Health Policy 119 (2015) 50–56
Contents lists available at ScienceDirect
Health Policy journal homepage: www.elsevier.com/locate/healthpol
Nationwide Smoking Cessation Treatment Support Program – Turkey project I˙ smail C¸elik a,∗ , Deniz Yüce a , Mutlu Hayran a , Mustafa Erman a , Saadettin Kılıc¸kap a , Turan Buzgan b , Hasan Irmak b , Nihat Tosun b , Murat Tuncer c , Recep Akda˘g d a b c d
Tobacco Control, Training, Taxation, and Research Center, Hacettepe University Cancer Institute, Turkey Republic of Turkey, Ministry of Health, Turkey Rector, Hacettepe University, Turkey Ministerial Leadership in Health Program, Harvard School of Public Health, Turkey
a r t i c l e
i n f o
Article history: Received 23 June 2014 Received in revised form 10 November 2014 Accepted 23 November 2014 Keywords: Smoking cessation National support program Varenicline Bupropion
a b s t r a c t Background: In 2011, Turkish Ministry of Health (MoH) initiated a nation-wide “Smoking Cessation Treatment Support Program” (SCTSP), to provide smoking cessation drugs free of charge. Methods: SCTSP was conducted in all 81 cities of Turkey, at 228 smoking cessation clinics, and by over 400 physicians. In total, 164,733 participants took advantage of the program between January and November 2011. Varenicline (Champix® , Pfizer) and Bupropion (Zyban® , GlaxoSmithKline) were used in the program at a ratio of 0.7 and 0.3 respectively. Post-program data were obtained by phone interviews from randomly selected participants, who had completed a 1-year follow-up after enrollment in the program. Findings: Quit rates were 29.6% for those given Varenicline and 25.1% for those given Bupropion. The quit rates for participants with hypertension (35.0%), diabetes mellitus (36.9%), coronary artery disease (32.1%) and cerebrovascular events (34.0%) were higher than those without. Increased age, female gender, longer duration of cessation drug use, low Fagerstrom score, the presence of hypertension, the absence of chronic obstructive pulmonary disease, and the absence of cancer were found to be associated with higher success rates. Interpretation: SCTSP is the first successful report of a nation-wide community-based smoking cessation intervention. The real-life quit rates obtained herein are comparable to those of clinical evidence to date. The centralization of smoking cessation clinics, standardization of treatment guidelines, application of a specific drug assignment algoritm, and provision of primary care support and follow-ups by trained physicians, appeared to be key elements for success. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction The consumption of tobacco products is a major health problem worldwide [1]. The most heavily affected
∗ Corresponding author. Tel.: +90 5323563185. E-mail address: [email protected] (I˙ . C¸elik). http://dx.doi.org/10.1016/j.healthpol.2014.11.017 0168-8510/© 2014 Elsevier Ireland Ltd. All rights reserved.
populations are from middle and low income countries, which consume approximately 80% of world’s tobacco production [2]. The first international agreement on tobacco control was the Framework Convention on Tobacco Control (FCTC) approved in the 56th World Health Assembly of the WHO on 21 May 2003. Article 14 of the FCTC requires countries to implement systems to provide tobacco dependence treatment, however, current data precludes
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
51
that provision of treatment services is far from satisfactory worldwide and varies substantially between countries [3]. Turkey signed FCTC on 28 April 2004 and the Turkish Ministry of Health (MoH) prepared a National Action Plan that covered 2008–2012. Thereafter, Turkey has become one of the six countries with the most comprehensive legal regulations on tobacco consumption (Ireland, England, New Zealand, Uruguay, Bermuda, and Turkey) [4] and one of the most successful countries in reducing smoking rates over the last five years. Smoking prevalence significantly decreased among adults from 31.2% in 2008 to 27.1% in 2012 [5]. Turkey is the first country to fully implement the WHO’s MPOWER package. Under MPOWER, the Turkish Ministry of Health established a toll-free quit-line at “171,” a service that provides counseling to smokers who are willing to quit, and provided smoking cessation clinics to the public. In 2011, the Turkish MoH conducted a program for supporting individuals with free medications. The program was named “Republic of Turkey, Ministry of Health, Smoking Cessation Treatment Support Program (SCTSP)”, the most comprehensive public intervention program for smoking cessation in the world. In Turkey, most of the healthcare expenditures are covered by the social security system. Likewise, medical assessments in smoking cessation services are available to the public under the security system. However, medications (Varenicline, Bupropion, and Nicotine Replacement Therapy) are not normally covered. The discordance in the evaluation and treatment of nicotine dependence has been the major challenge in successful smoking cessation. SCTSP overcame this challenge by providing medications free of charge. The Turkish government steadfastly took steps against the tobacco epidemic, and the project was led mainly by the Prime Minister and Minister of Health. After the program was completed, the present study was conducted to evaluate the SCTSP.
For each participant, complete medical history was taken and physical examination was performed at the time of first interview. Subjects were also questioned for their health status including smoking history, nicotine dependence and presence of any comorbid disease. Those being under 18 years of age, having alcohol and/or substance dependence, serious psychiatric disorder i.e. psychosis, major depression, bipolar affective disorder, schizophrenia, or any end-stage or life-threatening disease were not included to the program. For evaluation of nicotine dependence, Fagerstrom scale is used. The nicotine dependence was graded as “low (0–4), moderate (5–7) and high (8–10)” in a 10 point scale.
2. Materials and methods
2.3. Algorithm
2.1. Smoking Cessation Treatment Support Program
Algorithm of the SCTSP is presented in Fig. 1. This algorithm, applied through a web-based surveillance system, provided monitoring of the treatments in collaborating centers, prevention against drug abuse, monitoring of drug inventory and supplying the centers with new drugs without delay, monitoring of treatment compliance, and maximizing the number of participants by online drug inventory management. There was a lag time of 3–14 days between admission and drug assignment and distribution. This interval was planned to increase the compliance of the participants to the program by minimizing subjects who were not committed to smoking cessation. Individuals who reapplied to the centers were then regarded as participants, and the drug assignment process was initiated. Subjects whom were not eligible for the program, or declined the assigned treatment, were banned from re-entry for 6 months using the surveillance system. The second drug box was delivered after 25–35 days from the assignment, and the third drug box was delivered after 55–65 days after the assignment. Drug delivery was not available out of these dates, and when a participant
SCTSP was initiated with the decree by the Council of Ministers of the Republic of Turkey, that call for “supporting approximately two hundred and fifty thousand smokers countrywide with smoking cessation medications free of charge.” In addition, a quit-line “171” was established, and a press release of SCTSP was announced. The medications were provided, examined and stored by the different departments of the MoH including the General Directorate of Primary Health Care, Department of Cancer Control, and General Directorate of Curative Services. Smoking cessation clinics all over the country were few (n = 45) and worked independently before SCTSP. After the establishment of the program, all smoking cessation clinics were centralized, and treatment guidelines were developed for the standardization of service work. New clinics were established where necessary, while physicians were assigned, and trained on smoking cessation treatments. Training programs were held in the last months of 2010 and first months of 2011, and the attendees were certified as
“Smoking Cessation Physicians.” The SCTSP was monitored by a web-based surveillance system. The staff of the collaborating smoking cessation clinics attended educational seminars about the online system. In total, SCTSP was conducted at 228 smoking cessation clinics. There was at least 1 clinic (range: 1–26) established in all 81 cities of Turkey. The distribution of participating clinics was determined according to the census population of each city, and the rate of involvement in the program. The first group of smoking cessation clinics was established in the body of Cancer Early Detection, Screening and Training Centers (Turkish acronym-KETEM). These centers mainly deliver cancer-screening services to the public, and perform routine follow-up according to national screening programs. The second group of clinics was established in state hospitals, and the majority of these clinics were chest disease clinics, or psychiatry clinics. By the contribution of these two main groups of centers, SCTSP was conducted in primary, secondary and tertiary health-care facilities by 400 physicians (160 physicians in KETEMs, and 240 physicians in state hospitals). 2.2. Study population
52
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
Fig. 1. Algorithm of Smoking Cessation Treatment Support Program.
did not come to follow-up visits, he/she was considered as a dropout and was excluded from the program for six months. After a participant was deemed eligible for drug assignment, the web-based surveillance system randomly offered the medication according to the drug stock. After drug assignment, participants were regularly followed-up. In case of refusal to continue the program, refusal to attend the follow-up visits, any reported discomfort related with the assigned medication, and non-compliance to the recommended use of the medication, they were subsequently excluded. 2.4. Drug treatment Varenicline (Champix® , Pfizer), and Bupropion (Zyban® , GlaxoSmithKline) were purchased at a ratio of 0.7 and 0.3 respectively, in the SCTSP. According to the manufacturers’ directions, recommended treatment durations were 12–24 weeks for Varenicline and 7–52 weeks for Bupropion. To standardize the duration of treatment, Varenicline and Bupropion were given for 12 weeks which corresponded to 3 packs of commercial forms for both drugs in SCTSP. 2.5. Smoking Cessation Treatment Support Program evaluation In order to measure the efficacy of the program, post-program analyses were conducted for determining the smoking cessation rates. The Ethics Committee of Hacettepe University approved this study under the title “Republic of Turkey, Ministry of Health, Smoking Cessation
Treatment Support Program Evaluation Study (SCTSP)” on 21st of February 2012. The SCTSP Evaluation Study included a randomly selected 16,473 participants, corresponding to one tenth of the entire participants. The participants were contacted after 1-year of period over the last participant has completed the program. The contact information and the data regarding demographic variables, health status parameters including smoking history, nicotine dependence, comorbidities, medication consumption and follow-up records of the participants were obtained from the case files collected from study centers. Smoking status data were obtained by phone interviews conducted by trained call-center operators. 2.6. Statistical analyses IBM® SPSS® Statistics, version 21 was used for the statistical analyses. The presence of various comorbidities was both presented for the entire participants and the study group, by using tables of frequencies. Smoking cessation status was grouped into “completely quitted”, “quitted but restarted”, and “failure to quit” groups. The proportions in each group were presented by age group, gender, Fagerstrom score, duration of drug supply, medications, and medical history using cross tabulations. Variables associated with program success (maintenance of smoking cessation for 12 months) were investigated using the Chi-square test. For the multivariate analysis, the possible factors identified with univariate analyses were further entered into the logistic regression analysis to determine independent predictors of program success.
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
53
Table 1 Smoking cessation rates according to demographic characteristics. Quit completely n (%)
Quit but restarted n (%)
Failed to quit n (%)
Total n (%)
p
Age group
Contents lists available at ScienceDirect
Health Policy journal homepage: www.elsevier.com/locate/healthpol
Nationwide Smoking Cessation Treatment Support Program – Turkey project I˙ smail C¸elik a,∗ , Deniz Yüce a , Mutlu Hayran a , Mustafa Erman a , Saadettin Kılıc¸kap a , Turan Buzgan b , Hasan Irmak b , Nihat Tosun b , Murat Tuncer c , Recep Akda˘g d a b c d
Tobacco Control, Training, Taxation, and Research Center, Hacettepe University Cancer Institute, Turkey Republic of Turkey, Ministry of Health, Turkey Rector, Hacettepe University, Turkey Ministerial Leadership in Health Program, Harvard School of Public Health, Turkey
a r t i c l e
i n f o
Article history: Received 23 June 2014 Received in revised form 10 November 2014 Accepted 23 November 2014 Keywords: Smoking cessation National support program Varenicline Bupropion
a b s t r a c t Background: In 2011, Turkish Ministry of Health (MoH) initiated a nation-wide “Smoking Cessation Treatment Support Program” (SCTSP), to provide smoking cessation drugs free of charge. Methods: SCTSP was conducted in all 81 cities of Turkey, at 228 smoking cessation clinics, and by over 400 physicians. In total, 164,733 participants took advantage of the program between January and November 2011. Varenicline (Champix® , Pfizer) and Bupropion (Zyban® , GlaxoSmithKline) were used in the program at a ratio of 0.7 and 0.3 respectively. Post-program data were obtained by phone interviews from randomly selected participants, who had completed a 1-year follow-up after enrollment in the program. Findings: Quit rates were 29.6% for those given Varenicline and 25.1% for those given Bupropion. The quit rates for participants with hypertension (35.0%), diabetes mellitus (36.9%), coronary artery disease (32.1%) and cerebrovascular events (34.0%) were higher than those without. Increased age, female gender, longer duration of cessation drug use, low Fagerstrom score, the presence of hypertension, the absence of chronic obstructive pulmonary disease, and the absence of cancer were found to be associated with higher success rates. Interpretation: SCTSP is the first successful report of a nation-wide community-based smoking cessation intervention. The real-life quit rates obtained herein are comparable to those of clinical evidence to date. The centralization of smoking cessation clinics, standardization of treatment guidelines, application of a specific drug assignment algoritm, and provision of primary care support and follow-ups by trained physicians, appeared to be key elements for success. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction The consumption of tobacco products is a major health problem worldwide [1]. The most heavily affected
∗ Corresponding author. Tel.: +90 5323563185. E-mail address: [email protected] (I˙ . C¸elik). http://dx.doi.org/10.1016/j.healthpol.2014.11.017 0168-8510/© 2014 Elsevier Ireland Ltd. All rights reserved.
populations are from middle and low income countries, which consume approximately 80% of world’s tobacco production [2]. The first international agreement on tobacco control was the Framework Convention on Tobacco Control (FCTC) approved in the 56th World Health Assembly of the WHO on 21 May 2003. Article 14 of the FCTC requires countries to implement systems to provide tobacco dependence treatment, however, current data precludes
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
51
that provision of treatment services is far from satisfactory worldwide and varies substantially between countries [3]. Turkey signed FCTC on 28 April 2004 and the Turkish Ministry of Health (MoH) prepared a National Action Plan that covered 2008–2012. Thereafter, Turkey has become one of the six countries with the most comprehensive legal regulations on tobacco consumption (Ireland, England, New Zealand, Uruguay, Bermuda, and Turkey) [4] and one of the most successful countries in reducing smoking rates over the last five years. Smoking prevalence significantly decreased among adults from 31.2% in 2008 to 27.1% in 2012 [5]. Turkey is the first country to fully implement the WHO’s MPOWER package. Under MPOWER, the Turkish Ministry of Health established a toll-free quit-line at “171,” a service that provides counseling to smokers who are willing to quit, and provided smoking cessation clinics to the public. In 2011, the Turkish MoH conducted a program for supporting individuals with free medications. The program was named “Republic of Turkey, Ministry of Health, Smoking Cessation Treatment Support Program (SCTSP)”, the most comprehensive public intervention program for smoking cessation in the world. In Turkey, most of the healthcare expenditures are covered by the social security system. Likewise, medical assessments in smoking cessation services are available to the public under the security system. However, medications (Varenicline, Bupropion, and Nicotine Replacement Therapy) are not normally covered. The discordance in the evaluation and treatment of nicotine dependence has been the major challenge in successful smoking cessation. SCTSP overcame this challenge by providing medications free of charge. The Turkish government steadfastly took steps against the tobacco epidemic, and the project was led mainly by the Prime Minister and Minister of Health. After the program was completed, the present study was conducted to evaluate the SCTSP.
For each participant, complete medical history was taken and physical examination was performed at the time of first interview. Subjects were also questioned for their health status including smoking history, nicotine dependence and presence of any comorbid disease. Those being under 18 years of age, having alcohol and/or substance dependence, serious psychiatric disorder i.e. psychosis, major depression, bipolar affective disorder, schizophrenia, or any end-stage or life-threatening disease were not included to the program. For evaluation of nicotine dependence, Fagerstrom scale is used. The nicotine dependence was graded as “low (0–4), moderate (5–7) and high (8–10)” in a 10 point scale.
2. Materials and methods
2.3. Algorithm
2.1. Smoking Cessation Treatment Support Program
Algorithm of the SCTSP is presented in Fig. 1. This algorithm, applied through a web-based surveillance system, provided monitoring of the treatments in collaborating centers, prevention against drug abuse, monitoring of drug inventory and supplying the centers with new drugs without delay, monitoring of treatment compliance, and maximizing the number of participants by online drug inventory management. There was a lag time of 3–14 days between admission and drug assignment and distribution. This interval was planned to increase the compliance of the participants to the program by minimizing subjects who were not committed to smoking cessation. Individuals who reapplied to the centers were then regarded as participants, and the drug assignment process was initiated. Subjects whom were not eligible for the program, or declined the assigned treatment, were banned from re-entry for 6 months using the surveillance system. The second drug box was delivered after 25–35 days from the assignment, and the third drug box was delivered after 55–65 days after the assignment. Drug delivery was not available out of these dates, and when a participant
SCTSP was initiated with the decree by the Council of Ministers of the Republic of Turkey, that call for “supporting approximately two hundred and fifty thousand smokers countrywide with smoking cessation medications free of charge.” In addition, a quit-line “171” was established, and a press release of SCTSP was announced. The medications were provided, examined and stored by the different departments of the MoH including the General Directorate of Primary Health Care, Department of Cancer Control, and General Directorate of Curative Services. Smoking cessation clinics all over the country were few (n = 45) and worked independently before SCTSP. After the establishment of the program, all smoking cessation clinics were centralized, and treatment guidelines were developed for the standardization of service work. New clinics were established where necessary, while physicians were assigned, and trained on smoking cessation treatments. Training programs were held in the last months of 2010 and first months of 2011, and the attendees were certified as
“Smoking Cessation Physicians.” The SCTSP was monitored by a web-based surveillance system. The staff of the collaborating smoking cessation clinics attended educational seminars about the online system. In total, SCTSP was conducted at 228 smoking cessation clinics. There was at least 1 clinic (range: 1–26) established in all 81 cities of Turkey. The distribution of participating clinics was determined according to the census population of each city, and the rate of involvement in the program. The first group of smoking cessation clinics was established in the body of Cancer Early Detection, Screening and Training Centers (Turkish acronym-KETEM). These centers mainly deliver cancer-screening services to the public, and perform routine follow-up according to national screening programs. The second group of clinics was established in state hospitals, and the majority of these clinics were chest disease clinics, or psychiatry clinics. By the contribution of these two main groups of centers, SCTSP was conducted in primary, secondary and tertiary health-care facilities by 400 physicians (160 physicians in KETEMs, and 240 physicians in state hospitals). 2.2. Study population
52
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
Fig. 1. Algorithm of Smoking Cessation Treatment Support Program.
did not come to follow-up visits, he/she was considered as a dropout and was excluded from the program for six months. After a participant was deemed eligible for drug assignment, the web-based surveillance system randomly offered the medication according to the drug stock. After drug assignment, participants were regularly followed-up. In case of refusal to continue the program, refusal to attend the follow-up visits, any reported discomfort related with the assigned medication, and non-compliance to the recommended use of the medication, they were subsequently excluded. 2.4. Drug treatment Varenicline (Champix® , Pfizer), and Bupropion (Zyban® , GlaxoSmithKline) were purchased at a ratio of 0.7 and 0.3 respectively, in the SCTSP. According to the manufacturers’ directions, recommended treatment durations were 12–24 weeks for Varenicline and 7–52 weeks for Bupropion. To standardize the duration of treatment, Varenicline and Bupropion were given for 12 weeks which corresponded to 3 packs of commercial forms for both drugs in SCTSP. 2.5. Smoking Cessation Treatment Support Program evaluation In order to measure the efficacy of the program, post-program analyses were conducted for determining the smoking cessation rates. The Ethics Committee of Hacettepe University approved this study under the title “Republic of Turkey, Ministry of Health, Smoking Cessation
Treatment Support Program Evaluation Study (SCTSP)” on 21st of February 2012. The SCTSP Evaluation Study included a randomly selected 16,473 participants, corresponding to one tenth of the entire participants. The participants were contacted after 1-year of period over the last participant has completed the program. The contact information and the data regarding demographic variables, health status parameters including smoking history, nicotine dependence, comorbidities, medication consumption and follow-up records of the participants were obtained from the case files collected from study centers. Smoking status data were obtained by phone interviews conducted by trained call-center operators. 2.6. Statistical analyses IBM® SPSS® Statistics, version 21 was used for the statistical analyses. The presence of various comorbidities was both presented for the entire participants and the study group, by using tables of frequencies. Smoking cessation status was grouped into “completely quitted”, “quitted but restarted”, and “failure to quit” groups. The proportions in each group were presented by age group, gender, Fagerstrom score, duration of drug supply, medications, and medical history using cross tabulations. Variables associated with program success (maintenance of smoking cessation for 12 months) were investigated using the Chi-square test. For the multivariate analysis, the possible factors identified with univariate analyses were further entered into the logistic regression analysis to determine independent predictors of program success.
I˙ . C¸elik et al. / Health Policy 119 (2015) 50–56
53
Table 1 Smoking cessation rates according to demographic characteristics. Quit completely n (%)
Quit but restarted n (%)
Failed to quit n (%)
Total n (%)
p
Age group
