Household medication safety practices during the COVID-19 pandemic: a descriptive qualitative study protocol

Introduction Those who are staying at home and reducing contact with other people during the COVID-19 pandemic are likely to be at greater risk of medication-related problems than the general population. This study aims to explore household medication practices by and for this population, identify practices that benefit or jeopardise medication safety and develop best practice guidance about household medication safety practices during a pandemic, grounded in individual experiences. Methods and analysis This is a descriptive qualitative study using semistructured interviews, by telephone or video call. People who have been advised to ‘cocoon’/‘shield’ and/or are aged 70 years or over and using at least one long-term medication, or their caregivers, will be eligible for inclusion. We will recruit 100 patient/carer participants: 50 from the UK and 50 from Ireland. Recruitment will be supported by our patient and public involvement (PPI) partners, personal networks and social media. Individual participant consent will be sought, and interviews audio/video recorded and/or detailed notes made. A constructivist interpretivist approach to data analysis will involve use of the constant comparative method to organise the data, along with inductive analysis. From this, we will iteratively develop best practice guidance about household medication safety practices during a pandemic from the patient’s/carer’s perspective. Ethics and dissemination This study has Trinity College Dublin, University of Limerick and University College London ethics approvals. We plan to disseminate our findings via presentations at relevant patient/public, professional, academic and scientific meetings, and for publication in peer-reviewed journals. We will create a list of helpful strategies that participants have reported and share this with participants, PPI partners and on social media.


Introduction
There are a number of terms in the introduction that should be defined more specifically to aid understanding. Clarification is needed about what is meant by 'normal times.' Similarly, an explanation is needed of what is meant by 'lay involvement' in medication practices, as well as of 'medication performance' and of 'medication work.' The authors stated that evidence exists identifying that medication taking, and medication work, is a highly personalised and complex phenomenon that may be contingent upon, and contextualised by, one's situation, environment, processes and network. However, they provided little explanation of the complexities relating to influences in relation to what is already known from available evidence.
It is not clear what the authors mean by 'other events of major public health concern,' since in the preceding part of the sentence, they referred to lack of details about medication safety during pandemics.
The authors stated that previous studies describing drug-related problems have been undertaken from the healthcare professionals' perspective, rather than from the person taking the medication. Does this statement refer during the time of a pandemic or outside of a pandemic event? There have been numerous studies undertaken of the patients' perspective in relation to drug-related problems that consider the broader concepts of household medication practices, which the authors have not described or critiqued.
The aims and the specific objectives of the study appear appropriate.
Methods and analysis It is stated that patient and public involvement partners will be involved in data analysis. Clarification is needed about whether these individuals were involved in the development phases of the project.
For inclusion criteria, clarification is needed about which adults comprise those individuals who experience a medical vulnerability as it could be assumed that many individuals could encompass this group. Similarly for the remaining two criteria, there are many adults who are on at least one long-term medication or who have assistance from another individual with medication management.
While the authors intend to use a convenience sampling process, they will develop a matrix to document participants' backgrounds to ensure focused recruitment of a diverse sample.
It would be helpful to know about the types of individuals who utilise patient and carer advocacy groups, engagement with public and patient involvement, personal networks and social media. It is important potential participants comprise a wide array of characteristics to ensure adequate representation. It is encouraging to know that the authors will also seek out recruitment from charity groups.
The actual process of the recruitment has not been described, and further information is needed about this activity. How will the authors obtain the potential participants' contact details in order to arrange an interview?
For data analysis, clarification is needed about how sociotechnical assessment approaches using Safety I and II and Schafheutle et al.'s medication work framework will be applied.
For research rigour, the authors stated that a proportion of interviews will be quality assured by another member of the research team for validation of coding and analysis. Further explanation is needed about this process.

Impact
The authors seek to develop a person-centred medication practice safety framework for individuals staying at home and with reduced contact with others. From what is provided in the analysis section, which involves a constructivist-interpretive analysis approach, it is not clear how a person-centred medication practice safety framework will be developed. Further clarification is needed about the process of development of this framework and of the ways in which development of this framework will be influenced by other frameworks to be used during analysis.

REVIEWER
Dianne Goeman University of Newcastle, Australia REVIEW RETURNED 27-Sep-2020

GENERAL COMMENTS
This protocol paper describes a study that will explore the household medication practices of people over 70 yrs of age in the UK and the Republic of Ireland who are confined to home during the Covid-19 pandemic. The purpose of the proposed study is to develop a person-centred framework (including a list of strategies) of safe household medication practices to follow during a pandemic.
As the protocol paper is well written, meets all of the review checklist criteria and the proposed person-centred framework of safe medication practices is novel I recommend that the protocol paper be published. This protocol is well written and comprehensive and addresses an important and current medication safety topic.

Reviewers' Comments to the Author RESPONSES
Although the research team contains a good mix of academics, I note that there is no patient co-applicant. This would have been an appropriate addition to the current well developed PPI.
Many thanks for your constructive review and helpful comments on the article.
Thank you for your consideration of the research team composition and patient contribution. We notice you mention co-applicant, and we are assuming that you mean co-author and are responding to your comment on that basis.
PPI input to date has been highly valuable, as described in the protocol. Although our PPI partners did not meet the criteria for authorship of the study protocol, they are listed in the acknowledgements section, and have been offered the opportunity for co-authorship on the final paper describing our findings. We have now clarified this in the protocol manuscript.
The terminology in the title: 'household medication safety' made me immediately think of medicines kept in households in medicine cabinets -often referred to as 'household medicines'. Would it be better understood if described as 'Safe use of medicines in the home ...'?
Thank you for your suggestion and call for clarity in the title.
We have revised this to "Household Medication Safety Practices during the Covid-19 Pandemic: A Descriptive Qualitative Study Protocol". We believe this captures the essence of safe use of medicines in the home and focusses on the practices rather than on the storage.
The abstract mentions a 'Safety I/II perspective' -many people will not be familiar with this concept. Although it is expanded upon in the main part of the protocol, a brief sentence of explanation is needed here.
Upon reflection, we have removed reference to this sensitising concept from the abstract and have introduced it in the main paper where we are better able to explain these concepts.
Thank you for this valuable observation. We have reviewed the manuscript to ensure consistent use of the term "person-centred" as this reflects our consideration of both patients and carers.
Line 24: 'Reluctance to attend healthcare' could be better described as ''Reluctance to attend healthcare or restrictions on attending healthcare".
Again, thanks for this valuable suggestion. We agree and have revised accordingly.

RESPONSES General
This protocol provides details about the development of an approach to comprehensively investigate household medication practices among adults during the Covid-19 pandemic. Overall, the paper is well-written. However, there are a number of areas that need to be considered to improve the quality of the protocol, to ensure transparency of the protocol, and to make it relatively easy for readers to follow.
We are pleased that you find the paper to be mostly well written and have addressed your specific constructive suggestions for improvement below.

Abstract
During the Covid-19 pandemic, there would be many people who are staying at home, and attempting to reduce contact with other people. Additional clarification is needed to identify these individuals.
Clarification is needed in what is meant by 'as much as possible' in relation to individuals who are self-isolating.
If keeping the concepts relating to the Safety I and II perspective in the abstract, these concepts should be briefly defined. If not, then these concepts should be removed from the abstract.

Introduction
There are a number of terms in the introduction that should be defined more specifically to aid understanding. Clarification is needed about what is meant by 'normal times.' Similarly, an explanation is needed of what is meant by 'lay involvement' in medication practices, as well as of 'medication performance' and of 'medication work.' Thanks for this prompt to reflect on the terminology used. We have addressed each of these suggestions as follows: Normal times -We removed this term and specified the time periods in question.
Lay involvementpage 4, line 22. Change "Evidence suggests lay involvement" to "Evidence suggests that contribution by patients, informal carers, family members ('lay involvement'), We also added a clarification to the following sentence: "Examples of lay involvement include: patients and family members routinely take …" Medication performance -We have removed this concept from the paper.
Medication work -We have reviewed this and feel this term has been comprehensively introduced (page 4, line 34 onward). We hope that removing reference to the concept of medication performance now makes the concept of medication-related work clearer.
The authors stated that evidence exists identifying that medication taking, and medication work, is a highly personalised and complex phenomenon that may be contingent upon, and contextualised by, one's situation, environment, processes and network. However, they provided little explanation of the complexities relating to influences in relation to what is already known from available evidence.
Thank you for this observation.
While there is not room to comprehensively expand upon these complexities in this protocol paper, we have added the following to the manuscript: "Examples of such complexities include the medication user's individualised routines and strategies, the nature of medication(s) involved, the range of people involved, or the individual's illness burden (11)." It is not clear what the authors mean by 'other events of major public health concern,' since in the preceding part of the sentence, they referred to lack of details about medication safety during pandemics.
Thanks again, we have now removed 'major public health concerns' and focused on pandemics as follows: "Relatively little is known about medication safety or changes to household medication practices during a pandemic".
The authors stated that previous studies describing drug-related problems have been undertaken from the healthcare professionals' perspective, rather than from the person taking the medication. Does this statement We agree with the reviewer's statement and have taken the opportunity to highlight that our point related to the DRP classification system, rather than the topic of DRPs.
refer during the time of a pandemic or outside of a pandemic event? There have been numerous studies undertaken of the patients' perspective in relation to drug-related problems that consider the broader concepts of household medication practices, which the authors have not described or critiqued.
We have changed this text to: "Previous studies have generally classified drugrelated problems from a healthcare professional perspective, rather than that of the person taking the medication or their social network; drugrelated problems are also generally identified in the context of medication review, rather than routine household settings (35)".
The aims and the specific objectives of the study appear appropriate.
Thank you for this positive feedback.

Methods and analysis
It is stated that patient and public involvement partners will be involved in data analysis. Clarification is needed about whether these individuals were involved in the development phases of the project.
Thank you for the opportunity to clarify and highlight our reporting of this. We included this detail under the section titled "patient and public involvement" and have amended our wording slightly to make this more explicit. "PPI commenced during the development phase by partners validating our research aim and reviewing all participant-facing materials including recruitment materials, participant information leaflet, consent form and interview topic guide". For inclusion criteria, clarification is needed about which adults comprise those individuals who experience a medical vulnerability as it could be assumed that many individuals could encompass this group. Similarly for the remaining two criteria, there are many adults who are on at least one long-term medication or who have assistance from another individual with medication management.
Thanks for the opportunity to clarify this. The terms "shield" and "cocoon" are specific terms used by the UK and Irish government public health departments and have specific listed medical vulnerabilities or conditions associated with them. We have inserted the references to the websites providing this information. We have also reworded our inclusion criteria slightly to make this clearer.
While the authors intend to use a convenience sampling process, they will develop a matrix to document participants' backgrounds to ensure focused recruitment of a diverse sample. It would be helpful to know about the types of individuals who utilise patient and carer advocacy groups, engagement with public and patient involvement, personal networks and social media. It is important potential participants comprise a wide array of characteristics to ensure adequate representation. It is encouraging to know that the authors will also seek out recruitment from charity groups.
Thanks for this. We have now included detail of the variables we will include in our matrix.
We agree with the reviewer that it would be helpful to know about the types of individuals who utilise these groups and media and who participate in PPI. We will report on the study participant profile in our findings paper and we will reflect on any limitations associated with this. We are also mindful as recruitment progresses to make attempts to reach those who may not use the internet or social media.
Thanks for the invitation to clarify this.