| 1.1 |
Pharmacy team members do not work in accordance with the pharmacy's risk assessments and policies when prescribing and supplying prescription-only medicines and when selling over-the-counter P medicines through the online services provided. And the pharmacy does not use relevant information such as national prescribing safety updates to inform the contents of its risk assessments. |
Training and Compliance with SOP
Objective:
Ensure all team members are fully trained and comply with Standard Operating Procedures (SOPs).
Actions:
Conduct a mandatory training session on current SOPs for all staff, focusing on the importance of compliance.
Require all team members to sign a declaration confirming they have read, understood, and will adhere to the SOPs.
Introduce a quarterly refresher training program on SOPs and any updates to them.
Establish a monitoring system to ensure ongoing compliance with SOPs.
Risk Management and Assessment
Objective:
Enhance risk management processes to include all services and respond to new information.
Actions:
Review and update all risk assessments quarterly or in response to relevant new information, such as national patient safety alerts.
Ensure risk assessments for prescribing and supplying higher-risk medicines are comprehensive and up-to-date, particularly for services like weight loss that have received new guidelines.
Implement a system for verifying medical conditions independently before prescribing medicines for long-term conditions, with a focus on ensuring clinical appropriateness. SCR access is mandatory, if the patient is from different nation, a copy of repeat prescription or GP letter is required to confirm diagnosis. Patient is required to provide support documents to ensure continuous and up to date blood test. If appropriate, the pharmacy will offer blood test kits.
Develop a process for increased monitoring checks for Pharmacy (P) medicines subject to abuse, ensuring a pharmacist reviews all relevant information before dispensing. The developers are working hard to finish the new theme which can handle hundreds of requests at the same time. The proposed backend will have all the patient details and order history. The questionnaires will reviewed by the pharmacist or a qualified member of staff to accept or reject.
Technology and Record Keeping:
Objective:
Leverage technology to support error identification and maintain comprehensive records.
Actions:
Enhance the patient medication record (PMR) system to ensure it captures all near misses, with detailed records to support learning and improvement.
Secure a new website platform that requires patients to complete necessary questionnaires before purchasing P medicines, with fallback procedures to ensure no broken listings compromise patient safety.
Communication and Documentation
Objective:
Improve documentation and communication processes for continued care and decision-making.
Actions:
Document all communications with patients regarding the appropriateness of P medicine sales, supporting both decision-making and continuous care.
Create a clear procedure for handling situations where the pharmacy’s website issues might affect patient safety, including immediate actions and communications with patients.
Indemnity Insurance and Confidentiality
Objective:
Ensure all legal and regulatory requirements regarding indemnity insurance and confidentiality are met.
Actions:
Verify and document indemnity insurance arrangements for all prescribers, including independent nurse prescribers.
Implementation and Review
Objective:
Ensure effective implementation of the action plan and establish a review process.
Actions:
Assign responsibility for each action to specific team members with clear deadlines.
Set up a monthly review meeting to monitor progress, address any issues, and adjust the plan as necessary. |
01/05/2024 |
10/06/2024 |
| 1.2 |
The pharmacy does not undertake audits to support it in monitoring the safety and quality of the services it provides and to help it identify areas for learning and improvement. |
Audit and Continuous Improvement
Objective:
Implement ongoing audit processes to monitor risk and identify areas for continual improvement.
Actions:
Schedule and conduct a clinical audit on the supply of P medicines as a start and expand to other areas identified as risks. The audit will be carried out manually using Excel sheet formulas to identify multiple orders by checking the shipping postal codes and billing postcodes
Establish a regular prescribing review process to ensure adherence to pharmacy policies and current medical guidelines. The principals of the clinical audit is established in a separate document. The audit will carried out on monthly basis for 6 months to ensure compliance then becomes quarterly. The result of the audit will be shared with the team.
Introduce a system for recording and analysing mistakes, including near misses, to facilitate shared learning and improvement. The team is now live on the near misses tracker where they use their own phones to log in and record the near misses. |
01/05/2024 |
10/06/2024 |
| 4.3 |
The pharmacy does not have adequate processes for managing its waste medicines and any patient returned medicines it may receive. |
Disposal of Medicine Waste
Action Items:
Establish Waste Disposal System:
Secure contracts or arrangements with local waste management services to facilitate the safe disposal of medicine waste directly from the pharmacy.
Regular Audits:
Conduct regular audits to ensure compliance with waste disposal policies and regulations.
The contract has been arranged and is live with Anenta. The annual audit was sent to the pharmacy and completed on 22/03/2024 |
01/05/2024 |
10/06/2024 |
| 4.2 |
The pharmacy does not have adequate safeguards in place to make sure it always confirms people’s diagnosis and suitably verifies information before prescribing medicines for long-term conditions and for medicines requiring ongoing monitoring. It does not have a robust process to share what it prescribes with people's regular prescribers. And it does not always make the necessary checks when supplying people with over-the-counter P medicines. |
Improvement of Private Prescribing Services
Action Items:
Revise Consultation Questionnaires: Ensure that all questionnaires for P medicines and private prescriptions generate correctly and cover all necessary questions to assess suitability and safety.
Implement a Secondary Review Process: Introduce a secondary review of questionnaire responses by another qualified professional to catch any instances where medicines might be supplied without appropriate supporting information.
Educate Patients: Increase efforts to educate patients on the importance of reading patient information leaflets. Code extra messages to the consultation to make the patient aware of certain risks when taking the medication. For instance, code a messages about addiction when buy opiate based medication.
Verification of Patient Information
Action Items:
Enhance Identity Verification: Update the pharmacy's website and procedures to include details of the third-party identity checking provider. Ensure the process is robust and complies with current best practices. This will be done when patient order any POM medication for one time only. Manual verification is under review to include patients who have difficulties using technology.
Ensure Verification of Medical Information: Implement a stricter protocol for verifying patients' medical conditions, including requiring evidence of ongoing monitoring where necessary before issuing prescriptions, particularly for long-term medications like metformin and ramipril. If the patient needs a new blood test, the pharmacy can offer a test kit if appropriate.
Sharing Information with Regular Prescribers
Action Items:
Automate Sharing Mechanisms: Develop and integrate an automated system for sharing prescription information with patients' regular prescribers, ensuring consent is logged and correspondence is tracked and stored. The developers are working on it to be added to the backend.
Improvement of Over-The-Counter (OTC) Medicine Supply Checks
Action Items:
Enhance OTC Medicine Supply Process: Develop clear guidelines and training for pharmacy staff on conducting necessary checks when supplying OTC P medicines, ensuring suitability for each individual.
Patient Education: Increase efforts to educate patients on the correct use of OTC medicines, including the importance of reading information leaflets.
General Safeguards and Processes
Action Items:
Staff Training: Conduct comprehensive staff training focused on the areas of improvement identified in the inspection report, emphasizing the importance of adhering to best practices in all aspects of pharmacy service.
Implement Regular Audits Establish a schedule for regular internal audits to assess compliance with updated processes and guidelines, adjusting as necessary.
Have a monthly meeting with the prescriber to share the outcome of the audit and have an action plan if appropriate.
Open a direct channel with the prescriber to let her know of any changes in prescribing protocol.
Create open access to the prescriber to read and comment on the risk assessment and use them when needed. |
01/05/2024 |
01/08/2024 |
