| Standard not met | Reason | Action being taken by the Pharmacy | By when | Notification By Pharmacy Improvements Made |
|---|---|---|---|---|
| 1.1 | The pharmacy is not identifying and managing several risks associated with its services. The pharmacy's standard operating procedures (SOPs) are not specific to the nature of the business, and there is no evidence that they have been read by all the team, including the regular, responsible pharmacist. There is no evidence that the pharmacy has addressed or mitigated the risks involved with the pharmacy's business model. And there are indications that things have gone wrong because of this. |
- Following the inspection, the current SOPs were reviewed again to further ensure accurate and relevant to current activity and printed once more. All obsolete SOPs were removed. All pharmacy staff will read and sign the new printed copies of SOP. |
05/04/2023 | 11/05/2023 |
| 1.2 | The safety and quality of the pharmacy's service provided at a distance is not regularly reviewed and monitored. The pharmacy has been unable to verify that it has completed any audits to provide assurances that the service is safe. The pharmacy has no SOPs in place to provide guidance about dispensing incidents. And the pharmacy is not managing mistakes made with controlled drugs (CD) appropriately. Details are not always documented nor reported to the CD accountable officer. |
- Superintendent pharmacist has made 6 visits to the pharmacy site for quality assurance roughly every 2 months, last of which was on 20th February 2023. Audits and action plans have taken place however formal process for audits using specific audit tool documents were not used/carried out. Following inspection, these audits have now been carried out again using audit tools on Saturday 18th March 2023. This includes the following audits: - Two SOPs are in place to “deal with near misses and dispensing errors” and “recording concerns on the management of CDs”. The SOPs only mention to report to relevant reporting bodies however their information has not been provided. I have now included this with further additional guidance to clarify process. |
05/04/2023 | 11/05/2023 |
| 1.6 | The pharmacy is unable to demonstrate that it has been keeping all the necessary records to verify that its services are provided safely. The records should also be readily available for inspection, some of the pharmacy's records for assuring the safety of its services were not available at the point of inspection, or are incomplete. This includes the RP record, and records about supplies made against private prescriptions. |
- We have reverted back to responsible pharmacist logs being manually recorded using the conventional method with immediate effect due to potential delay in having the logs to hand. |
05/04/2023 | 11/05/2023 |
| 1.3 | The regular pharmacist routinely, and a regular locum pharmacist on occasion, have been acting as the responsible pharmacist (RP) for two pharmacies on the same day. This is not in line with legal requirements. |
- Immediate action in place to stop this happening. Regular pharmacist has taken note of this and sent written confirmation that they have refreshed their understanding of the RP duties, responsibilities and limitations. |
05/04/2023 | 18/05/2023 |
| 1.8 | The pharmacy does not have adequate processes in place to safeguard vulnerable people. It does not adequately address the safeguarding risks that some vulnerable people who use its services may face. And the regular pharmacist has not completed any recent training to a level appropriate to their role. This puts vulnerable people at risk. |
- Safeguarding policy now updated with key contact details and amendments made to suit the service better. |
05/04/2023 | 11/05/2023 |
| 4.4 | The pharmacy cannot show that it has the appropriate procedures in place to raise concerns when medicines or medical devices are not fit for purpose. The pharmacy team does not know how to access details about the drug alerts issued by the Medicines and Healthcare products Regulatory Agency. And they cannot demonstrate that the drug alerts are actioned appropriately. |
- The alerts were not coming directly into Pharmacy email system. This was addressed immediately after the initial visit and a file set up and documentation in place to evidence alerts being actioned. |
05/04/2023 | 11/05/2023 |
| 5.2 | None of the CD cabinets are secured in line with legal requirements. This is unlawful and compromises the security of these medicines. |
- CD Cabinets secured to the floor with four rag bolts since the visit (Saturday 18th) |
05/04/2023 | 11/05/2023 |
Pharmacy inspections
Inspection reports and learning from inspections