This proactive assessment highlights the upward trend in electronic cigarette use, and

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1 Alana M. Grabigel, Pharm.D. Candidate 2016 Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA Dominick DiLucente, Pharm.D. Candidate 2017 Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA Jamie L. McConaha, PharmD, CGP, BCACP Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA Article Category: Research Reports This proactive assessment highlights the upward trend in electronic cigarette use, and enhances patient care by presenting the topic in a forum that provides pharmacists and physicians the opportunity to become more familiar with the products when counseling patients. This study assesses physician s and pharmacist s knowledge of e-cigarette products (including perceived safety and its place in therapy as a smoking cessation aid), level of comfort with counseling patients on e-cigarettes, and the collection of e-cigarette usage as a marker of tobacco status.

2 Electronic Cigarettes: The Perceptions of Pharmacists and Physicians Alana M. Grabigel, Pharm.D. Candidate 2016 Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA Dominick DiLucente, Pharm.D. Candidate 2017 Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA Jamie L. McConaha, PharmD, CGP, BCACP Duquesne University Mylan School of Pharmacy 600 Forbes Avenue, Pittsburgh PA This study is supported by a grant from the Pennsylvania Pharmacists Association Educational Foundation. The authors have no conflicts of interest to declare relating to this study. Keywords: Electronic cigarettes, smoking cessation, survey

3 Introduction: Electronic cigarettes, also known as e-cigarettes, are electronic nicotine delivery systems that have been increasing in popularity in recent years. While many manufacturers of e-cigarettes advertise their product as a smoking cessation aid, there is insufficient evidence to support this claim. The long-term health outcomes associated with e-cigarette use remain unknown. Objectives: This study aimed to evaluate pharmacists and physicians perception and knowledge of e-cigarettes, including comfort level in counseling patients on these products. The study also assessed if, and to what extent, patient e-cigarette usage is collected by these healthcare professionals as a marker of tobacco use status. Study Design: A cross-sectional survey was distributed to two focused groups: pharmacists and physicians. Survey responses were analyzed utilizing descriptive and inferential statistics, as appropriate. Methods: Data was collected via survey methodology. Pharmacists practicing in the community pharmacy setting and physicians practicing in family medicine were the targeted subjects. The timeframe for survey distribution was set at a period of 3 months or until a total of 200 surveys were completed (100 surveys from each group). Results: Based on the results collected, it appears that pharmacists and physicians would benefit from further information on e-cigarettes. Most pharmacists and physicians reported not feeling fully confident on counseling patients about e-cigarettes. Mixed

4 results were gathered on whether participants believe e-cigarettes may be used as an effective smoking cessation tool. Conclusion: Due to the increasing popularity of e-cigarettes, pharmacists and physicians will be called upon to serve as care providers and informational resources to patients who are e-cigarette users. This survey promoted a better understanding of current opinions among pharmacists and physicians on e-cigarette products and provided a consensus that further steps should be taken to increase product training and information dissemination. I. Background Electronic cigarettes, also known as e-cigarettes, are a type of electronic nicotine delivery system that has been increasing in popularity among adults and adolescents in recent years. In 2007, e-cigarettes were introduced to the US market without FDA regulation. While manufacturers of e-cigarettes may advertise their product as a form of smoking cessation, there is insufficient evidence to support this claim. The long-term health-related outcomes associated with e-cigarettes remain unknown, and little data exists concerning associated adverse effects. It is important for pharmacists, physicians and other healthcare professionals to be mindful of the practice of e-cigarette use and that they are prepared to provide the appropriate education to their patients. While the number of conventional cigarette smokers in the US continues to decrease, it appears that the opposite is true with e-cigarette users. Since 2010, there has been an increase in the use of e-cigarettes, which has corresponded with an increase in the product s marketing. Although representative national data is limited, surveys show that from 2010 through 2013, the number of first-time users of e-cigarettes increased

5 from 3.3% to 8.5% in adults. 1 In the adolescent population, similar trends have also been observed. From 2011 to 2014, the use of e-cigarettes increased from 1.5% to13.4% in high school students and from 0.6% to 3.9% in middle school students. 2,3 Among cancer patients, a study indicated that rates of use have increased from 10.6% (2012) to 38.5% (2013). 4 Most adult and adolescent users of e-cigarettes concurrently smoke conventional cigarettes. During 2013, 76.8% of the people who had recently tried e-cigarettes also admitted to smoking conventional cigarettes. 5 Adults have also reported using e- cigarettes as a cessation tool and as a safer alternative to traditional cigarettes. Data has shown conflicting results when evaluating the use of e-cigarettes as a cessation device. A recent longitudinal study reported that daily users of e-cigarettes were 6 times as likely as non- users to report quitting. 6 In contrast, a study conducted on cancer patients who were enrolled in a tobacco cessation program indicated that patients who used e-cigarettes were twice as likely to be smoking at follow-up as compared with their counterparts that did not use e-cigarettes. 7 Another study supported the premise that e-cigarette users were also more nicotine dependent. 1 The FDA and the American Lung Association support the use of the seven approved therapies in combination with counseling as the most effective way to help patients achieve smoking cessation. These associations do not support the use of e-cigarettes. 8 Pharmacist and physician involvement is vital to successful smoking cessation and treatment of tobacco use. Pharmacists and physicians are accessible in all fields of practice to educate patients on the long-term risks of smoking and to encourage them to initiate the process that will lead them to a smoke-free life. Pharmacists and physicians

6 can help patients develop cessation plans and provide recommendations for lifestyle changes and pharmacologic therapies. Due to the increasing popularity of e-cigarettes, pharmacists and physicians will be called upon to serve as informational resources for patients seeking advice on the product as well as care providers for patients who use them. However, due to the scarcity of clinical data, many pharmacists and physicians may be under-informed on e-cigarettes and their associated risks of use. An assessment of pharmacists and physicians perceptions of e-cigarettes supports the advancement of pharmacy practice by identifying gaps that may exist in product awareness, popularity of use and risks to patient health. This survey promotes a better understanding of current opinions among pharmacists and physicians on e-cigarette products and provides consensus on whether further steps should be taken to increase product training and information dissemination. II. Methods This study utilized a survey methodology. Identical surveys composed of 13 questions were delivered to both pharmacist and physician groups. The survey encompassed a variety of questions assessing the healthcare professional s familiarity with e-cigarettes and their prevalence in the patient care setting. Survey questions are available for reference in Table 1. Survey distribution was planned for a time period of 3 months, or until 100 surveys were completed by each the pharmacist and the physician group, for a total of 200 surveys. Additionally, a goal of this study was to provide information to pharmacists and physicians on the prevalence and safety of e-cigarettes. In order to achieve this objective, we asked that any participant who was interested in receiving additional information on the topic provide an address. Upon request, an

7 educational electronic handout outlining relevant counseling points on e-cigarettes was provided to further improve awareness. Pharmacists were identified by using the GPS on mobile devices. This method identified and located community pharmacies within 15 miles of Duquesne University s address. To locate family medicine physicians, the Pennsylvania Academy of Family Physician s website was utilized to identify physician practices within 15 miles of Duquesne University s address. When time permitted, pharmacists and physicians were encouraged to complete the survey while survey distributors were present. If participants were unable to complete the survey while the surveyor was present, a pick-up time was established or a fax number was provided to return completed surveys. All data from thte surveys was compiled into an Excel spreadsheet. Patient identifiers were not transferred to the spreadsheet, but rather a coding system was used. Additionally, each subject received an informed consent form which outlined the purpose of the study and the explained the scope of the data requested. As the survey was anonymous, participants were not required to sign or return a copy of this consent form. As described, participant responses appeared only in statistical data summaries. Any study materials with personal identifying information will be maintained for three years after the completion of the research and then will be destroyed. This study was approved by the Institutional Review Board under expedited review at Duquesne University. A. Participant Selection Demographically and for inclusion in the study, pharmacists were required to be current practicing community pharmacists. Geographically, the pharmacies were only selected if their location was within a 15-mile radius of Pittsburgh, PA. Inclusion criteria

8 for physicians required that they currently be practicing in family medicine with practice sites located within a 15-mile radius of Pittsburgh, PA. Participants excluded from the study included pharmacists that provided indirect patient care or worked in an acute care setting. Physicians were excluded if they provided indirect patient care or practiced in a specialized area of medicine. Also, no pharmacist or physician was permitted to complete the survey more than once. B. Objectives The primary objectives of this study were to evaluate pharmacists and physicians perception and knowledge of e-cigarettes, including their comfort level in counseling patients on these products. The study also aimed to assess if, and to what extent, these healthcare professionals collect patient e-cigarette usage as a marker of tobacco use status. The final objective of the study was to provide pharmacists and physicians with pertinent information on e-cigarettes that could also be shared with patients. Successful attainment of the research objectives was achieved through the assessment of the following research questions: 1. Are pharmacists and physicians knowledgeable about e-cigarettes? 2. Are pharmacists and physicians observant of the increasing prevalence of e- cigarettes and the marketing tactics that target adolescents? 3. Are pharmacists and physicians aware of the previous lack of regulatory parameters associated with e-cigarette composition and manufacturing? 4. At what rate do pharmacists and physicians encounter patients that use e-cigarettes? 5. Do pharmacists and physicians ask about e-cigarette use when assessing a patient s smoking status, and if so, how do they quantify e-cigarette usage?

9 6. Are pharmacists and physicians aware of the adverse physiological effects associated with e-cigarette use? 7. Do pharmacists and physicians believe that e-cigarettes may be used as a cessation tool? C. Statistical Analysis Survey responses were analyzed utilizing descriptive and inferential statistics, as appropriate. Percentages were implemented for each assessment item on the survey in order to identify trends. Table 1. Survey Assessment Items

10 Results Data was collected and analyzed from a total of 69 pharmacist and 37 physician surveys. Participant demographics are noted in Table 2. A total of 75 surveys were distributed to pharmacists (response rate = 92.0%) and a total of 109 surveys were distributed to physicians (response rate = 33.9 %). Results are summarized in Figure 1. Table 2. Study Population Demographics

11 Figure 1. Survey Response Results 80% 70% 60% 50% 40% 30% Pharmacists Physicians 20% 10% 0% Smoking assessment includes e-cigarettes Full confidence in counseling on e- cigarettes Belief that e-cigarettes can be used as a cessation method Belief that further research is needed to determine safety Conclusions Pharmacists and physicians may benefit from further education and training on electronic cigarettes based on the survey results collected. With the recent FDA rulings

12 on e-cigarettes, it is anticipated that more information will become available to healthcare professionals and patients. Discussion Due to the rapid increase in prevalence of e-cigarette use, it was important to assess the opinions and baseline knowledge of healthcare professionals who will be encountering patients seeking advice and guidance relating to this topic. Though this survey, gaps in knowledge were identified in both pharmacist and physician groups. Areas of improvement, relating to the physiological effects associated with e-cigarettes, were identified in both participant groups, and likely warrant further education. Physicians most commonly quantified e-cigarette use by assessing the frequency of use by the patient, while pharmacists most commonly assessed frequency of use and nicotine content. Several physicians and pharmacists also were unaware if e-cigarettes are addictive and whether or not they produce secondhand emissions. Strengths of this study include the participation of both pharmacists and physicians, which allowed for a broad assessment of health care professionals involved in patient care. Also, survey distributors were Tobacco Treatment Specialist (TTS) certified pharmacy students. An obstacle to the study was reaching the anticipated number of survey participants. The study projected a survey collection of 200 total surveys; however, due to loss of surveys to follow-up, we completed the survey collection period after 3 months. This study was also geographically limited to participants practicing within 15-mile radius of Pittsburgh, PA.

13 Future research in this area could include educational interventions on e-cigarettes for healthcare professionals and their resulting influence on patient assessment and care, as well as further research into the impact of the new FDA regulations on e-cigarettes and other novel forms of nicotine delivery systems. References 1. Orellana-barrios MA, Payne D, Mulkey Z, Nugent K. Electronic Cigarettes A Narrative Review for Clinicians. Am J Med. 2015;128 (7): Centers for Disease Control and Prevention (CDC). Notes from the field: electronic cigarette use among middle and high school students - United States, MMWR Morb Mortal Wkly Rep 2013; 62: Arrazola RA, Singh T, Corey CG, et al. Tobacco use among middle and high school students - United States, MMWR Morb Mortal Wkly Rep 2015; 64: Borderud SP, Li Y, Burkhalter JE, et al. Electronic cigarette use among patients with cancer: characteristics of electronic cigarette users and their smoking cessation outcomes. Cancer 2014; 120: Hajek P, Etter JF, Benowitz N, et al. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction 2014; 109: Biener L, Hargraves JL. A longitudinal study of electronic cigarette use in a population-based sample of adult smokers: association with smoking cessation and motivation to quit. Nicotine Tob Res. 2015;17(2):

14 7. Borderud SP, Li Y, Burkhalter JE, Sheffer CE, Ostroff JS. Electronic cigarette use among patients with cancer: characteristics of electronic cigarette users and their smoking cessation outcomes. Cancer. 2014;120(22): E-cigarettes and Lung Health American Lung Association website. Updated March Accessed October 27, 2015.

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