Applications to provide NHS Pharmaceutical Services. A Consultation on the Control of Entry Arrangements and Dispensing GP Practices

Section 1: Context

1.1 In September this year, the Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, announced that he would immediately review the regulatory frameworks that support the pharmacy applications process and the powers given to NHS Boards to make arrangements with GP practices to dispense NHS medicines to patients registered on their practice lists.

1.2 The review was announced amid increasing concerns from some dispensing GP practices and the rural communities they serve that pharmacy applications in these areas, if successful, would destabilise local services provided by the GP practices concerned and the long term sustainability of the practices themselves.

1.3 At the time of publication, there are over 100 GP practices across Scotland who are required by Scottish Ministers to provide a dispensing service to their patients where the NHS Board has established that those patients would otherwise have serious difficulty in obtaining NHS dispensed medicines and appliances from a registered pharmacy.

1.4 These dispensing GP practices are in locations where the historic absence of a community pharmacy would suggest that prospective community pharmacy owners have considered a pharmacy to be unviable or at best marginal in terms of on-going business operation. In these circumstances, dispensing GP practices play an essential and vital role in the provision of NHS medicines.

1.5 In addition to the remuneration for the delivery of primary medical services, these practices receive funding for the dispensing of medicines to their patients.

1.6 Normally, NHS pharmaceutical services are provided through a registered community pharmacy. There are currently some 1,240 registered community pharmacies across Scotland providing NHS pharmaceutical services. They are mainly based in the high streets of our towns and cities.

1.7 The Scottish Government policy remains committed to the principle that, wherever possible, people across Scotland should have access to NHS pharmaceutical services provided by a registered community pharmacy.

Prescription for Excellence

1.8 Prescription for Excellence^[1], our Vision and Action Plan for pharmaceutical care, recognises that dispensing doctors play an essential role in the dispensing and supply of medicines to patients in rural communities. It is committed to the principle that collaborative working, wherever possible, between GPs and pharmacists provide the best care for patients making full use of their differing clinical skills and expertise.

1.9 Going forward NHS pharmaceutical care provision (the clinical skills of a pharmacist other than dispensing) should complement and support dispensing doctors and their patients. That is why Prescription for Excellence includes in its actions that the Scottish Government will work with patients, dispensing doctors and appropriate stakeholders to explore how rural communities can be further supported in terms of NHS pharmaceutical care.

Provision of pharmaceutical services

1.10 Section 27 of the National Health Service (Scotland) Act 1978^[2] ("the 1978 Act") provides the primary legislation that places a duty on every NHS Board to make arrangements for their resident populations to provide pharmaceutical services. This includes that permission to open a new community pharmacy should be granted where it is necessary or desirable in order to secure adequate provision of NHS pharmaceutical services by a community pharmacy in the neighbourhood where the proposed premises are located.

1.11 Any registered pharmacist or corporate body (such as a retail pharmacy business) can open and run a pharmacy anywhere in the country provided it is registered with the General Pharmaceutical Council^[3] (the regulatory body for pharmacists, pharmacy technicians and pharmacy premises in Great Britain). This does not require permission from a NHS Board. If the registered pharmacy wishes to provide NHS pharmaceutical services, it must seek entry onto the pharmaceutical list of that NHS Board.

1.12 Section 28 of the 1978 Act^[4] sets out the persons with whom a NHS Board may arrange the provision of NHS pharmaceutical services. Generally, arrangements may only be made with a registered pharmacist, or a person/corporate body lawfully conducting a retail pharmacy business in accordance with the Medicines Act 1968^[5], who undertakes that medicines will be dispensed by, or under the direct supervision of, a registered pharmacist.

1.13 The current regulations regarding GPs^[6],[7], only allow NHS Boards to authorise them to dispense where patients would otherwise have serious difficulty in obtaining drugs or appliances from a pharmacist because of distance, inadequacy of means of communication or other exceptional circumstances.

Current arrangements for considering applications

1.14 The arrangements made by NHS Boards with community pharmacists must comply with Regulations made under the 1978 Act. Those Regulations (the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009^[8] - "the 2009 Regulations") set out the ways persons can apply to provide NHS pharmaceutical services. The Regulations also set out the terms and conditions under which those services will be provided.

1.15 In April 2011, the Regulations were amended^[9] placing new and additional duties on NHS Boards. They included, for example, the requirement of NHS Boards to:

• − notify dispensing GP practices of any application to open a pharmacy if the proposed pharmacy is in, or near, a location where a dispensing GP practice is currently providing a dispensing service to its patients. Dispensing GP practices affected by a pharmacy application are now entitled to send written notice of interest or comments through their Area Medical Committee (AMC) to the NHS Board;
• − appoint an additional member to the NHS Board's Pharmacy Practice Committee nominated by the AMC where the pharmacy application directly affects a dispensing GP practice. This is to ensure appropriate representation on the Committee and that consideration of the issues regarding affected dispensing GP practices are taken into account in the overall process;
• − undertake a 60 day public consultation when an application is received; and
• − publish decisions about applications on their websites alongside the reasons for the decisions. This is to help ensure the process is as open as possible and that potential applicants are aware of previous applications in a given area.

1.16 In addition, applicants are required to advertise locally their intention to provide NHS pharmaceutical services and seek the views from the public within the area to which their application relates. Applicants are also required to provide the NHS Board with an assessment of the public involvement exercise and a summary of the feedback received.

1.17 The amended Regulations also strengthened the role of the National Appeal Panel (NAP) such that it may remit the decision back to the Board for consideration if it is the opinion of the Chair that the appeal is process based, or if a point of law has been raised.

The role of the NHS Board

1.18 It is the role of the NHS Board, in whose area the pharmacy is located, to administer the arrangements set up by the 1978 Act and related Regulations. This includes a requirement that NHS Boards must prepare lists of the persons with whom they have made arrangements for the provision of NHS pharmaceutical services and the premises from which they will provide those services. The list that Boards prepare is known as their "pharmaceutical list".

1.19 An application for inclusion in the pharmaceutical list is essentially an application to provide NHS pharmaceutical services in the relevant NHS Board's area. The procedure for consideration of applications is set out in the 2009 Regulations and is explained in more detail below. These Regulations apply only to registered pharmacies that wish to provide NHS pharmaceutical services.

1.20 An application may only be granted if the NHS Board's Pharmacy Practices Committee (PPC) is satisfied that it is "necessary or desirable"^[10] to approve the application in order to secure the adequate provision of NHS pharmaceutical services in the neighbourhood in which the premises are located. Cases of 'minor relocation', or where a new provider applies to take over existing arrangements for the provision of services, are excepted from this aspect of the control of entry Regulations ("the 2009 Regulations").

1.21 It is important to note that whilst NHS pharmaceutical services are normally provided from commercial premises, the commercial aspects are not a consideration when NHS Boards are determining whether an application should be granted. Similarly, the effect on neighbouring pharmacies' income is not a consideration.

1.22 On receipt of an application to which the 2009 Regulations apply, the NHS Board must first notify a number of parties about the application. These parties include relevant local NHS committees (such as the Area Pharmaceutical Committee and Area Medical Committee) and persons already included in a pharmaceutical list whose interests might be affected if the application were granted. These parties are entitled to make representations to the NHS Board and thereafter must be given notice of the NHS Board's decision.

1.23 These parties and the applicant are entitled to appeal against the decision and those appeals are determined by an independent body - the 'National Appeal Panel'.

1.24 The key aspect of the process is a legal test under which the NHS Board Pharmacy Practice Committee (the PPC) must consider all applications. In summary, this requires the PPC to:

• Identify the boundaries of the 'neighbourhood' in which the premises named in the application are located (this will vary greatly depending on the locality - e.g. in a city this may only be a street or two, whilst in a more rural setting, it could be a whole village(s));
• Consider and agree whether the current provision of NHS pharmaceutical services in that neighbourhood is adequate and;
• If the current provision is not adequate, consider and agree whether it is necessary or desirable to approve the application to secure the adequate provision of NHS pharmaceutical services in the neighbourhood.

1.25 Under the 2009 Regulations, when an application to open a new pharmacy is made, the NHS Board's PPC will consider: the pharmaceutical services already provided in the neighbourhood; the pharmaceutical services to be provided at the premises named in the application; any representations received by the Board; any information available to the Board which, in its opinion, is relevant to the consideration of the application; any public consultation responses received; and the NHS Board pharmaceutical care services plan.

1.26 An application should be granted only if the PPC is satisfied that the provision of NHS pharmaceutical services at the premises named in the application is necessary or desirable in order to secure adequate provision. In terms of the 1978 Act, the fact that there is a dispensing GP practice in the area is not a factor which the PPC can consider.

1.27 Where a pharmacy application is approved in an area served by a dispensing GP practice, the NHS Board would need to consider whether any patients would still have serious difficulties in collecting their medication. Where they decide that patients would still face serious difficulty, they may choose to instruct the GP practice to dispense to those patients.

Dispensing GP Practices

1.28 Under the terms of "the 1978 Act", NHS Boards are required to make and administer arrangements for the provision of NHS pharmaceutical services as well as primary medical services to people in their area.

1.29 NHS Boards must assess the needs of patients based on their individual circumstances. It is for the NHS Board to determine whether any patients will have serious difficulty in obtaining their medicines and to take steps to ensure they can receive that medication. Where a patient would have serious difficulty in having their prescribed medicines dispensed, NHS Boards can instruct GP practices to dispense medication to patients.

1.30 A patient on the dispensing list of a GP practice can choose to have their medicines dispensed from the practice dispensary or to have a prescription issued to present at a community pharmacy of their choice.

Patient list sizes and dispensing

1.31 There are currently just over 100 dispensing GP practices in Scotland - 86 are independent GP practices under contract to their local NHS Board to provide both NHS primary medical services and the dispensing of NHS medicines to some or all of their patients. The remainder are directly managed (or salaried) practices provided and managed by a NHS Board.

1.32 Most are located in the Highlands and Islands (64), NHS Dumfries & Galloway (13) and NHS Grampian (10). They account for around 10% of GP practices and around 4% of the population.

1.33 Registered patient list sizes range from around 130 to 14,900, with an average of 2,180 registered patients. Dispensing GP practices are not necessarily required to provide dispensing for all their registered patients. The dispensing list sizes vary from around 130 to 4,500. The percentages of patients being dispensed to range from 100% in 66 practices, with 90-99% in 9 practices, to less than a third of patients in 14 practices.

1.34 These figures may include practices with more than one location (i.e. with branch surgeries), so the number of patients being dispensed to from a discrete location by each practice may be smaller. In some cases it is the viability of branch surgeries which can concern local communities when an application to open a community pharmacy is made.

Going forward

1.35 Scottish Government remains clear that people living in remote, rural and island communities should have access to appropriate NHS pharmaceutical services and NHS primary medical services that are no less adequate than would be the case in non-rural areas.

1.36 It is committed to ensuring that where patients living in communities have serious difficulty in obtaining their medicines that the dispensing service provided by their GP practice will continue to be available to the communities they serve.

1.37 The Scottish Government's Action Plan for NHS pharmaceutical care (Prescription for Excellence^[11]) gives a firm commitment to explore ways in which rural communities and dispensing GP practices can be further supported by a pharmacist working with the GP practice, and how this can be provided to patients alongside the dispensing service offered by their GP.

1.38 The Action Plan reinforces that the skills and knowledge of the GP and of the pharmacist complement each other and together produce the best advice and care for patients and outcomes from their medicines.

NHS Board Pharmaceutical Care Services Plans

1.39 NHS Boards currently produce a Pharmaceutical Care Services Plan (PCSP) for their areas. These are intended to fulfil two main functions:

• To provide a comprehensive picture of the range, nature and quality of pharmaceutical care provided within the NHS Board area; and
• To identify needs and gaps in the provision of pharmaceutical care within the NHS Board area.

1.40 As discussed in the Action Plan for pharmaceutical care, Prescription for Excellence, in future there will be a shift in emphasis away from the system of Control of Entry for pharmacy applications to one that is based on identified need by NHS Boards. NHS Board Pharmaceutical Care Services Plans will be central to how NHS Scotland plans, provides and delivers pharmaceutical care and medicines to its communities.

1.41 Over the course of the next three years and beyond, NHS Board Pharmaceutical Care Services Plans will have implications for existing arrangements for service provision, and where and how it is provided. Plans will need to consider population needs, which include public health and health inequalities.

1.42 NHS Board Pharmaceutical Care Services Plans will have the statutory underpinning of both primary and secondary legislation and will be the main vehicle for the planning, procuring and provision of NHS pharmaceutical care. This will be particularly important in remote, rural and island areas of Scotland and the continuing role of essential dispensing by GP practices and how this can be enhanced and supplemented with clinical pharmaceutical care.

1.43 It is therefore important to recognise that the proposals set out in this consultation will be reviewed as we make the transition towards a new statutory framework for NHS Board Pharmaceutical Care Services Planning.

1.44 As part of the actions set out in Prescription for Excellence, the Scottish Government will consult on the statutory powers of NHS Board Pharmaceutical Care Services Plans and its impact on existing planning arrangements including dispensing doctors.

Amending Legislation

1.45 The proposals discussed in this consultation document would give effect to changes to Regulation 5 of and paragraph 3 and 4 of Schedule 3 to the NHS (Pharmaceutical Services) (Scotland) Regulations 2009; Paragraph 44, Schedule 5 of the NHS (General Medical Services Contracts) (Scotland) Regulations 2004; and Schedule 1, Paragraph 15 of the NHS (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004.