Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage

Áine Harris; Ryan Jayesinghe; Lorna Bonnici West; Derek Stewart; Tamasine Grimes; Patrick Redmond

doi:10.12688/hrbopenres.13800.1

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Study Protocol

Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage

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

Áine Harris ¹, Ryan Jayesinghe², Lorna Bonnici West³, Derek Stewart⁴, Tamasine Grimes⁵, Patrick Redmond¹

Áine Harris ¹, Ryan Jayesinghe², [...] Lorna Bonnici West³, Derek Stewart⁴, Tamasine Grimes⁵, Patrick Redmond¹

PUBLISHED 01 Dec 2023

Author details Author details

¹ Department of General Practice, (RCSI) Royal College of Surgeons in Ireland, 123 Stephen’s Green, Dublin 2, D02 YN77, Ireland
² Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, CB2 0QQ, UK
³ Applied Research and Innovation Centre, Malta College of Arts Science and Technology, Paola, PLA9032, Malta
⁴ College of Pharmacy, QU Health, Qatar University, Doha, Qatar
⁵ School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, The University of Dublin Trinity College, Dublin 2, D02 PN40, Ireland

Áine Harris
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Ryan Jayesinghe
Roles: Formal Analysis, Investigation, Validation, Writing – Review & Editing

Lorna Bonnici West
Roles: Validation, Writing – Review & Editing

Derek Stewart
Roles: Validation, Writing – Review & Editing

Tamasine Grimes
Roles: Data Curation, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Patrick Redmond
Roles: Conceptualization, Formal Analysis, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Introduction

A reduction in medicines wastage is an important objective in promoting appropriate use of finite resources. The objective of this systematic review is to both assess the effectiveness of interventions to reduce medicines wastage, and apply a systems based exploration of the factors affecting implementation of interventions.

Methods

A systematic review will be conducted following PRISMA reporting guidelines. Searches will be performed in Cumulated Index to Nursing and Allied Health Literature (CINAHL), Embase, Medline, PubMed, Science Citation Index, PsycInfo, Scopus, the Cochrane Library, grey literature, and trials registries. Data extraction and critical appraisal will be completed independently by two reviewers. If studies are sufficiently homogenous in terms of design and comparators, we will conduct a meta-analysis. Where this is not possible, we will provide a narrative synthesis of results grouping studies with similar interventions together. The barriers and enablers of the described interventions will then be analysed using the Systems Engineering Initiative in Patient Safety (SEIPS 101) model.

Conclusions

This review will describe the effectiveness of interventions to reduce medicines wastage and issues associated with their implementation in order to inform policy development and intervention implementation in the future. This will have the potential to reduce both the economic and environmental burden of medicines wastage on the health service.

PROSPERO registration

CRD42022335848 (12/06/2022)

Keywords

Drug utilisation, healthcare costs, waste management, systematic review, medicines wastage, waste reduction interventions, human factors, safety science, systems engineering.

Corresponding author: Áine Harris

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Harris Á 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: Harris Á, Jayesinghe R, Bonnici West L et al. Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:69 (https://doi.org/10.12688/hrbopenres.13800.1) First published: 01 Dec 2023, 6:69 (https://doi.org/10.12688/hrbopenres.13800.1) Latest published: 01 Dec 2023, 6:69 (https://doi.org/10.12688/hrbopenres.13800.1)

Introduction

Reducing all forms of wastage, including that of medicines, is a key goal in promoting the appropriate use of finite resources¹. The European Union Waste Framework Directive defines ‘waste’ as ‘any substance or object which the holder discards or intends or is required to discard’². A communication document issued in 2019 from the commission to the European parliament, outlines aims to reduce the wastage of ‘pharmaceuticals’ and their proper disposal - it codes pharmaceutical waste as ‘medicines’³.

Numerous UK reports have concluded that the direct costs of unused prescription medicines to the National Health Service (NHS) amounted to £300 million annually, with more than half being preventable^4–6. This is the cost of the many dispensed medicines that end up unused or wasted with 250 tonnes of out-of-date and surplus returned each year to pharmacies in the UK⁷. Similar costs are evident worldwide with the projected cost of wasted medicines in the US estimated as $117B in 2015⁸. A cross-sectional survey in Jordan also highlighted a total medicines wastage bill of $150 million in the capital Amman in 2013⁹. NHS England also report that the scale of this wastage will further increase as patient medicines lists become more complex in an aging population⁷.

There are many clear implications of medicines wastage with economic burden on the government and society being the most prominent. For example, poor medication compliance can worsen symptoms, and patients often return to GP practices and hospitals for more treatment, increasing the strain on health services¹⁰. There are also indirect costs of medicines wastage, such as diversion of resources to further supply, prescribing, and dispensing actions. The environmental effects associated with wastage disposal are also increasingly recognised. Medicines contribute to 25% of NHS emissions, with inhalers and anaesthetic gases accounting for 5% alone at point of use¹¹. Despite this, the area of sustainable medicines has only been minimally explored.

A number of reviews in this area have examined the causative factors of medicines wastage and potential interventions to reduce medicines wastage^12–16. Interventions to tackle this issue have included deprescribing, and the altering of duration or the nature of dispensing of repeat prescriptions¹⁷. The management of medicines wastage varies markedly across settings with factors such as patient/healthcare professional interaction, manufacturing, logistics, and existing safety systems amongst others all playing a role. This complexity can potentially be addressed by adopting a systems thinking approach to Human Factors¹⁸. The Systems Engineering Initiative for Patient Safety (SEIPS) model has been deployed widely and provides a usable Human Factors Engineering framework for application in healthcare systems. SEIPS proposes that systems contain work systems, each made up of elements, e.g., people, or tools, that interact dynamically in processes to produce outcomes. Understanding how the system works (and the micro, meso, and macro-organisational layers) provides knowledge to support system improvement. SEIPS has been applied to examine and improve several complex healthcare phenomena, including medication management^19–21. It provides an easy-to-use systems engineering approach with accompanying template tools and matrices²².

This review will build on these existing publications by updating the literature, focussing on the effectiveness of interventions and using the systems engineering (SEIPS) model to analyse the barriers and enabling factors affecting their implementation.

Objectives

The aim of this systematic review is to describe effectiveness of interventions to reduce medicines wastage and the factors affecting their implementation. Specific objectives include (1) identify interventions to reduce medicines wastage, (2) determine the effectiveness of these interventions, (3) and apply a systems based framework²¹ to examine the barriers and enabling factors affecting implementation.

Methods

We will conduct a systematic review and, where appropriate, meta-analysis. We will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in reporting and the Systems Engineering Initiative for Patient Safety (SEIPS 101) model to provide a structured framework to analyse the factors affecting intervention implementation²³. We registered the protocol prospectively (PROSPERO CRD42022335848) on 12^th June 2022. This protocol is reported in line with PRISMA-P guidelines²⁴.

Eligibility criteria

All primary research study designs (quantitative, qualitative and mixed methods) will be eligible for inclusion that report empirical data. Papers written in languages other than English, opinion pieces and letters not describing original data collection will be excluded. Studies describing medical wastage (e.g. clinical tissue wastage/medical devices), those that are focussed solely on medication storage and disposal or impact of medication wastage on the environment will also be excluded.

Full eligibility criteria include:

Population: Studies involving patients, healthcare professionals, students, commissioners, service providers, policy-makers and/or decision-makers in any healthcare setting. There will be no restriction in terms of age, gender, ethnicity, or location.

Interventions: Studies reporting interventions to reduce medicines wastage at any stage of the medicines use process (e.g. dispensing regimes, altered manufacturing procedures). The definition ‘medicines wastage’ as described in the EU report will be applied in this review. We will categorise interventions into broad categories, as defined by the Cochrane Effective Practice and Organisation of Care (EPOC) review group, including professional interventions, financial, organisational, and regulatory²⁵.

Comparison: Data on comparison groups (i.e. received ‘usual care’), where reported will be included but studies with no control or comparator population will also be eligible for inclusion.

Outcomes: The outcomes will be categorised as per SEIPS framework e.g. patient, professional, and organisational. We will also explicitly report cost and adverse effects outcomes where available.

Search strategy

We will systematically search the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Medline, PubMed, PsycInfo, Scopus, Science Citation Index and The Cochrane Library using terms relating to medicines wastage, surplus medicines, and solutions to wastage and limiting to studies from January 2011 to May 2022. The broad search strategy created by West et al.¹⁶ will be adapted to other databases using appropriate syntax and vocabulary for those databases. (A Medline search string is available as Extended data²⁶).

Conference abstracts will be included. Grey literature searches will also be conducted in Agency for Healthcare Research and Quality, Grey Literature report and the NICE website. Searches for registered ongoing/completed trials will be conducted in the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov. Additionally, we will review reference lists of all included studies and relevant systematic reviews.

Study selection

Search results from all sources will be collected and duplicate records removed. Two reviewers will independently assess the title, followed by abstract and any inconsistencies that arise between the reviewers will be resolved by consensus. The studies identified by this search will have full text retrieved and will be screened by the two independent reviewers to meet the inclusion and exclusion criteria. We will record the reasons for excluding studies following full text review.

Data extraction

Reviewers will extract data, using a predefined data collection template, based on a modified EPOC template²⁷, with a sample of 10% double checked for accuracy and disagreements resolved by discussion. Data extracted will include participants, country, study design, description of the training/intervention and comparator if applicable, setting and context, inclusion and exclusion criteria outcomes, funding, outcomes and system factors as described within the SEIPS framework. The three primary components of SEIPS include: Work System (including subcomponents of Person(s), Tasks, Internal Environment, External Environment, Tools and Technologies and Organisation), Processes (including subcomponents of Cognitive, Physical, Social and Behavioural) and Outcomes (including subcomponents of Patient, Professional and Organisational).

We will contact lead study investigators or corresponding authors for any missing trial data or data missing from published reports or for additional clarification. If there is any missing data from a study, we will explicitly state this.

We will tabulate and screen all pre-intervention and post-intervention results (sample sizes, means, proportions, 95% confidence interval (CI)) for each group within each outcome, and differences between the groups, where possible.

Risk of bias

Risk of bias will be judged independently by two reviewers using the Mixed Methods Appraisal Tool (MMAT)²⁸, a recognised tool developed for the appraisal of varied study types. MMAT classifies study designs as: (1) qualitative, (2) quantitative randomised, (3) quantitative non-randomised (non-randomised intervention studies and observational cohort studies), (4) quantitative descriptive (e.g. surveys, case series, incidence or prevalence study) or (5) mixed methods.

For each different study design, the MMAT determinesvarious domains of risk of bias criteria, each assessed as low, high or unclear risk of bias, but does not provide an overall summary risk of bias across domains. To facilitate the next stage, GRADE (the Grading of Recommendations, Assessment, Development and Evaluation) assessment, we will calculate a summary estimate for each individual study based on a global assessment across the several MMAT domains. Each study will be then be classified as low, high or unclear risk of bias overall. Regarding Human Factors, we will assess whether entities and interactions could be categorized using the SEIPS model.

We will use GRADE to assess the quality of the overall body of evidence for each outcome. GRADE categorises the overall evidence as high, moderate, low or very low²⁹.

Data synthesis

Firstly, we will define the system entities and categorize the factors considered to relate to these entities. Then we will identify work processes and categorize these according to SEIPS definitions. We will then identify interactions between the work system factors that have the potential to influence work processes and therefore the effectiveness of outcomes. The data will be presented in tables summarising and explaining the characteristics and findings of included studies³⁰.

Effectiveness - If studies are sufficiently homogenous in terms of design and comparators, we will conduct a meta-analysis. Studies will be categorised for meta-analysis based on study design (i.e. randomised and non-randomised evidence treated separately).

Summary of findings - Finally, we will prepare a ‘Summary of findings’ table to draw conclusions about the certainty of the evidence within the text of the review. We will use GRADE to assess the quality of the overall evidence for all outcomes.

Subgroup analysis

Subgroup analyses will be carried out where data allows according to the following characteristics:

• Setting of care

• Participants

• Intervention type

Sensitivity analysis

We will conduct, where possible, a sensitivity analysis to calculate the effect of risk of bias (including missing data) within studies on effect size, by calculating the effect of excluding or including studies with a higher risk of bias.

Dissemination and Patient and Public Involvement and Engagement (PPIE)

Throughout the duration of this project, we will engage with patients and the public to ensure their perspectives are considered, enhancing the relevance and impact of our work. We will involve a patient and public involvement (PPI) panel in the design and conduct of the systematic review, ensuring the research questions and outcomes align with the interests and concerns of those directly affected by medicine wastage. Further, we will facilitate two-way knowledge exchange by sharing progress and findings with PPI representatives and seeking their input at key stages of the review.

Our dissemination strategy aims to reach a broad range of audiences, including clinicians, healthcare managers, policy makers, patients, and the public. We will disseminate our findings through academic channels, including publication in a peer-reviewed journal and presentation at relevant conferences. Additionally, we will create accessible summaries of our findings for non-academic audiences, which will be disseminated via social media, newsletters, and local health forums. By engaging with diverse stakeholders in our research process and disseminating our findings widely, we hope to contribute meaningfully to efforts to reduce medicine wastage.

Study status

The study collection, data extraction and risk of bias stages of this study have been completed to date. We are currently completing the data synthesis stage. So far we have determined system components and the next step is categorising interventions based on SEIPS definitions. This will highlight work system factors so that intervention effectiveness can be assessed in the final stages of data synthesis.

Discussion

This systematic review and systems-based exploration will provide a comprehensive overview of interventions designed to reduce medicines wastage, assessing their effectiveness and identifying the factors affecting their implementation. In light of the economic and environmental burden of medicines wastage on the healthcare system globally, the findings of this review will be significant. Given the complex nature of medicines wastage, a holistic systems-based approach like SEIPS will enable a better understanding of the contributing factors, and can provide insights to guide the design and implementation of more effective interventions.

This review will advance current understanding of this problem by integrating the quantitative evidence on the effectiveness of various interventions, as well as understanding the human factors and systemic barriers to successful implementation. Further, this review will bring much-needed attention to this under-explored area of healthcare research and practice, potentially inspiring further research and system-level changes in the field of medicines wastage.

This protocol provides a transparent and replicable process, aligning with best practices in conducting systematic reviews. We expect that the results of this study will be of interest to a broad range of stakeholders, including citizens, healthcare providers, policy makers, researchers, and even pharmaceutical industries, who collectively play a pivotal role in reducing medicines wastage. Ultimately, this systematic review will inform the development of evidence-based policies and strategies to reduce medicines wastage, thereby reducing the economic burden on health services and society and mitigating environmental harm.

Data availability

Underlying data

No data are associated with this article.

Extended data

Zenodo: Appendix 1 and PROSPERO Registration of a protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage. https://doi.org/10.5281/zenodo.8072181²⁶.

Reporting guidelines

Zenodo: PRISMA-P 2015 Checklist: Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage.

https://doi.org/10.5281/zenodo.8432049²⁴.

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Faculty Opinions recommended

References

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2. Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008. Official Journal of the European Union, Published online 2008; Accessed May 12, 2022. Reference Source
3. Commision Notice: Separate Collection of Household Hazardous waste. Official Journal of the European Union, Published online November 6, 2020; Accessed May 11, 2022. Reference Source
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13. Jafarzadeh A, Mahboub-Ahari A, Najafi M, et al.: Medicine storage, wastage, and associated determinants among urban households: a systematic review and meta-analysis of household surveys. BMC Public Health. 2021; 21(1): 1127. PubMed Abstract | Publisher Full Text | Free Full Text
14. White KG: UK interventions to control medicines wastage: a critical review. Int J Pharm Pract. 2010; 18(3): 131–140. PubMed Abstract
15. Yemm R, Jones C, Mitoko T: Displaying medication costs on dispensing labels as a strategy to reduce wastage: views of the Welsh general public. Integr Pharm Res Pract. 2017; 6: 173–180. PubMed Abstract | Publisher Full Text | Free Full Text
16. West LM, Diack L, Cordina M, et al.: A systematic review of the literature on ‘medication wastage’: an exploration of causative factors and effect of interventions. Int J Clin Pharm. 2014; 36(5): 873–881. PubMed Abstract | Publisher Full Text
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Author details Author details

¹ Department of General Practice, (RCSI) Royal College of Surgeons in Ireland, 123 Stephen’s Green, Dublin 2, D02 YN77, Ireland
² Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, CB2 0QQ, UK
³ Applied Research and Innovation Centre, Malta College of Arts Science and Technology, Paola, PLA9032, Malta
⁴ College of Pharmacy, QU Health, Qatar University, Doha, Qatar
⁵ School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, The University of Dublin Trinity College, Dublin 2, D02 PN40, Ireland

Áine Harris
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Ryan Jayesinghe
Roles: Formal Analysis, Investigation, Validation, Writing – Review & Editing

Lorna Bonnici West
Roles: Validation, Writing – Review & Editing

Derek Stewart
Roles: Validation, Writing – Review & Editing

Tamasine Grimes
Roles: Data Curation, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Patrick Redmond
Roles: Conceptualization, Formal Analysis, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, 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 (1)

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Published: 01 Dec 2023, 6:69

https://doi.org/10.12688/hrbopenres.13800.1

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© 2023 Harris Á 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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Harris Á, Jayesinghe R, Bonnici West L et al. Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:69 (https://doi.org/10.12688/hrbopenres.13800.1)

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Reviewer Report 13 May 2024

Delyth H James, Cardiff Metropolitan University, Cardiff, Wales, UK

Approved

https://doi.org/10.21956/hrbopenres.15099.r38712

Thank you for inviting me to review this protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage. Medicines wastage is an enormous problem in our global societies, which comes with significant cost implications to our ... Continue reading

Thank you for inviting me to review this protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage. Medicines wastage is an enormous problem in our global societies, which comes with significant cost implications to our healthcare systems and clinical implications in terms of poor patient outcomes.
The protocol follows established convention and guidelines in terms of processes and presentation ,some of the minor issues are stated below:
1. How will you decide whether or not the studies are 'sufficiently homogenous in terms of design and comparators'. I understand that this might be difficult to describe a priori, however the inclusion of .all types of quantitative and qualitative research outputs means that this is likely to be a challenge at some point. Are you able to provide more details or propose a definition of 'sufficient'?
2. There are a few very minor inconsistencies with use of abbreviations where they are not stated in full first time (e.g. UK, US, B, GRADE put after the full term, , WHO, NICE).whereas most terms (e.g. CINAHL) are perfectly presented in this way, which is to be commended.
3. The term medication adherence is preferred to medication compliance in order to account for the full range of reasons that patients may not use their medicine.
4. Introduction - 'The .management of medicines wastage varies markedly...' I'm not sure that I fully understand these factors, for example manufacturing, logistics...Can you expand a bit further on this?
5. micro, meso and macro-organisational layers needs a reference.
6. Objectives - the missing before 'effectiveness'.
7. Eligibility criteria - line 2 - will be eligible for inclusion - move to the end of the sentence.
8. Full eligibility criteria - will carers be included in the population for exploration?
9. Interventions - move this word to the end of the sentence after 'regulatory'.
10. Reference list - there is some missing details for being able to access Refs 6, 7, 25, 26 and 28.

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: Systematic reviews, medicines waste, medicines adherence

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.

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Reviewer Report 08 May 2024

Elaine Aparecida Regiani de Campos, University of Sao Paulo, Sao Paulo, Brazil

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15099.r39138

Positive Feedback: The article presents a clear and relevant objective, addressing the need to reduce medicine wastage. The systematic review protocol is well-structured, following PRISMA guidelines and the SEIPS 101 model, enhancing the reliability and transparency of the

Positive Feedback: The article presents a clear and relevant objective, addressing the need to reduce medicine wastage. The systematic review protocol is well-structured, following PRISMA guidelines and the SEIPS 101 model, enhancing the reliability and transparency of the process. Including an analysis of human and systemic factors through the SEIPS model provides a holistic approach to understanding the factors influencing intervention implementation. The review has the potential to contribute to the development of evidence-based policies and strategies to reduce medicine wastage, as well as provide insights for future research and healthcare system changes.
Areas for Improvement: While the protocol has been well outlined, it might be useful to include a section discussing potential study limitations, such as possible selection or reporting biases. Providing more details on the criteria for excluding studies, especially regarding studies that will be deemed ineligible, would be beneficial. The discussion could be expanded to more clearly highlight the significance of the anticipated review outcomes and how they may impact clinical practice and healthcare policies.

Overall, the article presents a robust and relevant protocol for a systematic review addressing an important issue in healthcare. With some suggested improvements and careful execution of the protocol, this review has the potential to make significant contributions to clinical practice and health policy formulation.

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?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: -systematic review

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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Elaine Aparecida Regiani de Campos, University of Sao Paulo, Sao Paulo, Brazil
Delyth H James, Cardiff Metropolitan University, Cardiff, UK

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13 May 2024 | for Version 1

Delyth H James, Cardiff Metropolitan University, Cardiff, Wales, UK

5 Views Cite this report Responses(0)

Approved

Thank you for inviting me to review this protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage. Medicines wastage is an enormous problem in our global societies, which comes with significant cost implications to our healthcare systems and clinical implications in terms of poor patient outcomes.
The protocol follows established convention and guidelines in terms of processes and presentation ,some of the minor issues are stated below:
1. How will you decide whether or not the studies are 'sufficiently homogenous in terms of design and comparators'. I understand that this might be difficult to describe a priori, however the inclusion of .all types of quantitative and qualitative research outputs means that this is likely to be a challenge at some point. Are you able to provide more details or propose a definition of 'sufficient'?
2. There are a few very minor inconsistencies with use of abbreviations where they are not stated in full first time (e.g. UK, US, B, GRADE put after the full term, , WHO, NICE).whereas most terms (e.g. CINAHL) are perfectly presented in this way, which is to be commended.
3. The term medication adherence is preferred to medication compliance in order to account for the full range of reasons that patients may not use their medicine.
4. Introduction - 'The .management of medicines wastage varies markedly...' I'm not sure that I fully understand these factors, for example manufacturing, logistics...Can you expand a bit further on this?
5. micro, meso and macro-organisational layers needs a reference.
6. Objectives - the missing before 'effectiveness'.
7. Eligibility criteria - line 2 - will be eligible for inclusion - move to the end of the sentence.
8. Full eligibility criteria - will carers be included in the population for exploration?
9. Interventions - move this word to the end of the sentence after 'regulatory'.
10. Reference list - there is some missing details for being able to access Refs 6, 7, 25, 26 and 28.

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

Systematic reviews, medicines waste, medicines adherence

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.

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Reviewer Report

6 Views

08 May 2024 | for Version 1

Elaine Aparecida Regiani de Campos, University of Sao Paulo, Sao Paulo, Brazil

6 Views Cite this report Responses(0)

Approved With Reservations

Positive Feedback: The article presents a clear and relevant objective, addressing the need to reduce medicine wastage. The systematic review protocol is well-structured, following PRISMA guidelines and the SEIPS 101 model, enhancing the reliability and transparency of the process. Including an analysis of human and systemic factors through the SEIPS model provides a holistic approach to understanding the factors influencing intervention implementation. The review has the potential to contribute to the development of evidence-based policies and strategies to reduce medicine wastage, as well as provide insights for future research and healthcare system changes.
Areas for Improvement: While the protocol has been well outlined, it might be useful to include a section discussing potential study limitations, such as possible selection or reporting biases. Providing more details on the criteria for excluding studies, especially regarding studies that will be deemed ineligible, would be beneficial. The discussion could be expanded to more clearly highlight the significance of the anticipated review outcomes and how they may impact clinical practice and healthcare policies.

Overall, the article presents a robust and relevant protocol for a systematic review addressing an important issue in healthcare. With some suggested improvements and careful execution of the protocol, this review has the potential to make significant contributions to clinical practice and health policy formulation.

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?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

-systematic review

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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[1] 1. Communication from the Commission of the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions-Taking Sustainable Use of Resources Forward: A Thematic Strategy on the Prevention and Recycling of Wast. Commission of the European Communities, Published online 2005. Reference Source

[2] 2. Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008. Official Journal of the European Union, Published online 2008; Accessed May 12, 2022. Reference Source

[3] 3. Commision Notice: Separate Collection of Household Hazardous waste. Official Journal of the European Union, Published online November 6, 2020; Accessed May 11, 2022. Reference Source

[4] 4. Naughton M, Payne RA: The fight against climate change in primary care: a prescription for change. Fam Pract. 2023; 40(3): 508–510. PubMed Abstract | Publisher Full Text

[5] 5. Tennison I, Roschnik S, Ashby B, et al.: Health care’s response to climate change: a carbon footprint assessment of the NHS in England. Lancet Planet Health. 2021; 5(2): e84–e92. PubMed Abstract | Publisher Full Text | Free Full Text

[6] 6. York Health Economics Consortium, Trueman P, Lowson K, et al.: Evaluation of the Scale, Causes and Costs of Waste Medicines Final Report. Reference Source

[7] 7. Duerden M, Avery T, Payne R: Polypharmacy and medicines optimisation: Making it safe and sound. Accessed April 21, 2022. Reference Source

[8] 8. Law AV, Sakharkar P, Zargarzadeh A, et al.: Taking stock of medication wastage: Unused medications in US households. Res Social Adm Pharm. 2015; 11(4): 571–578. PubMed Abstract | Publisher Full Text

[9] 9. Abushanab AS, Sweileh WM, Wazaify M: Storage and wastage of drug products in Jordanian households: a cross-sectional survey. Int J Pharm Pract. 2013; 21(3): 185–191. PubMed Abstract | Publisher Full Text

[10] 10. Reducing Medicines Waste in Bristol - Bristol - Citizen Space. Accessed April 28, 2022.

[11] 11. Delivering a “Net Zero” National Health Service. Published 2020; Accessed May 5, 2022. Reference Source

[12] 12. Makki M, Hassali MA, Awaisu A, et al.: The Prevalence of Unused Medications in Homes. Pharmacy (Basel). 2019; 7(2): 61. PubMed Abstract | Publisher Full Text | Free Full Text

[13] 13. Jafarzadeh A, Mahboub-Ahari A, Najafi M, et al.: Medicine storage, wastage, and associated determinants among urban households: a systematic review and meta-analysis of household surveys. BMC Public Health. 2021; 21(1): 1127. PubMed Abstract | Publisher Full Text | Free Full Text

[14] 14. White KG: UK interventions to control medicines wastage: a critical review. Int J Pharm Pract. 2010; 18(3): 131–140. PubMed Abstract

[15] 15. Yemm R, Jones C, Mitoko T: Displaying medication costs on dispensing labels as a strategy to reduce wastage: views of the Welsh general public. Integr Pharm Res Pract. 2017; 6: 173–180. PubMed Abstract | Publisher Full Text | Free Full Text

[16] 16. West LM, Diack L, Cordina M, et al.: A systematic review of the literature on ‘medication wastage’: an exploration of causative factors and effect of interventions. Int J Clin Pharm. 2014; 36(5): 873–881. PubMed Abstract | Publisher Full Text

[17] 17. White KG: UK interventions to control medicines wastage: a critical review. Int J Pharm Pract. 2010; 18(3): 131–140. PubMed Abstract

[18] 18. Pickup L, Lang A, Atkinson S, et al.: The dichotomy of the application of a systems approach in UK healthcare the challenges and priorities for implementation. Ergonomics. 2018; 61(1): 15–25. PubMed Abstract | Publisher Full Text

[19] 19. Mundt MP, Swedlund MP: A human factors systems approach to understanding team-based primary care: a qualitative analysis. Fam Pract. 2016; 33(6): 721–726. PubMed Abstract | Publisher Full Text | Free Full Text

[20] 20. Werner NE, Rutkowski R, Graske A, et al.: Exploring SEIPS 2.0 as a model for analyzing care transitions across work systems. Appl Ergon. 2020; 88: 103141. PubMed Abstract | Publisher Full Text | Free Full Text

[21] 21. Wooldridge AR, Carayon P, Hoonakker P, et al.: Care transition of trauma patients: Processes with articulation work before and after handoff. Appl Ergon. 2022; 98: 103606. PubMed Abstract | Publisher Full Text | Free Full Text

[22] 22. Holden RJ, Carayon P: SEIPS 101 and seven simple SEIPS tools. BMJ Qual Saf. 2021; 30(11): 901–910. PubMed Abstract | Publisher Full Text | Free Full Text

[23] 23. Page MJ, McKenzie JE, Bossuyt PM, et al.: The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ. 2021; 372: n71. PubMed Abstract | Publisher Full Text | Free Full Text

[24] 24. Harris A, Jayesinghe R, West B, et al.: PRISMA-P 2015 Checklist: Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage. Zenodo. 2023. http://www.doi.org/10.5281/zenodo.8432049

[25] 25. Effective Practice and Organisation of Care (EPOC): The EPOC taxonomy of health systems interventions. EPOC Resources for review authors. Reference Source

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Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage

Abstract

Introduction

Methods

Conclusions

PROSPERO registration

Keywords

Introduction

Objectives

Methods

Eligibility criteria

Search strategy

Study selection

Data extraction

Risk of bias

Data synthesis

Subgroup analysis

Sensitivity analysis

Dissemination and Patient and Public Involvement and Engagement (PPIE)

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

References

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Reviewer Reports

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Protocol for a systematic review and systems-based exploration of interventions to reduce medicines wastage

Abstract

Introduction

Methods

Conclusions

PROSPERO registration

Keywords

Introduction

Objectives

Methods

Eligibility criteria

Search strategy

Study selection

Data extraction

Risk of bias

Data synthesis

Subgroup analysis

Sensitivity analysis

Dissemination and Patient and Public Involvement and Engagement (PPIE)

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

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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