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

3. PART ONE: CONTROL OF ENTRY (PHARMACY APPLICATIONS) AND DISPENSING GP PRACTICES

Background

3.1 The Scottish Government recognises the vital role that dispensing GP practices play in the dispensing and supply of medicines to patients in remote, rural and island communities. It is committed to ensuring that where patients have serious difficulty in obtaining (from a community pharmacy) any drugs, medicines or appliance required for their treatment, that the dispensing GP practice will continue to fulfil this vital role for patients on their list.

3.2 There have been concerns, however, that sometimes the impact of opening a community pharmacy in some rural communities could potentially impact on other NHS provided services or destabilise the overall disposition of NHS primary medical and pharmaceutical services. There are also concerns about the impact on the viability of the dispensing GP practice and the staff it employs.

3.3 Based on existing powers under Section 27(4)(d) of the NHS (Scotland) Act 1978, the Scottish Government proposes amending legislation to introduce the designation of "controlled remote, rural and island localities" for the purposes of considering pharmacy applications. These are areas that would be deemed by NHS Boards as rural in character taking account of the Scottish Government's Urban/Rural Classifications such as "remote small towns", "accessible rural", "remote rural", "very remote small towns" and "very remote rural"^[4].

3.4 In a "controlled remote, rural and island locality" the NHS Board Pharmacy Practices Committee (the PPC), in addition to the existing test of "necessary or desirable" (the adequacy test), will need to consider whether the application to open a pharmacy in the locality would adversely impact on the provision of existing NHS services, particularly NHS primary medical and pharmaceutical services, in the locality. This would be known as the "prejudice test".

3.5 The aim of introducing the prejudice test is to ensure that nothing must be done which would compromise the ability of people to access existing NHS pharmaceutical services, dispensing services or primary medical services. Prejudice arises where the pharmaceutical services or primary medical services that people can rightly expect to be provided by the NHS would, in some respect, cease or otherwise be curtailed or withdrawn without the replacement of those services potentially affected.

3.6 It is proposed that if the NHS Board PPC concludes that the opening of a pharmacy would affect NHS provided or contracted services in this way, then the application would be rejected regardless of whether it would otherwise be necessary or desirable in order to secure the adequate provision of pharmaceutical services in the locality.

Introducing the designation "controlled remote, rural and island localities" and introducing the prejudice test

Proposal 1

The Scottish Government proposes amending legislation that will introduce the designation of "controlled remote, rural and island localities" for the purposes of considering pharmacy applications in these areas of Scotland and introducing a "prejudice test" in addition to the test of "necessary or desirable" (the adequacy test).

3.7 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

3.8 80 respondents provided views on Proposal 1. Table 3.1 provides their responses to the closed aspect of the question. Two-thirds (66%) of those providing a view agreed with Proposal 1. All seven of the pharmacy contractors who responded disagreed, as did five of the eight representative or professional bodies.

Table 3.1 Level of agreement with Proposal 1

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	25		76	8	24	33
NHS Board committees	9		69	4	31	13
NHS Boards	8		80	2	20	10
Representative or professional bodies	3		38	5	62	8
Pharmacy contractors	-		-	7	100	7
GP practices	3		100	-	-	3
MSP/MP	1		50	1	50	2
Community Councils	1		100	-	-	1
NHS support organisations	1		100	-	-	1
Other	2		100	-	-	2
Total	53		66	27	34	80

Views on designation "controlled remote, rural and island localities"

3.9 Amongst the six respondents who gave specific reasons for supporting the designation, the following benefits were documented:

• Reflects the particular circumstances of rural locations, which are different to those of urban areas.
• Provides for national consistency in approach.
• Supports the concept of "rural proofing policy".

3.10 Seven respondents, from a range of categories, documented their reasons to oppose the designation. The dominant view was that the designation was not sensitive enough to distinguish between rural localities. For example, not all rural populations are the same demographically, with some localities containing much higher elderly populations than others; some areas might have remotely dispersed populations who may gravitate regularly to a central location (e.g. a market town).

3.11 One pharmacy contractor argued against the inclusion of "remote small towns" in the designation, as they considered that some remote small towns could support up to three viable community pharmacies.

3.12 Six respondents from three different categories (HBC, Pharm, Rep/Prof) considered that overall the designation required greater clarity of definition before they could provide a full appraisal.

3.13 Four respondents from NHS Board committees and NHS Boards argued that NHS Boards should be able to define their own "controlled localities" according to local circumstances such as population, geography and service access. The recommendation was made to introduce the designation "controlled localities" rather than "controlled remote, rural and island localities".

3.14 One NHS Board committee sought clarity on whether the designation referred to remote or rural, or remote and rural.

Views on introducing a prejudice test

3.15 Many respondents envisaged benefits associated with the introduction of a prejudice test. A common view across different categories was that implementation of the test would ensure that the overall health needs of the population within an area would be taken into consideration, thus reducing the risk of losing services altogether. Six individual respondents and an NHS support organisation considered that the prejudice test would provide reassurance that the wider implications for, and wishes of the local population, were being taken into account.

3.16 Others considered that the prejudice test would offer more stability in service provision; would increase fairness and transparency in the process of assessing applications; and may be beneficial in reducing the number of applications in areas where services provided by dispensing GP practices would be negatively affected.

3.17 Amongst opponents to the proposal to introduce a prejudice test, the most common argument was that the test may result in the refusal of genuine applications which could be of benefit to local communities. Indeed, a few NHS Board committees and one NHS Board advocated maintaining a 2-stage assessment process rather than filtering applications at the prejudice test stage, which they felt could debar a large majority of applications without considering the wider benefits to patients from greater availability of pharmaceutical care services.

3.18 Other arguments against the test were:

• Not needed. The adequacy test is sufficient.
• Could be deemed anti-competitive and illegal.
• Could result in innovation being stifled.
• Creates confusion.

3.19 More information on the detail of the prejudice test was called for by respondents from NHS Board committees, NHS Boards, representative or professional bodies and pharmacy contractors. Questions were asked about whether GP practice income would be taken into account with or without the dispensing element; would the test be based on business or patient care considerations; would the services to be taken into consideration be those generally expected or those actually in existence at the point of consideration the application?

3.20 Six respondents (all NHS Board committees and NHS Boards) recommended that robust guidance on implementation should accompany any introduction of the prejudice test.

3.21 One MSP/MP recommended learning lessons from other jurisdictions, such as the system of "controlled localities" operating in England and Wales, to inform the Scottish legislation.

3.22 Seven respondents from a range of categories argued that communities should have access to an appeals system in order for them to take action should they disagree with the use of the prejudice test in their area.

Periodic review of the designation of an area as a "controlled remote, rural and island locality"

Proposal 2

The Scottish Government proposes that the designation of an area as a "controlled remote, rural and island locality" should be reviewed periodically by NHS Boards so that NHS provided or contracted services are responsive to population changes, and changing healthcare needs and priorities both locally and nationally. It is proposed that the review should be carried out at a minimum of every three years.

3.23 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

3.24 78 respondents provided views on Proposal 2. Table 3.2 provides their responses to the closed aspect of the question. Just over half (56%) of those providing a view agreed with Proposal 2. Amongst those most likely to agree were NHS Boards. Representative or professional bodies, pharmacy contractors and GP practices were most likely to disagree.

Table 3.2 Level of agreement with Proposal 2

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	21		64	12	36	33
NHS Board committees	7		54	6	46	13
NHS Boards	7		70	3	30	10
Representative or professional bodies	2		25	6	75	8
Pharmacy contractors	2		29	5	71	7
GP practices	1		33	2	67	3
MSP/MP	-		-	-	-	-
Community Councils	1		100	-	-	1
NHS support organisations	1		100	-	-	1
Other	2		100	-	-	2
Total	44		56	34	44	78

3.25 11 respondents, including seven individuals, simply provided general support to the proposal to review periodically. Regular review was seen as important in order to identify and address any significant change, such as a new housing development, and to promote consistency across NHS Boards.

Views in favour of more frequent review

3.26 11 further respondents from a range of categories recommended periodic review more frequently than every three years. Their main arguments were:

• This will align with the PCSP which at present is prepared annually.
• More frequent review will promote a pro-active rather than reactive approach.
• Some changes can happen quickly and a more frequent review will help to protect against gaps in service in such circumstances.

Views of those agreeing with review at a minimum of every three years

3.27 16 respondents from a range of categories provided reasons as to why they agreed with the proposed minimum of three years for periodic review. The main rationale was that this achieves the balance between keeping plans current, whilst avoiding unnecessary work. Some respondents advocated maintaining the flexibility to undertake a review on an ad hoc basis should it be deemed necessary (e.g. if a significant change in population occurs).

Views of those recommending periodic review less frequently than every three years

3.28 17 respondents, again representing a range of categories, recommended reviewing the designation of an area less frequently than every three years. Review periods of five, between three and five, and five to ten years were suggested. Recurring reasons to support this view were:

• Shorter review periods create problems for long-term planning for GP practices by introducing uncertainty.
• Uncertainty impacts negatively on recruitment and retention.
• More frequent review is inefficient and wastes resources.
• In reality, there is usually very little change over three years in remote rural and island areas which will affect the designation.

Views of those opposing regular, periodic review

3.29 A recurring comment across NHS Board committees, NHS Boards, pharmacy contractors and representative or professional bodies was that the review of the designation should be encompassed within the PCSP and should therefore be undertaken at the same frequency. Respondents cautioned about duplication of effort, and considered that undertaking the review as part of the plan would enable a more strategic approach.

3.30 Two individual respondents opposed any review of the designation on grounds that a review would create uncertainty.

3.31 Questions were asked about whether patients and dispensing GPs would have a say in the review.

Other comments

3.32 Two individual respondents suggested that any review should be "event driven" and in response to key triggers such as population change. One recommended a patient survey be conducted when required to inform the review.

3.33 Two respondents (HB, HBC) suggested that the opportunity be taken at review time to examine other related issues such as GP lists of patients to whom they can dispense, to ensure these are kept up-to-date and patients removed who are no longer entitled to receive this service.

Supplementing GP dispensing with pharmaceutical care

Proposal 3

The Scottish Government is of the view that people living in remote, rural and island areas should have access to NHS pharmaceutical services and NHS primary medical services that are not less adequate than would be the case in other parts of Scotland.

When the dispensing by a GP practice is necessary, it should be supplemented with pharmaceutical care provided by a qualified clinical pharmacist sourced by the NHS Board to ensure the person-centred, safe and effective use of the medicines. NHS Boards would be required to develop local plans sensitive to local circumstances to achieve this.

3.34 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

3.35 79 respondents provided views on Proposal 3. Table 3.3 provides their responses to the closed aspect of the question. Almost three-quarters (72%) of those providing a view agreed with Proposal 3. Five of the seven pharmacy contractors who addressed this issue disagreed with the proposal.

Table 3.3 Level of agreement with Proposal 3

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	21		64	12	36	33
NHS Board committees	12		86	2	14	14
NHS Boards	10		100	-	-	10
Representative or professional bodies	4		67	2	33	6
Pharmacy contractors	2		29	5	71	7
GP practices	2		67	1	33	3
MSP/MP	1		100	-	-	1
Community Councils	1		100	-	-	1
NHS support organisations	1		100	-	-	1
Other	3		100	-	-	3
Total	57		72	22	28	79

Views in support of the proposal

3.36 Supporters in general felt that the proposal would result in more equitable access to high standards of pharmaceutical care across Scotland. Eight respondents from a range of categories considered that the arrangement would result in increased safety in patient care. One commented:

"....pharmacists provide an extra clinical check, improving patient safety. Pharmacists will bring additional skills and expertise to the service that will benefit patients" (Pharm).

3.37 Other advantages of the proposal which were identified by only a few respondents were:

• Promotes collaborative working between GPs and pharmacists.
• Efficiencies will be gained by sharing the same premises.
• Reduces the risk of losing primary medical services altogether.
• This challenges the view held by some that only community pharmacies can supply pharmaceutical services.
• Removes the conflict of interest currently existing when dispensing GPs both prescribe and dispense medication.
• The pharmaceutical care and supply of medicines should not be separated.

Views opposing the proposal

3.38 Seven respondents (four of them pharmacy contractors) provided their view that it would be more cost-effective to contract with the existing network of community pharmacies than for NHS Boards to source qualified NHS clinical pharmacists.

3.39 Six individual respondents remarked that the proposal represented duplication of effort, as in their view GP dispensing staff could provide pharmaceutical care, using their in-depth knowledge of their patients. One stated:

"Whilst a pharmacist working with a GP is helpful if funded by Health Boards it is not essential and never has been. NHS funding can be better spent on other services. If patients in rural areas had wanted the NHS services described above they would have asked for them. They have not done so. The proposal regarding employment of a qualified pharmacist is ridiculous. It seeks to maintain the myth that only a pharmacist can provide a safe and effective use of medicines" (Individual).

Queries about the proposal

3.40 Many respondents raised queries about what was being proposed. Most of their queries related to the financing of the proposal, with recurring comments being that "sourced by the NHS Board" does not necessarily mean "funded by". Some commented that if NHS Boards are footing the bill for the proposal, then they will require significant additional funds to do this. If GPs are asked to contribute funding, this raised questions for a few respondents over GP impartiality and also the potential for GPs to re-deploy the pharmacist to other tasks.

3.41 Questions were asked about governance, lines of accountability and liability. Clear governance arrangements, defined standards and performance management structures were called for. One respondent (Pharm) wondered whether the proposal would impact on the confidentiality of patient records.

3.42 A few respondents asked whether GPs would have a say in the appointments, what qualifications the pharmacist will require, and what hours they will work.

Other comments

3.43 Two respondents (Pharm, Rep/Prof) recommended that an inspection regime will be required on par with that already in place for community pharmacies.

3.44 Six respondents (three NHS Boards and three NHS Board committees) argued for flexibility in the arrangements, so that pharmacists could be sourced either from the NHS or from the existing network of community pharmacies. One NHS Board recommended that the proposal should not be compulsory.

3.45 13 respondents suggested that innovative ways of providing supplementary pharmaceutical care could be explored in order to promote cost effectiveness. Video-linking, telehealth, Skype, Face Time and home visiting were all identified as worth further consideration.

OVERVIEW

3.46 Prevalent themes throughout responses were the desire to maintain consistency of medical and pharmaceutical services provision across Scotland, with flexibility to adapt to changes in local demography and needs over time. There was a desire to ensure remote and rural communities benefit from genuine, sustainable services, with procedures in place to protect them from speculative, short-term ventures.

3.47 The proposed designation of "controlled remote, rural and island localities" for the purposes of considering pharmacy applications was well supported as was the proposal to introduce a "prejudice test" as an addition to the test of "necessary or desirable". It was generally felt that implementation of the prejudice test would ensure that the overall health needs of the population within an area would be taken into consideration when assessing applications, thereby reducing the risk of losing services altogether.

3.48 Most of those who provided a view considered that the designation of an area as a "controlled remote, rural and island locality" should be kept under regular review.

3.49 The supplementation of dispensing GP practices with pharmaceutical care provided by a qualified, clinical pharmacist sourced by the NHS Board was viewed as a way of promoting more equitable access to high standards of pharmaceutical care across Scotland. An emerging theme was that innovative ways of providing supplementary care, for example using telehealth, could be explored in order to promote cost effectiveness.