31 January 2017

REF: SHA/18502

APPEAL AGAINST LONDON REGION AREA

TEAM, NHS COMMISSIONING BOARD "NHS

ENGLAND" DECISION TO REFUSE AN

APPLICATION BY PHARMALINC LTD FOR

INCLUSION IN THE PHARMACEUTICAL

LIST AT STRATFORD WORKSHOPS, UNIT

157, BURFORD ROAD, STRATFORD,

LONDON, E15 2SP UNDER REGULATION 25

1 The Application

By application dated 15 February 2016, Pharmalinc Ltd (“the Applicant”) applied to

NHS England for inclusion in the pharmaceutical list at Unit 157, Burford Road,

Stratford, London E15 2SP under Regulation 25. In support of the application it was

stated:

1.1 In response to why the application should not be refused pursuant to

Regulation 31 the Applicant stated:

1.1.1 “n/a as the premises is not adjacent to, or in close proximity to another

pharmacy or dispensing appliance contractor”

1.2 In response to why the application should not be refused pursuant to

Regulation 25(2)(a) the Applicant stated:

1.2.1 “n/a because the proposed premises is not on the same site or in the

same building as the premises of a provider of primary medical

services with a patient list.”

Further Information in Relation to Provision of Essential Services in Accordance

With the Regulatory Requirements for Distance Selling Pharmacies

1.3 Please find below information to explain how the pharmacy procedures used

within the premises will secure:

1.3.1 (a) the uninterrupted provision of essential services during the opening

hours of the premises, to persons anywhere in England who request

those services, and

1.3.2 (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.

1 Trevelyan Square Boar Lane

Leeds LS1 6AE

Tel: 0113 86 65500 Fax: 0207 821 0029 Email: fhsau@nhsla.com

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1.4 The SOPs in respect of distance selling is in working progress. However, for

the purposes of this application, please find below, an explanation on how the

pharmacy procedures used within the premises will secure both parts of the

question above.

1.5 The pharmacy will only be staffed with a pharmacist during the opening hours

to enable the provision of essential services to persons anywhere in England

without any face to face contact. The pharmacist will be able to give advice

via telephone, website/email, and fax. Staff will not provide face to face

contact under any circumstances, in, or in the vicinity of the premises.

1.6 The premises has been carefully chosen to ensure that this is always the case;

the self contained unit is part of a commercial building which is secure and not

accessible to members of the public. The building management arrange a

security officer to keep watch of the entrances during normal working hours.

Access to the building is by means of a self closing door using a security code.

Therefore, access to the general public is not possible. On top of this, CCTV is

in operation 24/7 both inside and outside the building.

1.7 The pharmacy will have a dedicated website, for which a domain name has

already been secured and is www.your-chemist.com. The website will be

designed and maintained by a specialist company called 'the pharmacy centre'

who are accredited by the NPA.

1.8 The website will be accessible 24 hours per day so that the public have access

to health information at any time of the day. The website will provide the

signposting, self care and healthy lifestyle advice and will be supplemented by

leaflets and telephone advice.

1.9 The pharmacy will also have dedicated telephone lines and fax lines available

during normal working hours. These will be operated by trained staff who will

work according to robust standard operating procedures (SOPs) that have been

specifically tailored to suit distance selling. The pharmacist will be available

from 9.30am to 5.30pm, to monitor and issue prescription requests and to offer

telephone advice as required.

1.10 All the different methods of communication that will be available (website,

telephone and fax) will allow for trained staff to communicate effectively and

efficiently with potential patients on a national level, without any face to face

contact. This will enable the applicant to provide excellent provision of

pharmaceutical services to anyone wishing to utilise the website, telephone or

fax service.

1.11 Preliminary accounts have been set up - upon approval of contract - with

courier companies; Royal Mail and Igloo thermo logistics for the delivery to

patients nationwide.

1.12 A delivery driver will deliver products to patients that are local to the

pharmacy premises, as long as there isn't any cold chain to consider. Where

the patient is not at home when a delivery is made to the stated address, a card

stating so will be left at the address and the medication will be returned.

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1.13 A free post address set up will allow customers to send their prescriptions via

post to the applicant without them incurring postal charges.

Dispensing of medicines (including repeat dispensing)

1.14 There are various methods by which prescriptions will be received:

1.14.1 Sent electronically via the Electronic Prescription Service.

1.14.2 Sent to the pharmacy using its freepost address.

1.14.3 In situations where the patient is registered with a local GP, the

prescriptions will be collected by staff from surgeries.

There will be no face to face contact with the patient.

1.15 Once prescriptions are received, medicines will be dispensed by a registered

pharmacy.

1.16 These will be delivered using the most appropriate form of delivery:

1.16.1 In ALL cases where there are cold chain products, such as insulin, an

MHRA approved company called Igloo thermo-logistics will be

employed as they are approved to deal with fridge line deliveries.

1.16.2 In instances where there are controlled drugs, Royal mail special

delivery will be used as this courier service will enable the parcel to be

tracked electronically and will have the added safety measure of

requiring a signature upon delivery.

1.16.3 In cases where the delivery is to be made within a 15 mile radius to the

pharmacy premises, and does not include a cold chain, delivery will be

made by the pharmacy employed delivery driver who will be trained

and qualified to make deliveries of medicines.

1.17 If the patient is not at the delivery address, the courier company/delivery

driver will leave a card to inform the patient that a delivery had been

attempted, telephone and email contact details will be left to enable delivery at

a different time. No medication will be posted or left with neighbours, in fact,

the medication will then be returned to the pharmacy at the earliest

opportunity. A delivery will be rearranged, at no point will the customer be

allowed to come to the pharmacy and collect medicine.

1.18 If there is a delay due to medicine being 'out of stock', the responsible

pharmacist will contact the patient or their representative as a matter of

urgency, advise on expected deliver, and agree a course of action. Where

appropriate, a written confirmation will be sent to the patient or their

representative, and a written note of the items owed recorded against the

patient record.

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1.19 All dispensing will be recorded on the Patient Medication Records

system/program (PMR). Advice on appropriate use of medicines and storage

will be provided.

1.20 With regards to the declaration of exemptions on the back of prescriptions, the

customer will be asked to complete the relevant details on the website when

he/she registers to use the applicant’s services. The customer will be prompted

to select their exemption and record their exemption certificate number. This

information will then be stored on the PMR. When the certificate is about to

expire, the applicant will inform the patient so that they are able to renew.

Patients who do not qualify for an exemption, could either make a payment for

their prescription via the telephone or on a secure page on the applicant’s

website using a Debit or Credit Card.

1.21 Any advice or counselling will be given verbally over the telephone, in

addition to the patient information leaflet provided with the medicine. The

website will also provide the patient with health information relating to their

medicine.

Signposting

1.22 The website will detail a list of health organisations nationwide, as well as

provide a link to NHS Direct where patients can locate health organisations

local to them.

1.23 This information will also be provided by the pharmacist within telephone

contact with patients where appropriate.

1.24 All interactions, conversations and advice will be recorded so that there is an

audit trail.

1.25 All sign posting is done without any face to face contact.

Support for self care and healthy lifestyle promotion

1.26 In line with providing all the essential services set out in the pharmaceutical

contract, the applicant will participate in up to six campaigns at the request of

NHS England, which involves the display and distribution of leaflets provided

by NHS England. This will be achieved by displaying leaflets on the website

as well as distributing leaflets via post to patients. In addition, the applicant

will send leaflets to target groups. One example of this is the applicant will

identify people affected by Diabetes and blood pressure and send them

information relating to cardiovascular disease and prevention.

1.27 Another example is that where the applicant has a prescription request for

nicotine related products, the applicant will inform the patient, through either

telephone, leaflet, email about smoking cessation services offered in their local

area.

1.28 As mentioned within the dispensing section, advice which is relating to

prescribed medicines, will be given to patients verbally on the telephone and

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then supported through medicine literature posted to the patient and on the

website which they will be referred to.

1.29 The applicant’s website will house access to around 9000 pages of medicinal

information and advice on healthy living. This will be linked to NHS Choices

and will be updated accordingly. Healthy living advice and web pages will

include an array of information on obesity, dietary advice, stop smoking

advice, a symptom checker, diabetes information, to name but a few.

1.30 In conclusion, support for self care and healthy lifestyle will be done using the

website, backed up by verbal advice given over the telephone by trained staff,

and through leaflets which will be posted to the patients. The services the

applicant will provide will not involve any face to face contact and will be for

the use of patients nationwide.

1.31 Please note, that all advice given will be recorded on the applicant’s systems

to enable audits.

Disposal of unwanted medicines

1.32 Pharmacy staff will be trained on advising patients on how to dispose of

unwanted medicines over the telephone. The advice offered by staff in the first

instance would be to hand in unused medicines to their local pharmacy for

safe destruction. Staff will be able to assist patients by giving them the details

of pharmacies in their locality.

1.33 If patients wish to return the unused prescriptions to the applicant instead of

their local pharmacy, they will be advised by the trained staff on the procedure

for this, which will be :

1.33.1 Obtain an Authorised Returns Number from the pharmacy.

1.33.2 Pack the unwanted medicines in sealed packaging which is robust

enough to be sent through the post to our free post pharmacy address.

1.33.3 Staff will instruct the patients that the applicant will not accept any

sharp objects or chemicals.

1.34 Clear instructions will also be available on the website to advise patients on

how to dispose of unwanted medicines.

Clinical governance

1.35 The applicant will have a log for patient safety incidents. All staff will be

involved in critical incident analysis to further improve service.

1.36 This will all be based on the applicant’s standard operating procedures,

recording, audit an continuing professional development with the aim of

constantly improving the quality of the service for patients.

1.37 The pharmacy will participate in annual participation surveys.

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1.38 Annual audits will be carried out.

1.39 A practice leaflet will be available to download on the website.

1.40 All staff will undertake training on entering employment with the company

and the training will be ongoing.

1.41 Staff will have appropriate qualifications relevant to their role, references and

will comply with guidance on data protection and confidentiality The website

will also house a section which is easily accessible to patients to enable them

to make a complaint. Clear guidelines for which will be easily available.

Waste

1.42 The applicant will register with the environment agency with regards to de-

naturing controlled drugs and other drugs for disposal once the application is

granted.

1.43 This will include the T28 Exemption certificate, registering premises is a

simple and easy process, and once again, will be done once the application is

granted.

Conclusion

1.44 The applicant’s aim is to provide an alternative method of delivering

pharmacy services by way of an online pharmacy. This service would be

available to patients nationwide, without any face to face contact. This set up

will enable the applicant to provide pharmacy services to even those patients

who live in very remote parts of the country where access and choice to

pharmacies and different services that can be offered may be limited, or

difficult. The applicant will offer an efficient and easy service for the patient,

who will ultimately benefit from its services.

1.45 The applicant intends to provide the following services:

1.45.1 Essential Services.

1.45.2 Clinical governance.

1.45.3 Appliances – none.

1.45.4 Advanced and Enhanced services – none.

1.46 The Committee noted the applicant’s proposed core opening hours are:

1.46.1 Mon to Fri 9.30a.m. to 5.30pm

1.46.2 Sat -

1.46.3 Sun -

1.47 The applicant’s proposed total opening hours

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1.47.1 (As above).

2 The Decision

NHS England considered and decided to refuse the application. The decision letter

dated 27 September 2016 states:

2.1 NHS England has considered the application and is writing to confirm that it

has been refused.

Regulation 31

2.2 There are no current pharmacies listed at the proposed premises or adjacent to

the proposed premises. Therefore regulation 31 does not apply for this

application.

Regulation 25(2)(1)(a )

2.3 The proposed site is not on the same site or in the same building as the

premises of a provider of Primary Medical Services with a patient list.

Therefore this regulation does not apply for this application.

Regulation 25(2)(1)(b)(i)

2.4 NHS England is satisfied that pharmacy procedures for the pharmacy are

likely to secure the uninterrupted provision of essential services, during the

opening hours of the premises, to persons anywhere in England who request

those services.

Regulation 25(2)(1)(b)(ii)

2.5 NHS England is NOT satisfied that the applicant is likely to satisfy the criteria

as set out in the Terms of Service of Pharmacists for the safe and effective

provision of all essential services without face to face contact.

2.6 NHS England is NOT satisfied that the pharmacy procedures for the pharmacy

premises are likely to secure the safe and effective provision of essential

services without face to face contact between any person receiving the

services, whether on their own or on someone else's behalf, and the applicant

or the applicant's staff. Therefore NHS England have determined the

application should be refused.

2.7 A copy of the decision making report includes:

2.7.1 The premises in respect of which the application is made are not on the

same site or in the same building as the premises of a provider of

primary medical services with a patient list. NHS England have

determined that it is satisfied that pharmacy procedures for the

pharmacy are likely to secure the uninterrupted provision of essential

services, during the opening hours of the premises, to persons

anywhere in England who request those services.

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2.7.2 NHS England is not satisfied that the applicant has provided sufficient

information in relation to how drugs/appliances will be provided to the

patient, specifically in reference to how the ‘cold chain’ is maintained,

where relevant. There is mention of couriers SOPS within the

applicant’s own SOP 9, but this fails to provide sufficient information

about breaches of integrity of the cold chain and how these are dealt

with.

2.7.3 NHS England have determined that the applicant is not likely to satisfy

the criteria as set out in the Terms of Service of Pharmacists for the

safe and effective provision of all essential services without face to

face contact.

2.7.4 With regard to Regulation 31- there is currently no contractor included

in the Pharmaceutical list at the proposed premises or adjacent to these

premises.

2.7.5 Therefore, NHS England have determined that it is NOT satisfied that

the pharmacy procedures for the pharmacy premises are likely to

secure the safe and effective provision of essential services without

face to face contact between any person receiving the services, whether

on their own or on someone else's behalf, and the applicant or the

applicant's staff.

3 The Appeal

In a letter to the NHS Litigation Authority (“NHS LA”) dated 26 October 2016,

Charles Russell Speechlys LLP appealed on behalf of the applicant, against NHS

England’s decision. The grounds of appeal are:

Relevant Statutory Test

3.1 As the NHSCB will be aware, an application made in accordance with

Regulation 25 must satisfy the following criteria:

3.1.1 The proposed premises must not be in the same premises as a provider

of primary medical services with a patient list.

3.1.2 The NHSCB must be satisfied that the pharmacy procedures for the

premises are likely to secure:

3.1.2.1 (a) the uninterrupted provision of essential services to persons

anywhere in England who request them, and

3.1.2.2 (b) the safe and effective provision of essential services without

face to face contact between the pharmacy's staff and those

receiving the services.

Grounds of Appeal

The application satisfies the statutory test

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3.2 The applicant has produced a comprehensive set of standard operating

procedures which will be used in the pharmacy in the event that this

application is granted. Copies are attached. The procedures are such that the

Authority can be satisfied that they are likely to secure the safe and effective

provision of essential services, without face to face contact, and that services

will be provided on an uninterrupted basis to persons anywhere in England

who request them.

3.3 By way of example:

3.3.1 Supply of Controlled Drugs - The procedure which covers the

dispensing of prescriptions deals, specifically with the supply of

Controlled Drugs. This requires the courier or delivery driver to

complete a tracking form devised by the applicant in order to maintain

an audit trail. Additionally, the procedure requires the pharmacy to

telephone the patient after delivery to confirm safe receipt.

3.3.2 Prescription linked intervention - The pharmacy's procedures allow for

all members of staff to be alert to patients who will benefit from

prescription linked intervention. These will include patients who suffer

from certain health conditions including diabetes and high blood

pressure. Advice will be given to patients over the telephone or via

email contact. Leaflets providing further advice may also be sent to

patients with their medication. Records of any such interventions will

be made in the patient's medication record and a separate interventions

log.

3.3.3 Support for self-care - The procedure explains how pharmacy staff

should use the telephone, and email to communicate with patients in

order to support them in self-care where appropriate. The procedure

gives a list of certain types of medicines which particularly require the

involvement of a pharmacist in the event of a supply. The written

procedure emphasises that the supply of any Pharmacy Medicines must

be made under the supervision of a pharmacist, and that the supply of

medicines on the general sale list must also be monitored.

The NHSCB's decision was flawed.

3.4 The NHSCB was correct in concluding that the pharmacy's procedures are

likely to secure the uninterrupted provision of essential services to persons

anywhere in England who request them. However, it was wrong to conclude

that it could not be satisfied that the pharmacy's procedures were likely to

secure the safe and effective provision of pharmaceutical services without face

to face contact solely on the basis that the applicant's standard operating

procedure for the supply of cold chain medication failed to give sufficient

information about breaches of integrity of the cold chain and how these are

dealt with. This is because firstly, the applicant has provided a detailed

standard operating procedure (SOP 9) which deals with the delivery of both

controlled drugs and fridge items by both a delivery driver and courier.

Secondly, in its application, Pharmalinc Ltd explains that it has set up a

preliminary account with Igloo Thermo Logistics for the delivery of cold

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chain medication to patients throughout England. Igloo Thermo Logistics is

accredited for the delivery of cold chain medication by the MHRA, and

information on its website confirms that its vehicles and storage facilities are

temperature mapped on a daily basis and its vehicles are installed with

equipment to monitor temperature. In relation to the issue of temperature

integrity, Igloo states on its website:

3.4.1 "Temperature Integrity Igloo ensures temperature integrity throughout

the supply chain, from point of collection & goods-in to

pharmaceutical storage to final delivery.

3.4.2 All of our modern vehicles are equipped with heat & cool refrigeration

equipment.

3.4.3 Dual evaporators independently control the temperature of the front &

rear compartments of the vehicle hold.

3.4.4 For MHRA compliance our vehicles and storage facilities are

temperature mapped on a regular basis and installed with monitoring

equipment to provide temperature readings throughout the day"

3.5 In the event that its application is granted the applicant will enter into a

Technical Agreement with Igloo which will provide for certain steps being

taken in the event of a situation where medication has been stored or carried

incorrectly. These include the Pharmacy being informed and being consulted

as to whether the medication can still be delivered to the patient; Igloo having

contingency plans to protect medication in the event of a major storage system

or power failure, and that Igloo will carry out an investigation in the event of

such an incident occurring. A copy of the draft Technical Agreement is

provided.

3.6 As a consequence, the application should not have been rejected on this basis.

Conclusion

3.7 For the reasons stated above and in the documents submitted by the applicant,

this application satisfies the relevant statutory test. As a result, the NHSCB

should have granted it. The applicant, therefore, requests that the decision of

the NHSCB be quashed, and its appeal upheld and its application granted.

4 Summary of Representations

This is a summary of representations received on the appeal.

Day Lewis Pharmacy

4.1 Notwithstanding the fact that NHS England refused the application solely

based on lack of information regarding cold chain procedures, Day Lewis

believe there are other grounds for refusing this application.

4.2 Despite the fact the SOPs have now been provided, the appellant has still

failed to address the matters of:

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4.2.1 Access to pharmaceutical services for patients who suffer a disability

and are unable to use the proposed methods of communication.

4.2.2 The provision of suitable rest breaks for the pharmacist whilst

maintaining pharmaceutical services during contracted hours.

4.3 These matters were raised in Day Lewis original objection letter which is

attached for information.

Day Lewis pharmacy’s letter to NHS England dated 18 July 2016

4.4 As a preliminary matter, Day Lewis note that the applicant does not appear to

have provided any Standard Operating Procedures (SOPs). This leaves

significant doubt in respect of the applicant’s compliance with the

requirements of an application made under Regulation 25.

4.5 Day Lewis would suggest that NHS England (NHSE) will not be in a position

to grant this application if it is not in possession of this information in full.

Whilst the applicant has provided some supporting information in respect of

this application there are many gaps in the information provided.

4.6 NHSE is being asked to determine whether the application meets the

regulatory tests and can therefore be approved. This can only be determined

by reviewing each and every SOP in detail to ensure that:

4.6.1 all essential services will be provided without interruption during the

proposed opening hours of the pharmacy;

4.6.2 all essential services will be made available to anybody in England

who wishes to access them;

4.6.3 all essential services are likely to be secured in a safe and effective

manner;

4.6.4 all essential services will be provided without the face to face contact

between any person receiving the services, whether on their own or on

someone else’s behalf, and the applicant or the applicant’s staff.

4.7 In the absence of a full set of SOPs Day Lewis do not believe that NHS

England can be confident that the requirements of Regulation 25(2)(b) will be

met. For example:

All essential services will be provided without interruption during the

proposed opening hours of the pharmacy

4.8 Day Lewis can see no reference in the information provided to show how

services will be provided during any planned or unplanned absences of the

pharmacist during the core opening hours. It is inevitable that occasions will

arise when the pharmacist is absent and unless suitable contingency

procedures are in place the above obligation will not be complied with.

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4.9 Under the heading ‘disposal of unwanted medicines’ the applicant states that

patients would initially be advised to return unwanted medication “to their

local pharmacy” for disposal.

4.10 In Day Lewis opinion this does not meet the applicant’s obligations in respect

of this essential service. A pharmacy contractor is not permitted to simply pass

off its obligations to other contractors where it is inconvenient for it to provide

this service itself. Whilst the applicant does discuss making provision for

patients to return medicines to its pharmacy, it is clear that patients will be

actively discouraged from doing so.

All essential services will be made available to anybody in England who

wishes to access them

4.11 From the information provided, it is not clear how certain patient groups, such

as those with severe disabilities, sight loss or hearing loss will have equal

access to the services offered by this pharmacy. Where services require

internet or telephone access they may discriminate against patients who are

not able to make use of these communication methods for any reason.

4.12 Furthermore, whilst the applicant provides some information in respect of how

it proposes to offer essential services it is not clear how some of these will be

available to anybody in England who wishes to access them.

All essential services are likely to be secured in a safe and effective manner

4.13 In Day Lewis opinion there is insufficient detail provided for NHS England to

satisfy itself that every essential service will be provided to every patient in a

safe and effective manner.

4.14 Furthermore Day Lewis note that the applicant does not propose any breaks

within its core hours and it must assume, therefore, in the absence of other

information, that the pharmacist will work for at least 8 hours without a break.

In these circumstances the requirement to provide services in a safe and

effective manner may not be met.

4.15 The applicant suggests that conversations with patients will be recorded. There

is extensive legislation within the UK dealing with the recording of telephone

conversations yet the applicant provides no information on how this legislation

may be complied with. There is a risk that patients’ rights may not be

protected if suitable safeguards are not in place.

4.16 In Day Lewis opinion, NHS England has no choice but to refuse this

application based on the information received.

Boots UK Ltd

4.17 In the absence of any SOP's or marketing/website information, Boots would

like to highlight the following points that are not evident from the appellant's

original application:

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4.17.1 The Core hours match the Supplementary hours exactly therefore there

is nothing indicated in the applicants initial application that indicates

breaks for the pharmacists or provision of a second pharmacist. The

applicant has not detailed how rest periods will be taken so Boots can

assume therefore the pharmacist will work with no breaks or provision

of services will be interrupted.

4.17.2 There is no detail on how pharmaceutical services will be provided

nationwide.

4.17.3 There is little detail explaining how they will check and deal with

exemption.

5 Summary of Observations

No observations were received by the NHS LA in response to the representations

received on appeal.

6 Additional Comments

Charles Russell Speechlys LLP (on behalf of the applicant)

Letter dated 5 January 2017

6.1 The applicant would like to make the following final observations.Letter from

Day Lewis dated 28 November 2016

6.2 The applicant will provide several different methods of communication in

order to allow any patient in England who wishes to access services from its

pharmacy to do so. This will include patients who suffer from a disability.

These methods are common place for distance selling pharmacies.

6.3 The applicant will maintain sufficient staffing levels to ensure appropriate rest

breaks.

Letter from Boots dated 30 November 2016

6.4 The applicant has addressed the issue of rest breaks.

6.5 It is not correct for Boots to say that there is no detail on how services will be

provided throughout England. Information regarding provision of services is

provided in the SOPs attached to the applicant’s appeal.

6.6 Likewise information as to how the applicant will deal with exemptions

(including checking) is specifically dealt with in the Prescription Receipt SOP.

Letter dated 16 January 2016

6.7 The applicant provides a copy of the *representations which it made to NHS

England. These raise no new matters as the applicant’s response sets out how

it meets the statutory test as set out in Regulation 25 of the National Health

Service (Pharmaceutical and Local Pharmaceutical Services) Regulations

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2013. When considering the applicant’s appeal, the Authority should have

reference to the latest set of SOPs which were attached to the appeal dated 26

October 2016.

6.8 *A copy of this was noted by the FHSAU Pharmacy Appeals Committee

7 Consideration

7.1 The Pharmacy Appeals Committee (“Committee”) appointed by the NHS LA,

had before it the papers considered by NHS England. It also had before it the

responses to the NHS LA’s own statutory consultations.

7.2 On the basis of this information, the Committee considered it was not

necessary to hold an Oral Hearing.

7.3 The Committee noted that the applicant had confirmed to the NHS LA that it

had received with NHS England’s decision letter, a copy of the decision

making meeting report. The Committee was not certain however, whether the

report (which is referred to at paragraphs 2.7 and 2.7.5. above) had also been

sent by NHS England to interested parties. The Committee having noted the

reasons given in NHS England’s decision letter as well as the wording of the

decision report, was satisfied that any interested party who may not have been

sent a copy of the report had not been prejudiced.

7.4 The Committee had regard to the National Health Service (Pharmaceutical and

Local Pharmaceutical Services) Regulations 2013 (“the Regulations”).

Regulation 31

7.5 The Committee first considered Regulation 31 of the regulations which states:

(1) A routine or excepted application must be refused where paragraph (2)

applies

(2) This paragraph applies where -

(a) a person on the pharmaceutical list (which may or may not be the

applicant) is providing or has undertaken to provide pharmaceutical

services ("the existing services") from -

(i) the premises to which the application relates, or

(ii) adjacent premises; and

(b) the NHSCB is satisfied that it is reasonable to treat the services

that the applicant proposes to provide as part of the same service as

the existing services (and so the premises to which the application

relates and the existing listed chemist premises should be treated as

the same site).

7.6 The Committee noted that applicant’s comment at part 5 of its application, the

applicant stated: “n/a as the premises is not adjacent to, or in close proximity

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to another pharmacy or dispensing appliance contractor” The Committee

further noted NHS England’s decision letter states: “There are no current

pharmacies listed at the proposed premises or adjacent to the proposed

premises. Therefore regulation 31 does not apply for this application. The

Committee, having regard to the above information including that it had not

been disputed on appeal, considered that it was not required to refuse the

application under the provisions of Regulation 31.

Regulation 25

7.7 The Committee had regard to Regulation 25 of the Regulations which reads as

follows:

"(1) Section 129(2A) and (2B) of the 2006 Act (regulations as to

pharmaceutical services) does not apply to an application—

(a) for inclusion in a pharmaceutical list by a person not

already included; or

(b) by a person already included in a pharmaceutical list for

inclusion in that list in respect of premises other than those

already listed in relation to that person,

in respect of pharmacy premises that are distance selling premises.

(2) The NHSCB must refuse an application to which paragraph (1)

applies—

(a) if the premises in respect of which the application is made

are on the same site or in the same building as the premises

of a provider of primary medical services with a patient list;

and

(b) unless the NHSCB is satisfied that the pharmacy procedures

for the pharmacy premises are likely to secure—

(i) the uninterrupted provision of essential services,

during the opening hours of the premises, to

persons anywhere in England who request those

services, and

(ii) the safe and effective provision of essential services

without face to face contact between any person

receiving the services, whether on their own or on

someone else’s behalf, and the applicant or the

applicant’s staff."

7.8 The Committee also had regard to the provisions of Schedule 2 to the

Regulations shown below:

Additional information to be included with excepted applications

16

8. If the applicant (A) is making an excepted application, A must include

in that application details that explain—

(a) A’s belief that the application satisfies the criteria included in

one of the regulations in Part 4 which need to be satisfied if

section 129(2A) and (2B) of the 2006 Act (regulations as to

pharmaceutical services) are not to apply in relation to that

application; and

(b) if the regulation includes reasons for which the application

must be refused, why the application should not be refused for

those reasons.

Nature of details to be supplied

10. Where, pursuant to this Part, a person is required to provide details,

that obligation is only discharged if the information or documentation

provided is sufficient to satisfy the NHSCB in receipt of it, with good

cause, that no relevant information or documentation is missing,

having regard to the uses that the NHSCB may need to make of the

information or documentation when carrying out its functions.

7.9 Pursuant to paragraph 9(1)(a) of Schedule 3 to the Regulations, the Committee

may:

7.9.1 confirm NHS England’s decision;

7.9.2 quash NHS England’s decision and redetermine the application;

7.9.3 quash NHS England’s decision and, if it considers that there should be

a further notification to the parties to make representations, remit the

matter to NHS England.

Regulation 25(1)

7.10 In relation to Regulation 25(1), the Applicant is applying for inclusion in the

relevant pharmaceutical list, as a person not already included in a

pharmaceutical list, and paragraph (1)(a) therefore operates to disapply the

specified provisions of section 129 of the National Health Service Act 2006,

provided that paragraph (2) does not require the application to be refused.

Regulation 25(2)(a)

7.11 As far as Regulation 25(2)(a) is concerned, the Committee had regard to the

application form in which the Applicant states “n/a because the proposed

premises is not on the same site or in the same building as the premises of a

provider of primary medical services with a patient list.” The Committee

noted that this had not been disputed and that it had not been provided with

any information to persuade it otherwise. The Committee was therefore

satisfied that the proposed premises were not on the same site as, or in the

same building as the premises of a provider of primary medical services with a

patient list.

17

Regulation 25(2)(b)

7.12 As far as Regulation 25(2)(b) is concerned, the Committee considered the

information which had been provided by the Applicant in relation to its

procedures for the provision of essential services, including its Standard

Operating Procedures (SOPs) that it intends to use at the proposed pharmacy

premises.

7.13 The Regulations require the Committee to be satisfied as to a number of

matters, including that essential services will be provided on an uninterrupted

basis, in a safe and effective way, across England, and without face to face

contact.

7.14 Paragraph 8 of Schedule 2 requires an applicant to provide details in relation

to an application, and paragraph 10 of Schedule 2 indicates that the obligation

is only discharged if the information or documentation provided is sufficient

to satisfy NHS England in receipt of it, with good cause, that no relevant

information or documentation is missing, having regard to the uses that NHS

England may need to make of the information or documentation when

carrying out its functions.

7.15 The Committee has asked itself whether it has sufficient information and

documentation which would address the criteria in Regulation 25(2)(b). If the

Committee is to be satisfied of the matters in that paragraph, the Committee

must be provided with evidence to demonstrate these matters. In this case,

that evidence put forward has taken the form of the original application and

the Standard Operating Procedures (SOPs) which the applicant has prepared or

commissioned.

7.16 It is not for the Committee to 'approve' or 'disapprove' of these SOPs (as they

may contain matters not relevant to the Committee's consideration, and there

are many ways an applicant can choose to organise itself in order to comply

with the various requirements of the Regulations) and the Committee has not

sought to do so. The Committee has sought evidence within the SOPs and

application in order to satisfy itself that it is appropriate to grant the

application, the absence of which would require it to reject it.

7.17 The Committee considered if the applicant had shown if services would be

provided in an uninterrupted basis. The Committee noted the applicant’s

comment at paragraph 1.5 above:

7.17.1 “The pharmacy will only be staffed with a pharmacist during the

opening hours to enable the provision of essential services to persons

anywhere in England without any face to face contact.”

7.18 The Committee also noted the applicant’s comment at paragraph 1.9 above;

7.18.1 “The pharmacist will be available from 9.30am to 5.30pm, to monitor

and issue prescription requests and to offer telephone advice as

required.”

18

7.19 The Committee noted that on appeal, Day Lewis considered that the applicant

had failed to indicate suitable rest breaks for pharmacists. The Committee

noted however SOP 021 deals with absences by the responsible pharmacist,

and includes:

7.19.1 “Note NHS ToS require a RP on duty for ALL core opening hours. Any

absence should be covered by another RP e.g. a locum, or

Superintendent Pharmacist.”

7.20 The Committee having regard to the above, was satisfied that services would

be provided on an uninterrupted basis.

7.21 The Committee noted the applicant’s comment in its application that

“Preliminary accounts have been set up - upon approval of contract - with

courier companies; Royal Mail and Igloo thermo logistics for the delivery to

patients nationwide. A delivery driver will deliver products to patients that are

local to the pharmacy premises, as long as there isn't any cold chain to

consider.”

7.22 The Committee noted that aside from local deliveries, the applicant had only

referred to Royal Mail and Igloo couriers and only then apparently in relation

to CD’s and cold chain items. The Committee was provided with no

information to show how ordinary medication (not CD or cold chain items)

would be delivered by the applicant nationwide including the process for

despatch or what happens in the event of non-delivery by Royal Mail.

7.23 The Committee having regard to the above, was not satisfied that services

would be provided across England.

7.24 The Committee considered if the applicant had shown if services would be

provided without face to face contact. The Committee noted the applicant’s

comment at paragraph 1.6 above:

7.24.1 “The premises has been carefully chosen to ensure that this is always

the case; the self contained unit is part of a commercial building which

is secure and not accessible to members of the public . The building

management arrange a security officer to keep watch of the entrances

during normal working hours. Access to the building is by means of a

self closing door using a security code. Therefore, access to the

general public is not possible. On top of this, CCTV is in operation

24/7 both inside and outside the building.”

7.25 The Committee further noted the applicant’s comment at paragraph 1.10

above:

7.25.1 “All the different methods of communication that will be available

(website, telephone and fax) will allow for trained staff to

communicate effectively and efficiently with potential patients on a

national level, without any face to face contact. This will enable the

applicant to provide excellent provision of pharmaceutical services to

anyone wishing to utilise the website, telephone or fax service.”

19

7.26 The Committee was satisfied that the applicant had shown that services would

be provided without face to face contact.

7.27 The Committee was aware that when the pharmacy opens, it will be the

responsibility of NHS England, in keeping with Reg 64, to ensure that services

are provided other than with face to face contact.

7.28 The Committee was satisfied that the provision of services would be without

interruption, would be without face to face contact and would be available to

persons anywhere in England. The Committee went on to consider whether

safe and effective provision of essential services was likely to be secured.

7.29 The Committee considered each essential service in paragraphs 3 to 22 of

schedule 4 of the Regulations ("Terms of Service") in turn.

7.30 The Committee paid particular attention to the following aspects of the

essential services, which it considered were more difficult to provide safely

and effectively in a distance selling context:

7.30.1 Dispensing of drugs and appliances

7.30.2 Urgent supply without a prescription

7.30.3 Preliminary matters before providing ordered drugs or appliances

7.30.4 Providing ordered drugs or appliances

7.30.5 Refusal to provide drugs or appliances ordered

7.30.6 Further activities to be carried out in connection with the provision of

dispensing services

7.30.7 Disposal service in respect of unwanted drugs

7.30.8 Promotion of healthy lifestyles

7.30.9 Prescription linked intervention

7.30.10Public health campaigns

7.30.11Signposting

7.30.12Support for self-care]

7.31 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:

Dispensing of Drugs and Appliances

20

7.32 Whilst the Committee noted how non-electronic prescriptions will be provided

by the patient, it has already noted above, that the applicant had provided no

information to show how products will be provided to patients across England.

The Committee was therefore not satisfied the applicant had met the

requirements of paragraph 5(2)(3) of Schedule 4.

Providing Ordered Drugs or Appliances

Provision of Drugs and Appliances

7.33 The Committee noted the Applicant’s comments at paragraph 1.15 to 1.18

above:

7.33.1 “Once prescriptions are received, medicines will be dispensed by a

registered pharmacy.

7.33.2 These will be delivered using the most appropriate form of delivery:

7.33.2.1 In ALL cases where there are cold chain products, such as

insulin, an MHRA approved company called Igloo thermo-

logistics will be employed as they are approved to deal with

fridge line deliveries.

7.33.2.2In instances where there are controlled drugs, Royal mail

special delivery will be used as this courier service will enable

the parcel to be tracked electronically and will have the added

safety measure of requiring a signature upon delivery.

7.33.2.3In cases where the delivery is to be made within a 15 mile

radius to the pharmacy premises, and does not include a cold

chain, delivery will be made by the pharmacy employed

delivery driver who will be trained and qualified to make

deliveries of medicines.

7.33.3 If the patient is not at the delivery address, the courier

company/delivery driver will leave a card to inform the patient that a

delivery had been attempted, telephone and email contact details will

be left to enable delivery at a different time. No medication will be

posted or left with neighbours, in fact, the medication will then be

returned to the pharmacy at the earliest opportunity. A delivery will be

rearranged, at no point will the customer be allowed to come to the

pharmacy and collect medicine.

7.33.4 If there is a delay due to medicine being 'out of stock', the responsible

pharmacist will contact the patient or their representative as a matter

of urgency, advise on expected deliver, and agree a course of action.

Where appropriate, a written confirmation will be sent to the patient or

their representative, and a written note of the items owed recorded

against the patient record.”

21

7.34 The Committee noted the applicant’s SOP 008, ‘Delivery of Prescriptions’ P2-

P5, includes:

7.34.1 “All fridge deliveries will be tracked by the carrier in accordance with

their SOPs and proof of deliveries (POD) with signatures provided by

the carriers to complete the pharmacy audit. As per service agreement,

Igloo will send an email to confirm receipt of delivery and also proof

of temperature showing cold chain is maintained.

7.34.2 All CD deliveries carried out by Royal Mail special delivery service in

accordance with their SOPs and service agreement and proof of

deliveries (POD) with signatures provided by the carriers to complete

the pharmacy audit sent to us.

7.34.3 For CDs and Fridge Lines the pharmacy will ring the patient shortly

after expected delivery time to confirm safe receipt and to validate the

tracking information.

7.34.4 Use the CD internal tracking document for CD deliveries (attached as

required)

P2 Contract carrier specification

Responsibility: Superintendent Pharmacist/Carrier company

7.34.5 All carrier drivers will be trained in MHRA Good Distribution

Practice (GOP) in line with their own SOPs.

7.34.6 Carrier drivers will be trained in all the appropriate procedures

required to deliver medicines. Controlled Drug procedures require a

zero tolerance policy.

7.34.7 Ask the patient or representative for their name, address and signature

as proof of delivery in accordance with carrier SOPs. Where required,

request proof of 10.

7.34.8 For cold chain and CD deliveries, ask the patient or representative to

sign for their delivery.

7.34.9 If they are unable to sign (in exceptional circumstances), the driver

will hand the medication to the patient or representative, and write a

note on the delivery sheet with the reason why they are unable to sign.

P3 Contract carrier successful delivery

Responsibility: Pharmacist/Carrier company

7.34.10Confirmation of delivery would be received from the courier service

via their internal SOPs/systems/POD. All deliveries will be tracked via

the courier service from the pharmacy.

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7.34.11For CDs and Fridge Lines the pharmacy will ring the patient shortly

after delivery time to confirm safe receipt and to validate the tracking

information.

P4 Contract carrier unsuccessful delivery

Responsibility: Pharmacist/Carrier company

7.34.12If the patient or representative is not able to receive the delivery of

their medication, the driver must log this within their tracking system

and contact the pharmacy for further instructions.

7.34.13The driver WILL NOT:

7.34.13.1Post the medication through the letter/post box

7.34.13.2Leave the medication on the porch or any other out building

7.34.13.3Leave at an unauthorised address

7.34.14CD or Fridge Line (2-8°C) stock will be stored in a safe overnight

storage facility. The pharmacy will contact the patient to arrange

alternate delivery date/time. Cold chain will be moni (sic)

P5 Local deliveries

Responsibility: Pharmacist/delivery driver

7.34.15Where the delivery address is less than 15 miles from the Pharmacy

premises, stock not subject to cold chain requirements will be sent with

our delivery driver.

7.34.16A list for all local deliveries will be collated and the driver will sign to

accept responsibility for those stocks.

7.34.17The list will be retained for pharmacy audit purposes.

7.34.18CD deliveries will be subject to the same internal tracking document

as if the delivery driver was a courier.

7.35 In the event, the patient is not home, stock will be returned to the pharmacy

and a card will be left with the patient requesting them to contact the

pharmacy to rearrange delivery.”

7.36 Whilst the Committee noted that CD deliveries by the pharmacy’s own driver

will be subject to the same internal tracking document as if the delivery driver

was a courier, there was no reference to how the security of such items will be

maintained during transportation up to the point of delivery or, if necessary, on

return to the pharmacy. The Committee was not satisfied that the applicant had

explained how drugs/appliances will be provided to the patient (including to

ensure that (i) the ‘cold chain’ is maintained, where relevant, and (ii) that the

requirements of the Misuse of Drugs Regulations 2001 and, in particular,

23

Regulations 14 and 16, are met) and thus satisfied the requirements of

paragraph 8(1) of Schedule 4.

Further activities to be carried out in connection with the provision of

dispensing services

7.37 The Committee noted the applicant had not provided any information

including in SOP, 013 ‘NHS Repeat Dispensing’ P3, to indicate how patients

for whom Repeat Dispensing Service would be beneficial, will be identified

and how the benefits of that service will be promoted to them. The Committee

was not satisfied that the applicant had indicated how appropriate advice about

the benefits of repeat dispensing is given to any patient who i. has a long

term, stable medical condition (that is, a medical condition that is unlikely to

change in the short to medium term), and ii. requires regular medicine in

respect of that medical condition, and thus satisfy the requirements of

paragraph 10(1) of Schedule 4.

7.38 With regard to the provision of appliances, the Committee noted that the

applicant would not in the event that this application is granted, be able to

provide these given that it had not applied to do so.

7.39 The Committee noted that on appeal, Day Lewis considered that the applicant

had failed to address access for the disabled. The Committee was mindful that

patients with a disability would themselves make a choice as to whether they

wished to obtain pharmaceutical services from a distance selling pharmacy.

The Committee also noted however, that the applicant’s SOP29 does include

‘P1 Identification of Needs’ ;

7.39.1 “Confirm whether the person contacting the pharmacy is the patient,

or their carer/parent, and whether they are using the pharmacy for the

first time.

7.39.2 If the patient (or carer/parent) is new to the pharmacy, enquire if they

have any information and /or communication support needs relating to

a disability, impairment or sensory loss – if so ask them to explain how

the pharmacy team can meet those needs.”

7.40 On the information before it, the Committee could not be satisfied that there

are procedures likely to secure safe and effective provision of essential

services as required by Regulation 25(2)(b).

7.41 The Committee, taking into account the additional information which had

been provided by the Applicant on appeal, which had not been provided to

NHS England, reached a decision for different reasons to those of NHS

England. Therefore the Committee determined that the decision of NHS

England must be quashed.

7.42 The Committee considered whether there should be a further notification to

the parties detailed at paragraph 19 of Schedule 2 of the Regulations to allow

them to make representations if they so wished (in which case it would be

appropriate to quash the original decision and remit the matter to NHS

24

England) or whether it was preferable for the Committee to reconsider the

application.

7.43 The Committee noted that representations on Regulation 25 had already been

made by parties to NHS England, and these had been circulated and seen by

all parties as part of the processing of the application by NHS England. The

Committee further noted that when the appeal was circulated representations

had been sought from parties on Regulation 25.

7.44 The Committee concluded that further notification under paragraph 19 of

Schedule 2 would not be helpful in this case.

8 Decision

8.1 The Committee concluded that it was not required to refuse the application

under the provisions of Regulation 31.

8.2 Accordingly, the Committee:

8.2.1 quashes the decision of NHS England; and

8.2.2 redetermines the application as follows -

8.2.2.1 the Committee was satisfied that the proposed premises were

not adjacent to or in close proximity to other chemist premises.

8.2.2.2 the Committee was satisfied that the premises of the Applicant

are not on the same site or in the same building as the premises

of a provider of primary medical services with a patient list,

8.2.2.3 the Committee was satisfied that all essential services were

likely to be secured without interruption during the opening

hours,

8.2.2.4 the Committee was not satisfied that all essential services were

likely to be secured for persons anywhere in England,

8.2.2.5 the Committee was not satisfied that all essential services were

likely to be secured in a safe and effective manner,

8.2.2.6 the Committee was satisfied that all essential services were

likely to be secured without face to face contact;

8.2.3 The application is refused.

Ray Bushell

FHSAU Case Manager

A copy of this decision is being sent to:

25

Ms R Warren – Charles Russell Speechlys LLP (on behalf of the Applicant)

NHS England

Ms R Powell – Boots UK Ltd

Ms C Reid – Day Lewis Pharmacy