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Pharmacy inspections

Inspection reports and learning from inspections

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Primed Pharmacy (1039469) - Improvement action plan

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

The pharmacy does not properly assess the risks of its private services, including the medicines it provides to people. It does not have adequate documented procedures for its private services. And it doesn’t have suitable risk assessments for the medicines it supplies. This includes for weight loss medicines, aesthetics products, including botulinum toxins, and medicines being used outside of the manufacturer's product license.

The following risk assessments to be completed:
- Dispensing unlicensed/off label medicines
- Dispensing of aesthetic medicines
- Over prescribing and misuse of medicines - including risk based limits for the prescribing of products
- Risk assessment for provision of weight loss services
- New customer verification

Updated HCP verification
- Gaining prescriber evidence for training as part of customer registration - update SOP and technology accordingly.

Unlicensed/off-label medicines
- Implement a new SOP and process for dispensing of unlicensed/off-label medicines to ensure patients remain informed each time an unlicensed medication is dispensed to them. This will be in the form of a patient information leaflet.

- Ensure prescriber is aware of the unlicensed status of a prescribed medication through website notice and mandatory confirmation each time an off-label product is ordered

Aesthetic medicine

- Updated procedure for processing and dispensing aesthetic prescriptions to incorporate HCP confirmation of physical face to face consultation. Additionally the procedure will incorporate risk prevention and auditing measures to flag prescriptions where prescriber and patient are in different locations.

Risk management training
- CPPE Risk Management training for relevant team members at the pharmacy.

Following standard operating procedures to be incorporated:
- SOP for delivery of weight loss services - to include section on prescribing policies
- Dispensing of toxins and dermal fillers (inc guidance from JCCP)
- Dispensing weight loss medicines
- Dispensing off-label and unlicensed medicines
- Managing and recording clinical interventions
- Managing sensitive patient information
- Over prescribing and misuse of medicines
- Whistle blowing policy
- Update SOP on new HCP verification to include evidence of further training and appropriate insurance indemnity cover. Primed technology to be changed to enable this process.
- Create SOP for customer feedback

Technology changes:
- Additional warning information for each product on the website to ensure HCP are aware of relevant information this will be editable per product eg. licensed status, warnings etc
- Patient directions will become mandatory when HCP create prescriptions

14/09/2022 09/09/2022
1.2

The pharmacy does not proactively audit or review the quality and safety of its private services. It does not have adequate systems in place to identify trends to prompt effective interventions. There are no systems to audit the higher risk and higher volume medicines it supplies. And no systems to effectively identify and challenge overprescribing and oversupply.

Following audits to be implemented:
- Over prescribing & misuse of medicines
- Medicine interventions to ensure appropriate intervention measures are in place
- Customer verification with evidence of training and insurance
- Aesthetic medicines including prevention of remote prescribing
- Unlicensed/Off-label medicines to ensure patient and prescriber aware
- Ongoing monitoring of weight loss patients through periodic audits confirming BMI

As part of monthly safety meeting:
- A product usage report to identify trends in medicine usage
- Identify trends in usage of high risk products
-Review audits, taking account trends identified, frequency of audit and outcomes.

Maximum permissible limits for ordering per product per px.

14/09/2022 09/09/2022
1.6

The pharmacy does not keep complete and accurate records for its private services, to help pharmacy team members make effective clinical assessments of these prescriptions.

Records
An updated system and process to ensure accurate recording of;
- clinical interventions
- Records of patient notes
- Change in process to ensure mandatory checking and updating of patient notes for each px
- Tech and process driven mandatory check of previous prescriptions for each patient and px
- HCP to confirm

14/09/2022 09/09/2022
4.2

The pharmacy does not have adequate safeguards to ensure the safe and effective delivery of its private services. The pharmacy does not request information from their prescribers to make adequate clinical checks and to make sure the medicines they supply are safe and appropriate for people. They do not always make appropriate clinical interventions. And they do not record or have easy access to information to be able to make effective clinical assessments.

Procedures and technology to incorporate;
- Recording clinical interventions - now mandatory check with each px
- See patients medical history - now mandatory check with each px
- Record prescription directions - now mandatory with each px order
- Incorporation of 2 factor authentication for each px

As per updated procedures, HCP’s will now confirm and sign for the following for each px;
- For Saxenda; confirmation that the patient has lost at least 5% of bodyweight within 12 weeks of starting treatment
- For non-surgical injectable aesthetics confirmation of physical face to face consultation
- For off label/unlicensed prescribing confirm that the patient has been informed of the status of the medicine and the potential risks.

14/09/2022 09/09/2022