Nicotine Formulations as OTC Products
restrictsaccesstoNRTwithoutadequatelyconsideringthatthelikelyconsequencewillbe thecontinueddependenceontheuseofnicotine-containingtobacco,whichisextremely
harmfulanduniversallyavailable.Withtheaimofachievingharmreductioninsmoking children, pregnant women and patients with cardiovascular diseases or diseases of the
respiratorytracte.g.COPD,allthesecategoriesofpeopleshouldbepermittedtouse NRTnotonlyforsmokingcessation,butalsoforreducingthedailycigaretteconsumption
toanoptimumof10cigarettesday.AcritiqueofthecurrentsituationintheUKwas publishedin2001byMcNeilletal.
[76] .
Inonelargemeta-analysis,theeffectsofprescriptionandOTCsettingswerecompared intermsoftheireficacyinachievingsmokingcessation.Thestudiescomparedtheuseof
patchandgumformulationsofnicotine.OTCsuccessrateswereconsistentlyhigherthan prescriptionratesat6weeksforbothpatchOR=1.45;CI:1.05–1.98andgumOR=
2.92;CI:1.58–5.40,andremainedsigniicantat6monthsforthepatchOR=3.63;CI: 1.74–7.61butnotforgumOR=1.37;CI:0.73–2.58
[73] .AmongOTCandprescription
gumusers,16.1vs.7.7wereabstinentat6weeksand8.4vs.7.7at6months,respec- tively.AmongOTCandprescriptionpatchusers,abstinencerateswere19.0vs.16.0
after6weeksand9.2vs.3.0after6months [77]
.TheauthorsclaimthatNRTusewithin clinicalstudiesdoesnotfollow“real-world”prescriptionpractices.Indeed,manyphysi-
ciansprescribeNRTproductstotheirsmokingpatientswithonlyafewcommentscon- cerningtheiradministrationanduse.Inthisway,lowersuccessrateswillbeachievedthan
ifphysiciansprovidecomprehensiveadvicetotheirsmokingpatientsoverseveralconsul- tationscf.
Chap.15 .Incontrast,themeta-analysisiscorrectinconcludingthatthereis
nodifferenceineficacybetweenOTCand“real-world”prescribing.IftheOTCmethod ofsupplyingNRTweretobespreadacrosslargerpopulationsegments,thiswoulddra-
maticallyincreasethenumberofabstainingsmokers,andthisinturnwouldhaveasub- stantialpublichealthimpact.IntheUnitedStates,a20increaseinquitrateswasachieved
[78] .TheOTCmethodresultedinfewersmoking-attributabledeathsandinincreasedlife
expectancy [79,80]
.Worldwide,NRTmustbecomemoreaccessibletosmokersbyremov- ingregulatorybarrierse.g.France,Australia,Brazil,andearlyresultssuggestafavour-
ablepublichealthimpact [81]
.DifferencesbetweenEuropeancountriesconcerningthe saleofnicotineformulationsarelistedinTable
11.5 .Whilemostnicotineformulationsare
OTCproducts,bupropionisavailableonlyonprescription. AninterestingquestioniswhetherthechangeinNRTsalesfromprescriptiontoOTC
status affected smoking cessation. To assess this issue, the 1993–1999 Massachusetts TobaccoSurveyswereusedtocomparedatafromadultcurrentsmokersandrecentquit-
tersbeforeandaftertheOTCswitch [83]
.Interestingly,nosigniicantchangeovertime occurredintheproportionofsmokerswhousedNRTataquitattemptinthepastyear
20.1pre-OTCvs.21.4post-OTC,madeaquitattemptinthepastyear48.1vs. 45.2,orquitsmokinginthepastyear8.1vs.11.1.Fewernon-WhitesusedNRT
aftertheswitch20.7pre-OTCvs.3.2post-OTC,p=0.002,buttheproportionof WhitesusingNRTdidnotchangesigniicantly20.6vs.24.0.Itwasthereforecon-
cluded that there may be no increase in smokers’ rates of using NRT, making a quit attempt,orstoppingsmokingafterNRTbecameavailableforOTCsale.Thereappearto
beotherbarrierstotheuseofNRTbesidesvisitingaphysician,especiallyamongminor- itysmokers
[83] .
11.1 Nic
otine
327
Table 11.5
InterventionstosupportsmokingcessationinseveralEuropeancountries [82]
+yes;−no;d.n.a.datanotavailable;Bbupropion;oponprescription;NNSnicotinenasalspray; NInicotineinhaler;NPnicotinepatch
Country Trainingofhealth
professionalsand medicalstudents
Cessation clinics
Helplines Priceincentiveor reducedcostfor
treatment Pharmacotherapies
availableforcessation Pharmacotherapiesavailable
Onprescriptiononly Inpharmacies, withoutprescription
Austria +
+ +
− +
B+NNSop +
Belgium d.n.a.
d.n.a. d.n.a.
d.n.a. +
NP+Bop −
Denmark +
+ +
+ +
Bop +
Finland d.n.a.
+ d.n.a.
d.n.a. +
B+NNSop +
France +
+ +
+ +
− +
Germany +
d.n.a. +
d.n.a. +
B+NNSop +
Greece +
+ −
− +
+ +
Iceland +
+ +
+ +
− +
Ireland +
+ +
− +
B,NNS,NIop +
Italy +
d.n.a. +
d.n.a. +
Bop +
Luxembourg d.n.a. d.n.a.
d.n.a. d.n.a.
d.n.a. d.n.a.
d.n.a. Monaco
d.n.a. d.n.a.
d.n.a. d.n.a.
d.n.a. d.n.a.
d.n.a. Netherlands +
+ +
+ +
Bop +
Portugal −
+ −
− +
Bop +
Spain +
+ d.n.a.
d.n.a. +
Bop +
Sweden +
+ +
− +
B+NNSop +
U.K. +
+ +
+ +
Bop +
Hughesetal.determinedwhetherOTCNRTispharmacologicallyeficacious,whether itproducesabstinenceratessimilartothoseinprescriptionsettings,andtoestimatethelong
termthatis,greaterthan6monthabstinenceratewithOTCNRT [84]
.Usingameta- analysisapproach,studieswereanalysedthatcomparedOTCNRTvs.OTCplaceboorstud-
iescomparingOTCNRTvs.prescriptionNRTthatreportedabstinenceratesandforwhich afullstudyreportwasavailable.Fourstudieswererandomisedtrialsofnicotinevs.placebo
patchwithORsof2.1–3.2.Theseoutcomeswerehomogenousandwhencombinedresulted inanORfavouringNRTof2.595CI1.8–3.6.Amongthetworandomisedandtwonon-
randomisedtrialsofOTCNRTvs.prescriptionNRT,onesmallstudyhadanORof0.3,two othershadORsof1.0and1.4,andafourthstudyhadanORof3.6.Theseresultswerenot
homogenous;however,whencombinedviaarandomeffectsmodeltheestimatedORwas notlessthan1.0–thatis,OR1.495CI0.6–3.3.Thelong-termthatis,greaterthan6
monthsquitratesforOTCNRTwas1and6intwostudiesand8–11iniveotherstud- ies.Theseresultswerenothomogenous;however,whencombinedtheestimatedORwas
795CI4–11.ItwasconcludedthatOTCNRTispharmacologicallyeficaciousand producesmodestquitratessimilartothatseeninreal-worldprescriptionpractice
[84] .