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Pharmacy inspections

Inspection reports and learning from inspections

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Derix Healthcare Pharmacy (1092675) - Improvement action plan

Standard not met Reason Action being taken by the Pharmacy By when Notification By Pharmacy Improvements Made
1.1

The pharmacy cannot show that it identifies and manages the risks associated with its prescribing service adequately. It does not carry out adequate risk assessments for this service. And it cannot demonstrate that it shares information about the treatment it supplies with people's usual prescriber.

We will implement a formal process to identify and manage risks associated with the prescribing service. We will do this by conducting thorough risk assessments regularly and documenting these assessments. We will also demonstrate how we will implement sharing information about the treatment we supply with peoples usual prescriber via email.

1. Risk Identification- Medication error reporting: we will use the National Reporting and Learning System (NRLS) to report medication errors. This will helps in identifying patterns that may indicate systemic risks.

Prescription Review: Pharmacists will conduct thorough reviews of prescriptions to identify potential risks such as interactions and allergies.

Patient Consultation: We will actively engage with the patient or their caregivers to understand patient history, conditions, and potential risks associated with their medication.- This can also be done by accessing the patient's summery care records with their consent.

2. Risk Assessment- Clinical Checks: We will assess the clinical appropriateness of the prescription, including dosage, duration, and suitability for the patient's condition.

Risk Prioritisation: We will be determining the severity and likelihood of identified risks to prioritise management efforts.

3.Risk Control Strategies- Confirmation of medication use: Pharmacists will make sure to discuss medications with patients, ensuring they understand their treatment, which helps minimise risks of misuse or non-compliance.

Standard Operating Procedures (SOPs): Will implement SOPs that include safety checks and are in line with the pharmacy prescribing services.

Patient Education: The pharmacists will provide clear instructions and information to patients about their medications to reduce misuse and adverse effects.

4.Risk Monitoring and Reporting- Continuous Monitoring: Will implement an ongoing assessment of the effectiveness of risk control measures and identification of new risks as they arise.

Feedback Loops: Implementing systems for feedback from healthcare professionals and patients to identify and rectify issues promptly- this can be done by including a note at the end of each email sent to GPs while sharing prescribing information. In the patient's case, we can have a notice in the consultation room regarding any feedback they may want to give.

5.Learning and Improvement- Audit and Review: Arrange regular audits (yearly) of the prescribing process to identify areas for improvement.

Training and Development: Providing ongoing education and training advice/ recommendations for pharmacy prescribers using The Royal Pharmaceutical Society A Competency framework for all prescribers , the GPhC Standards of initial education and training for pharmacist prescribers and the learning outcomes, and to help identify any gaps and improve their knowledge. We will also stay on top of changes in medication safety guidelines set by MHRA, GPHC and NICE.

Legal and Regulatory Compliance

Adherence to Regulations: Ensuring compliance with laws and guidelines set by the Medicines and Healthcare products Regulatory Agency (MHRA), GPhC, and NICE.

Documentation and Record-Keeping: Maintaining accurate records of all aspects of the prescribing process, risk assessments, and management actions for accountability and legal protection.

We have developed this strategy aiming to protect patients from potential harm and enhance the quality of care they receive. It reflects a proactive approach to healthcare safety, emphasising prevention, vigilance, and continuous improvement. However, we may make small changes should we determine there is a better way of implementing a particular aspect in relation to managing improvements.

22/03/2024
1.2

The pharmacy does not sufficiently monitor the safety and quality of the various elements of its prescribing service. For example, by undertaking regular clinical audits.

We will implement a system to monitor safety and quality of our prescribing service. This will include regular clinical audits and reviews of prescribing patterns to ensure adherence to best practices. These audits will be completed once a year, against GPhC standards with the guidance from RPS and NICE.

In order to aim to enhance the quality, safety, and effectiveness of patient care, the elements we are looking to audit:

Prescription Accuracy and Appropriateness: Ensuring prescriptions are correctly written and appropriate for the patient's condition, including checks for dosages, duration, and medication choice according to current guidelines.

Clinical Effectiveness: We will assess whether the prescribed medications are effective for the intended clinical condition, based on the latest evidence and guidelines.

Patient Safety: we will identify and minimise risks related to medication errors, interactions and adverse effects. This includes monitoring for potential allergic reactions and ensuring that the medication is safe for the patient's specific health status.

Adherence to Guidelines: We will verify that prescribing practices adhere to national and local guidelines, such as those provided by NICE, and any relevant formulary restrictions.

Patient Experience and Engagement: We will assess how effectively patients are engaged in their treatment decisions, including the provision of information about their medications, potential side effects, and the importance of adherence to prescribed treatments.

Record Keeping and Documentation: We will review the quality and completeness of prescription records and clinical notes, ensuring they meet legal and professional standards for documentation.

Multidisciplinary Collaboration: We will assess the effectiveness of communication and collaboration between pharmacists, doctors, and other healthcare professionals involved in the prescribing process.

Additional audits may be required in response to specific issues, changes in practice, or the introduction of new guidelines or medications.

22/03/2024
1.6

The pharmacy does not keep adequate consultation records for its private prescribing service to show that this service is safe.

We will create a standardised form with necessary details of consultations to maintain adequate records. This will be a paper copy with the title "Derix Pharmacy Private Rx" and will include the following information,
-The date, patient's name, DOB, address, contact number, surgery details, Patient symptoms,, temperature, respiratory rate, blood pressure, pulse, urine colour, pain scores, gum/tooth colour, Other notes- ,Item(s) being prescribed, Instructions given, Route of which copy is sent to GP (i.e, e-mail, post or driver), prescriber's full name, GPhC number, address, telephone number, profession and signature.

22/03/2024
2.2

The pharmacy cannot sufficiently demonstrate that all its prescribers have the appropriate training and competence for the services they provide.

Will implement a training and competency assessment programme with regular updates and continuing education related to prescribing.

We will achieve this by producing a spreadsheet with every member of staff training log which will include- their name, training completed including PQS required training in relation to prescribing. Even if the member of staff is not a prescribing pharmacist, there will be courses they need to undertake in order to have the necessary knowledge to stay updated with the latest rules and regulations. i.e, mandatory training and or reading and understanding of mandatory policies such as safeguarding, data protection and confidentiality.

The spreadsheet for prescribing pharmacists will be separate as their list of courses and training to complete will be significantly different to regular members of staff.

08/03/2024
4.3

The pharmacy does not always manage its medicines properly or store them securely.

Review and amend storage protocols and records. Also ensure secure storage facilities and conduct regular audits of medication management practices and train staff on the proper handling and storage of medicines.

We will adhere strictly to the regulations set by the Misuse of Drugs Regulations 2001 and the Misuse of Drugs (Safe Custody) Regulations 1973 to ensure the secure storage and handling of controlled drugs. We will implement a system that includes daily checks to prevent controlled drugs from being misplaced or inappropriately placed in returns. Our driver is thoroughly trained to handle controlled substances correctly, and we maintain clear communication with care homes to inform them of the consequences of sending controlled drugs improperly packaged. All returned controlled drugs are securely stored in a safe until they are properly destroyed, following strict record-keeping. This process involves entering the details of the destruction into a dedicated destruction booklet, with a witness present to verify the procedure, ensuring full compliance with regulatory requirements and safeguarding against misuse or diversion of these substances.

08/03/2024
4.2

The pharmacy cannot demonstrate that its prescribing service is safe. For example, the pharmacy's prescriber does not make the appropriate records to show that medicines are only supplied when clinically appropriate. The pharmacy doesn't routinely seek consent to share information with other healthcare providers or share details about what has been prescribed with people's regular prescribers when it has consent to do so. It does not monitor the safety and quality of its prescribing service. The pharmacy cannot sufficiently demonstrate that it provides its vitamin B12 injection service in accordance with legal requirements.

Will develop a process in order to demonstrate safety of our prescribing service by creating protocols for prescribing, ensuring informed consent is obtained for sharing information with other healthcare providers and keeping detailed records of all the prescriptions issued especially when they deviate from what regular prescribers have provided. We will demonstrate that we provide our vitamin B12 service in accordance with legal requirements. Records will be kept (electronic records included) to show adherence to law.

The "protocols for prescribing" we will be developing and implementing are aiming to ensure that the prescribing service is safe, effective, and patient-centred. These protocols will ensure we are safeguarding patient welfare and ensuring high standards of care. These protocols and how they will help demonstrate the the prescribing service will be safe are as follows:

Clinical Governance and Audit: Clinical governance will ensure that we provide high-quality health services and continuously improve them. Regular audits of prescribing practices will help to identify areas for improvement and ensure compliance with the latest guidelines and regulations.

SOPs: Use of SOPs will provide a clear, step-by-step guide for pharmacists on how to manage the prescribing process, from assessing the patient's needs to the final dispensing of medication.

Training and Competency: Pharmacists involved in prescribing must complete additional training and demonstrate their competence. This will ensure they have the necessary skills and knowledge to prescribe safely, including an understanding of the legal and ethical aspects of prescribing.

Patient Consent and Confidentiality: We will ensure that patient consent is obtained before prescribing, ensuring patients are fully informed about their treatment options. Maintaining patient confidentiality is paramount, with strict guidelines on how patient information is stored and shared. This will also contribute to demonstrate that the prescribing service will be safe.

Clinical Decision Support Guidelines: Using national guidelines such as NICE will ensure that prescribing practices are evidence-based, promoting high-quality patient care, and enhancing patient safety. These guidelines provide us with up-to-date recommendations on the most effective treatments and medicines, reducing variability in practice and helping to standardize care across different settings.

Collaboration with Other Healthcare Professionals: Effective communication and collaboration with GPs, nurses, and other healthcare professionals are crucial for safe prescribing. We will stay in constant communication with patients healthcare providers in order to maintain a safe prescribing service.

Reporting and Learning from Errors: we will be encouraging a culture of reporting and learning from prescribing errors or near misses which is vital for improving safety. We are setting up mechanisms for reporting these incidents, analysing them, and implementing lessons learned to prevent future errors.

Regulatory Compliance: We will comply with regulations from bodies such as the GPhC and the MHRA. These regulations set out the legal requirements for safe prescribing and dispensing.

Patient Information and Support: Providing patients with clear information about their medications, including how to take them safely and what side effects to look out for, is an integral part of the prescribing process and something we will be implementing. Support may also include signposting to additional services or support groups which will also contribute to a safe prescribing service.

22/03/2024