient had on their last prescription in advance of the current prescription. Trays were then stored unlabelled until the prescription arrived, increasing the risk error if there were any changes to a patient's medication.

What improvements are required

The pharmacy should have written procedures for recording and investigating dispensing errors when they occur and the pharmacy team should be in a position to demonstrate learning from previous errors and near misses, which should also be recorded routinely. MDS trays should be assembled in accordance with the patient’s current prescription and in conmpliance with the pharmacy’s own standard operating procedure. Trays should be labelled at the point in which medicines are put into them and appropriate audit trails should be kept to indicate who has dispensed and checked the trays. Trays must not be left unlabelled containing medicines.

Highlighted standards

We have identified the standards most likely and least likely to be met in inspections, and highlighted examples of notable practice for each of these standards; to help everyone learn from others and to support continuous improvement:

  1. 1.1 Risk management
  2. 1.2 Reviewing and monitoring the safety of services
  3. 4.2 Safe and effective service delivery
  4. 4.3 Sourcing and safe, secure management of medicines and devices
  5. 2.2 Staff skills and qualifications