Shiffman S, Hughes J R, Pillitteri J L, Burton S L
Pinney Associates and University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA.
Tob Control. 2003 Sep;12(3):310-6. doi: 10.1136/tc.12.3.310.
In 1996, the US Food and Drug Administration (FDA) approved switching nicotine gum and patch from prescription to over-the-counter (OTC) status. Some expressed concerns that broader availability and lack of physician control might increase persistent use of nicotine replacement therapy (NRT)-that is, use beyond the period specified by the FDA approved label.
To estimate the incidence of persistent use of OTC nicotine gum and patch for periods of > 3 months, > or = 6 months, > or = 12 months, and > or 24 months.
Analysis of NRT purchase patterns in data from a population based panel of US households that electronically scanned all household purchases between January 1997 and March 2000.
In a national panel of 40,000 US households, 2690 recorded NRT purchases.
Among 805 households that purchased nicotine gum, 2.3% of new purchase incidents led to continuous monthly purchase of gum for > or = 6 months. For nicotine patches (2050 households) the percentage was 0.9%. For both gum and patch, the incidence of persistent purchase dropped below 0.4% by 24 months. Allowing one month gaps within a "continuous" purchase run resulted in increased estimates (for gum: 6.7% for > or = 6 months and 1.0% for > or = 24 months; for patch: 1.7% for > or = 6 months and 0.05% for > or = 24 months).
Persistent use of nicotine gum and patch is very rare and has not increased with the transition to OTC use, despite removal of physician oversight.
1996年，美国食品药品监督管理局（FDA）批准将尼古丁口香糖和贴片从处方药转为非处方药（OTC）。一些人担心，更广泛的可获得性以及缺乏医生管控可能会增加尼古丁替代疗法（NRT）的持续使用，即超出FDA批准标签规定期限的使用。
估计非处方尼古丁口香糖和贴片持续使用超过3个月、≥6个月、≥12个月以及≥24个月的发生率。
对基于美国家庭小组的数据中的NRT购买模式进行分析，该小组在1997年1月至2000年3月期间对所有家庭购买行为进行电子扫描。
在一个由40000个美国家庭组成的全国性小组中，有2690个家庭记录了NRT购买情况。
在购买尼古丁口香糖的805个家庭中，2.3%的新购买事件导致连续每月购买口香糖≥6个月。对于尼古丁贴片（2050个家庭），这一比例为0.9%。对于口香糖和贴片，持续购买的发生率到24个月时均降至0.4%以下。在“连续”购买过程中允许有一个月的间隔会使估计值增加（对于口香糖：≥6个月时为6.7%，≥24个月时为1.0%；对于贴片：≥6个月时为1.7%，≥24个月时为0.05%）。
尽管取消了医生监督，但尼古丁口香糖和贴片的持续使用非常罕见，并且在向非处方使用转变后并未增加。
