Contraindications for the Use of Nicotine Products

restricts฀access฀to฀NRT฀without฀adequately฀considering฀that฀the฀likely฀consequence฀will฀be฀ the฀continued฀dependence฀on฀the฀use฀of฀nicotine-containing฀tobacco,฀which฀is฀extremely฀ harmful฀and฀universally฀available.฀With฀the฀aim฀of฀achieving฀harm฀reduction฀in฀smoking฀ children,฀ pregnant฀ women฀ and฀ patients฀ with฀ cardiovascular฀ diseases฀ or฀ diseases฀ of฀ the฀ respiratory฀tract฀e.g.฀COPD,฀all฀these฀categories฀of฀people฀should฀be฀permitted฀to฀use฀ NRT฀not฀only฀for฀smoking฀cessation,฀but฀also฀for฀reducing฀the฀daily฀cigarette฀consumption฀ to฀an฀optimum฀of฀10฀cigarettesday.฀A฀critique฀of฀the฀current฀situation฀in฀the฀UK฀was฀ published฀in฀2001฀by฀McNeill฀et฀al.฀ [76] . In฀one฀large฀meta-analysis,฀the฀effects฀of฀prescription฀and฀OTC฀settings฀were฀compared฀ in฀terms฀of฀their฀eficacy฀in฀achieving฀smoking฀cessation.฀The฀studies฀compared฀the฀use฀of฀ patch฀and฀gum฀formulations฀of฀nicotine.฀OTC฀success฀rates฀were฀consistently฀higher฀than฀ prescription฀rates฀at฀6฀weeks฀for฀both฀patch฀OR฀=฀1.45;฀CI:฀1.05–1.98฀and฀gum฀OR฀=฀ 2.92;฀CI:฀1.58–5.40,฀and฀remained฀signiicant฀at฀6฀months฀for฀the฀patch฀OR฀=฀3.63;฀CI:฀ 1.74–7.61฀but฀not฀for฀gum฀OR฀=฀1.37;฀CI:฀0.73–2.58฀ [73] .฀Among฀OTC฀and฀prescription฀ gum฀users,฀16.1฀vs.฀7.7฀were฀abstinent฀at฀6฀weeks฀and฀8.4฀vs.฀7.7฀at฀6฀months,฀respec- tively.฀Among฀OTC฀and฀prescription฀patch฀users,฀abstinence฀rates฀were฀19.0฀vs.฀16.0฀ after฀6฀weeks฀and฀9.2฀vs.฀3.0฀after฀6฀months฀ [77] .฀The฀authors฀claim฀that฀NRT฀use฀within฀ clinical฀studies฀does฀not฀follow฀“real-world”฀prescription฀practices.฀Indeed,฀many฀physi- cians฀prescribe฀NRT฀products฀to฀their฀smoking฀patients฀with฀only฀a฀few฀comments฀con- cerning฀their฀administration฀and฀use.฀In฀this฀way,฀lower฀success฀rates฀will฀be฀achieved฀than฀ if฀physicians฀provide฀comprehensive฀advice฀to฀their฀smoking฀patients฀over฀several฀consul- tations฀cf.฀ Chap.฀15 .฀In฀contrast,฀the฀meta-analysis฀is฀correct฀in฀concluding฀that฀there฀is฀ no฀difference฀in฀eficacy฀between฀OTC฀and฀“real-world”฀prescribing.฀If฀the฀OTC฀method฀ of฀supplying฀NRT฀were฀to฀be฀spread฀across฀larger฀population฀segments,฀this฀would฀dra- matically฀increase฀the฀number฀of฀abstaining฀smokers,฀and฀this฀in฀turn฀would฀have฀a฀sub- stantial฀public฀health฀impact.฀In฀the฀United฀States,฀a฀20฀increase฀in฀quit฀rates฀was฀achieved฀ [78] .฀The฀OTC฀method฀resulted฀in฀fewer฀smoking-attributable฀deaths฀and฀in฀increased฀life฀ expectancy฀ [79,฀80] .฀Worldwide,฀NRT฀must฀become฀more฀accessible฀to฀smokers฀by฀remov- ing฀regulatory฀barriers฀e.g.฀France,฀Australia,฀Brazil,฀and฀early฀results฀suggest฀a฀favour- able฀public฀health฀impact฀ [81] .฀Differences฀between฀European฀countries฀concerning฀the฀ sale฀of฀nicotine฀formulations฀are฀listed฀in฀Table฀ 11.5 .฀While฀most฀nicotine฀formulations฀are฀ OTC฀products,฀bupropion฀is฀available฀only฀on฀prescription. An฀interesting฀question฀is฀whether฀the฀change฀in฀NRT฀sales฀from฀prescription฀to฀OTC฀ status฀ affected฀ smoking฀ cessation.฀ To฀ assess฀ this฀ issue,฀ the฀ 1993–1999฀ Massachusetts฀ Tobacco฀Surveys฀were฀used฀to฀compare฀data฀from฀adult฀current฀smokers฀and฀recent฀quit- ters฀before฀and฀after฀the฀OTC฀switch฀ [83] .฀Interestingly,฀no฀signiicant฀change฀over฀time฀ occurred฀in฀the฀proportion฀of฀smokers฀who฀used฀NRT฀at฀a฀quit฀attempt฀in฀the฀past฀year฀ 20.1฀pre-OTC฀vs.฀21.4฀post-OTC,฀made฀a฀quit฀attempt฀in฀the฀past฀year฀48.1฀vs.฀ 45.2,฀or฀quit฀smoking฀in฀the฀past฀year฀8.1฀vs.฀11.1.฀Fewer฀non-Whites฀used฀NRT฀ after฀the฀switch฀20.7฀pre-OTC฀vs.฀3.2฀post-OTC,฀p฀=฀0.002,฀but฀the฀proportion฀of฀ Whites฀using฀NRT฀did฀not฀change฀signiicantly฀20.6฀vs.฀24.0.฀It฀was฀therefore฀con- cluded฀ that฀ there฀ may฀ be฀ no฀ increase฀ in฀ smokers’฀ rates฀ of฀ using฀ NRT,฀ making฀ a฀ quit฀ attempt,฀or฀stopping฀smoking฀after฀NRT฀became฀available฀for฀OTC฀sale.฀There฀appear฀to฀ be฀other฀barriers฀to฀the฀use฀of฀NRT฀besides฀visiting฀a฀physician,฀especially฀among฀minor- ity฀smokers฀ [83] .