The Impact of Climate Change on Health Services in Low- and Middle-Income Countries: A Systematised Review and Thematic Analysis.

Aim: The aim of this study was to assess the impact of climate change on health services as categorized by the WHO's Building Blocks for creating Climate-Resilient Health Systems. Objective: The objective was to conduct a systematized review of the published literature concerning the impact of climate change, using a thematic analysis approach to address our aim and identify areas for further research. Design: A search was conducted on 8 February 2022 using the Embase and PubMed research databases. Peer-reviewed scientific studies that were published in English from 2012 to 2022, which described at least one report concerning the impact of climate change on health services in LMICs, were included. Studies were organized based on their key characteristics, which included the date of publication, objective, method, limitations, participants, and geographical focus. The Mixed-Methods Appraisal Tool (MMAT) was used to assess the risk of bias in the included studies. Results: Twenty-three studies were included in this review. Five areas of health services which align with the WHO building blocks framework were impacted by climate change. These health service areas included: (1) Service Delivery, (2) Human Resources, (3) Health Finance, (4) Healthcare Products and Technology, and (5) Leadership and Governance. However, research concerning the impact of climate change on health information systems, which is part of the WHO building blocks framework, did not feature in our study. The climatic effects were divided into three themes: meteorological effects, extreme weather events, and general. The research in this study found that climate change had a detrimental impact on a variety of health services, with service delivery being the most frequently reported. The risk of bias varied greatly between studies. Conclusions: Climate change has negatively impacted health services in a variety of different ways, and without further actions, this problem is likely to worsen. The WHO building blocks have provided a useful lens through which to review health services. We built an aligned framework to describe our findings and to support future climate change impact assessments in this area. We propose that further research concerning the impact of climate change on health information systems would be valuable, as well as further education and responsible policy changes to help build resilience in health services affected by climate change.

Access and use of immunoglobulins in supportive cancer care: A thematic analysis of a systematic review data set.

Background: Secondary immunodeficiency (SID) disorders are known to occur in patients with haematological malignancies (HM) due to immunosuppressive treatments. Recurring infections causing subsequent morbidity and mortality commonly occur in this patient cohort. Immunoglobulin replacement therapy (IgRT) benefits patients with primary antibody deficiencies. However, evidence supporting their therapeutic role is not as explicit in SID-associated antibody deficiencies, which raises the questions regarding its use in SID and the knock-on effects of this use on its access and availability more generally. Objectives: This study aimed to learn about the use of immunoglobulins in SID, identify themes concerning its use and access and suggest methods for improving access. Design: This study included a thematic analysis of a published data set of 43 articles concerning immunoglobulin use and access in SID. Data Sources and Methods: The data set used to perform the thematic analysis is based on research articles identified from Excerpta Medica Database (EMBASE) and PubMed databases, published as part of a systematic review and part 1 of this two-part publication series. Results: A thematic synthesis was conducted to identify recurrent themes. The three primary themes included (1) the context for IgRT prescription, which included patient characteristics and cost burden of IgRT administration, and its use in different countries; (2) factors contributing to inappropriate IgRT use, including health care professionals' awareness of IgRT, disparity between guidelines and actual clinical practice, and the effect of shortages on prescription and chemotherapy-induced hypogammaglobulinemia (HGG); and (3) measures identified to improve IgRT use and access, which included multidisciplinary involvement, improved diagnostic tools and safer withdrawal and stewardship protocols. Conclusions: IgRT use is increasing in HM as a supportive therapy but without comprehensive clinical guidelines and appropriate prescribing recommendations, medication wastage may occur with consequences for immunoglobulin access.

Access and Use of Immunoglobulins in Supportive Cancer Care: A Thematic Analysis of a Systematic Review Data Set This study covers the use of immunoglobulins in SID, identifies themes concerning its use and access and suggests ways for improving both using a thematic analysis approach. The study identified that IgRT use is increasing in haematological malignancies as a supportive therapy but without comprehensive clinical guidelines and appropriate prescribing recommendations, medication wastage may occur with consequences for immunoglobulin access.

What is the impact of antidepressant side effects on medication adherence among adult patients diagnosed with depressive disorder: A systematic review.

BACKGROUND: Medication adherence is a prerequisite to achieving beneficial treatment outcomes. In major depressive disorder, many patients fail to complete medication regimens, raising concern for poor treatment outcomes. It is usual to experience adverse drug reactions (ADRs) while taking antidepressants, and relative discomfort is reported by patients. AIMS: The present review focuses on the presence of antidepressant-related side effects and the subsequent relationship with medication non-adherence. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Following the preliminary research, the research question and eligibility criteria were created based on the PICO framework. All articles retrieved from the selected databases were exported to Covidence, a Systematic Review managing software tool. Two reviewers assessed the papers to identify the risk of bias using the Joanna Briggs Institute critical appraisal tool for cross-sectional studies. Seven studies with a low-moderate risk of bias fulfilled the eligibility criteria and were conducted from 2013 to 2020 in Europe, Africa and Asia. RESULTS: The results demonstrated high levels of suboptimal adherence ranging from 46% to 83% amongst the studied population. A variety of side effects were reported by a significant number of participants predominantly with moderate severity. A correlation between the presence of ADRs and suboptimal rates of adherence to antidepressants was found. Somnolence and headaches among other unspecified ADRs were found to increase the dropout rates for selective serotonin reuptake inhibitors. CONCLUSIONS: The present study elucidates the need for effective interventions to facilitate antidepressant adherence and enhance doctor-patient communication, benefiting both the individuals and the healthcare system and leading to better clinical outcomes and reduction of relapse-related costs.

Access and use of immunoglobulins in secondary supportive cancer care: A systematic literature review.

Background: Immunoglobulin replacement therapy (IgRT) benefits patients with primary immuno deficiency (PID) originating from the innate or polygenic defects in the immune system. However, evidence supporting their therapeutic role is not as explicit in secondary immuno deficiency (SID) resulting from the treatment of haematological malignancies. Objectives: This study aimed to (1) create a dataset of relevant research papers, which explore the use of IgRT in SID for analysis, (2) assess the risk of bias within this dataset and (3) study the characteristics of these papers. Design: This systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. In addition to the risk of bias, the study characteristics explored in this article included study design, study geographical location and year of publication. Data Sources and Methods: To identify studies relevant to the research question, EMBASE and PubMed databases were searched. The Population, Intervention, Comparison and Outcome (PICO) framework was used to assess study quality. Risk of bias and quality of studies were assessed in accordance with the study design. As one model was not appropriate to assess bias in all articles, several tools were used. Results: A total of 43 studies were identified from the literature search as relevant to the research objective. The most common study design was a retrospective case-control cohort study (n = 16/43), and randomised trials were among the least commonly used approaches (n = 1). Research in this area is occurring around the globe including the United States (n = 7), Italy (n = 7), China, India, Japan and throughout Europe. The annual number of papers in this area has varied from 2012 (n = 1) to 2021 (n = 7). The studies in this article demonstrated a varied risk of bias, with 9 of the 20 cohort studies scoring less than 5 out of 9 stars. Conclusions: Randomised controlled trials are less frequently used to assess access and use of immunoglobulins. More commonly, a retrospective case-control cohort study was used which correlates with the higher risk of bias seen in the studies in this article. Most of the research concerning immunoglobulin use and access occurs in higher-income countries.

Medicine quality in high-income countries: The obstacles to comparative prevalence studies.

The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient access to medicine. The COVID-19 pandemic has highlighted the importance of access to safe medicine through legitimate pharmaceutical supply chains and the willingness of criminals to target medical products such as PPE (personal protective equipment) and COVID-19 treatments. In this article, we analyse data from the United Kingdom (UK) national medicine alert and recall database to identify and understand recent cases of substandard and falsified medicine in the UK's healthcare systems. Using the UK as a case study, we describe that national drug alert and recall data are useful in their current form to record and understand cases of substandard and falsified medicines in the supply chain. However, if regulatory agencies published further data, these drug recall databases may be useful to support longitudinal and international comparative medicine quality studies. We suggest that regulatory agencies publish the number of affected medicine packs in each recalled batch, as part of the recall process. This will help policy makers, practitioners, and researchers to better understand, monitor and compare the quality of medicines within legitimate supply chains.

A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality.

Substandard and falsified (SF) medicines are a global issue contributing to antimicrobial resistance and causing economic and humanitarian harm. To direct law enforcement efficiently, halt the spread of SF medicines and antimicrobial resistance, academics, NGOs and government organisations use medicine quality sampling studies to estimate the prevalence of the problem. A systematic review of medicine quality studies was conducted to estimate how the methodological quality of these studies and SF prevalence has changed between 2013 and 2018. We also aimed to critique medicine sampling study methodologies, and the systematic review process which generates prevalence estimates. Based on 33 studies, the overall estimated median (Q1-Q3) prevalence of SF medicines appears to have remained high at 25% (7.7%-34%) compared with 28.5% in 2013. Furthermore, the methodological quality of prevalence studies has improved over the last 25 years. Definitive conclusions regarding the prevalence of SF medicines cannot be drawn due to the variability in sample sizes, consistency of design methods, and a lack of information concerning contextual factors affecting medicine quality studies. We contend that studies which present cumulative average prevalence figures are useful in a broad sense but could be improved to create more reliable estimates. We propose that medicine quality studies record the context of the study environment to allow systematic reviewers to compare like with like. Although, the academic rigour of medicine quality studies is improving, medicine sampling study limitations still exist. These limitations inhibit the accurate estimation of SF medicine prevalence which is needed to support detailed policy changes.

Medicine authentication technology: a quantitative study of incorrect quarantine, average response times and offline issues in a hospital setting.

OBJECTIVES: To introduce serialised medicines into an operational hospital dispensary and assess the technical effectiveness of digital medicine authentication (MA) technology under European Union Falsified Medicines Directive (EU FMD) conditions. DESIGN: Thirty medicine lines were serialised using 2D data matrix labels and introduced into an operational UK National Health Service (NHS) hospital dispensary. Staff were asked to check medicines for two-dimensional (2D) data matrices and scan those products, in addition to their usual medicine preparation and checking processes. Four per cent of the study medicines were labelled with a 2D barcode which generated a pop-up, identifying the medicine as either authenticated elsewhere (falsified), authenticated here, expired or recalled. SETTING: An NHS teaching hospital based in the UK, the same site as the Naughton et al 2016 study. PARTICIPANTS: General Pharmaceutical Council registered, accredited accuracy checking technicians and pharmacists. PRIMARY OUTCOME MEASURES: Average response times, offline issues, instances of incorrect quarantine and workarounds. The EU FMD maximum response time is 300 milliseconds (ms). RESULTS: During the checking stage of medicine preparation, the average response time for MA in this study was 131 ms. However, 4.67% of attempted authentications experienced offline issues, an increase of 4.23% from the previous study. An increase in offline instances existed alongside an increase in incorrect quarantine. CONCLUSIONS: Digital drug screening has the capability of operating with average response times which are below the maximum EU FMD limit of 300 ms. However, there was an increased incidence of offline errors and cases of incorrect quarantine. The practical and legal implications of supplying a substandard or falsified medicine during offline periods without prior authentication or withholding supply until online status resumes are not yet fully understood.

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists.

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.

Medicine authentication technology as a counterfeit medicine-detection tool: a Delphi method study to establish expert opinion on manual medicine authentication technology in secondary care.

OBJECTIVES: This study aims to establish expert opinion and potential improvements for the Falsified Medicines Directive mandated medicines authentication technology. DESIGN AND INTERVENTION: A two-round Delphi method study using an online questionnaire. SETTING: Large National Health Service (NHS) foundation trust teaching hospital. PARTICIPANTS: Secondary care pharmacists and accredited checking technicians. PRIMARY OUTCOME MEASURES: Seven-point rating scale answers which reached a consensus of 70-80% with a standard deviation (SD) of <1.0. Likert scale questions which reached a consensus of 70-80%, a SD of <1.0 and classified as important according to study criteria. RESULTS: Consensus expert opinion has described database cross-checking technology as quick and user friendly and suggested the inclusion of an audio signal to further support the detection of counterfeit medicines in secondary care (70% consensus, 0.9 SD); other important consensus with a SD of <1.0 included reviewing the colour and information in warning pop up screens to ensure they were not mistaken for the 'already dispensed here' pop up, encouraging the dispenser/checker to act on the warnings and making it mandatory to complete an 'action taken' documentation process to improve the quarantine of potentially counterfeit, expired or recalled medicines. CONCLUSIONS: This paper informs key opinion leaders and decision makers as to the positives and negatives of medicines authentication technology from an operator's perspective and suggests the adjustments which may be required to improve operator compliance and the detection of counterfeit medicines in the secondary care sector.

Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study.

OBJECTIVES: To identify the authentication and detection rate of serialised medicines using medicines authentication technology. DESIGN AND INTERVENTION: 4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit. SETTING: A site within a large UK National Health Service teaching hospital trust. PARTICIPANTS: Accredited checking staff, pharmacists and dispensers in a pharmacy department. PRIMARY OUTCOME MEASURES: Authentication and detection rate of counterfeit expired and recalled medicines. RESULTS: The operational detection rate of counterfeit, recalled and expired medicines scanned as a combined group was 81.4% (stage 1 (S1)) and 87% (stage 2 (S2)). The technology's technical detection rate (TDR) was 100%; however, not all medicines were scanned and of those that were scanned not all that generated a warning message were quarantined. Owing to an operational authentication rate (OAR) of 66.3% (over both stages), only 31.8% of counterfeit medicines, 58% of recalled drugs and 64% of expired medicines were detected as a proportion of those entered into the study. Response times (RTs) of 152 ms (S1) and 165 ms (S2) were recorded, meeting the falsified medicines directive-mandated 300 ms limit. CONCLUSIONS: TDRs and RTs were not a limiting factor in this study. The suboptimal OAR poses significant quality and safety issues with this detection approach. Authentication at the checking stage, however, demonstrated higher OARs. There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this technology in preparation for the incumbent European Union regulative deadline.