The decision by Primary Care Appeals (the body that determines appeals under delegated authority from the Secretary of State) to refuse an application submitted by Pharmacy2U ("P2U") for its new Leicester hub is significant not only for P2U but for the wider NHS pharmacy network. P2U's application was originally approved by NHS England, but that approval appears to have been largely based on the identity of the Applicant rather than any reasoned analysis of their application. In this post I want to take a look at the decision in more detail and what it might mean for P2U going forward.
The NHS has a duty to consider all applications fairly and impartially and Primary Care Appeals carried out the same analysis of the P2U application as it does of any other application made under regulation 25 for a distance selling contractor. There was no special treatment given to either the Applicant or the Appellant based on who they were, and that is as it should be.
The decision letter makes interesting reading as it is clear that some of the practices that P2U says it currently uses were questioned and rejected by Primary Care Appeals. Extracts from the final paragraph of the decision read as follows;
7.2 Accordingly, the Committee:
7.2.1 quashes the decision of NHS England; and
7.2.2 redetermines the application as follows -
22.214.171.124 the Committee was not satisfied that all essential services were likely to be secured without interruption during the opening hours,
126.96.36.199 the Committee was not satisfied that all essential services were likely to be secured for persons anywhere in England,
188.8.131.52 the Committee was not satisfied that all essential services were likely to be secured in a safe and effective manner,
184.108.40.206 the Committee was not satisfied that all essential services were likely to be secured without face to face contact;
7.2.3 The application is refused.
Behind this final decision are many pages of analysis of the procedures that P2U said it either already used at its Leeds facility or intended to use in Leicester. The main points to note from the analysis are that;
- P2U dispenses and delivers "appliances" to patients but they rely on patients to provide their own measurements and fit the appliances themselves. This contravenes the requirements of their Terms of Service which requires the pharmacy to both measure and fit the appliance where required.
- Despite assurances provided via their solicitors that the responsible pharmacist would not be absent from the premises during contracted hours, the Standard Operating Procedures ("SOPs") indicated that the pharmacist may be absent. The responsible pharmacist is not permitted to be absent from the pharmacy under the NHS contract even though the GPhC permits such an absence. I have previously written about this problem and it remains to be addressed.
- Despite stating that they were not permitted to offer essential services in a face to face manner at their premises, the SOPs talked about patients being "able to easily identify areas used for NHS healthcare, for example the prescription reception area and confidential consultation areas."
- No evidence was provided on any process that ensured P2U checked evidence of patients' entitlement to free NHS prescriptions. All pharmacy contractors are required to perform such checks as part of their Terms of Service.
- the Committee was provided with no information to show how the Applicant would ensure that the cold chain packaging had not been breached at any point prior to its delivery to the patient.
- The Committee noted the Applicant’s reference to patients who give consent to have their dispense items left in a "safe place" by Royal Mail. Again the Committee had no information to show that the Applicant had demonstrated how the cold chain can be maintained.
- The Committee concluded that the Applicant had provided insufficient information regarding the delivery of cold chain items such that it could not be satisfied that the integrity of any items would be maintained throughout the delivery process.
- No information had been provided to show how the security of dispensed controlled drug items would be maintained.
The decision is undoubtedly a setback for Pharmacy2U as the new Leicester hub was to be "a ‘mega facility’ in Leicester — six times larger than [the] one in Leeds and due to be fully operational by 2021" (according to a Pharmaceutical Journal article in 2019). The decision also calls into question the practices that P2U currently uses at its Leeds pharmacy which currently dispenses over 600,000 prescription items every month. The NHS Area Team in Leeds may need to consider whether it should now investigate possible breaches of the Terms of Service for the existing pharmacy. For example, if P2U has been dispensing appliances without providing a measuring and fitting service or failing to check entitlement to prescription charge exemptions? In its submission P2U highlighted that it had been operating since 1999 and had "many regulatory inspections", however, it is unlikely that any of these inspections assessed the pharmacy against the current NHS requirements for distance selling pharmacies - and that is what has now happened.
A good example of the problem this decision causes not only for P2U but for NHS England is that in their submissions P2U stated;
"[Pharmacy2U] believes that not offering to dispense appliances would significantly compromise the convenience of its service as these are often bulky items for which home delivery (distance selling) pharmacy is particularly well suited. The Applicant therefore intends to offer appliance dispensing whilst recognising that gathering measurements may be difficult in some circumstances; and [Pharmacy2U] is fully committed to helping patients to obtain their measurements and appliances elsewhere if this is the best option for them, as [Pharmacy2U] does in its existing pharmacy."
The Appeal decision was very clear that this is a breach of the Regulations as "there is a clear obligation within the regulation above, for a registered pharmacist to measure the person and where necessary fit the appliance." It will be interesting to see what NHS England chooses to do with this admission from P2U that they have not been complaint with the requirements of the Regulations. To put this into perspective, when I act for clients in Distance Selling applications I always recommend that the client states they will not provide appliances that require measuring or fitting. I do this because I recognise that it would be almost impossible to provide the service as required under the Regulations in a cost effective manner. Whilst I have sympathy for P2U in wanting to provide such appliances it is wrong for P2U to be providing them if other distance selling contractors are prevented from doing so because they are complying with the Regulations. Such an advantage would not just be unfair, it would be unlawful.
Perhaps more surprising to many people is the Committee finding that it could not be satisfied that the services would be available to any patient in England who requested them. It is fair to say that P2U did not explicitly state in their evidence that their service would be available to any patient in England, but equally I can see no evidence of any restriction in geography being suggested. The Committee simply proceeded on the basis that it was up to the Applicant to provide sufficient evidence to satisfy the legal test rather than the other way round and this approach supports the view that P2U were simply treated like any other Applicant has been.
Some people will focus solely on the comment that the Committee "was not satisfied that all essential services were likely to be secured in a safe and effective manner", but this is not the same as saying that processes were not safe and in some areas it was the absence of evidence that was the real problem rather than there being evidence of unsafe practices. However, there are some areas of their operation that P2U will need to look at carefully now as it is equally clear that, on the basis of the information they provided, they are likely to be in breach of their Terms of Service and may have been for many years. The same Committee at Primary Care Appeals has been very busy recently considering appeals against the decision of NHS England to recover quality payments made to pharmacy contractors where the pharmacy has failed to meet one of more parts of the relevant criteria for those payments (normally through misunderstanding or mistake). It will be interesting to see what NHS England does in this case albeit with different circumstances.
The appeal decision also considered the delivery processes that P2U uses. There has been a lot of talk amongst pharmacy contractors about whether P2U's delivery to a "safe place" option can really be safe. Similarly the appeal decision highlights problems with the delivery of controlled drugs and fridge lines to patients with concerns about security of controlled drugs and the integrity of cold chain medicine where a delivery failed.
The significant number of areas of concern raised in the appeal decision means this can also been seen as an opportunity to consider issues that may never have been considered before at P2U and any improvement in service will ultimately we welcomed by patients.
The decision can be read in full by clicking here