Evidence of the Effectiveness of Pictorial Health Warnings on Cigarette Packaging in Nepal

Tobacco usage possesses a serious threat on health. Every year, tobacco kills 24,800 Nepalese, nearly half of them prematurely, and causes the loss of 341,000 years of life. More than 3,500 of these lives lost are due to the exposure to second-hand smoke and 47% of deaths are among individuals under age 70 (NHEICC, 2019). Nearly 29% of adults aged 15-69 years (48.3% of men, 11.6% of women) use some type of tobacco. Two-thirds of people aged 15-69 years were exposed to secondhand smoke on a daily basis (Dhimal et al., 2020). Nepal signed a World Health Organization Framework Convention on Tobacco Control (WHO FCTC) in 2003 with ratification of the convention in 2006 (UN, 2021). The Tobacco Product (Control and Regulatory) Act was passed in 2010 (GoN, 2011) with a subsequent implementation of a PHWs Directives adopted in 2011 (MOHP, 2011). PHWs composed of both pictures and text and covered 75% of the upper front, upper back, and two sides of smoked tobacco product packaging and the upper front, Abstract


Introduction
Tobacco usage possesses a serious threat on health. Every year, tobacco kills 24,800 Nepalese, nearly half of them prematurely, and causes the loss of 341,000 years of life. More than 3,500 of these lives lost are due to the exposure to second-hand smoke and 47% of deaths are among individuals under age 70 (NHEICC, 2019). Nearly 29% of adults aged 15-69 years (48.3% of men, 11.6% of women) use some type of tobacco. Two-thirds of people aged 15-69 years were exposed to secondhand smoke on a daily basis (Dhimal et al., 2020).
Nepal signed a World Health Organization Framework Convention on Tobacco Control (WHO FCTC) in 2003 with ratification of the convention in 2006 (UN, 2021). The Tobacco Product (Control and Regulatory) Act was passed in 2010 (GoN, 2011) with a subsequent implementation of a PHWs Directives adopted in 2011 (MOHP, 2011). PHWs composed of both pictures and text and covered 75% of the upper front, upper back, and two sides of smoked tobacco product packaging and the upper front,

Study design
This was a cross-sectional study conducted between September 2014 and March 2015 in 9 districts (Kailali, Banke, Kaski, Chitawan, Parsa, Bhaktapur, Lalitpur, Kathmandu and Morang) of Nepal. Participants of aged 13 years and above were included in the study.

Sample size
A sample size was calculated using SurveyMonkey software (https://www.surveymonkey.com/mp/ sample-size-calculator/). A population of 26.4 million was taken into account while calculating a sample size with a margin error of 2.1% at a 95% confidence level. The required sample size was 2178 individuals. We recruited a sample of 2250 participants in the study.

Sampling frame
A multistage sampling technique was developed.
Step 1: stratification was done as per the regions (FWR =Far Western Region, MWR = Mid-western Region, WR = Western Region, CR = Central Region, ER = Eastern Region) with districts and population in each region in 2014.
Step 2: districts were selected randomly from each region considering the size of the population.
Step 3: District headquarters was selected in each district purposively.
Step 4: A simple random method was used to select two public places, two shopping centers, two university campuses, two bus terminals, and three senior high schools from the list made available by the local administration of each city.
Step 5: at least 250 participants were recruited randomly from the selected venues of each district.

Data collection
A direct interview was conducted in the Nepali language by 4 trained surveyors in each district. Once participants provided verbal consent for the interview, either they were interviewed on the spot or an interview was scheduled for another day as preferred by the participants. Interviews were carried out within a week of the agreement. They were followed up by telephone. Participants from university campuses and senior high schools were interviewed on the same day in their locations. A pre-tested semi-structured questionnaire was administered. Study participants were asked whether they saw PHWs on tobacco packs. Surveyors had shown the packs with PHWs to the participants who had not seen the PHWs before. Participants were asked regarding socio-demographic characteristics (age, sex, marital status occupation and education), smoking behavior, and perceived effectiveness of PHW. The interviews took an average of 30 minutes.

Measures
Five outcome indicators were developed to measure the perceived effectiveness of PHWs. The perceived effectiveness was assessed using a 5-point Likert scale of disagreement with a set of questions where 1 = ''not effective at all'' and 5 = ''extremely effective'. Key questions included were how effective would PHWs be to motivate smokers to quit smoking? How effective would PHWs be to convince youth not to start smoking? How effective would PHWs be to re-convince ex-smokers to remain quitter? How effective would PHWs be to build public awareness of the dangers of smoking? How effective would PHWs be to scare people into the danger of smoking?
The data were analyzed using IBM SPSS version 20.0 (Statistical Package for the Social Sciences Inc. Chicago, IL, USA). Descriptive, univariate and multivariate logistic regression analyses were conducted. To avoid small cell counts, answers were recoded into the following three categories: very effective (extremely effective and very effective), effective (effective and somewhat effective) and not effective (not effective at all). For the multivariate analysis, answers were recorded using the following two categories: effective (included extremely effective, very effective and somewhat effective) and not effective (included not effective at all). The level of significance was set at P<0.05 for all analyses.

Definitions
A current smoker was defined as who smokes daily at least one cigarette per day or at least 7 cigarettes per week, an occasional smoker was defined who smokes less than one cigarette per day or less than 7 cigarettes per week. An ex-smoker was defined as a person who used to smoke daily or occasionally but had not smoked in the last 6 months, not even a puff. Never smoking was defined as a person who has never smoked, not even a puff.

Ethical statement
The study was approved by the Nepal Health Research Council. Verbal informed consent was obtained from study participants. An official approval was received from participating schools in the study. No individual identifiers were provided to individuals outside the study team. Table 1 shows the characteristics of the overall study participants and the association of the perceived effectiveness of PHWs with sub-groups of demographic characteristics. The median age of participants was 23 years. Of the 2,250 participants, 76% were males, 51.9% were students, 87% had a high school degree or above, 29.8% (670) were current smokers, and 8.6% (193) were ex-smokers. Almost all (97.6%) participants believed smoking was addictive.

Perceived effectiveness of PHWs motivating smokers to quit
PHWs were found very effective by over a quarter (26.9%) and effective by more than half (53.3%) of the participants in motivating smokers to quit (Table 1). Current smokers (aOR = 1.94, 95% CI = 1.31-2.87) and ex-smokers (aOR = 2.92, 95%CI = 2.26-3.77) were found to be more likely than those who never smoked to perceive that the PHW would be effective in motivating smokers to quit smoking (Table 3). Current smokers particularly were asked about any change in smoking behaviour due to PHW on tobacco packs. It was reported that PHW made 58% of the current smokers think to quit smoking ( Figure 1a) and made the current smokers reduce cigarettes smoked per day up to 55% (from 11 cigarettes per day to 5 cigarettes per day) after implementation of a 75% pictorial health warning (ّ ّ Figure 1b).

Perceived effectiveness of PHW in convincing youth not to start smoking
About 40% of the participants perceived that PHWs were very effective in convincing youth not to start smoking (Table 1). It was found more effective among   16-3.27) and less than primary (aOR= 2.50, 95%CI = 1.29-4.86) education compared to those with high school and above. Current smokers (aOR = 3.93, 95%CI = 2.12-7.27), ex-smokers (aOR = 2.29, 95%CI = 1.74-2.99) and participants who thought smoking was addictive (aOR 2.03, 95%CI = 1.06-3.89) were more likely to perceive the effectiveness of PHWs in convincing youth not to start smoking (Table 4). Over 90% of the youth aged 13 to 18 years reported PHW was effective in discouraging them to start smoking (figure 1d).

Perceived effectiveness of PHW in promoting public awareness
More than half (52.4%) of the respondents perceived that PHW would be very effective in promoting public awareness (Table 1). Current smokers (aOR = 6.68, 95%CI = 2.40-18.58) were 6 times and ex-smokers were 3 times (aOR = 3.63, 95%CI = 2.44-5.39) more likely to perceive that the PHWs would be effective in promoting    (Table 6).

Smokers' behaviors in purchasing cigarettes after implementation of PHW
Of the 670 current smokers, 77.8% of them purchased loose/sticks cigarettes and only 22.2% purchased a pack of cigarettes in their last purchase (Figure 1c).

Discussion
Our findings suggest that PHWs on tobacco package was perceived effective in the five following ways: i) inducing scariness; ii) convincing smokers to quit; iii) convincing youth not to take up smoking; iv) re-convincing ex-smokers to remain quitters; and v) promoting public awareness on the dangers of tobacco use among the general population. The evidence suggests that PHWs on tobacco packs are effective and they are cost-effective means of communication and information sharing at the population level.

Perceived scariness of PHWs
Without any doubt, it is evident that PHWs on tobacco packaging are effective means of communication that carries hard-hitting self-explanatory information about the health risks of smoking in any segment of the population. PHWs on cigarette packs was noticed by almost all current smokers (99.3%), 95.9% of the ex-smokers and 90.9% of the never smokers as presented in our study. The 2019 NCD STEPS survey in Nepal also showed a higher proportion (75.7%) of adults who noticed the health warning on tobacco packages (Dhimal et al., 2020). Studies published in the last decade continue to show that the introduction of stronger health warnings results in warnings being more frequently noticed and read (Scollo, et al., 2019). Our study has shown an association with the perceived scariness of PHW among current smokers, ex-smokers and people who believed smoking was addiction, which might be partly due to frequent exposure to PHW on tobacco packs, as the addiction is attributable to push smokers for frequent smoking. These results reinforce the fact that it is the first thing observed when buying the package and the last thing observed before lighting up by the smokers (Kaiserman, 1993).

Perceived effectiveness of PHW motivating smokers to quit
Our study documented that PHW would be effective to convince smokers to quit smoking. Moreover, 58% of the current smokers were found more likely to be convinced to quit smoking when they first came out in 2013. After 5 years of introduction of PHW, the findings of the 2019 NCD STEPS survey present about 45% of current tobacco users thought of quitting because of the large health warnings (Dhimal et al., 2019). PHWs appear to drop some, but not all, of their effectiveness as smokers become used to seeing the pictures on the packs. Negative emotions elicited by health warnings encourage behaviour change, promoting attention to warnings and behavioural responses that positively predict quit attempts (Scollo et al., 2019). Other published studies have shown similar results regarding the effectiveness of PHWs for educating smokers concerning the health risks of smoking and increasing smokers' knowledge concerning these health risks and motivating smokers to quit smoking (Hammond et al., 2006;Borland et al., 2009;Li and Grigg, 2009). Our study also presents that PHW made the current smokers reduce the number of cigarettes smoked per day to 5 on average compared to 11 cigarettes smoked per day before the implementation of PHW. Reports of the NCD STEPS survey also revealed almost the same data that the average number of cigarettes smoked per month per smoker was 151 that was equivalent to 5 cigarettes per day (Dhimal et al., 2019). Scollo and colleagues noted that study conducted in 2018, 52% of Australian smokers reported that the enhanced graphic health warnings introduced in 2012 made them think about quitting and a survey of 1,500 smokers conducted in Pakistan in 2014 reported 32% of smokers attempted to quit following introduction of graphic health warnings (Scollo et al., 2019). Other studies concluded that the stronger the warnings, the greater the reactions, and thus the greater the quitting activity they evoke (Borland et al., 2009). These findings demonstrated that larger pictorial health warnings are powerful in warning smokers about the danger of smoking. The warning messages with pictures are required to improve and refreshed.

Perceived effectiveness of PHW in convincing youth not to start smoking
Our findings revealed that PHW would be effective in convincing youth not to start smoking. More than 90% of the youth aged 13 to 18 years reported that PHW discouraged them to start smoking. Similar results were presented in published studies in other countries. In a national survey in the United Kingdom, 90% of youth nonsmokers reported that warnings had put them off smoking (Moodie et al, 2009). Study's findings from 27 European Union (EU) member states and Norway found that three out of ten non-smokers reported that health warnings had been effective in discouraging them from smoking (EU, 2009). Studies from Nigeria and Lebanon as reported by Scollo and colleagues suggest that PHWs would prevent youth from initiating smoking and intention to quit (Scollo et al., 2019). Published studies showed that between one-fifth and two-thirds of youth non-smokers indicated that health warnings had helped prevent them from taking up smoking in Canada and Australia (Hammond, 2011;Shanahan P., 2009). Thus, PHW is an effective tool for encouraging non-smokers, including youth, not to start smoking

Perceived effectiveness of PHWs in re-convincing ex-smokers to remain quitters
Our findings have shown that ex-smokers were more likely to report the perceived effectiveness of PHWs in re-convincing them to remain quitters suggesting that exposure to PHWs might have an increased likelihood of the awareness on health risks. A study with former smokers from Australia, Canada, the UK and the USA has shown that health warnings can reduce the odds of a smoking relapse, because they may remind former smokers of the reasons they had for quitting (Partos et al., 2012).

Perceived effectiveness of PHW in promoting public awareness
Our study has shown that the effectiveness of PHWs does not differ by age, sex, marital status, educations and occupation in building public awareness on danger of smoking, suggesting that it attributes to easier access to information available with smokers most of the time.
Published studies suggest that PHWs increase smokers' knowledge about the health hazards of tobacco smoking (Hammond et al., 2006) and they capture attention and contribute to memorizing information for a longer time (Strasser et al., 2012). PHWs are a direct and cost-effective means of communication because they reach every smoker and have a continuous impact as smokers are confronted with a warning message every time, they have a pack in their hands (Sambrook Research International, 2009). Therefore, PHWs on cigarette packages are an important means of health education and communication.

Smokers' behaviors in purchasing cigarettes after implementation of PHWs
Our study findings revealed that current smokers more likely to change their practice to purchase loose or sticks forms of cigarettes instead of a pack of cigarettes after the introduction of PHW on tobacco packs. It suggests the credibility of PHWs to make smokers scared by communicating the health risk of smoking. The findings also suggest improving tobacco control regulation to ban the sale of single stick or loose cigarettes to further strengthen the effect of PHW on tobacco packs.
Our study has several strengths. This was the first study so far conducted in Nepal to measure the effectiveness of PHWs. Almost all major cities of Nepal were included in the study, from the far west to the eastern parts of Nepal.
The key questions included in the questionnaire have been already used in other countries such as Myanmar, Indonesia, and Cambodia. The study does, however, have some possible limitations. Information was largely obtained through interviews, and there might be some recall bias in the responses. The introduction of a PHW is a new intervention in Nepal. Participants might have responded to the effectiveness of a PHW with enthusiasm, which might have led to overestimating the effect.
In conclusion, Tobacco Control Act 2010, which included PHWs as one of the key measures to reduce tobacco-related morbidity and mortality in Nepal. The evidence presented in this study demonstrated that PHWs are effective in building public awareness, motivating smokers to build quit intentions, convincing youth not to start smoking, and re-convincing ex-smokers to remain quitters. The preliminary results of the study inspired the Ministry of Health and Population to make extraordinary progress in increasing the size of PHW from 75% to 90% with effective in June 2015 (MOHP, 2014). Further in 2016, the study results contributed to the Government of Nepal to release an enforcement notification of article 11 (4) of the tobacco control law 2010 regarding the ban of selling single sticks of cigarettes, cigars and bidi. Our study strongly suggests that larger PHWs on the cigarette packs would have larger visibility, credibility and the ability to convey the right messages directly to the right people at right time. PHWs are more likely to create cessation, prevent the initiation of smoking in youth and prevent relapse in ex-smokers. Therefore, PHWs are one of the best-buys recommended by WHO that contribute to reducing tobacco use.