Overview of current legislation, experiences and existing scenarios on allowing the sale of tobacco products only in tobacco stores: a scoping review protocol

This article presents the scoping review protocol on allowing the sale of tobacco products only in tobacco stores in Brazil. It is based on the hypothesis that limiting the sale of tobacco products only in tobacco shops would significantly prevent initiation and encourage cessation, thus reducing smoking prevalence and passive smoking in Brazil. The protocol aims to document the processes involved in the planning and methodological approach of an extensive scoping review, guided by Joanna Briggs Institute’s manual. The review protocol was prepared following PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. It was registered in the Open Science Framework.


Introduction
The present study aimed to allow the sale of tobacco products only in tobacco shops in Brazil. Smoking is recognized as a chronic disease caused by nicotine dependence present in tobacco products. According to the International Statistical Classification of Diseases and Related Health Problems 10 th Revision (ICD-10), smoking is part of the group of mental and behavioral disorders due to the use of a psychoactive substance (WHO, 1997). In addition, it is also considered the most significant preventable isolated cause of illness and early deaths worldwide (Drope et al., 2018).
The World Health Organization (WHO) points out that tobacco kills more than 8 million people a year. More than 7 million of these deaths result from direct use of this product, while about 1.2 million are the result of non-smokers exposed to secondhand smoke. WHO also says that about 80% of the world's more than one billion smokers live in low-and middle-income countries where the burden of tobacco-related diseases and deaths is higher (WHO, 2019a).
In Brazil, 443 people die each day from smoking, which corresponds to 161,853 avoidable deaths per year, of which: 37,686 correspond to Chronic Obstructive Pulmonary Disease, 33,179 to heart diseases, 25,683 to other cancers, 24,443 to lung cancer, 18,620 to passive smoking and other causes, 12,201 to pneumonia, and 10,041 to stroke. R$125.15 billion are some of the direct and indirect costs related to the damage caused by the consumption of tobacco products, including cigarettes, to the health system and the economy (IECS, 2020).
The prevalence of current tobacco product users was 12.8% (20.4 million people) in 2019, according to the National Health Survey (2019). In 2013, this percentage was 14.9%. The 2019 data indicate a higher consumption in males (16.2%) than in females (9.8%), and in 2013 the percentages were, respectively, 19.1% and 11.2%. The total percentage of passive smokers at home in 2019 was 9.2% -10.2% among women and 7.9% among men.
According to the Surveillance of Risk and Protective Factors for Chronic Diseases by Telephone Survey (VIGITEL,2019), the frequency of adult smokers was 9.8% in all 27 state capital cities. The results from the latest surveys indicate a 37.6% drop in smoking in Brazil in 14 years.
WHO considers smoking a pediatric disease because most adult smokers started smoking before they were nineteen years old (World Health Organization, 2019b).
The 2019 National School Health Survey (PeNSE) revealed that the experimentation of cigarettes among school children aged 13 to 17 years old, who had smoked cigarettes at some point in their lives, was 22.6%. This indicator was equivalent concerning gender: 22.5% in boys and 22.6% in girls. Regarding students aged 13 to 15 years old, who had tried cigarettes at some point in their lives, the percentage was 15.6% among boys and 18.4% among girls (IBGE, 2021).
There are millions of children among passive smokers worldwide. Exposure to environmental tobacco smoke causes premature delivery, low birth weight, sudden death syndrome in childhood, acute lower respiratory tract infections, asthma exacerbation, chronic respiratory syndromes in childhood, eye and nose irritation, and ear infections. Pregnant women exposed to passive smoking are at a higher risk of stillbirth and congenital malformation (INCA, 2021a).
Numerous factors in society contribute to smoking initiation. Among them are: the diversity of tobacco product points of sale that facilitates access to the products, points of sale near schools, retail sales, sales to minors, presence of an illegal tobacco market, the absence of plain packaging, the wide variety of nicotine delivery products, behavior models (influencers, parents or guardians, relatives and professionals living with children, adolescents and young people), and the low product price -Brazil has the fifth-lowest price for the best-selling brand pack of 20 cigarettes in the Region of the Americas (PAHO, 2018).
It should also be emphasized that advances in tobacco product advertising and promotion in electronic and social media facilitate experimentation and promote initiation. A high volume of illegal tobacco product sales in digital media also contributes to adolescents and young people trying the products (INCA, 2021b).
In Brazil, Federal Law No. 8,069/1990 implements the Statute of Children and Adolescents and states in its art. 81 that it is forbidden to sell products whose components may cause physical or psychic dependence, even if due to misuse, to children or adolescents. Another significant advance came with Federal Law No. 9,294/1996, which banned the sale of these products to people under eighteen years old. The Brazilian Internal Revenue Service, in its Normative Act No. 1,204/2011, determines that cigarettes sales and their exposure to purchase in the country will be made exclusively in packs containing twenty units, not allowing the sale of single cigarettes (BRASIL, 2011).
The Collegiate Board Resolution (RDC) No. 558 issued on August 30, 2021, by the Brazilian Health Regulatory Agency (ANVISA) also represents a strengthening to the protection of children and adolescents, once it highlights that tobacco product sales will only be allowed in their original packaging, intended for the final consumer, and not as single cigarettes. It is known that single cigarette sale contributes to the initiation promotion. The resolution also determines that points of sale must be located inside commercial establishments.
Social media has achieved great popularity among adolescents and young adults. So, the tobacco industry, aware of this, has created several strategies to promote and sell their products, especially electronic smoking devices. Experimentation is the first step towards future regular consumption of tobacco products (Szklo et al., 2020).
Faced with the challenges imposed, it was verified the opportunity to carry out a comprehensive search of papers related to tobacco product sales to know and systematize the knowledge about the possible favorable or limiting aspects of easy access to such products.
The study aimed to analyze the current legislation, experiences, and existing scenarios on allowing tobacco product sales only in tobacco shops. It is hypothesized that reducing and restricting tobacco product points of sale may be one of the measures that would contribute to the prevention of smoking initiation by children, adolescents and, young adults.
Thus, as Joanna Briggs Institute's methodological guidelines recommend, the scoping review's first stage consists of elaborating the protocol. Before starting the review, this protocol was developed to reduce biases on study screening and data extraction, make the process consistent and homogeneous among reviewers, ensure technical rigor, and allow reproducibility of its steps (Peters et al., 2020;Tricco et al., 2018).
Based on these considerations, the protocol aims to present and describe the structure of the previously planned steps that led to the development of a scoping review. Its objective is to analyze the current legislation, experiences, and existing scenarios on allowing tobacco product sales only in tobacco shops.

Type of study
To undertake the study, a scoping review protocol was elaborated using the PRISMA Checklist and Explanation structure. Its theoretical precepts include six methodological steps established for a scoping review: identifying the research question; identifying relevant studies; study selection; charting the data; collating, summarizing, and reporting the results; and A scoping review can be used to map key concepts in a research field, clarify working definitions and conceptual Research, Society and Development, v. 10, n. 16, e402101621884, 2021 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v10i16.21884 4 boundaries of a topic, summarize the evidence, and inform future research (Tricco et al., 2018;Peters et al., 2020).
The protocol preparation is essential to assist reviewers in the planning, organization, and development phases. Thus, the description of the entire process helps the result consistency and ensures the study reproducibility. The protocol was registered in the Open Science Framework (doi:10.17605/OSF. IO/EA4C9) to ensure the visibility and transparency of the process.
The proposed review was conducted according to the JBI methodology for scoping reviews (Peters et al., 2020).
Its general objective was to analyze current legislation, experiences, and existing scenarios on allowing tobacco product sale only in tobacco shops to obtain an overview of the current state of knowledge.
The specific review's objectives were: (phase 1) map papers on existing experiences and scenarios on allowing tobacco product sales only in tobacco shops globally; (phase 2) map legislation on existing experiences and scenarios on allowing tobacco product sales only in tobacco shops in 33 pre-selected countries.

Phase 1: Mapping papers on existing experiences and scenarios on allowing tobacco product sales only in tobacco shops globally
As proposed by JBI, the framework Population, Context, and Concept (PCC) was used to define the study question.
Thus, the following determinants to the study interest were defined: Population (P)papers and legislation on allowing tobacco product sale only in tobacco shops; Concept (C)successful international experiences on allowing tobacco product sale only in tobacco shops; and Context (C)global.
From these components, the following questions were elaborated: a) What are the topics related to allowing tobacco product sale only in tobacco shops? b) What is the approach described in the papers related to the study type and place? c) What strategies have been adopted by the tobacco industry to make it impossible to regulate sales in tobacco shops? d) What are the possible conflicts of interest identified in the papers?

Identification of studies
For each PCC framework item, a set of descriptors available in the Descritores em Ciências da Saúde (DeCS) and the Medical Subject Headings (MeSH) was selected.
The search strategy was elaborated through the combination of DeCS and MeSH terms (chart 1). It was based on the PCC framework, considered the application of boolean operators AND/E, OR/OU, and the crossing of descriptors. These were adapted considering the system language and particularities in the following databases:

Study Selection
The document selection was developed in three stages: initially, the title and abstract were read to include studies that address the research objective; then, the selected studies were read in full, and their reference list were scanned to capture and include studies that were not retrieved at the time of the search in the selected databases; finally, we carried out a complete reading of the included articles to highlight and summarize the information that addresses the review's objective (chart 3).
Chart 3. Study screening form, according to inclusion and exclusion criteria.

Inclusion criteria
Articles by Parties to the WHO FCTC Free full-text articles available online Government articles Articles in the Portuguese, English, and Spanish Studies published from January (2005) to December (2020) Case report and expert opinion studies Comparative studies on health policies between Brazil and other countries Exclusion criteria Studies that are out of the study objective Studies in editorial format, letter to the editor, and theoretical essays Source: Authors (2021).

Data extraction
A pre-defined charting form was elaborated with basic bibliographic information, study characteristics, and information that could connect them to the review's objective (phase 1) for subsequent analysis and synthesis of the recovered documents.
The form was fulfilled independently by the reviewers. The questions and doubts about the extractions were addressed by consensus between the two leading reviewers and, when not resolved, they were discussed with the activity supervisor. The information collected in the extraction phase was stored in an electronic database created in the Microsoft Excel for Windows program® 2019.

Phase 2: Mapping legislation on existing experiences and scenarios on allowing tobacco product sale only in tobacco shops in 33 pre-selected countries
Three premises were defined to select countries where we mapped the legislation on experiences and existing scenarios on allowing tobacco product sale only in tobacco shops.

Data extraction
A pre-defined charting form was elaborated with essential information to connect them to the review's objective (phase 2) for subsequent analysis and synthesis of the recovered documents. The form was fulfilled independently by the reviewers.
The questions and doubts about the extractions were addressed by consensus between the two leading reviewers and, when not resolved, they were discussed with the activity supervisor.
Chart 7. Data extraction form to make up the table with country information.

Restriction at points of sale and sales on the internet Promotion and advertising restrictions
Name of the selected country Information whether the country is a Party to FCTC and has ratified it Minimum age for purchasing tobacco products Information on restrictions at points sales and sales on the internet Information on promotion and advertising restrictions Source: Authors (2021).
The information collected in the extraction phase was stored in an electronic database created in the Microsoft Excel for Windows program® 2019.

Limitations
A challenge in the scoping review preparation was to analyze the official documents from the 33 selected countries.
Papers written in more than 20 languages were analyzed (Greek, Hungarian, Mandarin, German, Latvian, Slovak, Polish, French, Estonian, Lithuanian, Italian, Hebrew, Irish, Slovene, Japanese, Arabic, Spanish, and Turkish). When we did not find the document in English, it was necessary to use free translation programs to help with the interaction.

Data charting and analysis
The data extraction stage or charting consists of the organization, analysis, and interpretation of all data to elaborate a summary of the results that addresses the review's objective and the questions that guide it.

Ethical aspects
This study's prior approval by an ethics committee was not required once it used publicly available bibliographic information, documents, and legislation and did not involve human research. Moreover, the authors of this review are not linked to funding institutions that may characterize potential conflicts of interest.

Final Considerations
This protocol aims to describe and systematize the methodological steps for conducting a scoping review of current papers, legislation, experiences, and existing scenarios on allowing tobacco product sales only in tobacco stores, reducing biases in the papers' search and selection and defining clear and uniform criteria to be used by reviewers. It is also noteworthy that this scoping review data will support the development of arguments and information to a set of evidence-based recommendations to improve tobacco control policies on the restriction at points of sale.