Chapter 7 Smoking Cessation Kristine Petrasko, Bscpharm, CRE and Manjit Bains, Bscpharm

Psychiatric Conditions

Chapter 7 Smoking Cessation Kristine Petrasko, BScPharm, CRE and Manjit Bains, BScPharm

Pathophysiology dependency is the inability to discontinue tobacco use despite awareness of the various medical con- Nicotine addiction involves a variety of physical, psy- sequences.8 All forms of tobacco use have harmful 1,2,3 chological and behavioural factors. Nicotine acts effects. These include smokeless tobacco (chewing as a stimulant, increasing alertness and sense of well- tobacco and “snuff”), pipe tobacco, cigars, hookahs being as well as heart rate and blood pressure. Due to and other non-cigarette forms.7,9 rapid delivery to the mesolimbic pleasure-reward sys- tem in the brain, nicotine is highly addictive. With Health Risks continued use, chemical and biologic changes occur in the brain and tolerance develops very quickly. Nico- On average, 1 cigarette delivers 1–3 mg of nicotine to tine addiction is characterized by cravings for contin- the brain.2,10 Light or ultralight cigarettes may deliver ued smoking, a tendency to increase usage and pro- the same amount of nicotine as regular cigarettes, found physical and psychological symptoms elicited by regardless of the reported nicotine content, and are withdrawal. Table 1 describes various factors that rein- not safer than regular cigarettes.10 Many potential force nicotine addiction. factors are involved, such as more intense inhalation (“compensation”) or inadvertent blocking of the vent Prevalence holes on the cigarette filter by the lips or fingers during smoking. About 4.9 million Canadians (17% of the population) currently smoke.6 Nicotine addiction is the number The risks to health associated with smoking (see Table one cause of preventable death in Canada, killing over 2) are attributable to not only the nicotine in tobacco, 37 000 people every year, which is more than the num- but also to at least 50 of the other 4000 chemicals in ber associated with car accidents, suicides, homicides, tobacco smoke that are known carcinogens. These AIDS and other substance abuse issues combined.6 include: tar, arsenic, formaldehyde, ammonia and Now considered a chronic medical condition,7 tobacco nickel.

Table 1: Factors Reinforcing Nicotine Addiction

Category Reinforcing Factors3,4,5 Physical Pleasure or “high” similar to other addictive psychomotor stimulants Psychological Behavioural conditioning resulting from hand-to-mouth ritual repeated on average 250 times a day for a pack-a-day smoker Fear of weight gain associated with quitting Social Routine activities associated with smoking such as waking up in the morning, talking on the telephone, having a meal, spending time with family members or friends who also smoke; quitting does not eliminate these activities so they continue to act as triggers to smoke Withdrawal Symptoms Dysphoric or depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite/weight gain, gastrointestinal symptoms, headaches and insomnia Symptoms generally peak 24–72 hours after the last cigarette and subside after about 2 weeks Cravings can continue for years, but these are probably related more to behavioural and psychological aspects of nicotine addiction than to physiological factors

In addition to the risk to the smoker, environmental is when quitting, the better their overall quality of life, tobacco smoke (ETS) or second-hand smoke puts non- with a significant decrease in mortality rate.29,30 People smokers at risk, accounting for over 1000 lung can- who stop smoking versus those who continue when cer or cardiac deaths each year.6 Patients with chronic aged 25–34, 35–44, 45–54 and 55–64 lived longer by lung conditions may be most susceptible to ETS, with 10, 9, 6 and 4 years of life, respectively.31 This high- increased risk of asthma or COPD exacerbations. How- lights the importance of assisting the younger smoker ever, all nonsmokers are at risk for the effects of ETS, populations to quit, and more importantly, preventing which also include eye and throat irritation, coughing, them from starting in the first place. rhinitis, headaches and various types of cancer, particularly lung cancer. In children it has also been linked to Patient Assessment asthma, recurrent acute otitis media and sudden infant Health professionals are in an ideal position not only to death syndrome.27 help patients who have already decided to quit smok- For those who do quit, there are immediate and long ing, but also to identify smokers and assist them in mak- term health benefits: reduced risk of heart disease, ing the decision to quit. An assessment plan for smok- cancer, respiratory problems and infections. Quitting ing cessation is presented in Figure 1. before the age of 50 results in a 50% reduction in risk Health professionals should take the initiative to pro- of death in the next 15 years.28 The younger a person vide, at minimum, a brief intervention (3–5 minutes)

Table 2: Health Risks Associated with Tobacco Use Category Potential Health Effects Cancer Cancer of the lung, pancreas, kidney, bladder, lip, oral cavity and pharynx, esophagus and larynx are all increased 2–27 times for smokers compared to nonsmokers. Smoking accounts for about 30% of all cancer-related deaths.11 Cardiovascular Smokers have 2–4 times higher risk of coronary artery disease, 1.5 times higher risk of cerebral thrombosis12 and increased risk of arteriosclerotic peripheral vascular disease.13 Smoking cessation is an effective means of cardiovascular risk reduction and should be assessed in addition to blood pressure, lipid and blood glucose control.

Respiratory Smoking leads to chronic obstructive lung disease including chronic bronchitis and emphysema,14 as well as a higher incidence of lung and throat infections.15 Pregnancy and Smoking during pregnancy has been linked to increased risk of: intrauterine growth restriction postpartum (average 150 g lower birth weight at term); preterm and extremely preterm births; fetal and infant mortality; sudden infant death syndrome (SIDS); potential long-term effects such as increased risk of type 2 diabetes, obesity, asthma, certain childhood cancers.16,17,18 Oral diseases Smoking increases the risk of oral diseases such as leukoplakia (white premalignant lesions on oral mucosa), impaired gingival bleeding, periodontitis and ulcerative gingivitis, as well as lip, mouth and throat cancers that resulted in the deaths of 700 Canadians in 1996.19,20 Musculoskeletal Increased risk of lumbar disk disease and delayed bone healing. effects Decreased bone mineral density; though evidence of causality is lacking, bone loss associated with smoking could be expected to predict an increased risk of hip fractures, especially in postmenopausal women.21,22,23 Delayed wound Wounds resulting from trauma, disease, or surgical procedures heal slowly in smokers. Smokers healing experience a greater degree of complications as well as a higher incidence of unsatisfactory healing following reconstructive surgeries.24 Endocrine Chronic smokers develop insulin resistance. There is also an increased risk of microvascular complications in smokers who develop insulin resistance.25 Sexual function Erectile dysfunction is twice as likely to occur in smokers than nonsmokers; exposure to second-hand smoke is also a significant risk factor for erectile dysfunction.12 Peptic ulcer disease Increased incidence of bleeding and perforated ulcers.

Dermatologic effects Premature aging of skin and wrinkling.26

Copyright © 2013 Canadian Pharmacists Association. All rights reserved. Therapeutic Choices for Minor Ailments Chapter 7: Smoking Cessation 53 to assess smoking status and readiness to quit. Longer If the degree of physical dependence is low (see Table consultations (30–90 minutes) are even more effec- 3), the chances of successful smoking cessation are tive.7,34,35,36 good even with behavioural assistance alone. If the The following 3 assessment questions can be used to degree of physical dependence is moderate to high, the initiate a discussion with a patient: patient will likely require some form of pharmacotherapy (with or without behavioural assistance) to achieve 1. Do you smoke? success.7 2. Have you ever considered quitting? 3. Is now a good time? Goals of Therapy Assessing the patient's motivation to quit is based on The ultimate goal of therapy is to achieve lasting smok- the Stages of Change model of behavioural change (see ing cessation. Pharmacists can help patients achieve Figure 1). The precontemplation stage describes the this goal by: patient who is not even thinking about quitting. In the ■ Supporting smokers moving from pre-contempla- contemplation stage, the patient is considering quitting, tive and contemplative stages of change to prepa- typically in the next 6 months to a year. In the preparation and then action stages of smoking cessation. ration stage, the patient has made the decision to quit ■ Supporting smokers who successfully quit to and is preparing to begin the process. Next is the action achieve long-term abstinence (maintenance stage). stage where quitting actually occurs, followed by main- ■ These goals may be achieved by initiating dialogue, tenance, where the patient has been abstinent for at providing education and regularly following up with least 6 months and is working at remaining smoke-free. patients. See Figure 1 and Nonpharmacologic Therapy for intervention strategies for each stage of the process.

Table 3: Modified Fagerström Nicotine Tolerance Scale

Questionsa 0 points 1 point 2 points 3 points Score

1. How soon after you wake up do you smoke After 60 min Within 31–60 Within 6–30 Within 5 min your first cigarette? min min ___

2. Do you find it difficult to refrain from smoking No Yes – – in places where it is forbidden? ___

3. Which of all the cigarettes you smoke in a Any other First one in the – – day is the most satisfying one (the hardest than first morning one to give up)? one in the morning ___

4. How many cigarettes per day do you 10 or less 11–20 21–30 31 or more smoke? ___

5. Do you smoke more during the morning No Yes – – than during the rest of the day? ___

6. Do you smoke when you are so ill that you No Yes – – are in bed most of the day? ___

Total: ___ a For some nicotine replacement products, only question 1 or 4 is required to determine the appropriate initial dose. Score: <5 = low nicotine dependence; 5 = moderate nicotine dependence; 6–7 = high nicotine dependence; 8–10 = very high nicotine dependence Adapted with permission from Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict 1991;86:1119-27.

Figure 1: Assessment of Patients with Nicotine Dependence

Abbreviations: CAD = coronary artery disease; COPD = chronic obstructive pulmonary disease; HCP = health care professional; NRT = nicotine replacement therapy

Nonpharmacologic Therapy ■ Use the Modified Fagerström Nicotine Tolerance Scale (Table 3) to assess nicotine dependence, then Nonpharmacologic therapy for nicotine addiction help select the most suitable smoking cessation includes various behavioural interventions and alter- method. native therapies. Combining one or more of these methods may be sufficient for success in patients who ■ Address questions/concerns about smoking cessa- are light smokers. It is also the most appropriate option tion, e.g., nicotine withdrawal, nicotine replacement for patients in whom pharmacologic therapy is con- products, triggers, past quit attempts, weight gain. traindicated because of potential interaction with other ■ Prior to quitting, encourage patients to avoid smok- medications or because of other physical conditions ing in places where a great deal of time will be spent such as severe heart disease or pregnancy. such as in the car or at home in order to help minimize the behavioral and psychological aspects of Counselling approaches for patients at various stages smoking.38 of change might include: ■ Suggest avoiding triggers by removing smoking Precontemplation—Ask and Listen paraphernalia (e.g., ashtrays, lighters) from the home and vehicles and cleaning areas to remove the ■ Encourage patients to discuss their smoking openly smell of smoke. and to think about quitting, e.g., “What do you like and not like about smoking.” ■ Suggest strategies to deal with cravings, e.g., remembering the reasons for quitting smoking, ■ Reinforce relevant health consequences of smoking, distractions such as exercise, relaxation, taking but avoid confrontational or judgmental comments deep breaths, low calorie snacks and seeking social or body language. support. ■ When possible, use a personalized approach to ini- ■ Encourage patients to identify and inform individ- tiating a dialogue, e.g., “I am concerned about the uals they will count on for support during the quit effect smoking is having on your asthma. Would process, e.g., family, friends, co-workers. you be willing to discuss this at some point?” ■ Inform patients of community resources available ■ Empower patients with belief in their ability to quit. to assist with smoking cessation such as quit lines. ■ Provide information and reassurance that you will (See Table 4). be available to help when they are ready. Action—Congratulate Contemplation—Motivate and Assist ■ Provide positive feedback and praise for taking the ■ Encourage patients to think about their own pros and important step of quitting. cons for smoking versus quitting. Help them under- ■ Ask patient how they have been doing since you last stand that the benefits of quitting are well worth the saw them, e.g., “How are you dealing with cravings? challenge. Have you had any setbacks since we last spoke and ■ Be understanding if patients express ambivalence if so how did they affect you?” about quitting or seem discouraged from failed ■ Reinforce coping strategies that were successful or attempts to quit in the past. suggest new ones if necessary. ■ Provide encouragement and positive reinforcement ■ Reassess medication use and suggest changes as of their desire to quit and reassurance about any per- appropriate. ceived deterrents, e.g., “It is great that you are thinking about quitting. That is the first step towards ■ Continue to provide support and follow-up periodi- success. I know you are concerned about gaining cally. weight, but this is something that can be prevented. I Maintenance—Support can certainly help you with this. Let me know when ■ Continue to provide positive reinforcement. you are ready to talk more about it.” ■ Work on preventing relapse and encouraging long- Preparation—Show and Tell term self-management. ■ Help patients set a quit date (ideally within the next ■ Remind patients of their own reasons for quitting 2 weeks). The patient may choose to quit abruptly and help demonstrate their success and progress, on that day or to gradually reduce cigarettes smoked e.g., “You know, you have barely needed your blue before the quit date.37 inhaler in the last few months. This tells me that

your asthma is under much better control since you Even the simplest type of behavioral modification quit smoking.” programs may be beneficial. Self-help in the form of electronic aids such as internet sites and mobile tele- Relapse—Don't Give Up phone text messages designed to assist individuals to ■ Remind patients that this situation should be consid- stop smoking is effective in increasing the likelihood ered a “learning experience” rather than a failure. of long-term cessation.41,42 ■ Find out what stage of change they are currently in Many self-help materials, individual and group pro- and assist them with getting back into the prepara- grams and counselling programs are available to both tion stage. health care professionals and patients. A list of pro- ■ Identify triggers for relapse and discuss strategies grams in each province is available on the Health for prevention. Canada and Canadian Lung Association web sites (see ■ Help patients identify personal strengths and weak- Table 4). nesses and formulate a new plan of attack. To provide optimum support for smoking cessation, ■ Motivate and encourage them to try again no matter health care professionals need proper training.43 The what, e.g., “Quitting smoking is one of the most dif- “5 A's Approach” is a universally adopted tool phar- ficult things to do and it often takes a few attempts macists can utilize as part of a smoking cessation pro- before a person becomes completely smoke-free. gram. The 5 A's consist of: ask, advise, assess, assist With each attempt you are getting that much closer and arrange. Pharmacists and other health care profes- to quitting permanently. If you are willing to try sionals can be trained in this approach via several pro- again, we can discuss.” grams including QUIT and TEACH (see Table 4). Behavioural Modification Programs Acupuncture An estimated 1 in 5 smokers who are preparing to Acupuncture therapy for smoking cessation is based on stop smoking actually seek formal help with quitting. the Chinese science of energy pathways in the body. It Although smokers can become involved in self-help involves special needles placed at strategic points under programs, health professionals should be providing the skin of the nose or ear. Evidence of effectiveness in information on behavioural interventions for all smok- smoking cessation is not available; most studies were ers, regardless of the patient's motivation to quit. For poorly conducted, yielding unreliable results.44,45,46 effective recruitment strategies, see Suggested Read- ings . Aversion Therapy Even brief advice to quit from a primary care physi- Aversion therapy is based on the concept that asso- cian during a routine consultation has been effective in ciation of an unpleasant sensation with smoking can increasing the number of smokers who remain absti- reduce the desire to smoke. Techniques have included nent for at least 6 months. Person-to-person coun- mild electric shock, breath-holding, rapid smoking, selling over 4 or more sessions is especially effective. unpleasant taste, noise or smell and imagined stimuli. In general, greater contact between the patient and the Good evidence to support aversion techniques is lack- program provider leads to greater success.7,39 ing; rapid or excessive smoking has shown the most promise. Because of the potentially harmful effect on Regardless of their level of nicotine dependence, the heart and lungs, this method is not recommended encourage patients to participate in a behavioural as a smoking cessation strategy.44,46 modification program. Light smokers may be able to achieve lasting abstinence using behavioural modifi- Hypnosis cation alone, while moderate to heavy smokers benefit more from the addition of pharmacologic therapy. A Hypnosis is a deep, relaxed state of attention during Cochrane systematic review demonstrated that inter- which people are more responsive to suggestions. Hyp- ventions combining pharmacotherapy and behavioural notherapy for nicotine addiction attempts to change a support increase success rates in smoking cessation person's habits and attitudes to cigarettes. The thera- compared to usual care.40 This further validates the pist's skill and experience are very important, as are the importance of recommending patients to engage in patient's susceptibility to hypnosis and desire to quit. behavioural modification programs in addition to phar- Although there are reports of success with this method, macotherapy. a Cochrane review concluded there was insufficient

Table 4: Smoking Cessation Programs and Resources

Program Name Description Contact Information Cost One Step at a Time— Self-help program for patients—includes Canadian Cancer Society Freea A Smoker's Guide to Quitting books (For Smokers Who Want to Quit and 1-888-939-3333 For Smokers Who Don't Want to Quit) and a www.cancer.ca pamphlet for assisting others who wish to quit (also available through the Smoker's Helpline service) On the Road to Quitting— A 40-page self-help guide and online program Health Canada smoking cessation Freea A Guide to Becoming a to assist smokers with the quitting process web site Nonsmoker www.hc-sc.gc.ca/hc-ps/ tobac-tabac/quit-cesser/index- eng.php Smokers' Helpline Service provided by trained counsellors to www.smokershelpline.ca Freea assist patients who are seeking help with Toll free telephone numbers smoking cessation. Telephone assistance, provided for each province and on line and print materials available in French territory and English Centre for Addiction and Online information for the public on tobacco www.camh.ca Freea Mental Health (CAMH) use. HCP education programs such as the 1-416-535-8501 (Ext. 1600) TEACH project Canadian Action Network Mainly for HCPs; user can post online 1-416-535-8501 (Ext. 7427) Freea for the Advancement, questions to panel experts or colleagues. www.nicotinedependence- Dissemination and Adoption Quick reference to guideline updates clinic.com/English/CANADAPTT/ of Practice-informed Tobacco Pages/Home.aspx Treatment (CAN-ADAPTT) (affiliated with CAMH) QUIT—Quit Using and Inhaling Training program that provides useful Canadian Pharmacists Association b Tobacco resources and tools for practising 1-800-917-9489 pharmacists. Live workshops and an online www.pharmacists.ca lesson are available a Shipping costs may apply for large orders. b Fee for live and online workshops; resources free for participants. Abbreviations: HCP = health care professional; TEACH = training enhancement in applied cessation counselling and health evidence to consider hypnotherapy effective for smok- contain up to 70% tobacco, providing nicotine and the ing cessation.47 If this method is tried, advise patients same toxins as all-tobacco cigarettes.49,50 to combine it with behavioural modification or counselling. Follow-up counselling and support or combin- Electronic Cigarettes ing the therapy with other smoking cessation methods Electronic cigarettes look and behave like cigarettes, may also improve the success of hypnotherapy.44,46,48 but they contain a battery-powered mechanism to heat and vapourize a liquid chemical mixture composed of Laser Therapy varying amounts of nicotine, propylene glycol, other chemicals and/or impurities. The vapour produced and Similar to the application of acupuncture, laser ther- glowing tip resemble the smoke and burning tip of an apy uses laser beams which are directed at certain key actual cigarette, which may satisfy the behaviours asso- points on the body surface. This stimulation of key ciated with smoking (handling of cigarette, inhaling of points purportedly triggers a release of endorphins and smoke) in addition to nicotine addiction. Advocates relieves nicotine cravings. No reliable studies support of e-cigarettes praise them as a clean drug delivery this therapy.44,45,46 device, although the chemical safety is questionable. Clove and Herbal Cigarettes For example, propylene glycol is a known irritant and the long term effects on the lungs are unknown at this Imitation cigarettes containing ingredients such as time.51 Additionally, the FDA conducted a preliminary cloves and various herbs are available. However, these analysis on samples of e-cigarettes from leading brands products may also contain tar, carbon monoxide and and found known carcinogens and toxic chemicals.52 various other toxins. Clove cigarettes may actually Although the analysis conducted was preliminary, it

Therapeutic Choices for Minor Ailments Copyright © 2013 Canadian Pharmacists Association. All rights reserved. 58 Psychiatric Conditions illustrates the lack of research on these products and the In Canada, NRT medications are considered Sched- need for additional data on safety and effectiveness. ule U products (unscheduled) and can be obtained from a pharmacy without a prescription. Available Electronic cigarettes are currently marketed and sold dosage forms include chewing pieces (gum), lozenges, in Canada and are also available via the internet. How- inhalers, mouth sprays and transdermal patches (see ever, since the production is not regulated, some elec- Table 6). Although nasal sprays and sublingual tablets tronic cigarettes contain nicotine while others contain may be available in the US, they are not available in varying levels of other chemicals. It is important to Canada. note that only those products without nicotine or health claims can be legally imported and sold in Canada.53 Table 5: Estimated Six-month Abstinence Over 400 brands of electronic cigarettes are available.52 Rates for Smoking Cessation There is world wide debate concerning electronic ciga- Pharmacotherapy7,55 rettes, since the potential benefit of smoking cessation Estimated Abstinence may outweigh the potential risks. Health Canada does Intervention Rates at 6 Monthsa,b,c not recommend using electronic cigarettes due to lack of safety information regarding exposure to vapourized Nicotine gum 19% propylene glycol (among other chemicals used in the Nicotine patch 23.7% products) and their unknown long term effects.54 Nicotine inhaler 24.8% Pharmacologic Therapy Nicotine lozenge 19.9% Pharmacologic therapy for smoking cessation can be Bupropion 24.2% divided into 2 broad categories: nicotine replacement Bupropion plus nicotine patch 28.9% therapy and non-nicotine therapies. Nicotine patch plus as-needed 29.7% The purpose of pharmacologic therapy is to reduce the inhaler or gum or lozenge (average) physical effects of nicotine withdrawal (see Table 1), which peak within 72 hours and may continue inter- Varenicline 1 mg BID 33.2% mittently for several weeks. In some patients, phar- Varenicline 0.5 mg BID 25.4% macologic therapy is also needed to reduce the psy- a Average quit rates following usual course of therapy. chological effects of withdrawal (cravings), which can b Longer duration of therapy may result in slightly higher abstinence last up to several years, or as some ex-smokers will rates. attest, indefinitely.4,5 While many patients may bene- c Abstinence rates for placebo average 13%. fit from pharmacologic therapy, patients who are only Nicotine replacement therapy increases the rate of mildly addicted may not require it to quit successfully. smoking cessation by 50–70 percent.56 The success Pharmacotherapy may be contraindicated for certain of NRT is independent of dosage form, concurrent patients because of potential drug or disease interac- therapy and setting. tions. In general, the incidence of adverse effects is low pro- Abstinence rates associated with various smoking vided the patient receives adequate counselling on the cessation pharmacotherapy are presented in Table 5. appropriate use of the product. It is important to con- Use caution when comparing abstinence rates among sider that some contraindications may be relative rather treatments, as there is insufficient data regarding direct than absolute contraindications, requiring clinical judg- comparisons. Placebo success rates average around ment in the decision-making process. Given the sig- 13% in smoking cessation pharmacotherapy trials. nificant risks of continued smoking, the risk/benefit ratio for pharmacotherapy may be favourable even in Nonprescription Therapy pregnant patients or those with heart disease. These patients can often be successfully and safely managed Nicotine replacement therapy (NRT), designed to with NRT or other pharmacotherapy under guidance of replace the nicotine found in cigarettes, is the mainstay their physician or specialist. This concept will be fur- of nonprescription therapy for smoking cessation. ther discussed under Special Considerations.57,58

Copyright © 2013 Canadian Pharmacists Association. All rights reserved. Therapeutic Choices for Minor Ailments Therapeutic Table 6: Nicotine Replacement Therapy for Smoking Cessation For product selection, consult Products for Minor Ailments. Smoking Cessation Products.

Choices Drug Dose Peak Adverse Effects Contraindications Comments nicotine Initial strength: 20–30 min Jaw, mouth or throat Life-threatening Caution patients not to chew for polacrilex soreness. arrhythmia; severe like regular gum (increased

Minor Nicorette (see Table 3): 2 mg if chewing pieces score is ≤6, 4 mg if ≥7 CNS: depression, anxiety, angina pectoris; history side effects). (gum) irritability, insomnia; of recent stroke; Avoid use of acidic Ailments Thrive: 4 mg if ≥25 cigarettes/day, Nicorette, 2 mg if <25 cigarettes/day dizziness, weakness, temporomandibular beverages and foods joint disease; within Thrive Initial dose: 10–12 pieces per day headache. (coffee, fruit juices, soft Gastrointestinal: changes 2 wk following myocardial drinks, alcohol) while po. May increase to 20 pieces per infarction. day if needed in taste perception, chewing and 15 min hiccoughs dyspepsia, Relative contra- before as this decreases Place 1 piece of gum in the mouth. indications: pregnancy, absorption. Bite down once or twice then park nausea, vomiting. Cardiovascular: smoking while using Favourable dosing flexibility it between the teeth and gums for this medication (nicotine about 1 min. Repeat when the hypertension, palpitations, compared to patch. tachycardia, chest pain. toxicity), breastfeeding, desire to smoke arises, up to once age <18 y. per min for up to 30 min, then Skin: erythema, itching, discard piece rash, urticaria. Caution in Respiratory: dyspnea, hyperthyroidism, At weekly intervals, reduce pheochromocytoma, by 1 piece/day over 3 mo, as cough, hoarseness, sneezing, wheezing. insulin-dependent withdrawal symptoms allow. diabetes, active peptic Continue for maximum of 6 mo ulcer, uncontrolled hypertension. Copyright nicotine Initial strength: 1 mg if <20 20–60 min See nicotine polacrilex See nicotine polacrilex Caution patients not to bitartrate cigarettes per day, 2 mg if ≥20 gum. gum. swallow or chew lozenges dihydrate cigarettes per day (increased side effects). Chapter ©

2013 lozenges Dosing frequency: see nicotine Avoid acidic beverages and Thrive polacrilex lozenges; maximum foods (e.g., coffee, fruit

Canadian 15/day po for 2 mg strength, juices, soft drinks, alcohol) 25/day po for 1 mg strength during and 15 min prior to 7: using the lozenge as this Smoking

Pharmacists decreases absorption. Favourable dosing flexibility compared to patch. See nicotine polacrilex Association. lozenges. Cessation

(cont'd) All rights r eserved. 59 60 Copyright Table 6: Nicotine Replacement Therapy for Smoking Cessation (cont'd) For product selection, consult Products for Minor Ailments. Smoking Cessation Products. © 2013 Drug Dose Peak Adverse Effects Contraindications Comments Psychiatric

Canadian nicotine Use initial strength of 2 mg if first 20–60 min See nicotine polacrilex See nicotine polacrilex See nicotine bitartrate polacrilex cigarette of the day >30 min after gum. gum. dihydrate lozenges. lozenges waking, 4 mg if ≤30 min Pharmacists Nicorette Weeks 1–6: Dissolve 1 lozenge

in the mouth Q1–2H PRN for Conditions withdrawal symptoms (maximum 15 lozenges/day) Association. Weeks 7–9: Use 1 lozenge Q2–4H PRN po Weeks 10–12: Use 1 lozenge Q4–8H PRN po All

rights Discontinue when the dose has been reduced to 1–2 lozenges/day

r Use beyond 6 mo is not generally eserved. recommended Lozenges should be allowed to slowly dissolve and moved from one side of the mouth to the other periodically nicotine inhaler Initial therapy: Use at least 6 15 min Mainly mild local irritation, See nicotine polacrilex Each 10 mg cartridge Nicorette cartridges/day (maximum 12 per cough, throat irritation, gum. delivers 4 mg of nicotine day) for the first 3–6 wk. Begin to pharyngitis, stomatitis, (of which about 2 mg is taper slowly over the next 6–12 rhinitis. Headache, systemically absorbed); wk. Discontinue once usage is dyspepsia, nausea approximately equivalent to down to 1–2 times per day (after 3 may also be present. 20 min of puffing. mo ideally). Use may be continued Side effects are usually Nicotine vapour is absorbed with tapering dosage up to 6 mo. transient and decrease through the buccal lining Use for >6 mo not recommended with continued use. of the mouth, not from the Inhalers should be puffed similarly lungs. to a cigarette (~5–10 min at a time) Colder ambient Therapeutic temperatures decrease absorption rate. Cartridge can be used for

Choices up to 24 h once punctured. for Minor Ailments Therapeutic For product selection, consult Products for Minor Ailments. Smoking Cessation Products. Drug Dose Peak Adverse Effects Contraindications Comments Choices nicotine Apply patch to nonhairy, clean, dry 2–6 h Local skin reactions: See nicotine polacrilex Assess patient in first 2 wk transdermal skin site in upper arm or hip; use a erythema, pruritus, edema, gum. to ensure smoking has been for patch different site each day; avoid using blisters, rash, burning Generalized skin discontinued. If patient still

Minor 24–hour: the same site more than once sensation. disorders (severe smoking discontinue patch Habitrol, weekly CNS: headache, dizziness, eczema or psoriasis) and refer to physician.

Ailments Nicoderm Apply upon waking and wear paresthesias, insomnia, Relative contra- Check product monograph 16–hour: 16–24 h per day, depending on abnormal dreams, indications: pregnancy; re. wearing patch during Nicorette product depression, somnolence, mild atopic or eczema- strenuous exercise—varies General dosing instructions involve anxiety, emotional lability. tous dermatitis. by product. 6 wk of use of highest strength Cardiovascular: Hypersensitivity to topical Used patches should be (21 mg for Nicoderm or Habitrol, palpitations, chest pain, adhesives or nicotine. folded so that medicated 15 mg for Nicorette) followed blood pressure changes, sides are facing inward by 2 wk at the intermediate tachycardia. and discarded safely out of strength then 2 wk at the lowest Gastrointestinal: reach of children or pets. strength. Consult individual abdominal pain, Manufacturers do not product monographs for details dyspepsia, nausea, recommend cutting patches diarrhea, constipation, as this may damage the dry mouth, nausea and delivery device. vomiting, flatulence, Patients who experience stomatitis. insomnia from the 24–hour Respiratory: cough, patch may benefit from pharyngitis, rhinitis, removing the patch

Copyright dyspnea, sinusitis. at night and using an Other: myalgia, arthralgia, immediate-release product dysmenorrhea, toothache, first thing in the morning, then applying a new patch. Chapter

Canadian mouthspray min po. Maximum dose: headache, hiccoughs, gum. nicotine.

Nicorette 2 sprays/episode, 4 sprays/h, nausea and vomiting, Precautions: Unstable Mouthspray absorbed 7: QuickMist 64 sprays/day dyspepsia, oral soft tissue cardiovascular disease, through buccal mucosa. Smoking

Pharmacists pain, stomatitis, salivary Spray must be primed with first use diabetes mellitus, GI Avoid acidic beverages and hypersecretion, burning or after 2 days of not using disease, uncontrolled foods (coffee, fruit juices, lips, dry mouth. hyperthyroidism, soft drinks, alcohol) during pheochromocytoma, use and 15 min before Association. hepatic or renal use as this may decrease Cessation impairment. absorption. All rights r eserved. 61 62 Psychiatric Conditions

Combination NRT available, exercise caution before initiating varenicline For heavy smokers who continue to suffer withdrawal in patients with cardiovascular concerns. symptoms while using a single nicotine patch, total Safety concerns have also been raised regarding neu- daily doses of nicotine may be increased up to 35 ropsychiatric symptoms in patients with underlying mg per day for smokers previously using 21–40 cig- psychiatric disorders. Though severe behavioural arettes a day, and up to 40 mg per day for smokers changes (severe agitation, hostility, suicidal ideation) previously using more than 40 cigarettes a day, with are rare, psychological symptoms should be carefully reported safety and improved efficacy.59,60,61 This may assessed in all patients before starting varenicline be achieved by using additional patches or chewing and at each visit. Assessment should include asking pieces or the combination of both. Using more than 1 patients if any adverse psychological effects occurred patch or doses >21 mg requires physician supervision. on previous quit attempts.64,70 Combining the nicotine patch with as-needed gum, Varenicline is not recommended in combination inhaler or lozenges can be more effective than the with NRT due to an increase in side effects (nausea, 7,55,56 individual products, possibly because it provides headache, dyspepsia) without an increase in effi- a steady baseline level of nicotine with “boluses” for cacy.7,64 Varenicline is also contraindicated during flexibility and treatment of cravings. pregnancy as there is evidence of reproductive toxicity Prescription Therapy in animal studies, though no human pregnancy data are available as yet.71 A number of therapeutic agents have been investigated for use in nicotine addiction. See Table 5 for reported Nortriptyline may be as effective as buproprion for 62 quit rates for various single and combination therapies. smoking cessation, making it a suitable second-line option. Clonidine is somewhat effective but of limited Bupropion is effective for smoking cessation.7,62 use because of significant side effects.7,72,73 Contraindications include a history of seizures, anorexia or bulimia nervosa and concurrent MAOI Special Considerations therapy. More common adverse effects include dry Pregnancy mouth and insomnia. Less common are hypertension, arthralgia, myalgia, dizziness, tremor, somnolence, Nonpharmacologic choices are always first-line for bronchitis, pruritus, rash and taste perversion.63 Some pregnant patients as behavioral therapy has proven patients may develop agitation-like behavioural or effective for smoking cessation in pregnancy.74 Evi- emotional changes, which may increase the rare risk dence is insufficient to determine if NRT is effective of harm to themselves or to others. Close patient or safe for promoting smoking cessation in preg- monitoring is advised for all patients, but especially in nancy.75 However, those with moderate to high nicotine those with underlying psychiatric illness.63,64 dependence will likely require some form of pharmacotherapy.7 One must balance the risks and benefits As with other pharmacotherapeutic agents for smoking of continuing to smoke compared to using NRT. The cessation, bupropion should be used in combina- products are not officially approved for use in preg- tion with behavioural programs to assist the quitting nancy and NRT may have potential risks to the mother process, and can be used during pregnancy if benefit and fetus.7,76 However, cigarette smoking during preg- outweighs the risk.63,64 A combination of NRT and nancy would likely have far greater risks including buproprion may be more effective than buproprion exposure to nicotine and the 4000 other chemicals in alone.56 tobacco smoke. Therefore, most experts believe that Varenicline, an alpha4beta2-nicotinic receptor par- if nonpharmacologic and/or behavioral strategies fail, tial agonist, has higher quit rates compared to other interventions with NRT would be justified and can available agents.7 Advise patients about common side be attempted with close physician supervision.64 It is effects such as nausea, vomiting, headache, insomnia, important to incorporate behavioural interventions and abnormal dreams and dizziness. to use the lowest effective dose of NRT. Initiation of Concerns regarding potential cardiovascular risks of smoking cessation is important during the earlier stages of pregnancy (ideally within the first 16 weeks).64 varenicline,65,66 prompted Health Canada to review its cardiovascular safety.67 However, newer data suggests If NRT is to be used in pregnancy, choose an imme- no significant increase in cardiovascular adverse events diate-release form of NRT such as the gum, lozenge associated with varenicline use.68,69 Until further data is or inhaler rather than a continuous dosage form such

Copyright © 2013 Canadian Pharmacists Association. All rights reserved. Therapeutic Choices for Minor Ailments Chapter 7: Smoking Cessation 63 as the patch. Use the lowest effective dose, for the Dependence guideline update, adolescents are inter- shortest possible time, to reduce fetal exposure to nico- ested in quitting. A survey of about 5000 eleventh tine. If a patient is highly addicted to nicotine, use of grade students revealed that approximately 79% would the patch may be a more favourable option. In these be willing to discuss or acknowledge their smoking cases, a 16-hour patch may be preferable to a 24-hour habit if they were asked about it.7 This sets the stage patch (or a 24-hour patch can be applied for 16 hours for health care providers to engage in tobacco use and removed at night) to reduce fetal nicotine expo- discussion—simply by asking the 3 main assessment sure.64 Close supervision and monitoring is essential questions (see Patient Assessment). Though many for all pregnant patients and should involve the patient's patients may not be ready to quit at the first visit, ask- physician. ing about tobacco use and sending a strong message of abstinence and/or cessation to young patients and their Breastfeeding parents is important in the prevention of tobacco use in this young population. Although nicotine is excreted in breast milk during NRT, the risk to the infant is less than the risk from The current recommendation for smoking cessa- second-hand smoke, such as increased risk of sud- tion treatment of adolescent smokers is primarily den infant death syndrome, respiratory infections behavioural. Avoid incentive programs utilizing prizes or asthma.7,64 Intermittent use of immediate-release aimed to prevent smoking uptake, as they are not forms of NRT are preferred in breastfeeding mothers. effective.81 Although NRT has been shown to be safe Encourage the mother to breastfeed just before using in this population, it is generally not recommended, the NRT product, to minimize infant exposure to nico- and counselling is the most effective. There is little tine.76 evidence that pharmacotherapy is effective in promoting long-term abstinence rates in younger patients.7 Cardiovascular Disease Pharmacologic therapy (including NRT) in patients under 18 years of age should be initiated and moni- It is dangerous for patients with cardiovascular disease tored by their physician. Recommend Health Canada's to continue to smoke. Smoking can activate coagu- “Quit4Life” program to this age group (see Table 4). lation pathways in the body, promoting thrombosis formation and increased risk of myocardial infarction. Smokeless Tobacco Nicotine can also cause vasoconstriction as well as 2 Counselling is effective for treating patients who use increased heart rate and contractility. Despite this, smokeless tobacco products, and should be considered many experts now believe that short-term use of NRT first-line.7,82 If behavioural therapies are insufficient is safer than smoking, although there are risks involved (e.g., for moderately-highly addicted patients), vareni- with the use of NRT products. Evidence suggests that cline may increase smokeless tobacco abstinence NRT is generally safe in patients with stable cardiovas- 82 77,78 rates. Evidence is insufficient to support the use of cular disease. Caution and physician supervision buproprion and NRT for smokeless tobacco cessa- are recommended, particularly within 2 weeks follow- tion.82 Dosage conversion information is not available ing myocardial infarction or in patients with unstable for initiating NRT. angina or serious arrhythmias.7,79 The transdermal patch may be preferable to immediate-release dosage Drug Interactions forms because of more consistent nicotine plasma Cigarette smoking can affect the metabolism of many concentrations. drugs. One of the major lung carcinogens founds in Children and Adolescents tobacco smoke is polycyclic aromatic hydrocarbon (PAH). PAH, not nicotine, is responsible for induction For many years, tobacco use has been a major con- of hepatic enzymes CYP1A1, 1A2, and possibly 2E1.83 cern in the pediatric population.7 Experimentation Thus drug interactions only occur with the cigarette with nicotine and drugs is beginning at much earlier smoke and not with NRT. The clearance of drugs such ages (11–17 years) and it is not uncommon for nico- as caffeine, clozapine, diazepam, estrogens, fluvox- tine dependence to occur rapidly in this population. amine, methadone, nifedipine, olanzapine, rasagiline, Primary prevention is key and health care practition- theophylline, trifluoperazine and warfarin may be ers must deliver strong tobacco use prevention and increased in smokers. Conversely, when patients quit cessation messages to this group and their parents.80 smoking, increased monitoring and dosage reduction According to the 2008 Treating Tobacco Use and may be required once drug metabolism is no longer

affected by smoking. Refer patients to their physician patients attempt to quit on their own.7 Follow-up if they are taking drugs that may be affected by smok- should begin within the initial week following the quit ing and are planning to quit. Reduction of caffeine date, particularly if the patient is receiving NRT, to intake is advised to minimize caffeine-induced palpi- avoid adverse effects from excessive nicotine levels. tations and other side effects after quitting. Follow-up counselling should be provided regularly, e.g., every month for 3 months, then at 6 and 12 Monitoring of Therapy months. In general, more counselling time yields higher abstinence rates.7 Additional monitoring should Because of the large behavioural component of nicotine be considered for patients who are at high risk, e.g., addiction, monitoring of therapy is crucial to the suc- highly nicotine-addicted patients with history of many cess of smoking cessation therapy. Ideally, the patient previous smoking cessation attempts, patients experi- receives ongoing monitoring for a period of time by a encing severe psychosocial stress, those with comorbid clinician or therapist involved with a smoking cessation substance abuse disorders or history of depression or program (see Table 7). If this service is not provided schizophrenia, patients taking concomitant medication by the program, the pharmacist or other treating health that interacts with nicotine or cases where smoking professional should offer it. cessation is medically urgent. A suggested schedule Relapse rates are high, particularly at the beginning for more intensive monitoring might involve follow-up of smoking cessation, with 66% reportedly relapsing every 2 weeks for the first 3 months, then at 6, 9, 12, within 48 hours and 76% within the first week, when 18 and 24 months.

Table 7: Monitoring of Therapy for Smoking Cessation

Suggested Indicators/Goal/ Monitoring Parameter Time Frame Frequency Recommended Intervention

Smoking Patient reports no smoking. Patient: daily Inquire as to smoking level, provide encouragement Health professional: and support. monthly × 3 mo If patient has a relapse, discontinue nicotine then at 6 and 12 mo replacement therapy until patient is ready to quit again; encourage patient to reset a quit date; discuss possible reasons for relapse and help patient strategize about how to be more successful with the next quit attempt; be empathetic and avoid scolding the patient.

Desire to Patient reports level of As above Intense craving may require additional treatment smoke desire decreasing to minimal (e.g., bupropion) or switch to varenicline. (or none) by end of therapy Encourage behavioural changes to decrease desire; (3–6 mo); cravings may empathize with patient's difficulty and strongly never completely end for encourage perseverance. some.

Nicotine Patient on NRT reports As above If symptoms are bothersome, consider increasing dose, withdrawal reduction in withdrawal switching or adding an alternative method of NRT. symptoms symptoms (see Table 1) Remind patients that the most difficult period is the within 25 min to 24 h of first 2–14 days. Recommend additional behavioural initiating therapy. interventions if necessary.

Medication Patient reports no As above If minor side effects occur, suggest ways to modify adverse adverse effects when (e.g., for belching, hiccoughs and GI upset with gum, effects questioned specifically advise slower chewing) or consider switching to an throughout duration of alternative method of NRT. pharmacotherapeutic If serious adverse effects occur (e.g., hypertension, treatment. nicotine toxicity) consider reducing dose or discontinuing medication and/or switching to alternative (e.g., bupropion or varenicline).

(cont'd)

Table 7: Monitoring of Therapy for Smoking Cessation (cont'd)

Suggested Indicators/Goal/ Monitoring Parameter Time Frame Frequency Recommended Intervention

Weight Patient reports minimal or Patient: weekly Encourage healthy eating habits, exercise, having gain84,85 no weight gain over the Health professional: healthy snacks available to deal with cigarette cravings 6–12 mo following quitting. 3, 6, 9, 12, 18 and (e.g., carrot sticks) to prevent or minimize weight gain. 24 mo Reassure patient that slight weight gain is less harmful to their health than continued smoking.

Stress Patient reports minimal Patient: daily Assess for evidence of excessive stress (reported by additional stress due to Health professional: patient, or other physical or behavioural signs such as smoking cessation over 3, 6, 9, 12, 18 and weight loss, nervous habits, GI symptoms, headache). 6–12 mo following quitting. 24 mo Suggest behavioural therapy (deep breathing, muscle relaxation, positive self-talk) or refer to stress management program. Encourage exercise and other distracting activities. Treat stress-related symptoms as needed (refer to physician, recommend appropriate medication to reduce stress or treat stress-related physical symptoms).

Mood Patient reports minimal Patient: daily Assess for any signs of depressive illness, severe mood changes due to Health professional: agitation or mood changes (with or without smoking cessation. 3, 6, 9, 12, 18 and medications). Family and/or caregivers should be 24 mo informed and alerted to watch for these changes or symptoms. Abbreviations: NRT = nicotine replacement therapy

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Congratulations on deciding to quit smoking! Whether ■ Make a diary for a few days to keep track of when this is your first time quitting, or you have tried to quit and why you smoke. before, follow these tips to be successful. ■ Think of ways to avoid situations when you usually ■ Set a quit date. It should be within the next 2 weeks. smoke. Avoid a time when you will be under stress. ■ Think of things you can do instead of smoking (for ■ Think about why you want to quit and all the good example, chewing gum, sipping water, playing cards things that you expect as a result of quitting. or calling a friend). ■ If you have tried to quit before, you have probably ■ It is possible to gain weight while quitting. You can learned some valuable tips of what not to do this avoid this by healthy eating foods and increasing time. Think about what was most difficult last time daily activity. Keep healthy snacks around for times and why you gave up trying. Think about the things when you get the urge to nibble. you need to avoid this time. ■ Keep busy with healthy activities like walking or an ■ Decide what kind of support will be most helpful exercise program. Starting a new activity will help over the next 6 months to a year. For example, to break old habits connected with smoking. you can join a smoking cessation group or plan to ■ If you are taking medication to help you to quit fol- meet regularly with a health professional (such as a low the instructions carefully. Be sure to ask your pharmacist, nurse or doctor). pharmacist any medication-related questions. ■ Tell your family and friends that you are quitting. ■ If you are using nicotine replacement therapy, you Ask them to help you to stick to your plan. If they should either not smoke at all or reduce smoking as smoke, ask them to respect your decision to quit and much as possible, to avoid side effects. to not smoke in front of you. Think of things you can ■ Smoking (and quitting) can affect your metabolism. do to avoid smoking while with them. After you quit, reduce your caffeine intake to pre- ■ Choose someone you know who does not smoke and vent side effects, and talk to your pharmacist or doc- ask them to help you to quit. tor about other medicines you may be taking, in case the dose needs to be adjusted.