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Pharmacy inspections

Inspection reports and learning from inspections

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Weaknesses in monitoring and review mechanisms and an absence of key standard operating procedures.

Pharmacy type


Pharmacy context

The pharmacy is located on a busy road in a city centre. The pharmacy does not have an NHS dispensing contract. The pharmacy began trading recently and the owners are not registered pharmacy professionals. Services offered by the pharmacy included over the counter sales of human and veterinary medicines, patient group directions (PGDs) for erectile dysfunction, menstruation period delay, hair loss, weight loss, adult asthma, malaria prophylaxis, oral contraceptives, smoking cessation, Psoriasis, Chlamydia and dispensing of private prescriptions.

Relevant standards

  • 1.5 - Appropriate indemnity or insurance arrangements are in place for the pharmacy services provided
  • 1.7 - Information is managed to protect the privacy, dignity and confidentiality of patients and the public who receive pharmacy services
  • 1.8 - Children and vulnerable adults are safeguarded
  • 4.2 - Pharmacy services are managed and delivered safely and effectively
  • 4.4 - Concerns are raised when medicines or medical devices are not fit for purpose

Why this is poor practice

The pharmacy’s governance arrangements are unclear. The pharmacy’s Standard Operating Procedures do not cover all aspects of service provision, so staff were not clear what is expected of them. This was particularly the case in respect of dealing with incidents and near misses, sale of medicines, safeguarding and protecting patient confidentiality.

What the shortcomings are

The pharmacy had some Standard Operating Procedures (SOPs) in place for the services offered. However, there were no SOPs in relation to sale and supply of pet medicines, Information Governance, safeguarding vulnerable children and adults and the management of recalls and alerts. The SOP relating to supplying Opioid medicines was not sufficiently robust as it did not cover how the pharmacy would deal with private prescriptions for Opioid medicines, such as Tramadol. The Superintendent Pharmacist was unable to explain how adverse events such as dispensing errors and near misses would be managed, what questions to ask and what advice to give when selling pet medicines; guidance on suspicious transaction reporting and selling of non-medicinal poisons to the general public; and how to deal with medicine recalls and alerts. The pharmacy’s complaint procedure is neither advertised nor outlined on the pharmacy’s leaflet, so patients may not be aware of how to raise concerns or provide feedback.

What improvements are required

The pharmacy requires a complete set of SOPs covering all activities and appropriate training to ensure all staff know what to do, for example, in the event of a dispensing incident or near miss, or a safeguarding incident; how to protect patient confidentiality; and how to deal with concerns about the safety of 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