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Report to the Cabinet Member for Health and Wellbeing Report to the Deputy Leader of the County Council Report submitted by: Director of Public Health Date: 14 and 16 January 2014 Electoral Division affected: Fylde Borough Council, Lancaster City Council, Wyre Borough Council Proposal to Extend the Nicotine Replacement Therapy (NRT) Voucher Scheme Lancashire Wide (Appendix 'A' refers) Contact for further information: Jo McCullagh, 07876844160, Adult Services, Health and Wellbeing Directorate, Joanne.McCullagh@lancashire.gov.uk Executive Summary Smoking remains the single, greatest cause of preventable illness and death from respiratory disease, circulatory disease and cancer, responsible for 1,673 deaths each year in adults aged 35 years and over in Lancashire alone1. Smoking rates are higher in Lancashire than England as a whole in adults2 (22.3% vs 20%), pregnant women3 (18.3% vs 12.7%) and young people4,5 (16% vs 11%). However, two-thirds of smokers (63%) want to quit and welcome support to do so6. National guidance recommends that all smokers should be routinely referred to a Stop Smoking Service7,8 to receive behavioural support and pharmacotherapy as they are four times more likely to quit through this route than going it alone8. Three of the four Stop Smoking Services currently operating in Lancashire (East, Central and West) have been using a Nicotine Replacement Therapy (NRT) voucher scheme since 2009, which enables clients to obtain NRT from a Community Pharmacy without the need for a prescription. However, no equivalent programme is available in North Lancashire where Stop Smoking Service clients are issued with a letter requesting their GP to prescribe all smoking cessation pharmacotherapy. This necessitates an additional visit by the client to the GP to generate the NRT prescription and often a delay in obtaining therapy to support a quit attempt of up to a week. This proposal to extend the Pharmacy Enhanced Service Nicotine Replacement Therapy (NRT) Voucher Scheme to North Lancashire will address this service inequity, reduce the need for unnecessary visits to primary care and GP consultations and decrease waiting times for smoking cessation treatment. Recommendation The Cabinet Member for Health and Wellbeing is recommended to: (i) Approve the commissioning proposal to extend the the Pharmacy Enhanced Service Nicotine Replacement Therapy (NRT) Voucher Scheme to North Lancashire in 2014/15 and recurrent years. (ii) Request that the Deputy Leader of the County Council waives procurement rules 5.4 and 6.1 to enable contracts to be established with qualified pharmacy contractors in North Lancashire to deliver this scheme during 2014/15 and thereafter without the need to obtain three quotes or to advertise the contract. Background and Advice 1. Evidence Base and Local Context Smoking remains the single, greatest cause of preventable illness and death from respiratory disease, circulatory disease and cancer, responsible for 1,673 deaths each year in adults aged 35 years and over in Lancashire alone1. One in two lifelong users die prematurely as a result of smoking, half of these in middle age. On average, each smoker loses 20 years of life and experiences many more years of ill health than a non-smoker 9. Smoking rates are higher in Lancashire than England as a whole in adults2 (22.3% vs 20%), pregnant women3 (18.3% vs 12.7%) and young people4,5 (16% vs 11%). However, two-thirds of smokers (63%) want to quit and welcome support to do so6. The Tobacco Control Plan for England7 reasserts the government’s commitment to the provision of local Stop Smoking Services (SSS) tailored to the needs of local communities, particularly groups which have high prevalence, as a contribution to reducing health inequalities in health. There is strong evidence, which demonstrates that SSS are highly effective both clinically and in terms of cost. Smokers are four times more likely to quit with support from a SSS than going it alone8. Further to this, Department of Health guidance recommends that all smokers should be routinely offered advice to quit and a referral to the Stop Smoking Service8. Nicotine addiction has been shown to be a neurological brain disorder. Most adults do not smoke out of choice but because they become addicted to nicotine. Cigarettes are highly efficient nicotine delivery devices and are as addictive as drugs such as heroin and cocaine. NICE recommendations advocate the use of NRT, Varenicline (Champix) and Bupropion (Zyban) alongside behavioural support as part of a smoking cessation programme10. NRT has been shown to be both clinically and cost-effective and doubles the chances of a smoker wishing to achieve abstinence8. NRT aims to replace the nicotine in cigarettes with another form of delivery. It provides a background level of nicotine and alleviates the short-term difficulties smokers’ experience when trying to stop smoking by reducing craving and withdrawal symptoms. Forms of NRT currently available are patch (16 hour and 24 hour), inhalator, nasal spray, mouth spray, sublingual tablet, gum and lozenge. NRT is currently available on FP10 prescribed by a General Practitioner or Non-Medical prescriber, and can be bought as a general sale item. Adults can use a single NRT product or a combination of a patch with an oral product if they are heavily dependent smokers. Young people aged over 12 years and pregnant women are limited to a single NRT product8. Duration of treatment with NRT is usually 12 weeks for a cessation attempt8. 2. Current NRT Voucher Scheme Provision Three of the four Stop Smoking Services currently operating in Lancashire (East, Central and West) have been using a NRT voucher scheme since 2009. This enhanced pharmacy service is designed to meet the following aims: Patients • To improve access to and choice of Stop Smoking Services, including access to pharmacological and non-pharmacological stop smoking aids • To reduce smoking related illnesses and deaths by helping people to quit • To improve the health of the population by reducing exposure to secondhand • To reduce waiting times for smoking cessation treatment • To offer an alternative to a primary care visit or GP consultation to generate a • To remove anxiety about “bothering a doctor” • To reduce inappropriate consultations • To help achieve access targets • To provide an opportunity to work more closely with healthcare providers and • To deliver the vision of the Pharmacy White Paper; Building on Strengths Stop Smoking Advisors issue clients with a voucher to obtain NRT from a Community Pharmacy to enable them to receive NRT on the NHS without the need for a prescription. This provides holistic care to the client whilst reducing the need for unnecessary visits to primary care and GP consultations. Clients exempt from prescription charges may receive NRT free from participating pharmacies, whilst those clients who are not exempt from prescription charges may also receive NRT at the same cost as a prescription. Each voucher covers between one and four week’s supply of NRT and can be issued for up to 12 weeks per cessation attempt. Smokers unable to stop whilst on NRT are discharged from the service and invited to re-attend when they are ready to make another quit attempt. Varenicline and Bupropion are not available through the pharmacy enhanced service NRT voucher scheme because these are Prescription Only Medicines and the patient’s medical history is required to ensure there are no contra-indications. Therefore the pharmacological assessment, decision for treatment and prescribing of these products is undertaken by the individual’s G.P practice. 106 pharmacies are currently operating the enhanced service in the Central and East localities. Each one has to undertake accredited CPPE Stop Smoking training to participate in the scheme. They are reimbursed with the Drug Tariff price of each NRT product, plus VAT and a professional fee of £3.00 per voucher (Central) or £2.00 per voucher item (up to £4.00 in total, East) from the NHS Staffordshire and Lancashire Commissioning Support Unit (CSU) who manage the contract on behalf of Lancashire County Council. Negotiations are currently underway with the Lancashire Pharmacy Committee to standardise the professional fee to £2.00 per voucher in the 2014/15 contract. Table 1: Central and East Lancashire NRT Voucher Scheme 2011/12 *DH stop smoking service data return 2011/12 **Lancashire and South Cumbria Agency (LaSCA) data 2011/12 The estimated lifetime cost of treating a smoker with a smoking related disease in Lancashire is £15,12112. Key performance data of the NRT voucher scheme during 2011/12 illustrates that it was highly cost-effective with the pharmacotherapy cost per quit calculated at £239.29 and £237.17 for the Central and East localities respectively (Table 1). The 2013/14 expenditure forecast for these two localities is £811,283. 3. Programme Extension The existing NRT Voucher Scheme is only accessible to tobacco using people aged 12 years and over, registered with a G.P practice in East and Central Lancashire. No equivalent programme is running in North Lancashire and Stop Smoking Service clients are issued with a letter requesting their GP to prescribe all smoking cessation pharmacotherapy including NRT. This necessitates an additional visit by the client to the GP to generate the NRT prescription and often a delay in obtaining therapy to support a quit attempt of up to a week. Moreover, although many smokers require multiple attempts to quit and recurrent cessation treatments8, a number of GP surgeries in North Lancashire have implemented a six-month restriction in prescribing smoking cessation pharmacotherapy following relapse. This presents a significant health service inequality. Although Local Authorities took on responsibility for commissioning public health services from April 2013, at present there is a consultation on-going regards the Local Authority's responsibilities around funding the supply of medicines13. However, it is considered appropriate at this stage to extend the NRT Voucher Scheme county-wide to include North Lancashire in 2014/15 and recurrent years, rather than funding GPs to prescribe NRT in order to reduce the need for unnecessary visits to primary care and GP consultations and decrease waiting times for smoking cessation treatment. The annual cost of NRT prescribing in North Lancashire via primary care was £260,552 in 2012/13 (table 2). Table 2: North Lancashire NRT Prescribing 2012/13 *DH stop smoking service data return 2012/13 ** QOF data 2012/13 As table 2 highlights, 3,798 smokers set a quit date with North Lancashire Stop Smoking Service during 2012/13, of which 2,301 (60.6%) successfully quit at four-weeks. 1,305 of these quitters used NRT (56.7%). The total corresponding NRT prescribing budget for North Lancashire was £260,552 therefore the pharmacotherapy cost per quit was £199.66. The extension of the scheme will be linked in to the public health programme that is developing Healthy Living Pharmacies (HLP) across Lancashire. Pharmacies in North Lancashire are already providing a range of enhanced public health wellness and lifestyle services such as sexual health and substance misuse via service level agreements, which are also managed by the CSU. We would therefore like to invite all community pharmacies within North Lancashire to participate in the NRT Voucher Scheme, in line with the current service specification and management arrangements. Permissions to agree sign up of individual pharmacy contractors to a framework agreement is recommended. There is not a requirement to tender this scheme as by the nature of the service the contract will be let to any qualified pharmacy provider in North Lancashire. Providers will self-select whether to contribute to providing the NRT Voucher Scheme. Service requirement criteria will include: • The pharmacy contractor must agree to participate in all parts of the service. This agreement will be documented in the form of a Service Level Agreement signed by the contractor or the representative of the contractor. • The pharmacy must have an accredited consultation room. • A standard operating procedure (SOP) that clearly defines the roles and responsibilities of relevant staff must be produced and followed for each individual pharmacy (Appendix 1). • An accredited qualified Dispensing Technician may be delegated to undertake the consultation provided they adhere to the SOP. Overall responsibility and accountability will remain with the pharmacist in charge. • This service cannot be provided solely by an accredited pharmacy technician. At all times an accredited pharmacist must be present and accountable 75% of opening hours, except for annual leave and sick leave, when a locum (accredited or not accredited) may temporarily continue accountability of the service. • Pharmacists involved in the provision and/or accountability of this service must complete the ‘Stop Smoking – very brief advice’ e-package (NCSCT version) and the distance learning package ‘Stop Smoking’ available from the Centre for Postgraduate Pharmaceutical Education. Qualified Dispensing Technicians (NVQ level 3) must also receive training by the Stop Smoking Service to supply NRT under the scheme. The CSU will manage arrangements for eligible pharmacy contractors to be invited to sign up to the NRT Voucher Scheme. Payment will be in line with the Central and East scheme – reimbursement of the Drug Tariff price of each NRT product, plus VAT and a professional fee of £2.00 per voucher. The total amounts paid to any one pharmacy contractor will be lower than the values within the procurement threshold in terms of both Part A and Part B services. 4. Service Performance The CSU currently produces quarterly budget statements and reports to support the monitoring of the NRT Voucher Scheme for East and Central Lancashire and this will be extended to the North Locality. This includes the number of NRT products redeemed, the number of vouchers processed and the associated costs. The CSU has also established an audit trail for the vouchers so that they can all be individually tracked from the point of issue at the pharmacy through to their submission and undertake sample audits. The programme contributes to the following Public Health Framework Outcomes and Lancashire County Council Health and Wellbeing Priorities: Public Health Framework Outcomes • Smoking status at time of delivery (2.3) • Smoking prevalence – 15 year olds (2.9) • Smoking prevalence – adult (over 18s) (2.14) • Low birth weight of term babies (2.1) • Infant mortality (4.1) • Mortality from causes considered preventable (4.3) • Mortality from all cardiovascular diseases (including heart disease and stroke) • Mortality from respiratory diseases (4.7) • Excess under 75 mortality in adults with serious mental illness (4.9) Lancashire County Council Health and Wellbeing Priorities • Identify those who are at risk of admission into hospital and provide • Joined up support for vulnerable families (first pregnancy) 5. Budget The estimated total annual recurrent cost of delivering the NRT voucher scheme in North Lancashire based on 56.7% of quitters using NRT, a total four-week quit target of 2,624 (1,488 using NRT) and quit rate of 60.6% (4,330 smokers setting a quit date; 2,455 using NRT) is £326,554. * Within 2014/15 Stop Smoking Service contract **Within 2014/15 CSU contract ***Number of smokers setting a quit date using NRT (2,455) x average of 6 vouchers per quit x professional fee of £2 per voucher Consultations N/A Implications: This item has the following implications, as indicated: Financial The spending proposals identified in this report recommend the annual allocation from the Public Health grant of £326,554, for which there is provision, to deliver the NRT voucher scheme in North Lancashire for 2014/15 and each year thereafter. This is in addition to the existing annual recurrent cost of the Central and East NRT Voucher Schemes of £811,283. Legal The NRT Voucher Scheme will be provided by a large number of qualified pharmacy contractors local to the clientele, with each contract being fairly low in value (below the level of spend that would give rise to a published tender exercise). In the circumstances it is appropriate to waive the standing orders that require the authority to obtain quotes, or (in the event that any pharmacy contract leads to a spend in excess of £60,000) to advertise the contract publicly. Personnel Management of the North Lancashire NRT Voucher Scheme will be undertaken by the NHS Staffordshire and Lancashire Commissioning Support Unit within the current Pharmacy Enhanced Services contract. Similarly, the North Lancashire Stop Smoking Service will co-ordinate the voucher production and distribution and Pharmacy Contractor training as part of the 2014/15 specification. All qualified Pharmacy contractors in North Lancashire, many of whom are already providing enhanced services for sexual health and substance misuse, will be invited to participate in the NRT Voucher Scheme. Risk management If the request to extend the NRT Voucher Scheme to North Lancashire is declined, inequalities and gaps in service delivery will continue. The existing NRT Voucher Scheme is only accessible to tobacco using people aged 12 years and over, registered with a G.P practice in East and Central Lancashire. Smokers, wanting to quit in North Lancashire currently have to make additional visits and appointments with their GP to obtain a prescription for smoking cessation pharmacotherapy including NRT. This necessitates a total of six GP additional visits by the client to generate the NRT prescription every two weeks and often a delay in obtaining therapy of up to a week. In addition, a number of GP surgeries in North Lancashire have implemented a six-month restriction in prescribing smoking cessation pharmacotherapy following relapse, which prevents smokers from successfully quitting and in turn, impedes a reduction in smoking prevalence rate. Due to the internal review, public health commissioners do not have access to specialist professional support to safely manage a series of complex procurement and contracting exercises. Commissioners will require ready access to corporate legal, finance and policy guidance and in addition, access to specialist procurement, contracting and project management from individuals that have the necessary experience, knowledge, demonstrable skill and capability to manage procurement processes. These individuals may be temporary agency workers that commissioners will manage but they will require professional support and supervision from corporate services. List of Background Papers N/A Reason for inclusion in Part II, if appropriate N/A NHS Information Centre (2012) Statistics on Smoking England 2012 and Census 2011 all population aged 35 and over. Office for National Statistics (2012) General Lifestyle Survey Overview. A report on the 2010 General Lifestyle Survey. http://www.ons.gov.uk/ons/rel/ghs/general-lifestyle-survey/2010 NHS Information Centre for Health and Social Care (2013). Statistics on women’s smoking status at time of delivery: England. http://www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles/smoking Trading Standards (2013). Young Persons Alcohol and Tobacco Survey 2013, North West Results. TSNW, June 2013. The Information Centre for Health and Social Care (2012) Smoking, drinking and drug use among young people in England in 2011. West R (2010) Key findings from the Smoking Toolkit Study 2010 www.smokinginengland.info Department of Health (2011) Healthy Lives, Healthy People: A Tobacco Control Plan for England. London:DH. Department of Health (2011) Local Stop Smoking Services: Service Delivery and Monitoring Guidance 2011/12.London: DH Doll R et al (2004). Mortality in relation to smoking: 50 years’ observations on male British doctors. BMJ 328:1519 http://www.bmj.com/content/328/7455/1519.long 10. NICE (2008)Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities. NICE, February 2008. 11. Department of Health (2008) Pharmacy of England: Strengths in delivering the future. http://www.official- documents.gov.uk/document/cm73/7341/7341.pdf 12. Health Economics Research Group, Brunel University; Queen's Medical Centre, University of Nottingham & London Health Observatory (2012) Building the economic case for tobacco control: A toolkit to estimate economic impact of tobacco. http://www.brunel.ac.uk/herg/research-programme/building-the-economic-case-for-tobacco-control 13. Public Health England. Supply of medicines for public health commissioned services. A factsheet for local authorities. STANDARD OPERATING PROCEDURE FLOWCHART: LANCASHIRE PHARMACY ENHANCED SERVICE NRT VOUCHER SCHEME Ensure voucher is complete and has not expired. If any details are missing contact relevant Stop Smoking Service Manager Ensure NRT product requested is appropriate for client & in accordance with product licence and service specification If the GP needs to be informed of the quit attempt, check that this requirement has been fulfilled through the annotation on the voucher under the Advisors signature. If not fulfilled, pharmacy staff must inform the Ask client to complete section 2 of voucher, check proof of exemption or collect NHS fee. If proof of exemption not seen place a cross on back of voucher & endorse ‘proof of Re cord supply on the Patient Medication Records & label in accordance with RPSGB Guidelines. Provide advice and support regarding the product supplied and the Complete voucher with pharmacist’s name, pharmacy stamp. Retain middle (pink) and top (white) copies of voucher & keep for 2 years Complete voucher entry on the Pharm Outcomes & submit to CSU

Source: http://council.lancashire.gov.uk/documents/s34300/Report.pdf

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