A Comprehensive Analysis of Legislative Strategies for New Psychoactive Substances: The Brazilian Panorama

Round 1

Reviewer 1 Report

This is an interesting account of the historical development of NPS drug control policies in Brazil, which will serve as a useful reference point for international drug control efforts in other countries. I suggest the authors spend a little more time explaining why rapid expansion of NPS presents a major public health concern, including factors such as the illicit production and lack of quality control producing substances of uncertain purity (often with addition of bulking agents) and dose/strength. I also note that section 3.4 (other substances) actually refers to opioids and benzodiazepines, an example of diverted medicines with normal medicinal use but here subverted for recreational purposes.

Minor errors: 1) Lines 101-119 are a repeat of lines 80-100; 2) Figure 1 needs an informative title.

English language is written to a high standard and needs only final checks for minor errors.

Author Response

This is an interesting account of the historical development of NPS drug control policies in Brazil, which will serve as a useful reference point for international drug control efforts in other countries. I suggest the authors spend a little more time explaining why rapid expansion of NPS presents a major public health concern, including factors such as the illicit production and lack of quality control producing substances of uncertain purity (often with addition of bulking agents) and dose/strength.

Author response:  The authors appreciate this suggestion. Information about the illegal production and lack of standardization of these substances, which may lead to several serious adverse effects, was added to this version of the manuscript in the Discussion section.

 

I also note that section 3.4 (other substances) actually refers to opioids and benzodiazepines, an example of diverted medicines with normal medicinal use but here subverted for recreational purposes.

Author response: Thanks for the comments. We understand the considerations  and we emphasize in the text an indication that in the case of fentanyl, therapeutic and legal use can be made. Moreover, we added a sentence about furanylfentanyl (fentanyl analog), without therapeutic use in Brazil, which was seized and banned in 2018. Finally, we emphasize that synthetic/designer benzodiazepines (e.g. bromazolam) have no approved therapeutic use in Brazil.

 

Minor errors: 1) Lines 101-119 are a repeat of lines 80-100;

Author response: Thanks for the correction. We apologize for the error. The final two paragraphs of section 2 were repeated and were deleted in the new version of the manuscript.

 

2) Figure 1 needs an informative title.

Author response: Thanks for the comments. We added a title for Figure 1.

Author Response File: Author Response.docx

Reviewer 2 Report

Abstract

Although the problem is understood, please state the methodology you used to perform the analysis you report.

Please add a paragraph at the end of the abstract stating your findings and conclusions after performing the analysis.

1. Introduction

Although it is implicit, the authors must indicate in some paragraphs that this research problem deserves to be studied. It mentions that controlling NPS is challenging, but I think it is not enough. I think the second paragraph could be improved by adding statistics on people who use drugs or crimes committed under their influence.

2. Overview of substance control in Brazil

Surely the laws established to control these drug types appear on the government's website. Although they are in Portuguese, adding a link to them would be good.

The two paragraphs on lines 80 to 100 are the same as those on lines 101-119.

 

3. NPS distribution and control in the Brazilian territory

This section begins by mentioning and describing the most common substances. This is fine, but I recommend discussing a little more the legislations and their strategies, as the title of the paper indicates. In reading this section, only the drugs are identified, but very little is added to the legislation in place.

Again, I suggest a link to the legislative ordinances generated in case they can be accessed through the internet.

 

Discussion

There is much discussion of drugs and their effects; however, legislative strategies are expected to be discussed. Please try to respond:

1. Have they worked or are functional?

2.  Are the institutions doing their job?

3. What opportunities for improvement exist?

4. Is society aware of them?

5. How are they made known to the general public?

 

Conclusion

 

Improve the conclusion based on the legislative strategies.

Author Response

Abstract

Although the problem is understood, please state the methodology you used to perform the analysis you report.

Author response: Thanks for the suggestion. In this version of the manuscript, this information is added to the abstract.

 

Please add a paragraph at the end of the abstract stating your findings and conclusions after performing the analysis.

Author response: We appreciate this suggestion. A phrase stating some conclusions was added to the abstract.

 

1. Introduction

 

Although it is implicit, the authors must indicate in some paragraphs that this research problem deserves to be studied. It mentions that controlling NPS is challenging, but I think it is not enough. I think the second paragraph could be improved by adding statistics on people who use drugs or crimes committed under their influence.

Author response: The authors appreciate this comment. Some information about drug related deaths are now added to this version of the manuscript. Additionally, literature data regarding cases of adverse effects and deaths involving NPS was mentioned.

 

 

2. Overview of substance control in Brazil

 

Surely the laws established to control these drug types appear on the government's website. Although they are in Portuguese, adding a link to them would be good.

Author response: Thanks for the comments. We appreciate the suggestion and have added a link to the ANVISA (Brazilian regulatory agency) website containing the documents in full in each law’s references.

 

The two paragraphs on lines 80 to 100 are the same as those on lines 101-119.

Author response: Thanks for the correction. We apologize for the error. The final two paragraphs of section 2 were repeated and were deleted in the new version of the manuscript.

 

 

3. NPS distribution and control in the Brazilian territory

 

This section begins by mentioning and describing the most common substances. This is fine, but I recommend discussing a little more the legislations and their strategies, as the title of the paper indicates. In reading this section, only the drugs are identified, but very little is added to the legislation in place.

Author response: Thanks for the suggestions. First, we appreciate your recommendation and understand the concerns about a further legislation discussion. Topic 3 (NPS distribution and control in the Brazilian territory) was included as a way to show the Brazilian scenario of NPS, which is particular to each country. We exposed the main classes present in our country and a timeline of the appearance of these substances in Brazil. The knowledge about the context of NPS appearance is essential because this is what determined the inclusion of significant substances on regulatory lists and the creation of generic legislations as control strategies, made by ANVISA. At the end of each subtopic, we emphasize how legal control of the substance/group discussed was carried out with further examples of substances regulated by the nominal list strategy and the generic chemical structures contained in the generic legislation.

 

Again, I suggest a link to the legislative ordinances generated in case they can be accessed through the internet.

Author response: Thanks for the comments. As stated earlier, we appreciate the suggestion and have added a link to the ANVISA (Brazilian regulatory agency) website containing the documents in full in each law’s references.

 

 

Discussion

 

There is much discussion of drugs and their effects; however, legislative strategies are expected to be discussed. Please try to respond:

 

1. Have they worked or are functional?
2. Are the institutions doing their job?
3. What opportunities for improvement exist?
4. Is society aware of them?
5. How are they made known to the general public?

Author response: Thanks for the suggestions. We appreciate this comment and some of the points were included in this version of the manuscript. Regarding the implemented legislative strategies, we consider them functional, following the pattern of other mentioned countries. However, some considerations about the agility of some processes such as the actualization of controlled substances in the regulation lists. This requires a large effort of several related institutions that are continuously working together as in the creation of the Substance Control Classification Workgroup, as mentioned in Topic 2. Also, institutions from all Federal States can provide information to the Early Warning System. Improvement can be made by providing all States with resources and capacitance for NPS identification and proper intoxication handling, as well as the integration of all country’s data, as already mentioned in the Discussion section. Regarding the awareness of society about these legislative strategies, we believe that this information hardly reaches the general public. Although all documents are encountered on government websites, the interface is not “user friendly” and does not capture the public's attention. Some informative and marketing strategies should be performed for a better comprehension of these issues by the population. These considerations were added to this version of the manuscript. 

 

 

Conclusion

 

Improve the conclusion based on the legislative strategies.

Author response: Thanks for the suggestions. We thank the revisor for the suggestion and we made the corrections to the text. Although the authors acknowledge a few problems with the implementation of NPS legislation in Brazil, such as the delay when compared to the arrival of some of them in the market, we believe that legislative measures in the country are quite comprehensive and that this is not the major problem. Legislative measures alone are not effective. In order to apply the legislative measure, the country's agencies first need to be able to detect the substances and simultaneously promote other prevention and education strategies, so the demand for illegal substances and consequences caused by their use decrease. Therefore, we focused on appointing some strategies of what can be made to help the situation in the conclusion of the paper.

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

Thanks for attending my comments.