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Pharmacy inspections

Inspection reports and learning from inspections

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Inadequate risk assessment of monitored dosage system dispensing in a closed pharmacy

Pharmacy type


Pharmacy context

​An internet pharmacy on a business park close to the centre of an industrial town. It dispenses NHS prescriptions, but there is no public access to the pharmacy. People receive their medicines through a delivery service. The pharmacy also supplies medicines in multi-compartment compliance devices to people who live in their own homes.

Relevant standards

  • 4.2 - Pharmacy services are managed and delivered safely and effectively

Why this is poor practice

The pharmacy has not assessed the risks associated with the supply of multi-compartmental compliance devices to people. The devices are not labelled appropriately, and some are labelled and assembled before the prescription arrives at the pharmacy. There is a risk that people will not receive the correct information they require to take their medicine safely. There is also a risk that changes to medicine regimens may not be checked or addressed.

What the shortcomings are

The pharmacy used a module on the clinical software system to help manage the supply of multi-compartmental compliance devices. A sample of devices examined found that backing sheets contained incorrect details of the quantity of medicine supplied in each tray. The system defaulted to printing quantities such as 1.75 tablets instead of 7; however, the reason the system did this was not known. In addition, there was some assembling of trays before the pharmacy received prescriptions. This was to help manage timescales associated with dispensing the devices. However the risks relating to this practice had not been identified and managed through a standard operating procedure.

Pharmacy team members did not always sign to confirm that they had assembled devices. Pharmacists did sign trays as part of their final checking process. Descriptions of medicines in trays were only provided to people living in the supported living housing. Patient information leaflets were provided for new medicines or upon request only. Backing sheets accompanied filler trays, but these were not physically attached to the trays which breached medicine labelling requirements.

What improvements are required

The pharmacy needs to complete a risk assessment to help identify and manage the risks associated with providing the multi-compartmental compliance device service. The standard operating procedure put in place to manage the service should clearly show how risks have been considered and are being managed. All devices must be labelled correctly and in accordance with labelling requirements.

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