AC-2025-LON-000553 - [2025] EWHC 2616 (Admin)

On 4 December 2023, the Claimant applied to Kent and Medway Integrated Care Board for inclusion in the pharmaceutical list under Regulation 25 of the 2013 Regulations.

The application form dealt with various matters. One of the questions which had to be answered was as follows: “Please explain how the pharmacy procedures used within the premises will secure (a) the uninterrupted provision of essential services during the opening hours of the premises to persons anywhere in England who request those services, and (b) the safe and effective provision of essential services without face-to-face contact between any person receiving the services, whether on their own or someone else’s behalf, and the applicant or the applicant’s staff… You must ensure that you provide sufficient information within this application form to satisfy NHS England or the relevant delegated integrated care board on the above points.”

In response to that question, the Claimant provided information which related to a number of matters, under different headings. Under the heading “Delivering Medicines”, the Claimant said this:

“Medicines will be placed in a pharmacy bag and then packaged in a heavy-duty (re-enforced) cardboard box or padded envelopes of suitable size, including bubble wrap and/or polystyrene filling if needed. For deliveries using our delivery driver, medicines can be delivered using standard pharmacy bags unless fragile items are included. The storage requirements will be included in the delivery bag or box, for example “Store under 25 degrees C” or “CD – safe custody required”. All bags will have a printed address label attached and will include the number of bags to be delivered.

A note will be added to the bags to advise patients to return unwanted or expired medicines to a pharmacy and not to dispose of medicines in household waste, with a reference to our website for more information.

The Pharmacy will enter into a technical agreement with City Sprint for delivery of items with special storage instructions and for those patients that fall outside the catchment area for local deliveries (as an alternative to Royal Mail for those patients). City Sprint drivers are DBS checked and trained in the secure transportation of medicines, complying with GDP regulations with regards to transportation. The company provides live updates and electronic proof of delivery. When booking a delivery, we will indicate the nature and storage requirements of the medicines to be delivered.

The patient will be provided with a tracking number to track the status of the delivery online, if using Royal Mail or City Sprint.

Controlled drugs and fridge lines will be kept in the CD cabinet and fridge respectively until the delivery driver is collecting. The deliver sheet will include information on the medicines to be delivered, such as “CD”, or “FRIDGE”. CDs and fridge items will be packaged in separate bags and the bags will have the appropriate sticker affixed to it.

The delivery driver will verify the delivery sheet matches the delivery bags, including patient’s name, address, number of bags, and sign the delivery sheet. Once the delivery driver collects the medicines, he must ensure fridge lines are stored according to the storage instructions, and that CDs are placed in the dedicated section of the van. The delivery van must be locked at all times when the delivery driver is not in the vehicle, and medicines must be kept out of sight.

For fridge lines, if there is a temperature excursion outside of the 2-8 degree C temperature, the delivery driver must notify the pharmacist immediately and return any affected medicines to the pharmacy, where these will be quarantined pending investigation. The pharmacy staff will arrange a second delivery for the patient with another supply. The technical agreement in place with our courier will ensure that they can provide us with temperature monitoring data on demand and within a reasonable timeframe.

For CD deliveries, the delivery driver will sign the back of the prescription as the patient’s representative. CDs will be entered in the CD register at the point of collection by the delivery driver. The CD delivery sheet must be completed by the patient / representative. The delivery driver must check the identity of the patient / representative, unless already known.

Medicines can only be delivered at the agreed address and only left with the patient or agreed representative. Medicines must not be left with neighbours or someone else residing at the address (unless agreed with patient), outside the house, in front porch or delivered through mailbox. Any medicines not delivered will be returned to the pharmacy on the same day and a “Missed you” card left for the patient. No medicines must be left in the van overnight. Undelivered CDs must be re-entered in the CD register, with a note explaining that it was a missed delivery. The patient must be contacted the following working day to rearrange delivery.

On delivering medicines, the patient or authorised patient representative must sign the delivery sheet to accept the delivery of the medication.”

On 1 March 2024, the Interested Party sent a letter to Primary Care Support England, Pharmacy Administration Services, objecting to the application. The Claimant responded on 15 March 2024.

On 1 August 2024, the ICB granted the Claimant’s application. On 29 August 2024 the Interested Party appealed to the Defendant against the ICB’s 1 August 2024 decision.

The Claimant was invited to make representations and did so on 17 September 2024.

On 25 November 2024, as I have said, the Committee made the decision which is the target of this challenge. The overall conclusion, set out at paragraph 7.48, was that the Claimant’s application would be refused because the panel “could not be satisfied that there are procedures that are likely to secure safe and effective provision of essential services as required by Regulation 25(2)(b)”.

The committee was satisfied of all other relevant matters. It is important, in light of the issues raised by the Claimant, that I should set out the section of the decision in which the committee explained why it considered the Claimant’s application to have fallen short of what was required.

Paragraphs 7.36-7.42 of the decision stated:

“7.36

The Committee was of the opinion that the procedures adopted by the pharmacy were not likely to secure the safe and effective provision by the Applicant of the following essential services:

Providing ordered drugs or appliances

7.37

The Committee considered whether the Applicant had explained how drugs / appliances will be provided to the patient (including to ensure that (i) that cold ‘chain’ is maintained, where relevant, and (ii) that the requirements of the Misuse of Drugs Regulations 2011 and, in particular, Regulations 14 and 16, are met).

7.38

The Committee noted the information in the application form. [The Committee then quoted - in full - the extract set out at paragraph 5 above, from the Claimant’s application form]

7.39

Whilst the Committee noted the references to the cold chain being maintained, it was not clear from the information before it if this related to the pharmacy’s own delivery driver delivering fridge items. However, the Committee considered that if there was a deviation in temperature outside of the recommended limits, there was nothing provided as to how the driver would know that this had occurred and ensure that compromised medicines were not delivered.

7.40

The Committee went on to note that for those items that were delivered by courier, the Applicant stated “The technical agreement in place with our courier will ensure that they can provide us with temperature monitor data on demand and within a reasonable time frame”. The Committee was of the view that this appeared to be retrospective upon a request from the Applicant to the courier and that there was nothing provided to show how the courier would know in the first instance that there had been a deviation in temperature or what would happen if the temperature was not maintained. The Committee was of the view that a retrospective check presents the risk that a patient could technically have used medicines that had not been stored at the correct temperatures thus being compromised and any usage could have associated adverse consequences.

7.41

The Committee noted that whilst the Applicant had confirmed that controlled drugs would be delivered using a variety of methods including their own delivery driver, courier and Royal Mail, the information provided only appeared to relate to what would happen for a “missed delivery” if it was delivered by their own driver. The Committee was of the view that it had not been provided with any information as to what would happen in the event of a failed delivery of controlled drugs by either the courier or Royal Mail.

7.42

Taking all of the information before it into account the Committee was not satisfied that the Applicant had provided information sufficient to show that there would be compliance with paragraph 8(1) of Schedule 4.”

The Committee then reversed the decision of the IC, and refused the Claimant’s application.