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Pharmacy inspections

Inspection reports and learning from inspections

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Absence of standard operating procedures for the services provided by the pharmacy

Pharmacy type


Pharmacy context

The pharmacy was a newly registered closed pharmacy which dispensed approximately 3000 prescription items each month for care homes mainly using a monitored dosage system.

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
  • 3.4 - Premises are secure and safeguarded from unauthorized access
  • 5.1 - Equipment and facilities needed to provide pharmacy services are readily available
  • 5.2 - Equipment and facilities are: obtained from a reputable source; safe and fit for purpose; stored securely; safeguarded from unauthorized access; and appropriately maintained

Why this is poor practice

A closed pharmacy commenced operations without having appropriate arrangements and procedures in place for identifying and managing the specific risks presented by this pharmacy.

What the shortcomings are

The Standard Operating Procedures (SOPs) available were those from another pharmacy and not specific to the services provided from this pharmacy. All prescriptions dispensed from the pharmacy were in monitored dosage systems with the majority of these being assembled using a sealing machine. There was no service contract for the sealing machines at the pharmacy and so there was no assurance that the machines were working correctly. There was no dispensing audit trail for these and patient information leaflets (PILs) were not included. There was access to the back door by people other than the pharmacy staff.

What improvements are required

Implementation of SOPs specific to this pharmacy. The pharmacy needs to ensure that equipment for its MDS service is maintained in accordance with manufacturer’s instructions.

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