NSW Health - Guide for the management of nicotine ......Health to achieve its goals of reducing the...

Summary of evidence

Guide for the management of nicotine dependent inpatients

NSW HEALTH DEPARTMENT

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© NSW Health Department 2002

SHPN: (THU) 020009

ISBN: 0 7347 3385 2

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January 2002

This document has been developed to assist clinicians(doctors and nurses) manage nicotine dependence andtreat nicotine withdrawal in patients admitted toNSW Health facilities.

Smoking is recognised as a leading preventable causeof morbidity and premature mortality particularlyfrom cancer, cardiovascular disease and chronicobstructive pulmonary disease (COPD). Nicotine is the psychoactive drug within tobacco that affectsmood and performance. Such are the addictiveproperties of nicotine absorbed through thepulmonary circulation that the World HealthOrganisation has recognised that smoking is achronically relapsing condition warranting treatmentand support from all health care systems.

The Guide for the management of nicotine dependentinpatients – Flowchart has been developed inconsultation with doctors and nurses as a practicalreference tool intended for use on the wards in NSW Health facilities. It outlines the main steps in identification, treatment and referral for patients who smoke.The Summary of evidence provides moredetailed information including the pharmacology ofnicotine, assessment of dependence, pharmacotherapyand referral.

The Guide for the management of nicotine dependentinpatients has been developed within the context ofthe ‘NSW Health Smoke Free Workplace Policy’.This‘Policy’ provides a supportive environment for NSWHealth to achieve its goals of reducing the harmsassociated with tobacco use and promoting health bythe provision of smoke free environments and deliveryof appropriate interventions to those who smoke.

It is recommended that Area Health Services developspecific protocols that are appropriate for their localsettings to clarify role delineation to ensure promptdelivery of treatment to patients.

This document provides a bold and innovativeresponse to the issue of smoking and caring forsmokers in public health facilities. I believe it isground breaking in its scope and hope that it willencourage others to follow this approach. I commendthis document to you.

Yours sincerely

Dr Greg StewartA/Deputy Director General Public Healthand Chief Health OfficerNSW Department of Health

NSW Health Guide for the management of nicotine dependent inpatients – Summary of evidence i

ForewordGuide for the management of nicotine dependent inpatients

Guide for the management of nicotine dependent inpatients – Flowchart .................................................iv

01 Rationale ...........................................................1

02 ‘NSW Health Smoke Free Workplace Policy’(1999) ................................................................2

03 Burden of disease caused by tobacco smoking ....3

04 Prevalence of smoking ...................................... 4

Prevalence of inpatient smoking.........................4

05 Relationship between tobacco use,substance-use disorders and mental health ..........5

06 Identification of smoking status ..........................6

07 Brief intervention ............................................. 7

08 Nicotine ............................................................8

Pharmacology ...................................................8

Manipulation of dose .........................................8

Nicotine dependence .........................................9

Assessment of nicotine dependence ....................9

Nicotine withdrawal.........................................10

Nicotine toxicity............................................. 10

09 Nicotine Replacement Therapy (NRT)............11

Dosage............................................................ 11

Combination therapy .......................................12

Contraindications .............................................12

Directions for use of NRT products .................12

10 Bupropion ...................................................... 13

Contraindications .............................................13

11 Discharge and referral ......................................14

Quit plan .........................................................14

Relapse ............................................................14

12 Frequently asked questions about patient groups and pharmacotherapy............................15

Is NRT suitable for cardiovascular patients?..... 15

Is NRT safe for pregnant or lactating women? 16

Is pharmacotherapy safe for patients withpsychiatric comorbidity?...................................16

Is NRT safe for adolescents?.............................17

What is best to prevent weight gain? ............... 17

13 Resources for patients .....................................18

14 References ...................................................... 19

15 Acknowledgments ............................................22

NSW Health Guide for the management of nicotine dependent inpatients – Summary of evidence iii

Table of contentsGuide for the management of nicotine dependent inpatients

Guide for the management of nicotine dependent inpatients – Summary of evidence NSW Healthiv

NSW Health Guide for the management of nicotine dependent inpatients – Summary of evidence v

The primary goal of this protocol is the effectivetreatment of nicotine dependent patients in NSWHealth facilities.This includes the offer ofpharmacotherapy for nicotine withdrawal and deliveryof brief intervention for smoking cessation.

Tobacco smoking is the greatest single preventablecause of premature death and disease in Australia.It is estimated that smoking kills more than 19,000Australians each year, with thousands more sufferingdebilitating illness (Ridolfo & Stevenson 2001).

The World Health Organisation describes smoking asan epidemic that will cause one in three of all adultdeaths by 2020 (WHO 1999). It recommends that allhealth care premises and their immediate surroundingsbe smoke free and that hospital staff should:

• ask about patients’ smoking status prior to or onadmission

• offer brief advice and pharmacotherapy to thosewho need it

• assistance to those interested in stopping (WHO2001).

The recent report of the US Surgeon General regardstobacco dependence as a ‘chronic disease withremission and relapse’. It states that nicotine use, in theform of 10 or more cigarettes a day, providescontinuous neuroexposure resulting in tolerance andphysical dependence which in turn producewithdrawal symptoms. Nicotine dependence warrantsmedical treatments as do other drug dependencedisorders and chronic diseases (US Dept Health &Human Services 2000).

Many countries including the United Kingdom andthe U.S.A. have developed clinical guidelinesrecommending recognition of smoking as a chronicrelapsing disease and encouraging medical serviceproviders to provide treatment.

The ‘NSW Health Smoke Free Workplace Policy’(1999) (NSW Health 1999) provides a supportiveenvironment for abstinence during hospitalisation andopportunities for brief intervention to increase asmoker’s motivation to quit.This protocol proposesthat hospital staff:

• identify nicotine dependent patients

• give patients information about the smoke free policy

• provide prompt and appropriate treatment topatients experiencing nicotine withdrawal

• provide brief intervention for smoking cessation

• advise patients at discharge on options forpermanent cessation.

Incorporating these steps into routine patient care willsignificantly contribute to the health and well-being ofour patient population, the provision of effective smokefree environments at health facilities and deliver a clearmessage to the public of the health consequences ofsmoking (lethal for one in every two users).

It is therefore recommended that Area Health Servicesincorporate this model for the treatment of nicotinewithdrawal into their local ‘Smoke Free WorkplacePolicy’ implementation plans and develop specificprotocols for delivery that are appropriate for theirlocal settings.

NSW Health Guide for the management of nicotine dependent inpatients – Summary of evidence 1

Rationale 01for the treatment of nicotine dependent inpatients

Guide for the management of nicotine dependent inpatients – Summary of evidence NSW Health2

The NSW Department of Health is committed toensuring the health, safety and welfare of all personsutilising its facilities and services.The Department hashad a policy to reduce exposure to passive smoking onDepartment property since 1984. In 1988 this policywas amended to reflect concerns about the healtheffects of passive smoking and to incorporate therequirements of the NSW Occupational Health andSafety Act 1983.The 1988 policy focused on theobligations of the Department to provide a smoke freeworking environment following common law casesconcerning the effects of passive smoking.The 1988policy also acknowledged the Department’s role in thepromotion of healthy lifestyles and practices.

In addition, the Area Health Services Act 1986 states aprimary objective of an Area Health Service is (s.19)“to promote, protect and maintain public health”. Thepromotion of smoke free policies and other relatedhealth improvement strategies in health care facilitiesis an essential component in protecting the health ofthose who come into contact with these institutions.

The 1999 ‘Smoke Free Workplace Policy’ builds onthe 1988 policy (which prohibited smoking in allbuildings and vehicles) and has the goal of prohibitingsmoking throughout all property controlled by NSWHealth.There is the possibility of limited exemptedoutdoor areas during its staged implementation tomeet the needs of specific patients and/or staff.

The rationale for updating of the Department’s‘Smoke Free Workplace Policy’ was to:

• reduce the risks to health associated with tobaccouse amongst staff, patients, visitors and thecommunity, especially exposure to passive smoking

• provide a clear and consistent message to staff,patients, visitors and the community about thehealth risks of smoking

• provide leadership in the community aboutreducing the harm associated with smoking.

A key component of the policy is therecommendation for provision of support to thosepatients who smoke by the use of brief interventionand nicotine replacement therapies as appropriate.

A recent study conducted by Central Sydney AreaHealth Service evaluated the satisfaction ofhospitalised smokers with the management of theirnicotine dependence. Of those smokers who had alength of stay of greater than one day, 33% reportedthat they smoked during hospitalisation. 23% of thosethat reported smoking during hospitalisation alsoreported that they had problems with “not being ableto smoke”. Of those who did not smoke duringhospitalisation, 4% reported problems with “not beingable to smoke”.

The study also found that those patients who didsmoke were more likely to have a length of stay ofmore than 2 days and significantly more likely toreport smoking 10 or more cigarettes daily (Boomer &Rissel unpublished).

NSW Health Policy 02Smoke Free Workplace Policy (1999)

In New South Wales in 1998, cigarette smokingcaused an estimated 4,519 male deaths and 1,806female deaths (representing 19% and 9% of all maleand female deaths, respectively). In 1997/98 activesmoking caused an estimated 36,127 hospitalisationsamong males and 17,850 hospitalisation amongfemales (4.2% and 1.7% of all hospitalisations for malesand females, respectively) (NSW Report of Chief HealthOfficer 2000).

Tobacco is the risk factor associated with the greatestburden of disease in Australia. In 1996, it wasresponsible for about 9.7% (227,000) of DisabilityAdjusted Life Years (DALYs) – about 12% of the totalburden of disease and injury in males and 7% infemales (Mathers et al 1999).

Across Australia in 1998, 142,525 hospital separationswere attributable to tobacco (as against 43,033 toalcohol and 14,471 to illicit drugs).The largest specificcause of hospitalisation attributable to tobacco formales is ischaemic heart disease (29%), cancer (21%)and chronic obstructive pulmonary disease (19%).The cancer category is dominated by lung cancer(50%) and bladder cancer (23%).The largest specific cause of hospitalisation attributable to tobacco forfemales is chronic obstructive pulmonary disease(22%), ischaemic heart disease (19%) and cancer(14%).The cancer category is dominated by lungcancer (59%) and bladder cancer (17%) (Ridolfo &Stevenson 2001).

Evidence now exists that inhalation of environmentaltobacco smoke also has a significant impact on thehealth of non-smokers.Tobacco smoke containsapproximately 60 known or suspected carcinogenicchemicals and studies indicate that sidestream tobaccosmoke (drifting from the end of a burning cigarette) is more carcinogenic per unit weight than mainstreamsmoke (smoke exhaled by the smoker).

One quarter of cases of low birth weight areattributable to maternal smoking during pregnancy(NHMRC 1997).


Burden of disease 03caused by tobacco smoking

Prevalence of smokingIn 1997/98 smoking prevalence for persons aged 18 years and over was 27% for males and 21% forfemales. Prevalence for secondary school students aged12-17 years in 1996 was 19% for males and 21% forfemales (NSW Report of Chief Health Officer 2000).

Reported current smoking rates varied widely amongHealth Areas.These variations reflect the distributionof underlying social determinants of health withsmoking more prevalent among NSW adults who are single, unemployed, have not finished high school,live in economically disadvantaged areas, and amongmen from non-English speaking backgrounds (Harriset al 1999).

Prevalence of inpatient smokingA recent study, over a six month period, in a pre-admission clinic of a major Sydney teaching hospitalwithin Central Sydney Area Health Service identifiedan age-standardised smoking prevalence of 19% with afurther 3% of patients identified as ‘recent quitters’.

When including recent quitters, this study found thatsmoking prevalence was similar to the rates for theNSW adult population, but noted that there is likely tobe some under-reporting of smoking in the clinicalsetting. Using the ‘Fagerstrom Test for NicotineDependence’, one in five (18%) smokers were identifiedas highly nicotine dependent (Rissel et al 2000).

An earlier study in the Hunter region of New SouthWales found smoking prevalence of 16% with afurther 8% identified as ‘recent quitters’. Salivarycotinine assay found that 18% of the self reportednon-smokers tested positive. Of those patients whoreported smoking in the 3 months precedingadmission, 56% reported abstaining from smokingduring their hospital stay, yet 9 months post discharge3% remained abstinent (Nagle 1996).

A more recent unpublished study in the Hunterregion which surveyed 1,422 eligible consenting adultinpatients at admission in a large tertiary teachinghospital found self reported smoking rates (in the lastweek) of 23%, with a further 7% reporting smokingduring the last year (Nagle et al unpublished).


04Smoking and inpatient smoking

Prevalence

An analysis of results from the 1997 ‘AustralianNational Survey of Mental Health and Well-being’showed that current tobacco users were more likelythan never smokers to have a sedative, stimulant oropiate-use disorder (Odds Ratio [OR] 1.9), morelikely to meet criteria for an alcohol-use disorder(OR 2.9) and more likely to meet criteria for acannabis-use disorder (OR 5.0).They were also morelikely than never smokers to have met criteria for anaffective disorder (depression) within the past year(OR 2.3), to have met the criteria for an anxietydisorder (OR 2.5) and to have screened positively forpsychosis (OR 5.5) (Degenhardt and Hall 2001).

Degenhardt and Hall argue that the strongerrelationship between substance-use disorders andmental health disorders with tobacco use in morerecent times in Australia suggests that with the declinein overall population rates of tobacco use, people withsuch conditions may be more likely to begin smoking,and/or less likely to quit once they have started.

The results of the ‘National Survey of Mental Healthand Wellbeing’ also indicate that the association ofsmoking with affective, anxiety and substance usedisorders is age specific. In smokers aged 18-39 theprevalence of any mental disorder was 35% in bothmen and women. Given this high prevalence it ispertinent for health care workers to assess the mentalhealth in young patients who have difficulty inabstaining from smoking (Jorm 1999).

The treatment of tobacco dependence can beprovided concurrent to treating patients for otherchemical dependencies (alcohol and other drugs).Research has suggested that those who are abstinentfrom smoking are more likely to remain abstinentfrom alcohol and relapse to alcohol use is less likelyamong persons given a smoking cessation intervention(Degenhardt & Hall 2001).


Relationship 05between tobacco use, substance-use disorders and mental health

The first step in managing nicotine withdrawal is toidentify smokers as this increases rates of interventionand guides appropriate treatments (Fiore et al 1995).

The Alcohol and Other Drugs Policy for Nursing Practice inNSW: Clinical Guidelines (NSW Health Dept 2000),recommends the recording of a patient’s substance usehistory (including tobacco) upon admission. In viewof the relationship between tobacco use andsubstance-use disorders this is strongly recommendedto guide appropriate clinical treatments, especially forhighly dependent smokers.

It is also recommended that moderate to heavilynicotine dependent patients be screened and/ormonitored for depression. Patients with depressedmood and a history of problematic drinking havebeen reported as more likely to be nicotine dependentand have an anticipated greater difficulty in refrainingfrom smoking while hospitalised (Cargill et al 2001).


Identification 06of smoking status

The purpose of brief intervention for smokingcessation is to increase motivation to quit (US Dept of Health and Human Services 2000).

The World Health Organisation encourages provisionof brief opportunistic interventions delivered by allhealth professionals in the course of their routinework and proposes that involvement in offeringsmokers help be based on factors such as access tosmokers rather than professional discipline (WorldHealth Organisation 2001).

The ‘Cochrane Review’ (Silagy 2001) concludes thatbrief advice by doctors, nurses and other health careworkers is effective and that more intensiveinterventions only marginally increase the efficacy ofbrief advice. Overall the efficacy is low (2.5%), butbecause of wide reach this approach has the potentialto influence smoking prevalence in whole populations.

Hospitalisation is a time when the adverseconsequences of smoking may be especiallyhighlighted for the individual (Emmons 1992) and itcan provide the window of opportunity for a‘teachable moment’ (Lewis 1998).

Patients will respond most favourably to personalised,non-critical information and feedback that help themunderstand the impact of smoking on their health.Motivational interventions are most likely to succeedwhen the clinician is empathetic, promotes patientautonomy (eg. supports patient’s choices), avoidsarguments and encourages patient self-efficacy byidentifying previous successes in behaviour changeefforts (Fiore et al 2000).

Many clinicians report lack of relevant knowledge asa barrier to intervening with patients who smoke(Fiore et al 2000).

Health professionals who have received training aresignificantly more likely to intervene with smokers thanthose who have not been trained.Training needs to bea core health activity and supported by systems thatensure health professionals have access to it and tosupport them in using their new skills (Raw et al 1999).


Brief intervention 07for smoking cessation

PharmacologyNicotine is a psychoactive drug affecting moodand performance and is the source of addiction totobacco. Nicotine, found in tobacco, binds tonicotinic cholinergic receptors found on cellbodies and at nerve terminals in the brain andautonomic ganglia.Activation facilitates the releaseof neurotransmitters including acetylcholine,norepinephrine, dopamine, serotonin, B-endorphinand glutamate. Behavioural rewards from nicotine,and perhaps nicotine dependence as well, arelinked to dopamine release.

It takes 10-19 seconds for nicotine, administeredthrough the pulmonary circulation, to pass fromthe lung through the brain.

Nicotine levels in the brain decline betweencigarettes providing an opportunity forresensitization of receptors so that positivereinforcement can occur with successive cigarettes.Nicotine is rapidly and extensively metabolisedprimarily in the liver. Its half-life averages 2 hours,therefore regular smokers begin to go intowithdrawal and feel the need to ‘top up’ theirnicotine levels every hour or so. Consistent with a 2 hour half-life, nicotine levels in the body riseduring the first 6-8 hours, plateau for theremainder of the day during regular smoking and fall overnight.

Primary metabolites are cotinine and nicotine-N-oxide. Because of its long half-life (16-20 hours)cotinine is commonly used as a marker of nicotine intake.

Nicotine crosses the placenta freely and has beenfound in amniotic fluid and in the umbilical cordblood of neonates. It is found in breast milk butconcentration is so low that the dose of nicotineconsumed by an infant is unlikely to be ofphysiological consequence.

Manipulation of doseCigarette smoking produces rapid dosing ofnicotine. Benowitz advises that arterial bloodnicotine concentrations may be as high as100ng/ml and concentrations in the heart andbrain may be as high as 200-300ng/mlimmediately after a cigarette.Venus blood nicotineconcentrations are typically 20%-30% of those ofarterial concentrations.

A smoker can manipulate (titrate) the dose ofnicotine from a cigarette to regulate a particularlevel of nicotine in the body. Intake of nicotinefrom a given product depends on factors such aspuff volume, depth of inhalation, rate and intensityof puffing. Smokers tend to titrate higher levels ofnicotine from ‘light’ cigarettes by breathing indeeper and holding the smoke in the lungs longer.

Similarly, smokers who reduce the number ofcigarettes smoked per day will often increase theiraverage intake of nicotine from each cigarette.

There is considerable peak-to-trough oscillation inblood levels from cigarette to cigarette. Regularcigarette smoking plateaus at daily plasmaconcentrations of 20 to 35 ng/mL (and 5% to 10%carboxyhemoglobin) (Benowitz 1998).


Nicotine 08Information and facts

Question Answer Score

1. How soon after waking up do you smoke your first cigarette? Within 5 minutes 3

6-30 minutes 2

31-60 minutes 1

2. Do you find it difficult to abstain from smoking in places where it is forbidden? Yes 1

No 0

3. Which cigarette would you hate to give up? The first one in the morning 1

Any other 0

4. How many cigarettes a day do you smoke? 10 or less 0

11-20 1

21-30 2

31 or more 3

5. Do you smoke more frequently in the morning than in the rest of the day? Yes 1

No 0

6. Do you smoke even though you are sick in bed for most of the day? Yes 1

No 0

Total

Score 0-2 very low dependence 6-7 high dependence

3-4 low dependence 8+ very high dependence

5 medium dependence

Table 1. Fagerstrom Test for Nicotine Dependence


Nicotine dependenceTobacco use produces tolerance to nicotine,withdrawal symptoms and difficulty in controllingfuture use (US Dept of Health and Human Services2000). The bolus of nicotine to the brain achieved bysmoking is one of the key reinforcers of dependence(Benowitz 1998).

Human use of nicotine from tobacco meets thecriteria for drug dependence as presented by the USSurgeon General and nicotine and smoking also meetthe World Health Organisation’s InternationalClassification of Diseases (ICD-10) (WHO1992)criteria for substance dependence.The AmericanPsychiatric Association’s Diagnostic and Statistical Manualof Mental Disorders (DSM-IV) (American PsychiatricAssoc 1995) states that nicotine dependence andwithdrawal can develop with use of all forms oftobacco. Features of nicotine dependence include:smoking soon after waking, smoking when ill,difficulty refraining from smoking, reporting the firstcigarette of the day to be the one most difficult togive up and smoking more in the morning than in the afternoon.

Smokers appear to be motivated by both positivereinforcement (including reported relaxation, reducedstress, alertness, improved concentration, moodregulation and lower body weight) and negativereinforcement (relief of nicotine withdrawal symptomsin the context of physical dependence). However, it isdifficult to separate reported positive reinforcementfrom relief of withdrawal symptoms in smokers(Benowitz 1998).

Assessment of nicotine dependence Dependence on nicotine may be assessed using the‘Fagerstrom Test for Nicotine Dependence’ (FTND)below which is based on criteria listed in the DSM-IV(Fagerstrom et al 1990).

When time and resources are limited, nicotinedependence can be assessed using the two questions intable 2 on page 10 as these consistently return higherbiochemical indicators of smoking (Heatherton et al1989; Fagerstrom et al 1990).

Consider a depression measure, for example CES-D(NSW Government Action Plan. Mental Health forEmergency Departments 2001) if there is a past historyof depression.

Nicotine withdrawalIn addition to craving for tobacco, the DSM-IV statesthat symptoms of nicotine withdrawal include four (or more) of the following within 24 hours ofcessation or reduction of nicotine intake:

• depressed mood

• insomnia

• irritability frustration or anger

• anxiety

• difficulty in concentration

• restlessness

• decreased heart rate

• increased appetite or weight gain.

These symptoms cause clinically significant distress, arenot due to a general medical condition and are notbetter accounted for by another mental disorder.

Some smokers report that smoking helps relievedepression and conversely some smokers becomeseverely depressed after stopping smoking.Neurochemical effects of nicotine, including release of dopamine, norepinephrine and serotonin resembleeffects of some antidepressant medications (Degenhardt& Hall 2001).

Nicotine toxicityNicotine toxicity in smokers is extremely rare.A child first attempting to smoke may experiencenausea, dizziness and sweating. Due to rapid toleranceto nicotine (within several cigarettes or a few days ofsmoking) these symptoms would not occur in asmoker (Benowitz 1998).

When using nicotine replacement therapy (NRT),some people may confuse nicotine withdrawal withnicotine toxicity. Interpretation of symptoms in peoplewho have recently stopped smoking and who areusing NRT can be complicated by the emergence ofnicotine withdrawal symptoms which can be similarto some of the toxic effects of nicotine.

Given that nicotine replacement therapy provides thebody with plasma nicotine levels approximating the‘trough’ achieved by smoking, toxicity from NRT ishighly unlikely.


Question Answer Score

1. How soon after waking up do you smoke your first cigarette? Within 5 minutes 3

6-30 minutes 2

4. How many cigarettes a day do you smoke? 10 or less 0

11-20 1

21-30 2

31 or more 3

Total

Score 0-2 very low 5 high

3 low 6 very high

4 moderate

Table 2. Use these two questions when time and resources are limited

This treatment aims to replace some of the nicotineobtained from cigarettes, thus reducing withdrawalsymptoms when stopping smoking.The principle issimilar to the detoxification and treatment of heroindependence using methadone.

Use of NRT (and other approved pharmacotherapy) is preferable to smoking with respect to healthconsequences because unlike smoking, thesemedications do not (a) contain non-nicotine toxicsubstances such as carbon monoxide and ‘tar’,(b) produce dramatic surges in blood nicotine levels(c) produce strong dependence (Fiore et al 2000).

NRT is available in Australia as gum, patch andinhaler.

The ‘Cochrane Review’ (Silagy et al 2001) states that:

• odds ratio for abstinence with NRT compared to control was 1.73 (patch 1.76, gum 1.66,inhaler 2.08)

• these odds were largely independent of theintensity of additional support provided to the smoker or the setting in which the NRT was offered

• in highly dependent smokers there is significantbenefit of 4mg gum over 2mg gum (odds ration 2.67)

• NRT increases quit rates approximately 1.5 to 2 fold regardless of setting.

NRT is safe and should be routinely recommended tosmokers, the choice of product depending on practicaland personal considerations (Raw et al 1999).

Dosage

A study by Hurt et al found that plasma nicotinelevels were significantly lower in subjects using NRTthan when they were smoking.This study on serumnicotine and cotinine levels in subjects with severenicotine dependency during 22mg transdermalnicotine-patch therapy, found that both nicotine andcotinine levels reached steady state on about day 3.Median levels were significantly below that at entryand for day 3 and beyond, the median percentage ofentry-level value ranged from 41% to 53% fornicotine and from 46% to 53% for cotinine. Nosubject had toxic levels or showed signs of nicotinetoxicity.The steady-state levels of nicotine andcotinine achieved with a 22mg transdermal patchwere much lower than the levels observed when thesubjects were smoking prior to initiation of therapy.The study concluded that a fixed dose of transdermalnicotine will not be efficacious for all patients andmay lead to underdosing in highly nicotine dependentpatients. Underdosing is likely to result in persistentwithdrawal symptoms that may make relapse tosmoking more likely (Hurt et al 1993).


09Nicotine Replacement Therapy (NRT)

Nicotine

Therapy Dosage

Gum (S2) Maximum 40mg/day

Patch (S2) Healthy people, >10 cigs/day, >45 kgs:

one patch daily 21mg/24 hr or 15mg/16 hr

Cardiovascular disease, <10 cigs/day,

<45 kgs: one patch daily 14mg/24hr

or 10mg/16hr

Inhaler (S3) Inhale air through cartridge for 20 minutes.

Self titrate dose according to withdrawal

symptoms. 6-12 cartridges/day.

(MIMS 2001)

Regular cigarette smoking plateaus at levels of 20 to35 ng/mL (and 5% to 10% carboxyhemoglobin)(Benowitz 1991). Peak plasma concentrations ofnicotine achieved with the transdermal patch typicallyrange from 10-15 ng/mL.Thus, the daily dose ofnicotine and peak blood levels of nicotine are lowerthan those of a one-pack-per-day smoker.

Ad libitum use of nicotine 2mg and 4mg gum resultsin mean plasma nicotine levels of 11.8 ng/mL and23.2 ng/mL respectively (McKendree et al 1982).

Ad libitum use of the ‘Nicorette’ Inhaler typicallyproduces nicotine plasma concentrations of 8-10ng/mL (Pharmacia Aust 2001).

The gum and inhaler permit more control over thedose and how quickly it is obtained.

The inhaler delivers a quick bolus of nicotine andresembles a cigarette. It may be useful for people who want a substitute for the act of smoking and have particular relevance for mental health/dementiapatients.

Combination therapyCombining the nicotine patch with a self-administered form of nicotine replacement therapy(gum/inhaler) may be more efficacious than a singleform of nicotine replacement and patients should beencouraged to use combined treatments if they areunable to remain abstinent, or if they are stillexperiencing withdrawal symptoms using a single typeof pharmacotherapy. It appears that the increasedsuccess depends on the use of two distinct deliverysystems: one passive and one ad libitum (Fiore 2000).

ContraindicationsIn Australia, NRT is currently contraindicated forsome patient groups and use by these patients requiresspecial consideration.

Directions for use of NRT products


Therapy Patient group

Gum (S2) Non-tobacco users, pregnancy, lactation,

children (<12 yrs)

Patch (S2) Non-tobacco users, acute MI, unstable

angina pectoris, severe arrhythmias,

recent CVA, skin disease, children (<12 yrs)

pregnancy, lactation.

Inhaler (S3) Non-tobacco users, hypersensitivity to

menthol, pregnancy, children (< 12 years)

(MIMS 2001)

Therapy Directions

Gum The gum is effectively a mouth patch and

nicotine is absorbed through the oral

mucosa. Chew till a peppery/tingling

feeling, flatten gum and ‘park’ between

the gum and cheek, or under tongue.

Chewing the gum continuously like

ordinary chewing gum will inhibit uptake

of nicotine. The nicotine will flow into the

stomach with saliva and lead to feelings

of nausea. Acidic beverages (coffee, soft

drinks) inhibit buccal absorption of

nicotine and are best avoided 15 minutes

before and during use of gum.

Patch Place on clean, non-hairy site on chest or

upper arm upon waking. Rotating the

patch to a new site each day will prevent

skin reaction.

Inhaler Inhale air through cartridge for 20 minutes.

Self titrate dose according to withdrawal

symptoms. 6-12 cartridges/day.

Bupropion is the first non-nicotine medicationavailable in Australia for smoking cessation and itsmechanism of action is presumed to be mediated byits capacity to block neural re-uptake of dopamineand/or noradrenaline (Fiore 2000).

Because Bupropion is initiated approximately oneweek prior to the quit day, it will have limitedpractical application for inpatient settings. Bupropionmay be an option for patients after discharge andpatients can be referred to their GP to discuss theiroptions.To date, it is the only pharmacotherapyavailable on Pharmaceutical Benefits Scheme.

ContraindicationsBupropion is contraindicated in patients with a seizuredisorder, a current or prior diagnosis of bulimia oranorexia nervosa, current or use of a MAO inhibitorwithin the previous 14 days. Precautions includelowered seizure threshold; renal hepatic impairment,bipolar disorder, latent psychosis, concomitanttransdermal nicotine, elderly, pregnancy, lactation,children.


Bupropion 10Facts

Every patient identified as a smoker should be assessedprior to discharge to determine interest in quitting.

In Australia around 80% of smokers have madeattempts to quit (Borland & Hill 1990). The 1994‘Health Promotion Survey’ found that 43% of smokershad made at least one quit attempt in the previoustwelve months and figures from the 1998 ‘NSWHealth Survey’ indicated that around 50% of male andfemale current smokers were planning on quitting inthe next six months (NSW Health 1999).

Quit planFor those patients ready to quit, a few key points canincrease their chance of success:

• Set a date to stop and stop completely on that day

• Use pharmacotherapy (whichever product suits best)

• Review past periods of abstinence to determinewhat helped and what hindered

• Identify future problems and make a plan to dealwith them (problem-solving)

• Enlist support (family, friends, colleagues) (Fiore et al 2000)

• Avoid alcohol

• Reduce caffeine consumption

Because of the high correlation between use ofalcohol and relapse to smoking (Garvey 1992), it isrecommended that alcohol be avoided, especially forthe first two weeks of a cessation attempt.

Continuous caffeine consumption with smokingcessation has been associated with more than doubledcaffeine plasma levels (Swanson 1997). It is thereforerecommended that caffeine consumption be reducedduring a cessation attempt.

An antidepressant used in the presence of a depressionhistory may need to be continued for at least threemonths and reviewed by an appropriate clinician.

Relapse In Garvey’s study of relapse across one year of follow-up of 235 adults attempting to quit unaided,approximately 62% had returned to smoking within 2 weeks and almost 80% had relapsed at 3 months.Those who smoked any cigarettes at all in the post-cessation period had a 95% probability of resumingtheir regular pattern of smoking. Predictors of relapseinclude: short periods of abstinence in previous quitattempts, low motivation to quit, low confidence inability to quit, greater proportion of smokers insubject’s environment and higher pre-cessation alcoholconsumption. Common triggers for relapse includeother people smoking, alcohol, stressful or negativeevents and depression (Garvey 1992).

Cannabis use would also predict relapse given thecommon practice of mixing marijuana with tobacco(Burns et al 2000).

Relapse prevention should include discussion of high-risk situations and developing coping strategies(eg. using pharmacotherapy, reducing alcoholconsumption) and reinforcing total abstinence.

Many smokers cannot stop without more intensivehelp and these will usually be heavier smokers whoare more at risk of smoking related disease.Thesepeople should be referred to a specialist treatmentservice, such as Area Health Drug and AlcoholServices, their General Practitioner or the Quitline for telephone counselling. Outpatient clinics also needto be advised of hospital treatment.


11Plans and relapse

Discharge and referral

Is NRT suitable for cardiovascular patients?

There is no evidence of increased cardiovascular riskwith NRT. NRT delivers plasma nicotineconcentrations which are usually below thoseproduced by smoking and does not expose the smokerto carbon monoxide or other harmful substances.

Despite early concerns regarding the safety of nicotinereplacement therapy in smokers with heart disease, it is now clear that the health risks of using NRT toassist such patients to stop, or significantly reduce,smoking far outweigh any treatment-related risks(Balfour et al 2000).

Clinical trials of NRT in patients with underlying,stable coronary disease suggest that nicotine does notincrease cardiovascular risk (Benowitz 1997).

There has been debate about the adverse affects ofNRT on cardiac patients. Several studies have showngood tolerance to NRT (patches and gum) in patientswith CAD.Trials have shown no change in anginafrequency, overall cardiac symptoms, nocturnal cardiacevents or ECG, despite some patients continuing tosmoke (Working Group for the study of transdermalnicotine in patients with coronary artery disease 1994).

In a randomised controlled double blind placebo trial(n=584 outpatients with at least one cardiacdiagnosis), it was found that at least one primary endpoint (ie. death, MI, cardiac arrest, admission tohospital with increased angina symptoms, arrhythmiaor congestive heart failure) was reached by 5.4% ofthe active patch group compared to 7.9% in theplacebo group (not significant, P=0.37).After 14weeks of treatment, abstinence was 21% in the activepatch group compared to 9% in the placebo group(p=0.001).They concluded that transdermal nicotinedoes not cause a significant increase in cardiovascularevents in high risk outpatient cardiac patients (Joseph etal 1996).

NRT is currently contraindicated in patients withacute MI, unstable angina pectoris, severe arrhythmiasand recent CVA (MIMS 2001).


FAQ’s 12Frequently asked questions about patient groups and pharmacotherapy

Is NRT safe for pregnant or lactatingwomen?

Pharmacotherapy should be considered when apregnant woman is otherwise unable to quit, andwhen the likelihood of quitting, with its potentialbenefits, outweighs the risks of the pharmacotherapyand potential continued smoking (Fiore et al 2000).

Benowitz states that NRT is likely to be less harmfulthan smoking during pregnancy because of a lowertotal nicotine dose and absence of exposure to carbonmonoxide and other toxic substances. He concludedthat the benefits of NRT substantially outweigh therisks of smoking or the risks of nicotine replacementper se, for pregnant smokers, but suggests that NRTonly be offered to pregnant smokers if they cannotstop without it.

NRT is clearly beneficial to more highly dependentsmokers as it is these who are more at risk for adversereproductive outcome and who are less likely to stopsmoking when becoming pregnant (Benowitz 1991).

If the clinician and pregnant or lactating patientdecide to use NRT, clinicians should considerchoosing delivery systems that yield intermittent,rather than continuous drug exposure (ie. inhaler/gum) due to potential neurotoxicity in the foetus ofcontinuous exposure to nicotine (Fiore et al 2000,Benowitz 1991).

“A maternal 10% blood carboxyhemoglobin level, which canbe observed in a two-pack-per-day cigarette smoker, can beassociated with a 10% to 15% higher carboxyhemoglobinlevel in the foetus than in the mother.This has been equatedto a 60% reduction in foetal blood flow” (Benowitz 1991).

A pregnant smoker should receive encouragement andassistance in quitting throughout her pregnancy.

The high rate of post-partum relapse may bedecreased by continued emphasis on the relationshipbetween maternal smoking and poor health outcomesin infants and children.

The nicotine inhaler is not contraindicated forlactating women.

Is pharmacotherapy safe for patientswith psychiatric comorbidity?

The finding that tobacco use is associated withaffective disorders and depressive symptoms haspotentially important clinical implications. Depressiondecreases the likelihood that attempts at abstinencewill be successful and depressed mood is a commonsymptom of nicotine withdrawal.Antidepressants maytherefore aid abstinence in persons who havesymptoms of depression (Degenhardt & Hall 2001).It is also possible that smoking increases the risk ofdepression perhaps by affecting neurontransmittersystems (Jorm 1999).

A recent follow-up study of 76 participants with ahistory of major depression (excluding bipolardisorders) who stopped smoking found they wereseven times more likely to have a recurrence of majordepression than people who continued to smoke. Riskof depression did not generally arise immediately aftercessation but was distributed across the entire studyperiod of six months (Glassman et al 2001).

The ‘National Survey of Mental Health and Wellbeing’found that current smokers also have higher rates ofanxiety disorders and, as with depression, anxiouspersons may find it more difficult to remain abstinent.Evidence suggests that anxiolytics are not effectivesmoking cessation aids (Degenhardt & Hall 2001).

Current smokers were significantly more likely toscreen positively for psychosis and this finding is inaccord with the high rates of tobacco smokingobserved in clinical samples of persons with psychoticillness, particularly schizophrenia. Studies indicate that70% or more of schizophrenia patients smoke (Jorm1999). It has been suggested that nicotine may beused to self-medicate some psychotic symptoms andevidence suggests that persons with psychosis smokemore heavily and use higher tar cigarettes.

Although psychiatric comorbidity places smokers atincreased risk for relapse, such smokers can be helpedby smoking cessation treatments. Stopping smokingmay affect the pharmacokinetics of certain psychiatricmedications (eg. anti-psychotic medications), thereforeclinicians may wish to monitor closely the actions orside effects of psychiatric medications in smokersattempting abstinence (Fiore et al 2000).


A recent study of 55 patients hospitalised in a smoke-free ward demonstrated a definite preference for thenicotine inhaler over the transdermal patch (D’Mello et al 2001).

Is NRT safe for adolescents?

Young people can become addicted to tobacco veryquickly.

When treating adolescents, clinicians may considerpharmacotherapy when there is evidence of nicotinedependence. Factors such as degree of dependence,number of cigarettes per day and body weight shouldbe considered (Fiore et al 2000).

Prescription guidelines from pharmaceuticalcompanies recommend 21 mg patch if >45 kilos, 14mg patch if < 45 kilos.

What is best to prevent weight gain?

The body weight of smokers is on average 2.7 to 4.5kg lower than that of non-smokers (Benowitz 1998).When a smoker stops, s/he typically gains weight(gaining an average of 2.3kg) in the subsequent yearto approximately the level of those who have neversmoked.This is of great concern to some smokers,especially women and adolescents, and can act as amotivator to start or continue smoking.

NRT (in particular gum) and bupropion delay, butdon’t prevent post-cessation weight gain (Fiore et al2000).

If a person is concerned about weight gain aftercessation of smoking you could:

• advise that the health risks of moderate weightgain are small compared to the risks of continuedsmoking

• advise patients to concentrate on cessation untilthey are confident they will not return to smoking

• recommend a regular exercise program and healthyeating to control weight.


• A 10-minute video for patients is available toexplain nicotine addiction, treatment, how to usenicotine patches and gum, problem solving and thequitting process.This was produced by ABCTelevision Productions for the Smoking CessationProgram, Royal Hobart Hospital, Department ofHealth and Human Services, Hobart 2001.Thisvideo can be ordered by contacting Ms SylviaCowles Tel.(03) 6222 8784.

• A leaflet titled Products to help you quit smokingexplains pharmacotherapies, withdrawal symptomsand behavioural strategies to assist cessation.

This leaflet is available in plain English and 13community languages and can be downloadedfrom the NSW Health multi culturalcommunication tobacco website at:www.mhcs.health.nsw.gov.au

• Quitkits can be ordered in bulk from the BetterHealth Centre – Publications Warehouse:Tel. (02) 9879 0443Fax. (02) 9879 0994

• Information on these resources is available from theNSW Health Tobacco and Health Unit:Tel. (02) 9391 9000


Resources 13for patients

Ridolfo B and Stevenson C. The quantification of drug-caused mortality and morbidity in Australia, 1998.Australian Institute of Health and Welfare,Canberra 2001.

The World Health Report 1999: Making a Difference.WHO 1999

WHO Evidence Based Recommendations on the Treatmentof Tobacco Dependence. WHO 2001

US Department of Health and Human Services.Reducing Tobacco Use:A Report of the Surgeon General.Atlanta, Georgia: US Department of Health andHuman Services, Centres for Disease Control andPrevention, National Centre for Chronic DiseasePrevention and Health Promotion, Office on Smokingand Health, 2000.

Smoke Free Workplace Policy 1999, NSW HealthDepartment. Sydney 1999.

Boomer MJ, Rissel C. An evaluation of an Area HealthService Smoke Free Environment Policy in two Sydneyhospitals. (Unpublished, in preparation).

Report of the Chief Health Officer 2000. The Healthof the people of New South Wales. NSW HealthDepartment. Sydney. 2000.

Mathers C,Voss T and Stevenson C. The burden ofdisease and injury in Australia. Canberra:AustralianInstitute of Health and Welfare, 1999.

National Health and Medical Research Council. TheHealth Effects of Passive Smoking. Commonwealth ofAustralia. Canberra 1997.

Harris E, Sainsbury P, Nutbeam D (editors). Perspectiveson health inequity. Sydney:Australian Centre for HealthPromotion, 1999

Rissel C, Salmon AM, Hughes AM. Evaluation of a(pilot) stage-tailored brief smoking cessation interventionamong hospital patients presenting to a pre-admission clinic.Australian Health Review 23(3):83-89,2000.

Nagle AL, PhD Thesis. University of Newcastle. 1996Impact of hospitalisation on patient smoking: current practiceand potential for nurse provided smoking cessation care.

Nagle AL, Schofield MJ, Hensley MJH. Inpatient self report of smoking rates at admission. (Unpublished,in preparation).

Degenhardt L, Hall W. The relationship between tobaccouse, substance-use disorders and mental health: results fromthe National Survey of Mental Health and Well-being.Society for Research on Nicotine and Tobacco (2001)3,225-234 online.

Jorm AF. Association between smoking and mentaldisorders: Results from and Australian National PrevalenceSurvey.Aust NZ Journal of Public Health199923(3):245248

Fiore MC, Jorenby DE, Schensky AE, Smith SS, BauerRR, Baker TB. Smoking status as the new vital sign: effecton assessment and intervention in patients who smoke.Mayo Clinic Proceedings. 70(3):209-13, 1995, March.

Alcohol and Other Drugs Policy for Nursing Practice inNSW: Clinical Guidelines 2000-2003. NSW HealthDepartment. Sydney. 2000.

Cargill BR, Emmons KM, Kahler CW, Brown RA.Relationship among alcohol use, depression, smokingbehaviour, and motivation to quit smoking with hospitalisedsmokers. Psychology of Addictive Behaviours.15(3):272-5, 2001 September.


References 14Guide for the management of nicotine dependent patients


Silagy C, Stead LF. Physician advice for smoking cessation(Cochrane Review). In:The Cochrane Library, Issue 4,2001. Oxford: Update Software.

Emmons KM, Goldstein MG. Smokers who arehospitalized:A window of opportunity for cessationinterventions. Preventive Medicine. 21(2):262-269,1992.

Lewis SF, Piasecki TM et al. Transdermal nicotinereplacement for hospitalised patients: a randomised clinicaltrial. Preventive Medicine 27:296-303,1998.

Fiore MC, Bailey WC, Cohen SJ et al. Treating TobaccoUse and Dependence. Clinical Practice Guideline.Rockville MD: US Department of Health andHuman Services. Public Health Service. June 2000

Benowitz, NL. Nicotine Safety and Toxicity. OxfordUniversity Press. 1998.

World Health Organisation. International StatisticalClassification of Diseases and related Health Problems, 10thRevision. Geneva,World Health Organisation 1992.

American Psychiatric Association. Diagnostic andStatistical Manual of Mental Disorders, 4th Edition (DSM-IV) Washington.American PsychiatricAssociation, 1995.

Heatherton TF, Kozlowski LT, Frecker RC, Rickert W,Robinson J. Measuring the Heaviness of Smoking: usingself-reported time to the first cigarette of the day and numberof cigarettes smoked per day. British Journal of Addiction(1998)84,791-800.

Fagerstrom KO, Heatherton TF, Kozlowski LT. NicotineAddiction and Its Assessment. Ear Nose and ThroatJournal 89(11):763-765, 1990.

NSW Government Action Plan. Mental Health forEmergency Departments. NSW Health Department 2001.

Silagy c, Lancaster T, Stead L, Mant D, Fowler G.Nicotine replacement therapy for smoking cessation(Cochrane Review). In:The Cochrane Library, Issue3,2001 Oxford: Update Software.

Raw M, McNeille A,West R. Smoking Cessation:Evidence based recommendations for the healthcare system.BMJ 1999;318:182-185 (16 Jan)

MIMS 2001

Hurt RD, Lowell MD, Dale MD et al. Serum nicotineand cotinine levels during nicotine-patch therapy.Clin Pharmacol Ther 1993;54:98-106.

Benowitz NL. Nicotine Replacement Therapy DuringPregnancy. JAMA 1991;266:3174-3177.

McKendree E, McNabb MD, Richard V et al. Plasmanicotine levels produced by chewing nicotine gum. JAMA,1982;248:865-868.

Pharmacia Consumer Healthcare Australia. Productinformation 2001.

Borland R, Hill D. Two month follow up on callers to atelephone quit smoking service. Drug and AlcoholReview. 1990;9:211-218.

Epidemiology and Surveillance Branch. NSW HealthSurvey (HOIST). NSW Health Dept. Sydney. 1999.

Garvey AJ, Bliss RW, Hitchcock JL et al. Predictors ofsmoking relapse among self-quitters:A Report of theNormative Aging Study. Addictive Behaviours.1993(17):367-377

Swanson JA, LeeJW, et al. The impact of caffeine use ontobacco cessation and withdrawal. Addictive Behaviours.22(1):55-68, 1997.

Burns CB, Ivers RG, Lindorff KJ, Clough AR.Cannabis:A Trojan horse for nicotine? Letter to Aust NZJournal of Public Health. 24(6):637. 2000

Balfour D, Benowitz NL, Fagerstrom K, Keil U.Diagnosis and treatment of nicotine dependence withemphasis on nicotine replacement therapy. European HeartJournal 21(6):438-45,2000.

Benowitz NL, Gourlay SG. Cardiovascular toxicity ofnicotine: implications for nicotine replacement therapy.Journal American College Cardiology 1997Jun;29(7):1422-31

Working Group for the study of transdermal nicotinein patients with coronary artery disease. Nicotinereplacement therapy for patients with coronary artery disease.Arch Int Med. 1994;154(9):989-95

Joseph AM, Norman, SM et al. The safety of transdermalnicotine as an aid to smoking cessation in patients withcardiac disease. N Engl J Med 1996; 335(24):1792-1798

Glassman AH, Covey LS, Stetner F, Rivelli S. Smokingcessation and the course of major depression: a follow-upstudy.The Lancet 357:1929-1932. 2001 (16 June)

D’Mello DA, Bandlamudi GR, Colenda CC. Nicotinereplacement methods on a psychiatric unit. AmericanJournal Drug & Alcohol Abuse 2001;27(3):525-529.

This document was developed by the Tobacco andHealth Unit, NSW Health. The principal author,Keren Kiel, wishes to acknowledge the contributionof the following people and organisations.

Advisory Group

• ASH Australia, Ms Anne Jones

• Central Sydney Area Health Service, Dr JeanetteWard [resigned June 2001), Dr Chris Rissel

• National Heart Foundation – NSW Division,Dr Amanda Nagle

• NSW Health,Tobacco and Health Unit,Ms Keren Kiel

• NSW Health, NSW Public Health Officer TrainingProgram, Ms Elayne Mitchell

• The Australian Medical Association, Ms ElizabethMcMaugh

• The Cancer Council NSW, Ms Jeanie McKenzie

• The NSW Nurses Association, Mr Greg Wilcox

• The Royal Australian College of GeneralPractitioners, Professor Nicholas Zwar

• South Western Sydney Area Health Service, alsorepresented by Professor Nicholas Zwar

Consultation and qualitative research(focus groups)

• Macquarie Area Health Service

• Wentworth Area Health Service

Written feedback was received from

Area Health Services

Central Coast, Central Sydney, Greater Murray, Hunter,Illawarra, Macquarie, Mid North Coast, Mid Western,New England, Northern Rivers, Northern Sydney,South Eastern Sydney, Crookwell District HospitalSouthern, South Western Sydney,Wentworth,WesternSydney,The Children’s Hospital at Westmead

NSW Health Department

Centre for Research and Clinical Policy, Clinical Data,Drug Programs Bureau, Policy Division, Office of theChief Nursing Officer, Centre for Mental Health

Others

Cancer Control Network, NSW Nurses Association,Royal Australasian College of Surgeons, RespiratoryClinical Expert Reference Group members – Dr GuyMarks, Dr Matthew Peters, SmithKline Beecham(Australia) Pty Ltd, Sydney University Department ofPsychiatry,Tobacco Research Unit – Renee Bittoun


Acknowledgments 16Guide for the management of nicotine dependent patients

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