In the 2002 edition of the CPS all brands of nicotine gum and patch are contraindicated during pregnancy. The monograph for Nicotrol®, available only in the US, elaborated on the reasoning behind the contraindication, stating tobacco smoke and nicotine through animal studies have been shown to cause fetal harm. Therefore the use of this nicotine product may also cause damage to the human fetus.
Most guidelines on the use of NRT and pregnancy, however, do not agree with such restrictions. The Ontario Medical Association (OMA) in literature published in 1999 have recommended that "NRT should be made available to pregnant women who are unable to quit using non-pharmacological methods [
32]. Physicians should closely monitor nicotine dosage to ensure that nicotine levels do not exceed smoking levels. As with other drugs, NRT dosage should be matched to suit the smoker's needs." It was also recommended that "Health Canada's labelling requirements should be modified to include consideration of NRT use among pregnant women." The American Agency for Health Care Policy and Research (AHCPR) has similar recommendations for its clinical practice guideline [
33]. It is recommended that due to the risks of smoking to the fetus, pregnant smokers should be given more rigorous psychosocial interventions (e.g. videos, quit packages) that go beyond typical advice to quit. Such smoking cessation interventions should persist throughout the pregnancy to ensure abstinence. However if psychosocial intervention is not successful, pharmacotherapy is recommended as a consideration if the benefits of its use surpass the risks of the treatment and continued smoking. The Royal College of Physicians has also expressed similar recommendations for NRT and pregnancy use in Britain [
34]. Currently, both France and Germany permit the use of all forms of NRT under physician advice and supervision, provided non-pharmacological methods have been unsuccessful [
35]. The United Kingdom has made similar recommendations for the nicotine gum, lozenge, patch and tablet. However, the nicotine spray and inhaler remain contraindicated in pregnancy [
35]. In the publication titled
Women and the Tobacco Epidemic: Challenges in the 21
st
Century by the World Health Organization, Richard Windsor also recommends the use of NRT if non-pharmacological methods are unsuccessful [
36]. Furthermore, it is suggested that five questions be considered by the physician when making the recommendation of NRT to a pregnant patient:
1.
Has the patient been provided "Best Practice" (e.g. videos, information packages) methods yet did not quit?
2.
Has the patient reported smoking more than 10 cigarettes per day?
3.
Does the patient smoke her first cigarette within the first 60 minutes of getting up?
4.
Has the patient indicated that she want to quit?
5.
Is the fetus's gestational age less than 20 weeks?
There has been a suggestion that the recommendation to initially treat pregnant smokers with psychosocial interventions before considering NRT may not be beneficial to all patients. McNeill et al, in a critique of current NRT practices, suggests that smoking cessation therapy in pregnant patients will have the greatest impact if a medical professional assessed the patient's situation, earlier on in pregnancy, based on past quit attempts and smoking history [
37]. A pregnant woman with a low probability of quitting smoking by non-pharmacological means should not be subjected to psychosocial interventions because of the risk of a failed quit attempt causing decreased motivation to stop and resulting in continual smoking during pregnancy. Therefore, the authors suggest the contraindication of NRT use in pregnancy be removed and medical professionals conduct an early assessment, suggesting NRTs to the pregnant mother if the probability of cessation without it is minimal.