| Standard not met | Reason | Action being taken by the Pharmacy | By when | Notification By Pharmacy Improvements Made |
|---|---|---|---|---|
| 1.1 | The pharmacy does not identify and manage all the risks for the services it provides. It does not have documented written procedures for all aspects of the service. For example, to support the team to understand the requirements of the clinical check, including checking dosage instructions are appropriate and printed on the label. And there are no instructions about using people's body mass index (BMI) to support checking prescriptions for weight loss. The pharmacy does not document how and when the team make checks to ensure face-to-face consultations happen with the prescriber for botulinum toxins. And although it has written risk assessments (RA) for the treatments it supplies, these are incomplete for some areas. And there are differences between the maximum quantity of botulinum toxins that can be supplied in the RA and the process being followed. |
We will update and amend the existing risk assessments for Botox supply to ensure accurate and consistent quantities are reflected. Specifically, we will correct discrepancies between the maximum quantities listed in the RA and the actual quantities supplied in practice. We will update the SOPs and risk assessments to include guidelines on the use of Body Mass Index (BMI) in the clinical check process for weight loss prescriptions. This will include clear instructions to support pharmacists in assessing prescriptions for weight loss by considering BMI, ensuring that dosage and treatment protocols are aligned. We will establish a more robust audit process to track and verify face-to-face consultations between prescribers and patients. We will document how and when prescribers/patients are called as noted below. To ensure all team members are fully equipped to comply with the updated procedures and protocols, we will implement ongoing training sessions. Training will focus on: All changes, updates, and actions taken will be fully documented and retained for GPhC inspection purposes. This includes updated risk assessments, SOPs, training logs, and records of audits and clinical checks. |
25/03/2025 | |
| 4.2 | The pharmacy does not have sufficiently robust systems to ensure it always makes the necessary checks when dispensing medicines and to ensure they are appropriate for people to use. Clinical assessments are basic and relate more to confirming the accuracy of the medicine supplied rather than its clinical suitability. For botulinum toxins the team don't always ensure the instructions of how and where to administer are included on the label. And the label does not always include mandatory warning labels. The pharmacy doesn't always have information such as height and weight available when dispensing medicines used for weight loss. The team can access previous dispensing history, but this is difficult to do on the system, and is not completed for each medicine supplied. This makes it difficult to ensure the medicine is appropriate for the patient and the necessary monitoring of doses, frequency of prescribing, and weight loss is being completed. There is little intervention and consideration of risks when people are prescribed unlicensed medicines, for example Ozempic for weight loss. |
We will amend our SOPs to ensure that a weight loss questionnaire is mandatory and reviewed before any supply of weight loss treatments, such as Mounjaro or Wegovy, is considered. This will ensure that all necessary patient information is collected and reviewed to support appropriate treatment decisions. We will require prescribers to provide specific, detailed dosage instructions, rather than using vague instructions such as "as directed." These instructions will be printed clearly on patient labels alongside any relevant warning labels. We will enhance the pharmacist’s clinical check process for Botox prescriptions by: We will overhaul our PMR system to ensure that it clearly shows each patient’s prescription history, including past Botox treatments and relevant medical information. This will allow pharmacists to better identify any contraindications or issues during the clinical check process. |
25/03/2025 | |
| 4.2 | The pharmacy regularly delivers medicines which require cold storage. But it has not made the necessary checks to ensure the packaging it uses to deliver these medicines appropriately maintains these medicines at the correct temperature. So, it cannot be sure these medicines are suitable for use by practitioners. |
To ensure that medicines are delivered at the correct temperature and in suitable packaging, we will implement a new and improved cold chain audit system. This will include the use of a temperature probe to monitor the temperature during the transportation of temperature-sensitive medicines. The probe will provide real-time data and documentation for all deliveries to confirm compliance with the required temperature ranges. |
25/03/2025 |
Pharmacy inspections
Inspection reports and learning from inspections