The North Yorkshire Council

 

Health and Adult Services

 

Executive Member Meeting

 

11th July 2025

 

REPORT TO Director of Public Health, in consultation with the Executive Member for Health and Adult Services

 

Patient Group Directive – 2026 to 2029

 

1.0          Purpose Of Report (required)

 

To seek approval from the Director of Public Health, in conjunction with the Executive Member for Health and Adult Services, to procure a Patient Group Directive (PGD) via Community Pharmacy within North Yorkshire. This will enable smokers in North Yorkshire looking to quit to access stop smoking medications, via the local stop smoking service Living Well Smokefree, supporting Smokefree Generation ambitions and improving the health of the local population. The medications overseen by this PGD will be Varenicline and Cytisinicline, in line with the national recommendations and templates designed by the Specialist Pharmacy Service, on behalf of NHS England.  

 

 

2.0          Executive Summary

 

The Department of Health and Social Care, on behalf of the Government, have provided additional funding to support the aims of creating a smokefree generation. To support this ambition in North Yorkshire, the Living Well Smokefree service is working to ensure that any smoker wishing to quit has access to most effective quit aids as possible, including stop smoking medication.

 

Living Well Smokefree are working closely with the Local Pharmaceutical Council to develop a Patient Group Directive. This will enable community pharmacies to sign up to provide chosen stop smoking medications on behalf of the local stop smoking service. A full options appraisal was completed in late 2024 and has been presented to the North Yorkshire Public Health, Involvement and Governance Leadership Team, who supports the recommendation for use of the PGD.

 

A procurement exercise is required to allow for the use of the Patient Group Directive as part of the Living Well Smokefree offer.

 

3.0          Background

 

North Yorkshire has received the second year of five years of additional investment of £70million for local stop smoking services across England to support people to stop smoking in an effort to achieve a 5% national prevalence by 2030. Smoking remains the biggest preventable killer in the UK, contributing to a wide range of health conditions and costing North Yorkshire an estimated £400m per year on health, social care and other costs (ASH Ready Reckoner, 2025). Therefore, ensuring that support is in place to help as many people quit is important to ensuring people live as long and healthy life as possible.

Funding per Local Authority area has been calculated based on local smoking prevalence – with £642k being identified for North Yorkshire Council for 2025/26. The funding allocations are based on the average smoking prevalence over a 3-year period between 2021 and 2023.

To support the work of the Living Well Smokefree service, it is vital to have a range of effective options of pharmacotherapy available alongside behavioural support to help smokers accessing the service to quit. This is particularly important with the smoking prevalence in North Yorkshire sitting at 9.8%, as the remaining smokers are likely to be from population groups that have found it harder to access stop smoking services in the past and may require multiple quit attempts and/or multiple types of pharmacotherapies to best meet their individual needs.

 

The pharmacotherapy options available to smokers accessing the Living Well Smokefree service has fluctuated in recent years, with prolonged periods where options have been severely limited. Varenicline was withdrawn from market across England in 2021, leaving Bupropion as the only oral medication licensed. However, due to cautions and contra-indications, this is only suitable for a limited cohort. Nicotine replacement therapy (NRT) has been consistently available throughout. The addition of e-cigarettes to the options in North Yorkshire in 2023 enhanced the local offer significantly, as will the addition of new (to the UK) oral medication Cytisinicline to the North Yorkshire and York formulary.

 

Prior to Varenicline being withdrawn in 2021, this stop smoking medication was both a popular and effective method of supporting a smoker to quit. Whilst alternatives have been available in the intervening period, its return to market in late 2024 has been welcomed by the wider Tobacco Control system, as well as smokers themselves. Cytisinicline is a relatively new medication to the UK market but has been available in other parts of Europe for several years.

 

Both medications have been the subject of national support in helping local stop smoking services add these into local delivery options. The Specialist Pharmacy Service, on behalf of NHS England, have developed national PGD templates for both medications (Varenicline and Cytisinicline). A PGD enables any community pharmacy who signs up, to deliver the chosen medication on behalf of the local stop smoking service. Creating these national templates enables local stop services to adapt these to fit within local delivery models in the hope of expediting local implementation and delivery.

 

Within North Yorkshire, an options appraisal was completed in late 2024 mapping out the various methods which could support the delivery of these stop smoking medications to smokers living within the county. These included the use of local GP practices, a PGD, direct employment of clinical staff, use of NHS bank staff and the option of formally contracting a clinical element to a third-party organisation. A strengths, weaknesses, opportunities and threats analysis was undertaken for each of the above options, in addition to financial modelling to explore potential costs of each.

 

Considering all of the above, in addition to national and regional support of a PGD delivery model, it was agreed in consultation with the Public Health, Involvement and Governance Leadership Team that a PGD seemed the most effective option available. A PGD is in place for a period of three years, so it was agreed to have this live in North Yorkshire in line with the period of the additional grant funding. Therefore, the ambition is for it to be in place from 2026 until 2029.

 

The PGD scheme is designed to significantly improve service delivery from pharmacies by enabling them to supply Varenicline and Cytisinicline treatment without the need to have an NHS prescription. This Service will also help to:

·         Increase the support and advice to Service Users/smokers that wish to cease smoking.

·         Increase the numbers of quitters in more deprived areas where there are high numbers of people living in poverty, high rates of unemployment and inadequate housing.

·         Raise people’s awareness of the risks of smoking and the support available to help smokers to quit.

·         Develop and enhance the skills of the Service staff to improve the public health provision within the population of North Yorkshire.

 

 

4.0          Issues

 

Procurement have helped to map out the potential risks and issues that may arise as a PGD is developed across North Yorkshire. These include:

 

·         Full countywide coverage may not be achieved or may be limited when the contract commences. Mitigation to try and avoid this includes strong engagement with providers via Community Pharmacy North Yorkshire (CPNY) as representatives of the local provider market. Part of this engagement includes complimentary communications to providers to ensure they understand the process and the practicalities of using the Council’s procurement platform well in advance of the tender going live too.

·         This PGD will be going live at a time when demand for NHS services is increasing, which is where the majority of pharmacy income streams come from. Therefore, ensuring this contract is attractive to providers will be key to ensuring appropriate sign-up and coverage across North Yorkshire. CPNY have been involved in the development of the specification to make sure it fits within standard ways of operating within community pharmacies, Equally, negotiations will be completed with CPNY committee to ensure remuneration is fair and reflective of the capacity required from community pharmacy staff.

 

5.0          Performance Implications

 

As part of the additional grant funding via the Department of Health and Social Care, there are ambitions for each Local Authority to be able to support more people to stop smoking. As a result of the investment the Government wants to increase access to evidence-based behavioural support to quit and targeted support to people more likely to smoke, to reduce health inequalities.

 

The Government’s ambition for this investment is to see 360,000 people set quit dates, with 198,000 successful quits (measured as 4-week quits) in England each year. This approach takes the total number of additional quit dates and distributes them as a proportion across each local authority area. It also factors in a gradual increase of set quit dates with an expectation of what these numbers will look like over 5 years of the programme.

 

Ensuring access to a full complement of quit aids, particularly previously popular quit aids such as Varenicline, should have a positive impact on smokers reaching out for support via local stop smoking services. This would have a positive impact on the number of referrals and people seen by Living Well Smokefree within North Yorkshire, which, in turn, would contribute to the overall ambition of the additional grant funding.

 

6.0          Policy Implications

 

There are no policy implications for proceeding with procuring this PGD. Once procurement is in place, procedures within Living Well Smokefree will be updated to ensure the safe and effective mobilisation of the new treatment options within the service.

 

7.0          Alternative Options considered

 

As outlined in section 3 above, a full options appraisal was undertaken to identify the best delivery model for facilitating access to Varenicline and Cytisinicline within Living Well Smokefree. The recommended option of procuring a PGD via Community Pharmacies ( is in line with national and regional preference. Following implementation of the PGD, individuals receiving support from Living Well Smokefree will have access to a range of different treatment options also including Nicotine Replacement Therapy and E-cigarettes alongside behavioural support from trained advisors to best meet their needs and give the best chance of making a successful quit attempt.

 

8.0          Financial Implications

 

As part of the Options Appraisal, financial modelling was completed to help give an understanding of likely cost of each option reviewed – including a PGD. Modelling pharmacotherapy costs can be a challenge due to the variance in both offer and patient choice. However, a combination of historical cost of pharmacotherapy in North Yorkshire, alongside known costs of both medications since their return to market, helped provide an indication of what this could look like locally – with anticipated whole life costs of the PGD not expected to exceed £450,000.

 

To balance the potential financial impact of this delivery model, it is recommended to procure this PGD until 2029, which is the indicative end date of the additional grant funding. This provides extra capacity to absorb potential costs of delivering these stop smoking medications within the local Tobacco Control system.

 

Whilst this additional grant funding is only agreed on a recurring 12-month basis, it has also been explicitly stated by the Government that the funding has been identified for five years through to 2028/29. However, the Department of Health and Social Care, who are distributing the funding to Local Authorities, are unable to confirm the specific funding allocations to respective Local Authorities beyond 12 months at a time. This limitation is due to the annual Government spend review that is required to take place before any future allocations can be confirmed. This includes the acknowledgement that any curtailing of the grant-funded programme would result in a scaling back of activity within stop smoking services. Therefore, reducing demand/spend through this PGD accordingly.

 

9.0          Legal Implications

 

The procurement process will be in accordance with the Health Care Services (Provider Selection Regime) Regulations 2023. Contracts will be drafted by Legal Services to include appropriate terms and conditions and will be entered into in accordance with the Council’s Procurement and Contract Procedure Rules.

 

10.0       Consultation undertaken and responses

 

Public Health have engaged with the local governing body for community pharmacies (Community Pharmacy North Yorkshire) via their committee. This gave an opportunity to flag that a PGD was in development for stop smoking medications and to gauge potential interest in both of the medicines available, Varenicline and Cytisinicline.

 

This engagement has continued with the Chief Executive of Community Pharmacy North Yorkshire being part of the working group developing the specification to ensure the voice of local providers is included. Subject to the approval to proceed with the PGD, members of the Public Health team will meet again with the Community Pharmacy committee to discuss some of the financial tariffs for providing this service on behalf of North Yorkshire Council.

 

11.0       Impact on other services/organisations

 

The benefits from this funding and access to new stop smoking medications will be felt across the wider tobacco control system, not only the Living Well Smokefree service within North Yorkshire Council. As the focus of the funding is to address prevalence rates within priority population groups, Public Health colleagues have already begun exploring opportunities   to work more closely with relevant directorates across the council, e.g., housing and leisure to increase referrals into the service. This is in addition to redefining how we can work closely with voluntary and community sector (VCS) organisations.

 

It is also widely demonstrated the impact that stopping smoking can have across the wider Local Authority and healthcare system through system’s savings. As mentioned earlier in this report, smoking currently costs £400m per year across North Yorkshire (ASH Ready Reckoner, 2025). Ensuring upstream prevention can be done in helping smokers quit as early as possible, this will have significant impact on reducing future costs across healthcare, social care and emergency services – in addition to improving the overall quality of life for the person stopping smoking.

 

12.0       Contribution to Council priorities

 

This proposal supports the delivery of the North Yorkshire Council plan, in particular the ambition around health and wellbeing for residents of the county. Tobacco remains the biggest preventable killer in the UK, so improving access to methods of quitting smoking will support more people in North Yorkshire to achieve a successful and sustained quit – having a positive impact on other areas of delivery across the Local Authority and local NHS system.

 

13.0       Human Resources Implications

 

As part of mobilisation of this new offer, appropriate training will be provided, and procedures will be updated within the Living Well Smokefree service. The PGD specification will outline requirements of Community Pharmacies in ensuring that the:

·         Service is delivered in line with the NHS (Pharmaceutical Services) Regulations 2013 and the NHS Community Pharmacy Contractual Framework.

·         Most recent guidance on medicines from the Medicines and Healthcare products Regulatory Agency (MHRA) is adhered to.

·         General Pharmaceutical Council’s Standards for Pharmacy Professionals and Pharmacy Premises is adhered to.

 

The service specification also outlines that it is the duty of the pharmacy contractor to ensure that the service is delivered by staff who have the necessary training and competence in this intervention, and that all pharmacists and registered pharmacy technicians have signed the PGD authorisation form.

 

14.0       Equalities Implications

 

As previously mentioned, the implementation of this PGD will look toincrease activity within Living Well Smokefree, over the next 4 years to reduce smoking prevalence rates in North Yorkshire. This will enable a sharper focus on priority population groups where prevalence rates are higher than the general population, as interventions will be targeted and tailored to them to support in reducing inequalities.  As part of the procurement process, an Equality Impact Assessment screening form has been completed in adherence to the governance process.

 

15.0       Climate change implications

 

This funding is likely to have a negative impact on emissions from travel and air pollution moving forward with regards to individuals accessing community pharmacies for their instalments of their medication. Prioritising a strong number of providers signing up across North Yorkshire should help mitigate the need to travel vast distances by ensuring local provision in as many localities in the county as possible. As part of the procurement process, an Climate Change Impact Assessment screening form has been completed in adherence to the governance process

 

16.0       ICT implications

 

No additional impact on the ICT systems in place within North Yorkshire Council to support the local stop smoking service.

 

17.0       Reasons for recommendation

 

·         To deliver the vision of a Smokefree Generation, in line with national guidance for this funding and to help deliver North Yorkshire Tobacco Control strategy 2015-2025

·         To improve access to quit methods for people living in North Yorkshire and being supported by Living Well Smokefree, by expanding provision and support within communities across the county

·         To improve outcomes for priority populations, which in turn will have a positive impact on reducing inequalities within smoking prevalence, and subsequent health outcomes.

 

14.0     Recommendation

 

To request approval from the Director of Public Health, in consultation with the Executive Member for Health and Adult Services, to proceed with the procurement of a PGD delivery model for Varenicline and Cytisinicline via community pharmacies. This will provide medication to individuals in North Yorkshire looking to stop smoking via support from the local stop smoking service, Living Well Smokefree.

 

 

 

 

Report Author – Dan Atkinson (Public Health Manager), Katie Needham (Public Health Consultant) and Naomi Smith (Head of Health Improvement)