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Pharmacy inspections

Inspection reports and learning from inspections

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Inadequate identification and management of the risks associated with the provision of medicines to people overseas.

Pharmacy type

Community

Pharmacy context

The pharmacy is situated on a high street in an old part of the town. There are two parts to the pharmacy’s activities. During the day, it dispenses NHS and private prescriptions to people in the local community and it has a travel clinic. Several people have prescriptions dispensed which are issued by the drug and alcohol team. The pharmacy offers a prescription delivery service to the surrounding villages, as well as the town. It also supplies medicines in multi‐compartment compliance packs to people. During the night, the pharmacy operates as an online pharmacy, led by the superintendent pharmacist, providing a dispensing service for people living outside the UK.

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
  • 1.3 - Pharmacy services are provided by staff with clearly defined roles and clear lines of accountability
  • 1.6 - All necessary records for the safe provision of pharmacy services are kept and maintained
  • 1.8 - Children and vulnerable adults are safeguarded
  • 3.1 - Premises are safe, clean, properly maintained and suitable for the pharmacy services provided
  • 4.2 - Pharmacy services are managed and delivered safely and effectively
  • 4.3 - Medicines and medical devices are: obtained from a reputable source; safe and fit for purpose; stored securely; safeguarded from unauthorized access; supplied to the patient safely; and disposed of safely and securely

Why this is poor practice

The pharmacy does not adequately identify and manage the risks associated with the provision of medicines to people overseas. It does not check the identity of patients, or ensure that higher‐risk medicines, including methotrexate and misoprostol, are supplied safely. Pharmacy professionals involved in the supply of medicines overseas do not fully understand their responsibilities or accountabilities. The pharmacy does not make accurate or complete records about the supplies it makes of prescription‐only medicines to patients overseas. It also does not adequately monitor the temperature of medicines which require cold storage.

What the shortcomings are

The day‐time pharmacy service is generally safe and team members understand their roles and responsibilities. But the risks associated with the pharmacy’s night‐time online service are not fully managed. And pharmacy professionals involved in this part of the service do not fully understand their responsibilities or accountabilities. The pharmacy is not complying with the current GPhC guidance for supplying medicines at a distance. It does not assess risks in the online business, relying on others to do so. The record keeping for the online business does not comply with legal requirements in the UK. The pharmacy does not make accurate records of the supplies it makes to overseas patients. It cannot show what has been dispensed or sent to whom. And it does not have any systems for safeguarding the welfare of vulnerable overseas people who receive its services.The supplies that it makes to people overseas are not labelled with all the information people may need to use their medicines correctly. It doesn’t always make safety checks to ensure the medicines are suitable for the people who receive them. And the pharmacy does not keep all the records it should do so it cannot clearly show what it has supplied or what has been delivered. Only the current temperatures of the medicines fridges were recorded, and not the maximum and minimum temperature ranges. This meant that the pharmacy couldn’t show that medicines requiring cold storage had always been correctly stored.

What improvements are required

The pharmacy should review its compliance with GPhC guidance on providing services at a distance, ensuring all services, including those provided by third parties are subject to a risk assessmet. This is to ensure the safety of people using the pharmacy's services.

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