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Pharmacy inspections

Inspection reports and learning from inspections

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Failing to maintain controlled drug running balances and investigate discrepancies.

Pharmacy type

Community

Pharmacy context

The pharmacy provides NHS dispensing services,including dispensing medicines to some people in multi-compartment compliancepacks. The pharmacy also provides a substance misuse service.

Relevant standards

  • 1.1 - The risks associated with providing pharmacy services are identified and managed
  • 1.6 - All necessary records for the safe provision of pharmacy services are kept and maintained
  • 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 always manage its high-risk controlled drug medicines as it should. It does not act appropriately when discovering a balance discrepancy within its controlled drug register. And it does not follow due process to investigate and account for the discrepancy. It does not identify the risks which come from this poor controlled drug management. And there is also an absence of shared learning to help prevent similar adverse events from happening again.

What the shortcomings are

The pharmacy checked its controlled drug (CD) register against physical stock regularly. This meant the pharmacist could be assured of correct CD stock levels and this helped them have control over the management of CDs. It also highlighted potential errors, including dispensing errors and it helped protect against stock diversion. But when the team found a discrepancy during its checks it had done nothing about it. For example, on one occasion the methadone balance check showed that 180ml was missing from the expected balance. It was noted that the pharmacy had a person who received 180ml of methadone every week. But the team had not made efforts to investigate the discrepancy and identify the cause. And so, it had not ensured that all controlled drug supplies and controlled drug register entries had been made lawfully. And it had also missed an opportunity to learn from its mistakes and improve its processes.

What improvements are required

The pharmacy needs to improve aspects of its controlled drug management to protect patients’ safety. It needs to investigate all discrepancies associated with the running balance of controlled drugs in a timely manner. And accurately record the conclusions of these investigations clearly within its controlled drug register. The pharmacy must report any unresolved discrepancies in a timely manner to the NHS controlled drug accountable officer

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