Regulator issues CD storage enforcement action against care home DSP
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A distance-selling pharmacy principally serving care homes has been told not to obtain, sell or supply Schedule 2 and 3 controlled drugs that carry safe storage requirements after a GPhC inspection uncovered “system-wide failures” in its risk management.
An August 5 inspection of Pro Chemist, which is located in a business park in north west London, revealed “inadequate governance and oversight arrangements in relation to the management of Schedule 2 and 3 controlled drugs requiring safe custody,” said the regulator.
The enforcement action notice added: “The pharmacy was unable to demonstrate that controlled drugs, primarily patient returned controlled drugs, were being appropriately recorded, reconciled, monitored and stored safely.
“The conditions need to be imposed without notice as any delay would prejudice the health, safety or wellbeing of members of the public.”
The pharmacy also received a wide-ranging improvement notice after the inspector found “insufficient evidence that its written procedures have been fully implemented into the day-to-day running of the pharmacy,” undermining its risk management efforts.
The regulator said: “The pharmacy was undertaking registerable activity in non-registered premises and storing patient-returned controlled drugs there without ensuring they were complying with safe custody regulations.”
The eight-point improvement notice ordered the pharmacy to “appropriately dispose of all returned, out-of-date or obsolete medicines” and keep a list of all care home returns, to ensure core services are delivered solely from the premises, to date-check all medicines and dispose of out-of-date drugs, and to ensure services are delivered by trained staff working in accordance with SOPs.
The company told P3pharmacy that it was found to be compliant with all improvement orders by the deadline of September 2. The CD enforcement action notice is listed as ongoing on the GPhC’s inspections website at the time of publication.
A spokesperson for Pro Chemist told P3pharmacy: “At the time of the GPhC inspection, Pro Chemist was undergoing a significant refurbishment and operational reorganisation. While this provided some context to the circumstances at the time, we fully recognise that appropriate governance and medicines management standards must be maintained throughout any period of change.
“We took the concerns identified by the GPhC extremely seriously and immediately undertook a comprehensive programme of improvements. This included strengthening our procedures around controlled drugs and returned medicines, enhancing staff training and SOP compliance, introducing additional audit and monitoring arrangements, and making improvements to our pharmacy premises and storage facilities.
“We have worked openly and constructively with the GPhC throughout the process and welcomed the opportunity to demonstrate the improvements that have been made.
“Following our subsequent engagement with the GPhC and the evidence provided, the GPhC has formally confirmed that the requirements of the Improvement Notice have been met.
We have used the experience to make significant and lasting improvements to our governance and systems and remain committed to maintaining these standards and providing a safe and high-quality pharmacy service to the patients and care homes we support.”