Magnitude and determinants of drug-related problems among patients admitted to medical wards of southwestern Ethiopian hospitals: A multicenter prospective observational study

Firomsa Bekele; Tesfaye Tsegaye; Efrem Negash; Ginenus Fekadu

doi:10.1371/journal.pone.0248575

Peer Review History

Original SubmissionSeptember 24, 2020
8 Dec 2020 Decision Letter - M. Mahmud Khan, Editor PONE-D-20-30167 Magnitude and Determinants of Drug Related Problems among Patients Admitted to Medical wards of Ilu Ababor and Buno bedele zonal Hospital: A Multicenter Prospective Observational Study PLOS ONE Dear Dr. Bekele, 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 Jan 17 2021 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, M. Mahmud Khan Academic Editor PLOS ONE Additional Editor Comments: In addition to the reviewer's report, I have reviewed the paper and my comments are below: 1. The paper should provide more information on drugs used by patient characteristics, i.e., major drugs with problems can be cross-tabulated with age, morbidity status, etc. 2. In the introduction, authors mentioned that a significant proportion of patients get admitted to hospitals due to adverse drug events. What approach did the study follow to ensure that the patient was not admitted due to adverse drug reactions? 3. Define the drug therapy problem "Unnecessary drug therapy" and since it is quite high, is there some specific patient groups that are more likely to be affected by this? Does it indicate error in physician prescription? 4. Paper needs thorough editing and revisions. 5. Methodology should be clearly presented (see the reviewer #1 comment on this as well) Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Thank you for including your ethics statement: "Ethical clearance was obtained from the ethics review board of Mettu University. Permission was obtained from medical director of the MKH, DH and BH to access medical ward patients and conducts the study." a.Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. b.Once you have amended this/these statement(s) in the Methods section of the manuscript, please add the same text to the “Ethics Statement” field of the submission form (via “Edit Submission”). For additional information about PLOS ONE ethical requirements for human subjects research, please refer to http://journals.plos.org/plosone/s/submission-guidelines#loc-human-subjects-research. 3. 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During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published works, some of which you are an author. - https://www.jbclinpharm.org/articles/assessment-of-drug-related-problems-and-its-associated-factors-among-medical-ward-patients-in-university-of-gondar-teaching-hospit.html - https://link.springer.com/article/10.1007%2Fs11096-017-0504-9 - http://isfcppharmaspire.com/issueforpublication.aspx?Article=PHARMASPIRE_1_2017 - https://www.hindawi.com/journals/cdtp/2020/2509875/ - https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-018-3612-x https://www.research.ed.ac.uk/portal/en/publications/the-apical-protein-apnoia-interacts-with-crumbs-to-regulate-tracheal-growth-and-inflation(70776d5d-4841-4fe5-b7f9-c614328149ee).html - https://www.omicsonline.org/open-access/assessment-of-drug-related-problems-among-hypertensive-patients-2167-065X.1000122.php?aid=31481 The text that needs to be addressed involves the Background section of your manuscript. We would like to make you aware that copying extracts from previous publications, especially outside the methods section, word-for-word is unacceptable. In addition, the reproduction of text from published reports has implications for the copyright that may apply to the publications. Please revise the manuscript to rephrase the duplicated text, cite your sources, and provide details as to how the current manuscript advances on previous work. Please note that further consideration is dependent on the submission of a manuscript that addresses these concerns about the overlap in text with published work. We will carefully review your manuscript upon resubmission, so please ensure that your revision is thorough. [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No ****** 3. 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. 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(Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The manuscript needs proof reading. there are awkward sentences that are difficult to understand that can be easily fixed at a proof reading stage. For example the first sentence in the abstract is not correct. Also in many places through the manuscript words that shouldn’t be capitalized are capitalized. In many instances of importance to evaluate the manuscript rigor the provided text is missing critical information. For example the author say in the method section, it says a questionnaire was developed. But then the authors reference medical chart review. The connection between the different steps need to be further developed to allow the reader to understand what was actually done. ****** 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. 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. Attachments Attachment Submitted filename: PONE-D-20-30167_reviewer.pdf https://doi.org/10.1371/journal.pone.0248575.r001
Revision 1
6 Jan 2021 Author Response M. Mahmud Khan Editor, PLOS ONE Dear Editor in chief of the Manuscript PONE-D-20-30167 entitled " Magnitude and Determinants of Drug Related Problems among Patients Admitted to Medical wards of Ilu Ababor and Buno bedele zonal Hospital: A Multicenter Prospective Observational Study," submitted to PLOS ONE. Thanks for your time and consideration in editing and reviewing the manuscript. We have carefully read your comments and corrected inline of your comments and suggestions. All comments raised were edited and incorporated in the revised manuscript. Here are the responses and elaborations for the comments from editor and reviewer! EDITORS COMMENTS Editor comment: The paper should provide more information on drugs used by patient characteristics, i.e., major drugs with problems can be cross-tabulated with age, morbidity status, etc. Author response: In table 5 of revised manuscript most common drugs was cross tabulated with the variables like sex, residence, co-morbidity and age Editor comment: In the introduction, authors mentioned that a significant proportion of patients get admitted to hospitals due to adverse drug events. What approach did the study follow to ensure that the patient was not admitted due to adverse drug reactions? Author response: ADR was assessed by using the Naranjo algorithm of the ADR probability scale Editor comment: Define the drug therapy problem "Unnecessary drug therapy" and since it is quite high, is there some specific patient groups that are more likely to be affected by this? Does it indicate error in physician prescription? Author response: In operational definition we have added the definition and criteria of unnecessary drug therapy Editor comment: Paper needs thorough editing and revisions. Author response: The whole manuscript was edited as per your comments Editor comment: Methodology should be clearly presented (see the reviewer #1 comment on this as well) Author response: We carefully revised and edited the methodology part Editor comment: Regarding o Journal Requirements Author response: The manuscript was written as per PLOS ONE's style Editor comment: Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. Author response: The full name of the ethics committee/institutional review board(s) was written in revised manuscript and Ethics Statement” field of the submission � The written consent was be obtained � The statements showing that the Institutional Review Board (IRB) approved use of oral consent was written in revised manuscript Editor comment: We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. Author response: We have edited the English grammar throughout the manuscripts Editor comment: Regarding the data availability statement Author response: We have updated the data availability statement in which it is placed as supporting information. Editor comment: Regarding to text overlap Author response: The manuscript was paraphrased to minimize the texts overlap REVIEWER COMMENTS Reviewer 1 Reviewer comments: The conclusions must be drawn appropriately based on the data presented. Author response: The conclusion was edited to relate with data presented Reviewer comments: Regarding statistical analysis Author response: The data was re-analyzed Reviewer comments: Is the manuscript presented in an intelligible fashion and written in Standard English? Author response: We have edited the English grammar throughout the manuscripts Reviewer comments: The manuscript needs proof reading. There are awkward sentences that are difficult to understand that can be easily fixed at a proof reading stage. For example the first sentence in the abstract is not correct. Also in many places through the manuscript words that shouldn’t be capitalized are capitalized. Author response: The manuscript was edited carefully and the first sentence in the abstract was corrected. Finally any capitalization was corrected Reviewer comments: In many instances of importance to evaluate the manuscript rigor the provided text is missing critical information. For example the author say in the method section, it says a questionnaire was developed. But then the authors reference medical chart review. The connection between the different steps need to be further developed to allow the reader to understand what was actually done. Author response: It was written as data was collected using questionnaire which was developed after reviewing different literature and checklist was prepared to verify the patient’s medical information in revised manuscript Reviewer comments: Don’t capitalize the P in pharmaceutical Author response: The capitalization was removed Reviewer comments: Replace DTP by DRP Author response: In abstract under result DTP was replaced by DRP Reviewer comments: Re word A total of 331 DRPs were identified on average, 1.057 DRPs per Patient to a total of 331 DRPs were identified, an average of 1.06 DRPs per patient. Author response: It was written as per your comment Reviewer comments: This sentence doesn’t make sense. Maybe something like the three-leading categories of DRPs were found to be unnecessary (not sure unnecessary what prescription of drug or consumption of drugs) with 92 cases (27.79%), non-adherence with 57 patients (17.22%) and high drug dosage with 56 cases (16.92%). Author response: It was corrected as prescribed drugs Reviewer comments: Is the term drug therapy problem the same as DRPs? Author response: We have used them interchangeably Reviewer comments: missing reference on ADR and The connection between these two sentences is not clear.Also two sentences can’t make a paragraph you need at least 5. I think the authors are trying to convey the significance of the problem and that if 5-20% patients may lose trust in the physicians treating them. But the authors never explain why that is a bad thing or make the actual connection. Author response: The sentence regarding ADR was cited • The two sentence was connected appropriately and many references was added to explain more about DRP • We have discussed the reasons for high burden of ADR Reviewer comments: What treatment that was poorly controlled? This thought is not complete Author response: It was corrected in revised manuscript as hypertensive patient’s was poorly controlled Reviewer comments: This time frame in of concern since the pandemic really started. Wouldn’t that impact the stress of physicians and health workers. Should be addressed in the limitaitons Author response: The impact of COVID-19 on stress of physicians was written as limitation Reviewer comments: You never explain ADR Author response: ADR was assessed by using Naranjo algorithm of ADR probability scale. Accordingly, ADR Probability Scale was categorized by taking sum of 10 questions and grouped as definite, probable, possible or doubtful, if the total score is ≥9, 5-8, 1-4 and 0 respectively. Thanks for your time and consideration, Regards! Attachments Attachment Submitted filename: plose one DTP esponse letter.docx https://doi.org/10.1371/journal.pone.0248575.r002
25 Jan 2021 Decision Letter - M. Mahmud Khan, Editor PONE-D-20-30167R1 Magnitude and determinants of drug related problems among patients admitted to medical wards of south-western Ethiopian hospitals : A multicenter prospective observational Study PLOS ONE Dear Dr. Bekele, 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 Mar 11 2021 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, M. Mahmud Khan Academic Editor PLOS ONE Additional Editor Comments (if provided): Unfortunately, the paper needs thorough editing, maybe by a professional English language editor. I still find many language and expression related issues in the revised version. Without thorough editing, the paper cannot be accepted for publication. Thanks [Note: HTML markup is below. Please do not edit.] [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. https://doi.org/10.1371/journal.pone.0248575.r003
Revision 2
8 Feb 2021 Author Response M. Mahmud Khan Editor, PLOS ONE Dear Editor in chief of the Manuscript PONE-D-20-30167 entitled " Magnitude and determinants of drug-related problems among patients admitted to medical wards of south-western Ethiopian hospitals: A multicenter prospective observational study" submitted to PLOS ONE. Thanks for your time and consideration in editing and reviewing the manuscript. We have carefully read your comments and corrected inline of your comments and suggestions. All comments raised were edited and incorporated in the revised manuscript. Here are the responses and elaborations for the comments from editor and reviewer! EDITORS COMMENTS Editor comment: The paper should provide more information on drugs used by patient characteristics, i.e., major drugs with problems can be cross-tabulated with age, morbidity status, etc. Author response: In table 5 of revised manuscript most common drugs was cross tabulated with the variables like sex, residence, co-morbidity and age Editor comment: In the introduction, authors mentioned that a significant proportion of patients get admitted to hospitals due to adverse drug events. What approach did the study follow to ensure that the patient was not admitted due to adverse drug reactions? Author response: ADR was assessed by using the Naranjo algorithm of the ADR probability scale Editor comment: Define the drug therapy problem "Unnecessary drug therapy" and since it is quite high, is there some specific patient groups that are more likely to be affected by this? Does it indicate error in physician prescription? Author response: In operational definition we have added the definition and criteria of unnecessary drug therapy. Patients presents with infectious disease were highly affected by unnecessary drug therapy because in our study are ceftriaxone was used unnecessarily. Any medication error occurred during prescribing, administration and dispensing was considered as unnecessary drug therapy Editor comment: Paper needs thorough editing and revisions. Author response: The whole manuscript was edited as per your comments Editor comment: Methodology should be clearly presented (see the reviewer #1 comment on this as well) Author response: We carefully revised and edited the methodology part Editor comment: Regarding o Journal Requirements Author response: The manuscript was written as per PLOS ONE's style Editor comment: Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. Author response: The full name of the ethics committee/institutional review board(s) was written in revised manuscript and Ethics Statement” field of the submission � The written consent was be obtained � The statements showing that the Institutional Review Board (IRB) approved use of oral consent was written in revised manuscript � The oral consents was clearly documented in separate checklists Editor comment: We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. Author response: We have edited the English grammar throughout the manuscripts Editor comment: Regarding the data availability statement Author response: We have updated the data availability statement in which it is restricted Editor comment: Regarding to text overlap Author response: The manuscript was paraphrased to minimize the texts overlap REVIEWER COMMENTS Reviewer 1 Reviewer comments: The conclusions must be drawn appropriately based on the data presented. Author response: The conclusion was edited to relate with data presented Reviewer comments: Regarding statistical analysis Author response: The data was re-analyzed Reviewer comments: Is the manuscript presented in an intelligible fashion and written in Standard English? Author response: We have edited the English grammar throughout the manuscripts Reviewer comments: The manuscript needs proof reading. There are awkward sentences that are difficult to understand that can be easily fixed at a proof reading stage. For example the first sentence in the abstract is not correct. Also in many places through the manuscript words that shouldn’t be capitalized are capitalized. Author response: The manuscript was edited carefully and the first sentence in the abstract was corrected. Finally any capitalization was corrected Reviewer comments: In many instances of importance to evaluate the manuscript rigor the provided text is missing critical information. For example the author say in the method section, it says a questionnaire was developed. But then the authors reference medical chart review. The connection between the different steps need to be further developed to allow the reader to understand what was actually done. Author response: It was written as data was collected using questionnaire which was developed after reviewing different literature and checklist was prepared to verify the patient’s medical information in revised manuscript Reviewer comments: Don’t capitalize the P in pharmaceutical Author response: The capitalization was removed Reviewer comments: Replace DTP by DRP Author response: In abstract under result DTP was replaced by DRP Reviewer comments: Re word A total of 331 DRPs were identified on average, 1.057 DRPs per Patient to a total of 331 DRPs were identified, an average of 1.06 DRPs per patient. Author response: It was written as per your comment Reviewer comments: This sentence doesn’t make sense. Maybe something like the three-leading categories of DRPs were found to be unnecessary (not sure unnecessary what prescription of drug or consumption of drugs) with 92 cases (27.79%), non-adherence with 57 patients (17.22%) and high drug dosage with 56 cases (16.92%). Author response: It was corrected as prescribed drugs Reviewer comments: Is the term drug therapy problem the same as DRPs? Author response: We have used them interchangeably Reviewer comments: missing reference on ADR and The connection between these two sentences is not clear.Also two sentences can’t make a paragraph you need at least 5. I think the authors are trying to convey the significance of the problem and that if 5-20% patients may lose trust in the physicians treating them. But the authors never explain why that is a bad thing or make the actual connection. Author response: The sentence regarding ADR was cited • The two sentence was connected appropriately and many references was added to explain more about DRP • We have discussed the reasons for high burden of ADR Reviewer comments: What treatment that was poorly controlled? This thought is not complete Author response: It was corrected in revised manuscript as hypertensive patient’s was poorly controlled Reviewer comments: This time frame in of concern since the pandemic really started. Wouldn’t that impact the stress of physicians and health workers. Should be addressed in the limitaitons Author response: The impact of COVID-19 on stress of physicians was written as limitation Reviewer comments: You never explain ADR Author response: ADR was assessed by using Naranjo algorithm of ADR probability scale. Accordingly, ADR Probability Scale was categorized by taking sum of 10 questions and grouped as definite, probable, possible or doubtful, if the total score is ≥9, 5-8, 1-4 and 0 respectively.It is mentioned as ”Regarding to the patients that were developed ADR, about 4(50%), 3(37.5%),1(12.5%) were definite, probable, possible ADR’’. Thanks for your time and consideration, Regards! Attachments Attachment Submitted filename: plose one DTP esponse letter.docx https://doi.org/10.1371/journal.pone.0248575.r004
2 Mar 2021 Decision Letter - M. Mahmud Khan, Editor Magnitude and determinants of drug-related problems among patients admitted to medical wards of southwestern Ethiopian hospitals : A multicenter prospective observational study PONE-D-20-30167R2 Dear Dr. Bekele, 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, M. Mahmud Khan Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0248575.r005
Formally Accepted
4 Mar 2021 Acceptance Letter - M. Mahmud Khan, Editor PONE-D-20-30167R2 Magnitude and determinants of drug-related problems among patients admitted to medical wards of southwestern Ethiopian hospitals: A multicenter prospective observational study Dear Dr. Bekele: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. 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 plosone@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. M. Mahmud Khan Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0248575.r006

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