Local Authority Service Specification (LASS) Forpharmacysupport to Stop Smoking 2015-2016

Local Authority Service Specification (LASS) forPharmacySupport to Stop Smoking 2015-2016

Contents:

1.Background

2.Service Aims

3.Service Specification

4.Clinical Governance Arrangements

5.Criteria for Eligibility

6.Reporting and Monitoring

Appendix 1PGD for the supply of Varenicline (Champix®)

1.Background

In North Somerset approximately 300 residents die prematurely from smoking-related illness each year. In 2010/11 there were 2046 smoking attributable hospital admissions with an estimated cost of £4.4 million. The estimated cost of lost productivity in the workplace from smoking breaks in North Somerset is £9.2 million. The total cost to the NHS of smoking in North Somerset is £8.5 million. Health damage from second hand smoke is substantial. Smoking is the single greatest cause of premature death and disease in North Somerset. It is the single largest factor in health inequalities and a major driver of poverty. There are an estimated 26,401 smokers in North Somerset and it is estimated that each year smoking costs society approximately £43.6 million.

2.Service Aims

The overall aim of this service is to support the reduction of smoking prevalence in North Somerset and to reduce health inequalities. By supporting adults to stop smoking the service will also help reduce the uptake of smoking in young people.

The Support to Stop Smoking service is a cost effective and evidenced based national programme offering both support and medication to smokers who are motivated to quit. Smoking cessation has been linked to the potential for teachable moments meaning that all healthcare professionals can have a positive impact on a smoker’s decision to stop.

Pharmacies have daily contact with a significant number of smokers and can play a key role in both identifying and referring patients (brief intervention), offering an NHS Support to Stop Smoking service and therefore contribute to the reduction in morbidity and mortality as a result of smoking.

3.Service Specification

Pharmacies participating in this scheme will be expected to deliver the following elements:

Promote the service and identify smokers

• Ensure that all pharmacy staff who have face to face contact with customers have been trained in Brief Interventions (available at no charge from Smokefree North Somerset)

• Advertise the availability of the Support to Stop Smoking service within the pharmacy

• Ensure a smoker does not have to wait more than 2 weeks for a stop smoking appointment and if this is not possible contact Smokefree North Somerset so alternative arrangements can be made.

Behavioural support and medication

• Provide services consistent with the latest NICE guidance in NHS Stop Smoking Services: Service and Monitoring Guidance – 2014andaccurately inform patients about NRT, Varenicline and Bupropion and prescribe as appropriate to smokers being supported by the Support to Stop Smoking advisor. In addition provide supporting information for patients about the relative chances of success of each intervention type e.g. one to one, groups etc. and pharmacotherapy

• On receipt of a referral, the pharmacy based Support to Stop Smoking advisor will confirm the client’s suitability for the programme by assessing motivation and determining whether the client will benefit from intensive support. This may be conducted face to face, by telephoneor using a questionnaire. Clients not yet ready to quit should be provided with brief advice and leaflets and advised to rejoin the scheme when ready to set a quit date. Clients not wanting support to quit cannot receive NRT from the pharmacy scheme but can still buy their NRT

• Pharmacy–based Support to Stop Smoking advisor can host stop smoking groups in-house if they have attended the relevant training in “Running a Stop Smoking Group” provided by the Smokefree North Somerset or equivalent

• Ensure that trained Support to Stop Smoking advisors keep up-to-date. An advisor within the pharmacy is expected to attend at least one update meeting annually and update the rest of the pharmacy re any new information or guidance

• Ensure smoking cessation guidelines are included in written pharmacy protocols

• Refer any smoker who requires more intensive specialist support including but not limited to smokers with mental health problems or learning difficulties, to Smokefree North Somerset Specialist Support to Stop Smokingservice.If a smoker does not want to, is not ready to, or is unable to stop smoking using the Abrupt Quit approach, alternative optionsmay be available via the Specialist Service. Those with known substance misuse issues may be referred to the relevant agencies who are also equipped to deal with smoking

• Monitor, support and evaluate a quitter’s progress, particularly at 4 weeks following the quit date, including those who do not attend (DNA)

• CO testing should be carried out on all smokers as a minimum both a baseline (pre-quit) level and a four week validation (post quit) level this includes those children aged 12 years and over eligible for NRT if Fraser competent

• Complete monitoring forms (IRS) for each person setting a quit date, return all IRS forms after 4 week follow-up, irrespective of outcome to Smokefree North Somerset

• Organise an annual meeting of all pharmacy staff in conjunction with Smokefree North Somerset to review this agreement

• Service provision cannot be subcontracted to other parties and claims made on this basis will not be paid

• Smokefree North Somerset will provide a CO monitor for each pharmacy. The responsibility for keeping the monitor in good working order and arranging to calibrate the monitor if required every 6 months rests with the practice

• Allsupport to stop smoking advisors will be given help and support by the specialist service who will monitor the progress and the quality of the service provided.

E-cigarettes

• Electronic cigarettes are currently not included as pharmacotherapy and are therefore not available on the supply form; however a client can receive behavioural support from the advisor if they purchase their own e-cigs to support their quit attempt.

PGD Varenicline

• We operate a PGD for pharmacists to supply Varenicline in North Somerset. For those pharmacies that wish to participate in the above scheme, the requirement is that they have a trained Support to Stop Smoking advisor based in the pharmacy and that the pharmacist completes the annual pharmacy update training which includes any updates to the PGD training offered by Smokefree North Somerset. They also need to complete the relevant paperwork that supports the PGD delivery online via pharmoutcomesand ensure that they familiarise themselves with any updates. If a pharmacist has received PGD training for Varenicline in another area any training needs will need to be assessed and met before being able to deliver the PGD in North Somerset. The voucher handling fee (Appendix E) will apply.

4.Clinical Governance Arrangements

Support to Stop Smoking services should be delivered according to NICE guidance and in accordance with the Service and Monitoring Guidance – 2014National Centre for Smoking Cessation and Training NCSCT training requirements.An advisor within the pharmacy is expected to attend at least one update meeting annually and update the rest of the pharmacy re any new information or guidance

Clinical Governance

Competence in providing a service is not only facilitated through training but in regular service provision in order to cement learning through practical application of the skills learnt, the expectation therefore is taht advisors see a minimum of 15 smokers during the year pharmacies will be monitored this year against this recommendation with a view to set a minimum number of clients to be seen in next years contract.

Smokefree North Somerset will monitor and review services on a quarterly basis.

The pharmacy will use Smokefree North Somerset incident reporting framework to report any clinical or non clinical risks associated with the provision of this service in a timely fashion.

5.Criteria for Eligibility

All North Somerset pharmacies are eligible and encouraged to provide the Support to Stop Smoking service.

Advisors who have received the Smokefree North Somerset 2 day advisor training for this role from Smokefree North Somerset or an accredited NHS provider can deliver the service provided they have been active in supporting smokers over the last year. Advisors are also encouraged to undertake the free online NCSCT level 1 training within one year of having attended the Smokefree North Somerset 2 day advisor training.

This training and group training will continue to be provided by Smokefree North Somerset at no cost to the pharmacy.

6.Reporting and Monitoring and Payment Arrangements

Smokefree North Somerset will monitor and review services on a quarterly basis and provide a performance report for each pharmacy highlighting the percentage of COverified quit attempts and quit rates.

This is a cost and volume agreement with payments being made as set out below. Whilst pharmacies are encouraged to achieve increasing levels of uptake Smokefree North Somerset will closely monitor activity on a quarterly basis and may cap activity according to budget allocation.

The payment associated with the provision of this service is based on the initial appointment lasting at least 30 minutes and then weekly 10 – 15 minute appointments should be offered for at least 4 weeks after the quit date, thereafter every two weeks up to a period of 12 weeks.

Each pharmacy contracted to provide this service will receive a fee of £30 for every client setting a quit date and who is supported through to the four week follow up stage and if the following criteria have been met:

• Where possible the four week follow-up should be completed face to face and the client’s carbon monoxide level recorded, along with the quit attempt outcome
• If a client defaults from the scheme at any stage after setting a quit date, the advisor must still follow up the client at four weeks, making at least 2 attempts by telephone. These attempts must be recorded on the Individual Record Sheet
• The four week follow up must be completed or attempted at least twice within 4 – 6 weeks of the quit date.

The fully completed individual record sheet ( IRS) monitoring form must be submitted prior to the deadlines which will be available and circulated in due course.

Incomplete monitoring forms will not receive a payment, monitoring forms returned after the six week follow up date will also not receive a payment but will count towards targets.

It is the intention to move towards a paperless system. This will cut down on paperwork and postage costs, help pharmacies meet the DOH deadlines and ensure that pharmacies receive the correct payments. We will therefore be asking some pharmacies to pilot inputting the IRS forms using an online database.

The cost of any pharmacotherapy supplied under the Pharmacy Support to Stop Smoking scheme will be reimbursed (drug tariff cost plus VAT@5%) on a monthly basis, following the receipt of a maximum of 3 supply forms which match a monitoring form. Payment for Varenicline supply will be via Pharmoutcomes.

Payment will only be authorised for claims submitted within 6 months of the medication issue date.

A handling fee of £1 will be paid for each four week supply of medication given to a client where the Support to Stop Smoking advisor is based in a community setting. This fee will be pro-rata accordingly.

Pharmacies will receive a one off payment of £150 if the pharmacy has signed up to and delivered the PGD for Varenicline. In addition there will be a one-off payment of £150 to pharmacies that deliver aVareniclineonly service to clients who are receiving behavioural support via the Support to Stop Smoking Service (StSS) and roving/community advisors. The payment recognises the consultation and continuation time of the pharmacist for this service.

The Contractor is expected to take part in any Smokefree North Somerset audit relevant to this service that may periodically be requested.

Appendix 1 PGD for the supply of Varenicline (Champix®)

Patient Group Direction (PGD) for the supply of VARENICLINE

This Patient Group Direction (PGD) is a specific written instruction for the supply of VARENICLINE to groups of patients within the area covered by NHS North Somerset.

This PGD will enable designated COMMUNITY PHARMACISTS to supply treatment in accordance with the following protocol and the recommendations of the Department of Health and NHS North Somerset’s Medicines Policy.

The majority of clinical care should be provided on an individual patient basis. The supply of medicines under Patient Group Directions should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability.

Background information

This PGD is a written with the objective of allowing the supply of a Prescription Only Medicine (POM) on the NHS by health professionals who do not have prescribing rights.
Varenicline (Champix TM in the UK) was launched as a POM for smoking cessation in December 2006. It was approved for use in Scotland by the Scottish Medicines Consortium in January 2007; and for use in England and Wales by the National Institute of Health and Clinical Excellence (NICE) in July 2007. The main recommendations of the two documents are consistent:
Varenicline is recommended within its licensed indications as an option for smokers who have expressed a desire to quit smoking.
Varenicline should normally be prescribed only as part of a programme of behavioural support.
The purpose of this PGD is to enable a pharmacist working in North Somerset, who has received training and has been assessed as competent, and is working with a smoking cessation practitioner ( formerly known as trained level 2 Smoking Cessation Advisor) to supply varenicline in accordance with the criteria set out for this patient group direction (PGD).
The MHRA have advised that medicines supplied under a PGD would usually be considered to be "dispensed medicines". It is therefore considered appropriate for such medicines to be supplied to patients with the same labelling and other information which they would otherwise receive if the medicine had been supplied against a prescription. In a majority of cases, the pack to be issued under a PGD will need to be labelled to reflect the dose exactly as authorised in the PGD, as if it were being dispensed against a prescription.

1. Clinical condition or situation to which the direction applies

Indication / For adults who are accessing Pharmacy Stop Smoking Services and are in need of pharmacological treatment as an aid to stop smoking
Criteria for inclusion /

• Dependent smoker (i.e. they smoke within 30 minutes of waking up and/or find quitting unaided difficult)

• Smoker, over 18yrs old, who has approached the Stop Smoking Service and who satisfies the criteria for treatment by the stop smoking service and as per the North Somerset Protocol (Appendix 1)
• The patient should set a date to stop smoking. Varenicline dosing should start 1-2 weeks before this date.
• Patient should be willing to continue a course of treatment which includes behavioural support for 12 weeks unless unable to because of side effects
• Valid consent

Criteria for exclusion /

• Patient under 18 years of age;
• Tobacco users not sufficiently motivated to quit
• Pregnancy;
• Breast-feeding;
• End-stage renal disease – creatinine clearance <30ml/min (use with caution in elderly patients, if unsure of renal function refer to a GP.)
• Patients with a history of psychiatric illness, including a history of depression should be referred to their GP.
• Patients with unstable cardiovascular disease.
• Clients with hypersensitivity to varenicline or any of its excipients
• Patients with Epilepsy or history of seizures or conditions that lower the seizure threshold.
• Patients taking medication that lowers seizure threshold

Action if excluded / Explain the reasons for exclusion under the PGD to the patient.Where appropriate ensure they are advised to attend their GP practice to discuss whether treatment by the GP is possible.

2. Description of treatment

Name of Drug & Strength / Varenicline (Champix) 0.5mg and 1mg
Formulation / Film coated Oral Tablets
Method/route / Varenicline tablets should be swallowed whole with water and can be taken with or without food
Dose, dose range, frequency of administration and quantity to supply / Patients should be treated for 12 weeks. There should be clear labelling to indicate instructions to follow for the course.
Days 1 – 3:
0.5 mg (white tablets) once daily
Days 4 – 7:
0.5 mg twice daily
Day 8 to the end of treatment:
1 mg (light blue tablets) twice daily
Patients should be supplied a 14 day initiation pack and should set a quit date 7 to 14 days after initiation;
Only 14-day prescription packs should be used at any one time throughout the quit attempt
Patients should be seen weekly for at least 4 weeks after the quit date;
For patients with moderate renal impairment (creatinineclearance between 30 to 50ml/min) may require a dose reduction to 1mg daily if intolerable side effects are experienced.
Patients who cannot tolerate Varenicline because of adverse effects eg nausea the dose can be temporarily lowered to 0.5mg twice daily. If used, this lower dose should be reviewed at the follow up appointment.
For patients who have successfully stopped smoking at the end of 12 weeks one additional course of up to 12 weeks treatment with varenicline at 1 mg twice daily may be considered based on consultation with the client and as per the NHS North Somerset protocol included in Appendix 1.
Legal status / POM – Prescription only medicine.
Advice to be given to the patient before treatment is provided /

• Patients should be advised to set a quit date 7 to 14 days after initiation;

• The major reasons for varenicline failure are:

- Unrealistic expectations;
- Lack of preparation for the fact that the tablets may cause nausea;
- Insufficient or incorrect use.