| 1.1 |
The pharmacy hasn’t adequately identified and managed the risks associated with its hub-and-spoke dispensing model and its private prescribing service.
The pharmacy doesn't have written procedures for its hub-and-spoke dispensing model or its private prescribing service, or some of the other services it provides. And it hasn’t reviewed the written procedures it does have for quite some time.
The pharmacy doesn’t have prescribing policies for each of the conditions covered by its prescribing service. And there is no clear indication or evidence that health information provided by people during the consultation process is independently verified. This raises concerns about the clinical appropriateness and safety of the service. |
Immediate Suspension of Private Prescribing Service
· Following the GPhC inspection, the pharmacy has temporarily suspended all private prescribing activities until full governance structures are in place.
· The service has been replaced with authorised Private PGDs (Patient Group Directions) only, ensuring prescribing occurs strictly within approved clinical frameworks.
· All pharmacist prescribers have been instructed not to issue private prescriptions outside of PGD scope.
· A notice has been circulated to all branches and staff to confirm this suspension and to refer any clinical queries to the Superintendent Pharmacist.
Use Approved Private PGDs Only
· The pharmacy now only provides private clinical services via accredited PGD platforms such as Sonar, Pharma Doctor, and Voyager.
· These PGDs are governed by MHRA-approved protocols with built-in clinical decision pathways and consultation forms.
· Each PGD includes defined:
• Inclusion and exclusion criteria
• Dosage guidance
• Referral and escalation procedures
• Clinical record-keeping requirements
· Pharmacists are authorised only after completing platform-specific training and demonstrating competence.
Implement comprehensive Standard Operating Procedures (SOPs)
· A full suite of SOPs has now been created and implemented for:
• Hub-and-Spoke Dispensing Model (including dosette preparation, transport, Golden Tote process, and audit trail).
· SOPs are approved, signed, and available at all branches.
· Review frequency set to every 12 months or sooner following updates to NHS or GPhC guidance.
Hub-and-Spoke Dispensing Governance
· The Hub and Spoke SOP has been finalised and implemented (including blister pack and Golden Tote workflow).
· A written agreement between the hub and each spoke branch is in place, and notification has been submitted to the Integrated Care Board (ICB) as per NHS Terms of Service.
· Each spoke pharmacy now retains:
• Prescription transmission logs
• Tote reconciliation sheets
• Assembly and accuracy check records
Staff Training and Competence
· All pharmacists and support staff have completed refresher training on SOPs, PGD use, and GPhC Standards for Registered Pharmacies.
· Pharmacists authorised under PGDs have completed clinical governance and safeguarding training (October 2025).
Verification of Clinical Information
· For PGD consultations, pharmacists must now verify key health details (e.g., allergies, concurrent medication) directly with patients before supply.
· Any cases requiring medical validation or falling outside PGD criteria are referred to the patient’s GP or another appropriate healthcare provider.
· The consultation record, eligibility assessment, and outcome are securely stored within the PGD platform and available for audit. |
01/12/2025 |
28/11/2025 |
| 1.6 |
The pharmacy doesn’t keep adequate consultation records relating to its pharmacist prescribing service and these lack important details. This raises concerns about the robustness of clinical governance and the ability to review or justify prescribing decisions effectively.
The pharmacy doesn’t always keep accurate records of who has prescribed some of the medicines it dispenses on private prescriptions. And it sometimes doesn’t complete all of the supplier’s details and the headings in its controlled drugs register. |
1. Immediate Suspension of Pharmacist Prescribing
· The pharmacist-led private prescribing service has been suspended across all branches.
· No pharmacist is currently authorised to issue private prescriptions until governance systems have been fully strengthened.
· All clinical services are now provided solely under approved Private PGDs to ensure documentation, audit trails, and accountability.
2. Implementation of Standardised Clinical Record Templates
· A new Clinical Consultation Record Template has been created and implemented for all PGD and prescribing activities.
· Each consultation record now includes:
• Patient full name, DOB, contact details, and ID verification method
• Presenting condition, history, allergies, concurrent medicines, and red-flag screening
• Inclusion/exclusion criteria documentation (as per PGD)
• Clinical reasoning and outcome (supply/referral/declined)
• Prescriber or responsible pharmacist full name, GPhC number, and signature
• Date, time, and site of consultation
. Templates are stored electronically and available for inspection or audit for at least two years.
3. Strengthening Prescriber Identification and Accountability
· Every prescriber or pharmacist involved in issuing private prescriptions must now use a unique prescriber identifier that links to their GPhC or GMC registration.
· Making sure each private prescription is signed and dated clearly, with the prescriber’s name, qualification, and address recorded.
· The pharmacy has updated its Private Prescription Logbook to include prescriber details, medicine supplied, date, and pharmacist checker initials electronically.
4. Controlled Drugs (CD) Register Compliance
· The CD register has been fully reviewed and updated to ensure that:
• All mandatory columns are completed (Date, Quantity Obtained/Supplied, Running Balance, Supplier, and Recipient).
• Entries are made on the day of supply or next working day in accordance with Misuse of Drugs Regulations. ·
• The prescriber’s name and address are always entered for private prescriptions.
• Running balances are verified weekly by the Responsible Pharmacist and countersigned monthly by the Superintendent or designated deputy.
5. Staff Training and Competence
· Pharmacists and dispensary staff have been retrained (October 2025) on:
• Record-keeping and professional documentation standards
• Private prescription and PGD record requirements
• Controlled Drug handling and CD register legal obligations
• Clinical governance and accountability in prescribing
· Competency assessments and signed training records are retained for GPhC inspection. |
01/12/2025 |
28/11/2025 |
| 4.2 |
The pharmacy is unable to demonstrate that its prescribing service operates in a safe and effective manner. It cannot provide evidence that it checks the identity or health information of individuals accessing the service, nor that it routinely informs patients' GPs or implements appropriate systems for monitoring, follow-up, or safety netting. Additionally, there is a lack of procedures to demonstrate effective antimicrobial stewardship and safeguard against the inappropriate use of antibiotics.
The pharmacy’s multi-compartment compliance pack service isn’t adequately managed. And multi-compartment compliance packs are often assembled in advance of the prescription. This increases the risk of errors or supplies being made unlawfully. The pharmacy doesn’t routinely supply packaging leaflets with multi-compartment compliance packs. This means people may not have all the information they need to take their medicines safely. |
As the private prescribing service is currently suspended, no antibiotics will be prescribed or supplied under this service until safe procedures are established.
Develop and implement a robust Antimicrobial Stewardship Policy before the service resumes.
Ensure all future prescribing follows evidence-based national and local guidelines (e.g., NICE, NHS England).
Introduce a clinical review process for all antibiotic prescriptions to confirm clinical appropriateness, dose, and duration.
Provide mandatory training for all prescribers and pharmacists on antimicrobial stewardship and responsible antibiotic use.
Conduct an audit of antimicrobial prescribing before reinstatement of the service to confirm compliance with new procedures.
Review and update procedure for multi- compartment compliance pack service – ensure packs are prepared after valid prescriptions are received
Strengthen governance arrangements to ensure safe and effective service delivery.
The consultation room glass is now covered. Change vaccination room and use front consultation rooms for vaccinations.
All blister packs have been removed from the consultation room.
Brief all pharmacy staff and document training. |
01/12/2025 |
28/11/2025 |
| 4.3 |
The pharmacy cannot show that all its medicines it needs to keep in a refrigerator have been stored at the right temperature. |
1. Implementation of Daily Temperature Monitoring Protocol
· All pharmacy refrigerators used for storing medicines now have digital thermometers with min/max recording.
· Staff are required to:
• Record temperatures daily in Proscript and store electronically
• Document minimum, maximum, and current readings.
• Sign and date each entry.
· Reports are downloaded and reviewed monthly, and stored electronically for two years for audit and GPhC inspection evidence.
· Alarms are configured to alert staff if the temperature moves outside the 2–8°C range.
2. Corrective Action and Escalation Procedure
· A Corrective Action Protocol has been introduced for all temperature excursions:
• Quarantine affected stock immediately.
• Store all vaccines in the main dispensary fridge.
• Record excursion details, duration, and possible cause.
• Consult the manufacturer or wholesaler for stability advice.
• Document outcome and action taken in the Fridge Excursion Record Sheet.
· The Superintendent Pharmacist reviews all incidents and signs off investigations before any stock is returned to use or destroyed.
3. Staff Training and Accountability
· All staff have been retrained on cold-chain storage, temperature logging, and escalation procedures (October 2025).
· The training includes recognition of temperature breaches, actions to take, and documentation standards.
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01/12/2025 |
28/11/2025 |
