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In the early 1920s, there was a shortage of insulin, which is when drug scarcity first appeared in the records. Drug shortages are now more prevalent globally than they were back then. The goal of this essay is to pinpoint the key components that make up a definition for medication shortages and to pinpoint the circumstances that should be considered when reporting drug shortages in databases. Understanding the factors that led certain organizations to create their own definition of a medicine shortage was crucial for achieving these goals. The pharmaceutical regulatory environment can be connected to several reasons why there are medication shortages, including parallel trading, quality standards, and business choices to halt or reduce manufacturing. The many rules governing medicine shortages have not yet been the subject of a thorough investigation. This protocol’s objective is to analyze the pertinent legislative and regulatory frameworks in the European pharmaceutical system that affect medication shortages. The objectives of the study will be the non–availability of drugs at an outpatient pharmacy and to analyze the reason of non–availability of drugs. Methods An observational study will be adopted in this study. It includes a collection of data from the patient coming to the outpatient pharmacy of AVBRH Sawangi (Meghe) Wardha. Expected result It can lead to delayed treatment for patients seeking alternative medication. It can also lead to increased healthcare costs if patients seek alternative treatments that are more expensive or require additional medical care. The unavailability of drugs can also lead to frustration and anxiety for patients who need medication to manage their health condition. It can also negatively impact the reputation of the hospital. 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F1000Research 2024, 12 :1287 ( https://doi.org/10.12688/f1000research.139510.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] Abhishek Bakare https://orcid.org/0009-0006-7850-4606 1 , Aditya Bhargav 1 Abhishek Bakare https://orcid.org/0009-0006-7850-4606 1 , Aditya Bhargav 1 PUBLISHED 14 Oct 2024 Author details Author details 1 Department of Hospital Administration., Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha., Maharashtra, 442001, India Abhishek Bakare Roles: Conceptualization, Resources, Writing – Original Draft Preparation Aditya Bhargav Roles: Supervision, Validation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Introduction Throughout history and up until the present, there has been a medicine shortage. In the early 1920s, there was a shortage of insulin, which is when drug scarcity first appeared in the records. Drug shortages are now more prevalent globally than they were back then. The goal of this essay is to pinpoint the key components that make up a definition for medication shortages and to pinpoint the circumstances that should be considered when reporting drug shortages in databases. Understanding the factors that led certain organizations to create their own definition of a medicine shortage was crucial for achieving these goals. The pharmaceutical regulatory environment can be connected to several reasons why there are medication shortages, including parallel trading, quality standards, and business choices to halt or reduce manufacturing. The many rules governing medicine shortages have not yet been the subject of a thorough investigation. This protocol’s objective is to analyze the pertinent legislative and regulatory frameworks in the European pharmaceutical system that affect medication shortages. The objectives of the study will be the non–availability of drugs at an outpatient pharmacy and to analyze the reason of non–availability of drugs. Methods An observational study will be adopted in this study. It includes a collection of data from the patient coming to the outpatient pharmacy of AVBRH Sawangi (Meghe) Wardha. Expected result It can lead to delayed treatment for patients seeking alternative medication. It can also lead to increased healthcare costs if patients seek alternative treatments that are more expensive or require additional medical care. The unavailability of drugs can also lead to frustration and anxiety for patients who need medication to manage their health condition. It can also negatively impact the reputation of the hospital. READ ALL READ LESS Keywords Outpatient pharmacy, drug, tertiary care hospital, unavailability of drug, opd, invalid prescription Corresponding Author(s) Aditya Bhargav ( [email protected] ) Close Corresponding author: Aditya Bhargav Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Bakare A and Bhargav A. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Bakare A and Bhargav A. An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.12688/f1000research.139510.2 ) First published: 09 Oct 2023, 12 :1287 ( https://doi.org/10.12688/f1000research.139510.1 ) Latest published: 14 Oct 2024, 12 :1287 ( https://doi.org/10.12688/f1000research.139510.2 ) Revised Amendments from Version 1 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. See the authors' detailed response to the review by Unyime Israel Eshiet READ REVIEWER RESPONSES Introduction Throughout history and up until the present, there has been a medicine shortage. In the early 1920s, there was a shortage of insulin, which is when drug scarcity first appeared in the records. Drug shortages are now more prevalent globally than they were back then. 1 The goal of this protocol is to pinpoint the key components that make up a definition for medication shortages and to pinpoint the circumstances that should be considered when reporting drug shortages in databases. Understanding the factors that led certain organizations to create their own definition of a medicine shortage was crucial for achieving these goals. 2 The pharmaceutical regulatory environment can be connected to several reasons why there are medication shortages, including parallel trading, quality standards, and business choices to halt or reduce manufacturing. The many rules governing medicine shortages have not yet been the subject of a thorough investigation. This protocol’s objective is to analyze the pertinent legislative and regulatory frameworks in the European pharmaceutical system that affect medication shortages. 3 Local ordering problems, regional or national distribution problems, or manufacturing problems can all lead to supply problems that could lead to shortages on a regional or national scale. The United States has a complicated just-in-time inventory system that is used to distribute medications. A cost-saving method used to reduce the costs of carrying extra inventory is just-in-time inventory. This demonstrates that there is generally no product overstock anywhere throughout the supply chain. Generally, wholesalers are used to distribute the pharmaceuticals that manufacturers make. AmerisourceBergen, Cardinal, and McKesson are the top three wholesalers in the US. These wholesalers' distribution centers are dispersed throughout the nation. 4 Nonetheless, it would be mistaken to ignore the reality that medicine shortages are also moral and political challenges if we just saw them as technical and economic events. Two things are intended by this: First, medicine shortages affect governments' and practitioners' ability to uphold their moral commitments to citizens and society when they occur Namely, to offer benefits, reduce damage, and encourage equity. Second, Social values lead to pharmaceutical shortages, particularly the choices we've made regarding what we value most in the pharmaceutical and biotechnology sectors, in government regulations, and in health care. These insights are significant because they emphasize the moral and political need to forcefully combat medicine shortages and the requirement that those who do so do it in politically and morally astute ways. 5 The key factor causing medicine shortages in Saudi Arabia is the absence of a mechanism for early warning that may send out notifications about impending shortages. There is no penalty for failure to alert the Saudi Food and Drug Administration (SFDA) of any anticipated at a minimum six months prior to any shortages as there are currently no rules requiring such notification from pharmaceutical businesses and importers. Likewise, there are no effective sanctions against authorized importers and distributors of pharmaceutical firms who disregard Saudi government restrictions. Additional causes that cause medicine shortages in Saudi Arabia include inadequate local pharmaceutical production, flawed supply chain management systems, poor profit margins for some essential critical pharmaceuticals, tight regulatory requirements for biological medical goods, and excessive reliance on medication imports. 6 Ethics and consent The synopsis for this study has been sent to the IEC (DMIHER (DU)/IEC/2023/1162) in the institute for ethical approval and is currently under consideration. Written consent will be taken from the participants who are participating in the study. Objectives • To understand the flow at an outpatient pharmacy. • To study the unavailability of medications at the outpatient pharmacy. • To examine the cause of the medications' unavailability. Study design This study will be an observational study. The study will be conducted in Acharya Vinoba Bhave Rural Hospital. The duration of the study will be two years. Sample size The sample size of the study is 354. The data of this study is going to be conducted from an outpatient pharmacy and self-questionnaires. Questions will be given to the participant for data analysis. Sample size formula N ≥ Z 1 − α / 2 2 × p 1 − p d 2 Where, Z 2 1 – α/2 is the level of significance at 5% i.e. 95% Confidence interval = 1.96 Alpha (α) = 0.05 Estimate proportion (p) = 0.36 (48 out of 60 were the patient satisfying result as per reference article) Estimate error (d) = 0.05 N = 1.96 2 ∗ 0.36 ∗ 1 − 0.36 0.05 2 N = 354 N = 354 subjects needed in the study Inclusion and exclusion criteria Included in this study will be the Patient willing to give a consent form, Patient having a valid prescription. And the Patient is willing to comply with the study protocol. excluded from the study will be Inpatient Invalid prescriptions. Survey and questionary development of a verified self-questionary and direct open-ended questionary for outpatients who will be coming to the outpatient pharmacy. Data collection techniques The primary data for this study will be collected through an observational approach. This will involve in-depth interviews with patients and pharmacy staff, as well as observations of the pharmacy and its operations. Data will also be collected through hospital records to track the availability of drugs over time. Questionnaire will be provide to the patient and the pharmacists. Variable like availability of brands that are prescribed by the doctors, fewer counters, cost of the medications, etc. Statistical analysis plan Statistical techniques, such as Fisher's exact test or chi-square test, may be employed in this observational study to examine categorical factors associated with drug availability. To evaluate group differences for continuous variables, t-tests or ANOVA could be used. Furthermore, logistic regression may be helpful in determining the causes of unavailability. Data analysis Data will be analyzed by using simple descriptive statistics. Data will be presented in graphical, tables, charts, etc. Microsoft Excel will be used for data analysis. Limitations of the study This study will be only limited in AVBR Hospital, Sawangi (Meghe), Wardha 442001, Maharashtra. Expected result It can lead to delayed treatment for patients seeking alternative medication. It can also lead to increased healthcare costs if patients seek alternative treatments that are more expensive or require additional medical care. The unavailability of drugs can also lead to frustration and anxiety for patients who need medication to manage their health conditions. It can also negatively impact the reputation of the hospital. Discussion An observational study carried out in Belgium, on 30 October 2015 found that currently, there are more frequent medicine shortages. Although numerous definitions of “drug shortages” are provided in legislation, by various organizations, authorities, and other initiatives, a thorough analysis of the issue is still required. To properly interpret national databases and the findings of scientific investigations and allow for international comparison, it is crucial to understand the fundamental definition of drug shortages. The goal is to establish the many components that should be considered in a standardized definition for drug shortages in the European Union (EU) and to identify the various circumstances in which drug shortages should be reported. The methods employed involved searching scientific databases and grey literature for definitions of drug shortages. Similar subjects were found, and organizations were approached to develop the definitions' supporting arguments. According to the findings, there are over 20 different definitions of medicine shortages. There is a discrepancy between the terminology used for reporting drug shortages and the definitions used in general. The definitions' elements—such as when a supply issue turns into a scarcity of drugs, whether they are permanent or temporary, their typology, and their duration—show both parallels and differences. There are four levels at which a supply issue becomes a shortage: (i) demand side; (ii) supply side; (iii) drug delivery; and (iv) drug availability. Definitions of drug shortages do not usually include permanent drug discontinuations. Some definitions solely consider medications needed to treat serious illnesses or medications for which there is no effective substitute. The observed time intervals ranged from one day to twenty days. The study's conclusion was to enable worldwide benchmarking, a standardized definition of drug shortages must be established, together with a list of the situations in which reporting drug shortages is preferred. A number of studies related to shortages in outpatient pharmacy were reported. 7 - 11 This essay can be used as a reference to highlight all the various factors that should be considered while formulating a definition that will be used throughout the EU. 3 Dissemination The study will be published in an institutional-indexed journal. Study status The study is under process with 50% Completion. Data availability No data associated with this article. Acknowledgment I would like to acknowledge and thanks my guide and faculty of the Hospital Administration department who made this work possible. References 1. Shukar S, Zahoor F, Hayat K, et al. : Drug Shortage: Causes, Impact, and Mitigation Strategies. Front. Pharmacol. 2021; 12 : 693426. Publisher Full Text 2. De Weerdt E, Simoens S, Casteels M, et al. : Toward a European definition for a drug shortage: a qualitative study. Front. Pharmacol. 2015; 6 : 253. PubMed Abstract | Publisher Full Text | Free Full Text 3. De Weerdt E, Simoens S, Hombroeckx L, et al. : Causes of drug shortages in the legal pharmaceutical framework. Regulatory toxicology and pharmacology: RTP. 2015; 71 (2): 251–258. Publisher Full Text 4. Fox ER, Sweet BV, Jensen V: Drug shortages: a complex health care crisis. Mayo Clin. Proc. 2014; 89 (3): 361–373. PubMed Abstract | Publisher Full Text 5. Lipworth W, Kerridge I: Why drug shortages are an ethical issue. Australas Med. J. 2013; 6 (11): 556–559. PubMed Abstract | Publisher Full Text | Free Full Text 6. Alsheikh MY, Alzahrani MA, Alsharif NA, et al. : Community Pharmacy Staff Knowledge, Opinion and Practice toward Drug Shortages in Saudi Arabia. Saudi pharmaceutical journal: SPJ: the official publication of the Saudi Pharmaceutical Society. 2021; 29 (12): 1383–1391. PubMed Abstract | Publisher Full Text | Free Full Text 7. Ghonmode S, Shrivastava S, Kadaskar AR, et al. : Socioeconomic burden of orthodontic treatment: a systematic review. Medicine and Pharmacy Reports. 2023; 96 : 154–163. PubMed Abstract | Publisher Full Text | Free Full Text 8. Vyas PU, Khobragade DS, Mundhada DR, et al. : A Comparative Study of Concentration of Growth Factors in Lyophilized PRP with Fresh PRP at Different Storage Conditions. International Journal of Drug Delivery Technology. 2023; 13 : 173–179. Publisher Full Text 9. Vyas PU, Khobragade DS, Mundhada DR, et al. : A Comparative Study of Concentration of Growth Factors in Lyophilized PRP with Fresh PRP at Different Storage Conditions. International Journal of Drug Delivery Technology. 2023; 13 : 173–179. Publisher Full Text 10. Shete VS, Telange DR, Mahajan NM, et al. : Development of phospholipon®90H complex nanocarrier with enhanced oral bioavailability and anti-inflammatory potential of genistein. Drug Deliv. 2023; 30 : 30. PubMed Abstract | Publisher Full Text | Free Full Text 11. Gabhane KB, Khan AM, Desmukh MP, et al. : Development of Dose Sipping Technology, a New Design Approach for Improving Drug Delivery of Acyclovir in Pediatric Medication. Indian Journal of Forensic Medicine and Toxicology. 2020; 14 (4): 6589–6592. Publisher Full Text Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 09 Oct 2023 ADD YOUR COMMENT Comment Author details Author details 1 Department of Hospital Administration., Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha., Maharashtra, 442001, India Abhishek Bakare Roles: Conceptualization, Resources, Writing – Original Draft Preparation Aditya Bhargav Roles: Supervision, Validation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (2) version 2 Revised Published: 14 Oct 2024, 12:1287 https://doi.org/10.12688/f1000research.139510.2 version 1 Published: 09 Oct 2023, 12:1287 https://doi.org/10.12688/f1000research.139510.1 Copyright © 2024 Bakare A and Bhargav A. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Bakare A and Bhargav A. An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . 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Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.173200.r331620 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v2#referee-response-331620 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 03 Dec 2024 Unyime Israel Eshiet , University of Uyo, Uyo, Nigeria Approved VIEWS 0 https://doi.org/10.5256/f1000research.173200.r331620 Satisfactory. ... Continue reading READ ALL Satisfactory. Please accept for indexing. Competing Interests: No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Eshiet UI. Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.173200.r331620 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v2#referee-response-331620 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 09 Oct 2023 Views 0 Cite How to cite this report: Eshiet UI. Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r294888 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-294888 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 09 Sep 2024 Unyime Israel Eshiet , University of Uyo, Uyo, Nigeria Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.152787.r294888 This is an interesting study and well conceived. The authors have however not explicitly presented the specific objectives of the study. The proposed study designed is not clearly described to ascertain suitability. Also the method is not sufficiently described. Authors ... Continue reading READ ALL This is an interesting study and well conceived. The authors have however not explicitly presented the specific objectives of the study. The proposed study designed is not clearly described to ascertain suitability. Also the method is not sufficiently described. Authors should kindly provide details of the data collection instrument(s). What are the possible limitations of the study? Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Eshiet UI. Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r294888 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-294888 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 14 Oct 2024 Abhishek Bakare , Department of Hospital Administration., Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha., 442001, India 14 Oct 2024 Author Response Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been ... Continue reading Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. Thanks for your kind perusal. Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. Thanks for your kind perusal. Competing Interests: nil Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 14 Oct 2024 Abhishek Bakare , Department of Hospital Administration., Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha., 442001, India 14 Oct 2024 Author Response Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been ... Continue reading Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. Thanks for your kind perusal. Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. Thanks for your kind perusal. Competing Interests: nil Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Huyghebaert T. Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r281983 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-281983 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 24 Jun 2024 Trudy Huyghebaert , School of Health and Wellness, Bow Valley College, Calgary, Alberta, Canada Approved VIEWS 0 https://doi.org/10.5256/f1000research.152787.r281983 This is a very important topic and I think one of the key aspects of this is with regard to the moral and ethical obligation of drug companies to provide a consistent supply to their medication for patients, which may ... Continue reading READ ALL This is a very important topic and I think one of the key aspects of this is with regard to the moral and ethical obligation of drug companies to provide a consistent supply to their medication for patients, which may involve re-evaluating their just-in time approach to inventory as described. Overall, this is a very well written protocol. It is a study protocol and there are no results to evaluate Comments are added below for a few minor revisions: 1. Provide an expended definition of parallel trading 2. The authors refer extensively to the United States system and wholesalers and then segway into Saudia Arabia system. If possible, please explain more about the correlation (or similarities) between the two systems. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: quality improvement, primary care, evidence based medicine I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Huyghebaert T. Reviewer Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r281983 ) The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-281983 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 09 Oct 2023 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 2 (revision) 14 Oct 24 read Version 1 09 Oct 23 read read Trudy Huyghebaert , Bow Valley College, Calgary, Canada Unyime Israel Eshiet , University of Uyo, Uyo, Nigeria Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Eshiet U. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 03 Dec 2024 | for Version 2 Unyime Israel Eshiet , University of Uyo, Uyo, Nigeria 0 Views copyright © 2024 Eshiet U. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Satisfactory. Please accept for indexing. Competing Interests No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Eshiet UI. Peer Review Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.173200.r331620) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-1287/v2#referee-response-331620 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Eshiet U. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 09 Sep 2024 | for Version 1 Unyime Israel Eshiet , University of Uyo, Uyo, Nigeria 0 Views copyright © 2024 Eshiet U. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is an interesting study and well conceived. The authors have however not explicitly presented the specific objectives of the study. The proposed study designed is not clearly described to ascertain suitability. Also the method is not sufficiently described. Authors should kindly provide details of the data collection instrument(s). What are the possible limitations of the study? Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 14 Oct 2024 Abhishek Bakare, Department of Hospital Administration., Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha., 442001, India Thanks for your valuable time and suggestions. 1. We have added the objectives as suggested. 2. The methodology part has been updated and details about data collection instruments have been added. Also, the limitations of the study are added. Thanks for your kind perusal. View more View less Competing Interests nil reply Respond Report a concern Eshiet UI. Peer Review Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r294888) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-294888 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Huyghebaert T. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 24 Jun 2024 | for Version 1 Trudy Huyghebaert , School of Health and Wellness, Bow Valley College, Calgary, Alberta, Canada 0 Views copyright © 2024 Huyghebaert T. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is a very important topic and I think one of the key aspects of this is with regard to the moral and ethical obligation of drug companies to provide a consistent supply to their medication for patients, which may involve re-evaluating their just-in time approach to inventory as described. Overall, this is a very well written protocol. It is a study protocol and there are no results to evaluate Comments are added below for a few minor revisions: 1. Provide an expended definition of parallel trading 2. The authors refer extensively to the United States system and wholesalers and then segway into Saudia Arabia system. If possible, please explain more about the correlation (or similarities) between the two systems. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise quality improvement, primary care, evidence based medicine I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Huyghebaert T. Peer Review Report For: An assessment of the factors contributing to the unavailability of drugs at outpatient pharmacy of tertiary care hospital: an observational study [version 2; peer review: 2 approved] . F1000Research 2024, 12 :1287 ( https://doi.org/10.5256/f1000research.152787.r281983) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-1287/v1#referee-response-281983 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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