| Standard not met | Reason | Action being taken by the Pharmacy | By when | Notification By Pharmacy Improvements Made |
|---|---|---|---|---|
| 2.2 | The pharmacy does not always ensure that its team members have completed or are enrolled on the required training courses for the activities they are undertaking, including dispensing medicines. This means the pharmacy cannot provide adequate assurances that team members have the right skills and knowledge to work safely. |
1. Complete a full staff training and competency audit for every team member against the duties they undertake. 2. No team member will undertake dispensing, MDS preparation or another technical activity unless appropriately qualified, enrolled on the relevant recognised training programme, or working under suitable supervision while in training. 3. Maintain an up-to-date training matrix showing role, qualification/course, enrolment date, progress, competency assessment and review date. 4. Complete and document competency assessments for relevant tasks, particularly MDS preparation. 5. Review training progress regularly and restrict duties where training or competence cannot be evidenced. |
29/09/2026 | |
| 4.2 | The pharmacy cannot demonstrate that its monitored dosage system (MDS) service is managed and delivered safely and effectively. Assembled trays are left unsealed prior to them being accuracy checked, increasing the risk of medicines being displaced, contaminated, or omitted before supply. Some compliance packs are not appropriately labelled, meaning patients and carers may not always have access to the information needed to support the safe administration of medicines. These weaknesses increase the risk of medication errors and reduce assurance that patients receive their medicines safely. In addition, trays are sometimes prepared by team members who have not received appropriate training or been assessed as competent for the process. This increases the risk of assembly errors going undetected and compromises the safety of the service. The pharmacy's systems and controls are not sufficiently robust to ensure the consistent and safe provision of MDS prescriptions. |
1. Revise the MDS workflow so that assembled trays are sealed promptly following assembly and are protected from displacement or contamination while awaiting the accuracy check. 2. Introduce a documented MDS preparation/checking procedure and checklist covering patient details, medicines, quantities, backing sheets/labels, warnings, descriptions and final sealing/supply. 3. Audit all MDS labelling requirements and ensure every compliance pack contains the information required to support safe administration. 4. Only staff who are appropriately trained and have documented competency will prepare MDS trays; trainees will work under appropriate supervision. 5. Introduce routine MDS quality audits and record errors/near misses, trends and corrective action. 6. Re-train all staff involved in the MDS service on the revised procedure and retain signed training records. |
29/09/2026 | |
| 4.3 | The pharmacy cannot provide assurance that it adequately monitors fridge temperatures required for the appropriate storage of cold chain medicines. This means it cannot always be certain that medicines requiring cold storage remain suitable for supply. In addition, records of expiry date checks are not maintained, which increases the risk that medicines may be overlooked, including those that are expired or approaching their expiry date. Patient-returned high-risk medicines are not clearly separated and are found to be mixed with stock medicines, creating a risk that unsuitable medicines could be inadvertently supplied. Furthermore, medicines are not consistently stored on shelves in appropriate packaging or with adequate labelling, increasing the risk of selection errors, stock management issues, and the supply of medicines that may not be readily identifiable or suitable for use. |
1. Introduce a documented daily fridge-temperature monitoring process, including minimum/maximum/current temperatures, reset procedure and action to take for readings outside the required range. 2. Maintain a formal expiry-date checking schedule and written records of checks, with short-dated stock identified and managed appropriately. 3. Create a clearly designated and labelled quarantine area for patient-returned and other medicines not suitable for supply, physically separated from usable stock. 4. Review all stock shelving and ensure medicines are kept in appropriate original/clearly labelled packaging and can be readily identified. 5. Carry out an initial stock-room audit followed by regular documented checks of fridge records, expiry dates, quarantine arrangements and shelf storage. 6. Any discrepancy identified will be corrected promptly and recorded, with learning shared with the team. |
29/09/2026 | |
| 1.2 | The pharmacy has procedures in place to deal with dispensing incidents and near misses, but these are not always followed, and team members do not always record their errors. This could make it harder for the team to review mistakes and identify any patterns or trends, and it could be missing out on opportunities to make the pharmacy's services safer. |
1. Re-brief all staff on the dispensing incident and near-miss SOP and make clear that every near miss and dispensing incident must be recorded. 2. Introduce a consistent near-miss/error log that records the date, medicine, type of error, contributing factors, action taken and learning. 3. The pharmacist/manager will review records regularly to identify recurring themes, LASA medicines and other trends. 4. Learning and preventative actions will be discussed with the pharmacy team and documented, with SOPs/workflows amended where necessary. 5. Compliance with recording will be checked through routine management review. |
29/09/2026 | |
| 1.6 | The pharmacy does not maintain adequate records to demonstrate that medicines and controlled drugs are managed safely and in accordance with legal and professional requirements. Responsible Pharmacist (RP) records are editable, reducing assurance that entries are accurate, complete, and tamper evident. Records for higher-risk medicines are inadequately maintained, with required headers missing, which increases the risk of inaccuracies and makes effective auditing more difficult. In addition, patient-returned high-risk medicines are not recorded when received, limiting the pharmacy's ability to demonstrate appropriate handling and destruction arrangements for these medicines. Records of emergency supplies are not maintained appropriately, meaning the pharmacy may not be able to demonstrate that such supplies are made appropriately and in line with legal requirements. |
1. Replace/adjust the Responsible Pharmacist recording system so that completed RP records are secure, complete and tamper-evident and cannot be retrospectively altered without an appropriate audit trail. 2. Review all higher-risk medicine and controlled-drug records and introduce compliant registers/logs containing all required headings and information. 3. Introduce a dedicated record for patient-returned higher-risk/controlled medicines, documenting receipt and subsequent safe handling/destruction arrangements. 4. Review the emergency-supply process and ensure every emergency supply is recorded with all legally required information. 5. The Superintendent Pharmacist will carry out periodic audits of these records and address any omissions immediately. |
29/09/2026 | |
| 1.1 | The pharmacy has standard operating procedures and team members can access them. But the procedures do not cover all the relevant topics. For example, in relation to the services provided to care homes. This means that team members may not always be working safely in line with current best practice. |
1. Review and update the pharmacy SOP suite to ensure it fully covers the care-home service and all stages of the MDS process, including receipt of prescriptions, ordering, preparation, labelling, checking, supply, delivery, queries, returns and incident management. 2. Introduce a specific care-home/MDS SOP and supporting workflow/checklist. 3. Ensure all relevant team members read the revised SOPs, sign a training/read-and-understood record and are briefed on their responsibilities. 4. Review the SOPs at least annually and sooner following an incident, service change or change in guidance. |
29/09/2026 |
Pharmacy inspections
Inspection reports and learning from inspections