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CLINICAL PRACTICE GUIDELINES ON TREATMENT OF TOBACCO DEPENDENCE (2002) IN MALAYSIA FOREWORD Smoking accounts for one out of every five deaths in Malaysia. It is the most important modifiable cause of premature death, responsible annually for an estimated 120,000 years of potential life lost. About 10,000 Malaysia die each year as a result of smoking. Since early studies in the 1950s and 1960s, a large body of epidemiological evidence has accumulated regarding the health effects of smoking. Major cohort studies, many case-control studies, and other data sources provide consistent, convincing evidence linking the use of tobacco with a variety of serious pulmonary, cardiovascular, and neoplastic diseases. A number of consistent findings from this body of evidence are well established. Tobacco consumption had markedly reduced in most high-income countries. In the United States of America for instance, by 1997 the prevalence of smoking among Americans had dropped to 23% from 40% in 1964. In contrast, however, tobacco consumption in recent years has been rising in developing countries including Malaysia. The prevalence of smoking among Malaysian adults aged 15 years and above had increased from 21% in 1985 to 31% in 2000. Some 49% of all adult males and 5% of all adult females are now current smokers. Due largely to population increase, the number of smokers will continue to rise. Today there are about 5 million smokers in Malaysia, each consuming an average of 14 cigarettes per day. Of these smokers aged 15 years and above 90% are male. Half of these smokers alive today will eventually be killed by tobacco, and the number of annual deaths attributable to smoking will be triple over the next three decade from 10,000 in 1998 to 30,000 by the year 2030. Nonetheless, as a result of our intensive anti smoking activities since 1991 in conjunction with our National Healthy Life Style Campaign, the level of awareness with regard to the hazard of smoking among the general public both smokers and non smokers alike have markedly increased. Among the current smokers, about 43% of them have attempted to quit on their own, but unfortunately most of them had been unsuccessful. We know now that smoking is seriously difficult habit to break, and very few smokers succeed in their attempts to quit. Outside of individual strengths and willpower, various countries have proven that healthcare professionals can play an active role in helping smokers to break free of their tobacco addiction through a properly organized smoking cessation programs. Studies have found that a few minutes of firm advice from the doctor, supported by educational materials and the mutual understanding that there would be follow up, gave a 5% quit smoking rate which translated to about 25 ex-smokers per year per doctor. Other studies have shown that the greater the intensity of invention coupled with appropriate pharmacotherapy, the higher the success of smoking cessation. Health Ministry recognized the need for doctors and other health professionals to participate in smoking cessation program. This Clinical Practice Guideline is timely produced to assist doctors and other health professionals to help smokers to quit smoking for good. (Y.Bhg Tan Sri Datu DR. HJ. MOHD. TAHA BIN ARIF) Director General of Health. CONTENTS 1. Introduction 2. List of guideline development workgroup 1 2. Executive summary 3. Methodology 4. Assessment of tobacco use 2 5. Brief clinical intervention 3 6. Intensive clinical intervention 19 7. Special population 20 - Pregnant women - Hospitalised patients - Psychiatric patients - Children and adolescents - Elderly - Orang Asli 8. Management of Weight Gain 9. References 10. Glossary INTRODUCTION Tobacco cessation strategy is a significant component of an overall tobacco control program to reduce mortality due to tobacco-related diseases(CDC, 1984). Unfortunately quitting smoking is not easy. So many smokers have undergone the dilemma of wishing to quit and then been unsuccessful(CDC, 1990-1991; Hatziandreu et al., 1990). It seems obvious therefore there must be more to their smoking than just bad habit. Today enough scientific evidence has been gathered to explain why some smokers had such difficulties with quitting( ). No matter how intellectually astute a smoker may be, no amount of rationalization will be able to curtail their craving for cigarette. Neither IQ nor education has anything to do with their smoking behaviour, nor does gender, age or social status. It is an accepted fact that cigarette smoking is an addiction. Within a few years of daily smoking, most smokers will become dependence, both physical and psychological dependence. This dependence is due to the neurobiological effects of nicotine on the brain. Nicotine receptors are found in the region of the brain involved in reward and emotion and in those areas associated with learning and memory namely the hippocampus(Piccittio, 1998). The existence of these nicotine receptors which directly connected to the reward system in the brain provide physical evidence of how nicotine found in tobacco exert its addictive effects. Most smokers, if not all attempt to quit at some point in their smoking lives and almost all fail on their first unaided attempt. The chance of success in a single unaided quit attempt is in the region of 1 in 100, and 98% of them relapse within a period of 12 months(Fiore et al., 1995). It is not uncommon to see smokers who stopped for quite a while and slipped back into smoking and then quit again and then slipped back again and the cycle continues. Research suggest that people who smoke go through a five stage tobacco addiction cycle that leads them from being non-smokers to new smokers to committed smokers to smokers trying to stop to finally reformed smokers(Prochaska & Goldstein, 1991). Unfortunately only a few stay in that final stage. In reality the tendency is for recent or renewed quitters to relapse into nicotine addiction, and the overall cycle. If smokers can be persuaded to not only quit smoking but also more importantly to stay clean of their addiction, they can benefit their own health and finance, as well as ease the burden on the society that must shoulder their healthcare costs. Fortunately, we have now sufficient evidence-based treatment modalities that are both efficacious and effective ranging from behavioural therapy to pharmacotherapy. Several cost-effectiveness analyses have shown that cessation treatments compare quite favourably with routine medical interventions such as the treatment of hypertension and hypercholesterolemia, and with other preventive interventions such as periodic mammography(Eddy, 1986; Health and Human Service, 1991; Tengs et al.,1995; Lightwood & Glantz, 1997). This CPG has been developed to serve as a useful tool for doctors and other health professionals in Malaysia to treat tobacco dependence in various settings, including hospitals, clinics or pharmacies. It will be reviewed and updated accordingly with the most recent development. 2. LIST OF GUIDELINE DEVELOPMENTAL WORKGROUP 3. EXECUTIVE SUMMARY Tobacco use is recognized as the main cause of premature and preventable death in our country.Tobacco dependency does not only cause physical withdrawal, it also causes life long addiction. Hence, due recognization should be given to it as a chonic disease. Malaysia has a high prevalence of smokers especially among the males and adolescents. However despite the high prevalence of tobacco use, health-care providers are not well trained to manage this problem effectively. Furthermore health care providers lack the knowledge and awareness that treating tobacco dependence is cost effective thus fail to intervene in the treatment of tobacco cessation. Despite all these problems, there is no clinical practice guideline available in Malaysia. Therefore it is imperative that the Ministry of Health produce a clinical practice guideline (CPG) which is best suited for Malaysians. With this in mind, the Division of Disease Control initiated and coordinated the preparation of this manual,enlisting the help of experts from the various medical fields relevant to tobacco cessation. This group corraborated for a total of one year, going through the various local and international resources to produce this CPG. This included the review of national statistics , The US Dept. of Health and Human Services, Public Health Service CPG on treating tobacco use and dependance, The Cochrane Collaboration and the New Zealand Smoking Cessation Guidelines. This CPG was reviewed by independent experts and end-users at a national level conference. The objective of this CPG is to provide the latest and updated treatment protocols to assist health care providers in managing tobacco dependance effectively. This guideline is based on a combination of two methods, namely adaptation from the three leading and prominent CPGs on tobacco cessation in addition to the latest literature review based on a systematic search for evidence. All recommendations in this CPG were graded based on the appropriate level of evidence and are specific and unambiguous. The health benefits, adverse effects and risks of all recommended pharmacological agents are detailed in table forms. The overall treatment guideline is provided in a clinical pathway format. Furthermore, the effectiveness and health benefits that are derived from each recommendation in this CPG are taken into consideration. It is hoped that clinicians and other allied health personnels can adopt this evidence -based guideline to maximize the success rate of tobacco cessation. However, this CPG is not meant as a substitute for clinical judgement and clinicians are recommended to individualize their treatment strategies. This CPG is planned for a review at every two-year interval by the committee and appropriately updated if the need arises. Evaluation of this CPG would include an assessment of the number of smoking cessation services and the outcome of smokers treated throughout Malaysia. Studies to look at improvement in standard of practice regarding smoking cessation treatment will also be conducted. This CPG has been developed using available data published in other countries due to the lack of local data regarding smoking cessation treatment. However, the committee strongly feels that the data is still clinically relevant and applicable to our local setting. 4. METHODOLOGY This guideline is based on a combination of 2 methods, namely adaptation from the clinical practice guidelines (CPGs) as mentioned below and incorporation of the latest literature review. The adaptation were from: 1. Treating Tobacco Use and Dependence 2000,US Department of Health and Human services.(Fiore et al., 2000) 2. Guideline for smoking cessation 2001, New Zealand National Advisory Committee on Health and Disability. 3. American Psychiatric Association. Practice guideline for the treatment of patients with nicotine dependence 1996. The above CPGs looked at the data up to the year of 1999. Literature reviews were done looking at the latest literature up to May.2001.The literature reviews were on Medline database search, Cochrane review (up to early September) and Yale search based mesh words on reports on Nicotine/ Tobacco treatment, medications, and clinical management. (120 articles published in peer reviewed journals ,in English). The evidence level used adapted from The US/Canada Prevention Services Task Force. Level of Evidence Scale I Evidence obtained from at multiple well-designed randomised controlled trial II Some evidence from randomised clinical trials supported the recommendation, but the scientific support was not optimal. For instance, few randomised trials existed, the trial that did exist were somewhat inconsistent, or the trial were not directly relevant to the recommendation. III Reserved for important clinical situations where the panel achieve consensus on the recommendation in the absence of relevant randomised control trials 3. ASSESSMENT OF TOBACCO USE The first step in treating tobacco use and dependence is to identify tobacco users. All patients should be asked if they use tobacco and should have their tobacco-use status documented on a regular basis. Evidence has shown that this significantly increases rates of clinician intervention.(Fiore et al., 1995; Ahluwalia, 1997; Ahluwalia 1999) FIGURE 1: ALGORITHM FOR TREATMENT OF TOBACCO USE AND DEPENDENCE This clinical practice guideline is organized to provide the clinician with simple, but effective interventions for all of these patients. The assessments are to look for : 1. Level of addiction (using Fagestrom Questionnaires + number of cigarette smoked)- see Appendix 2. Readiness for quitting (Miller & Rollnick, 1991).Prochaska & DiClemente's model).-ses appendix. Screening for current or past tobacco use will result in four possible responses: the patient uses tobacco and is now willing to make a quit attempt; the patient uses tobacco but is not now willing to make a quit attempt; the patient once used tobacco but has since quit; the patient never regularly used tobacco. 3. CLINICAL INTERVENTIONS There are 2 types of clinical intervention depending on the intensity of intervention and level of service provided. They are: Brief clinical intervention Intensive clinical intervention BRIEF CLINICAL INTERVENTION Brief clinical intervention by the physician increases quit rates effectively (I). It is vital to change clinical culture and practice patterns to ensure that every patient who uses tobacco is identified and offered treatment. The compelling time limits on primary care physicians often require brief interventions, although more intensive interventions would produce greater success. Although many smokers are reluctant to seek intensive cessation programs they nevertheless can receive a brief intervention every time they visit a clinician. The five major steps (the "5 A's") to intervention in the primary care setting are described below. The strategies are designed to be brief and minimal clinician's time is required(Glynn & Manley, 1989; Glynn et al., 1990). The "5 A's" for brief intervention 1. Ask about tobacco use: Identify and document tobacco use status for every patient at every visit. What needs to be done? Expand the vital signs to include tobacco use or use an alternative universal identification system (e.g., stickers on patient charts). 2. Advise to quit: In a clear, strong and personalized manner urge every tobacco user to quit. Advice should be: Clear-"I think it is important for you to quit smoking now and I can help you." "Cutting down while you are ill is not enough." Strong-"As your clinician, I need you to know that quitting smoking is the most important thing you can do to protect your health now and in the future. The clinic staff and I will help you." Personalised-Tie tobacco use to current health/illness, and/or its social and economic costs, motivation level/readiness to quit, and/or the impact of tobacco use on children and others in the household. 3. Assess willingness to make a quit attempt: Is the tobacco user willing to make a quit attempt at this time? If the patient is willing to make a quit attempt at this time, provide assistance If the patient will participate in an intensive treatment, deliver such a treatment or refer to an intensive intervention. If the patient clearly states he or she is unwilling to make a quit attempt at this time, provide a motivational intervention. If the patient is a member of a special population (e.g., adolescent, pregnant smoker), consider providing additional information. 4. Assist in quit attempt: For the patient willing to make a quit attempt, use counsellingcounsellingwith pharmacotherapy (when indicated) to help him or her quit. Preparations for quitting: Set a quit date. Ideally, the quit date should be within 2 weeks. Reduce the number of cigarettes gradually before the set date. Tell family, friends, and coworkers about quitting and request understanding and support. Also, help patient obtain extra-treatment social support from self-help groups. Other smokers in the household. Patients should encourage household members to quit with them or not smoke in their presence to minimize risk of treatment failure and exposure to second-hand smoking. Advice patient to remove tobacco products from his or her environment. Prior to quitting, avoid smoking in places where a lot of patient's time is spent (e.g., work, home, car). Provide a supportive healthcare environment while encouraging the patient in his or her quit attempt. Anticipate challenges to planned quit attempt, particularly during the critical first few weeks. These include nicotine withdrawal symptoms. Discuss challenges/triggers and how patient will successfully overcome them. Provide patients with problem solving/skills training. Abstinence. Total abstinence is essential. Not even a single puff after the quit date. Past quit experience. Identify what helped and what hurt in previous quit attempts. Alcohol. Since alcohol can cause relapse, the patient should consider limiting/abstaining from alcohol while quitting. Recommend the use of approved pharmacotherapies, if indicated. Explain how these medications increase smoking cessation success and reduce withdrawal symptoms. Provide supplementary materials. 5. Arrange followup: Schedule follow-up contact, preferably within the first week after the quit date. Timing. Follow-up contact should occur soon after the quit date, preferably during the first week. Subsequent follow-ups are recommended weekly within the first month, and then every two weeks for the 2nd and 3rd month, and monthly after that up to 6 months. For those who successfully quit, schedule follow-up contact, either in person or via telephone. Actions during follow-up contact. Congratulate success. If tobacco use has occurred, review circumstances and elicit recommitment to total abstinence. Remind patient that a lapse can be used as a learning experience. Identify problems already encountered and anticipate challenges in the immediate future. Assess pharmacotherapy use and problems. Consider using more intensive treatment, if not available, referral is indicated. Abstinence rate is better when smoking cessation interventions are delivered by health care providers as compared when there is no clinician involved (e.g., self-help interventions). However, studies have shown that interventions by doctors are cost-effective and their non-pharmacological interventions produced better abstinence rates than those by other healthcare personnel (I). Therefore, doctors should take the lead role in tobacco cessation programs involving a multidisciplinary team.(Cochrane ref) Four specific types of counsellingand behavioural therapy categories yield statistically significant increases in abstinence rates relative to no-contact (e.g., untreated control conditions)(Davis et al., 1984; Platt et al., 1997). These categories are: providing practical counselling such as problem solving/skills training/ relapse prevention/stress management providing support during a smoker's direct contact with a clinician (intra-treatment social support intervening to increase social support in the smoker's environment (extra-treatment social support) using aversive smoking procedures (e.g., rapid smoking, rapid puffing, other smoking exposure). FIGURE 2: FLOW CHART FOR MANAGEMENT OF TOBACCO USE AND DEPENDENCE Guidelines for non-pharmacological intervention Every tobacco user should be offered at least a brief intervention whether or not he or she is referred to an intensive intervention as this has been proven to increase overall tobacco abstinence rates(Robinson et al., 1995; Ahluwalia et al., 1999). There is a strong dose-response relation between the session length of person-to-person contact and successful treatment outcomes(Fiore et al., 2000). Intensive interventions are more effective than brief interventions and should be used whenever possible(Fiore et al., 2000). Person-to-person treatment delivered for four or more sessions appears especially effective in increasing abstinence rates. Therefore, if feasible, clinicians should strive to meet four or more times with individuals quitting tobacco use (I). Individual and group counselling formats are effective and should be used in smoking cessation interventions. Smoking cessation interventions that are delivered in multiple formats increase abstinence rates and should be encouraged. Studies have shown that individual counselling resulted in higher abstinence rates as compared to group or phone counselling and self-help (I). Methods of conducting proper counselling(individual, group or proactive phone counselling) is detailed in Appendix) It is important to understand that self-help alone is insufficient to achieve the desired outcome. However, it is a useful adjunct to other formats of interventions (II). Clinical guidelines for prescribing pharmacotherapy All smokers with scores from Fagerstrom's questionnaire (Appendix) of > 4 and smoking > 10 cigarettes per day should be offered pharmacotherapy (I). If pharmacotherapy is considered in smokers with Fagerstrom's score < 4 or smokes < 10 cigarettes/day, clinicians may use a lowered dose (JAMA 2001). Agents proven to be efficacious (I) which are recommended as first line agents for pharmacotherapy includes: Nicotine replacement therapies (NRT, e.g., gum, patch and inhaler) Sustained release (SR) bupropion Choice of a specific first-line pharmacotherapy must be guided by factors such as clinician's familiarity with the medications, contraindications for selected patients, patient preference, previous patient experience with a specific pharmacotherapy (positive or negative), and patient characteristics (e.g., history of depression, concerns about weight gain (Henningfield, 1995; Hughes & Goldstein, 1999). Special consideration should be given before using pharmacotherapy in selected populations: having medical contraindications (recent myocardial infarction, life-threatening arrhythmia, unstable or worsening angina, recent cerebrovascular accident or hypersensitivity to nicotine (Benowitz, 1997; Mahmarian, 1997) pregnant/breastfeeding women (Windsor et al.,1985: Walsh et al., 1997) adolescent smokers (Pierce et al., 1998) Patients with hypertension, stable angina pectoris, cerebrovascular accident, occlusive peripheral arterial disease, heart failure, hyperthyroidism, diabetes mellitus, renal or hepatic impairment or peptic ulcer need closer monitoring (Hughes & Goldstein, 1999) Table 3. Suggestions for the clinical use of bupropion SR Patient selection Appropriate as a first-line pharmacotherapy for smoking cessation. Precautions Pregnant smokers should be encouraged to quit first without pharmacologic treatment. Bupropion SR should be used during pregnancy only if the increased likelihood of smoking abstinence, with its potential benefits, outweighs the risk of bupropion SR treatment and potential concomitant smoking. Similar factors should be considered in lactating women (FDA Class B). Cardiovascular diseases ?Generally well tolerated; infrequent reports of hypertension. Side effects ?The most common side effects reported by bupropion SR users were insomnia (35-40%) and dry mouth (10%). Contraindications ?Bupropion SR is contraindicated in individuals with a history of seizure disorder, a history of an eating disorder, who are using another form of bupropion or who have used an MAO inhibitor in the past 14 days. Dosage Patients should begin with a dose of 150 mg q AM for 3 days, then increase to 150 mg b.i.d. Dosing at 150 mg b.i.d. should continue for 7-12 weeks following the quit date. Unlike nicotine replacement products, patients should begin bupropion SR treatment 1-2 weeks before they quit smoking. For maintenance therapy, consider bupropion SR 150 mg b.i.d. for up to 6 months. Availability Not yet available Prescribing instructions Cessation prior to quit date ?Recognize that some patients will lose their desire to smoke prior to their quit date, or will spontaneously reduce the amount they smoke. Scheduling of dose ?If insomnia is marked, taking the PM dose earlier (in the afternoon, at least 8 hours after the first dose) may provide some relief. Alcohol ?Use alcohol only in moderation. Table 4. Suggestions for the clinical use of nicotine gum Patient selection Appropriate as a first-line pharmacotherapy for smoking cessation. Precautions Pregnancy ?Pregnant smokers should be encouraged to quit first without pharmacologic treatment. Nicotine gum should be used during pregnancy only if the increased likelihood of smoking abstinence, with its potential benefits, outweighs the risk of nicotine replacement and potential concomitant smoking.Similar factors should be considered in lactating women (FDA Class D).* Cardiovascular diseases. NRT is not an independent risk factor for acute myocardial events, but it should be used with caution among certain cardiovascular patient groups: those in the immediate (within 2 weeks) post myocardial infarction period, those with serious arrhythmias, and those with serious or worsening angina pectoris. Side effects. Common side effects of nicotine chewing gum include mouth soreness, hiccups, dyspepsia, and jaw ache. These effects are generally mild and transient, and often can be alleviated by correcting the patient's chewing technique (see prescribing instructions below). Dosage Nicotine gum is available in 2 mg and 4 mg (per piece) doses. The 2 mg gum is recommended for patients smoking less than 25 cigarettes per day, while the 4 mg gum is recommended for patients smoking 25 or more cigarettes per day. Generally, the gum should be used for up to 12 weeks with no more than 24 pieces/day. Clinicians should tailor the dosage and duration of therapy to fit the needs of each patient. Availability Nicorette 2 and 4 mg Prescribing instructions Chewing technique. Gum should be chewed slowly until a peppery or minty taste emerges, then parked between cheek and gum to facilitate nicotine absorption through the oral mucosa. Gum should be slowly and intermittently chewed and parked for about 30 minutes or until the taste dissipates. (see figure 3). Absorption. Eating and drinking anything except water should be avoided for 15 minutes before and during chewing as acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine. Scheduling of dose. Patients often do not use enough gum to get the maximum benefit: they chew too few pieces per day and they do not use the gum for a sufficient number of weeks. Instructions to chew the gum on a fixed schedule (at least one piece every 1-2 hours during waking hours) for at least 1-3 months may be more beneficial than ad libitum use. Table 5. Suggestions for the clinical use of the nicotine inhaler Patient selection Appropriate as a first-line pharmacotherapy for smoking cessation. Precautions Pregnancy and cardiovascular diseases. As for nicotine gum. Local irritation reactions. Local irritation in the mouth and throat was observed in 40% of patients using the nicotine inhaler. Coughing and rhinitis occur in 32% and 23%, respectively. Severity was generally rated as mild, and the frequency of such symptoms declined with continued use. Dosage A dose from the nicotine inhaler consists of a puff or inhalation. Each cartridge delivers 4 mg of nicotine over 80 inhalations. Recommended dosage is 6-16 cartridges/day. Recommended duration of therapy is up to 6 months. Instruct patient to taper dosage during the final 3 months of treatment. Availability 4 mg/cartridge Prescribing instructions Ambient temperature. The inhaler and cartridges should be kept at room temperature. Duration. Use is recommended for up to 6 months with gradual reduction in frequency of use over the last 6-12 weeks of treatment. Absorption. Acidic beverages (e.g., coffee, juices, soft drinks) interfere with the buccal absorption of nicotine, so eating and drinking anything except water should be avoided for 15 minutes before and during inhalation. Best effects. Best effects are achieved by frequent puffing. Table 7. Suggestions for the clinical use of the nicotine patch Patient selection Appropriate as a first-line pharmacotherapy for smoking cessation. Precautions Pregnancy. Pregnant smokers should be encouraged to quit first without pharmacological treatment. The nicotine patch should be used during pregnancy only if the increased likelihood of smoking abstinence, with its potential benefits, outweighs the risk of nicotine replacement and potential concomitant smoking. Similar factors should be considered in lactating women. (FDA Class C) Cardiovascular diseases. As per gum. Skin reactions. Up to 50% of patients using the nicotine patch will have a local skin reaction. Skin reactions are usually mild and self-limiting, but may worsen over the course of therapy. Local treatment with hydrocortisone cream (1%) or triamcinolone cream (0.5%) and rotating patch sites may reduce such local reaction