Table 2 Guide for using the algorithm in figure 1 (*quotations included are from Delphi panel participants)
Factors to consider in prescribing pharmacotherapy
Three distinct types of pharmacotherapy have demonstrated efficacy for smoking cessation: (a) nicotine replacement therapy (including patch, gum, inhaler, lozenge, nasal spray), (b) bupropion and (c) varenicline (for a description of these pharmacotherapy, including dose and side effects/drug interactions, see table 3). Selecting a particular type of pharmacotherapy should be guided by the following seven factors:
1. Evidence
The importance of evidence-based medicine is the top priority in considering which form of pharmacotherapy to prescribe or recommend to a patient. The decision to prescribe smoking cessation medications needs to be based on evidence of effectiveness and safety (see Fiore et al36).
2. Patient preference
Patient preference is an important priority in facilitating adherence to the treatment protocol. There is no value in prescribing or recommending a medication that a patient will not take. “It is essential that the patient be comfortable with the decision, have reasonable expectations for product efficacy, and have confidence in their ability to use the medication appropriately”. Preference is particularly important if a patient does not want to use a specific product. However, patient preference can be modified through an informed and shared decision-making process between the clinician and patient.
3. Patient experience
The patient’s expectation of success is exceedingly important in determining actual success. Expectations are often informed by experience. Therefore, a patient’s experience with smoking cessation attempts and use of pharmacotherapy needs to be a significant factor in influencing choice of pharmacotherapy. “A clinician must understand what the patient has tried and why the patient did not succeed”. If the patient was successful with a particular medication for a period of time, it may be prudent to try the same medication again; if unsuccessful with a particular medication, then probably should not use again.
4. Patient needs
Because there is little evidence-based information to guide tailoring of specific pharmacotherapy to specific patients, patient needs are vital. Consideration of patient needs is important in determining their willingness to use medications, the ease of use of various smoking cessation products and likelihood of compliance. Other patient needs to take into account before prescribing or recommending a particular pharmacotherapy include: extent and severity of cravings, situations or times when cravings are strongest, triggers for smoking, specific hurdles to overcome, etc.
5. Patient history
“Patient history provides the framework within which I can prescribe”. Many patients have comorbidities (medical, psychiatric, alcohol/drug abuse) which need to be taken into account. For example, a patient with a history of alcohol abuse or seizures would be excluded from bupropion use. Smoking history, past quit attempts and experience with pharmacotherapy are all factors influencing the decision of pharmacotherapy choice.
6. Patient clinical suitability for pharmacotherapy
Some patients may not be suitable for pharmacotherapy interventions and potential contraindications need to be considered. Generally, pharmacotherapy would not be recommended for patients having a low level of nicotine dependence. In addition, a patient may prefer a non-pharmacological approach to treatment.
7. Potential drug interactions/side effects
Issues of safety are fundamental in determining choice of pharmacotherapy. Contraindications, use of other medications, and the side effect profile all need to be considered. However, this is generally a minor problem with cessation drugs. “Potential drug interactions are a show-stopper when it is relevant, but it is rarely an issue, so it is important but infrequent”.
Combinations of pharmacotherapy
For some patients, choosing a combination of pharmacotherapy will increase their ability to stop smoking. Combination pharmacotherapy is indicated for patients based on five factors:
1. Failed attempt with monotherapy
Use of monotherapy which resulted in a failure to quit smoking is the top priority when considering use of combination pharmacotherapy. The general principle is that intensity of medications should be increased when monotherapy has resulted in relapse. A caveat is that the medication was used appropriately and that there was “a ‘true’ attempt to quit”.
2. Patients with breakthrough cravings
Breakthrough cravings may be an indication that more treatment is needed. An additional form of NRT or an addition of NRT (as needed) to a non-NRT oral medication may be helpful. Combinations of NRT can be used for steady-state delivery (patch) and as needed (gum/lozenge).
3. Level of dependence
Highly dependent smokers are more likely to benefit from combination pharmacotherapy. It may be important to begin with combination pharmacotherapy for these individuals. Because this group has a difficult time in quitting smoking, combination therapy may facilitate increased success.
4. Multiple failed attempts
Multiple failed attempts may be an indication that more intensive therapy is needed. “Careful assessment of previous attempts usually reveals complex situations which are more likely to be addressed with combination pharmacotherapy.” However, it is important to keep in mind that failed attempts may also be based on patient lack of commitment rather than insufficient medication.
5. Patients with nicotine withdrawal
Patients experiencing nicotine withdrawal can be a trigger for their relapse to smoking. The combination of pharmacotherapies (for example, addition of NRT to another pharmacotherapy) can be a helpful response for managing nicotine withdrawal symptoms.
Specific combinations of pharmacotherapy
When prescribing or recommending combinations of pharmacotherapy, first select combinations of NRT. Then, prescribe a combination of bupropion and NRT for more heavily dependent patients.
1. Two more forms of NRT
The use of two or more forms of NRT has the strongest evidence base and is the most commonly used form of combination therapy. There is a high level of confidence that this combination can be used safely and effectively. “This approach permits optimal titration of NRT to meet nicotine needs and can be achieved easily and cheaply”.
2. Bupropion + form of NRT
Bupropion plus a form of NRT can be effective for some patients. This combination is generally used in more heavily dependent patients.
Impact of comorbidities on selection of pharmacotherapy
When prescribing pharmacotherapy to patients having a dual diagnosis (that is, medical, psychiatric or other substance use in addition to smoking), specific attention should be given to:
1. Contraindications
Attention to contraindications is the top priority in the selection of type of pharmacotherapy in patients with comorbidities. Ensuring the safety of a patient is always of primary importance in prescribing or recommending medications. Contraindications are primarily an issue with use of bupropion (that is, history of seizures, alcohol problems) and with patients who are already taking other medications.
2. Specific pharmacotherapy useful for certain comorbidities
Specific pharmacotherapy may be useful for treatment of certain comorbidities in addition to smoking cessation. For example, bupropion may be a good choice for depressed patients who want to quit smoking. However, for patients with anxiety disorders or eating disorders, bupropion would not be a good choice.
3. Dual purpose medications
“It’s nice to treat two things with one med so if I can do that I will”. Most common is use of bupropion for depressed patients who want to quit smoking. Bupropion can also be useful for patients who do not want to gain weight. Dual purpose medications may have added value in enhancing compliance.
Frequency of monitoring
All patients taking pharmacotherapy should be monitored carefully. The frequency of monitoring should be determined by:
1. Patient need
The top priority for frequency of monitoring should be determined by patient needs. For example, patients with multiple or difficult quit attempts will likely require more support.
2. Type of pharmacotherapy
Some types of pharmacotherapy may require more frequent monitoring, particularly if there is potential for adverse events (for example, drug interaction, side effects).