Medicines Shortages Reporting Systems (MSRS): An exploratory review of access and sustainability.

BACKGROUND: The efficacy of medicines depends on their accessibility and availability. Dedicated medicine shortage reporting systems (MSRS) have been set up in different countries, either mandatory or voluntary, following the recommendations of the World Health Organisation to ensure these. OBJECTIVES: To explore how the Medicine Shortages Reporting System (MSRS) can tackle medicine shortages through improved access and sustainability. METHODS: Personnel directly involved in the reporting mechanisms for medicine shortages in eight (8) countries participated in semi-structured interviews. An interview protocol based on the Dynamic Capabilities View and Organisational Information Processing Theory (OIPT) was developed. It contained questions related to participant's views on the process involved in MSRS and how it was used to tackle shortages. Data were thematically analysed. RESULTS: Three core elements were identified to influence MSRS's ability to tackle shortages and ensure sustainability; (1) the ability to identify what information requirements the reporting system needs, (2) identify information processing capabilities, and (3) the ability to match requirements and information processing capabilities through a dynamic capability decision-making process. The dynamic decision-making process involves reiteratively sensing shortages by understanding and validating information received. CONCLUSION: Building MSRS to tackle shortages for accessibility and sustainability is a systemic process that entails understanding the various elements and processes of MSRS. It includes defining medicine shortages, reconfiguring resources, defining accessibility and ensuring the system's sustainability. Our study provides insights into MSRS developed for mitigating medicine shortages and provides a framework for a sustainable MSRS. The findings extend the literature on medicine shortage management by identifying the various elements required to set up an MSRS. It also provides practical implications for countries that seek to establish MSRS to mitigate medicine shortages. Further studies could extend the number of participating countries to provide a clearer picture of the MSRS and how it can reduce medicine shortages.

Person-centred deprescribing for patients living with frailty: a qualitative interview study and proposal of a collaborative model.

OBJECTIVES: (1) Present deprescribing experiences of patients living with frailty, their informal carers and healthcare professionals; (2) interpret whether their experiences are reflective of person-centred/collaborative care; (3) complement our findings with existing evidence to present a model for person-centred deprescribing for patients living with frailty, based on a previous collaborative care model. METHODS: Qualitative design in English primary care (general practice). Semi-structured interviews were undertaken immediately post-deprescribing and 5/6 weeks later with nine patients aged 65+ living with frailty and three informal carers of patients living with frailty. Fourteen primary care professionals with experience in deprescribing were also interviewed. In total, 38 interviews were conducted. A two-staged approach to data analysis was undertaken. KEY FINDINGS: Three themes were developed: attitudes, beliefs and understanding of medicines management and responsibility; attributes of a collaborative, person-centred deprescribing consultation; organisational factors to support person-centred deprescribing. Based on these findings and complementary to existing evidence, we offer a model for person-centred deprescribing for patients living with frailty. CONCLUSIONS: Previous models of deprescribing for patients living with frailty while, of value, do not consider the contextual factors that govern the implementation and success of models in practice. In this paper, we propose a novel person-centred model for deprescribing for people living with frailty, based on our own empirical findings, and the wider evidence base.

Exploration of meaning, motivation, and preparedness to care amongst the one-child policy generation in China.

OBJECTIVES: In China there is a cultural expectation (Xiao, -filial piety) that offspring should provide care for their parents. However, the sustainability of this is threatened by the impact of the One-Child Policy (OCP) (1979-2015), which has resulted in a diminution in numbers of children available to care, rapid urbanisation and increase in the number of women in employment. In this context, the objective was to explore the motivations, meaning, and preparedness for future caregiving of offspring affected by the OCP. DESIGN AND METHODS: We adopted a constructivist position using a hermeneutic phenomenology approach and interviewed eight current and prospective caregivers aged 20-35 years about future caregiving responsibilities. Data were obtained through in-depth interviews, analysed using reflective Thematic Analysis. RESULTS AND CONCLUSION(S): Three prominent themes: (i) Caregiving beliefs, (ii) Caregiving conditions and (iii) Contextual factors were identified under an overarching theme "Competing pressures-meanings, motivation and preparedness". Despite the inherent stress, participants envisaged providing or organising care in the future to fulfil Xiao, and most viewed long-term care settings as unviable. Ultimately, the findings suggested that the actual performance of caregiving would not always measure up to ideal expectations, resulting in 'filial discrepancy' that is, a gap between societal expectations for caregiving to older relatives and actual caregiving performance. This could adversely impact the caregivers and quality of care provided. The findings highlighted the urgent need to develop culturally attuned services, including education and training for family caregivers, health and social care professionals.

Co-designing an intervention to improve the process of deprescribing for older people living with frailty in the United Kingdom.

BACKGROUND: In older people living with frailty, polypharmacy can lead to preventable harm like adverse drug reactions and hospitalization. Deprescribing is a strategy to reduce problematic polypharmacy. All stakeholders should be actively involved in developing a person-centred deprescribing process that involves shared decision-making. OBJECTIVE: To co-design an intervention, supported by a logic model, to increase the engagement of older people living with frailty in the process of deprescribing. DESIGN: Experience-based co-design is an approach to service improvement, which uses service users and providers to identify problems and design solutions. This was used to create a person-centred intervention with the potential to improve the quality and outcomes of the deprescribing process. A 'trigger film' showing older people talking about their healthcare experiences was created and facilitated discussions about current problems in the deprescribing process. Problems were then prioritized and appropriate solutions were developed. The review located the solutions in the context of current processes and procedures. An ideal care pathway and a complex intervention to deliver better care were developed. SETTING AND PARTICIPANTS: Older people living with frailty, their informal carers and professionals living and/or working in West Yorkshire, England, UK. Deprescribing was considered in the context of primary care. RESULTS: The current deprescribing process differed from an ideal pathway. A complex intervention containing seven elements was required to move towards the ideal pathway. Three of these elements were prototyped and four still need development. The complex intervention responded to priorities about (a) clarity for older people about what was happening at all stages in the deprescribing process and (b) the quality of one-to-one consultations. CONCLUSIONS: Priorities for improving the current deprescribing process were successfully identified. Solutions were developed and structured as a complex intervention. Further work is underway to (a) complete the prototyping of the intervention and (b) conduct feasibility testing. PATIENT OR PUBLIC CONTRIBUTION: Older people living with frailty (and their informal carers) have made a central contribution, as collaborators, to ensure that a complex intervention has the greatest possible potential to enhance the experience of deprescribing medicines.

Issues affecting supply of palliative medicines into community pharmacy: A qualitative study of community pharmacist and pharmaceutical wholesaler/distributor perspectives.

Background: Patient access to medicines in the community at end-of-life (pertaining to the last year of life) is vital for symptom control. Supply of such medicines is known to be problematic, but despite this, studies have failed to examine the issues affecting community pharmacy access to palliative medicines. Objective: To identify community pharmacists' and pharmaceutical wholesalers'/distributors' views on supply chain processes and challenges in providing access to medicines during the last year of life, to characterise supply in this UK context. Methods: Qualitative design, with telephone interviews analysed using Framework Analysis. Coding frames were developed iteratively with data analysed separately and then triangulated to examine differences in perspectives. Findings: Thirty-two interviews (24 community pharmacists and 8 wholesalers/distributors) were conducted. To ensure appropriate palliative medicines were available despite occasional shortages, community pharmacists worked tirelessly. They navigated a challenging interface with wholesalers/distributors, the Drug Tariff to ensure reimbursement, and multiple systems. IT infrastructures and logistics provided by wholesalers/distributors were often helpful to supply into community pharmacies resulting in same or next day deliveries. However, the inability of manufacturers to predict operational issues or accurately forecast demand led wholesalers/distributors to encounter shortages with manufactured stock levels, reducing timely access to medicines. Conclusions: The study identifies for the first time how palliative medicines supply into community pharmacy, can be improved. A conceptual model was developed, illustrating how influencing factors affect responsiveness and speed of medicines access for patients. Work is required to strengthen this supply chain via effective relationship-building and information-sharing, to prevent patients facing disruptions in access to palliative medicines at end-of-life.

Experiences of patients with heart failure with medicines at transition intervention: Findings from the process evaluation of the Improving the Safety and Continuity of Medicines management at Transitions of care (ISCOMAT) programme.

BACKGROUND: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co-designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient-held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. DESIGN: Twenty one-to-one semi-structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co-analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. RESULTS: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. CONCLUSION: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design, as qualitative data co-analysts and as co-authors.

Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot.

INTRODUCTION: Heart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients. METHODS AND ANALYSIS: ISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and planned discharge to the geographical area of the cluster will be recruited. The MaTI consists of training for staff, a toolkit for participants, transfer of discharge information to community pharmacies and a medicines reconciliation/review. Treatment as usual is determined by local policy and practices. The primary outcome is a composite of all-cause mortality and heart failure-related hospitalisation at 12 months postregistration obtained from national electronic health records. The key secondary outcome is continued prescription of guideline-indicated therapies at 12 months measured via patient-reported data and Hospital Episode Statistics. The trial contains a parallel mixed-methods process evaluation and an embedded health economics study. ETHICS AND DISSEMINATION: The study obtained approval from the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee; REC reference 18/YH/0017. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. Amendments to the protocol are disseminated to all relevant parties as required. TRIAL REGISTRATION NUMBER: ISRCTN66212970; Pre-results.

Barriers and facilitators of successful deprescribing as described by older patients living with frailty, their informal carers and clinicians: a qualitative interview study.

OBJECTIVE: To explore the barriers/facilitators to deprescribing in primary care in England from the perspectives of clinicians, patients living with frailty who reside at home, and their informal carers, drawing on the Theoretical Domains Framework to identify behavioural components associated with barriers/facilitators of the process. DESIGN: Exploratory qualitative study. SETTING: General practice (primary care) in England. PARTICIPANTS: 9 patients aged 65+ living with frailty who attended a consultation to reduce or stop a medicine/s. 3 informal carers of patients living with frailty. 14 primary care clinicians including general practitioners, practice pharmacists and advanced nurse practitioners. METHODS: Qualitative semistructured interviews took place with patients living with frailty, their informal carers and clinicians. Patients (n=9) and informal carers (n=3) were interviewed two times: immediately after deprescribing and 5/6 weeks later. Clinicians (n=14) were interviewed once. In total, 38 interviews were undertaken. Framework analysis was applied to manage and analyse the data. RESULTS: 6 themes associated with facilitators and barriers to deprescribing were generated, respectively, with each supported by between two and three subthemes. Identified facilitators of deprescribing with patients living with frailty included shared decision-making, gradual introduction of the topic, clear communication of the topic to the patient and multidisciplinary working. Identified barriers of deprescribing included consultation constraints, patients' fear of negative consequences and inaccessible terminology and information. CONCLUSIONS: This paper offers timely insight into the barriers and facilitators to deprescribing for patients living with frailty within the context of primary care in England. As deprescribing continues to grow in national and international significance, it is important that future deprescribing interventions acknowledge the current barriers and facilitators and their associated behavioural components experienced by clinicians, patients living with frailty and their informal carers to improve the safety and effectiveness of the process.

Mapping the resilience performance of community pharmacy to maintain patient safety during the Covid-19 pandemic.

BACKGROUND: The first UK wave of the Covid-19 pandemic in 2020 placed unprecedented stress on community pharmacy. Various policies and initiatives were announced during this period to support community pharmacy to continue to perform in a manner that prioritised patient safety. However, little is understood about how these policies and initiatives were implemented by staff working in community pharmacy, and the system adaptions and responses that were initiated to maintain patient safety. OBJECTIVE: The study aimed to investigate how staff working in UK community pharmacy during the first waves of the COVID-19 pandemic in 2020 responded and adapted to system stressors to maintain patient safety. METHODS: We adopted a qualitative interview approach, underpinned by Resilient Healthcare theory, with interview data collected between July 2020 and January 2021. Data were synthesised and analysed using Framework Analysis. RESULTS: 23 community pharmacy staff from England and Scotland were interviewed. We identified five themes supported by between two and six sub-themes: 1. Covid-19, an impending threat to system; 2. Patient safety stressors during the first waves of Covid-19; 3. Altering the system, responding to system stressors; 4. Monitoring and adjusting and 5. Learning for the future. CONCLUSION: Privileging the accounts of community pharmacy staff working on the frontline during the pandemic illuminated how responses and adaptions were developed and deployed, how continual monitoring occurred, and the factors that supported or hindered system resilience. The key learning derived from this study can serve to shorten the gap between 'work as imagined' and 'work as done', and in doing so, support the future resilience performance of community pharmacy during future outbreaks of Covid-19 or similar events.

Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial.

INTRODUCTION: A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention. METHODS AND ANALYSIS: The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021. ETHICS AND DISSEMINATION: Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. TRIAL REGISTRATION NUMBER: ISRCTN66212970.

Can We Create a Circular Pharmaceutical Supply Chain (CPSC) to Reduce Medicines Waste?

BACKGROUND: The increase in pharmaceutical waste medicines is a global phenomenon and financial burden. The Circular Economy, as a philosophy within the pharmaceutical supply chain, aims to promote waste reduction, maximise medicines value, and enable sustainability within this supply chain (increasing circularity). Circularity strategies for pharmaceuticals are not currently implemented in many countries, due to quality and safety barriers. The aim of this study was to determine whether the application of circular economy principles can minimise pharmaceutical waste and support sustainability in the pharmaceutical supply chain; Methods: a detailed narrative literature review was conducted in order to examine pharmaceutical waste creation, management, disposal, and the application of circular economy principles; Results: the literature scrutinised revealed that pharmaceutical waste is created by multiple routes, each of which need to be addressed by pharmacists and healthcare bodies through the Circular Economy 9R principles. These principles act as a binding mechanism for disparate waste management initiatives. Medicines, or elements of a pharmaceutical product, can be better managed to reduce waste, cost, and reduce negative environmental impacts through unsafe disposal. CONCLUSIONS: the study findings outline a Circular Pharmaceutical Supply Chain and suggests that it should be considered and tested as a sustainable supply chain proposition.

Gaps, traps, bridges and props: a mixed-methods study of resilience in the medicines management system for patients with heart failure at hospital discharge.

INTRODUCTION: Poor medicines management places patients at risk, particularly during care transitions. For patients with heart failure (HF), optimal medicines management is crucial to control symptoms and prevent hospital readmission. This study explored the concept of resilience using HF as an example condition to understand how the system compensates for known and unknown weaknesses. METHODS: We explored resilience using a mixed-methods approach in four healthcare economies in the north of England. Data from hospital site observations, healthcare staff and patient interviews, and documentary analysis were collected between June 2016 and March 2017. Data were synthesised and analysed using framework analysis. RESULTS: Interviews were conducted with 45 healthcare professionals, with 20 patients at three time points and 189 hours of observation were undertaken. We identified four primary inter-related themes concerning organisational resilience. These were named as gaps, traps, bridges and props. Gaps were discontinuities in processes that had the potential to result in poorly optimised medicines. Traps were features of the system that could produce errors or unintended adverse medication events. Bridges were features of the medicines management system that promoted safety and continuity which ensured that, despite varying conditions, care could be delivered successfully. Props were informal, temporary or impromptu actions taken by patients or healthcare staff to avoid potential adverse events. CONCLUSION: The numerous opportunities for HF patient safety to be compromised and for suboptimal medicines management during this common care transition are mitigated by system resilience. Cross-organisational bridges and temporary fixes or 'props' put in place by patients and carers, healthcare teams and organisations are critical for safe and optimal care to be delivered in the face of continued system pressures.