Guidelines for Nicotine Replacement Therapy Issuing of Vouchers For use by the Stop Smoking in Pregnancy Service DOCUMENT CONTROL: Version: 1 Ratified by: Clinical Effectiveness Committee Date ratified: 06 May 2014 Name of originator/author: Operational Team Manager, Smoking in Pregnancy Service Name of responsible Medicines Management Committee committee/individual: Date issued: 02 June 2014 Review date: May 2017 Target Audience All staff
Introduction Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. This Standard operating procedure (SOP) outlines the procedures, for the staff within the smoking in pregnancy service and appropriate staff within the 0-5 health visiting pathway, to issue nicotine replacement therapy (NRT) vouchers to client groups, in Doncaster. The voucher will be redeemed at participating pharmacies in the Doncaster area. Purpose The purpose is to outline the assessment criteria for issuing the NRT vouchers to pregnant ladies who smoke and their significant others. This SOP will also extend to:- Women who are post-delivery up to the child 1 st birthday. Pre-conceptual women if the woman has had an adverse outcome to a previous pregnancy i.e. miscarriage, still birth Scope Only clients receiving stop smoking support from the RDaSH Stop Smoking in Pregnancy Service will be issued with an NRT voucher. Clients must meet the support with medication criteria. The vouchers enable the supply of eight NRT products(single of dual therapy only considered): I. Nicorette invisi patch 25mg &15mg & 10mg. II. NiQuitin patch 21mg & 14mg & 7mg III. Nicotinelle patch 21mg & 14mg & 7mg IV. Nicorette gum 2mg & 4mg. V. Nicorette Quickmist 1mg/spray VI. Nicorette Inhalator 15mg VII. Nicorette Cools 2mg & 4mg VIII. NiQuitin Minis 1.5mg & 4mg
Applicable Regulations and Policies I. Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities (NICE 2008). Visit: http://publications.nice.org.uk/smoking-cessation-services-ph10 II. III. Local Stop smoking Services: Service delivery and monitoring guidance 2011/12. (Department of Health 2011). Visit: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/docum ents/digitalasset/dh_125939.pdf RDaSH Patient Identification Policy. Who will Undertake the Procedure All specialist and advisor staff working for the RDaSH Stop Smoking in Pregnancy Service who have completed the service s Level 2 Intermediate Training and deemed competent by RDaSH service operational team manager. All appropriate staff working within the 0-5 Health Visiting Pathway who have received Level 2 Intermediate Training and deemed competent by RDaSH operational team manager. The community pharmacist (or appropriately trained pharmacy staff under their supervision) registered currently GPhC and working with a Doncaster community pharmacy, will be responsible for issuing the nicotine replacement products and faxing a copy of the voucher to the service for invoicing. The GP copy will then need to be sent to the GP practice. The Operational Team Manager is responsible for holding/monitoring a training log for all trained advisors and community pharmacists.
Procedure Voucher 1 I. Check the client s identification in accordance with the Trust s Identification Policy and against the record on SystmOne. II. Check the client s eligibility against the inclusion criteria Inclusion Criteria Registered with a local area General Practice Pregnant Post-delivery including breast feeding Significant others of smoking pregnant ladies including post delivery partners Committed to completing the stop smoking in pregnancy program Agree to set a quit date Age 12 years plus if accompanied by a parent or guardian or if attending alone is assessed as Fraser competent see trust consent policy for further information. III. IV. Assess the client for motivation and commitment to the process of quitting, using a scaling technique of 1-10. Assess the clients dependency on nicotine with the Fagerstrom Questionnaire (see appendix 1) Smokes within 5 minutes of waking Smokes within 6-30 minutes of waking Smokes within 30-60 minutes of waking Smokes within 60 minutes of waking Less than 10 cigarettes per day 10-20 cigarettes per day 20-30 cigarettes per day More than 30 cigarettes per day Medium High Very High Very High Medium High Very High Very High Low Medium High Very High Low Medium High Very High a. Clients with low dependency on nicotine, may benefit from using NRT occasionally. b. If smoking at regular intervals during the day and smoking within 30 minutes of waking all products can be considered including dual products, in line with NICE guidance.
c. Pregnant women metabolise nicotine 60% faster than the normal population group and so a standalone product may not deliver sufficient levels of nicotine. V. Discuss all appropriate products, including side effects and usage on first session and give supporting information to client to consider until next subsequent session. (If in exceptional circumstances the client has demonstrated an imminent commitment to quit i.e. they have been through a stop smoking service before, an NRT voucher can be issued) VI. On the second session discuss with client the choice of NRT products as per previous visit / clinic session and issue NRT voucher 1. VII. One week supply of NRT to be issued on Voucher 1 and recorded in the client s clinical record (System 1). Records to include: a. Voucher number b. Brand, strength and quantity VIII. Dual products can be given on one voucher if deemed necessary and appropriate in accordance with the following guide for assessment on nicotine dependency. Dual products NB. Second product (oral) can only be used in conjunction with a patch. 1 st Product Supplementary product (only one can be issued) Nicotine patches (Niquitin, Nicorette, Nicotinell) (24 hour patches only to be used for 16 hours for pregnant and breast feeding women) Nicorette Quick Mist mouth Spray 1mg Nicorette Inhalator 15mg Nicorette Cools 2mg and 4mg Gum 2mg and 4mg (do not use Liquorice flavour) Niquitin Mini s 1.5mg and 4mg IX. Vouchers must not be issued if the client does not demonstrate a willingness to the process of quitting. X. Vouchers must not be issued if the client meets (or is unable/unwilling to answer) any of the exclusion criteria in the table below, without referral to the GP NRT Voucher Exclusion Criteria The client has a history of: Unstable angina, Myocardial Infarction (heart attack) or abnormal heart rhythm within the last A stroke or transient ischaemic attack (TIA or mini-stroke) within the last Hyperthyroidism (over active thyroid) not controlled by medication Phaeochromocytoma (rare tumour of the adrenal gland) The client takes clozapine (Clozaril, Denzapine, Zaponex) ropinirole (Requip), theophylline (Nuelin SA, Slo-Phyllin, Uniphyllin Continus) or aminophylline.
XI. Complete the first 3 sections of the voucher (see appendix 2), i.e. the client details, the advisor details and the product/dose and quantity (see table below). Product Cigarettes smoked/day Dose Max supply per voucher (1 week) Max supply per voucher (2 week) Nicorette Invisi 10 or more 25mg 7 14 Patch Less than 10 15mg 7 14 Less than 10 (if preferred by client) 10mg 7 14 Niquitin 24 hour patch Nicotinell 24 hour patch 10 or more 21mg 7 14 Less than 10 14mg 7 14 Less than 10 (if preferred 7mg 7 14 by client) 20 or more 21mg 7 14 Less than 20 14mg 7 14 Less than 20 (if preferred 7mg 7 14 by client) Nicorette Gum More than 20 4mg 105 210 20 or less 2mg 105 210 Nicorette QuickMist N/A 1mg/sp ray 13.2ml (one bottle) 24.6 ml (Duo pack only) Nicorette Inhalator N/A 15mg 36 cartridges 56 cartridges NiQuitin Minis More than 20 4mg 120 180 20 or less 1.5mg 120 180 Nicorette Cools More than 20 4mg 80 160 20 or less 2mg 80 160 XII. XIII. XIV. Issue the bottom 2 copies of the voucher (green and blue copies) to the client and retain the top white copy for record keeping purposes, vouchers cannot be issued to a client representative. Vouchers can be redeemed at participating pharmacies only (see attached list) and the products will be supplied under the supervision of a pharmacist. Inform the client of the participating pharmacies where the voucher can be redeemed.
Voucher 2-4 Vouchers will be issued on a weekly basis for the first. Assessment completed on each session to check for compliance of quit date and correct usage and side effects. Second and subsequent vouchers to be issued once the client has demonstrated all the above criteria Dual products will be reissued in accordance with usage (i.e. may not necessarily be issued on a weekly basis, if client has sufficient quantities from previous voucher) Voucher 5-8 Vouchers will be issued on a fortnightly basis to a maximum total of 1 supply. Assessment completed on each session to check for compliance of quit date and correct usage and side effects. Second and subsequent vouchers to be issued once the client has demonstrated all the above criteria Dual products will be reissued in accordance with usage (i.e. may not necessarily be issued on a weekly basis, if client has sufficient quantities from previous voucher) NB/ If a client is assessed as needing more than the 1 supply of NRT discuss with Operational Team Manager or Specialist Advisor for discussion with Commissioners NB/ Products will be given according to need for example, may not be given out on a weekly basis if the client has sufficient amounts of the product left over from previous voucher.
Course of Treatment: Clients who smoke 20 cigarettes or more per day are recommended to follow the course of treatment as follows: Nicotinell 24 hour patch (up to 12 week course) NB/ Only use for 16 hours per day 21mg 14mg 7mg Clients who smoke less than 20 cigarettes per day are recommended to follow the course of treatment as follows: Nicotinell 24 hour patch (up to 12 week course) NB/ Only use for 16 hours per day 14mg 7mg This is an eight week course of treatment Clients who smoke 10 or more cigarettes per day are recommended to follow the course of treatment as follows: Nicorette Invisi Patch (up to 12 week course) Niquitin 24 hour patch (up to 10 week course) NB/ only use for 16 hours per day 25mg 15mg 10mg 21mg 14mg 7mg 8 weeks 6 weeks Clients who smoke less than 10 cigarettes per day are recommended to follow the course of treatment as follows: Nicorette Invisi Patch (up to 12 week course) 15mg 10mg 8 weeks Niquitin 24 hour patch (up to 10 week course) NB/ only use for 16 hours per day 14mg 6 weeks 7mg This is an 8 week course of treatment
Side effects Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include the following: dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate; and increased appetite or weight gain. Common side effects include local irritation, for example irritation of the skin around the site of the patch or oral irritation if using an oral product. More serious side effects are rare. For more detail on the potential side effects of individual products visit the Electronic Medicines Compendium at: http://www.medicines.org.uk/emc/default.aspx Adverse Reaction Procedure Compliance and adverse reactions will be monitored at the weekly follow-up. Clients will be advised regarding the correct usage of the medication to reduce the likelihood of an adverse reaction (e.g. advised to change the site of a patch). Significant adverse reactions will be recorded in the client record and the client will be advised to stop taking the medication immediately and to contact their GP. The incident will be escalated through the providers incident reporting system. Staff will report any adverse reactions in accordance with the UK Adverse Drug Reaction Reporting Guidelines (Yellow card system available at; http://www.yellowcard.gov.uk/). The MHRA recommend all adverse reactions to black triangle and OTC medications should be reported. Follow-up Advice Discuss the use of NRT and any side effects at each weekly contact, advise the client to call the service 01302 876 290 or get in touch via Facebook/ Twitter or on the Website, if they need advice in addition to the weekly visit. Safekeeping of Vouchers Vouchers will have serial numbers and each advisor will sign out their allocated serial numbered vouchers. Voucher number must be included in the clients notes. Vouchers should be written in the presence of the client and given directly to the client. Unused vouchers must be stored each night in a safe place. The service s copy of a used voucher must be passed onto admin as soon as is practicable. If a mistake is made on a voucher which renders it void (note void number in client s notes and pass void voucher to admin staff), Advisors must not dispose of void vouchers themselves.
Supporting Materials Nicotine Replacement Therapy Client Assessment Form (the voucher). Definitions SystmOne is RDaSH Stop Smoking in pregnancy Service dedicated electronic client record.