Monitoring medicine prescriptions before, during and after pregnancy in Italy

Filomena Fortinguerra; Valeria Belleudi; Francesca Romana Poggi; Serena Perna; Renata Bortolus; Serena Donati; Paola D’Aloja; Roberto Da Cas; Antonio Clavenna; Anna Locatelli; Antonio Addis; Marina Davoli; Francesco Trotta; MoM-Net group

doi:10.1371/journal.pone.0287111

Peer Review History

Original SubmissionOctober 18, 2022
9 Jan 2023 Decision Letter - Linglin Xie, Editor PONE-D-22-25133Monitoring medicine prescriptions before, during and after pregnancy in ItalyPLOS ONE Dear Dr. Fortinguerra, 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, especially the comments about the confounding variance. Please submit your revised manuscript by 03/06/2023. 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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Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 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. 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 ****** 4. 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 ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I was kindly asked to review the manuscript entitled “Monitoring medicine prescriptions before, during and after pregnancy in Italy” by Fortinguerra F et al. The aim of the study was to describe the clinical attitude about drug prescription in Italy, with regard to one of the most vulnerable population, id est pregnant women, and in the period before and after pregnancy. Results are interesting and well mirror clinical practice, but, given that it should be conducted by an evidence-based approach and in light of clinical practice guidelines, it makes results not so novel and surprising as well. Surely, authors put many efforts in this study and the reason behind is of relevance, but, as ascertained, its only strength regards the large sample size. In my personal opinion, this study presents the following main limitation. The analysis is not adjusted by confounding variables such as race, BMI and type of pregnancy (single, twin, natural conception or IVF, etc…). Furthermore, It should be also valuable to investigate the relationship, if any, between the incidence of the most meaningful drugs and pregnancy outcomes in mothers and fetuses. Before publication, I suggest authors to consider my comment if suitable to improve their study, if suitable to improve their study, and the following minor points: - line 55: TP abbreviation needs to be defined; - line 58: “…≥40” should be followed by “years”; - line 127: This sentence does not make sense, rephrase or delete. ****** 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. https://doi.org/10.1371/journal.pone.0287111.r001
Revision 1
14 Mar 2023 Author Response Journal 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 Authors’ answer: we checked the manuscript and confirm that our manuscript meets all PLOS ONE's style requirements 2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. 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 Authors’ answer: we added the details on participant consent reported in Ethics statement also in the Methods section of the manuscript. 3. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ Authors’ answers: the corresponding author have a validated ORCID ID in Editorial Manager. 4. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. "Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Authors’ answer: we updated the Data Availability statement in the manuscript. 5. Review Comments to the Author Reviewer #1: I was kindly asked to review the manuscript entitled “Monitoring medicine prescriptions before, during and after pregnancy in Italy” by Fortinguerra F et al. The aim of the study was to describe the clinical attitude about drug prescription in Italy, with regard to one of the most vulnerable population, id est pregnant women, and in the period before and after pregnancy. Results are interesting and well mirror clinical practice, but, given that it should be conducted by an evidence-based approach and in light of clinical practice guidelines, it makes results not so novel and surprising as well. Surely, authors put many efforts in this study and the reason behind is of relevance, but, as ascertained, its only strength regards the large sample size. In my personal opinion, this study presents the following main limitation. The analysis is not adjusted by confounding variables such as race, BMI and type of pregnancy (single, twin, natural conception or IVF, etc…). Furthermore, It should be also valuable to investigate the relationship, if any, between the incidence of the most meaningful drugs and pregnancy outcomes in mothers and fetuses. Before publication, I suggest authors to consider my comment if suitable to improve their study, if suitable to improve their study, and the following minor points: - line 55: TP abbreviation needs to be defined; - line 58: “…≥40” should be followed by “years”; - line 127: This sentence does not make sense, rephrase or delete. Authors’ response to Reviewer #1 Dear reviewer, thank you for your comments, which give us the opportunity to better clarify the objectives and implications of our study. We well know that the outcomes on health status of both women and newborns of medication use during pregnancy is a topic of great interest in the field of public health. However, we believe that monitoring medicine prescriptions in clinical practice is a necessary step in assessing the impact of therapeutic choices in pregnant women as well as the adherence to the available clinical guidelines. Despite some limitations of our study (like not collecting information on outcomes of drug use in pregnancy or not adjusting by confounding variables such as race, BMI and type of pregnancy), its added value is to compare the prescriptive trends and patterns in Italy to those reported in other European countries and to identify any critical aspects in the current clinical practice first; in our opinion these elements are essential for the medical community in order to improve the current medical care for pregnant and childbearing woman on the basis of the already available evidence and clinical guidelines. Since we did not investigate the correlation between the incidence of the most meaningful drugs and pregnancy outcomes in mothers and fetuses, we did not adjust our analysis by confounding variables such as race, BMI and type of pregnancy (single, twin, natural conception or IVF, etc…). If we only evaluate the prescriptions and adherence to evidence-based clinical guideline why do we think that an obese woman should receive a different prescription? However, we have investigated the effect of the maternal age on drug prescribing profile. Based on these assumptions and given the limited information on medications currently used in Italian pregnant women, we performed a large population-based study, accounting about 59% of total births occurred in Italy during the study period, to provide a representative and updated overview of drug prescribing before, during and after pregnancy in Italy. The novelty of this study is that it is promoted by a regulatory agency, which set up a Working Group called MoM-Net (Monitoring Medication Use During Pregnancy Network) involving a network of eight Italian regions and a number of experts from Italian public and academic institutions, focused on a very delicate issue, such as the monitoring drug use during pregnancy by integrating various regional health databases; the objective is the periodically monitoring of the prescription patterns of drugs supplied by the Italian National Health Service to pregnant women, not only during the gestational period, but also in pre-conception and post-pregnancy. Also to estimate the treatment dropout rate is important. With this study we want to underline the importance of the network to investigate drug use in pregnancy, which can be enlarged. The data produced were robust and consistent on some information, testing the importance of the use of the information flows within a wide network to answer to emerging health issue in the field. Any issues related to clinically inappropriate prescribing, non-adherence to treatment or drug discontinuation due to pregnancy, switches analysis (replacement of a non-recommended drug in pregnancy with another considered safer or transition from poly-therapy to monotherapy), heterogeneity in prescriptive medical habits between Italian Regions and subgroups of populations (foreign women and women with births multiple) could be also investigated. The added value of these study results is also to hypothesize and propose lines for future research in the field. A more in-depth studies could be conducted for some categories of drugs for which no safety information is available on pregnancy and for which investigating the health outcomes of the pregnancy use or non-use of medications is essential in order to guarantee an optimal medical assistance. The integration of different regional databases, together with the sharing of data, has made it possible to produce sufficiently representative results and to obtain an exhaustive overview of the use of drugs in pregnancy in Italy, while emphasizing the importance of periodic monitoring of the information flows produced, training and information aimed at both prescribers (and pharmacists) and women on the appropriate use of drugs in the context of assistance to women of childbearing age, pregnancy and post-partum. In addition, these results can represent a valid tool for the prescribers who wants to become aware of the real use of the drug in pregnancy. This approach, although tiring, represents a moment of professional growth for the prescribers who, in addition to measuring his own activity, produces robust data useful for the scientific community, strategic directions and colleagues. In addition, we think that our results provide useful information to identify evidence and research gaps or inappropriate clinical practice, on the basis of which to plan training activities and/or information interventions on the appropriate use of medicines for both prescribers (and pharmacists) and childbearing women. Finally, we found that other authors have already published studies like this on PLOS One, therefore we hope that our study will also be accepted for publication by the journal. Thank you. As suggested by the reviewer, we checked the following lines in the manuscript: - line 55: TP abbreviation needs to be defined; We have replaced the acronym TP with the words “trimester of pregnancy”. Thank you - line 58: “…≥40” should be followed by “years”; We added the word. Thank you - line 127: This sentence does not make sense, rephrase or delete. We deleted the sentence. Thank you Attachments Attachment Submitted filename: Response to the Editor&Reviewer.docx https://doi.org/10.1371/journal.pone.0287111.r002
5 May 2023 Decision Letter - Linglin Xie, Editor PONE-D-22-25133R1Monitoring medicine prescriptions before, during and after pregnancy in ItalyPLOS ONE Dear Dr. Fortinguerra, 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 Jun 19 2023 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, Linglin Xie 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. [Note: HTML markup is below. Please do not edit.] 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 #2: (No Response) ******** 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 #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 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 #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: Table 1: The sums of percentages provided in table for demographic characteristics are more than 100% in some cases e.g., age distribution. ****** 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 #2: 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. https://doi.org/10.1371/journal.pone.0287111.r003
Revision 2
10 May 2023 Author Response 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. Authors’ answer: We checked our reference list to ensure that it is complete and correct. No retracted article were found. 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 #2: Table 1: The sums of percentages provided in table for demographic characteristics are more than 100% in some cases e.g., age distribution. Authors’ answer: We thank the reviewer for the comment. We checked and revised the numbers and the percentages reported in Table 1, as suggested. We have uploaded the revised version of the manuscript, accordingly. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0287111.r004
30 May 2023 Decision Letter - Linglin Xie, Editor Monitoring medicine prescriptions before, during and after pregnancy in Italy PONE-D-22-25133R2 Dear Dr. Fortinguerra, 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, Linglin Xie Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0287111.r005
Formally Accepted
5 Jun 2023 Acceptance Letter - Linglin Xie, Editor PONE-D-22-25133R2 Monitoring medicine prescriptions before, during and after pregnancy in Italy Dear Dr. Fortinguerra: 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. Linglin Xie Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0287111.r006

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