A new model for prescribing varenicline

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1 Pharmacist Independent Prescribers in partnership with A new model for prescribing varenicline Dear Stop Smoking Advisor You will be aware of the stop smoking drug varenicline that goes under the brand name Champix and that it is another support option for your Stop Smoking clients, available as an alternative to nicotine replacement therapy. Why is this needed? Because varenicline (Champix ) is a Prescription Only Medicine you are not been able to issue it either directly or by voucher to the client, but have had to refer them to their GP. Some advisors have experienced problems with such referral, including Delay of up to two weeks for the client to access the drug Reluctance by some GPs to prescribe this drug Loss of the client to your Stop Smoking Programme, and so loss of service fee What has changed? To overcome these problems we have introduced a new model for prescribing varenicline. You can now refer the client to a team of pharmacist independent prescribers (PIPs) who will carry out a telephone consultation, and then issue prescriptions for varenicline as appropriate. This system has been successfully trialled since December 2011 and the advantages have been Client consultation and receipt of prescription within a couple of days Prescribing by clinicians with specific training and experience of the drug Feedback between prescriber and yourself as advisor Client continues to receive your support You continue to receive all usual fees Increased use of varenicline and increased quit rates Audit of the efficacy and safety of varenicline When can I start? This service is now live and available to all Stop Smoking Advisors contracted by Smokefree Bristol. What do I do? Included with this letter are the referral forms, an explanatory flowchart, and client information sheet. Remember that clients should still be offered the whole range of support options, and varenicline is not intended to replace NRT. However, if you and the client decide this is the preferred option then complete the varenicline Client Assessment and the varenicline Referral forms, and fax to

2 What happens next? The client will be contacted within two working days. If varenicline is not appropriate the prescriber will contact you and refer the client back to you. Otherwise a prescription will be posted to the client or faxed to the pharmacy of their choice. The prescriber will contact the client a week after starting the drug to review treatment. Three more prescriptions for the full 12 week course posted to client s pharmacy. Client must continue to keep appointments with you, their Stop Smoking Advisor. What about our Stop Smoking Advisor fees? Remember to still complete and send off your claim forms in the normal way. The only thing you will not be doing is issuing NRT either directly or by voucher. Where can I go for more information? To contact the prescribing team at any time either with queries about procedure, or concerns about an individual client you can fax a message to the PIPscript number If you have clinical questions you can contact the prescribing lead Chris Howland-Harris either by chris.howland-harris@nhs.net or on For any other queries you can contact the Smokefree Bristol team on

3 Varenicline Referral Pharmacist Prescriber This client is currently attending a community stop smoking group or clinic on a weekly basis and is receiving behavioural support from a stop smoking advisor. Please would you contact them to assess suitability for varenicline (Champix) and issue a prescription if clinically appropriate. Client Name Date of Birth Address GP Practice name I consent for this form to be sent outside the NHS for contact by a pharmacist prescriber for the purpose of assessment for suitability for Champix to be prescribed: Client Signature: Telephone Number Date: Best time to call Client Information Prescriber will telephone client: 1. Within 2 working days of referral date for initial assessment 2. One week after 1 st prescription issued to assess how client managing with Champix. 3. At 12 weeks from initial contact to check completed medication and quit status Client must continue to attend support sessions with the stop smoking advisor. To be completed by Stop Smoking Advisor Advisor name Date of client attendance Group/clinic/pharmacy client attending Advisor Signature Advisor contact Tel no. Advisor Fax Number: If the client is suitable for varenicline, the first prescription is the starter pack as detailed below. It will normally be posted to the client (although it can be faxed to the pharmacy if there would otherwise be an unacceptable delay) 1 st script = Starter Pack 11 x 0.5mg tablets and 14 x 1mg tablets 2 weeks supply (25 tablets) Once the starter pack is issued, the prescriber will normally contact the client after one week to check progress. If appropriate to continue, the prescriber will then post three further prescriptions to the pharmacy to be issued as follows: 2 nd script = 1mg twice daily MAINTENANCE 2 weeks (28 tablets) 3 rd script = 1mg twice daily MAINTENANCE 4 weeks (56 tablets) Final script = 1mg twice daily MAINTENANCE 4 weeks (56 tablets) ******FAX TO: ******

4 Varenicline Client Assessment Client Name: Date: Absolute contraindications: (If YES to 1. or 2. then Varenicline cannot be considered) 1. Under 18yrs of age? No 2. Pregnant, breast-feeding or trying to get pregnant? No Necessary: 3. A regular smoker? Yes 4. Strongly motivated to quit? Yes For consideration by the prescriber: 5. Chronic kidney disease (or over 70yrs age)? (May require dose adjustment in CKD3b or CKD4) 6. History of severe depression or severe psychiatric illness? (e.g. Sectioned, admitted, thoughts of or attempted self harm) 7. Heart disease or stroke? (Patient should notify any new or worsening symptoms) 8. Epilepsy? (Varenicline has not been tested in patients with epilepsy). 9. Injecting insulin? (increased risk of hypoglycaemia, low blood glucose) 10. Does the patient drive for a living?(varenicline may have a mild affect on ability to drive or operate machinery) Is the client being prescribed any of the following? Theophylline Warfarin Cimetidine Insulin Varenicline has no drug interactions, but stopping smoking may alter metabolism of drugs which may necessitate dosage adjustment. Depresssed mood, rarely including suicidal ideation and suicide attempt, may be a sympton of nicotine withdrawal. In addition, smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness (eg. depression). Patient has been advised to discontinue treatment and seek prompt medical advice if they develop agitation, depressed mood, or suicidal thoughts. Patient supplied with information leaflet. Yes Yes Start taking varenicline 1-2 weeks before agreed quit date Dose: 0.5mg od for 3 days, then 0.5mg bd, for 4 days, then 1mg bd If patient cannot tolerate side effects dose may be reduced to 0.5mg bd for duration of course. CKD3 with side effects continue at 1mg od CKD4 dose 0.5mg od 3 days then 1mg od.

5 Pharmacist Independent Prescribers in partnership with Varenicline (Champix ) client information What is Varenicline? Varenicline is the drug in the prescription-only medicine Champix, designed specifically to help people stop smoking as part of a smoking cessation programme. The Stop Smoking Advisor can refer you for consultation with a prescriber who will arrange treatment. The treatment is a 12 week course of tablets in addition to reviews with your Stop Smoking Advisor. How does Varenicline work? Varenicline can help relieve the craving and withdrawal symptoms associated with stopping smoking. Varenicline also reduces the effects of nicotine and the enjoyment you feel from smoking tobacco. Who can take Varenicline? Varenicline is suitable for someone motivated to quit. It should not be used by anyone under 18 years of age, or anyone who is pregnant, trying to get pregnant, or breastfeeding. It may not be suitable for someone who has had severe depression or other psychiatric illness the prescriber will discuss this with you. How do I take Varenicline? You start taking Varenicline before you quit smoking. This allows time for the drug to build up in your body, and it gives you time to prepare yourself for quitting. For the first 3 days you take a 0.5mg tablet once daily. From days 4 to 7 you take a 0.5mg tablet twice daily. Following that you remain on the treatment dose of 1mg twice daily for up to 12 weeks, one tablet in the morning and one in the evening. It is important to take the tablets with food, and with plenty of water. When do I stop smoking? Ideally you should stop smoking before the end of the second week of treatment usually between days 8 and 14. Some people find they cut down and stop automatically, while others have to make a conscious decision to stop it is different for everyone. What side effects might I experience? The most common side effect for Varenicline is nausea. Other common side effects include headaches, difficulty sleeping and vivid dreams. Taking Varenicline with food can help reduce nausea, and to reduce insomnia and disturbed dreams take the second tablet early evening rather than bedtime. Varenicline can rarely cause dizziness and sleepiness, in which case you should not drive or operate machinery. Giving up smoking with or without treatment can cause various symptoms including changes of mood (like feeling depressed, irritable or anxious), sleeplessness, difficulty concentrating and increased appetite. If you develop agitation, severely depressed mood, or suicidal thoughts you must stop the medication and speak to your doctor. Can I take Varenicline with my other medications? Varenicline has no significant drug interactions. However, stopping smoking (with or without varenicline) may alter the way other medications work (eg theophylline, warfarin and insulin) so dose adjustment may be necessary in some cases. You should be advised by your prescriber or pharmacist. 3-Apr-2012

6 Week 1 Client attends community stop smoking group, clinic or pharmacy and would like to use varenicline Stop Smoking Advisor (SSA) completes referral form and faxes to Pharmacist Independent Prescriber (PIP) PIP phones client within 48hrs of fax for telephone consultation to assess suitability for varenicline Suitable PIP posts 2/52 Rx to client and reports back to SSA Unsuitable or unable to contact Weeks 2 to 7 Client attends weekly sessions and still committed to quitting SSA assesses client progress in line with current STS PIP phones client one week after expected start date for assessment. OK to continue PIP sends three post-dated scripts for 2/52, 4/52 and 4/52 to client s nominated pharmacy, with covering letter No contact or not continuing PIP contacts SSA to advise Client collects Rxs from pharmacy as needed Make three at temps to contact client, then advise PIP that client is lost to follow-up. PIP will attempt contact, and then send letter giving notice that the scripts will be cancelled if no contact within one week (or otherwise at PIP s discretion) Week 12 PIP phones client at 12/52 to check completed medication, assess progress and quits status

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