In 1996, the U.S. Food and Drug Administration reclassified nicotine gum and the nicotine patch—used to help people to quit smoking—from prescription only to over-the-counter availability.
Between July 2002 and June 2005, under a grant to Health Research Incorporated, a not-for-profit corporation affiliated with the New York State Department of Health and the Roswell Park Cancer Institute (Buffalo, N.Y.), researchers at Roswell Park examined whether use of these nicotine replacement therapies (also called NRT) and smoking quit rates changed after reclassification.
The project was part of the Robert Wood Johnson Foundation's (RWJF) national Substance Abuse Policy Research Program (SAPRP) (for more information see the Program Results Report).
- Overall nicotine replacement therapy usage increased from 5.1 percent to 8.1 percent. Annual use rates of the patch increased from 3.6 percent of smokers before reclassification to 6.1 percent after reclassification. Gum use rates increased from 1.8 percent of smokers to 2.4 percent.
- The increase in usage was seen in spite of the increase in the cost of the gum and the patch to smokers, as insurance coverage for nicotine replacement therapies dropped from 26 percent before 1996 to 14 percent after 1996, when they became available without a prescription.
- Smoking quit rates in patch-assisted attempts decreased from 22.5 percent prior to reclassification. Smoking quit rates in gum-assisted attempts did not change significantly during the two periods (11.9% vs. 10.5%).
- After reclassification, 14.6 percent of nicotine gum users had quit smoking compared with 9.7 percent before reclassification. The percentage of patch users who quit smoking remained the same at about 15 percent during both periods.