| 1.1 |
The pharmacy does not have standard operating procedures (SOPs) available for the team members to refer to, so this may create a risk if they are not following the correct procedure. |
Make SOPs Accessible to All Staff • We have consolidated all relevant SOPs in a dedicated Google Drive folder. • A physical file of current SOPs is also kept in the dispensary (see attached photographs). • New and existing team members are shown where to find SOPs both online and in the pharmacy to ensure immediate access. • Staff Training Logs and Acknowledgements: (Maintained in pharmacy records)
Staff Training and Acknowledgment • All staff are required to review the SOPs and complete an acknowledgment form confirming they have read and understood them. • A training log is maintained to record each staff member’s progress and sign-off. • Staff have also been directed to the e-learning modules on the Medlrn platform (linked below) to supplement their understanding. Ongoing Review and Updates • We will review SOPs at least annually or whenever changes occur (e.g., new guidance or updated procedures). • Any updates will be communicated to staff immediately, and staff will sign off on any revised SOP. • The Pharmacy Manager (Faheem Ahmed) will oversee these updates and maintain a schedule for regular SOP reviews. Supporting Links & Evidence • Google Drive (SOPs): https://drive.google.com/drive/folders/1ZGJ1PYzhJ3vj0iqwikTdmB5zK7_q9nAW?usp=drive_link • E-learning (Medlrn modules): https://edu.medlrn.com/courses/pharmacy-assistant-course • Photographs of SOP Location: (Attach or reference where the pictures can be viewed.) • Staff Training Logs and Acknowledgements: (Maintained in pharmacy records)
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06/05/2025 |
22/04/2025 |
| 1.2 |
Team members do not routinely keep records of the mistakes they make. This makes it harder for them to learn from them, and to assess the safety and quality of services they provide. |
Implementation of Near-Miss and Error Logging Procedure • Near-Miss Log: A dedicated near-miss log (see attached link and sample) is now in place. All team members must record any near-misses as they happen. • Error Reporting & Response: We have an Error Reporting SOP which outlines the process for reporting, investigating, and implementing corrective actions for dispensing errors. • Root Cause Analysis (RCA): When an error occurs, a brief RCA session is conducted to identify underlying causes and implement changes to prevent recurrence. 2. Staff Training and Engagement • Regular Reminders: The pharmacy manager holds a weekly briefing to remind staff of the importance of error logging and to discuss any reported incidents. • Ongoing Training: All staff are trained to understand what constitutes a near miss or dispensing error and how to record it (see Google Docs link for guidance). • Culture of Openness: We encourage non-punitive reporting, emphasizing learning and improvement over blame. 3. Review and Analysis of Near Misses • Monthly Review Meeting: The pharmacy team meets monthly to review logged mistakes, discuss common themes, and implement improvements (e.g., adjusting shelf layout, adding warning labels). • Action Plans & Follow-Up: Any identified trends lead to targeted action plans. Follow-ups are conducted to ensure changes are effective. 4. Audit and Continuous Improvement • Quarterly Audit: The pharmacy manager conducts a quarterly audit of the near-miss logs to ensure accurate and consistent recording. • Feedback Loop: Audit findings are shared with all team members. Where ongoing issues are identified, additional staff training or SOP updates will be provided.
See attached near miss log picture Staff actively entering logs
Dealing with errors
https://docs.google.com/document/d/16RDo_6jDFTUMy7e8Aw3cBlVo25aQLzGD/edit?usp=drive_link&ouid=112852584048477152377&rtpof=true&sd=true
Near miss logs
https://docs.google.com/document/d/16RDo_6jDFTUMy7e8Aw3cBlVo25aQLzGD/edit?usp=drive_link&ouid=112852584048477152377&rtpof=true&sd=true
Patient safety incident
https://docs.google.com/document/d/16RDo_6jDFTUMy7e8Aw3cBlVo25aQLzGD/edit?usp=drive_link&ouid=112852584048477152377&rtpof=true&sd=true
Training Logs: Copies of staff training attendance, sign-off sheets, and ongoing refresher sessions (kept on file; available on request). |
06/05/2025 |
22/04/2025 |
| 1.6 |
The pharmacy does not keep all the records it needs to by law. Its team maintains records of some controlled drugs on photocopied controlled drug register sheets stapled together which do not meet legal requirements. And the responsible pharmacists (RPs) do not always sign out at the end of their session so the RP record is not complete. |
Action Being Taken by the Pharmacy 1. Implementation of Legally Compliant Controlled Drug Registers • We have procured a hardbound CDR that meets all legal requirements (i.e., pre-printed page numbers, permanent record). • Any old or photocopied sheets are being withdrawn. All data on these sheets are being transcribed accurately into the new official register—ensuring any transcriptions are signed, dated, and referenced to maintain audit trails. • New SOPs clearly outline how to complete entries correctly, in line with current legislation, including timeliness (entries made on the day or next day at the latest), accuracy, and completeness of each entry (including running balances). 2. Enhanced Responsible Pharmacist (RP) Logging Procedures • We have reiterated to all pharmacists the requirement to sign in and sign out each day to ensure the RP record is complete. • A daily check has been introduced by the pharmacy manager (or a designated team member) to ensure the RP signs out before leaving. • Any omissions are followed up immediately, and corrective entries are made in line with legal guidelines for amending the RP record. 3. Training and Reinforcement • Staff Training: All dispensary staff and pharmacists have been briefed on the revised procedures for CD and RP recordkeeping. • Ongoing Refresher Sessions: We hold monthly reminders during team meetings to reinforce the importance of maintaining compliant records and to review any near misses or deviations from these procedures 4. Audit and Monitoring • Weekly CD Balance Checks: We now conduct weekly audits of CD stock and compare them against the new register to identify and resolve any discrepancies promptly. • Monthly RP Record Review: The pharmacy manager will review the RP register monthly to confirm that all on-duty pharmacists have completed the sign-out process. • Any anomalies detected are investigated and documented in an incident log to enable continuous improvement.
Supporting Documents & Evidence • New Hardbound CD Register (or Approved Electronic Register): • Photos or screenshots available upon request to demonstrate new record format. • Example entries showing correct, compliant recording. • Revised SOPs • Outlining how to maintain the CD register and complete the RP record. • Held in the pharmacy’s SOP file and accessible to all staff. • Staff Training Logs: • Attendance records and acknowledgment signatures confirming that staff have been trained on new procedures. • Available for inspection on request. • Audit Reports: • Documentation of weekly CD balance checks and monthly RP register reviews (with corrective action records if needed).
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06/05/2025 |
22/04/2025 |
| 1.7 |
The pharmacy cannot show that it is registered with the Information Commissioners Office. And it does not display a privacy notice for people to read. This means people may not have confidence that their personal information is protected, and what the pharmacy uses it for. |
See attached prof of ICO registration https://ico.org.uk/ESDWebPages/Entry/ZB826750 |
06/05/2025 |
22/04/2025 |
| 1.8 |
The pharmacy team cannot satisfactorily explain how it reports any safeguarding concerns it may have. And it cannot show that it has a written procedure for this. This means it may not be able to help protect vulnerable people as well as it should. |
1. Written Safeguarding Procedure • A Safeguarding SOP has been developed and is now available to all staff (see link below). • The SOP details the exact steps team members must follow if they suspect or identify a safeguarding concern, including how to escalate concerns to the relevant authorities and any internal leads. 2. Staff Training and Awareness • All staff are required to read the Safeguarding SOP and complete a training record confirming they understand their obligations. • We have integrated safeguarding training into our induction programme for new starters, ensuring they know the reporting process from day one. • Regular Refresher Sessions: We are scheduling periodic safeguarding refresher courses to ensure everyone stays current with policy changes and external guidelines (e.g., local authority updates). 3. Named Safeguarding Lead • A Designated Safeguarding Lead (DSL) within the pharmacy team has been appointed), who will be the main point of contact for any concerns. • The DSL maintains up-to-date contact details for local safeguarding authorities (Adult and Child Social Services) and provides prompt support to any team member reporting a concern. 4. Monitoring and Review • We will review the Safeguarding SOP and training logs annually (or sooner if legislation or guidance changes). • If a safeguarding incident arises, the DSL will coordinate an incident review to ensure correct procedures were followed and identify any opportunities for improvement. See attached link to safeguarding SOP
https://docs.google.com/document/d/1NSFnXxi4XNB1VGxeXhptQNwID3oIfcBH/edit?usp=drive_link&ouid=112852584048477152377&rtpof=true&sd=true
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06/05/2025 |
22/04/2025 |
| 2.2 |
The pharmacy does not keep appropriate records of the training completed by its healthcare assistants, even though it has enrolled them on suitably accredited courses. This means they may not have been adequately trained and unable to provide pharmacy services to the standard expected of them |
1. Consolidation of Training Records • We have introduced a centralized training log (see link below) where all staff (including HCAs) record their completed modules and certifications. • Any certificates or evidence of completion (e.g., screenshots, PDFs) are now digitally stored in an organized folder with clear file names for easy tracking. 2. Routine Updates and Verification • Monthly Training Updates: Each HCA will meet with the Pharmacy Manager or a designated supervisor monthly to update their training record and confirm progress on accredited courses. • Managerial Sign-Off: The Pharmacy Manager (or delegated senior member) will verify the completion of each module or assessment by cross-referencing course documentation. 3. Clear Training Pathways & Deadlines • We have established individual training plans for each HCA, detailing required modules, accreditation timelines, and completion deadlines. • This ensures staff and management can track progress and identify any training gaps promptly. 4. Ongoing Monitoring & Review • Quarterly Review Meetings: Senior staff will review the training logs quarterly to ensure consistent record-keeping and adherence to timelines. • Any identified discrepancies or delays will prompt additional support or remedial actions (e.g., scheduling specific study time).
See attached training logs
https://docs.google.com/document/d/19ysCQaECqgC1Q6mrtKvlE0T0yj1MIzkZ/edit?usp=drive_link&ouid=112852584048477152377&rtpof=true&sd=true
All staff are updating their training records.
Certificates & Completion Evidence: • Digitally stored in a dedicated folder, available for inspection upon request. • Individual Training Plans: • Outline modules, deadlines, and manager’s sign-off schedule. |
06/05/2025 |
22/04/2025 |
| 4.2 |
The pharmacy allows people to consume their medicines in an insecure area which does not protect their privacy. This creates additional risks for both them and the pharmacy. |
1. Designated Private Consumption Area • We have identified or created a designated area (e.g., a consultation room or a screened-off section) where people can consume medication securely and privately, away from the main retail space. • Clear signage now directs patients who need to take medication onsite to request or use this private area. 2. Review and Update SOPs • A new or revised SOP now clearly outlines the process for supervised consumption or any on-premise medication-taking. This ensures staff direct patients to the private area and provide any necessary support (e.g., water, disposal of cups/packaging). • Staff are being trained to follow this SOP to safeguard patient privacy and protect their dignity. 3. Staff Training and Awareness • All team members have been re-trained on the importance of patient privacy, confidentiality, and the safe handling of medication consumption onsite. • This training includes scenario discussions on how to gently guide patients to the private area and how to handle difficult situations (e.g., if a patient refuses). 4. Risk Assessment & Ongoing Monitoring • We have conducted a risk assessment on the current premises layout, identifying any remaining vulnerabilities. • The pharmacy manager will periodically review how effectively the new procedure is being implemented (e.g., staff compliance, patient feedback) and make further adjustments if needed.
Supporting Documents & Evidence • Updated SOP for Onsite Consumption: • Detailing the process and staff responsibilities for ensuring privacy. • Staff Training Records: • Confirming each staff member has received additional training on patient privacy and confidentiality. • Risk Assessment Report: • Documenting the changes made to the premises and any planned improvements.
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06/05/2025 |
22/04/2025 |