Pharmacist-Delivered Smoking Cessation Program in Community Pharmacy (The FINE Program) in Japan—The Development of a Training Course and a Feasibility Study

2019 ◽  
pp. 089719001988974
Author(s):  
Mitsuko Onda ◽  
Takashi Kuwanoe ◽  
Atsunori Hashimoto ◽  
Michiko Horiguchi ◽  
Masayuki Domichi ◽  
...  

Aim: Although smoking cessation support has been recommended as a routine component of pharmacists’duties, there is limited evidence of smoking cessation being achieved successfully in community pharmacy. The aim of this study was to develop a new smoking cessation program for use in the community pharmacy setting and investigate its feasibility. Methods: A feasibility study (the Family pharmacist’s Intervention for Nicotine Elimination [FINE] program) was conducted using 8 pharmacists at 2 community pharmacies in Japan. The pharmacists recruited as subjects smokers 20 or more years of age who were taking medications such as antidiabetes drugs. The patients completed questionnaires assessing their smoking status, and the pharmacists provided them with smoking cessation support services. Participating patients met with the pharmacists or talked to them on the phone 5 times at 2- to 4-week intervals and received personalized and structured brief smoking cessation advice. The primary outcome was continuous abstinence determined by Micro Smokerlyzer carbon monoxide monitor at 3 months. Results: Of 5306 patients, 2296 patients were screened and the rate of smoking was found to be 12.7%. Five smoking patients received the FINE program from pharmacists who had received training. One of the 5 succeeded in quitting smoking after 3 months. Conclusions: This is the first study to target Japanese smoking patients in community pharmacies with a brief structured intervention. The results tentatively support the feasibility of the FINE program. Further research including a randomized controlled trial is required to confirm the effectiveness of the FINE program.

2020 ◽  
Vol 42 (1) ◽  
Author(s):  
Yuya Kawasaki ◽  
Yun-Shan Li ◽  
Yuko Ootsuyama ◽  
Kazuhiko Nagata ◽  
Hiroshi Yamato ◽  
...  

Abstract Introduction Urinary nicotine and cotinine levels are often measured as biomarkers for tobacco smoke exposure. However, these biomarkers are not appropriate to evaluate the effects of quitting smoking for several days, because of their short half-lives. In this study, we focused on the changes in the urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) levels of 55 patients in a smoking cessation program, because of the long half-life. At the same time, urinary 7-methylguanine (m7Gua) and 8-hydroxy-2′-deoxyguanosine (8-OHdG), as DNA damage markers of cigarette smoking, were also measured. Results In the subjects who completed the quit-smoking program (18 subjects out of 55), the urinary nicotine and cotinine levels decreased to 1.7 and 0.2% at 8 weeks after the first visit to the clinic. By contrast, the NNAL levels decreased to 12.3% at 8 weeks after quitting smoking. During the same period, the urinary m7Gua levels significantly decreased, from 27.32 μg/mg creatinine to 14.17 μg/mg creatinine by the elimination of subjects who showed increased levels of NNAL during the smoking cessation program. The 8-OHdG levels were also reduced within the same period, but were not significantly different. From the all data analysis, the urinary levels of cotinine and NNAL positively correlated with the level of m7Gua. Conclusions NNAL may be an appropriate exposure marker for evaluating the smoking status of patients in a smoking cessation program. The urinary cotinine and NNAL levels positively correlated with the m7Gua levels.


10.2196/17270 ◽  
2020 ◽  
Vol 8 (5) ◽  
pp. e17270
Author(s):  
Ayaka Kato ◽  
Tomoyuki Tanigawa ◽  
Kohta Satake ◽  
Akihiro Nomura

Background Smoking cessation helps extend a healthy life span and reduces medical expenses. However, the standard 12-week smoking cessation program in Japan has several notable problems. First, only 30% of participants complete this program. Second, participants may choose not to participate unless they have a strong motivation to quit smoking, such as health problems. Third, the program does not provide enough support during the period between clinical visits and after 12 weeks. Objective This study examined the efficacy of the 24-week ascure program to address the problems of accessibility and continuous support. The program combines online mentoring, over-the-counter pharmacotherapy, and a smartphone app. Methods Using a retrospective study design, we investigated data for 177 adult smokers who were enrolled in the ascure smoking cessation program between August 2017 and August 2018. The primary outcomes were continuous abstinence rates (CARs) during weeks 9-12 and weeks 21-24. To confirm smoking status, we performed salivary cotinine testing at weeks 12 and 24. We also evaluated the program adherence rate. Finally, we performed exploratory analysis to determine the factors associated with continuous abstinence at weeks 21-24 to provide insights for assisting with long-term continuous abstinence. Results The CARs of all participants for weeks 9-12 and weeks 21-24 were 48.6% (95% CI 41.2-56.0) and 47.5% (95% CI 40.0-54.8), respectively. Program adherence rates were relatively high throughout (72% at week 12 and 60% at week 24). In the analysis of the factors related to the CAR at weeks 21-24, the number of entries in the app’s digital diary and number of educational videos watched during the first 12 weeks were significant factors. Conclusions The ascure program achieved favorable CARs, and participants showed high adherence. Proactive usage of the smartphone app may help contribute to smoking cessation success in the long-term.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Mitsuko Onda ◽  
Michiko Horiguchi ◽  
Masayuki Domichi ◽  
Naoki Sakane

Objectives. To investigate the effectiveness of a smoking cessation program (FINE program) in community pharmacies. Methods. A cluster-randomized controlled trial was conducted in 11 community pharmacies in Japan. The participants were randomly assigned to a pharmacist-led structured smoking cessation program (intervention group) or pharmacist-led usual care (control group). The intervention group was followed up over the telephone on the third day of smoking cessation, and ongoing follow-up and advice were provided according to the original smoking cessation guidebook developed for the current study based on a behavioral change approach. The control group received brief advice and ready-made pamphlets on smoking cessation from pharmacists upon their visit to these community pharmacies. The primary outcome was continued smoking cessation as determined by self-reporting and carbon monoxide monitoring with a microsmokerlyzer after 3 months. Results. Five hundred and seventy-two smokers who met the eligibility criteria visited the pharmacies included in the study. Of these individuals, 24 patients agreed to participate in the study. The quit rates were 45.5% and 18.2% in the intervention and control groups, respectively ( P = 0.380 , effect   size = 0.60 ). Conclusion. Based on the effect size values, the FINE program may be effective to some extent, but the difference was not significant. We speculate that this is related to the small sample size due to difficulty in recruiting. Further studies with an effective recruitment method and larger sample sizes are needed to accurately verify the effectiveness of this program.


2018 ◽  
Vol 22 (3) ◽  
pp. 346-353 ◽  
Author(s):  
Jeremy E Drehmer ◽  
Deborah J Ossip ◽  
Emara Nabi-Burza ◽  
Bethany Hipple Walters ◽  
Julie A Gorzkowski ◽  
...  

Abstract Introduction National and international organizations have done an excellent job of advocating and promoting breast feeding for all mothers. This study assessed to what extent an intervention increased delivery of cessation assistance to breast-feeding mothers who smoke. Methods Data were collected between April and October 2015 in five US states as part of a cluster randomized controlled trial in 10 pediatric practices. Practices were randomized to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention or usual care control arms. Mothers were asked about their smoking status and breast-feeding history during a screening interview upon exiting the practice and eligible mothers who agreed to participate in an enrollment interview were asked if they received smoking cessation assistance during their child’s visit. Mothers with a child 1 year old and younger were included in the analyses. Results Current breast feeding was associated with a reduced likelihood of current smoking (adjusted odds ratio [aOR] = 0.38, 95% confidence interval [95% CI] = 0.25 to 0.57) and a greater likelihood of quitting smoking (aOR = 2.33, 95% CI = 1.29 to 4.21) after controlling for known confounders. Mothers who concurrently smoked and breast-fed were more likely to be asked about smoking (66.7% vs. 28.6%, p = .01), advised to quit (61.1% vs. 21.4%, p < .01), prescribed nicotine replacement therapy (50.0% vs. 0%, p < .001), and enrolled into the quitline (27.8% vs. 0%, p < .01) at CEASE practices compared to control practices. Conclusion Breast-feeding mothers were less likely to be current smokers and more likely to have recently quit smoking. Among mothers who continue to smoke and breast feed, the CEASE intervention enhances delivery of smoking cessation assistance. Implications Breast feeding and eliminating infants’ exposure to tobacco smoke are important protective factors for serious pediatric health risks including sudden infant death. This study shows that breast feeding was positively associated with desirable tobacco control outcomes, specifically that breast feeding was associated with a lower likelihood of smoking among ever smokers and a greater likelihood of recently quitting smoking. This is also the first study to look specifically at delivery of smoking cessation assistance to breast-feeding mothers seen at pediatric offices and demonstrates the effectiveness of delivering evidence-based smoking cessation assistance to them in this context. Trial Registration www.ClinicalTrials.gov (identifier NCT01882348).


2019 ◽  
Author(s):  
Ayaka Kato ◽  
Tomoyuki Tanigawa ◽  
Kohta Satake ◽  
Akihiro Nomura

BACKGROUND Smoking cessation helps extend a healthy life span and reduces medical expenses. However, the standard 12-week smoking cessation program in Japan has several notable problems. First, only 30% of participants complete this program. Second, participants may choose not to participate unless they have a strong motivation to quit smoking, such as health problems. Third, the program does not provide enough support during the period between clinical visits and after 12 weeks. OBJECTIVE This study examined the efficacy of the 24-week ascure program to address the problems of accessibility and continuous support. The program combines online mentoring, over-the-counter pharmacotherapy, and a smartphone app. METHODS Using a retrospective study design, we investigated data for 177 adult smokers who were enrolled in the ascure smoking cessation program between August 2017 and August 2018. The primary outcomes were continuous abstinence rates (CARs) during weeks 9-12 and weeks 21-24. To confirm smoking status, we performed salivary cotinine testing at weeks 12 and 24. We also evaluated the program adherence rate. Finally, we performed exploratory analysis to determine the factors associated with continuous abstinence at weeks 21-24 to provide insights for assisting with long-term continuous abstinence. RESULTS The CARs of all participants for weeks 9-12 and weeks 21-24 were 48.6% (95% CI 41.2-56.0) and 47.5% (95% CI 40.0-54.8), respectively. Program adherence rates were relatively high throughout (72% at week 12 and 60% at week 24). In the analysis of the factors related to the CAR at weeks 21-24, the number of entries in the app’s digital diary and number of educational videos watched during the first 12 weeks were significant factors. CONCLUSIONS The ascure program achieved favorable CARs, and participants showed high adherence. Proactive usage of the smartphone app may help contribute to smoking cessation success in the long-term.


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015637 ◽  
Author(s):  
Liz Steed ◽  
Ratna Sohanpal ◽  
Wai-Yee James ◽  
Carol Rivas ◽  
Sandra Jumbe ◽  
...  

ObjectiveTo develop a complex intervention for community pharmacy staff to promote uptake of smoking cessation services and to increase quit rates.DesignFollowing the Medical Research Council framework, we used a mixed-methods approach to develop, pilot and then refine the intervention.MethodsPhase I: We used information from qualitative studies in pharmacies, systematic literature reviews and the Capability, Opportunity, Motivation—Behaviour framework to inform design of the initial version of the intervention.Phase II: We then tested the acceptability of this intervention with smoking cessation advisers and assessed fidelity using actors who visited pharmacies posing as smokers, in a pilot study.Phase III: We reviewed the content and associated theory underpinning our intervention, taking account of the results of the earlier studies and a realist analysis of published literature. We then confirmed a logic model describing the intended operation of the intervention and used this model to refine the intervention and associated materials.SettingEight community pharmacies in three inner east London boroughs.Participants12 Stop Smoking Advisers.InterventionTwo, 150 min, skills-based training sessions focused on communication and behaviour change skills with between session practice.ResultsThe pilot study confirmed acceptability of the intervention and showed preliminary evidence of benefit; however, organisational barriers tended to limit effective operation. The pilot data and realist review pointed to additional use of Diffusion of Innovations Theory to seat the intervention in the wider organisational context.ConclusionsWe have developed and refined an intervention to promote smoking cessation services in community pharmacies, which we now plan to evaluate in a randomised controlled trial.Trial registration numberUKCRN ID 18446, Pilot.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Stephen I Rennard ◽  
Douglas E Jorenby ◽  
David Gonzales ◽  
Nancy A Rigotti ◽  
Arjen de Vos ◽  
...  

Background: Cigarette smoking triples the risk of dying from heart disease among middle-aged men and women. A nicotine vaccine (NicVAX®) has been developed to produce nicotine-specific antibodies as a means of reducing entry of nicotine into the brain as an aid to smoking cessation. Objective: To assess 12-month safety, efficacy and immunogenicity of NicVAX in smokers who want to quit. Method: Randomized, double-blinded, placebo-controlled multicenter clinical trial with 2 dose levels of NicVAX (200μg & 400μg) and 2 schedules. Generally healthy adults who smoked ≥ 15 cigarettes/day were recruited. Subjects were randomized 2:1, active:placebo, at 9 sites in the US. The primary endpoint was self reported continuous abstinence for weeks 19 – 26 confirmed by expired CO levels of ≤ 8 ppm. Secondary endpoints include point prevalence abstinence at 12 months. Results: 301 subjects (52% female) with a mean age of 48, smoking on average 24 cigarettes/day were enrolled. A pre-defined analysis of antibody levels for subjects receiving NicVAX were reviewed and divided into low and high responder groups, with the top 30 th percentile representing the high responder group. Analysis for the primary endpoint demonstrated that 15/61 (24.6%) of subjects having the highest antibody titers achieved an 8 week period of continuous abstinence between weeks 19 –26, compared to 13/100 (13.0%) for the subjects who received placebo (p=0.04). In contrast, the quit rate for those subjects that did not achieve a high antibody titer was not significantly different from placebo (14/140, 10%). There was a significant relationship between anti-nicotine antibody levels and continuous abstinence from smoking (p=0.0001). NicVAX was well-tolerated and showed no differences in adverse events or in local/systemic reactions between placebo and each active vaccine group. Conclusion: Proof-of-concept has been established by the strong correlation of high antibody titers with smoking abstinence. Interim data (6 months post vaccination) demonstrate that generating antibodies to nicotine may be a useful approach for aiding smoking cessation. This study will be completed in Sept 2007. Immunogenicity, sustained smoking cessation and relapse rates at 12 months after vaccination will be presented.


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