Guidance

Pharmaceutical needs assessments: information pack for local authority health and wellbeing boards

Updated 31 July 2025

Applies to England

Preface

This information pack has no statutory standing, nor does it constitute non-statutory guidance, but it aims to support local authorities to interpret and implement their duties with regard to pharmaceutical needs assessment (PNAs).

The rules themselves are not, in the main, set out word-for-word in this document. In order to make it easier to read, the detailed rules have, in most cases, been paraphrased. However, all those responsible for administering or applying the law must bear in mind that it is the law that must be applied, not the interpretation that is set out below.

This document’s legal status is that it is an analysis of the rules of law together with appropriate notes of guidance, designed to assist health and wellbeing boards (HWBs) in producing PNAs within the framework of the law. It is not an authoritative statement of the law.

Summary

Section 128A of the National Health Service Act 2006 (the 2006 Act) requires each HWB to assess the need for pharmaceutical services in its area and to publish a statement of its assessment. Termed a ‘PNA’, the NHS (Pharmaceutical Services and Local Pharmaceutical Services) Regulations 2013, as amended (the 2013 regulations) set out the minimum information that must be contained within a PNA and outline the process that must be followed in its development.

In summary, the 2013 regulations:

• define what is meant by pharmaceutical services in relation to PNAs (regulation 3(2))
• set out the minimum information requirements for a PNA (regulation 4 and Schedule 1)
• confirm when the next PNA is to be published (regulation 6(1)), or where a new HWB comes into being when it is required to publish its first PNA (regulation 6(A3))
• set out the circumstances where an HWB may need to produce a new PNA sooner than the usual 3 yearly cycle (regulation 6(2)), or when a supplementary statement may/must be published (regulation 6(3) to (4))
• require each HWB to ensure that NHS England has access to its PNA and any supplementary statements that have been published (regulation 7(2)). Since 1 April 2023 NHS England has delegated the commissioning of pharmaceutical services to the integrated care boards (ICBs). Therefore, each HWB should also ensure that the ICB or ICBs, for its area has, or have, access to its PNA and any supplementary statements
• set out the minimum consultation process that each HWB is required to undertake during the development of its PNA (regulation 8)
• set out specific matters that the HWB must consider when drafting its PNA (regulation 9)

This information pack is intended to support local authority HWBs in a practical way in understanding and implementing these requirements.

Introduction and legislative background

Introduction

If a person (a pharmacy contractor or a dispensing appliance contractor, operating as a sole trader, partnership or body corporate) wants to provide pharmaceutical services, they are required to apply to the NHS to be included in a pharmaceutical list. As at June 2025, pharmaceutical lists are prepared and maintained by the ICBs and published by NHS England as a consolidated list. This is commonly known as the NHS ‘market entry’ system.

Under the 2013 regulations, a person who wishes to provide pharmaceutical services must apply to NHS England to be included in the relevant pharmaceutical list by proving they are able to meet a need for, or secure improvements or better access to, pharmaceutical services that are included in the relevant PNA. There are exceptions to this, such as:

• applications for benefits not foreseen in the PNA (‘unforeseen benefits’ applications)
• providing pharmaceutical services on a distance-selling (internet or mail order only) basis

From April 2013, HWBs became responsible for PNAs. Within this information pack we have included hints and tips to assist HWBs in drafting their PNA.

Since 1 April 2023 NHS England has delegated the commissioning of pharmaceutical services to the ICBs. Therefore, while NHS England has a statutory duty to make arrangements for essential and advanced services with pharmacies and dispensing appliance contractors and may choose to commission enhanced services from pharmacies to meet the needs of the population, in reality market entry and the commissioning of pharmaceutical services is undertaken by the ICBs.

As at June 2025, both the 2006 Act and the 2013 regulations refer to NHS England. Both will be amended in due course to reflect the abolition of NHS England but in the meantime those writing the PNA should continue to reference NHS England and the ICBs as appropriate.

Legislative background

The Health and Social Care Act 2012:

• established HWBs
• transferred responsibility to develop and update PNAs from primary care trusts to HWBs with effect from 1 April 2013

At the same time responsibility for using PNAs as the basis for determining market entry to a pharmaceutical list transferred from primary care trusts to NHS England and NHS Improvement. As noted above this responsibility has been delegated by NHS England to the ICBs.

The 2006 Act, amended by the Health and Social Care Act 2012, in Section 128A, sets out the requirements for HWBs to develop and update PNAs and gives the Department of Health and Social Care (DHSC) powers to make regulations.

Wider context

The Health and Social Care Act 2012 also amended the Local Government and Public Involvement in Health Act 2007 to introduce duties and powers for HWBs in relation to joint strategic needs assessments (JSNAs). The aim of JSNAs is to improve the health and wellbeing of the local community and reduce inequalities for all ages. They are not an end in themselves, but a continuous process of strategic assessment for the health and wellbeing needs of the local population. They will be used to determine what actions local authorities, the NHS and other partners need to take to meet health and social care needs and to improve health outcomes and address health inequalities.

The preparation and consultation on the PNA should take account of the JSNAs and other relevant strategies in order to prevent duplication of work and multiple consultations with health groups, patients and the public. The development of PNAs is a separate duty to that of developing JSNAs as PNAs will inform commissioning decisions by:

• local authorities
• NHS England
• ICBs

HWBs may therefore wish to note that PNAs, as a separate statutory requirement, cannot be subsumed as part of these other documents but can be annexed to them.

Implications for HWBs

As the PNA is a key document for those wishing to open new pharmacy or dispensing appliance contractor premises and is used by the ICBs and, on appeal, NHS Resolution to determine such applications, there are serious implications for HWBs who fail to meet their statutory duties. They may also be referred to as part of a judicial review of the decision on an application for inclusion in a pharmaceutical list.

There is no right of appeal against the findings or conclusions within a PNA. HWBs (although in reality this will be the local authority) therefore face the risk of a judicial review if they fail to:

• develop a PNA that complies with the minimum requirements for such documents as set out in the 2013 regulations
• follow due process in developing their PNA, for example by failing to:
  • consult in line with the requirements set out in the regulations
  • take into consideration the results of the consultation exercise undertaken
  • publish by the required deadline

In addition, a PNA that does not meet the requirements of the 2013 regulations, or is poorly worded, may lead to:

• an increase in applications for premises that are not required
• applications being granted when they should be refused
• applications being refused when they should be granted
• applications for new pharmacy premises being granted but which do not meet the local authority’s strategic plans
• an increase in the number of appeals against decisions made by the ICBs

Further information on the governance arrangements that should be put in place can be found in the ‘Process overview’ section.

Joint assessments

It is permissible for 2 or more HWBs to make joint arrangements for their functions under section 128A of the NHS Act 2006 of:

• assessing the needs for pharmaceutical services in each area
• publishing statements of those assessments

That is, we consider that the section 128A functions are amenable to joint exercise under section 198 of the Health and Social Care Act 2012.

However, the joint assessment must result in a published statement that meet the requirements of the legislation in respect of each area separately. So, for example, the question of whether in the area of one of the HWBs there was sufficient choice, that assessment must have regard to the provision of services by any neighbouring HWB (which might or might not be the other HWB in the joint arrangement) but ultimately the issue of sufficient choice must be determined for each area separately. The outcome of that separate determination must be reflected in a transparent way in the joint document.

Understanding the regulations

Definitions

Within the 2013 regulations there are a number of words and phrases that need to be understood in the context of PNA. The most relevant ones are explained below.

Advanced services

Advanced services are those services that pharmacy and dispensing appliance contractors may choose to provide if they meet the required standards. Information on these standards and the services themselves are set out in the Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2013 which can be found in Part VIC of the Drug Tariff.

As at May 2025, pharmacies may provide the following advanced services:

• new medicine service
• community pharmacy seasonal influenza vaccination service
• NHS community pharmacy hypertension case-finding service
• NHS smoking cessation service
• NHS pharmacy contraception service
• NHS lateral flow device tests supply service
• NHS Pharmacy First

There are 2 appliance advanced services that pharmacies and dispensing appliance contractors may choose to provide:

• appliance use reviews
• stoma appliance customisation

Further practical user information on each of the advanced services can be found on Community Pharmacy England’s website.

The PNA will need to look at the provision of each of these services and identify any current or future gaps in their provision.

Appliances

While drugs are the most common healthcare intervention and a large proportion of the HWB’s population will be prescribed them on a regular or occasional basis, a smaller proportion will require access to appliances. Those that are available on the NHS are set out in Part IX of the Drug Tariff and include:

• catheters
• dressings
• elastic hosiery
• hernia support garments
• trusses
• colostomy bags
• urostomy bags

The PNA will therefore need to consider access to both drugs and appliances.

While pharmacies are required to dispense valid NHS prescriptions for all drugs, both they and dispensing appliance contractors may choose which appliances they provide in their normal course of business. They may choose to provide:

• a certain type of appliance
• certain types of appliances
• all appliances
• no appliances

A large proportion of patients who are regular users of appliances will have them delivered, often by dispensing appliance contractors based in other parts of the country (see ‘Dispensing appliance contractors’ section below).

Controlled localities

Controlled localities are areas that have been determined to be ‘rural in character’ by an ICB (or a preceding organisation) or on appeal by NHS Resolution. There is no one factor that determines whether or not an area is rural in character: ICBs will consider a range of factors which may include:

• population density
• the presence or absence of facilities
• employment patterns
• community size and distance between settlements
• the availability of public transport

Their importance comes into play in relation to the ability for a GP practice to dispense to its registered patients. In order to be dispensed to, as a starting point, the patient must live in a controlled locality, more than 1.6 kilometres (measured in a straight line) from a pharmacy. There are, however, other requirements to be satisfied.

Directed services

This is a collective term for advanced and enhanced services.

Dispensing appliance contractors

Dispensing appliance contractors are different from pharmacy contractors because:

• they only dispense prescriptions for appliances. They cannot dispense prescriptions for drugs
• they are not required to have a pharmacist
• they do not have a regulatory body
• their premises do not have to be registered with the General Pharmaceutical Council

Dispensing appliance contractors tend to operate remotely, receiving prescriptions either by post or the electronic prescription service, and arranging for dispensed items to be delivered to the patient. There are far fewer of them compared to pharmacies (there were 111 dispensing appliance contractor premises as of March 2025 compared to 10,420 pharmacies). Consequently, not every HWB will have a dispensing appliance contractor operating in their area; however residents will be accessing their services elsewhere in the country.

Dispensing doctors and/or practices

While the majority of people living in the HWB’s area will have their prescriptions dispensed by a pharmacy or dispensing appliance contractor, some will have them dispensed by their GP practice. In order to be dispensed to by their GP practice, a patient must meet the requirements in the 2013 regulations, which in summary are:

• they must live in a controlled locality
• they must live more than 1.6km (measured in a straight line) from a pharmacy
• the practice must have approval for the premises at which they will dispense to them
• the practice must have the appropriate consent for the area the patient lives in

NHS England is required to maintain and publish a dispensing doctor list for the area of each HWB, although the responsibility to prepare and maintain them has been delegated to the ICBs. However, if there are no controlled localities within an HWB’s area there will be no dispensing doctors.

In some cases, a GP practice with premises within a town will still be able to dispense because some of their patients live in a controlled locality and meet the other requirements of the 2013 regulations. Dispensing practices are not required to have a pharmacist in their dispensary and their premises do not have to be registered with the General Pharmaceutical Council.

Distance selling premises (DSPs)

DSPs are pharmacies, but the 2013 regulations do not allow them to provide essential services to people on a face-to-face basis. They will receive prescriptions either by the electronic prescription service or through the post, dispense them at the pharmacy and then either deliver them to the patient or arrange for them to be delivered using a courier, for example.

They must provide essential services to anyone, anywhere in England, where requested to do so. They may choose to provide advanced services, but when doing so must ensure that they do not provide any element of the essential services while the patient is at the pharmacy premises. They are also required to stop providing COVID-19 and flu vaccinations at their premises from 1 April 2026 and must cease providing all other advanced and enhanced services face-to-face at their pharmacy premises from 1 October 2025. This prohibition extends to the vicinity of premises, as well as the registered premises footprint. As of March 2025, there were 408 DSPs in England, based in 121 HWBs. Not every HWB therefore has one in their area, but it is likely that an increasing number of their residents will use one.

Enhanced services

Enhanced services are the third tier of services that pharmacies may provide, and they can only be commissioned by NHS England and the ICBs. The services that may be commissioned are listed in the Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2013 (as amended) which can be found in the Drug Tariff.

While the local authority may commission public health services from pharmacies, these do not fall within the legal definition of enhanced services and are not to be referenced as such in the PNA. See ‘locally commissioned services’ below.

Essential services

All pharmacies, including DSPs, are required to provide the essential services. As of May 2025, there are 7 essential services. These services are:

• dispensing of prescriptions
• dispensing of repeatable prescriptions. These are prescriptions which contain more than one month’s supply of drugs on them. For example, an electronic repeatable prescription may say that the prescription interval is every 28 days, and it can be repeated 6 times. This would give a patient approximately 6 months’ supply of medication, dispensed every 28 days with the prescriber only needing to authorise the supply once
• disposal of unwanted medicines returned to the pharmacy by someone living at home, in a children’s home, or in a residential care home. (A ‘residential care home’ is defined in the 2013 regulations as an establishment which exists wholly or mainly for the provision of residential accommodation, together with board and personal care, for persons in need of personal care because of old age, mental or physical disability, past or present dependence on alcohol or drugs, any past illnesses, or past or present mental disorder)
• promotion of healthy lifestyles, which includes:
  • providing advice to people who:
    • appear to have diabetes
    • appear to be at risk of coronary heart disease (especially those with high blood pressure)
    • smoke
    • are overweight
  • participating in 6 health campaigns where requested to do so by NHS England or the ICBs
• signposting people who require advice, treatment or support that the pharmacy cannot provide to another provider of health or social care services, where the pharmacy has that information
• support for self-care, which may include advising on over the counter medicines or changes to the person’s lifestyle
• discharge medicines service. This service was introduced in 2021 and aims to reduce the risk of medication problems when a person is discharged from hospital. It is estimated that 60% of patients have 3 or more changes made to their medicines during a hospital stay. However, a lack of robust communication about these changes may result in errors being made once the person has left hospital. In summary, under this service a pharmacist will review a person’s medicines on discharge and ensure that any changes are actioned accordingly

Further information on the essential services requirements can be found in schedule 4 of the 2013 regulations.

Dispensing appliance contractors have a narrower range of services that they must provide. These include:

• dispensing of prescriptions
• dispensing of repeatable prescriptions
• delivery of certain appliances to the patient (delivering in unbranded packaging), including providing a supply of wipes and bags, and providing access to expert clinical advice
• where the contractor cannot provide a particular appliance, signposting or referring a patient to another provider of appliances who can

Further information on the essential dispensing appliance contractor services requirements can be found in schedule 5 of the 2013 regulations.

It should be noted that clinical governance is not an essential service. Instead it is a framework which underpins the provision of all pharmaceutical services.

Local pharmaceutical services

NHS England and the ICBs do not hold signed contracts with the majority of pharmacies. Instead, pharmacies provide services under a contractual framework and the terms of service are set out in the 2013 regulations.

The one exception to this rule is local pharmaceutical services. A local pharmaceutical services contract allows NHS England and the ICBs to commission services that are tailored to meet specific local requirements. It provides flexibility to include within a locally negotiated contract a broader or narrower range of services (including services not traditionally associated with pharmacy) than is possible under national pharmacy arrangements set out in the 2013 regulations. The contract must, however, include an element of dispensing.

As of March 2025, there were 13 local pharmaceutical services contracts in 11 HWBs.

Care should be taken when using the term local pharmaceutical services as it has a specific meaning in the 2013 regulations. It must not be used to describe pharmaceutical services that are provided locally.

Locally commissioned services

Locally commissioned services are services commissioned from pharmacies by local authorities, NHS trusts or NHS foundation trusts. As noted in the definition of enhanced services above, they are not enhanced services because they are not commissioned by NHS England or the ICBs.

Where an ICB commissions a service from one or more pharmacies using the NHS standard contract, this is a locally commissioned service and not an enhanced service. The HWB will therefore need to seek clarification from the ICB or ICBs for its areas on the contracting route used to commission services from pharmacies in order to establish whether they are enhanced services or locally commissioned services.

HWBs should reference locally commissioned services in their PNA as other NHS services (see Other NHS services).

Necessary services

The 2013 regulations require the HWB to include a statement of those pharmaceutical services that it has identified as being necessary to meet the need for pharmaceutical services in its area within the PNA. There is no definition of necessary services within the 2013 regulations and the HWB therefore has complete freedom in this matter.

Opening hours

Pharmacies and dispensing appliance contractors have 2 different types of opening hours: core and supplementary.

In general pharmacies will have 40 or minimum 72 core opening hours per week, although some may have more or less than 40 or more than 72.

Dispensing appliance contractors are required to have no less than 30 core opening hours per week, although again some may have more or less.

Pharmacies and dispensing appliance contractors are not required to open on:

• Christmas Day
• Good Friday
• Easter Sunday
• any bank holiday

Some may, however, decide to open for all of part of their usual opening hours on those days.

Core opening hours can only be changed by first applying to the relevant ICB. If the ICB refuses the application, the decision can be appealed to NHS Resolution.

Any opening hours that are over and above the core opening hours are called supplementary opening hours. A pharmacy may reduce its supplementary opening hours by giving the relevant ICB at least 5 weeks’ notice. Dispensing appliance contractors are required to give at least 3 months’ notice.

Under the NHS (Pharmaceutical Services) Regulations 2005, as amended, it was possible for a person to apply to open a pharmacy that had 100 core opening hours. These were referred to as 100 hour pharmacies and it was a condition of their inclusion in the relevant pharmaceutical list that the contractor ensured they were kept open for 100 hours per week for the provision of pharmaceutical services.

The 2013 regulations were amended in 2023 to allow a contractor to apply to the relevant ICB to reduce the total number of core opening hours of its 100 hour pharmacy. Such applications are to be granted as long as the total number of core opening hours will be 72 or more, and there are no changes to:

• the pharmacy’s core opening hours on a Monday to Saturday at times between 5pm and 9pm
• the pharmacy’s core opening hours on a Sunday between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which is no longer than one hour and starts at least 3 hours after the pharmacy opens and ends at least 3 hours before the pharmacy closes
• the total number of core opening hours on a Sunday

An HWB is likely to find that many of the 100 hour pharmacies in its area have successfully applied to reduce their core opening hours since the last PNA was published.

Other NHS services

Other NHS services are those services that are provided as part of the health service. They include services that are provided or arranged by:

• a local authority (for example the public health services commissioned from pharmacies)
• NHS England
• an ICB
• an NHS trust
• an NHS foundation trust

Examples of other NHS services are included in the Information to be contained in PNAs section.

Other relevant services

These are services that the HWB is satisfied are not necessary to meet the need for pharmaceutical services, but their provision has secured improvements, or better access, to pharmaceutical services.

Once the HWB has determined which of all the pharmaceutical services provided in or to its area are necessary services, the remainder will be other relevant services.

Pharmaceutical services

Section 126 of the 2006 Act places an obligation on NHS England to put arrangements in place so that drugs, medicines and listed appliances ordered by NHS prescriptions can be supplied to persons. It is also required to make arrangements for “such other services as may be prescribed”. This refers to the other essential services.

Section 127 of the 2006 Act allows the Secretary of State for Health and Social Care to give directions to NHS England:

• requiring it to arrange for the provision of advanced services
• allowing it to commission enhanced services

Schedule 12 of the 2006 Act allows NHS England to commission local pharmaceutical services contracts. The commissioning of these services is undertaken by the ICBs on behalf of NHS England.

Pharmaceutical services is a collective term for the above range of services commissioned by NHS England and the ICBs. In relation to PNAs it includes:

• essential, advanced and enhanced services provided by pharmacies
• essential and advanced services provided by dispensing appliance contractors
• the dispensing service provided by some GP practices
• services provided under a local pharmaceutical services contract that are the equivalent of essential, advanced and enhanced services

Unforeseen benefit applications

The PNA sets out needs for, or improvements or better access to, a range of pharmaceutical services or one specific service. This then triggers applications to meet those needs or secure those improvements or better access.

However, there are 2 types of application which lead to the opening of new premises that are not based on the pharmaceutical needs assessments: those offering unforeseen benefits and those for DSPs. In 2025, these 2 types of applications accounted for approximately 82% of the applications submitted to open new premises (approximately 40% and 42% respectively).

Where an applicant submits an unforeseen benefits application, they are offering improvements or better access that were not foreseen when the PNA was written but would, in the applicant’s opinion, confer significant benefits on people in the area of the HWB.

Process overview

There are 8 stages to developing a PNA. A high-level timeline can be found in appendix 1 and this section provides an overview of the process. HWBs should allow up to 12 months for the process of drafting, consulting on and publishing the PNA.

Governance

The HWB should ensure that there is board level sign-up to the process of developing the PNA, and a named board member who will take overall responsibility for ensuring the document meets the regulatory requirements and is published in a timely manner.

As HWBs are under a statutory duty to produce and publish a new PNA at least every 3 years, it is imperative that sufficient resources, both human and financial, are identified and that there is board level support for the development of the document. Due to the serious consequences of not following due process in developing the PNA, it is recommended that the board includes production of the PNA in the council’s risk register.

It is strongly recommended that a steering group is established to support the process. This will need to be done early on, allowing members sufficient notice of the first meeting. An outline agenda for the first meeting can be found in the ‘Engagement’ section.

The HWB will need to decide whether signoff of both the consultation and final versions of the PNA will be undertaken by:

• the HWB
• the steering group
• a combination of both

When coming to a decision the HWB should bear in mind the frequency and timing of its meetings and the requirement to publish a new PNA within 3 years of the publication of the current version.

Gathering of health and demographic data

The gathering of the required health and demographic data can begin before the first steering group meeting, as it is information that will be held by the public health team. It will, however, require liaison with other departments and teams within the council, for example highways and planning teams for information on known housing developments, regeneration projects or transport developments that are current or will occur within the lifetime of the PNA. The timeline allows 4 weeks for the data gathering.

Once this data is gathered it will then need to be analysed, unless this has already been done as part of the JSNA. Three weeks has been allowed for this within the timeline.

Public and contractor engagement

While not required by the 2013 regulations, it is strongly recommended that the views of the public are gathered. This will allow the HWB to test some of its assumptions and provide useful information for the document.

Suggested topics for questions can be found in the Engagement section. It is suggested that the questionnaire starts shortly after the first steering group meeting, running for 4 weeks. Three weeks has been allowed in the timeline for analysis of the responses, though this could be shortened if most of the questions do not allow free text questions and if not many off-system responses (such as paper copies of the questionnaire) are received.

Similarly, it will also be necessary to gather information from those who are providing the services that is not otherwise already in the public domain. Suggested information that will need to be collected from contractors can be found in the Engagement section. As with the public questionnaire, 4 weeks has been allowed for this in the timeline, with 2 weeks for analysis of responses as the questionnaire can be run solely online and the majority of questions are likely to have tick box answers.

Pharmaceutical services information

Much of the information on the provision of pharmaceutical services can be sourced from the NHS Business Services Authority (NHSBSA) website, with supplementary information from the ICB or ICBs. However, some of it will need to be gathered from contractors using questionnaires.

Two weeks has been allowed in the timeline for the collation of this information with 4 weeks to analyse and map service provision. See the ‘Information to be contained in PNAs’ section for further information on this element of the project.

Analysis and drafting

As the required data and information is gathered the document can begin to be drafted. It is recommended that a checklist of the statements that must be included is produced in order to ensure the document meets the requirements of the 2013 regulations. Twelve weeks has been allowed for in the timeline for this stage, although this could be shortened if required. The steering group will need to decide whether it wishes to receive chapters as they are drafted or whether it would prefer to wait until a complete full draft of the document is available.

Review and sign-off

Once the analysis and drafting are complete the steering group must:

• review the document
• identify any gaps in provision that either currently exist or will arise within the 3-year lifetime of the document
• articulate these gaps as needs for, or improvements or better access to, a pharmaceutical service or services

The next draft of the document can then be produced and shared with the steering group for review. Two weeks has been allowed for this in the timeline.

The PNA must then be signed off by the steering group or passed to the relevant committee or the HWB for sign-off prior to the consultation.

Consultation

The HWB must consult with certain organisations about the contents of the PNA at least once, and that consultation must run for a minimum period of 60 days. Further information on the consultation requirements can be found in the ‘Consultation’ section.

The timeline allows 7 weeks for sign off of the document if this is to be done by the HWB, recognising that there will be a lead-in time for papers and that the board may not meet every month. However if the board delegates sign-off of the consultation draft of the PNA to the steering group the consultation can be brought forward by a number of weeks.

Review, sign-off and publication

A report on the consultation must be included in the final version of the document. The steering group will need to:

• review the responses to the consultation
• agree its response to the points raised
• include its response in the report
• consider what, if any, changes need to be made to the document as a result of the consultation

One week has been included in the timeline for this stage. This is a short period of time because it is assumed that if robust engagement has been undertaken throughout the process of drafting the document there should be no surprises from the consultation.

Once the document is finalised it will then need to be signed off by the relevant committee or the HWB and published. Four weeks has been allowed for in the timeline for this stage, and it assumes that there will be a committee and/or board meeting in the month before the date on which the PNA must be published. If that is not the case the timeline will need to be amended accordingly.

The 2013 regulations do not specify how or where the PNA is published, but it is recommended that it is published on the local authority’s website. If it is published on another website, then a link to that site must be included on the local authority’s website, as the HWB is under a duty to ensure that NHS England and the ICB or ICBs have access to the document and any supplementary statements that are published alongside it.

Engagement

The HWB will need to undertake engagement with the main stakeholders throughout the process of developing the PNA, and this is a separate process to the formal consultation. This can be done through:

• the steering group
• a public engagement questionnaire
• contractor questionnaires

Steering group

As noted in the previous section it is strongly recommended that a steering group is established to support the process, with representation from:

• the public health team
• the communications and engagement team
• the local pharmaceutical committee
• the local medical committee if there are dispensing practices in the HWB’s area
• Healthwatch
• the ICB or ICBs. For some HWBs there will be more than one ICB covering its area

Representatives from other teams or organisations may be included either as regular members of the group or invited to attend meetings for particular discussions.

It is likely that more than one person from the ICB will be on the steering group, as input will be required from more than one team. For example, the steering group might include:

• a member of the team that holds information about:
  • the pharmaceutical and dispensing doctor lists
  • core and supplementary opening hours (and applications or notifications to change them)
  • which pharmacies have signed up to the advanced services
  • which pharmacies are commissioned to provide which enhanced services
  • applications for inclusion in the pharmaceutical list or lists, and dispensing doctor list if there is one (this may include applications that are in progress and have not been determined, or have been granted but the applicant has not yet submitted their notice of commencement and/or consolidation)
  • contractors who have given notice to withdraw premises from the relevant list
• a member of the GP contracting team who is able to provide information on any known GP practice mergers, contract terminations, or practice relocations
• a team member who is able to provide information on:
  • the ICB’s primary care commissioning plans
  • how pharmacies fit into these plans
  • what the ICB requires from the provision of pharmaceutical services
  • any gaps in provision that have been identified or will arise during the lifetime of the PNA

Some members of the steering group may not need to attend meetings if they provide the required information by email.

The primary role of the group is to advise and develop structures and processes to support the preparation of a comprehensive, well researched, well considered and robust PNA, building on expertise from across the local healthcare community. Establishing the group will also ensure that the views of the main stakeholders are taken into account throughout the process of writing the document.

The steering group could report directly to the HWB or to another committee in line with the council’s usual reporting structures. The HWB will need to decide how much it wishes to delegate to the steering group, for example whether it wishes to sign off the consultation version of the PNA or whether this will be delegated to the group.

As there will be local experience of producing PNAs it may not be necessary for the steering group to meet on a monthly basis. As HWBs will have built up experience of producing a PNA it may only be necessary for there to be 4 meetings over the course of the production of the PNA.

At the first meeting the steering group should agree:

• the terms of reference for the group
• the project timeline
• how the area will be divided up into localities
• the content of the contractor questionnaire or questionnaires depending on whether there are dispensing appliance contractors and dispensing doctors in the area as well as pharmacies
• the content of the public engagement questionnaire, how it will be made available and any other ways of engaging with the public
• which services are necessary services, and which are other relevant services
• the structure of the document

Other topics for the agenda may include identifying the specific patient groups in the area, and which services fall into the category of NHS services.

The second meeting would take place once a complete draft of the document is available and would focus on the locality chapters in order to consider whether there are any gaps in the provision of services currently, or whether any will arise within the lifetime of the document. These are then to be articulated as needs for, or improvements or better access to, one or more pharmaceutical services.

A third meeting may be required to sign off the consultation version of the document either for recommendation to the HWB or so that it can go out to consultation. Alternatively, this could be done by email.

The fourth meeting would be held after the consultation. At this meeting the group will review the responses to the consultation, consider whether any changes are to be made to the PNA and agree the response to the consultation.

A final meeting may be required to sign off the final version of the document either for recommendation to the HWB or so that it can be published. Alternatively, this could be done by email.

Members of the public

PNAs should be drafted with the involvement of patients and the public, and it is recommended that involving them is undertaken early in the process in order to inform the drafting of the document. The views of patients and the public should be sought at the same time as the contractor questionnaires are open.

To date the majority of engagement with the public has been through online questionnaires. However, HWBs should be aware that not everyone can access the internet or read. Consideration should therefore be given as to how the views of those groups can be gained. Healthwatch and the council’s communications and engagement team will be best placed to advise and assist with this. Options could include views being sought through:

• meetings
• focus groups
• telephone calls
• making hard copies of the questionnaire available

Engagement with harder to reach groups will also need to be considered as part of this process, as some patient groups are less likely to engage with general practice but may seek healthcare advice from other sources such as pharmacies. This is especially true where language barriers exist, or for groups that are not permanently resident in the area (such as Traveller and Gypsy communities).

Online questionnaires should be promoted as widely as possible, and the steering group may wish to consider the use of posters with QR codes displayed in places such as:

• pharmacies
• GP practices
• health centres
• libraries

Consideration should also be given to providing flyers to be included in bags of dispensed medication by pharmacies and dispensing practices. Questionnaires can be included in the council’s consultations section on the website which will then ensure that those who have registered for consultation alerts are made aware of it. The steering group may also wish to consider a press release.

Suggested questions for the questionnaire could include:

• why do you usually visit a pharmacy?
• how often do you use a pharmacy?
• what time is most convenient for you to use a pharmacy?
• what day is the most convenient for you to use a pharmacy?
• do you use the same pharmacy or different pharmacies?
• what influences your choice of pharmacy?
• how do you travel to the pharmacy and how long does it usually take?

Providing multiple choice answers will speed up analysis but free text options will be required for some of the questions.

As with the contractor questionnaires it is recommended that only the information that is required for the PNA is asked for.

Contractors

Most of the information regarding the provision of pharmaceutical services can be sourced from the ICB or the NHSBSA website, but some will need to be sourced from the contractors themselves. It is recommended that the contractor questionnaire is kept as short as possible and to only seek information that is required for the PNA but cannot be sourced elsewhere.

Information required from contractors which can be sourced elsewhere includes:

• premises opening hours. This information can be sourced from the ICB, which will have records showing the core and supplementary opening hours for each pharmacy and dispensing appliance contractor (if any)
• services provided. Information on which advanced services are provided and the level of activity can be sourced from the NHSBSA website (see the Information to be contained in PNAs section). Information on whether advanced services or enhanced services are provided can be sourced from the ICB
• premises facilities. All pharmacies must have a confidential consultation room, except DSPs and those that the ICB or NHS England has deemed to be too small to have a consultation room. Information on DSPs can be sourced from the NHSBSA contractor details data set, and small pharmacies can be identified by the ICB

The information that HWBs are most likely to need to ask as part of the contractor questionnaire includes:

• whether prescriptions for appliances are dispensed at the premises, and whether all appliances are provided or just specific types
• whether the contractor has installed an automated collection point to enable patients to collect prescriptions when the pharmacy is closed, and the location of this collection point
• if the contractor provides a delivery service, and if so whether it is:
  • free of charge or chargeable
  • restricted to certain patient groups (noting that DSPs must deliver all dispensed NHS items without charge)
• what languages are spoken each day at the premises other than English
• recognising that the demand for services is increasing, whether there is capacity to manage that increase within their existing premises and staffing levels, and if not, whether adjustments could be made to manage an increase in demand

The same questions can be asked of any dispensing appliance contractors and dispensing doctors in the HWB’s area.

Information to be contained in PNAs

Legislation

Regulation 4 and schedule 1 of the 2013 regulations outline the minimum requirements for PNAs. In addition, regulation 9 sets out matters that the HWB is to have regard to.

In summary the 2013 regulations require a series of statements of:

• the pharmaceutical services that the HWB has identified as services that are necessary to meet the need for pharmaceutical services
• the pharmaceutical services that have been identified as services that are not provided but which the HWB is satisfied need to be provided in order to meet a current or future need for a range of pharmaceutical services or a specific pharmaceutical service
• the pharmaceutical services that the HWB has identified as not being necessary to meet the need for pharmaceutical services but have secured improvements or better access
• the pharmaceutical services that have been identified as services that would secure improvements or better access to a range of pharmaceutical services or a specific pharmaceutical service, either now or in the future
• other NHS services that affect the need for pharmaceutical services or a specific pharmaceutical service

Other information that is to be included or taken into account includes:

• how the HWB has determined the localities in its area
• how it has taken into account the different needs of the different localities, and the different needs of those who share a protected characteristic
• a report on the consultation
• a map that identifies the premises at which pharmaceutical services are provided
• information on the demography of the area
• whether there is sufficient choice with regard to obtaining pharmaceutical services
• any different needs of the different localities
• the provision of pharmaceutical services in neighbouring HWB areas

This section looks at these requirements in more detail.

Localities

The 2013 regulations require the HWB to divide its area up into localities. To do this, it is suggested that the steering group uses existing boundaries such as:

• borough or district council boundaries
• super output areas
• electoral wards
• those used in the JSNA

In deciding how to divide up the area, it may help to consider on what geographical basis the required information can be sourced.

HWBs should be mindful that the localities should not be so large that they mask variations in need, but not too small that the document becomes too unwieldy. Note that the 2013 regulations also require the PNA to have regard to the different needs of the different localities. Once the basis for the localities has been decided the justification for this must be included in the PNA.

Demographic and health needs data

The 2013 regulations require the HWB to have regard to the demography of its area. It is therefore recommended that the PNA contains a chapter on the demographics of the population, and a second chapter on their general health needs.

Much of the required demographic data will already be available and contained within the JSNA. HWBs will wish to note that once their PNA is published, any cross-reference in that PNA to other published documents such as a specific version of the JSNA will be fixed at that point. In other words, relevant subsequent revisions to a JSNA following publication of the PNA may not be adequately reflected in the PNA unless the PNA itself is subsequently revised. It is therefore recommended that information from other documents is copied into the PNA rather than create a link between the PNA and other documents.

Information on the current population and the changes expected within the 3-year lifetime of the document will need to be included. This might include:

• information on known housing developments (including the projected number of houses to be built within the 3-year period) and regeneration projects. These will be available from the planning department
• information on any highways developments that may affect, either positively or negatively, how people access services now and in the future. This can be provided by the local authority highways department or National Highways
• demographic data from DHSC’s Strategic Health Asset Planning and Evaluation (SHAPE) application

The JSNA and public health team will also be able to provide the required information on the health needs of the population. Other sources of such data include:

• DHSC’s public health profiles (‘Fingertips’)
• DHSC’s SHAPE application
• GP quality and outcomes framework data published by NHS Digital

HWBs may wish to then include a chapter which looks at how the health needs of the population can be met by the provision of pharmaceutical services. It should be borne in mind that when assessing the need for pharmaceutical services, it is not possible for such services to meet all of the health needs of the population. By including a chapter which identifies those that can be met will help focus attention when it comes to the identification of any gaps in service provision.

Once the overall health needs of the population have been identified, along with those that can be met by the provision of pharmaceutical services, the PNA will then need to identify the different needs of those who share a protected characteristic as defined in the Equality Act 2010. It is recommended that the PNA also identifies other patient groups that may exist within the area. This may include:

• higher and further education students (including how the relevant term times can impact on service needs)
• ex-offenders
• homeless and rough sleepers
• refugees and asylum seekers
• military veterans
• business or tourism visitors to the area

This requirement of the 2013 regulations can be met by including a chapter which identifies the different patient groups within the HWB’s area and what their specific needs are for pharmaceutical services.

Information on the number of visitors to the area may be available on the Visit Britain website.

Provision of pharmaceutical services

ICBs are required to prepare and maintain a list of:

• the pharmacies in an HWB’s area (the pharmaceutical list)
• the dispensing appliance contractors (if any, also referred to as the pharmaceutical list)
• the dispensing doctors (if any, referred to as the dispensing doctor list)
• those providing services under a local pharmaceutical services contract (if any, referred to as the local pharmaceutical services list)

HWBs will therefore need to ask their ICB or ICBs for a copy of the pharmaceutical list or lists and dispensing doctor list (if there is one) for their area. They may also wish to consult:

• the consolidated list of all pharmaceutical and local pharmaceutical services published by NHSBSA on behalf of NHS England
• the NHSBSA contractor details data set

These will assist in the identification of out of area providers.

The pharmaceutical lists contain the organisation data service code (also known as the F code) for each of the pharmacies and dispensing appliance contractor premises. These codes will be required to assist in analysing service provision.

Information on the number of items dispensed by each pharmacy and dispensing appliance contractor, along with activity for the advanced services, is available from NHSBSA’s dispensing contractors’ data reports. Each month a report is published which contains information on the provision of some of the essential services and all of the advanced services. From August 2024 the information identifies the HWB in whose area the premises are located making it easier to identify the required contractor premises, particularly where a change of ownership has changed the organisation data service code for the premises.

The information is provided on a national basis so the organisation data service codes will be needed to extract the relevant information. When a pharmacy changes ownership, the organisation data service code may change. HWBs will therefore need to identify which pharmacies have changed ownership during the year and capture the activity under both organisation data service codes.

HWBs will need to ask the ICBs for information on which pharmacies have signed up to provide the newer advanced services in order to be able to identify any geographical gaps, as well as looking for any gaps in provision of these services.

Information on the number of dispensing patients registered with dispensing GP practices is also available through NHSBSA’s Catalyst portal in the ‘practice list size and GP count’ report.

As well as identifying the provision of pharmaceutical services by contractors within the HWB’s area the PNA will also need to identify provision by contractors who are outside of the area. In order to do this the organisation data codes for all the services that generate prescriptions will be required. These can be either be provided by the ICBs or sourced from NHSBSA’s practice list size and GP count report.

Services that generate prescriptions include the GP practices but may also include:

• GP out of hours providers
• GP extended access hubs
• prisons (although many prescriptions for people in prison are dispensed under separate contracts and so do not fall within the definition of pharmaceutical services)
• urgent care centres and walk-in centres
• substance misuse services
• drug and alcohol services
• community nursing teams

Once the list of services and codes has been collated it will then be possible to identify where all the prescriptions written are dispensed using the monthly practice prescribing dispensing data reports published by NHSBSA. It should be noted that these reports are very large as they contain information on where all the prescriptions written in England are dispensed. However, once the information relevant to the HWB’s area is extracted it will be easier to manipulate.

The data can be analysed by:

• prescribing service, to identify the total number of items prescribed in a fixed period by each practice and service
• dispenser, to allow the identification of out of area providers of the dispensing service

Once the out of area providers have been identified they can be classified as either a pharmacy or dispensing appliance contractor by using the consolidated pharmaceutical list and/or NHSBSA’s contractor details data set. They can also be identified by DSPs using the contractor details data set if required.

The most common reasons for prescriptions being dispensed out of area are that:

• they are dispensed by a contractor that is just over the border in a neighbouring HWB’s area
• the prescription was for an appliance and was dispensed by a dispensing appliance contractor
• the patient chose to use a DSP

While several hundred different out of area pharmacies may have dispensed prescriptions the majority are dispensed by a much smaller number of pharmacies or dispensing appliance contractors.

Information on the provision of other pharmaceutical services by out of area providers is not available. However, it can be assumed that as some people will have their prescription dispensed out of area, they will also access other services out of area. It is not necessary to identify where all services are provided; it can merely be noted that people may have accessed other essential services, and also advanced and enhanced services, from an out of area provider.

HWBs will need to decide on the cut-off point for data collection. It will take a number of months between starting the process and getting to the point of signing off the consultation version of the document and during that time it is possible that things will change, such as:

• pharmacies opening, closing or relocating
• new services being commissioned
• services ceasing to be commissioned

It is recommended that a cut-off point is set once all the required data has been collated. This should be clearly stated throughout the document, as in the following examples:

• in November 2024 there were 150 pharmacies included in the pharmaceutical list for the area of Anytown HWB
• in the first 4 months of the financial year 2024 to 2025, 140 of the 150 pharmacies had provided a total of 3,750 new medicine service reviews
• at the time of drafting (November 2024), 50 of the 150 pharmacies had signed up to provide the new hypertension case-finding service advanced service. It is anticipated that more will sign up to provide the service over the coming months and this will be reviewed after the consultation

Any changes that subsequently occur can then be noted and included in the post-consultation version of the document. HWBs will, however, need to note that if any of the changes to service provision or availability are such that they create a gap and this leads to the identification of a new need, improvements or better access, a second period of consultation will need to be undertaken, although it does not need to be for 60 days.

Necessary services

Once the provision of all pharmaceutical services has been identified, the necessary services should be identified. These are defined within the 2013 regulations as those that are necessary to meet the need for pharmaceutical services and could be provided within or outside of the HWB’s area.

The 2013 regulations do not include a definition of what is a necessary service and what is not, so HWBs may choose to define which services are necessary services by:

• the type of service, for example all essential services and certain advanced and enhanced services
• by pharmacy, location, or time and day of the week that services are provided. This may be harder where, for example, there are 4 pharmacies in a town all providing the same range of services at approximately the same times of the day and days of the week. The HWB may have difficulty in deciding which are necessary and which are other relevant services (see below)

Once it has determined which services are necessary services the HWB will need to include a statement to this effect within the PNA. It then needs to go on to describe the current provision of these services, for example where they are provided and the times they are provided at.

Other relevant services

The remaining pharmaceutical services are deemed to be other relevant services and a statement to this effect is to be included in the PNA. It then needs to go on to describe the current provision of these services, for example where they are provided and the times they are provided at.

Other NHS services

The 2013 regulations then require the PNA to include a statement of the other NHS services that the HWB considers affect the need for pharmaceutical services. It is recommended that these are included as a separate chapter.

Those NHS services that may reduce the need for pharmaceutical services, in particular the dispensing service, include:

• hospital pharmacies
• personal administration of items by GP practices
• GP out of hours service (as it may give patients a course of treatment rather than a prescription)
• public health services commissioned by the local authority (as this reduces the need for such services to be commissioned as enhanced services)
• prison pharmacy services (if applicable)
• flu vaccination by GP practices

NHS services that may increase the demand for pharmaceutical services include:

• GP out of hours services (where a prescription is issued)
• walk-in centres and minor injury units (where a prescription is issued)
• GP extended access hubs
• community nursing prescribing
• dental services
• drug and alcohol services
• services that have been moved into the primary care setting

The number of items prescribed by the above services can be identified as described under Provision of pharmaceutical services, although this will not be exhaustive as some providers will not have an organisation data code. For example:

• the level of dental prescribing is not available at HWB level, although NHSBSA can provide information on the number of items prescribed by dental practices which are dispensed by pharmacies in an HWB’s area
• the provision of pharmacy services to any prison in the HWB’s area is unlikely to be part of pharmaceutical services, and the number of items may not be available

Maps

The PNA must include a map that identifies the premises at which pharmaceutical services are provided within the area of the HWB. This can be produced using DHSC’s SHAPE application (which has the premises pre-loaded) or other mapping software applications. This map must be kept up to date (without needing to republish the whole document or publish a supplementary statement).

It is likely that, due to the size of the HWB’s area, the markers for some of the premises overlap and the map may therefore be of limited value. It is recommended that locality level maps are also included as they may be clearer.

There is no cap on the number of maps that may be included. HWBs may therefore wish to consider mapping the location of premises:

• against indicators such as population density and deprivation
• providing each of the advanced and any enhanced services

Mapping travel times to premises by private and public transport and on foot can help in the identification of any geographical gaps in provision and these maps can be produced using DHSC’s SHAPE application.

Choice with regard to obtaining pharmaceutical services

The 2013 regulations require the HWB to have regard to whether there is sufficient choice in obtaining pharmaceutical services.

Earlier in this section a suggested process for identifying where prescriptions are dispensed was described. This will allow the HWB to identify the number of different pharmacies and dispensing appliance contractors that residents chose to use on either a regular or infrequent basis.

It should also be borne in mind that in May 2025 each resident had the choice of using any of the 416 DSPs in England, all of which are required to provide all of the essential services remotely to anyone anywhere in England who may request them. However, these pharmacies may only be suitable for repeat prescriptions and not for medicines needed on the day. It should not be assumed that if there are no accessible brick and mortar pharmacies to collect prescribed medicines from, patients have a choice of a pharmacy just because they can choose to use a DSP.

Other pharmacies provide delivery services. While these are not a pharmaceutical service, where provided they can improve the provision of, or access to, services, particularly dispensing services, in the areas that the pharmacy delivers to. The HWB however should note that this is a private service. It can therefore be withdrawn at any time and not all patients may be able to afford it. It will therefore need to decide how much weight to place on such services.

In addition, since 2021 all pharmacies are required to facilitate, to a reasonable extent, remote access to the pharmaceutical services they provide. It is likely that this will be an attractive option for certain residents, but not all as there will be those who do not have access to the internet or who prefer to access services on a face-to-face basis.

Possible factors to be considered in terms of the benefits of sufficient choice include:

• the current level of access within the HWB’s area to pharmaceutical services
• the extent to which services already offer people a choice, which may be improved by the provision of additional facilities
• the extent to which current service provision is adequately responding to the changing needs of the community it serves
• whether there is a need for specialist or other services, which would improve the provision of, or access to, services such as for specific populations or vulnerable groups

Taking into account the above, and by asking residents what influences their choice of pharmacy as part of the patient and public engagement questionnaire, will allow the HWB to establish whether it considers that residents have sufficient choice with regard to obtaining pharmaceutical services.

Identifying gaps and articulating needs, improvements and better access

Background

In order to provide pharmaceutical services in England a person and the premises from which they will provide services must be included in the relevant pharmaceutical list. Applications for inclusion in one of these lists are submitted to Primary Care Support England and determined by the relevant ICB.

The main purpose of the PNA is to inform the submission of applications for inclusion in a pharmaceutical list, and the subsequent determination of such applications.

There are a number of different types of application which can be submitted where someone wishes to open new pharmacy or dispensing appliance contractor premises. These include:

• to meet a current need identified in the relevant PNA
• to meet a future need identified in the relevant PNA
• to secure improvements or better access identified in the relevant PNA
• to secure future improvements or better access identified in the relevant PNA
• to secure improvements or better access that were not identified in the relevant PNA
• to open DSPs

The 2013 regulations require PNAs to include statements of the pharmaceutical services that the HWB has identified that are not provided within its area but which the board is satisfied:

• need to be provided in order to meet a current need
• will need to be provided in specified circumstances in order to meet a future need
• would, if they were provided, secure improvements or better access
• would, if they were provided in specified future circumstances, secure future improvements or better access

The needs, improvements or better access could be for a particular service or for a range of services. It is to be noted that a pharmacy is not a service, and neither are opening hours.

Where the HWB does not identify any needs for, or improvements or better access to, pharmaceutical services within the PNA, the only types of application for new premises that could be submitted are those offering unforeseen benefits.

Identifying gaps in current provision

Paragraphs 2(a) and 4(a) of Schedule 1 to the 2013 regulations require a statement setting out the pharmaceutical services not provided in an HWB’s area but which need to be provided in order to meet a current need, or would secure improvements or better access to pharmaceutical services.

At this stage, an HWB will need to identify whether or not there are any gaps in the current provision of pharmaceutical services. Such gaps could be for:

• a pharmacy providing a specified range of services
• a specific service
• a service, or services, to be provided at specified times or on specified days of the week

The 2013 regulations do not specify how the HWB should identify gaps. It is suggested that there are 3 levels where gaps may exist:

• geographical gaps in the location of premises. This might involve checking whether premises are in the right locations, or whether there are any current gaps in the spread of premises
• geographical gaps in the provision of one or more services
• gaps in the times at which, or days on which, services are provided

Once any gaps are identified they are to be articulated as needs for, or improvements or better access to, pharmaceutical services.

Care needs to be taken when articulating needs, improvements or better access as vague or incomplete statements could lead to applications either being:

• granted inappropriately because:
  • the applicant is not offering the service that was required
  • the location of their premises is in the wrong place
  • their opening times are the same as, or similar to, the other pharmacies and they are offering no additional benefit
• refused inappropriately because either the ICB or NHS Resolution was unclear as to what the need, improvement or better access is and therefore whether the applicant is offering to meet or secure it

Current geographical gaps in the location of premises

In order to identify gaps in the location of premises it is recommended that a travel time standard is chosen and then access mapped against it. Information gained from the public engagement questionnaire will help inform the travel time standard used, along with information on how the public travels to pharmacies.

Using mapping software or DHSC’s SHAPE application will allow the HWB to map travel times to the current premises within its area by public and private transport, or on foot. Some mapping software will confirm the number of people who do not live within the travel time, but not all will. Where it does not, the use of freely available mapping applications will allow analysis of whether or not there is a resident population in the area or areas.

Having mapped access to the premises within the HWB’s area, those areas that are outside of the travel time need to be identified. These are likely to be on the edge of the board’s area so it will be necessary to add on those pharmacies in the neighbouring area in order to avoid identifying gaps that do not actually exist.

For example, SHAPE shows that all but a small part of Hertfordshire is within 20 minutes of a pharmacy within the county by car (circled in red in the map below).

In the following maps the darker the colour the shorter the journey, with the darkest green representing journey times of up to 5 minutes.

Google Maps reveals that the area is mostly open countryside with only a few scattered homes.

Figure 1: map 1 - 20-minute travel time to Hertfordshire pharmacies

© Crown copyright and database rights 2024 Ordnance Survey 100016969; parallel; Mapbox; OpenStreetMap contributors

Map 1 shows that people living in most parts of Hertfordshire can reach a pharmacy located in the same county within a 20 minute drive.

Analysis of where prescriptions are dispensed (as described in the Information to be contained in PNAs section) will help map out of area providers and therefore whether it is appropriate to include pharmacies in neighbouring areas in the mapping of travel times. SHAPE can also be used to plot the GP practices and map where their prescriptions were dispensed in the most recently available month (usually 3 months in arrears).

For example, the data shows that prescriptions are dispensed in Buckinghamshire. When access to pharmacies in Buckinghamshire is mapped, the area shown on map 1 in the red circle is now within a 10-minute drive of a pharmacy.

Figure 2: map 2 - travel time to pharmacies within and outside of Hertfordshire

© Crown copyright and database rights 2024 Ordnance Survey 100016969; parallel; Mapbox; OpenStreetMap contributors

Map 2 shows that people living in most parts of Hertfordshire and neighbouring areas can reach a pharmacy within a 20 minute drive.

In addition, GP practices may have branch surgeries that are outside of the HWB’s area and this will need to be taken into account as it will affect where people access pharmaceutical services.

For example, one of the GP practices in Tring has a branch surgery in a village in Buckinghamshire. When analysing where that practice’s prescriptions are dispensed SHAPE shows that a proportion are dispensed by the pharmacy in that village as can be seen from the map below.

Figure 3: map 3 - mapping where practice prescriptions are dispensed

© Crown copyright and database rights 2024 Ordnance Survey 100016969; parallel; Mapbox; OpenStreetMap contributors

Map 3 shows that the majority of prescriptions prescribed by a GP practice located in Tring, Hertfordshire are dispensed at a pharmacy in Buckinghamshire.

Use of this data will provide evidence of where prescriptions are dispensed and help to validate the travel time standard chosen.

If a 15-minute drive time was chosen for Hertfordshire then other parts of the county would also fall outside of that standard, in particular to the north and north-east of Saffron Walden as shown in the map below.

Figure 4: map 4 - 15-minute travel time to Hertfordshire pharmacies

© Crown copyright and database rights 2024 Ordnance Survey 100016969; parallel; Mapbox; OpenStreetMap contributors

Map 4 shows that people living in certain areas of Hertfordshire, particularly to the north and north-east of Saffron Walden, are further than 15 minutes’ drive from a pharmacy located in Hertfordshire.

However, when the pharmacies over the border in Cambridgeshire, Suffolk and Essex are taken into account, the areas are within a 15-minute drive of a pharmacy.

Figure 5: map 5 - travel time to pharmacies within and outside of Hertfordshire

© Crown copyright and database rights 2024 Ordnance Survey 100016969; parallel; Mapbox; OpenStreetMap contributors

Depending on the geography of the HWB’s area it may be necessary to have 2 travel standards - one for rural areas and one for built-up areas. In rural areas the provision of a dispensing service by GP practices will need to be taken into account so that gaps are not inappropriately identified.

Current geographical gaps in the provision of services

Provision of each of the advanced services and any enhanced services that are commissioned will then need to be mapped in order to establish any geographical gaps in provision. However, if all pharmacies provide a particular service this will not be necessary.

Current gaps in the times at which, or days on which, services are provided

Consideration will then need to be given as to whether there are any gaps in the times at which services are provided. This could be for a specific service, such as the need for the provision of Pharmacy First or a range of services at the weekend, or if a patient is able to access a pharmacy following a GP appointment in the evening. If available, usage data for Pharmacy First and the GP out of hours providers will assist in quantifying demand for services outside of normal opening hours Monday to Friday and at weekends.

HWBs will need to decide how much weight is to be given to the provision of pharmaceutical services during supplementary opening hours, bearing in mind that these hours can be reduced with at least 5 weeks’ notice.

Access to services at certain times or on certain days may have been highlighted as part of the public engagement questionnaire and this should be taken into account in this consideration.

Articulating current needs

It is not sufficient simply to say that there is a gap. The PNA must state:

• what is required to meet the need, considering whether this is one service or a range of services
• when the service is required, at what times and/or on what days
• where the service is required, at a specific location or in a general area

Health and wellbeing boards need to be as precise as possible in articulating any current need, clearly setting out what service is provided, at what times it needs to be provided, and where. Words such as ‘may’, ‘might’ or ‘could’ must be avoided in order to avoid any indication that the HWB is unsure what is required and also to ensure that only applications that will meet the identified need are granted.

Including a statement such as “There might be a need for services in the area” is too vague and does not meet the requirements of the 2013 regulations.

A statement that better meets the requirements of the 2013 regulations would be as follows:

“Taking into account the above information, the HWB is satisfied that there is a current need for the provision of the Pharmacy First service on Saturdays and Sundays between the hours of 9am and 7pm, in Anytown, to the north of the river.”

This statement clearly sets out:

• what service is required
• when the service is to be provided
• where the service is to be provided

If the HWB is of the opinion that a new pharmacy is required, the PNA should state that. However, it should be noted that a pharmacy of itself is not a pharmaceutical service, therefore the need would be expressed as follows.

There is a current need for a pharmacy providing the following services, Monday to Saturday:

• all essential services
• the Pharmacy First service
• the new medicine service
• flu vaccinations

The pharmacy is to be located in the district centre of the housing development that is currently being built on the site of the former steelworks.

Should an application then be submitted offering to meet that need, the ICB can clearly assess the application against the identified need and determine whether or not to grant it. In addition, the ICB can hold the applicant to providing the advanced services (the provision of the essential services is a given for all pharmacies included in a pharmaceutical list).

The HWB could go on and specify the required opening hours, for example 9am to 7pm Monday to Friday and 9am to 6pm on Saturday. While this would total more than 40 core opening hours per week an applicant could apply and offer these core opening hours. The ICB could then grant the application partly on the basis of these core opening hours and hold the applicant to them once the pharmacy opens.

Articulating current improvements or better access

While current needs may be identified in relation to the lack of provision of a particular service or services, the HWB may also identify improvements or better access to the existing provision of services. This is most likely to be in relation to the times at which the existing services are provided, although it could be in relation to reducing the travelling time or distance to access a service.

HWBs should note that opening hours of themselves are not pharmaceutical services. Therefore, they should avoid identifying a need for, or improvement or better access to, opening hours. If there is a gap in the provision of services at certain times this would be articulated as an improvement or better access to specified services at specified times.

Instead of saying “Extended opening hours on weekday evenings would lead to better access to services”, it should be articulated as:

Better access to the following services would be secured by their provision on weekday evenings between 5pm and 7.30pm:

• all essential services
• Pharmacy First
• the new medicine service

The PNA would then go on to confirm where the better access is required, for example in X ward, or in A, B and C wards.

Identifying gaps in future provision

Paragraphs 2(b) and 4(b) of Schedule 1 to the 2013 regulations require a statement setting out the pharmaceutical services not provided in an HWB’s area but which need to be provided in specified future circumstances in order to meet a future need or would secure improvements or better access to pharmaceutical services.

This means that the PNA must also set out any needs for pharmaceutical services that may arise during the 3-year lifetime of the document. Matters to consider here include:

• housing developments
• regeneration projects
• highways projects that will affect how services are accessed
• the creation of new retail and leisure facilities that will draw people to an area
• changes in the provision of primary medical services, for example:
  • the relocation of GP practices
  • mergers of GP practices
  • known closures of GP practices
• other changes to the demand for services, such as:
  • increases in the range of services within primary care that increase the number of prescriptions that need to be dispensed
  • care or nursing home developments

The HWB would then go through the same process as it did to identify any gaps in the current provision of pharmaceutical services.

The services that pharmacies provide are subject to national negotiation, and it is therefore possible that during the lifetime of the PNA new essential or advanced services will be rolled out. It is not possible for the HWB to foresee what new advanced services may be launched (any new essential services would have to be provided by all pharmacies), so this would be something to consider as part of the ongoing duties with regard to producing new PNAs and/or publishing supplementary statements (see the Updating of PNAs and supplementary statements section).

Articulating future needs, improvements, or better access

In relation to future needs, improvements or better access, the HWB must ensure it describes the future circumstances in which those needs, improvements or better access will arise. This means that the PNA must include a clearly identifiable trigger point at which the need will arise.

Information that will be useful to inform the discussion on future needs, improvements or better access includes knowledge of the existing contractors’ capacity (gathered as part of the contractor questionnaires) as it is not possible to assume a pharmacy that dispenses the highest number of items per month is at capacity and the pharmacy that dispenses the lowest has spare capacity. Contractors will have different operating and staffing models and may use a dispensing hub elsewhere in the country, and these will affect their ability to meet an increase in demand for their services.

In relation to new housing developments the HWB will need to consider not just the contractors’ capacity but also the ability of residents to access the nearest pharmacies. Information on those that will be among the first to move in is unlikely to be available, but the following information will assist:

• the type of housing that will be built during the 3-year period
• the estimated occupancy rate (this may vary depending on the type of housing being built)
• access to public transport
• footpaths and cycle paths into and out of the area
• the distance to the nearest pharmacies and/or dispensing doctors
• what other facilities currently exist or will be built during the 3-year period, for example:
  • GP practices
  • schools
  • retail and leisure facilities
  • employment

The PNA will need to identify the demand for pharmaceutical services that will be generated, the ability for the existing contractors to meet that demand, and the ability for residents to access the existing contractors. It should be borne in mind that the residents will have access to all the DSPs in England who are required to provide all the essential services, and pharmacies will increasingly be offering remote access to services where this is appropriate. In addition some of the existing contractors will offer private delivery services.

If a pharmacy providing a specified range of services is identified as needed within a housing development, then consideration will need to be given as to the trigger for that need. This may be the point at which:

• a certain number of houses are completed
• a certain number of houses are occupied
• a certain phase of the development is completed
• the whole development is completed
• some or all of the other facilities are completed

Whatever the trigger is, it needs to be clearly articulated in the PNA and should be based on information that is measurable so that an accurate assessment can be made. For example:

“There is a future need for a pharmacy within the village centre of the development on occupation of 1,000 houses, that is open Monday to Friday between 9am and 7pm, and on Saturdays 9am to 5.30pm, providing the following services:

• all essential services
• the following advanced services:
  • Pharmacy First
  • flu vaccination
  • hypertension case-finding service”

If an application is then submitted to meet this future need the ICB could either:

• defer determination of it until 1,000 houses are occupied
• determine and grant the application subject to the condition that services are not provided until 1,000 houses are occupied

The same applies to applications to secure future improvements or better access.

HWBs should also identify areas that are dependent on one pharmacy and assess the risks to the provision of pharmaceutical services should that pharmacy close, and the subsequent impact on patients. The number of pharmacies nationally has declined over the last couple of years and HWBs should therefore give consideration as to whether they need to future-proof their PNA to ensure that if the sole pharmacy in an area close with the subsequent loss of pharmaceutical services, the PNA responds accordingly.

For example, a village is served by one pharmacy, with the next nearest pharmacies approximately 15 miles away. Current residents living in the village are able to access a pharmacy within 10 minutes on foot, but if that pharmacy closes, they would then face a 20-minute car drive to the nearest pharmacy. While the HWB may have determined that a 20-minute drive is appropriate it needs to give consideration to the fact that this population is accustomed to accessing services without a journey by car. The HWB may decide that it would not be appropriate to expect this population to have to travel for 20 minutes to access services if this pharmacy closes when it is accustomed to being able to walk to a pharmacy within 10 minutes.

The HWB could therefore include a future need for specified services in its PNA. However, care needs to be taken to ensure that the circumstances in which the future need will arise are clearly articulated in order to reduce the risk of future need applications being submitted in circumstances not intended by the HWB.

For example, the PNA says:

“The health and wellbeing board has identified that there is a future need for the provision of the following services in Anyvillage:

• all essential services
• the following advanced services:
  • Pharmacy First
  • pharmacy contraception service
  • hypertension case-finding service
  • the new medicine service

Provision of these services would be required Monday to Friday between 9am and 6pm, and Saturdays between 9am and 1pm, from premises in Anyvillage.”

There is no trigger for when that future need will arise. There is therefore a risk that an applicant will submit an application offering to meet that future need in full and it would have to be granted by the ICB despite the lack of evidence that there is a need for 2 pharmacies in the village.

The above statement also does not comply with the requirements of the regulations as these require the PNA to specify the future circumstances in which the need will arise.

The future need should therefore be identified as follows.

“The health and wellbeing board has identified that should there be a total and permanent loss of pharmaceutical services being provided from pharmacy premises in Anyvillage, there will be a future need for the provision of the following services:

• all essential services
• the following advanced services:
  • Pharmacy First
  • pharmacy contraception service
  • hypertension case-finding service
  • the new medicine service

Provision of these services would be required Monday to Friday between 9am and 6pm, and Saturdays between 9am and 1pm, from pharmacy premises in Anyvillage.”

If the pharmacy did close then any potential applicant is aware of what they need to offer in order to maximise the likelihood of their application being granted, and the integrated care board is able to properly determine the application. If the pharmacy does not close within the lifetime of the pharmaceutical needs assessment, then the future need would not arise.

HWBs also need to consider the impact of any loss of opening hours and whether this would require the PNA to identify future improvements or better access to one or more services if there is a loss of opening hours on weekday evenings, or at the weekend. A similar approach to that described above can be followed to future-proof the PNA in the event of a loss of opening hours.

This will be particularly important in relation to the 100 hour pharmacies, or those 100 hour pharmacies that have reduced their core opening hours to no fewer than 72. These pharmacies are usually open into the evening and at the weekends, and therefore have an important role to play in ensuring people are able to access services outside of the more usual 9am to 6pm Monday to Friday opening hours.

If a town has a pharmacy with core opening hours into the evening and at weekends then the HWB will need to consider future-proofing the PNA so that if that pharmacy closes, the document responds.

For example, there is one 100 hour pharmacy in a town which is open until 11pm Monday to Friday, 10pm on Saturday and 10am to 4pm on Sunday; no other pharmacies are open beyond 6pm and none have core opening hours on Saturday afternoons or on Sunday. The primary care network covering the town ensures the provision of extended access to primary medical services between 6.30pm and 8pm Monday to Friday, and 9am and 5pm on Saturday. There is an urgent treatment centre in the town as well as an A&E department at the hospital and the GP out of hours is based on the hospital site.

The contractor gives notice to withdraw the pharmacy from the relevant pharmaceutical list, but the PNA did not plan for this eventuality and the HWB concluded that no future gaps in the provision of pharmaceutical services would arise. While the HWB could issue a supplementary statement as this is a change to the availability of pharmaceutical services that would be relevant to the granting of unforeseen benefits, it cannot set out in that statement what is now required.  

As a result, residents of the town are no longer able to access pharmaceutical services after 6pm on weekdays even though there are extended access appointments until 8pm. Residents would now have to travel 20 miles to the next nearest town to access a pharmacy or go to the urgent treatment centre or A&E. Anyone requiring a prescription to be dispensed would face a 40-mile round trip or have to wait until the following day to start treatment.

While there may be no indication that the 100 hour pharmacy would close during the lifetime of the PNA, it would be prudent to futureproof it in case of such an eventuality. For example:

“The HWB has identified that if the 100 hour pharmacy at [address] is withdrawn from the pharmaceutical list, there will be a future need for the provision of the following services:

• all essential services
• the following advanced services:
  • Pharmacy First
  • pharmacy contraception service
  • hypertension case-finding service
  • the new medicine service

Provision of these services would be required [insert required core opening hours], from premises in [location].”

With regard to the required core opening hours, these could be the 100 hour pharmacy’s current core opening hours or could be different ones that would meet the needs of the residents. For example, there may be evidence to suggest that there is little demand for pharmaceutical services after 10pm and therefore the Monday to Saturday core opening hours could be 7am to 10pm, and 9am to 5pm on Sundays.

With regard to the location, it would not be appropriate to specify the current address of the pharmacy, but the PNA could identify the ward or wards in which the new pharmacy would need to be located.

Consultation

Regulatory requirements

Regulation 8 requires the HWB to consult a specified range of organisations on a draft of the PNA at least once during the process of drafting the document. They must be given a minimum period of 60 days to submit their response, beginning on the day by which they are ‘served with a draft’ of the document.

Within the 2013 regulations, a consultee is treated as served with a draft of the document when the HWB notifies them of the website on which the document is available and will continue to be available for a period of at least 60 days.

HWBs should note that it is sufficient to send consultees the weblink to the document. However, if one of the consultees requests a hard copy of the document this must be provided as soon as practicable, and in any event within 14 days, free of charge.

Consultees

The following organisations must be consulted:

• the local pharmaceutical committee
• the local medical committee
• pharmacy and dispensing appliance contractors included in the pharmaceutical list for the area of the HWB
• dispensing doctors included in the dispensing doctor list for the area of the HWB, if any
• any pharmacy contractor that holds a local pharmaceutical services contract with premises that are in the HWB’s area
• Healthwatch, and any other patient, consumer, or community group in the area which the HWB believes has an interest in the provision of pharmaceutical services
• any NHS trust or NHS foundation trust in the HWB’s area
• NHS England
• any neighbouring HWB

The HWB is free to consult with any other organisation and/or members of the public if it so wishes but is not obliged to do so. This would include the ICB or ICBs who, as the delegated commissioner of primary care services, is better placed to provide views on the requirements for pharmaceutical services than NHS England.

While there is no requirement to consult with the public on a draft of the PNA, if it is standard practice for the council to consult with the public on technical documents the HWB may wish to open the consultation to the public.

Suggested questions

The 2013 regulations do not specify what is asked as part of the consultation. It is suggested that views are sought on the following questions:

• has the purpose of the PNA been explained?
• does the PNA reflect the current provision of pharmaceutical services within your area?
• are there any gaps in service provision, for example when, where and which services are available that have not been identified in the PNA?
• does the draft PNA reflect the needs of your area’s population?
• has the PNA provided information to inform market entry decisions, such as decisions on applications for new pharmacies and dispensing appliance contractor premises?
• has the PNA provided information to inform how pharmaceutical services may be commissioned in the future?
• has the PNA provided enough information to inform future pharmaceutical services provision and plans for pharmacies and dispensing appliance contractors?
• are there any pharmaceutical services that could be provided in the community pharmacy setting in the future that have not been highlighted?
• do you agree with the conclusions of the PNA?
• do you have any other comments?

Consultation report

The 2013 regulations require a report of the consultation to be included in the final version of the PNA. This should include the responses to the consultation, the response to them by the HWB, and a list of any amendments or changes subsequently made to the PNA.

It should be noted that if, as a result of the consultation, the HWB identifies new needs for, or improvements or better access to, pharmaceutical services, then there will need to be a second period of consultation, although this does not have to be for 60 days. HWBs should therefore bear this in mind when agreeing the project timeline.

Updating of PNAs and supplementary statements

Legislation

The previous deadline for HWBs to publish their PNAs was 1 October 2022. Following this, HWBs are required to publish their next PNA within 3 years of the date on which the 2022 version was published.

However, there may be occasions where an HWB will need to publish its next PNA sooner. In addition, the HWB may need to publish a supplementary statement or statements. Once the document is published, the HWB will therefore need to establish a process to meet the regulatory requirements regarding publishing new versions and/or supplementary statements. A decision-making flowchart is included at appendix 2 to assist HWBs with these requirements.

Subsequent PNAs

Once a PNA is published, the 2013 regulations require the HWB to produce a new one if it identifies changes to the need for pharmaceutical services, which are of a significant extent. This could be due to changes to:

• the number of people in the area who require pharmaceutical services
• the demography of the area
• risks to the health or wellbeing of people in the area (both residents and visitors)

The only exception to this requirement is where the HWB is satisfied that producing a new PNA would be a disproportionate response to the changes.

Example 1: is a new PNA required?

While drafting its next PNA, the HWB notes that the regeneration of a steelworks plant is due to start in 4 years’ time. As well as 15,000 houses there will also be a business park, retail area and extensive leisure and recreational facilities. It is anticipated that when finished the development will draw a considerable number of daily visitors.

While groundworks will start in year 3 of the PNA, building of the first phase of housing is not due to start until the following year. The HWB is of the opinion that a pharmacy providing a specified range of pharmaceutical services 7 days a week will be required in the future but decides not to include the project in the PNA as it will not generate any need for pharmaceutical services within the 3-year lifetime of the document.

Six months after the PNA is published, it is announced that the project is being bought forward in order to stimulate the local economy and the first phase of housing will commence within the next 6 months.

Due to the location of the development on the edge of a town from which it is separated by a busy motorway, there is no easy access to the nearest pharmacies.

The HWB is of the opinion that this represents a significant change to the need for pharmaceutical services and starts the process of producing its next PNA.

To avoid having to produce a new PNA within 3 years, the HWB could have identified the future need for a pharmacy within the development providing a specified range of pharmaceutical services 7 days a week and described the circumstances within which that future need would arise, for example on occupation of the 5,000th house. Although at the time of drafting the HWB was satisfied those circumstances were unlikely to arise, it has future-proofed the PNA just in case.

If the development progresses as expected the future need will not arise and therefore no future need applications can be submitted and granted. However, if, as the example demonstrates, the development was brought forward the PNA would respond accordingly if the future circumstances (the occupation of the 5,000th house) arose.

Amendments to a PNA

The HWB will therefore need to put a system in place that allows it to identify any changes to the need for pharmaceutical services that would, in specified future circumstances, arise during the 3-year lifetime of the PNA.

HWBs should note that unlike other needs assessments published by the council, it is not possible to update or amend the findings and conclusions in the PNA. An amendment to the 2013 Regulations to help make this clear is expected, subject to parliamentary approval, to come into force on 1 October 2025. The only part of a PNA that may be updated is the map showing the location of the providers of pharmaceutical services within the HWB’s area. Updating maps is different from the process of issuing supplementary statements, which is explained below.

If an HWB wishes to update or amend the PNA for any other reason, it must undertake a 60-day consultation on a draft of the document with the statutory consultees.

Supplementary statements

The HWB will also need to put in place a system which allows it to identify any changes to the availability of pharmaceutical services and then determine whether or not it needs to issue a supplementary statement. This responsibility could be delegated to a committee or sub-committee or could remain with the board.

Primary Care Support England is responsible for notifying a range of organisations when:

• a pharmacy or dispensing appliance contractor opens new premises or relocates to new premises
• a change of ownership application takes place
• a pharmacy or dispensing appliance contractor closes existing premises

ICBs are responsible for notifying a range of organisations when:

• core and/or supplementary opening hours change
• when a dispensing practice ceases to dispense either to a particular area or completely

HWBs should ensure that Primary Care Support England and the ICBs are aware of who to send these notifications to. Contact details for pharmacy contract teams can be found on NHS England’s website.  

There is currently no mechanism for HWBs to be automatically notified when a contractor signs up to provide an advanced or enhanced service or ceases to provide such a service. This will therefore need to be discussed with the ICB to agree a process.

A supplementary statement is to be published to explain changes to the availability of pharmaceutical services where:

• the changes are relevant to the granting of an application or applications for inclusion in the PNA list for the area of the HWB’s area
• the HWB is either:
  • satisfied that producing a new PNA would be a disproportionate response to those changes
  • already producing its next PNA but is satisfied that it needs to immediately modify the existing document in order to prevent significant detriment to the provision of pharmaceutical services

Supplementary statements are statements of fact regarding a change or changes to the availability of pharmaceutical services. They do not make any assessment of the impact the change may have on the need for pharmaceutical services. Instead, they identify new facts to be taken into account when assessing applications for new pharmacy premises or making decisions about new services, where not identifying those new facts would be of significant detriment to proper service provision.

Subject to parliamentary approval, it is anticipated that a change will be made to the 2013 Regulations on 1 October 2025 making it clear that, with one exception, a supplementary statement must not provide (and even if they do provide, they must not be read as providing) a new analysis of service provision. Instead, they identify new facts to be taken into account when assessing applications for new pharmacy premises or making decisions about new services, where not identifying those new facts would be of significant detriment to proper service provision They are not to be used for updating what the PNA says about the need for pharmaceutical services, but the facts they identify may have consequences, in particular for unforeseen benefits applications but also for other decisions (see below). It is a subtle distinction but an important one. A new analysis of needs, suggesting gaps in provision, requires local engagement; a new statement of facts does not.

The one exception to this principle is where there has been a successful consolidation application, the supplementary statement needs to state the opinion that the outcome of that application does not create a gap in pharmaceutical services provision (see below).

Once published the supplementary statement becomes part of the PNA and will therefore be referred to by the ICB when it determines applications for inclusion in the relevant pharmaceutical list. It will also be referred to by NHS Resolution when it determines an appeal. Supplementary statements therefore must be published alongside the PNA.

The issuing of a supplementary statement indicates to the ICB that the HWB is of the opinion that the change in availability of pharmaceutical services is relevant to the granting of applications for inclusion in a pharmaceutical list. As indicated above, this will predominantly affect unforeseen benefits applications, unless the analysis of service provision in the PNA already identifies a current or future need for, or improvements or better access to, pharmaceutical services in the area that the change in availability has occurred. However, it could also be relevant to the ICB’s consideration of whether it needs to direct a pharmacy to open at certain times or on certain days or invite a contractor to increase the total number of core opening hours of its pharmacy.

Examples of supplementary statements can be found in appendix 3.

Example 2: change of ownership to a pharmacy

The HWB is notified that there has been a change of ownership of a pharmacy. This is not a change to the availability of pharmaceutical services and therefore no supplementary statement is to be issued.

Example 3: relocation of a pharmacy

The HWB is notified that a pharmacy has relocated 3 doors down the road. This is a very minor change to the availability of pharmaceutical services and is not relevant to the granting of an application for inclusion in the pharmaceutical list. No supplementary statement is therefore to be issued. The HWB may need to update the map showing the premises at which pharmaceutical services are provided depending upon the scale of it. As the move is such a short distance it is likely that the marker representing the pharmacy is unlikely to move that far, or at all, on the map.

Example 4: change of supplementary opening hours to a pharmacy

One of 3 pharmacies that are on the same road within 600 metres of each other reduces its supplementary opening hours on a Saturday and now closes at 1pm instead of 5pm. The other 2 pharmacies open on Saturday afternoons, one until 9pm as it is a 100 hour pharmacy. While this is a change to the availability of pharmaceutical services, due to the close proximity of the 2 other pharmacies, one of which must stay open until 9pm, it is unlikely to be relevant to the granting of an application for inclusion in the pharmaceutical list and therefore a supplementary statement does not need to be issued.

Example 5: closure of a pharmacy

The only pharmacy in a deprived part of a town closes. The next nearest pharmacy is 2 miles away. This is a change to the availability of pharmaceutical services, so the HWB would need to consider whether the change would be relevant to the granting of an unforeseen benefits application for inclusion in the pharmaceutical list. The closure would only be relevant to the granting of an application offering to meet a current or future need, or secure improvements or better access, if the PNA has already identified such a need, improvement or better access. The supplementary statement should not provide a new analysis of service provision and cannot go on to identify a gap and what is required to fill it. This can only be done by drafting, consulting on, and publishing a new PNA.

One way of identifying whether the change is relevant is to consider if, when the PNA was written, the pharmacy had not been there whether it would have been identified as a gap in the provision of pharmaceutical services. In making this decision the HWB will need to take into account travel times to the nearest pharmacies, the availability of essential services through over 400 DSPs (as of March 2025), the availability of private and public transport, the fact it is likely to be too far to walk for many people, and the availability of other NHS services such as GPs.

If the HWB considers that if the pharmacy had not been open during the writing of the PNA there would have been a gap in the provision of pharmaceutical services then it would need to publish a supplementary statement, although its own analysis of services provision is not part of what it publishes. What it publishes is a record of changes to the availability of services. However, this would then indicate to the ICB that the closure is relevant to the granting of unforeseen benefits applications and should be considered alongside the matters that the ICB is required to have regard to in determining such applications.

Whatever the outcome of its deliberations as to whether or not a supplementary statement is to be issued, the HWB must update the map showing the premises at which pharmaceutical services are provided once the pharmacy has closed.

Example 6: opening of a new pharmacy

The PNA identifies the current need for a new pharmacy providing a specified range of services. An application is subsequently received and granted, and the pharmacy opens. This is a change to the availability of pharmaceutical services and is also relevant to the granting of further applications as the ICB would, if a second current need application was received, need to determine if a second pharmacy is required to meet the identified need. A supplementary statement would therefore need to be published so as to avoid the submission of unnecessary applications or indicate to the ICB that the HWB is of the opinion that the current need has been met by the opening of the new pharmacy. Following the opening of the pharmacy the HWB must update the map showing the premises at which pharmaceutical services are provided.

Example 7: unforeseen benefits application for a pharmacy is granted

An unforeseen benefits application for a pharmacy within a village is granted. This is a change to the availability of pharmaceutical services and is also relevant to the granting of further applications. A supplementary statement would therefore need to be published so as to avoid the submission of unnecessary applications or indicate to the ICB that the HWB is of the opinion that further provision of pharmaceutical services in the village by a second pharmacy is not required. However, it is an indication only. No new analysis of needs should be in the supplementary statement.

Changes not requiring a supplementary statement

Where the HWB identifies changes to the availability of pharmaceutical services that are not relevant to the granting of applications and therefore does not issue a supplementary statement, it will need to keep a record of these changes so that they can be incorporated into the next version of the PNA.

Supplementary statements and pharmacy consolidations

Since 5 December 2016 pharmacies have been able to apply to NHS England (now the ICB) to consolidate the provision of pharmaceutical services at 2 pharmacies onto one site if one set of premises closes. Such applications:

• cannot involve DSPs
• can only involve 2 pharmacies that are in the area of the same HWBs
• may be submitted where the applicant owns both pharmacies
• may be submitted where the applicant owns one of the pharmacies and another contractor owns the other pharmacy

An ICB is directed to refuse a consolidation application if it is satisfied that to grant it would create a gap in pharmaceutical services provision that could be met by an application offering to:

• meet a current or future need for pharmaceutical services
• secure improvements or better access to pharmaceutical services

HWBs will be notified of such applications and must make representations in writing within 30 days which indicate whether or not granting the application would create such a gap. HWBs must therefore put in place, if they have not already done so, a process by which a consideration can be made as to whether the closure of one of the pharmacies would result in such a gap.

If a consolidation application is granted the applicant will have 6 months within which to consolidate the pharmacies (potentially extended to an overall total of 9 months). When the pharmacy that is to close does so the HWB will be notified of this by Primary Care Support England. At that point the HWB is to issue a supplementary statement where it is of the opinion that the closing of that pharmacy does not create a gap that could be met by an application offering to meet a need for, or secure improvements or better access to, pharmaceutical services.

Such a supplementary statement remains in place and provides regulatory protection for the continuing pharmacy against an application offering to meet a need for, or secure improvements or better access to, pharmaceutical services for the remaining lifetime of the PNA. Having granted a consolidation application the ICB must then refuse any unforeseen benefits applications by other pharmacy contractors seeking inclusion in the pharmaceutical list if the applicant is seeking to rely on the consolidation as evidence of a gap in provision. This would be the case at least until the next revision of the PNA.

When the PNA is to be revised, the HWB will need to consider again where there are any current geographical gaps in the location of premises (see the Identifying gaps and articulating needs, improvements and better access section). The HWB will be aware that the consolidation did not previously create a gap and a supplementary statement was published at the time to this effect. Unless there have been other changes in the locality, and these are sufficient to have created a need for the provision of a pharmaceutical service or services at certain times and/or on certain days, there will continue to be no gap. It is recommended that within the new PNA that it is noted that a pharmacy previously closed as a result of a consolidation but that did not create a gap and the HWB remains of that opinion. This will then ensure that the regulatory protection conferred by the consolidation will continue for the lifetime of the next PNA. HWBs should, however, note that unforeseen benefits applications could still be submitted where the basis is for a different reason to the fact there used to be a pharmacy, but it closed as a result of a consolidation application.

HWBs should note that if a consolidation application is refused the owner of the site that was to be closed can still give notice to the ICB that they intend to close the pharmacy. The HWB would then need to consider whether it will need to provide a supplementary statement following this closure. If the refusal was because the ICB was satisfied that to grant the consolidation would create a gap in pharmaceutical services provision, then a supplementary statement would be required following the closure of the premises. This would then potentially allow the granting of an unforeseen benefits application.

There may be instances where the HWB does not agree with the decision to grant a consolidation application (either by the ICB or on appeal by NHS Resolution). However, the regulations do not allow the HWB to issue a supplementary statement which states that the closure has created a gap in the provision of pharmaceutical services. That would be to express an opinion of a type which it is expected, subject to parliamentary approval, that the 2013 Regulations will make clear from 1 October 2025 should not be in a supplementary statement. The HWB would nevertheless need to respond to the closure as to any other change to the availability of pharmaceutical services and decide whether it is appropriate to issue a supplementary statement confirming the closure of the pharmacy. As above, however, that statement should not include a new analysis of pharmaceutical services provision for the area.

Appendix 1: process summary

This appendix sets out suggested consecutive steps to be taken by HWBs to support the development of the PNA. A separate spreadsheet is available that may be used by HWBs to support planning of the process.

Step 1: governance

1. Invite stakeholders to join the steering group and set date of first meeting.
2. Steering group meetings to be scheduled in line with the group’s wishes (suggested minimum meetings included).
3. Board meetings (schedule board update reports as required).

Step 2: health needs and priorities 

1. Obtain reference documentation, such as needs assessments.
2. Obtain information on known housing development, regeneration projects or transport developments that are current or will occur within the lifetime of the PNA.
3. Obtain any additional data.
4. Agree localities to be used at first steering group meeting.
5. Analyse data.

Step 3: public questionnaire

1. Agree questionnaire at first steering group meeting.
2. Upload questionnaire to online platform.
3. Promote questionnaire through the council’s websites, communications channels and online presence, and by press release.
4. Questionnaire runs for 4 weeks.
5. Analysis of questionnaire responses.

Step 4: current pharmaceutical services provision 

1. Contractor questionnaires to be agreed at first steering group meeting.
2. Upload contractor questionnaires to online platform.
3. Contractor questionnaires open for 4 weeks.
4. Analyse responses.
5. Obtain dispensing data and advanced and enhanced services activity data.
6. Analyse and map service provision data.

Step 5: drafting

1. Draft overview, health needs, identified patient groups and public engagement results sections of the PNA.
2. Draft pharmaceutical services section.
3. Undertake locality assessments.
4. Share first complete draft PNA with the steering group, or share chapters as drafted. The steering group is to agree which option is to be adopted.
5. Steering group to review the PNA sections.
6. Steering group meeting to agree changes to the PNA.
7. Incorporate comments from steering group.
8. Share final draft of consultation version of the PNA with steering group.
9. Submit consultation draft of PNAs to HWB, committee or sub-committee for sign-off, if not delegated to the steering group.
10. PNA signed off for consultation.

Step 6: consultation

1. Consultation questions agreed.
2. Consultation documents drafted.
3. Liaison with council’s communications team.
4. Consultation runs for 60 days.
5. Review consultation responses and produce first draft of consultation report.
6. Consultation report shared with steering group.
7. Steering group to agree response to the consultation.

Step 7: publication

1. PNA finalised.
2. Final PNA submitted to the HWB.
3. Final PNA signed off by HWB.
4. PNA published no later than 3 years after the current document was published.

Appendix 2: PNA update process

Once the PNA has been published, the HWB will need to establish a process for publishing new versions and supplementary statements. This appendix sets out the decision-making process. A flowchart has also been provided that reflects the decision-making process set out below.

Figure 6: flowchart showing the HWB decision-making process when updating a PNA

The flowchart shows the HWB decision-making process when updating a PNA. Firstly, if as part of its regular review of the provision of pharmaceutical services in its area the HWB identifies a change since the publication of the current PNA, it should consider whether the change is relevant to the granting of market entry applications. If not, the change should be incorporated into the next PNA. No further action is required.

If the change is relevant, the next step is dependent on whether the HWB is currently producing its next PNA.

If the next PNA is in production, the HWB must consider whether it needs to issue a supplementary statement explaining the changes to the availability of pharmaceutical services. If this is not necessary, the HWB can continue producing the next PNA, incorporating the change. If a supplementary statement is required, the HWB must issue a supplementary statement explaining the changes to the availability of pharmaceutical services and continue to produce a new PNA, incorporating the change.

If the next PNA is not in production, the HWB must consider whether producing a new PNA is a disproportionate response to the changes. If a new PNA would be disproportionate, the HWB must consider whether a supplementary statement explaining the changes to the availability of pharmaceutical services is required, and if so the HWB must issue the supplementary statement.

If a new PNA would not be disproportionate, the HWB must start the process of developing a new PNA, including full consultation. The HWB must also consider whether it is satisfied that it needs to immediately modify the PNA in order to prevent significant detriment to the provision of pharmaceutical services in its area. If not, the HWB must continue with revising the PNA. If so, the HWB must issue a supplementary statement explaining the changes to the availability of pharmaceutical services and continue to produce a new PNA.

Appendix 3: template supplementary statements

These templates are available as Microsoft Word attachments on the Pharmaceutical needs assessment: information pack page.

1. Opening of a new pharmacy following grant of an application

HWB logo and address

Supplementary statement to the [insert name] PNA

Date PNA published:

Date supplementary statement issued:

The PNA for the area of [insert name] HWB identified in [section/chapter X] the following [current/future] [need/improvement or better access]:

[insert details of need, improvement and/or better access that is identified in the PNA]

[[name] ICB/NHS Resolution] granted an application by [insert name of contractor] to open a pharmacy at [insert address] to provide the following pharmaceutical services:

[insert all pharmaceutical services that the applicant is to provide]

These services will be provided at the following times:

[insert core and supplementary hours as detailed in the application]

The pharmacy opened on [insert date of opening].

Supplementary statement issued by: [this should be the name of the person, panel or committee who has been authorised to issue supplementary statements]

Post:

Date:

2. Opening of a new pharmacy following grant of an unforeseen benefits application

HWB logo and address

Supplementary statement to the [insert name] PNA

Date PNA published:

Date supplementary statement issued:

[[name] ICB/NHS Resolution] granted an unforeseen benefits application by [insert name of contractor] to open a pharmacy at [insert address] to provide the following pharmaceutical services:

[insert all pharmaceutical services that the applicant is to provide]

These services will be provided at the following times:

[insert core and supplementary hours as detailed in the application]

The pharmacy opened on [insert date of opening].

Supplementary statement issued by: [this should be the name of the person, panel or committee who has been authorised to issue supplementary statements]

Post:

Date:

3. Closing of a pharmacy

HWB logo and address

Supplementary statement to the [insert name] PNA

Date PNA published:

Date supplementary statement issued:

The following pharmacy has closed:

[insert name and address of pharmacy]

The pharmacy provided the following pharmaceutical services:

[insert all pharmaceutical services that the pharmacy provided]

These services were provided at the following times:

[insert core and supplementary hours]

The pharmacy closed on [insert date of opening].

Supplementary statement issued by: [this should be the name of the person, panel or committee who has been authorised to issue supplementary statements]

Post:

Date:

4. Consolidation of 2 pharmacies

HWB logo and address

Supplementary statement to the [insert name] PNA

Date PNA published:

Date supplementary statement issued:

The following pharmacy has closed as a result of a successful consolidation application:

[insert name and address of pharmacy]

The pharmacy provided the following pharmaceutical services:

[insert all pharmaceutical services that the pharmacy provided]

These services were provided at the following times:

[insert core and supplementary hours]

The pharmacy closed on [insert date of opening].

It is the opinion of [insert name] HWB that the removal of this pharmacy from the pharmaceutical list does not create a gap in pharmaceutical services provision that could be met by a routine application:

• to meet a current or future need for pharmaceutical services
• to secure improvements, or better access, to pharmaceutical services

Supplementary statement issued by: [this should be the name of the person, panel or committee who has been authorised to issue supplementary statements]

Post:

Date:

5. Loss of opening hours

HWB logo and address

Supplementary statement to the [insert name] PNA

Date PNA published:

Date supplementary statement issued:

The following [pharmacy/dispensing appliance contractor] has changed its opening hours with effect from [date]:

[insert name and address of pharmacy]

The previous core and supplementary opening hours were:

[insert core and supplementary opening hours]

The new core and supplementary opening hours are:

[insert core and supplementary opening hours]

Supplementary statement issued by: [this should be the name of the person, panel or committee who has been authorised to issue supplementary statements]

Post:

Date: