ARTICLE. Access of Over-the-counter Nicotine Replacement Therapy Products to Minors

ARTICLE Access of Over-the-counter Nicotine Replacement Therapy Products to Minors Karen C. Johnson, MD, MPH; Lisa M. Klesges, PhD; Grant W. Somes, PhD; Mace C. Coday, PhD; Margaret DeBon, PhD Background: Public health policy guidelines recommend that health care providers (eg, physicians, nurses, others) counsel adolescent smokers to quit and that nicotine replacement therapy (NRT) may be considered to aid in smoking cessation for nicotine-dependent youth. This recommendation is discrepant with Food and Drug Administration approved labeling of NRT products, stating that they not be sold to persons younger than 18 years. It is not clear how easily minors are able to purchase NRT products in retail markets. Objective: To explore youth access to NRT by conducting the first study, to our knowledge, to determine the ability of minors to purchase over-the-counter NRT products. Design: Observational case series of NRT purchase attempts and survey description of store characteristics. Setting: Retail businesses in Memphis, Tenn. Participants: Population-based sample of 165 stores that sold over-the-counter medications. Main Outcome Measure: Successfully completed purchase attempts of NRT by the minor buyer. Results: In most stores that stocked NRT products, the age of the minor was not queried at any time during the purchase attempt (79%) and the minor was able to successfully purchase the product (81%). If the minor was asked her age, the store was much less likely to sell the NRT product. Stores in which a cash register gave an age query prompt or in which alcohol was sold were more likely to inquire about the minor s age and less likely to sell NRT products. Conclusions: Nicotine replacement therapy products were successfully obtained in most purchases by a minor buyer without proof of age. While ease of purchasing NRT products is potentially beneficial to young smokers attempting to quit, these purchases are discrepant with Food and Drug Administration labeling regarding the sale of NRT products to minors. Arch Pediatr Adolesc Med. 2004;158:212-216 From the Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis. CIGARETTE SMOKING IS THE leading cause of preventable disease and death in the United States. 1,2 Even though the morbidity and mortality associated with smoking have been well documented, cigarette smoking remains a significant problem among US adolescents. 3 An estimated 28.5% of high school students smoke cigarettes, 4 and millions of dollars in sales will result from For editorial comment see page 205 purchases of tobacco products by minors. 5 More than half of high school smokers report wanting to stop, and more than half try to quit each year 3 ; however, many have trouble quitting smoking. 6 To aid in adolescent cessation attempts, public health policy guidelines 7 recommend that health care providers (eg, physicians, nurses, others) counsel adolescent smokers to quit and that nicotine replacement therapy (NRT) may be considered to aid in smoking cessation for nicotinedependent youth. However, the cost and availability of NRT may make it difficult for adolescents to adhere to these recommendations. While some NRT products are available by prescription only (ie, an inhaler), nicotine gum and patches have been reclassified from a prescription medication to an over-the-counter (OTC) product by the Food and Drug Administration (FDA). The approved labeling of NRT products indicates that they should not be sold to persons younger than 18 years. 8 While these restrictions were made to protect against po- 212

tential harm to youth, they are at odds with adolescent attempts to obtain these products as an aid to smoking cessation. Policies to increase access to NRT must balance the potential harm for inappropriate use of NRT by minors with the potential benefit of aiding cessation. 9 Given that, to our knowledge, no previously published research has described youth access to NRT, we conducted a study to determine the ability of minors to purchase OTC NRT products. This report will focus on the results of the purchase attempts by a minor and the characteristics of the businesses and the sellers who sold the NRT products. METHODS A list of businesses recorded in the telephone directory in the Memphis and Shelby County, Tennessee, area was enumerated. This list consisted of businesses that potentially sold OTC NRT, and included groceries, pharmacies, and retail stores. A buying attempt was made at all 207 identified locations. To standardize data collection, a buying questionnaire was developed and pilot tested to assess the characteristics of the business and the seller of the NRT products. The questionnaire included items such as type of store, type of NRT sold, whether assistance was required to obtain the NRT, the location of the NRT display, if the age of the buyer was queried during the attempt, the type of store personnel the buyer interacted with during the buying attempt, demographic characteristics of the seller, whether the cash register gave the seller a prompt to ask the age of the buyer, how many persons were in line behind the buyer, and whether the store also sold cigarettes or alcohol. A standard training protocol for the purchase attempt was developed based on methods used for tobacco purchases by minors. 10 To standardize the purchase attempt across sites, a single buyer (a 15-year-old white female whose height was 158 cm) and a single adult supervisor were trained and made all purchase attempts. The buyer was instructed to seem her stated age (ie, not to wear makeup and to wear age-appropriate clothing). The buyer was instructed to enter each store alone, to request or select from the self-service display the NRT products available, and to attempt to make the purchase. The buyer was instructed to answer truthfully if asked her age, but did not have any identification or proof of age. The minor continued to attempt to purchase the NRT product until the sale was complete or the seller refused to make the sale. If challenged, the minor departed from the store and did not attempt to indicate that the purchase was for an adult. The sale was considered complete if the seller asked for money after ringing the sale on the cash register. After money was requested, the minor said that she did not bring enough cash for the purchase and left the store immediately. Informed consent was obtained from the minor and her legal guardian before training and attempting the first purchase. The adult supervisor transported the minor to each business, but entered separately after the minor. The supervisor observed each purchase attempt, but had no direct contact with the minor or the seller. Following the purchase attempt, the supervisor and the minor left the store separately and completed the study questionnaire. This study was approved by a constituted Institutional Review Committee in regard to the rights of human subjects, and the study protocol conformed to the 1975 Declaration of Helsinki. Data from the buying questionnaire were entered into a computer program (Epi Info, version 6) 11 and exported to SAS statistical software for analysis. 12 Analyses included descriptive statistics using means and frequencies and Pearson 2 statistics to compare categorical variables. A 2-tailed P.05 was considered an indication of statistical significance. Table 1. Frequencies of Store and Seller Characteristics for Age Queries RESULTS Age Query* No Yes Characteristic (n = 131) (n = 34) P Value Cash register age prompt Yes 25.0 75.0 No 90.0 10.0 Assistance required to obtain NRT Yes 77.1 22.9 No 82.6 17.4.39 Area in store where purchased Pharmacy 75.0 25.0 Nonpharmacy 83.5 16.5.18 Sex of seller Female 81.6 18.4 Male 76.9 23.1.69 Race of seller White 77.2 22.8 Black 86.0 13.9.26 Abbreviation: NRT, nicotine replacement therapy. *Data are given as percentage of each group. Determined from a 2 test. In total, a buying attempt was made at all 207 businesses by the minor. Of the stores visited, 20% did not stock either the nicotine patch or gum, 5% stocked only the patch, 7% stocked only the gum, and 68% stocked the nicotine patch and gum. This report will focus on the 165 stores that stocked either NRT product. Most (58%) of the stores that stocked NRT products placed them in areas that required assistance from store personnel to obtain. In the stores that required assistance to obtain the product, the pharmacist and the pharmacy assistant were the most common persons to assist the minor in obtaining the NRT product (30% and 40%, respectively). In most stores, the minor was not asked her age at any time during the purchase attempt (79%) and the minor was able to successfully purchase the product (81%). In most purchase attempts (95%), the cash register did not prompt the seller to inquire about the minor s age. However, in stores in which the cash register gave an age prompt, the seller was much more likely to inquire about the age of the minor than in stores in which no cash register age prompt was given ( 2 =26.16, P). Whether the cash register gave an age prompt did not seem to be related to store type or to whether the store sold alcohol or cigarettes. When the age of the minor was queried, the cashier, pharmacist, and pharmacy assistant were the most common persons to inquire (50%, 21%, and 21% of the time, respectively). Whether the minor was asked her age did not seem to be related to the site in the store where the purchase attempt was made (ie, pharmacy vs nonpharmacy area), whether assistance was required to obtain the product, or the type of personnel with whom the minor interacted (cashier or pharmacist). The sex, race, and perceived age of the seller were not associated with whether the age of the minor was queried (Table 1). 213

Table 2. Frequencies of Store and Seller Characteristics for Successful NRT Purchases % of Stores 100 80 60 40 20 0 Successful Purchase* No Yes Characteristic (n = 32) (n = 133) Age query of minor Yes 91.2 8.8 No 0.8 99.2 Cash register age prompt Yes 75.0 25.0 No 7.9 92.1 Assistance required to obtain NRT Yes 14.5 85.5 Stores in Which the Minor's Age Was Asked Stores in Which NRT Was Purchased 1 2 3 Cigarette and Alcohol Availability P Value No 22.9 77.1.18 Area in store where purchased Pharmacy 23.8 76.3.17 Nonpharmacy 15.3 84.7 Sex of seller Female 16.1 83.9 Male 15.4 84.6 Race of seller White 19.3 80.7 Black 11.6 88.4 Abbreviation: NRT, nicotine replacement therapy. *Data are given as percentage of each group. Determined from a 2 test. Cigarette and alcohol availability and their effects on whether the minor was asked her age and whether the nicotine replacement therapy (NRT) product was purchased. 1 indicates stores in which neither cigarettes nor alcohol was sold; 2, stores in which cigarettes only were sold (no store sold only alcohol); and 3, stores in which cigarettes and alcohol were sold. The total number of stores was 165..95.30 The 15-year-old female white buyer was able to successfully purchase NRT products in most stores (81%). The success of the purchase did not seem to be related to the site in the store where the purchase attempt was made (pharmacy vs nonpharmacy), whether assistance was required to obtain the product, or the type of personnel with whom the minor interacted (cashier or pharmacist). In addition, the success of the purchase attempt was not associated with the sex, race, or perceived age of the seller (Table 2). The most common reasons given for refusal to sell the product to the minor were age and no identification, with 97% of stores that refused to sell giving these reasons. However, one store refused to sell because the minor did not have a prescription for the OTC NRT product. If the minor was asked her age during the purchase attempt, the store was much less likely to sell the NRT product than in stores in which no age inquiry was made (9% vs 99% sold NRT; 2 =141.20, P). Furthermore, in stores in which the cash register gave an age prompt, the seller was much less likely to sell the NRT to the minor than in stores in which no cash register age prompt was given (25% vs 92% sold NRT products; 2 =31.80, P). Most stores that stocked NRT products also sold cigarettes (80%), and many sold alcohol (43%). Stores in which alcohol was sold were less likely to sell NRT to the minor than stores in which alcohol was not sold (72% vs 87%; 2 =6.10, P=.01) (Figure). Furthermore, stores in which alcohol was sold were more likely to inquire about the age of the minor than stores in which alcohol was not sold (28% vs 15%; 2 =4.33, P=.04). While not statistically significant, stores in which cigarettes were sold tended to be less likely to sell the NRT product to the minor than stores in which cigarettes were not sold (78% vs 91%; 2 =2.78, P=.10) (Figure). In addition, there seemed to be a trend for stores in which cigarettes were sold to be more likely to inquire about the age of the minor than stores in which cigarettes were not sold (23% vs 9%; 2 =3.32, P=.07). COMMENT Nicotine replacement therapy products that are available OTC have demonstrated efficacy in helping adult smokers quit smoking. 7,13-15 While few efficacy data are available for NRT use in youth, the addictive properties of NRT seem low, 16 and guidelines recommend that NRT be considered for adolescent smokers. However, these products are not recommended for sale to minors. At the time of reclassification as an OTC drug, the FDA recommended that NRT products not be sold to minors (those aged 18 years), that proof of age be required for purchase, and that NRT not be sold where proof of age could not be verified. 8 Our study demonstrates that minors can easily purchase OTC NRT products and that proof of age is rarely required for this purchase. Furthermore, this study provides evidence that this sale occurs despite the printed warnings on the NRT packaging. An interesting but unexpected finding of our study was decreased success in buying the NRT product in stores in which alcohol was sold. It is reasonable to postulate that this type of store may have a training program and a policy in place to inquire about age of minors with regard to purchasing alcohol. While store training policy was not ascertained in our study, we speculate that such a store policy regarding age may translate to age inquiries when selling other ageregulated products. Also of interest was that the require- 214

ment of assistance to obtain the NRT product was not associated with increases in asking the age of the minor or with the success or failure of the purchase attempt. We were surprised by these findings, because one would expect that increased interaction with the minor would prompt more age inquiries and increase the failure rate of the purchase attempts. Furthermore, interaction with a pharmacist was also not associated with increased age inquiries or with the success or failure of the purchase attempt. This is particularly surprising given the pharmacist s level of education relative to other sellers. Our interpretation of these findings is that FDA-approved product labeling regarding the sale of the OTC NRT products is not well known or understood by persons in retail businesses. We acknowledge that our study has several limitations. We were only able to attempt to purchase the NRT product once from each store. Therefore, our study is limited in its inferences regarding store characteristics (ie, store policy regarding the sale of the NRT product). However, we believe that if a business had strong prohibitions against the sale of the NRT products to minors, this would have been reflected to a greater degree in the behavior of each individual seller. Thus, we assume that one purchase attempt is generalizable to multiple purchase attempts at any given store in this sample; however, this assumption was not formally tested. Another limitation of our study is that only one white female minor was used to purchase the NRT product. Therefore, we were unable to examine the demographic characteristics of the minor as related to the purchase attempt. Several studies 10 have revealed that a minor s ability to purchase cigarettes is a function of the minor s sex and age, with male and younger minors having more difficulty purchasing cigarettes OTC. Because previous studies have shown that female minors are more successful in purchasing cigarettes, we acknowledge that there may be an overestimate of the true availability of the NRT product to minors in general. Nevertheless, we consider that our study results are accurate regarding easy access to NRT, because the buyer in our study did seem her stated age. We acknowledge that further study is needed using minor buyers with different demographic characteristics to explore areas such as minimal age of successful purchase and sex and ethnic differences. Furthermore, because this is the first NRT buying study, to our knowledge, we believe that this information is particularly important to the public health community and to the FDA regarding labeling of OTC products. While our study clearly shows that minors have easy access to NRT products, the price of the NRT products may be prohibitively high for most minors, thus discouraging use. 17 However, state laws restricting access of cigarettes to minors and increased taxation of cigarettes may result in increased difficulty in obtaining cigarettes for minors. Thus, the NRT products may become more appealing to minors as a source of nicotine. Furthermore, if the price of the NRT products decreases with the marketing of generic NRT products, then the prevalence of NRT use among minors may increase. Therefore, we believe that a What This Study Adds To aid cessation attempts by adolescent smokers, health practitioners are being encouraged to recommend NRT to their patients. 7 These guidelines are discrepant with FDA labeling that restricts sales of NRT to minors. 8 Information is unavailable on youth access to NRT in retail markets. Our study demonstrated that while 81% of NRT purchase attempts by a minor were successful, some young smokers may not be able to obtain NRT as recommended by their practitioner. Public health benefits will be maximized if adolescent smokers obtain NRT and use it appropriately for cessation. longitudinal study of the prevalence of use of NRT products is needed to assess the effect of these policy changes over time. A cross-sectional prevalence study 9 of NRT use by minors has been conducted, and has determined that the rate of use is approximately 5% among all high school juniors, smokers and nonsmokers. One may ask if use of NRT products by minors is a beneficial or harmful event. Use of NRT by adolescents may be preferable to continued smoking. However, if NRT is misused, then use of NRT products could be considered detrimental to minors. One prevalence study 9 indicates that almost three quarters of adolescent smokers endorsed use of NRT for reasons other than trying to quit smoking, and some youth reported simultaneous use of NRT while smoking cigarettes. Undoubtedly, use of NRT for smoking cessation and misuse of NRT products by minors require further evaluation and should be explored in future studies. Our study demonstrates that most purchases of NRT were obtained by a minor buyer without proof of age, despite warnings printed on the product. Given these findings, we conclude that the FDA-approved product labeling has little effect on actual sales practice. However, health practitioners recommending NRT to adolescent smokers attempting to quit should consider potential barriers to youth access. In addition, efforts to promote appropriate use of NRT at the point of sale should be explored to guard against inappropriate use, reduce potential harm, and maximize the effectiveness of NRT use to aid nicotine-dependent smokers in cessation. Accepted for publication July 28, 2003. This study was supported by a grant from the Partnership for Women s and Children s Health (Methodist Hospital, Le Bonheur Children s Medical Center, and The University of Tennessee, all in Memphis). We thank Meghan Somes and Brenda Somes for their efforts in data collection. Materials were adapted for use in this project from Tobacco Policy Options for Prevention at the Division of Epidemiology, University of Minnesota, Minneapolis. Corresponding author: Karen C. Johnson, MD, MPH, Department of Preventive Medicine, The University of Tennessee Health Science Center, 66 N Pauline, Suite 633, Memphis, TN 38163 (e-mail: KJohnson@UTMEM.EDU). 215

REFERENCES 1. US Department of Health and Human Services. Reducing the Health Consequences of Smoking: 25 Years of Progress: A Report of the Surgeon General 1989. Washington, DC: US Dept of Health and Human Services; 1989. DHHS publication (CDC) 89-8411. 2. Cigarette smoking attributable mortality and years of potential life lost: United States, 1990. MMWR Morb Mortal Wkly Rep. 1993;42:645-649. 3. Youth tobacco surveillance: United States, 2000 [erratum published in MMWR CDC Surveill Summ. 2001;50:1036]. MMWR CDC Surveill Summ. 2001;50:1-84. 4. Trends in cigarette smoking among high school students: United States, 1991-2001. MMWR Morb Mortal Wkly Rep. 2002;51:409-412. 5. DiFranza JR, Tye JB. Who profits from tobacco sales to children? JAMA. 1990; 263:2784-2787. 6. US Department of Health and Human Services. Preventing Tobacco Use Among Young People: A Report of the Surgeon General. Atlanta, Ga: Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Public Health Service, US Dept of Health and Human Services; 1994. 7. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence: Clinical Practice Guideline. Rockville, Md: Public Health Service, US Dept of Health and Human Services; 2000. 8. Nicorette Gum New Drug Application #18-612/s-022. Washington, DC: Food and Drug Administration; 1996. Public Health Service, US Dept of Health and Human Services. 9. Klesges LK, Johnson KC, Somes G, Zbikowski S, Robinson L. Nicotine replacement therapy use in adolescent smokers and nonsmokers. Arch Pediatr Adolesc Med. 2003;157:517-522. 10. Forster JL, Hourigan M, McGovern P. Availability of cigarettes to under-age youth in three communities. Prev Med. 1992;21:320-328. 11. Dean AG, Dean JA, Coulombier D, et al. Epi Info Version 6: A Word Processing, Database, and Statistics System for Epidemiology on Microcomputers. Atlanta, Ga: Centers for Disease Control and Prevention; 1994. 12. SAS/STAT Users Guide Version 6. 4th ed. Cary, NC: SAS Institute Inc; 1990. 13. Townnesen P, Norregard J, Simonsen K, Sawe U. A double-blind trial of a 16- hour transdermal nicotine patch in smoking cessation. N Engl J Med. 1991;325: 311-315. 14. Transdermal Nicotine Study Group. Transdermal nicotine for smoking cessation: six-month results from two multicenter controlled clinical trials. JAMA. 1991; 266:3133-3138. 15. Klesges RC, Ward KD, Debon M. Smoking cessation: a successful behavioral/ pharmacologic interface. Clin Psychol Rev. 1996;16:479-496. 16. Nicotine Addiction: Research Report Series. Bethesda, Md: National Institute on Drug Abuse, National Institutes of Health; 1998. NIH publication 98-4342. 17. Meier KJ, Licari MJ. The effect of cigarette taxes on cigarette consumption, 1955 through 1994. Am J Public Health. 1997;87:1126-1130. 216