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The place of pharmacotherapy products in smoking cessation

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Jennifer Percival, RGN, RM, RHV, Dip Couns, FETC.

Manager, Royal College of Nursing Tobacco Education Project

Tobacco dependence is a chronic relapsing disease. Despite the fact that effective clinical treatments exist many smokers still make unaided attempts to quit. Most smokers want to stop, but find it very difficult because of the powerful addiction related to tobacco use. Only 2-3% of smokers who try to quit unaided succeed, which is why health professionals play such a vital role in offering support (RCP Tobacco Advisory Group, 2000).

Tobacco dependence is a chronic relapsing disease. Despite the fact that effective clinical treatments exist many smokers still make unaided attempts to quit. Most smokers want to stop, but find it very difficult because of the powerful addiction related to tobacco use. Only 2-3% of smokers who try to quit unaided succeed, which is why health professionals play such a vital role in offering support (RCP Tobacco Advisory Group, 2000).

Smoking carries a very high personal risk of illness, including cancer and cardiovascular and pulmonary diseases. Smokers under 35 who do not subsequently quit lose, on average, about eight years of life compared with those who have never smoked (NICE, 2002). Successful smoking cessation results in immediate and long-term health benefits. Benefits accrue at any age, although they are greatest among younger smokers (Consensus Statement on the Treatment of Tobacco Dependence, 2003).

NICE recommendations
In March 2002 the National Institute for Clinical Excellence (NICE) recommended that nicotine replacement therapy (NRT) and the drug bupropion (Zyban) be prescribed to smokers trying to give up, in conjunction with advice and support (NICE, 2002).

These products are considered to be among the most cost-effective health-care interventions. There is currently insufficient evidence to recommend the use of an NRT and bupropion in combination (NICE, 2002).

When deciding which of the available therapies to use and in which order they should be prescribed, practitioners should take into account:

- Intention and motivation to quit

- Likelihood of compliance

- Availability of counselling or support

- Previous use of smoking cessation aids

- Contraindications and potential for adverse effects

- Personal preferences of the smoker.

NICE believes that using these treatments will result in huge long-term savings for the NHS. Health-care professionals must be able to offer accurate information and advice on using NRT, as these products double a smoker's chance of quitting (NICE, 2002).

Nicotine withdrawal symptoms
Many smokers experience serious withdrawal symptoms when trying to quit, because of their dependence on nicotine (Royal College of Physicians, 2000). These symptoms can be frightening if a smoker is not prepared for them or given support to manage them. See Box 1 for symptoms of nicotine withdrawal.

Nurses should reassure clients that these are expected signs of withdrawal that will eventually pass and advise them that pharmacotherapy products will greatly reduce these symptoms and double their chance of long-term quitting.

Nicotine replacement therapy (NRT)
Clinical trials have shown that NRT doubles the chance of success of smokers wishing to stop (West et al, 1998). NRT does not provide a complete replacement for the nicotine obtained from x cigarettes, nor does it eradicate the need for willpower. However, it is effective for managing withdrawal symptoms, while allowing the smoker to concentrate on breaking the social and psychological habits. NRT is not a magic cure but an active facilitator to smokers who are motivated to stop. It is most effective alongside professional advice and support.

NRT provides nicotine in a way that is slower and less satisfying, but safer and less addictive than cigarettes. Unlike tobacco smoke, it does not contain tar and carbon monoxide. It only contains nicotine and there is currently no evidence that nicotine on its own causes cancer.

Very few people become addicted to NRT. Some ex-smokers have continued to use it long-term, but this is mainly due to concern about returning to smoking. For the best results, NRT should be used in sufficient quantities and for ample time.

Smokers should follow the instructions on the package or seek advice from a member of their primary health-care team or smoking cessation service if they require more information.

Availability and cost
The availability of NRT products varies world wide. In some countries it can be bought over the counter from pharmacies; in some it is available on general sale in shops and supermarkets and in others it is only available on a doctor's prescription.

In the UK, NRT can be purchased over the counter in pharmacies, on general sale in supermarkets and shops or can be provided on NHS prescription and will therefore be free of charge if the user is exempt from prescription charges. There are some local variations on the amount of NRT made available on prescription and some areas require the smoker to also sign up for attendance with an NHS smoking-cessation service. NICE (2002) recommends that a relapsed smoker should wait for a period of six months before a further course of treatment be made available on the NHS. Some areas have extended this period to a year. It is therefore important to assess the patient's motivation and readiness to change before they embark on a course of treatment.

Which product?
There are currently six types of NRT products available, with more formulations being developed by manufacturers. They are:

- Chewing gum

- Patches

- Nasal spray

- Sublingual tablet

- Inhalator

- Lozenges.

As yet there is no controlled trial evidence favouring any one form. Since they result in similar success rates, the choice is a practical and personal one. However, the way in which nicotine is delivered and controlled varies between products:

Nicotine patch
This is most suitable for those with a regular pattern of smoking as nicotine delivery is continuous during the time the patch is worn. There are two types: 16-hour and 24-hour. The 24-hour patch can be useful for the control of cravings on waking, or for people who smoked in the night, but a continuous dose of nicotine may cause sleep disturbances.

In contrast the 16-hour patch is not worn overnight but is replaced each morning. The nicotine-free period overnight can reduce sleep disturbance. Each patch is available in three strengths, which are intended to be used in a gradual step- down process. The recommended time for using a patch is 12 weeks.

Occasionally the patches can cause local skin irritation, although this can pass after a few days. It is important to rotate the site of the patch daily. The patch offers a discreet method of nicotine delivery and is most helpful for a smoker with a low behavioural dependence on cigarettes.

Recent research has shown that smokers trying to quit are more likely to experience a relapse in the afternoon or evening, contrary to the commonly held belief that the morning is the most vulnerable time (Ussher and West, 2003).

Nicotine gum
This comes in 2mg or 4mg doses and in a variety of flavours. It is essential that the gum is used in a 'chew-rest-chew' technique. The manufacturers recommend this as any nicotine that is swallowed is wasted and can cause unpleasant side-effects.

The correct technique is to chew the gum slowly to release the nicotine and, once the taste becomes strong, chewing should stop. This allows the nicotine to be absorbed through the oral mucosa. The gum should then be 'parked' between the gum and cheek and when the taste has faded it should be chewed again. The 2mg gum is most effective for smokers of 20 or fewer cigarettes a day and the 4mg for those who smoke more than 20 a day.

Nicotine nasal spray
A small bottle of nicotine solution delivers a dose of nicotine in a liquid spray to each nostril. It is absorbed more quickly than other products. This form of NRT may suit more highly addicted smokers and is recommended for smokers of more than 20 cigarettes a day and/or for those who light up within 30 minutes of waking. This product can cause local irritant effects such as runny nose, sneezing and throat irritation. The side-effects should lessen with use, usually after a few days.

Nicotine inhalator
This consists of a plastic mouthpiece, into which a cartridge of nicotine is inserted. Smokers draw on it like a cigarette. Despite its name, the nicotine does not reach the lungs, but is absorbed via the buccal mucosa. This product is most appropriate for smokers of 20 or fewer cigarettes a day. It is a unique form of NRT as it addresses both the physical and behavioural aspects and is particularly useful for smokers who miss the hand-to-mouth activity of smoking.

Nicotine sublingual tablet
When placed under the tongue this delivers a 2mg dose of nicotine. The tablet dissolves gradually within 30 minutes. The nicotine is absorbed via the oral mucosa. This product is suitable for both high and low dependency smokers by using either one or two tablets per dose. It should not be sucked, chewed or swallowed as this prevents the absorption of nicotine.

Nicotine lozenge
Available in three different strengths: 1mg, 2mg and 4mg, the 1mg lozenge is most effective for smokers of 20 or fewer cigarettes a day, the 2mg for those who smoke after 30 x minutes of waking up and the 4mg for those who normally smoke within 30 minutes of waking up. The technique for using the lozenge is the same for all strengths. It should be sucked until the taste becomes strong. It should then be parked between the gum and cheek until the taste has faded. It should then be sucked again. This 'suck and park' technique should continue until the lozenge has dissolved completely.

Who can use NRT?
NRT can be used by all smokers over 18, unless there are specific medical reasons for not doing so. Although most NRT research has been carried out on people who smoke at least 15 cigarettes a day, research trials have proved that the patch and 2mg gum are just as effective with lighter smokers.

Who should not use NRT?
There are some contraindications and cautions relating to the use of most NRT products. For example, in:

- Pregnancy

- Breastfeeding

- Clients under 18 years of age

- Clients with cardiovascular disease

- Clients with active peptic ulcers

- Clients with hyperthyroidism

- Clients with diabetes mellitus

- Clients with severe renal or hepatic impairment.

Expert opinion denotes that NRT is much safer than continuing to smoke (Jorenby, 1999).

A risk-benefit analysis may be needed for young and for pregnant smokers and those with specific diseases. Medical supervision is recommended for smokers in these groups. Guidance on this may be included by manufacturers in some countries and for some products in the summary of product characteristics.

For example, the use of the microtab sublingual tablet is allowed during pregnancy with medical support and if the woman would be unable to stop smoking without pharmacotherapy.

Risks of NRT tobacco cessation treatments
Most smokers can safely use nicotine medications. The only contraindication involves patients with hypersensitivity or allergy to nicotine or to any other components of the delivery system. The risk of dependence on nicotine medications is low when using the gum, inhaler and transdermal nicotine, but may be of concern with nasal sprays.

Even for smokers who continue smoking while taking NRT, the combination appears to be relatively safe. In fact, several studies explicitly used NRT with continued smoking as a harm-reduction strategy and reported no significant adverse events. There are no known deaths reported in the literature due to nicotine medications (Jimenez-Ruiz et al, 1998).

Period of use
Smokers derive the greatest benefit from taking the full 10-12 week course of NRT, as recommended by the manufacturers.

The future of NRT
A recent paper by McNeill et al (2001) discusses the regulation of nicotine replacement therapies and gives a critique of current practice. This paper argues that the current regulatory framework restricts access to NRT without adequately considering that the likely consequence is continued dependent use of a far more harmful and widely available version of the same drug: tobacco.

McNeill et al also argue that minors, pregnant smokers and smokers with cardiovascular disease (CVD) should be allowed to use NRT and that these products should be made as widely available as cigarettes.

Bupropion
Bupropion (Zyban) is a non-nicotine smoking cessation aid, which is licensed as a prescription-only drug. In the USA, bupropion is also used as an antidepressant and licensed as Wellbutrin. It is a relatively weak but selective inhibitor of the neuronal re-uptake of dopamine and noradrenaline. The exact mechanism of action is unclear, but as with NRT, cravings are reduced (NICE, 2002).

Bupropion is recommended for use with motivational support in nicotine-dependent clients. Research has confirmed that it is an effective treatment for tobacco dependence with the 12-month continuous abstinence rate being 23% in one comparative clinical trial (Jorenby, 1999).

Unlike in NRT the smoker continues to smoke during the first week of treatment. On the seventh day of treatment, daily medication is increased from 150mg to 300mg. However, it is recommended that older clients and those who have to take special precautions should remain on the lower dose throughout treatment.

The full course of bupropion lasts for eight weeks. Its use is associated with a dose-dependent risk of seizure of 0.1% (1 in a 1000). Bupropion is contraindicated for clients with a history of seizures, those suffering from bulimia or anorexia nervosa and in clients on monoamine oxidase inhibitor antidepressants. It is contraindicated in those with head injury or cerebral tumour, severe liver disease or those withdrawing from diazepam or alcohol.

Special precautions are also needed when the client is taking other medications which may lower the seizure threshold. These include antidepressants, antimalarials, antipsychotics, theophylline, oral hypoglycaemics, insulin and systemic steroids.

There have not been any studies using bupropion in pregnancy, although animal studies have not shown evidence of harm to the fetus. The manufacturer advises that women should not take bupropion while breastfeeding.

Bupropion use is associated with minor side- effects such as dry mouth, insomnia, drowsiness, skin disorders and nervous system disturbances such as headache and dizziness. Adverse event reporting has been in line with expected incidence of side-effects.

Adverse event reporting has been in line with the expected incidence of side-effects, despite negative media reports (NICE, 2002; Percival, 2002). To put adverse events in context, tobacco dependence kills half of all regular smokers, and smoking cessation for those not ill already may be life-saving.

The role of the nurse
Offering motivational support and counselling is essential to helping a smoker through the process of stopping. The smoker will have to change their lifestyle and set routines and habits, which can take time. It is therefore more important to let the person describe their situation and experiences than give advice.

Although research trials demonstrate the positive results that can be achieved, success rates are relatively small on an individual basis (Thorax, 1998). Some professionals may be put off by this, but even achieving a 5% success rate would, if reproduced internationally, have a huge impact on reducing smoking prevalence. The benefits of cessation go far wider than the individual. Each pregnant woman who gives up for good improves not only her own health but that of her family. Each parent who stops smoking improves the chances of their children choosing not to take up the habit.

Cost-effectiveness
Helping smokers stop is extremely cost-effective as smoking is associated with over 50 diseases. Stopping smoking significantly reduces the risks. For example, the risk of heart attack after the first year of stopping smoking falls to about half that of a smoker (US DHSS, 1990). The potential savings to the NHS drugs bill are considerable.

Over 80% of patients currently prescribed statins to lower their blood pressure would fall below the threshold if they stopped smoking. In 2000 the NHS spent 12 times as much on statins (lipid-regulating drugs) as on smoking cessation, even though smoking cessation is around 17 times more cost-effective (West et al, 2000).

Conclusion
Addressing the subject of smoking with patients, however briefly, definitely saves lives, prevents unnecessary disability and disease and saves the NHS money.

Using one of a proven range of effective treatments doubles a person's chance of success in quitting. Every health professional needs to know and apply the basic information about NRT and bupropion. The new, larger health warnings on cigarette packets are driving more and more smokers to seek help. Nurses need to be prepared to listen and ask questions that help patients help themselves. u

- The next paper in this series will examine the impact of new health warnings on cigarette packets on smokers and on health-care workers

ACTIVITY 1
Examine the prescribing practices around NRT and bupropion (Zyban) in your clinical area. Compare and contrast these with recommendations in the NICE guidance (2002).

ACTIVITY 2
Source NRT product samples and manufacturer's literature for each of the formulations currently available to use with smokers unsure of which product to use.

ACTIVITY 3
When supporting someone through a quit attempt, ask them to list why they want to stop and what may get in their way. This helps them to recognise that they need to make further preparation.

Useful information
If you would like to find out more or get involved with UK tobacco control activities, contact Action on Smoking and Health (ASH) on 020-77395902or www.ash.org.uk.

Further reading
Royal College of Nursing. Clearing the Air 2 Smoking and tobacco control - an updated guide for nurses.

RCN members can obtain a copy from RCN Direct 0845-7726100.

Non-RCN members can obtain a copy from 020-88673235.

Consensus Statement. (2003)Consensus statement on the treatment of tobacco dependence. Journal of Clinical Psychiatry 18: 1, 2-3.

Jimenez-Ruiz, C., Kunze, M., Fagerstrom, K.O. (1998)Nicotine replacement: a new approach to reduce tobacco-related harm. European Respiratory Journal 11: 473-474.

Jorenby, D.E., Leischow, S.J., Nides, M.A., et al. (1999)A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. New England Journal of Medicine 340: 9, 685-691.

McNeill, A., Foulds, J., Bates, C. (2001)Regulation of nicotine replacement therapies (NRT): a critique of current practice. Addiction 96: 1757-1768.

National Institute for Clinical Excellence. (2002)Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. Technology Appraisal Guidance No. 39. London: NICE. www.nice.org.uk

Percival, J. (2002)Responding to patients presenting scare stories. Practice Nursing 13: 6.

Royal College of Physicians Tobacco Advisory Group. (2000)Nicotine Addiction in Britain. London: Royal College of Physicians.

Thorax. (1998)Smoking cessation guidelines and their cost-effectiveness. Thorax 53: S5 (part 2), S11-S16.

US Department of Health and Human Services. (1990)The Health Benefits of Smoking Cessation: A report of the Surgeon General. Washington, DC: US DHHS.

Ussher, M., West, R. (2003)Diurnal variations in first lapses to smoking for nicotine patch users. Human Psychopharmacology Clinical and Experimental 18: 5. www.interscience.wiley.com

West, R., McNeill, A., Raw, M. (2000)Smoking cessation guidelines for health professionals: an update. Thorax 55: 987-999.

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