Prevalence of unqualified sources of antimalarial drug prescription for children under the age of five: A study in 19 low- and middle-income countries

Md Sabbir Hossain; Talha Sheikh Ahmed; Mohammad Anamul Haque; Muhammad Abdul Baker Chowdhury; Md Jamal Uddin

doi:10.1371/journal.pone.0300347

Peer Review History

Original SubmissionAugust 27, 2023
20 Nov 2023 Decision Letter - Sylla Thiam, Editor PONE-D-23-27254Prevalence of unqualified sources of antimalarial drug prescription for children under the age of five: a study in 19 low- and middle-income countriesPLOS ONE Dear Dr. Uddin, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== ACADEMIC EDITOR: The paper provides useful informations that will improve MIS data collection and analysis and their use to improve malaria control and elimination strategies. However the paper needs to be reworked by taking into account the following comments in addition to reviewer's comments ============================== Please submit your revised manuscript by Jan 04 2024 11:59PM. 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Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Methods - Even though the MIS received ethical clearance in the respective countries. It would have been good for the researchers to seek for an ethical clearance from their own institution - The reasons given by the authors on the absence of information related to « non response » is too light. Because translation could be used to translate documents in english and access to key information. Results: Suggest to improve the countries map by comparing the malaria patterns and the antimalaria prescriptions maps by country Discussion: This sentence is repeated twice in two successive paragraphs « Regulatory bodies in the country lack the necessary power to effectively control drug pricing or curb the excessive usage of generic medicines. As a result, the availability of generic drugs is limited, leading to a significant markup in prices » [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? 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Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: General comments The authors should edit number in table 1 and Figure 1 and rework the discussion to focus it according the goal of this study. The authors also should make more effort to summarize the sections to reduce the number of pages. I appreciated this article because of its originality and recommended its publication provided the authors will do the revision according our comments. Abstract Background Antimalarial resistance poses a severe danger to global health. add drug resistance Findings About 60% instead 40% Introduction Introduction must be more focus with the tittle: First describe malaria situation around the world emphasizing the part of children under five on malaria cases and death, the strategies of malaria diagnostic and treatment, the availability of the diagnostic tools and antimalarial drug and the drug resistance management plan. The second section of the introduction must talk about the justification that unqualified treatments is significantly identified and will need to better documented to understand the causes and the possible effects including the threat in malaria drug resistance. Methods Methods have been well described according data sources, sampling methods and data analyses. Some inputs to take into account related to the narrative: Data Gap Analysis on Antimalarial Prescriptions. In the future, surveys will be able to follow kids both throughout the cascade and after their treatment is finished to assess the outcomes of the causality of the child's quality of malaria care. This sentence must be moved to the Conclusion section Results Descriptives Analysis Decimals must be broken into whole numbers in figure 1 and in the narrative. Total in table 1 for each column doesn’t match with what we have in the text and in figure 1. Had Fever Recently Antimalarial taken for Malaria Antimalarial taken from Qualified Sources, Total 29480 11171 7522 In the narrative 29 478 9477 7511 Males make up 54035.8 of them, or 50.9%, while females make up 5229.2, or 48.1%. Not found nor in table 1 neither in Figure 1 Country Descriptives Page 17. In this section, we presented the region-wise prevalence of five countries with the highest antimalarial prescriptions from qualified sources for recent malarial fever in children under five. This section must be more summarized as it is expected that there would not be a big difference between zones. Discussion P 14. The reasons for the high percentages of qualified prescriptions of antimalarial for recent malarial fever in children under five across the LMICs are manifold…….. P 22. Several studies highlight the shortcomings of ostensibly straightforward approaches (such as fever charts or RDTs) to properly manage fevers and drug usage at the community level45,46,47 . To be deleted and focus must in Africa, about malaria prescription and malaria drug consumption in children under five. Below this section, from ‘’Moreover, several studies that found various factors that influence high rates of qualified prescriptions are insufficient diagnostic services, a lack of antibiotic guidelines, difficulty in monitoring patient progress, unsatisfactory intensive care facilities in rural areas, patient demand for immediate relief, apparent patient anticipations from prior prescriptions, using up production, and apprehension about losing patients to competition’’, this is appreciated to be in the discussion. The discussion must be reworked to follow the different points: • Had Fever Recently, • Antimalarial taken for Malaria • Antimalarial taken from Qualified Sources I putsome aspects that would be taken into account in the discussion et recommendations. Antimalarial taken for Malaria Discussion For the high percentages, it will be necessary to ascertain whether they are suspected or confirmed cases. If suspected, are there national guidelines for the diagnosis and treatment of malaria? If so, why are they not respected? If not, what are the constraints for having the guidelines? If malaria is confirmed, does the low-test positivity rate justify the low percentages of antimalarial drug use? Recommendations Make available guidelines for the management of malaria cases and their application Require confirmation of malaria cases before prescribing antimalarials Antimalarial taken from Qualified Sources Discussion For the low, it will be necessary to try to find the main causes for each country concerned. Assessment of the level of knowledge of malaria by the population and the control interventions? Are there communication strategies for early use of health facilities? Are inputs for malaria diagnosis and treatment available and accessible? Level of collaboration between traditional practitioners and the Ministry of Health? Recommendations Strengthen communication regarding the use of the nearest health facilities. Implement sustainable strategies capable of counteracting non-compliant treatment causes. Make available and permanent diagnostic inputs and medicines for the treatment of malaria cases. Making health care delivery points accessible ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. 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Revision 1
11 Feb 2024 Author Response Review Responses Review Comments to the Author Reviewer #1: General comments The authors should edit number in table 1 and Figure 1 and rework the discussion to focus it according to the goal of this study. The authors also should make more effort to summarize the sections to reduce the number of pages. I appreciated this article because of its originality and recommended its publication provided the authors will do the revision according to our comments. Response: We express our gratitude to the reviewers for their invaluable feedback aimed at enhancing the quality of our research. In response to their comments, we have made the necessary updates to Table 1 and Figure 1. Additionally, as per their suggestions, the discussion section has undergone a thorough revision to provide a more concise and summarized overview. Abstract Background Antimalarial resistance poses a severe danger to global health. add drug resistance. Response: We have revised the abstract accordingly on lines: 27 and page: 2. “Antimalarial drug resistance poses a severe danger to global health.” Findings About 60% instead 40% Response: We have revised the abstract accordingly on lines: 42 and page: 2. “In several LMICs (Tanzania, Nigeria, and Ghana), a substantial portion of recent antimalarial prescriptions for malaria was taken from unqualified sources (about 60%).” Introduction Introduction must be more focus with the tittle: First describe malaria situation around the world emphasizing the part of children under five on malaria cases and death, the strategies of malaria diagnostic and treatment, the availability of the diagnostic tools and antimalarial drug and the drug resistance management plan. The second section of the introduction must talk about the justification that unqualified treatments is significantly identified and will need to better documented to understand the causes and the possible effects including the threat in malaria drug resistance. Response: We have revised the introduction following the suggestions provided by the reviewer on lines: 57-141 and pages 3-5. Methods Methods have been well described according to data sources, sampling methods and data analyses. Some inputs to take into account related to the narrative: Data Gap Analysis on Antimalarial Prescriptions. In the future, surveys will be able to follow kids both throughout the cascade and after their treatment is finished to assess the outcomes of the causality of the child's quality of malaria care. This sentence must be moved to the Conclusion section. Response: Thank you for your comments. We moved the sentence “In the future, surveys will be able to follow kids both throughout the cascade and after their treatment is finished to assess the outcomes of the causality of the child's quality of malaria care.” to the conclusion section. Results Descriptives Analysis Decimals must be broken into whole numbers in figure 1 and in the narrative. Total in table 1 for each column doesn’t match with what we have in the text and in figure 1. Had Fever Recently Antimalarial taken for Malaria Antimalarial taken from Qualified Sources, Total 29480 11171 7522 In the narrative 29 478 9477 7511 Males make up 54035.8 of them, or 50.9%, while females make up 5229.2, or 48.1%. Not found nor in table 1 neither in Figure 1 Response: We updated the text and Figure 1 accordingly on lines:266-272 and pages:10. Country Descriptives Page 17. In this section, we presented the region-wise prevalence of five countries with the highest antimalarial prescriptions from qualified sources for recent malarial fever in children under five. This section must be more summarized as it is expected that there would not be a big difference between zones. Response: We have summarized this section on lines: 293-233 and pages:10-13. Discussion P 14. The reasons for the high percentages of qualified prescriptions of antimalarial for recent malarial fever in children under five across the LMICs are manifold…….. P 22. Several studies highlight the shortcomings of ostensibly straightforward approaches (such as fever charts or RDTs) to properly manage fevers and drug usage at the community level45,46,47 . To be deleted and focus must in Africa, about malaria prescription and malaria drug consumption in children under five. Below this section, from ‘’Moreover, several studies that found various factors that influence high rates of qualified prescriptions are insufficient diagnostic services, a lack of antibiotic guidelines, difficulty in monitoring patient progress, unsatisfactory intensive care facilities in rural areas, patient demand for immediate relief, apparent patient anticipations from prior prescriptions, using up production, and apprehension about losing patients to competition’’, this is appreciated to be in the discussion. Response: We removed section “P14. The reasons for the high percentages of qualified prescriptions of antimalarial for recent malarial fever in children under five across the LMICs are manifold…….. P 22.”and keep from ‘’Moreover, several studies that found various factors that influence high rates of qualified prescriptions are insufficient diagnostic services, a lack of antibiotic guidelines, difficulty in monitoring patient progress, unsatisfactory intensive care facilities in rural areas, patient demand for immediate relief, apparent patient anticipations from prior prescriptions, using up production, and apprehension about losing patients to competition’’ on lines The discussion must be reworked to follow the different points: • Had Fever Recently, • Antimalarial taken for Malaria • Antimalarial taken from Qualified Sources I putsome aspects that would be taken into account in the discussion et recommendations. Antimalarial taken for Malaria Discussion For the high percentages, it will be necessary to ascertain whether they are suspected or confirmed cases. If suspected, are there national guidelines for the diagnosis and treatment of malaria? If so, why are they not respected? If not, what are the constraints for having the guidelines? If malaria is confirmed, does the low-test positivity rate justify the low percentages of antimalarial drug use? Response: We have added a section in the discussion as suggested by the reviewers on lines:515-524 and pages 19-20. “The high percentages of antimalarial prescriptions for recent malarial fever in children under five are suspected cases. It is essential to explore the existence and adherence to national guidelines for the diagnosis and treatment of malaria. Several studies have highlighted challenges in implementing guidelines, including ineffective testing, inefficient malaria care, and the administration of antimalarials without proper blood tests, potentially contributing to overprescription28-29. A study in Sub-Saharan Africa found that overprescription was linked to limited diagnostic competence, reliance on clinical symptoms, and noncompliance with treatment recommendations34. Addressing these issues is crucial to ensuring that antimalarials are prescribed judiciously, avoiding unnecessary use and potential development of resistance 18,46-47.” Recommendations Make available guidelines for the management of malaria cases and their application Require confirmation of malaria cases before prescribing antimalarials Antimalarial taken from Qualified Sources Discussion For the low, it will be necessary to try to find the main causes for each country concerned. Assessment of the level of knowledge of malaria by the population and the control interventions? Are there communication strategies for early use of health facilities? Are inputs for malaria diagnosis and treatment available and accessible? Level of collaboration between traditional practitioners and the Ministry of Health? Recommendations Strengthen communication regarding the use of the nearest health facilities. Implement sustainable strategies capable of counteracting non-compliant treatment causes. Make available and permanent diagnostic inputs and medicines for the treatment of malaria cases. Making health care delivery points accessible. Response: We adjusted the recommendation section based on the reviewer's feedback on lines:526-554 and pages: 20-21 “In Sub-Saharan African countries, it is imperative to implement a comprehensive approach for the effective management of malaria cases. Clear and updated guidelines should be developed and disseminated widely, emphasizing the importance of confirming malaria cases before prescribing antimalarials, with healthcare professionals receiving adequate training. Rigorous quality assurance measures must be in place to ensure that antimalarial medications are sourced exclusively from qualified and reputable suppliers. Understanding the root causes of malaria prevalence in each country is crucial, requiring comprehensive studies that account for regional variations. Regular assessments should be conducted to gauge the population's knowledge of malaria and the effectiveness of existing control interventions, with tailored health education programs addressing awareness gaps. Communication strategies promoting early utilization of health facilities, the availability of diagnostic tools, and collaboration with traditional practitioners are vital components. Sustainable strategies to counteract non-compliance with treatment regimens and efforts to improve healthcare delivery point accessibility, particularly in rural areas, are essential. Strengthening communication about the nearest health facilities and ensuring a reliable supply chain for diagnostic inputs and medicines are paramount for successful malaria management in the region.” Attachments Attachment Submitted filename: Response to Reviewers (1).docx https://doi.org/10.1371/journal.pone.0300347.r002
27 Feb 2024 Decision Letter - Sylla Thiam, Editor Prevalence of unqualified sources of antimalarial drug prescription for children under the age of five: a study in 19 low- and middle-income countries PONE-D-23-27254R1 Dear Dr. Uddin We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Sylla Thiam, M.D, MPH Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I confirm that all comments were taken account by the authors . My only additional comment is related to the fig 13 which must be moved as fig 2. Also in this figure the authors have to add the number of male and female. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes: Abdoulaye Diop ******** Attachments Attachment Submitted filename: Reviewer DiopA.docx https://doi.org/10.1371/journal.pone.0300347.r003
Formally Accepted
8 Mar 2024 Acceptance Letter - Sylla Thiam, Editor PONE-D-23-27254R1 PLOS ONE Dear Dr. Uddin, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Sylla Thiam Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0300347.r004

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