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Pharmacy inspections

Inspection reports and learning from inspections

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Medical Specialists (1104466) - Improvement action plan

Standard not met Reason Action being taken by the Pharmacy By when Notification By Pharmacy Improvements Made
1.6

The pharmacy's consultation notes for its prescribing service do not always contain the relevant information. It does not record communication which has taken place between the PIP and the person receiving care.

We have now changed our SOP for Prescribers which now emphasises comprehensive note taking.

We have always recorded notes of conversations between all pharmacy staff (admin staff and Prescribers) and patients. However, we are improving in this regard and all requests made by patients, both declined and approved, will have more detailed notes where possible recorded in the system, including notes justifying the supply if the consultation has been approved by the Prescriber.

17/09/2024 03/10/2024
1.2

The pharmacy does not sufficiently monitor the safety and quality of its prescribing service. It doesn’t analyse data from audits that it completes to identify learning and improvement opportunities.

We will be changing our auditing process.
We will be conducting condition specific audits with the aim to follow them with reactive reviews.

We will also be implementing peer reviews/audits for our Prescribers to conduct on each other’s prescribing, after which feedback can be given.

Audits we will be conducting over the coming 12 to 18 months will include:

● HRT
● Asthma
● Diabetes
● Hypercholesterolemia
● Parasitic infections
● Antimicrobial prescribing
● Migraines (Sumatriptan)
● Jet lag
● Topical steroids (eczema/psoriasis)
● Anal fissure
● Bacterial skin infections
● Erectile dysfunction treatment

17/09/2024 03/10/2024
1.1

The pharmacy does not adequately mitigate all of the risks associated with its prescribing service. Medicines are prescribed by relying solely on an online questionnaire. And there is no independent verification of the information people submit to help make sure that the treatments it provides are safe and appropriate.

We applied for Summary Care Record access on the 14th June 2024. We received an email on 25th June from the National Care Records Team. Once the Team are in a position to progress our application, they will be in touch with us.

However, whilst we wait for this from the NHS, we will request GP details and consent to inform the GP for all medications that require long term management and other medicines, (on every request) such as:

• NSAIDS
• Antibiotics (systemic)
• Constella
• Melatonin
• Statins
• HRT
• Asthma
• Diabetes

We will amend the online consultations for asthma, diabetes and HRT so that the patient has to upload evidence of diagnosis / prescribed medication previously (such as obtained from their NHS or Patient Access app).

For asthma consultations, there will be a new image upload Q: “Please upload evidence of your recent asthma review. If you do not have this, you can still proceed, but our Prescribers will need to contact you by phone to conduct a review of your condition if you do not provide this on future requests”.

For diabetes consultations, patients will now have to upload evidence in the consultation of their recent HBA1C reading.

For HRT and oral contraceptive pill consultations, patients will now have to upload evidence in the consultation of their recent blood pressure reading.

The above changes will further improve patient safety in respect of the long-term and ongoing management of these conditions.

17/09/2024 03/10/2024
2.2

Prescribers do not complete adequate additional training for some of the specialist services provided.

Certain medicines have already been marked as unavailable on our website. We are currently seeking specially trained Prescribers who have been signed off as competent by their DPP in certain areas.

Prescribers without the required training for the treatment will not be sent consultations out of their competency.

We check:
• GPhC status (also checked on a rolling basis each month)
• Indemnity insurance
• DBS status

• Once verified we send over send over a prescribing SOP to the Prescriber
• Confidentiality agreement (signed and returned to us by Prescriber)
• Remote Prescriber’s agreement (signed and returned to us by Prescriber)
• We also send over a competency declaration document (signed and returned to us by Prescriber)
• We request a completed BCPS statement (NPA)

We train the Prescribers to work our systems effectively and work in adherence to our medication policies, which they can have input in and can request to change or improve as necessary going forward.

We expect the Prescribers to organise/conduct their own training in the particular field(s) they want to. We are fully supportive with this and we will help them in any way we can. Going forward, we will conduct quarterly meetings with the Prescribers to discuss their expectations, as well as further discuss any training or issues they may wish to bring up. If they request further training or specific courses, we will assist them with this to develop them as far as possible.

17/09/2024 10/10/2024
3.1

The pharmacy advertises off-label medicines on its website which cannot be considered factual nor balanced because the medicines have not been assessed for quality, efficacy and safety for the indications they are advertised for.

We do not advertise any medications as such. However, certain medicines have already been marked as unavailable on our website. We are currently seeking specially trained Prescribers who have been signed off as competent by their DPP in certain areas.

Once we have such Prescribers in place, we will work with them in respect of off-label medicines and request their input should any improvements or alterations be required.

Any off-label medications that we have on our website will have clear references to past studies / medical papers which have assessed for quality, efficacy and safety.

In certain cases, blood tests are required prior to supply, and then every 6 months from the patient (which are provided to the patient’s GP), plus their GP is informed during every supply.

We have contacted the MHRA as of 08/08/24 for advice and clarification on point 3.1.

Until we receive further clarification and guidance from the MHRA on this matter, we will temporarily remove the product pages of Spironolactone and Lumigan so they will not be visible to any patients who use our website.

17/09/2024 27/09/2024
4.2

The pharmacy does not always obtain consent to communicate with a person's regular practitioner when using the prescribing service. And it does not take additional steps when prescribing for long term conditions or higher risk medicines to help make sure it is appropriate when consent is not obtained. Supplies of medicines for conditions which require ongoing monitoring are made without seeking sufficient assurances to ensure they are clinically suitable.

We are further rigorously monitoring repeat patients than we already currently do. For regular requests, particularly on long term conditions, we are now seeking for consent to inform patient’s GP of the supply, even if the patient has initially said they will inform their own GP. Without this consent, we will not make the supply and refer the patient back to their own GP.

The long-term conditions such as these, the GP will be informed with EVERY request. This is compulsory and no supply will be made without consent and the GP details supplied.

Our consultations will be changed so that the patient has to input GP details during the online consultation process.

This is also the case with other previously mentioned medications in point 1.1 such as NSAIDs, HRT, etc.

If consent is given, then a letter is sent out to the address supplied in the consultation at the same time as the order is dispatched. All this information is also noted on the patient's record.

According to the Global Initiative for Asthma (GINA) and NICE guidelines, the use of 12 or more short-acting beta-agonist (SABA) inhalers within a 12-month period is indicative of poor asthma control and is associated with a higher risk of exacerbations. To ensure that we proactively manage our patients’ asthma, we have decided to set a more stringent threshold. Specifically, our new protocol will trigger a review when a patient has been prescribed more than 6 Salbutamol inhalers within a 12-month period.

For example, if no evidence of a review has been uploaded into the consultation in this timeframe with their own asthma nurse or GP, the Prescriber or pharmacist will attempt to contact the patient for a telephone review, and details of this will be logged in the patient’s notes together with any advice that may have been provided to the patient. (No supply will be made until this has been conducted).

Questions asked to the patient will be from www.asthmacontroltest.com, plus any additional relevant questions that the Prescriber may deem necessary, as this will provide a quick and efficient way of checking if the patient’s condition is controlled via a scoring system.

We believe that this proactive approach will significantly contribute to better health outcomes for our patients by identifying and addressing issues with asthma control earlier than current standard thresholds suggest.

17/09/2024 03/10/2024
4.3

The pharmacy does not have a robust procedure in place to deal with medicines that have not been successfully delivered to people. Returned medicines are redelivered to people without any assurances that they have been stored in line with manufacturer's recommendations.

We will be changing our procedures with failed deliveries. We will no longer be redelivering, and instead all medication will be returned to the pharmacy for immediate disposal.

Patients will be notified regarding this via the website prior to placing any requests
(E.g. no assurances / guarantees of the storage of the medicine are the courier’s warehouse).

17/09/2024 03/10/2024