What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol.

Lucy Hackett; Deirdre M. D'Arcy; Juliette O'Connell; Samuel Cromie; Déirdre Daly; Tamasine Grimes

doi:10.12688/hrbopenres.14100.1

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Study Protocol

What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol.

[version 1; peer review: 2 approved with reservations]

Lucy Hackett ¹, Deirdre M. D'Arcy¹, Juliette O'Connell¹, Samuel Cromie², Déirdre Daly^3,4, Tamasine Grimes¹

Lucy Hackett ¹, Deirdre M. D'Arcy¹, [...] Juliette O'Connell¹, Samuel Cromie², Déirdre Daly^3,4, Tamasine Grimes¹

PUBLISHED 10 Apr 2025

Author details Author details

¹ School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, The University of Dublin, Dublin 2, D02 PN40, Ireland
² School of Psychology, Áras an Phiarsaigh, Trinity College Dublin, the University of Dublin, Dublin 2, Ireland
³ School of Nursing and Midwifery, Trinity College Dublin, The University of Dublin, 24 D’Olier Street, Dublin 2, D02 T283, Ireland
⁴ Trinity Centre for Maternity Care Research (TCMCR), School of Nursing and Midwifery, Trinity College Dublin, The University of Dublin, 24 D’Olier Street, Dublin 2, D02 T283, Ireland

Lucy Hackett
Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Deirdre M. D'Arcy
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Juliette O'Connell
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Samuel Cromie
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Déirdre Daly
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Tamasine Grimes
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Maternal and Child Health collection.

Abstract

Background

Breastfeeding is the recommended method of infant feeding. The postpartum period can be a challenging time for women who experience illness requiring pharmacotherapy. However, breastfeeding women may use medication less frequently than their counterparts who are not breastfeeding. Some women report the need for pharmacotherapy as a reason for earlier than desired breastfeeding cessation. The experiences of women in relation to self-management of medication use and breastfeeding are poorly understood.

Aim

The aim of this systematic review is to explore the barriers and facilitators to self-management for women who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum, using mixed-methods and a systems-based theoretical framework.

Methods

Systematic searches will be performed using five electronic bibliographic databases. Dual independent selection, data extraction and quality assessment of studies will be carried out. A convergent integrated approach to data synthesis will be used. The System Engineering Initiative for Patient Safety (SEIPS) model will be used as a theoretical framework to guide data synthesis. Input and collaboration from public and patient involvement (PPI) contributors will be sought throughout.

Conclusion

Enhancing understanding of mothers’ self-management experiences when they wish to breastfeed and take medication is arguably key to improving maternal and child health and quality of life. The proposed review will synthesise the available data regarding the barriers and facilitators to self-management for women who face the need for concurrent pharmacotherapy and breastfeeding. In doing so, important supports and unmet needs of this cohort will be revealed.

PROSPERO registration number

CRD420251000918. Amendments to this protocol will be uploaded as revision notes to any platforms where the protocol was published.

Keywords

Medication, pharmacotherapy, breastfeeding, infant feeding, postpartum, experience

Corresponding author: Lucy Hackett

Competing interests: No competing interests were disclosed.

Grant information: This research was funded by the Panoz Pharmaceutical Innovation PhD Scholarship at Trinity College Dublin.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Hackett L et al. 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: Hackett L, D'Arcy DM, O'Connell J et al. What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol. [version 1; peer review: 2 approved with reservations]. HRB Open Res 2025, 8:53 (https://doi.org/10.12688/hrbopenres.14100.1) First published: 10 Apr 2025, 8:53 (https://doi.org/10.12688/hrbopenres.14100.1) Latest published: 10 Apr 2025, 8:53 (https://doi.org/10.12688/hrbopenres.14100.1)

Background

Breastfeeding is recommended due to the benefits it offers both babies and their mothers. Globally, 48% of infants under 6 months of age are exclusively breastfed¹. Breastfeeding rates tend to be lower in high-income countries compared to low- and middle-income countries². In Ireland, for example, breastfeeding rates are among the lowest in the world³. Despite limited data, it is reported that only 15% of babies are exclusively breastfed to 6 months of life in Ireland⁴. The reasons behind low breastfeeding rates are often multi-faceted, however some women report the need to take medication as a reason for earlier than desired breastfeeding cessation^5–7.

Most women will require some form of medication during the first two years after giving birth. The postpartum period may be a challenging time for women, with many reporting that they experience pain, infection, frequent minor illnesses, severe headaches or migraines, and persistent mental health problems^8,9. Other women may have acute or chronic health conditions. Pharmacotherapy is often the first-line treatment for many of these issues. Studies report that between 49–96% of women use some form of medication during breastfeeding^10–13, however breastfeeding mothers are reported to use medication less frequently than their counterparts who are not breastfeeding¹⁰.

Medication use for the management of chronic conditions has been shown to decline in pregnancy and remains low in the months following, most likely due to breastfeeding¹⁴. This may suggest that some women will prioritise infant feeding over their own health if they perceive that these goals are incompatible. It has been reported that women who discontinue pre-existing medications while breastfeeding have shorter breastfeeding duration and are less likely to meet their personal breastfeeding goals than women who breastfeed while continuing effective medications¹⁵. This is a highly unfavourable situation, as women may suffer morbidity due to medication discontinuation, while also not benefiting from the protective effects of continued breastfeeding for themselves or their infants.

Women may be fearful to take medication while breastfeeding due to concerns about medication transfer to the infant through the breastmilk^16,17. This may result in them refraining from either breastfeeding or taking required medication, or doing one of these actions in an impractical manner^18,19. While a small number of medications are accepted as contraindicated during breastfeeding^20–22, many medications needed during this period may be considered safe or to have a safe alternative; there are a relatively small number of adverse events reported in breastfed infants whose mothers have taken medication²³ and the amount of drug transferred to the infant via the breastmilk is usually too small to exert any effect²⁴. However, deciphering which medicines are safe may be a difficult task.

Fear regarding decision-making in this setting may stem from the fact that there is less safety data available regarding pharmacotherapy for pregnant and breastfeeding women compared to the general population. These cohorts are usually excluded from drug trials and research, with current evidence often based on case studies that have evolved over time²⁵. Therefore, despite the likely safety of (or safe alternatives for) many medications^23,24,26, few drugs are licenced for use in lactation and thus it may be perceived that either breastfeeding or pharmacotherapy cannot go ahead due to the risk to the infant^23,27. However, decisions regarding the relative safety of drugs in lactation may be made in many cases by considering factors such as infant age, the frequency of breastfeeding, concurrent infant disease, whether the medication is licenced for paediatric use, and pharmacokinetics^22,26,27. Thus, advice and decision-making regarding pharmacotherapy during lactation is complex and needs to be individualised. To do this however, prescribers may need to seek out specialised literature and take professional responsibility for their clinical judgement in these situations^22,27.

Medication self-management is the series of steps a person takes to use their medication safely and effectively²⁸. These steps may fall under the definition of “patient work”^{29, p1676}. Breastfeeding women may encounter difficulties in relation to medication self-management due to their own, or healthcare professionals’ (HCPs), concerns regarding the transfer of medicines through breastmilk.

Existing literature reviews^18,30 have sought to investigate the knowledge, attitudes, practices and behaviours of women and HCPs regarding medication use during breastfeeding. While the literature outlines the perceived “safety behaviours”^{18, p111} that women may adopt, these behaviours cannot be understood due to the lack of literature detailing women’s knowledge and attitudes regarding medication use while breastfeeding¹⁸. The proposed review will help to address this gap in the literature by providing insight into the barriers and enablers to effective and concurrent pharmacotherapy and breastfeeding as experienced by women. While these reviews have sought to examine features of the individual (e.g. knowledge, attitudes, behaviours), the proposed review will use the Systems Engineering Initiative for Patient Safety (SEIPS) model^29,31,32 to examine the experiences of women within the context of the system around them. The complexity of self-management for women who wish to breastfeed and require pharmacotherapy may be best understood in this context. Such understanding may better explain women’s knowledge and behaviours in this setting and reveal potential research and innovation opportunities to enhance breastfeeding, medication safety and maternal experience.

Rationale for the research

Supporting safe and effective breastfeeding and medication use may have significant returns for maternal, child and global health. To make this a reality, the barriers and facilitators to effective and concurrent pharmacotherapy and breastfeeding, as experienced by women, must be understood. Through the lens of the SEIPS model, opportunities for support and innovation may be revealed, which will facilitate medication optimisation through improved medication safety and maternal medication self-management. It may also enhance maternal experience, as well as rates of breastfeeding initiation and duration. A systematic review addressing this topic, designed in collaboration with women themselves, is overdue.

A search of PROSPERO and Medline did not identify any previous systematic review on this topic.

Aims and objectives

The aim of this systematic review is to explore the barriers and facilitators to self-management for women who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum, using mixed-methods and a systems-based theoretical framework. The objectives are to:

1. Comprehensively synthesise the available data from quantitative, qualitative and mixed-methods studies relating to self-management for women who wish to breastfeed and take medication.
2. Use the SEIPS framework to identify the component parts of maternal self-management of breastfeeding and medication use, and map the interactions between them. Use this to develop an understanding of the barriers and facilitators to safe and effective medication use while breastfeeding, and the barriers and facilitators to breastfeeding while undergoing pharmacotherapy, as experienced by mothers.
3. Identify potential research and innovation opportunities across the system to improve women’s experiences, medication safety, breastfeeding rates, and maternal and child health.

Methods

This protocol was developed in line with the Preferred Reporting Items for Systematic Reviews and Meta Analyses checklist for protocols (PRISMA-P)^33,34.

A mixed-methods systematic review has been chosen as most appropriate to investigate this research question to ensure that all relevant literature is integrated, allowing for a comprehensive understanding of the complexities of this topic. Collating evidence from quantitative, qualitative, and other mixed-methods research studies may allow for different aspects and perspectives of the same issue to triangulated in one review³⁵. This approach may also facilitate the findings of one type of data to be explained or contextualised by the other type of data³⁵.

The PICO (Population, Intervention/Exposure, Comparison and Outcomes)³⁶ tool was used to further define the research question, develop the search strategy and to generate the inclusion and exclusion criteria. This tool was favoured over others because it has been shown to yield a greater number of relevant studies for inclusion in the review than other question frameworks³⁷.

Population: Studies which focus on the perspectives of mothers who breastfed their child(ren) at any point in the first two years of life, or women who considered breastfeeding. Studies which exclusively focus on the perspectives of healthcare professionals or other individuals will be excluded.
Intervention/Exposure: Studies which address the need for simultaneous breastfeeding and pharmacotherapy. This may be understood as breastfeeding women who considered taking medication, or women who were undergoing pharmacotherapy and then considered breastfeeding. Medication in this context may be prescription-only medication, over-the-counter medication, or dietary supplements.
Comparison: This section is not applicable to the proposed review.
Outcome: The barriers and facilitators (or related concepts) to safe and effective self-management of medication use and breastfeeding, as experienced by mothers who face the need for these actions to be done concurrently.

Search strategy

Five electronic databases will be systematically searched: CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE (Excerpta Medica Database), PsycINFO, Medline (Ovid) and Maternity and Infant Care. Databases will be searched using terms related to medication, breastfeeding, women, experience, barriers, and facilitators. Searches will be limited to peer reviewed, empirical studies published in the English language, and not limited by year. Other literature reviews will be excluded. A sample of the search strategy for one database is available³⁴. Additionally, literature will be hand-searched from identified pertinent systematic reviews or included studies by checking for relevant cited or citing papers.

Screening and selection

Retrieved results will be exported to EndNote software and duplicates removed. The remaining results will then be exported to Covidence, a management software for systematic reviews for further de-duplication, followed by screening and selection for inclusion in the review.

Screening and selection of studies will be conducted in two rounds and presented using a Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA 2020) flowchart in the review³⁸.

Round 1 will comprise title and abstract screening. Dual independent screening will be carried out by two members of the research team to reduce bias and ensure high quality screening. Should discrepancies or disagreements arise, the paper will be forwarded to round 2 for full text screening.

Round 2 will comprise full text screening. Again, results will undergo dual independent screening by two researchers. Any discordance regarding the inclusion of a paper at this stage will be resolved by consensus between the two reviewers or following input from a third reviewer from the research team if required.

Data extraction

Data from relevant studies will be extracted and evaluated to answer the review question using a standardised data extraction form which was produced using the PICO and SEIPS frameworks³⁴. In this form, details about the study characteristics, the participants, the context of medication use while breastfeeding, and the barriers and facilitators to self-management will be grouped under the headings of the PICO and SEIPS frameworks. This form will be piloted on two studies identified from the list of included studies in the review and refined following this if necessary. This will be formatted using Covidence software and will allow for dual data extraction. Authors of included papers will be contacted if necessary for clarification purposes or to request missing data. Data will be extracted primarily by one researcher (LH), and a sample of this cross-checked by a second member of the research team. Any disagreements between the two researchers will be resolved through discussion and, if necessary, the inclusion of a third member of the research team.

Quality assessment

The Mixed-Methods Appraisal Tool (MMAT)³⁹ will be used to guide the assessment of included studies for methodological quality. This will be undertaken by one researcher (LH), with dual independent appraisal by another member of the research team. The quality rating of each study will be assessed by assigning a methodological response rating of ‘yes’, ‘no’, or ‘can’t tell’ to the quality criteria. Quality assessment results will be compared between the two researchers, and discrepancies resolved through discussion or with the involvement of a third researcher from the team. Studies will not be excluded for low methodological quality, but the methodological quality will be reported and considered in the findings and discussion sections of the review. Similarly, limitations or potential biases of included studies will be acknowledged.

Data synthesis

The Joanna Briggs Institute methodological guidance for mixed-methods systematic reviews³⁵ will be followed for data synthesis in this review. The proposed review question may be answered by both qualitative and quantitative research; therefore data synthesis will follow a convergent integrated approach. Dependent on the results of the systematic search, the most suitable approach for data transformation will be chosen. This data will then be combined to allow for further analysis.

The SEIPS model will be used as a theoretical framework to guide data synthesis^29,31,32. Deriving from the field of human factors and ergonomics, this framework seeks to illustrate how work systems influence health-related outcomes³¹. The proposed review will use the SEIPS model to investigate the work systems, processes and outcomes relating to medication use while breastfeeding, how the components of these interact with one another and how this is experienced by women.

The SEIPS 2.0 model²⁹ will primarily be used as it has a distinct focus on patient engagement and patient work, which is highly relevant to the concept of maternal self-management of medication use and breastfeeding. Some concepts may also be drawn from SEIPS 3.0³², which has a unique focus on the patient journey and experience, as well as care coordination within the healthcare system. The SEIPS framework will guide deductive analysis in the proposed review. Should any data fall outside of this model, inductive analysis may be required. If data from the literature permits, analysis will differentiate between occasional and chronic medication needs and how each of these are associated with breastfeeding, as well as other subgroups such as infant age categories.

Public and Patient Involvement

Public and patient involvement (PPI) will be valued throughout the development of the systematic review in line with the Authors and Consumers Together Impacting on eVidencE (ACTIVE) framework⁴⁰. Past participants of the Maternal health and Maternal Morbidity in Ireland (MAMMI) study who had agreed to be contacted for future projects were approached regarding this study, and a PPI panel formed. Members of this panel were consulted prior to publication of this protocol for their input and validation of the research question. They will be offered opportunities to be involved in different stages of the research process such as data interpretation or the dissemination and outreach activities related to the study. Collaboration between the PPI panel and the research team will be key to analysing the barriers and facilitators experienced by women and co-developing a list of potential research and innovation opportunities to enhance medication safety during breastfeeding. The feedback and views of the PPI panel will be invaluable for the production and dissemination of a high-quality and impactful systematic review which focuses on a relevant research question.

Dissemination plan

This mixed-methods systematic review will be submitted for publication to a relevant high-impact, top-percentile journal. Findings will be shared at relevant research conferences and promoted using internet and social media platforms. A strategy will be designed for sharing the findings with the public. Outreach activities may, for example, include meetings with relevant maternal advocacy or breastfeeding groups, or a free online webinar for women. Lay summaries and infographics will be developed for these activities, and consideration will be given to optimising accessibility for people with all levels of health literacy. Dissemination material will be co-designed and co-presented with PPI contributors to ensure that information and resources are accessible and engaging for the women that this research will affect. Dissemination will be considered throughout the lifetime of the project.

Conclusion

Effective and appropriate medication use can allow women to lead healthier and better-quality lives. Similarly, encouraging and supporting more women to initiate and continue breastfeeding will have significant returns for maternal, child and global health. Empowering and facilitating concurrent breastfeeding and appropriate medication use, where safe, may allow for optimisation of maternal and child health and wellbeing. Such a reality requires an in-depth understanding of what women currently perceive as barriers and facilitators to self-management of breastfeeding and medication use. The proposed systematic review will address this gap in the literature and seek to identify relevant research and innovation opportunities.

Time frame and current review status

The review protocol has been developed and published to date. The PPI panel were consulted for their contribution to the research question prior to publication of the protocol. Implementation of the search strategy commenced in the last week of January 2025. It is anticipated that the review will be completed and submitted for publication by the end of 2025.

Ethics and consent

Ethical approval and consent were not required.

Data availability

Underlying data

No data are associated with this article.

Extended data

Open Science Framework (OSF): What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol: Extended data. https://doi.org/10.17605/OSF.IO/DUFMG³⁴

This project contains the following extended data:

Search strategy for one electronic database – CINAHL
Draft data extraction form
Eligibility criteria table
PRISMA-P checklist
PRISMA flow diagram to date

Reporting guidelines

Open Science Framework: PRISMA-P checklist for ‘What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol.’ https://doi.org/10.17605/OSF.IO/D UFMG³⁴.

Data are available under the terms of the Creative Commons Zero 1.0 Universal licence.

Software availability

The research team will use Covidence and Endnote proprietary software. Alternative tools which are free and open access include Rayyan for screening of papers and Zotero for reference management.

Faculty Opinions recommended

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Version 1

VERSION 1 PUBLISHED 10 Apr 2025

Author details Author details

¹ School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, The University of Dublin, Dublin 2, D02 PN40, Ireland
² School of Psychology, Áras an Phiarsaigh, Trinity College Dublin, the University of Dublin, Dublin 2, Ireland
³ School of Nursing and Midwifery, Trinity College Dublin, The University of Dublin, 24 D’Olier Street, Dublin 2, D02 T283, Ireland
⁴ Trinity Centre for Maternity Care Research (TCMCR), School of Nursing and Midwifery, Trinity College Dublin, The University of Dublin, 24 D’Olier Street, Dublin 2, D02 T283, Ireland

Lucy Hackett
Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Deirdre M. D'Arcy
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Juliette O'Connell
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Samuel Cromie
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Déirdre Daly
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

Tamasine Grimes
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This research was funded by the Panoz Pharmaceutical Innovation PhD Scholarship at Trinity College Dublin.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Published: 10 Apr 2025, 8:53

https://doi.org/10.12688/hrbopenres.14100.1

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© 2025 Hackett L et al. 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.

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Hackett L, D'Arcy DM, O'Connell J et al. What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol. [version 1; peer review: 2 approved with reservations]. HRB Open Res 2025, 8:53 (https://doi.org/10.12688/hrbopenres.14100.1)

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Version 1

VERSION 1

PUBLISHED 10 Apr 2025

Views

13

Reviewer Report 06 Jun 2025

Sue Jordan, Swansea University, Swansea, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15493.r47082

Protocol for systematic review on barriers to breastfeeding whilst taking medicines

Thank you for the opportunity to review this protocol. Women’s knowledge and attitudes are important.
The main concern with this review protocol relates to the ... Continue reading

Protocol for systematic review on barriers to breastfeeding whilst taking medicines

Thank you for the opportunity to review this protocol. Women’s knowledge and attitudes are important.
The main concern with this review protocol relates to the omission of probably the most critical factor determining the initiation, continuation and success of breastfeeding: the biological effects of medicines on the physiology of lactation and infant behaviour. For example, the biological effects of serotonergic agents (including many antidepressants) on lactation are reported in both biomedical [1,2] and pharmaco-epidemiological research [3,4], independently of the underlying condition [5]. Women prescribed antidepressants have more difficulty in breastfeeding, with delays of ~15 hours reported [1], and need additional support [5,6,7]. Many medicines impair lactation and breastfeeding, including amphetamines, oestrogens, ergotamine derivatives, aripiprazole, promethazine, diuretics, opioids and alcohol. Polypharmacy and recreational drug use are important considerations for any work on breastfeeding [5] and should be included in all analyses.
Healthcare professionals and families may also consider the need for additional monitoring of infants, particularly those born preterm, exposed to some medicines via breastmilk, including psychotropic medicines and sedatives [8], and the impact on services [5].
It should be acknowledged that, for some medicines, such as clozapine or mycophenolate mofetil, the benefits of breastfeeding may not outweigh possible adverse effects of medicines ingested via breastmilk; this is reflected in manufacturers’ advice [8].
It would have been helpful to view the search strategy alongside the methods. There are also questions regarding the selection and deployment of ‘risk of bias’ tools, and the PICO format without identified comparators. The authors should clarify any funding from the pharmaceutical industry, making it even more critical that a holistic approach be taken to the relationship between prescribed medicines and breastfeeding. I hope this review will help the team contextualise their work.

References
1.Marshall AM, Nommsen-Rivers LA, Hernandez LL, Dewey KG, Chantry CJ, Gregerson KA, Horseman ND. 2010 (Ref 1)
2. Nyárády, K., R. Turai, and S. Funke 2020 (Ref 2)
3. Gorman, J. R., et al. 2012 (Ref 3)
4. Grzeskowiak LE, Saha MR, Nordeng H, Ystrom E, Amir LH. (Ref 4)
5. Jordan S, Davies GI, Thayer DS., Tucker D., HumphreysI. 2019 (Ref 5)
6. LactMed, Drugs and Lactation Database (LactMed®) Bethesda (MD): 2025 (Ref 6)
7. Jordan S, Komninou S, Lopez Leon S 2023 (Ref 7)
8. BNF/ Medicines Complete 2025 Psychotropic drug directory MedicinesComplete — CONTENT > Psychotropic Drug Directory > Problem areas: 3.9 Perinatal https://www.pharmaceuticalpress.com/products/psychotropic-drug-directory/

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

References

1. Marshall AM, Nommsen-Rivers LA, Hernandez LL, Dewey KG, et al.: Serotonin transport and metabolism in the mammary gland modulates secretory activation and involution.J Clin Endocrinol Metab. 2010; 95 (2): 837-46 PubMed Abstract | Publisher Full Text
2. Nyárády K, Turai R, Funke S, Györgyi E, et al.: Effects of perinatal factors on sirtuin 3, 8-hydroxy-2'- deoxyguanosine, brain-derived neurotrophic factor and serotonin in cord blood and early breast milk: an observational study.Int Breastfeed J. 2020; 15 (1): 57 PubMed Abstract | Publisher Full Text
3. Gorman JR, Kao K, Chambers CD: Breastfeeding among women exposed to antidepressants during pregnancy.J Hum Lact. 2012; 28 (2): 181-8 PubMed Abstract | Publisher Full Text
4. Grzeskowiak LE, Saha MR, Nordeng H, Ystrom E, et al.: Perinatal antidepressant use and breastfeeding outcomes: Findings from the Norwegian Mother, Father and Child Cohort Study.Acta Obstet Gynecol Scand. 2022; 101 (3): 344-354 PubMed Abstract | Publisher Full Text
5. Jordan S, Davies GI, Thayer DS, Tucker D, et al.: Antidepressant prescriptions, discontinuation, depression and perinatal outcomes, including breastfeeding: A population cohort analysis.PLoS One. 2019; 14 (11): e0225133 PubMed Abstract | Publisher Full Text
6. Sertraline. 2006. PubMed Abstract
7. Jordan S, Komninou S, Lopez Leon S: Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review.PLoS One. 2023; 18 (4): e0284128 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Medicines management, breastfeeding, pregnancy, polypharmacy.

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.

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Reviewer Report 03 Jun 2025

Ana Veronica Scotta, Universidad Nacional de Cordoba, Córdoba, Cordoba, Argentina

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15493.r47232

This mixed-methods systematic review protocol aims to explore the barriers and facilitators to self-management for women who consider breastfeeding during pharmacotherapy within the first two years postpartum. The rationale for this review is sufficiently detailed, as well as the gap ... Continue reading

This mixed-methods systematic review protocol aims to explore the barriers and facilitators to self-management for women who consider breastfeeding during pharmacotherapy within the first two years postpartum. The rationale for this review is sufficiently detailed, as well as the gap in the evidence it aims to address.
Background: When mentioning two previous reviews about the topic of breastfeeding and pharmacotherapy, I advise the authors to mention that none of these articles follow a systematic review methodology. Therefore, the proposed review would contribute to improving the quality of the existing evidence.
Research question: The authors have followed the PICO framework, but seem to have struggled to fit their research question into such a framework. Since this review does not consider a comparison, a PIO (population-intervention-outcome) or PEO (population-exposure-outcome) framework seems more appropriate. Furthermore, as no specific intervention is under study, the term “exposure” may be more fitting than “intervention.” I advise the authors to explore alternative frameworks for structuring their research question.
Search strategy: I suggest including the Global Index Medicus database, which is free to consult and covers data from peripheral countries often underrepresented in mainstream databases. Also, authors should consider searching gray literature sources. I am aware that this decision might significantly increase the workload for the authors, but gray literature does provide valuable data for systematic reviews.

Paez, A. (2017). Gray literature: An important resource in systematic reviews. Journal of Evidence‐Based Medicine, 10(3), 233-240.

Screening and selection: I see your literature search has retrieved over 8000 articles. This volume is exceedingly large for only two reviewers to manage, particularly during the full-text screening and data extraction phases. I recommend involving additional reviewers at later stages of the process, especially if the authors intend to publish the final review in 2025. Also, a third reviewer could be added for conflict resolution during the screening of abstracts, to reduce the workload during the full text stage.
Data extraction: I recommend using a bigger sample for piloting of the data extraction form.
Quality assessment: Does the MMAT checklist have cut-off points to cathegorize methodological quality? How are the authors planning to determine whether the quality of the studies is high or low? Moreover, the MMAT checklist is not comprehensive enough to determine risk of bias, which is necessary for a systematic review. Consider including other, more comprehensive tools, such as JBI’s (taking into account that the authors already use the JBI manual to guide their methodology).
Data synthesis: Are the authors planning to conduct a meta-analysis of the quantitative data? If so, the methodology for this analysis should be clearly outlined.
Public and patient involvement: Please clarify the role of the PPI panel in the review process. The current wording only states that they will be “consulted” during several stages, which is vague. A more explicit explanation of their specific contributions is needed.

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?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Maternal health, breastfeeding determinants, epidemiology.

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.

CITE

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Respond or Comment

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Version 1 10 Apr 25	read	read

Ana Veronica Scotta, Universidad Nacional de Cordoba, Córdoba, Argentina
Sue Jordan, Swansea University, Swansea, UK

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Reviewer Report

13 Views

06 Jun 2025 | for Version 1

Sue Jordan, Swansea University, Swansea, UK

13 Views Cite this report Responses(0)

Approved With Reservations

Protocol for systematic review on barriers to breastfeeding whilst taking medicines

Thank you for the opportunity to review this protocol. Women’s knowledge and attitudes are important.
The main concern with this review protocol relates to the omission of probably the most critical factor determining the initiation, continuation and success of breastfeeding: the biological effects of medicines on the physiology of lactation and infant behaviour. For example, the biological effects of serotonergic agents (including many antidepressants) on lactation are reported in both biomedical [1,2] and pharmaco-epidemiological research [3,4], independently of the underlying condition [5]. Women prescribed antidepressants have more difficulty in breastfeeding, with delays of ~15 hours reported [1], and need additional support [5,6,7]. Many medicines impair lactation and breastfeeding, including amphetamines, oestrogens, ergotamine derivatives, aripiprazole, promethazine, diuretics, opioids and alcohol. Polypharmacy and recreational drug use are important considerations for any work on breastfeeding [5] and should be included in all analyses.
Healthcare professionals and families may also consider the need for additional monitoring of infants, particularly those born preterm, exposed to some medicines via breastmilk, including psychotropic medicines and sedatives [8], and the impact on services [5].
It should be acknowledged that, for some medicines, such as clozapine or mycophenolate mofetil, the benefits of breastfeeding may not outweigh possible adverse effects of medicines ingested via breastmilk; this is reflected in manufacturers’ advice [8].
It would have been helpful to view the search strategy alongside the methods. There are also questions regarding the selection and deployment of ‘risk of bias’ tools, and the PICO format without identified comparators. The authors should clarify any funding from the pharmaceutical industry, making it even more critical that a holistic approach be taken to the relationship between prescribed medicines and breastfeeding. I hope this review will help the team contextualise their work.

References
1.Marshall AM, Nommsen-Rivers LA, Hernandez LL, Dewey KG, Chantry CJ, Gregerson KA, Horseman ND. 2010 (Ref 1)
2. Nyárády, K., R. Turai, and S. Funke 2020 (Ref 2)
3. Gorman, J. R., et al. 2012 (Ref 3)
4. Grzeskowiak LE, Saha MR, Nordeng H, Ystrom E, Amir LH. (Ref 4)
5. Jordan S, Davies GI, Thayer DS., Tucker D., HumphreysI. 2019 (Ref 5)
6. LactMed, Drugs and Lactation Database (LactMed®) Bethesda (MD): 2025 (Ref 6)
7. Jordan S, Komninou S, Lopez Leon S 2023 (Ref 7)
8. BNF/ Medicines Complete 2025 Psychotropic drug directory MedicinesComplete — CONTENT > Psychotropic Drug Directory > Problem areas: 3.9 Perinatal https://www.pharmaceuticalpress.com/products/psychotropic-drug-directory/

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

References

1. Marshall AM, Nommsen-Rivers LA, Hernandez LL, Dewey KG, et al.: Serotonin transport and metabolism in the mammary gland modulates secretory activation and involution.J Clin Endocrinol Metab. 2010; 95 (2): 837-46 PubMed Abstract | Publisher Full Text
2. Nyárády K, Turai R, Funke S, Györgyi E, et al.: Effects of perinatal factors on sirtuin 3, 8-hydroxy-2'- deoxyguanosine, brain-derived neurotrophic factor and serotonin in cord blood and early breast milk: an observational study.Int Breastfeed J. 2020; 15 (1): 57 PubMed Abstract | Publisher Full Text
3. Gorman JR, Kao K, Chambers CD: Breastfeeding among women exposed to antidepressants during pregnancy.J Hum Lact. 2012; 28 (2): 181-8 PubMed Abstract | Publisher Full Text
4. Grzeskowiak LE, Saha MR, Nordeng H, Ystrom E, et al.: Perinatal antidepressant use and breastfeeding outcomes: Findings from the Norwegian Mother, Father and Child Cohort Study.Acta Obstet Gynecol Scand. 2022; 101 (3): 344-354 PubMed Abstract | Publisher Full Text
5. Jordan S, Davies GI, Thayer DS, Tucker D, et al.: Antidepressant prescriptions, discontinuation, depression and perinatal outcomes, including breastfeeding: A population cohort analysis.PLoS One. 2019; 14 (11): e0225133 PubMed Abstract | Publisher Full Text
6. Sertraline. 2006. PubMed Abstract
7. Jordan S, Komninou S, Lopez Leon S: Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review.PLoS One. 2023; 18 (4): e0284128 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Medicines management, breastfeeding, pregnancy, polypharmacy.

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.

Respond to this report

Responses (0)

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Reviewer Report

13 Views

03 Jun 2025 | for Version 1

Ana Veronica Scotta, Universidad Nacional de Cordoba, Córdoba, Cordoba, Argentina

13 Views Cite this report Responses(0)

Approved With Reservations

This mixed-methods systematic review protocol aims to explore the barriers and facilitators to self-management for women who consider breastfeeding during pharmacotherapy within the first two years postpartum. The rationale for this review is sufficiently detailed, as well as the gap in the evidence it aims to address.
Background: When mentioning two previous reviews about the topic of breastfeeding and pharmacotherapy, I advise the authors to mention that none of these articles follow a systematic review methodology. Therefore, the proposed review would contribute to improving the quality of the existing evidence.
Research question: The authors have followed the PICO framework, but seem to have struggled to fit their research question into such a framework. Since this review does not consider a comparison, a PIO (population-intervention-outcome) or PEO (population-exposure-outcome) framework seems more appropriate. Furthermore, as no specific intervention is under study, the term “exposure” may be more fitting than “intervention.” I advise the authors to explore alternative frameworks for structuring their research question.
Search strategy: I suggest including the Global Index Medicus database, which is free to consult and covers data from peripheral countries often underrepresented in mainstream databases. Also, authors should consider searching gray literature sources. I am aware that this decision might significantly increase the workload for the authors, but gray literature does provide valuable data for systematic reviews.

Paez, A. (2017). Gray literature: An important resource in systematic reviews. Journal of Evidence‐Based Medicine, 10(3), 233-240.

Screening and selection: I see your literature search has retrieved over 8000 articles. This volume is exceedingly large for only two reviewers to manage, particularly during the full-text screening and data extraction phases. I recommend involving additional reviewers at later stages of the process, especially if the authors intend to publish the final review in 2025. Also, a third reviewer could be added for conflict resolution during the screening of abstracts, to reduce the workload during the full text stage.
Data extraction: I recommend using a bigger sample for piloting of the data extraction form.
Quality assessment: Does the MMAT checklist have cut-off points to cathegorize methodological quality? How are the authors planning to determine whether the quality of the studies is high or low? Moreover, the MMAT checklist is not comprehensive enough to determine risk of bias, which is necessary for a systematic review. Consider including other, more comprehensive tools, such as JBI’s (taking into account that the authors already use the JBI manual to guide their methodology).
Data synthesis: Are the authors planning to conduct a meta-analysis of the quantitative data? If so, the methodology for this analysis should be clearly outlined.
Public and patient involvement: Please clarify the role of the PPI panel in the review process. The current wording only states that they will be “consulted” during several stages, which is vague. A more explicit explanation of their specific contributions is needed.

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?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Maternal health, breastfeeding determinants, epidemiology.

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.

Respond to this report

Responses (0)

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[14] 14. Bakker MK, Jentink J, Vroom F, et al.: Maternal medicine: drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy‐related drugs in the Netherlands. BJOG. 2006; 113(5): 559–568. PubMed Abstract | Publisher Full Text

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[16] 16. Julsgaard M, Nørgaard M, Hvas CL, et al.: Self-reported adherence to medical treatment, breastfeeding behaviour, and disease activity during the postpartum period in women with Crohn’s disease. Scand J Gastroenterol. 2014; 49(8): 958–966. PubMed Abstract | Publisher Full Text

[17] 17. Spiesser-Robelet L, Maurice A, Gagnayre R: Understanding breastfeeding women’s behaviors toward medication: Healthcare Professionals’ viewpoint. J Hum Lact. 2019; 35(1): 137–153. PubMed Abstract | Publisher Full Text

[18] 18. Spiesser-Robelet L, Brunie V, de Andrade V, et al.: Knowledge, representations, attitudes, and behaviors of women faced with taking medications while breastfeeding: a scoping review. J Hum Lact. 2017; 33(1): 98–114. PubMed Abstract | Publisher Full Text

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What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol.

Abstract

Background

Aim

Methods

Conclusion

PROSPERO registration number

Keywords

Background

Rationale for the research

Aims and objectives

Methods

Search strategy

Screening and selection

Data extraction

Quality assessment

Data synthesis

Public and Patient Involvement

Dissemination plan

Conclusion

Time frame and current review status

Ethics and consent

Data availability

Underlying data

Extended data

Reporting guidelines

Software availability

References

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What barriers and facilitators to self-management are experienced by mothers who wish to breastfeed but require concurrent pharmacotherapy in the first two years postpartum? A mixed-methods systematic review protocol.

Abstract

Background

Aim

Methods

Conclusion

PROSPERO registration number

Keywords

Background

Rationale for the research

Aims and objectives

Methods

Search strategy

Screening and selection

Data extraction

Quality assessment

Data synthesis

Public and Patient Involvement

Dissemination plan

Conclusion

Time frame and current review status

Ethics and consent

Data availability

Underlying data

Extended data

Reporting guidelines

Software availability

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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Are you a HRB-funded researcher?

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