| Standard not met | Reason | Action being taken by the Pharmacy | By when | Notification By Pharmacy Improvements Made |
|---|---|---|---|---|
| 1.1 | The pharmacy doesn’t manage its risks appropriately. And it doesn’t have all the standard operating procedures it needs to make sure its team works safely. |
The pharmacy has taken steps to address the issue of Standard Operating Procedure (SOP) accessibility and awareness. The complete suite of SOPs has been located and moved to a more prominent location where they can be easily found by all staff members. Additionally, a physical copy of the SOPs is now available within the pharmacy itself, ensuring that reference materials are readily accessible during day-to-day operations. To build on these improvements, the pharmacy will implement a comprehensive plan to ensure all staff are informed about the new SOP locations. This will involve a staff meeting and email communication to disseminate the information effectively. A brief training session will also be conducted to reinforce the importance of SOPs and guide staff on their proper usage. To maintain the relevance and effectiveness of the SOPs, a system will be put in place for regular review and updates. The pharmacy will monitor the success of these changes through weekly accessibility checks and monthly staff quizzes on SOP content. This approach aims to not only meet the GPHC standard but also to foster a culture of safety and compliance within the pharmacy team. |
13/08/2024 | 28/08/2024 |
| 1.2 | The pharmacy doesn’t review the quality or the safety of the services it delivers. And, for example, it doesn't have a written process to make sure it records any dispensing mistakes it makes or the steps its team takes to stop the same sort of things happening again. |
The pharmacy has taken immediate action to enhance its risk management practices. A near miss log book has been ordered and put into use, providing a crucial tool for identifying and tracking potential safety issues. This proactive approach allows the pharmacy team to record and analyze incidents that could have led to errors, creating opportunities for preventive measures. The pharmacy has committed to regularly reviewing these near misses, ensuring that any patterns or recurring issues are promptly addressed. Importantly, the team will implement changes as soon as risks are identified, rather than waiting for more serious incidents to occur. This responsive approach to risk management extends beyond near misses to encompass all aspects of the pharmacy's operations. The pharmacy will now conduct routine risk assessments for both current and new services. These assessments will help identify potential hazards, evaluate their likelihood and potential impact, and develop strategies to mitigate risks before they materialize. By incorporating these practices into their standard procedures, the pharmacy aims to create a safer environment for both staff and patients, demonstrating a commitment to continuous improvement and adherence to GPHC standards. |
13/08/2024 | 28/08/2024 |
| 1.5 | The pharmacy doesn’t have the insurance it needs to protect people if things go wrong. |
On the day of the inspection, the pharmacy took immediate action to address a critical oversight in risk management. A Professional Indemnity insurance policy was promptly purchased, providing essential coverage for the pharmacy and its staff. This insurance is crucial for protecting the business against potential claims arising from professional services rendered. Recognizing the importance of this documentation, the pharmacy shared proof of the newly acquired policy with the inspector after the inspection. This response demonstrates the pharmacy's commitment to meeting regulatory requirements and safeguarding its operations. The acquisition of Professional Indemnity insurance not only brings the pharmacy into compliance with GPHC standards but also provides a financial safety net for unforeseen professional liabilities. Moving forward, the pharmacy will ensure that such essential policies are maintained and regularly reviewed to provide continuous protection and compliance with regulatory standards. |
13/08/2024 | 09/07/2024 |
| 1.6 | The pharmacy doesn’t do enough to make sure it keeps records in the way the law requires it to do so. These records include its controlled drug (CD) register, emergency supply records, private prescription records and its responsible pharmacist log. |
Following the inspection, the pharmacy took swift and comprehensive action to address issues related to Controlled Drug (CD) management and record-keeping. Approved CD registers were immediately ordered and implemented, with all entries for received and dispensed CDs promptly completed. A thorough balance check was conducted to ensure accuracy. The pharmacy has revised its processes to ensure that CD register entries are made as soon as delivery confirmation is received from the driver. In cases where same-day entry is not possible, records will be completed later that day to maintain audit integrity. All CD registers have been transferred to the recommended bound format, complete with proper headings, while the old loose records were closed and archived appropriately. The pharmacy has also improved its management of private prescriptions. The Patient Medication Record (PMR) system will now maintain detailed and accurate records for private prescriptions, including three key dates: the date on the prescription, the dispensing date, and the collection date. To protect patient privacy and data integrity, staff training on the PMR system will now use a test patient record rather than live patient data. To address the unreliability of the PMR log for recording responsible pharmacist information, a physical responsible pharmacist logbook has been implemented. This ensures a reliable, tamper-evident record of pharmacist responsibility is maintained at all times. All emergency supplies at the request of a patient should be accurately recorded on the PMR rather than picking the default prescriber option. These actions demonstrate the pharmacy's commitment to compliance with regulations, accurate record-keeping, and continuous improvement in its operational processes. The prompt implementation of these changes reflects a proactive approach to addressing the issues identified during the inspection and ensures better alignment with GPHC standards. |
13/08/2024 | 28/08/2024 |
| 4.2 | The pharmacy doesn’t keep adequate records to show its working practices are safe and effective. It sometimes supplies medicines when it doesn’t have the authority to do so. It can’t show it has delivered the right medicine to the right person or show who was responsible for each service it. And its team don't follow the correct procedures all the time. |
Following the inspection, the pharmacy took immediate action to address the accessibility and implementation of Standard Operating Procedures (SOPs). The complete suite of SOPs was located and relocated to a more prominent and easily accessible area within the pharmacy. This strategic placement ensures that all staff members can readily find and refer to these crucial documents as needed. To reinforce the importance of these procedures, each staff member was required to read and sign the SOPs relevant to their specific roles. This process not only ensures that staff are familiar with the procedures but also creates a record of their acknowledgment and understanding. In addition to improving SOP management, the pharmacy has introduced a new system for tracking deliveries. Delivery log sheets have been implemented to enhance accountability and traceability. These sheets are now dated to accurately reflect the date of medication delivery. Furthermore, the pharmacy has instituted a new policy requiring the receiving party to sign upon delivery. This practice creates a clear record of when medications were delivered and who received them, improving the pharmacy's ability to track and verify deliveries. In response to the inspection findings, the pharmacy has implemented several significant changes to enhance patient safety and regulatory compliance. A comprehensive audit trail for all Monitored Dosage System (MDS) patients will now be maintained, including the creation of patient record cards with up-to-date information. To improve patient and carer understanding, all MDS trays will be accompanied by patient information leaflets. Additionally, a new accountability measure has been introduced where both a dispenser and a pharmacist will sign each MDS tray, confirming that clinical and accuracy checks have been performed. The pharmacy has also revised its emergency supply process to align with legal requirements. Moving forward, emergency supplies will be limited to a maximum of 30 days, ensuring strict adherence to regulations. The emergency supply process for Schedule 4 and 5 CDs has been reviewed and supplies will be limited to a maximum of 5 days. Contraceptive pill emergency supply at the request of a patient process has also been reviewed and not more than one cycle’s worth of tablets should be given. The pharmacy will now ensure that all records are accurate. Furthermore, the supply and recording of Schedule 2 controlled drugs have been reviewed and strengthened. These changes demonstrate the pharmacy's commitment to improving its processes, enhancing patient safety, and maintaining regulatory compliance. By implementing these measures, the pharmacy aims to provide more robust and accountable services, particularly in areas of medication management that require careful oversight and documentation. These actions demonstrate the pharmacy's commitment to enhancing its operational procedures, ensuring compliance with regulations, and maintaining high standards of patient care and safety. |
13/08/2024 | 28/08/2024 |
| 4.3 | The pharmacy doesn’t suitably store all its medicines that it needs to keep in a refrigerator. And unwanted medicines are not being disposed of properly. |
Immediately following the inspection, the pharmacy took decisive action to address issues with medication refrigeration monitoring. The pharmacy team reached out to the fridge manufacturer for expert guidance on resetting the thermometer, ensuring they had the correct information directly from the source. Once this information was obtained, a comprehensive training session was conducted for all relevant staff members. This training covered two crucial aspects: the proper method for resetting the thermometer and the correct procedure for recording both high and low temperature readings. To further strengthen their temperature monitoring practices, the pharmacy introduced a dedicated fridge temperature log on the same day as the inspection. This log provides a systematic way to record and track refrigerator temperatures, allowing for easy identification of any fluctuations that could potentially compromise medication efficacy. By implementing these measures, the pharmacy has significantly improved its ability to maintain proper storage conditions for temperature-sensitive medications. The swift response demonstrates the pharmacy's commitment to patient safety and regulatory compliance, ensuring that all refrigerated medications are stored under optimal conditions. This proactive approach not only addresses the immediate concern raised during the inspection but also establishes a robust system for ongoing temperature monitoring and management. A formal medicines disposal contract has now been established and put into effect. This contract ensures that all expired, damaged, or unwanted medications are disposed of safely, legally, and in an environmentally responsible manner. By implementing this contract, the pharmacy has not only aligned itself with regulatory requirements but has also demonstrated its commitment to public safety and environmental stewardship. |
13/08/2024 | 28/08/2024 |
Pharmacy inspections
Inspection reports and learning from inspections