PONE-D-23-33682

Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Porous Borders; the Case of Ethiopian side of Ethiopia-Sudan-Eritrea corridor.

PLOS ONE

Dear Dr. Ashenef,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we have decided that your manuscript does not meet our criteria for publication and must therefore be rejected.

Specifically:

1-Please provide rational of selecting the sample sites. How and why you select the sites? Detail methodology is mandatory.

2-Inside experimental, Please write two headings 1) Instrumentation 2) Chemicals. Provide the source of all items and % purity of chemical used. Please provide details on the validation of instrument. Yes or No. If Yes then who validated the instruments? line 129-144 has been written poorly and several source missing. Kindly read quality manuscript on how to write the details. The source details are mandatory. The country name is not enough to justify.

3- The study design is missing such as sampling methodology, sample size calculation. The current methodology need to improve before we procced. Include the heading of study design and explain each items.

4- The experimental details with reference were missing such as Assay methods.

5- There is no rational on the selection of the United States Pharmacopoeia 2020? Why? It is necessary to provide the details. There is no sampling methodology, we do not know the product follow which standard (BP/USP). We cannot generalized the results on one standard. 

I am sorry that we cannot be more positive on this occasion, but hope that you appreciate the reasons for this decision.

Kind regards,

Muhammad Shahzad Aslam, Ph.D.,M.Phil., Pharm-D

Academic Editor

PLOS ONE

Additional Editor Comments:

1-Please provide rational of selecting the sample sites. How and why you select the sites? Detail methodology is mandatory.

2-Inside experimental, Please write two headings 1) Instrumentation 2) Chemicals. Provide the source of all items and % purity of chemical used. Please provide details on the validation of instrument. Yes or No. If Yes then who validated the instruments? line 129-144 has been written poorly and several source missing. Kindly read quality manuscript on how to write the details. The source details are mandatory. The country name is not enough to justify.

3- The study design is missing such as sampling methodology, sample size calculation. The current methodology need to improve before we procced. Include the heading of study design and explain each items.

4- The experimental details with reference were missing such as Assay methods.

5- There is no rational on the selection of the United States Pharmacopoeia 2020? Why? It is necessary to provide the details. There is no sampling methodology, we do not know the product follow which standard (BP/USP). We cannot generalized the results on one standard.

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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For journal use only: PONEDEC3

PONE-D-23-33682R1Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Porous Borders; the Case of Ethiopian side of Ethiopia-Sudan-Eritrea corridor.PLOS ONE

Dear Dr. Ayenew Ashenef,

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.

Please submit your revised manuscript by April 25, 2024. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Obed Kwabena Offe Amponsah, PharmD, Ph.D.

Academic Editor

PLOS ONE

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“We want to thank EFDA for their permission to do the work in their medicine quality control laboratory. Addis Ababa University graduate thesis work support to TD and the Ministry of Innovation and Technology, government of Ethiopia to AA funded this study.”

We note that you have provided additional information within the Acknowledgements Section that is not currently declared in your Funding Statement. Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form.

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

‘Addis Ababa University to TD Ministry of Innovation and technology, government of Ethiopia to AA.”

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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: (No Response)

Reviewer #2: (No Response)

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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: Partly

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #2: N/A

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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: (No Response)

Reviewer #2: Yes

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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

Reviewer #2: Yes

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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: Reviewer comments (PONE-D-23-33682R1)

General comments

• The Authors are appreciated for using an ISO 17025 qualified laboratory for conducting the quality test.

• There are grammatical errors and punctuation marks that need to be addressed throughout the manuscript and I recommend proof-reading of the manuscript again.

• Use terms consistently throughout the manuscript. For example the words medicine Vs drug, falsified Vs counterfeit. Better to remove the word counterfeit from the article.

• Contesting/disputing issues such as locations, administrative demarcation on the study area, or use of unofficial demarcation of territories in scientific studies is not encouraged. Better to be silent or indicate in neutral way.

• The National Regulatory Authority in Ethiopia has a guideline for PMS including data collection; did you use that or any other model for your study? Describe this.

Specific comments

1. Title of the study (line 1-2)

• Delete the phrase ‘’Ethiopia side of’’.

• Replace ; by :

• Rephrased title: Post-marketing Quality Surveillance of Selected Antibacterials Marketed in Porous Borders: the Case of Ethiopia-Sudan-Eritrea border.

Abstract (lines 25-51)

• Though the abstract contains all the contents, it is good to structure it into background, objectives, Methods, Results and Conclusions.

• Better to replace the phrase ‘low-quality medicines’ to poor-quality medicines’

• Line 31, delete corridor

• Lines 35-36, use the correct name (i.e. replace electronic registration Information system(ERIS) database by Electronic Regulatory Information System (eRIS).

• Line 38 reads as 15.49% (11/71) were registered but the license period had expired. Have you checked the current application status in the eRIS? This comment also applies to the result section.

• Line 47, do you think the conclusion is appropriate. During the study period, there was war/conflict in the area which might be open for illegal distribution of medicines. It is wise to adjust the conclusion considering the situation.

 

Introduction

• The introduction has coherence problem. Some concepts that are not aligned with this study (example disease burden) should be removed. The justification should also be stated in one paragraph. It should not be stated here and there (lines 84-85, line 97…, line 99 ,,,, etc.

• Lines 72-73, proper regulation includes both continuous post-marketing surveillance, and fast regulatory actions. Either delete both continuous post-marketing surveillance and fast regulatory actions or focus on ‘post-marketing surveillance’.

• Lines 75-77 states about the burden of infectious disease. This is another concept which does not align with the research objective. You can mention it as a problem that can be exacerbated by substandard and falsified products.

• Lines 81-85; care should be taken here. 1). Are you sure about the absence of comprehensive evaluation of basic regulatory functions, 2). I do not think, it is worthy to mention about maturity level in this study. Better to remove lines 81-83. Line 84 and 85 are enough to justify for your study.

• Line 87, replace with national drug policy or use the correct name.

• Align lines 81-82, and the last paragraph of the introduction section.

• Lines 90-94, better to indicate in the method section

• Seriously review lines 98-104 - repetition of terms and concepts.

• Line 107 is repetition. It is stated earlier in the introduction section

Methods and Materials

• Properly describe the method section

• Line 117: Both zones are located in the Amhara regional state of Ethiopia. This is a contesting issue. Better to to remove.

• From the 114 health institutions available, how many of them did you include in the data collection process? Please, make it clear.

• What is your sample size and how do you calculate it? The authors should clarify and describe it.

• Sampling procedure is not clearly outlined. How do you select your sampling sites from the existing sites? In addition, describe your inclusion and exclusion criteria for both the medicines to be collected and the sampling sites?

• The authors should describe the sampling technique.

• Line 160, correct it as commented earlier.

• Line 230: describe why the authors use excel sheet for the data management and analysis?

Results and discussion

• Line 257: do you think, the reason is weak regulation during release at the port? The illegal medicines might enter to the country through other channels which were unknown to the regulatory authority. Instead of using the word release, it is better to use enter or crossing the border.

• Line 259: It is a concerning issue for the Ethiopian Medicine Regulatory Agency (MRA). Does this statement value to your results and discussion? Better to remove it.

• In your results and discussion, it is wise to remove the use of falsified medicines. The authors did not encounter falsified medicines. Example line 263.

• Lines 261-263, better remove it. It is known and practiced that if this illegal practice is known or encountered by the authority, strict actions has been taken.

• Line 268: only 7.89% (3/38) of the imported samples were not registered. What if these three products are authorized by the authority though they are not register? In Ethiopian law, there are circumstances that unregistered but authorized medicine may enter to the market of Ethiopia. Example donation. The Authors should consider the circumstances that are allowed by the Ethiopian law or you need to review the laws and reviser your results about the issue of registration of medicines. This also include for the locally produced medicines.

• For the samples failed to meet the standards in the identification, assay, disillusion, disintegration, etc., tests; what is the reason behind for the failure? It is good to indicate the possible reasons (i.e. failure of manufacturing, storage, transportation, or other reasons).

Conclusions

• Line 388: make it conclusions

• Lines 389-392: already stated in the result section. Adjust the conclusions accordingly.

• Line 393: replace the regulatory authority (EFDA) by the Ethiopian Food and Drug Authority and the region regulatory bodies

Reviewer #2: The introduction is well written and states clearly the matter at hand.

Method

The materials and methods used have been well elaborated

Results and Discussion

Visual inspection

"Hence, it had to strengthen the regulation system, especially in the prone areas where the study sites are located"

Consider changing had to has

For most of the subsections under results and discussion they appear to be only results. Please consider discussing the subheadings as well.

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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

Reviewer #2: No

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Attachments

Attachment

Submitted filename: Reviewer comments (PONE-D-23-33682_R1).docx

PONE-D-23-33682R2Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Porous Borders; the case of Ethiopia-Sudan-Eritrea border.PLOS ONE

Dear Dr. Ashenef,

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.

Please see the reviewer comments on updating the references as well as checking for topographical and grammar errors in the manuscript. If possible, I would recommend using an English grammar service to address this if you desire. Please pay attention to the reviewer comments to further improve the manuscript. Thank you for the effort put into making this manuscript a more improved version of the initial submission.

Please submit your revised manuscript by Aug 22 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Obed Kwabena Offe Amponsah, PharmD, Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments (if provided):

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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

Reviewer #2: All comments have been addressed

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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

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

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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

Reviewer #2: Yes

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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

Reviewer #2: Yes

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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: All comments are addressed as per the recommendation. The authors should still conduct topographic and grammatical checks. It is worth to mention one important issues to be addressed. No falsified medicine was encountered during the assessment and it is good to indicate this in the result and conclusion part of the manuscript.

Reviewer #2: The manuscript looks better now.

However, some of your references are rather too old.

Reference 1 although very old appears to support a historic fact and this is allowed.

References 8, 9 and 11 however are over 10 years old and do not accurately reflect currents status of the situations as cited in the manuscript. In most of these cases recent literature are available, consider replacing or citing alongside more recent literature.

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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: No

Reviewer #2: No

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[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Porous Borders; the case of Ethiopia-Sudan-Eritrea border.

PONE-D-23-33682R3

Dear Dr. Ashenef,

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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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.

Please ensure to remove the word "that" from line 392 in the conclusion during the proof stage.

Kind regards,

Obed Kwabena Offe Amponsah, PharmD, Ph.D.

Academic Editor

PLOS ONE