Understanding factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: a systematic review using the Theoretical Domains Framework.

BACKGROUND: Adverse drug reactions (ADRs) are known to cause hospitalisation, longer hospital stays, as well as higher healthcare costs and mortality. Unrecognised ADRs are anticipated throughout the medicine lifecycle as, before the medicine reaches the market, clinical trials are conducted for a short period on a limited number of people, who might underrepresent the actual population. After the medicine reaches the market, emergent information that could affect its benefit-to-risk balance is usually shared by regulatory agencies and pharmaceutical companies through medicine risk communications. Medicines risk communications aim to prevent harm to patients by targeting their behaviour, knowledge, and attitudes, as well as those of health care professionals (HCPs). Despite their important role in translating these communications into their clinical practice, HCPs do not always adhere to the recommendations provided in risk communications. Measurement of medicine risk communications' effectiveness does not necessarily guarantee their implementation, cost-effectiveness, or transferability in real-world situations. To enhance the impact of drug regulatory interventions, implementation science has been encouraged. However, implementation science was not previously used to identify factors affecting HCPs' implementation of medicines risk communications. A recently widely used framework is the Theoretical Domain Framework (TDF). In this systematic review, the TDF was employed to categorise a range of different factors that could affect HCPs' implementation of medicine risk communications within their clinical contexts. METHODS: The search strategy involved a set of predefined search terms and fifteen databases, such as EMBASE, PubMed, Web of Science and CINAHL PLUS. Searches were conducted from April to May 2018 and updated in June 2021 using PubMed, Scopus, and CINAHL PLUS. A second reviewer independently conducted the screening process of the initial search. The total number of records screened was 10,475. A study was included if it reported any factors influencing HCPs' uptake of medicine risk communications. Only studies with English or Arabic abstracts were included. Those studies that did not include pharmacovigilance-related medicine risk communications were excluded. Additionally, studies only assessing HCPs' practice or evaluating the effectiveness of risk minimisation measures were excluded. Likewise, studies related to occupational hazards, case reports, interventional studies, and studies not involving HCPs were excluded. In case the published information was insufficient to decide whether to include or exclude a study, the authors were contacted. Furthermore, the authors of seven eligible abstracts were contacted for full-text articles. The mixed method appraisal tool (MMAT) was used to evaluate the quality of the included studies. All included studies were assessed by one reviewer, and a total of 16 studies were assessed by two reviewers independently. Disagreements were resolved through discussion. Using thematic analysis and concept mapping, a narrative synthesis was performed, followed by a critical reflection on the synthesis process. This review presents the results of the concept mapping, which involved matching the identified factors to the TDF. RESULTS: A total of 28 studies were included. Eleven domains influenced HCPs' implementation of medicine risk communications. A large number of studies included factors related to the "Knowledge" domain (n = 23), followed by "Beliefs about Consequences" (n = 13), "Memory, Attention and Decision Processes" (n = 12) and "Environmental Context and Resources" domains (n = 12). Seven studies reported "social influences" and six studies included factors relating to "Goals", followed by four studies involving factors related to "Social/Professional Role and Identity". Underrepresented domains included "Emotion" (n = 2), "Beliefs about Capabilities" (n = 2), "Behavioural Regulation" (n = 1), and "Reinforcement" (n = 1). On the other hand, none of the identified factors were related to the "Skills", "Optimism", or "Intentions" domains. Except for "Beliefs about Consequences", most studies contributing to the other three most commonly reported domains ("Knowledge"; "Environmental Context and Resources"; and "Memory, Attention and Decision Processes") scored low (1 or 2 out of 5) on the MMAT quality assessment. Moreover, the same number of studies (n = 5) contributing to the "Beliefs about Consequences" domain had low (1 or 2 out of 5), and intermediate (3 out of 5) scores on the MMAT. CONCLUSION: Medicines risk communications are important tools for disseminating information that may influence the benefit-to-risk balance of medicines. Even though HCPs are required to implement the recommendations of these communications, they do not always adhere to them. Using the TDF enabled the categorization of the range of factors that affect whether or not HCPs implement the recommendations provided in a medicine risk communication. However, most of these factors relate to four domains only ("Knowledge"; "Beliefs about Consequences"; "Memory, Attention and Decision Processes"; and "Environmental Context and Resources"). Additionally, most of the studies contributing to three of these four domains were of low quality. Future research should focus on using implementation science to identify target behaviours for actionable medicine risk communications. Regulators should use such science to develop cost-effective strategies for improving the implementation of medicines risk communication by HCPs.

Factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: A systematic review.

BACKGROUND: Regulatory medicines risk communications aim to prevent patient harm through the dissemination of safety information to healthcare professionals (HCPs), patients, and the public. Evidence suggests that in addition to implementing the required changes, HCPs also respond to these communications through unintended and unwarranted actions and behaviours such as stopping medicine courses unnecessarily, and blanket actions spilling over to unintended patients' populations. Misunderstanding and mis-implementation of medicines risk communications could jeopardise patients' safety and clinical outcomes. Therefore, it is important to understand the determinants that affect HCPs responses to medicines risk communications. This systematic review aims to identify the factors that affect the implementation of risk communications by healthcare professionals. METHODS: Fifteen databases, including EMBASE, PubMed, Scopus, Web of science, CINAHL PLUS were searched in April-May 2018, and the search was updated again in June 2021 to identify studies reporting on factors influencing HCPs' uptake of medicine risk alerts. We used keywords such as risk communication, safety update, and safety regulation. Studies were excluded if they did not involve pharmacovigilance or patient safety alerts; or if they only focused on measuring HCPs' practice after alerts; or evaluating the effectiveness of risk minimisation measures without reporting on factors affecting HCPs' actions. Studies relating to occupational hazards, case reports, interventional studies, and studies not involving HCPs were also excluded. The Mixed Method Appraisal Tool (MMAT) was used to assess the quality of the included studies. A Narrative synthesis approach was undertaken using thematic analysis and concept mapping, followed by a critical reflection of the synthesis. RESULTS: Twenty-eight studies met our criteria and were included in the synthesis. We identified four themes summarising the factors influencing HCPs' implementation of risk communications. These include HCPs: knowledge of medicine alerts; perceptions of alerts; attitudes, and concerns regarding medicine alerts; and the self-reported impact of these alerts. Our concept mapping exercise identified key interactions between different stakeholders, and these interactions determine HCPs' implementation of medicine risk communications. These stakeholders comprise of alert developers, including the sources and senders of safety information, and the receivers of safety information including health care institutions, HCPs, patients and their carers. CONCLUSIONS: Healthcare professionals are crucial to translating risk communication messages into clinical practice. However, if they have inadequate information about the content of the alert, and have inaccurate perceptions about the alert, they may not implement the required clinical changes as intended. Communication of medicine risk alerts does not always translate into improved patient care, due to a complex interaction between stakeholders involved in the creation and implementation of these alerts. These complex interactions should be the subject of future research efforts to understand the alert-implementation trajectory and identify the mediators for change and interventions to improve implementation.

Diabetes Self-management Apps: Systematic Review of Adoption Determinants and Future Research Agenda.

BACKGROUND: Most diabetes management involves self-management. Effective self-management of the condition improves diabetes control, reduces the risk of complications, and improves patient outcomes. Mobile apps for diabetes self-management (DSM) can enhance patients' self-management activities. However, they are only effective if clinicians recommend them, and patients use them. OBJECTIVE: This study aimed to explore the determinants of DSM apps' use by patients and their recommendations by health care professionals (HCPs). It also outlines the future research agenda for using DSM apps in diabetes care. METHODS: We systematically reviewed the factors affecting the adoption of DSM apps by both patients and HCPs. Searches were performed using PubMed, Scopus, CINAHL, Cochrane Central, ACM, and Xplore digital libraries for articles published from 2008 to 2020. The search terms were diabetes, mobile apps, and self-management. Relevant data were extracted from the included studies and analyzed using a thematic synthesis approach. RESULTS: A total of 28 studies met the inclusion criteria. We identified a range of determinants related to patients' and HCPs' characteristics, experiences, and preferences. Young female patients were more likely to adopt DSM apps. Patients' perceptions of the benefits of apps, ease of use, and recommendations by patients and other HCPs strongly affect their intention to use DSM apps. HCPs are less likely to recommend these apps if they do not perceive their benefits and may not recommend their use if they are unaware of their existence or credibility. Young and technology-savvy HCPs were more likely to recommend DSM apps. CONCLUSIONS: Despite the potential of DSM apps to improve patients' self-care activities and diabetes outcomes, HCPs and patients remain hesitant to use them. However, the COVID-19 pandemic may hasten the integration of technology into diabetes care. The use of DSM apps may become a part of the new normal.

Leaving No One Behind: Interventions and Outcomes of the COVID-19 Vaccine Maximising Uptake Programme.

The devastating impact of COVID-19 on individuals and communities has accelerated the development of vaccines and the deployment of ambitious vaccination programmes to reduce the risks of infection, infection transmission and symptom severity. However, many people delay or refuse to get vaccinated against COVID-19, for many complex reasons. Vaccination programmes that are tailored to address individual and communities' COVID-19 concerns can improve vaccine uptake rates and help achieve the required herd-immunity threshold. The Maximising Uptake Programme has led to the vaccination of 7979 people from February-August 2021 in the South West of England, UK, who are at high risk of severe illness from COVID-19 and/or may not access the COVID-19 vaccines through mass vaccination centres and general practices. These include: people experiencing homelessness; non-English-speaking people; people from minority ethnic groups; refugees and asylum seekers; Gypsy, Roma, Travelers and boat people; and those who are less able to access vaccination centres, such as people with learning difficulties, serious mental illness, drug and alcohol dependence, people with physical and sensory impairment, and people with dementia. Outreach work coupled with a targeted communication and engagement campaign, co-designed with community leaders and influencers, have led to significant engagement and COVID-19 vaccine uptake among the target populations.

Clinical Efficacy of Hydroxychloroquine in Patients with COVID-19: Findings from an Observational Comparative Study in Saudi Arabia.

The aim of this study was to assess the clinical effectiveness of Hydroxychloroquine-based regimens versus standard treatment in patients with the coronavirus disease admitted in 2019 to a hospital in Saudi Arabia. A comparative observational study, using routine hospital data, was carried out in a large tertiary care hospital in Al Baha, Saudi Arabia, providing care to patients with COVID-19 between April 2019 and August 2019. Patients were categorized into two groups: the Hydroxychloroquine (HCQ) group, treated with HCQ in a dose of 400 mg twice daily on the first day, followed by 200 mg twice daily; the non HCQ group, treated with other antiviral or antibacterial treatments according to protocols recommended by the Ministry of Health (MOH) at the time. The primary outcomes were the length of hospital stay, need for admission to the intensive care unit (ICU), time in ICU, and need for mechanical ventilation. Overall survival was also assessed. 568 patients who received HCQ (treatment group) were compared with 207 patients who did not receive HCQ (control group). HCQ did not improve mortality in the treated group (7.7% vs. 7.2%). There were no significant differences in terms of duration of hospitalization, need for and time in ICU, and need for mechanical ventilation among the groups. Our study provides further evidence that HCQ treatment does not reduce mortality rates, length of hospital stay, admission and time in ICU, and need for mechanical ventilation in patients hospitalized with COVID-19.

Antimicrobial Stewardship Program Implementation in a Saudi Medical City: An Exploratory Case Study.

Antimicrobial stewardship programs (ASPs) in hospitals have long been shown to improve antimicrobials' use and reduce the rates of antimicrobial resistance. However, their implementation in hospitals, especially in developing countries such as Saudi Arabia, remains low. One of the main barriers to implementation is the lack of knowledge of how to implement them. This study aims to explore how an antimicrobial stewardship programme was implemented in a Saudi hospital, the challenges faced and how they were overcome, and the program outcomes. A key stakeholder case study design was used, involving in-depth semi-structured interviews with the core members of the ASP team and analysis of 35 ASP hospital documents. ASP implementation followed a top-down approach and involved an initial preparatory phase and an implementation phase, requiring substantial infectious diseases and clinical pharmacy input throughout. Top management support was key to the successful implementation. ASP implementation reduced rates of multi-drug resistance and prescription of broad-spectrum antimicrobials. The implementation of ASPs in hospital is administrator rather than clinician driven. Outsourcing expertise and resources may help hospitals address the initial implementation challenges.

Antimicrobial Stewardship Programmes in Saudi Hospitals: Evidence from a National Survey.

Saudi hospitals and healthcare facilities are facing increasing rates of antimicrobial resistance and the emergence of new multi-drug resistant strains. This is placing an unprecedented threat to successful treatments and outcomes of patients accessing those facilities. The inappropriate use of antimicrobials is fueling this crisis, warranting urgent implementation of interventions to preserve antimicrobials and reduce resistance rates. Antimicrobial stewardship programmes (ASPs) can improve antimicrobial use, treatment success rates and reduce the levels of antimicrobial resistance. The Saudi Ministry of Health (MOH) devised a national antimicrobial stewardship plan to implement ASPs in hospitals, but little is known about the progress of implementation and the factors affecting it. This study aims to assess the level and the factors affecting the adoption and implementation of ASPs in Saudi hospitals at a national level. A nationwide cross-sectional survey was conducted in 2017 using an online questionnaire sent to all MOH hospitals. Overall, 147 out 247 MOH hospitals responded to the survey (54%). Only 26% of the hospitals reported the implementation of ASPs. Hospitals lack the knowledge, technological and staff resources to adopt and implement ASPs. Alternative models of ASP adoption could be explored to improve the rates of implementation of ASPs.

Antibiotics' Use in Thailand: Community Pharmacists' Knowledge, Attitudes and Practices.

Thailand spends $203 million on antibiotics every year, and patients can still access antimicrobials over the counter without a prescription. Community pharmacy plays a pivotal role in improving access and ensuring the appropriate use of antimicrobials. However, little is known about current practices in this setting. This study aims to assess Thai community pharmacists' knowledge, attitudes and practices (KAP) regarding antimicrobials' use and resistance. A cross-sectional study was conducted in Bangkok and Chonburi province in 2017 using an online self-administered questionnaire. The questionnaire was completed by 372 community pharmacists (71.4% response rate). The most commonly encountered infections in the community were upper and lower respiratory tract infections. The most commonly dispensed antimicrobials were broad-spectrum antibiotics including aminopenicillins and fluoroquinolones. Thai pharmacists have a good knowledge, attitude, and practice regarding antimicrobials' use and resistance. They dispense anti-microbials in line with local guidelines, although international guidelines may not indicate anti-biotics for viral self-limiting infections. While community pharmacy in Thailand could be the most accessible healthcare resource for patients, inappropriate provision of antimicrobials for self-limiting viral infections by pharmacists will increase antimicrobial resistance. This highlights the need for updated guidance and improved pharmacists' training.

Exploring the Determinants of Mobile Health Adoption by Hospitals in China: Empirical Study.

BACKGROUND: Although mobile health (mHealth) has the potential to transform health care by delivering better outcomes at a much lower cost than traditional health care services, little is known about mHealth adoption by hospitals. OBJECTIVE: This study aims to explore the determinants of mHealth adoption by hospitals using the technology-organization-environment (TOE) framework. METHODS: We conducted an interviewer-administered survey with 87 managers in Chinese public hospitals and analyzed the data using logistic regression. RESULTS: The results of our survey indicate that perceived ease of use (ß=.692; P<.002), system security (ß=.473; P<.05), top management support (ß=1.466; P<.002), hospital size (ß=1.069; P<.004), and external pressure (ß=.703; P<.005) are significantly related to hospitals' adoption of mHealth. However, information technology infrastructure (ß=.574; P<.02), system reliability (ß=-1.291; P<.01), and government policy (ß=2.010; P<.04) are significant but negatively related to hospitals' adoption of mHealth. CONCLUSIONS: We found that TOE model works in the context of mHealth adoption by hospitals. In addition to technological predictors, organizational and environmental predictors are critical for explaining mHealth adoption by Chinese hospitals.

Perceptions regarding antimicrobial use and resistance among adult hospital patients in Saudi Arabian Ministry of Health (MOH) hospitals.

BACKGROUND: Education, a key strategy within antimicrobial stewardship programmes (ASPs), has been mainly directed towards healthcare professionals and prescribers more than hospitalised patients. AIM: To examine patients' knowledge and perceptions of antibiotic use and resistance, while evaluating the institutional role of patient education on antibiotic use in two Saudi Arabian hospitals, one with an implemented ASP and one without an ASP. METHOD: A cross-sectional self-administered survey was developed and piloted. A total of 400 surveys were distributed, 200 within the hospital with an ASP and another 200 within the hospital without an ASP. Data were coded and analysed. Ethical approval was obtained before the start of the study. FINDINGS: 176 patients responded to the survey with 150 surveys completed and analysed. 78% of patients agreed that they should only take an antibiotic when prescribed by the doctor, however they still tended to keep left over antibiotics for future use. 84% of patients were unaware 'antibiotic resistance', with 48% believing that antibiotics help them get better quicker when they had a 'cold'. Information on antibiotic use and resistance were provided to patients in the hospital with an ASP in contrast to the hospital without an ASP. CONCLUSION: Overall there are poor perceptions regarding antibiotic use and resistance among hospital patients in Saudi Arabia. Patients in the hospital with ASP demonstrated greater knowledge during their hospitalisation. ASPs should not only focus on educating healthcare professionals but should involve the patients and seize the opportunity to educate them while hospitalised.

Barriers to implementing antimicrobial stewardship programmes in three Saudi hospitals: Evidence from a qualitative study.

OBJECTIVES: This study explored antimicrobial stewardship programme (ASP) team members' perspectives regarding factors influencing the adoption and implementation of these programmes in Saudi hospitals. METHODS: This was a qualitative study based on face-to-face semistructured interviews with healthcare professionals involved in ASPs and activities across three Ministry of Health (MoH) hospitals in Saudi Arabia (n = 18). Interviews were also conducted with two representatives of a General Directorate of Health Affairs in a Saudi region and two representatives of the Saudi MoH (n = 4) between January-February 2017. RESULTS: Despite the existence of a national strategy to implement ASPs in Saudi MoH hospitals, their adoption and implementation remains low. Hospitals have their own antimicrobial stewardship policies, but adherence to these is poor. ASP team members highlight that lack of enforcement of policies and guidelines from the MoH and hospital administration is a significant barrier to ASP adoption and implementation. Other barriers include disintegration of teams, poor communication, lack of recruitment/shortage of ASP team members, lack of education and training, and lack of health information technology (IT). Physicians' fears and concerns in relation to liability are also a barrier to their adoption of ASPs. CONCLUSION: This is the first qualitative study exploring barriers to ASP adoption and implementation in Saudi hospitals from the perspective of ASP team members. Formal endorsement of ASPs from the MoH as well as hospital enforcement of policies and provision of human and health IT resources would improve the adoption and implementation of ASPs in Saudi hospitals.

Hospital adoption of antimicrobial stewardship programmes in Gulf Cooperation Council countries: A review of existing evidence.

Antimicrobial resistance is increasing at an alarming rate in the Gulf Cooperation Council (GCC) owing to the overuse and misuse of antimicrobials. Novel and rare multidrug-resistant strains can spread globally since the region is host to the largest expatriate population in the world as well as a pilgrimage destination for more than 4 million people annually. Adoption of antimicrobial stewardship programmes (ASPs) could improve the use of antimicrobials and reduce antimicrobial resistance in the region. However, despite the established benefits of these interventions, little is known about the level of their adoption in the region and the impact of these programmes on antimicrobial use and resistance. This study aimed to review existing evidence on the level of adoption of ASPs, the facilitators and barriers to their adoption, and outcomes of their adoption in GCC hospitals.

The role of glucocorticoid receptor phosphorylation in Mcl-1 and NOXA gene expression.

BACKGROUND: The cyclin-dependent kinase (CDK) and mitogen-activated protein kinase (MAPK) mediated phosphorylation of glucocorticoid receptor (GR) exerts opposite effects on GR transcriptional activity and affects other posttranslational modifications within this protein. The major phosphorylation site of human GR targeted by MAPK family is the serine 226 and multiple kinase complexes phosphorylate receptor at the serine 211 residue. We hypothesize that GR posttranslational modifications are involved in the determination of the cellular fate in human lymphoblastic leukemia cells. We investigated whether UV signalling through alternative GR phosphorylation determined the cell type specificity of glucocorticoids (GCs) mediated apoptosis. RESULTS: We have identified putative Glucocorticoid Response Elements (GREs) within the promoter regulatory regions of the Bcl-2 family members NOXA and Mcl-1 indicating that they are direct GR transcriptional targets. These genes were differentially regulated in CEM-C7-14, CEM-C1-15 and A549 cells by glucocorticoids and JNK pathway. In addition, our results revealed that the S211 phosphorylation was dominant in CEM-C7-14, whereas the opposite was the case in CEM-C1-15 where prevalence of S226 GR phosphorylation was observed. Furthermore, multiple GR isoforms with cell line specific patterns were identified in CEM-C7-14 cells compared to CEM-C1-15 and A549 cell lines with the same antibodies. CONCLUSIONS: GR phosphorylation status kinetics, and site specificity as well as isoform variability differ in CEM-C7-14, CEM-C1-15, and A549 cells. The positive or negative response to GCs induced apoptosis in these cell lines is a consequence of the variable equilibrium of NOXA and Mcl-1 gene expression potentially mediated by alternatively phosphorylated GR, as well as the balance of MAPK/CDK pathways controlling GR phosphorylation pattern. Our results provide molecular base and valuable knowledge for improving the GC based therapies of leukaemia.