The effect of job and personal demands and resources on healthcare workers' wellbeing: A cross-sectional study.

The COVID-19 pandemic presented many psychological stressors which affected healthcare worker wellbeing. The aim of this study was to understand the factors that affect the wellbeing of healthcare professionals in the Kingdom of Saudi Arabia using Job-Demand and Resource (JD-R) Model. The proposal model consisted of demand factors (Work load-job demand, loneliness-personal demand), support factors (organizational support-job resource, and resilience-personal resource), mediators (burnout and work engagement), and outcome (wellbeing) A cross-sectional, descriptive study was conducted across 276 healthcare workers from hospitals and primary healthcare centers, including healthcare professionals, health associate professionals, personal care workers, health management and support personnel, and health service providers, and others between February-March 2022. The proposed model was tested using partial least squares structural equation modeling. Among the respondents, the majority were female (198, 71,7%), married (180, 65.2%), healthcare professionals (206, 74.6%), being more than 10 years in the profession (149, 51.6%), and non-Saudi nationality (171, 62.0%). Burnout accounted for a significant effect on wellbeing. Of the demands (workload and loneliness) and the resources (organizational support and resilience), workload had the greatest impact on burnout. Healthcare organizations should invest in reducing workloads and promoting resilience to reduce burnout and increase healthcare worker wellbeing.

The landscape of biosimilars in Saudi Arabia: preparing for the next decade.

INTRODUCTION: The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. AREAS COVERED: We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes. EXPERT OPINION: The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.

Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study.

AIMS: This study estimated, for Saudi Arabia, the cost-efficiency of converting patients from reference Neupogen and Neulastim to one of two filgrastim biosimilars (Nivestim, Zarzio); the budget-neutral expanded access to supportive care with biosimilar filgrastim and therapeutic care to ado-trastuzumab emtansine thus afforded; and the number-needed-to-convert (NNC) to provide supportive or therapeutic treatment to one patient. MATERIALS AND METHODS: Replicating prior studies, we modeled the cost-efficiencies gained from converting varying proportions of a hypothetical panel of 4,000 patients undergoing six cycles of cancer treatment from Neupogen or Neulastim to one of the two biosimilar G-CSF formulations, using national cost inputs. Cost-savings in USD were used to estimate the additional doses of biosimilar G-CSF and expanded access to ado-trastuzumab emtansine on a budget-neutral basis, and NNC to purchase one additional dose of supportive or therapeutic treatment. RESULTS: Savings from conversion from reference to a biosimilar filgrastim were $3,086,400 (Nivestim) and $3,460,800 (Zarzio). With reference pegfilgrastim, savings from conversion were $11,712,240 (Nivestim) and $12,086,640 (Zarzio). Biosimilar conversion from reference to biosimilar filgrastim enabled expanded access to ado-trastuzumab emtansine ranging from 61 patients (5 days, Nivestim) to 191 patients (14 days, Zarzio). For supportive care, biosimilar conversion enabled expanded access ranging from 8,244 patients (5 days, Nivestim) to 25,882 patients (14 days, Zarzio). For biosimilar conversion from daily filgrastim, the NNC for treatment with ado-trastuzumab emtansine decreased as days of injections increased [5 days: 395 (Nivestim), 352 (Zarzio); 14 days: 141(Nivestim), 126 (Zarzio)]. Alternately, for biosimilar conversion from single-injection pegfilgrastim to daily biosimilar filgrastim, the NNC for treatment with ado-trastuzumab emtansine rose as days of injections increased, being highest under the 14-day scenario (146, Nivestim; 130, Zarzio). CONCLUSION: This simulation study demonstrated significant potential cost-savings from biosimilar conversion. These savings provide budget-neutral increased access to supportive and therapeutic cancer care.

An Institutional Guide for Formulary Decisions of Biosimilars.

Biologics have changed the landscape for the management of many debilitating chronic diseases but account for a significant expenditure of medications globally. Fortunately, advances in technology paved the way for the introduction of biosimilars, which are highly similar to the originator biologics. In the quest to reduce the budget impact of biologics, organizations have begun to adopt biosimilars. Institutions evaluating biosimilars for inclusion in the hospital formulary must make informed formulary decisions by conducting a thorough review of key elements for evaluation of biosimilars and address the multidimensional aspects during the selection process of different biosimilar products. Therefore, we aim to present an institutional guide of these elements to inform formulary decisions. These key elements include biosimilar evaluation for formulary addition; regulatory approval; substitution, interchangeability, and switching; extrapolation; product characteristics, manufacturing, and supply chain issues; pharmacoeconomic evaluations; traceability, nomenclature, and coding; education; and pharmacovigilance.

Perceived barriers and enablers of a personal health record from the healthcare provider perspective.

Personal health records (PHRs) have been implemented around the world as a means to increase the safety, quality, and efficiency of health care. The Ministry of National Guard Health Affairs in the Kingdom of Saudi Arabia launched their PHR in 2018. This study aimed to explore healthcare provider (HCP) perspectives of barriers to and enablers of PHR adoption in Saudi Arabia. The 291 participating HCPs (40.5% nurses, 23.0% pharmacists, 17.2% physicians, 15.5% technicians, and 3.8% other) selected the following as top-3 barriers to PHR adoption: 1) lack of patient awareness (19.4%), 2) patient low literacy (17.7%), and 3) patient resistance to new technologies (12.5%). Of these, 36 responded to the open-ended question gauging feedback on the PHR. Three main themes were identified from the comments: 1) general perceptions of the PHR (positive attitudes, negative attitudes, additional features); 2) patient engagement as a requirement for the successful implementation of the PHR; and 3) education/training of HCPs, patients, and caregivers. This analysis extends our understanding of HCP perspectives of barriers and enablers to PHR adoption. Further qualitative research with patients is required to confirm our findings.

Changing paradigms in detecting rare adverse drug reactions: from disproportionality analysis, old and new, to machine learning.

PLAIN LANGUAGE SUMMARYYour physician, pharmacist, nurse, or even you can voluntarily report suspected adverse events associated with drugs. The FDA Adverse Reporting System (FAERS) and the WHO Vigibase are large databases that store individual reports of adverse drug reactions (ADRs). While some ADRs are very common, others are seen rarely. Detecting rare and very rare ADRs is extremely difficult but very important for the safe use of drugs. Databases such as FAERS and WHO Vigibase contain a large amount of data and are commonly used for analysis applying a statistical method called disproportionately analysis. This type of analysis determines whether there is a higher-than-expected number of adverse reactions for a particular drug. In the future, machine learning will complement this process by applying algorithms to the data, constructing and refining rules of inference, and building predictive models of ADRs. This paradigm change in testing for ADRs is expected to provide a better understanding of the factors impacting drug safety.

Predicting Health Care Providers' Acceptance of a Personal Health Record Secure Messaging Feature.

BACKGROUND: Personal health records (PHRs) can facilitate patient-centered communication through the secure messaging feature. As health care organizations in the Kingdom of Saudi Arabia implement PHRs and begin to implement the secure messaging feature, studies are needed to evaluate health care providers' acceptance. OBJECTIVE: The aim of this study was to identify predictors of health care providers' behavioral intention to support the addition of a secure messaging feature in PHRs using an adapted model of the Unified Theory of Acceptance and Use of Technology as the theoretical framework. METHODS: Using a cross-sectional survey design, data on acceptance of secure messaging features in PHRs were collected from health care providers working at the Ministry of National Guard Health Affairs between April and May 2021. The proposed model was tested using partial least squares structural equation modeling in SmartPLS. RESULTS: There were 224 participants: female (66.5%), 40 to 49 years of age (39.9%), nurses (45.1%), and those working more than 10 years in the organization (68.8%). Behavioral intention to support the addition of a secure messaging feature was significantly influenced by performance expectancy (ß = 0.21, p = 0.01) and attitude (ß = 0.50, p < 0.01), while other predicting factors, such as effort expectancy, social influence, and facilitating condition, did not significantly affect the intention. Furthermore, age, years of experience, and professional role did not moderate the relationships. CONCLUSION: Health care professionals will support introducing a secure messaging feature in the PHRs if they serve the intended purpose. Considering attitude also plays a significant role in acceptance, it is necessary to arrange for training and support, so that caregivers, health care providers, and the patients become familiar with the benefits and expected outcomes of using the feature.

Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study.

OBJECTIVE: Prescribing a drug for a child is not an easy task and requires using the best available evidence as a guide, especially when a drug is used off-label. The practice of prescribing a drug for off-label use is fairly widespread worldwide. The FDA does not regulate prescribing patterns or practices of individual practitioners and, therefore, allows off-label use. The main objective of this study is to evaluate off-label prescribing among the pediatric population in the Kingdom of Saudi Arabia (KSA). METHOD: This is a retrospective, simple random selection observational study of children (≤15 years) who visited pediatric clinics and had at least 1 drug prescribed over a 12-month period (January to December 2018). RESULTS: A total of 865 drugs (mean 1 and SD 0.24) were prescribed to 326 children. Off-label was identified in 39.4% of the drugs with a frequency of 512 (as 1 drug may belong to more than 1 off-label category). The most common reason for off-label prescribing was related to doses that were "higher or lower than the recommended use" (48.6%), and the most frequently identified drug class prescribed for off-label use was anti-infective drugs for systemic use (39.9%). The percentage of off-label drug use was found to be higher in girls and in the age group of 1 month to 2 years (P = .001) for both variables. In addition, a significant association was found between off label drug use and the total number of drugs prescribed, P < .001. CONCLUSION: The findings of this study showed a high incidence of off-label prescribing mainly related to dosing and indication. The results of this observational study support the need to establish a unified national pediatric dosing formulary guide to ensure safe drug use in pediatrics.

Health Care Providers' Acceptance of a Personal Health Record: Cross-sectional Study.

BACKGROUND: Personal health records (PHRs) are eHealth tools designed to support patient engagement, patient empowerment, and patient- and person-centered care. Endorsement of a PHR by health care providers (HCPs) facilitates patient acceptance. As health care organizations in the Kingdom of Saudi Arabia begin to adopt PHRs, understanding the perspectives of HCPs is important because it can influence patient adoption. However, no studies evaluated HCPs' acceptance of PHRs in the Kingdom of Saudi Arabia. OBJECTIVE: The aim of this study was to identify predictors of HCPs' acceptance of PHRs using behavioral intention to recommend as a proxy for adoption. METHODS: This cross-sectional study was conducted among HCPs (physicians, pharmacists, nurses, technicians, others) utilizing a survey based on the Unified Theory of Acceptance and Use of Technology. The main theory constructs of performance expectancy, effort expectancy, social influence, facilitating conditions, and positive attitude were considered independent variables. Behavioral intention was the dependent variable. Age, years of experience, and professional role were tested as moderators between the main theory constructs and behavioral intention using partial least squares structural equation modeling. RESULTS: Of the 291 participants, 246 were included in the final analysis. Behavioral intention to support PHR use among patients was significantly influenced by performance expectancy (ß=.17, P=.03) and attitude (ß=.61, P<.01). No moderating effects were present. CONCLUSIONS: This study identified performance expectancy and attitude as predictors of HCPs' behavioral intention to recommend PHR to patients. To encourage HCPs to endorse PHRs, health care organizations should involve HCPs in the implementation and provide training on the features available as well as expected benefits. Future studies should be conducted in other contexts and include other potential predictors.

Predicting Patients' Intention to Use a Personal Health Record Using an Adapted Unified Theory of Acceptance and Use of Technology Model: Secondary Data Analysis.

BACKGROUND: With the rise in the use of information and communication technologies in health care, patients have been encouraged to use eHealth tools such as personal health records (PHRs) for better health and well-being services. PHRs support patient-centered care and patient engagement. To support the achievement of the Kingdom of Saudi Arabia's Vision 2030 ambitions, the National Transformation program provides a framework to use PHRs in meeting the 3-fold aim for health care-increased access, reduced cost, and improved quality of care-and to provide patient- and person-centered care. However, there has been limited research on PHR uptake within the country. OBJECTIVE: Using the Unified Theory of Acceptance and Use of Technology (UTAUT) as the theoretical framework, this study aims at identifying predictors of patient intention to utilize the Ministry of National Guard-Health Affairs PHR (MNGHA Care) app. METHODS: Using secondary data from a cross-sectional survey, data measuring the intention to use the MNGHA Care app, along with its predictors, were collected from among adults (n=324) visiting Ministry of National Guard-Health Affairs facilities in Riyadh, Jeddah, Dammam, Madinah, Al Ahsa, and Qassim. The relationship of predictors (main theory constructs) and moderators (age, gender, and experience with health apps) with the dependent variable (intention to use MNGHA Care) was tested using hierarchical multiple regression. RESULTS: Of the eligible population, a total of 261 adult patients were included in the analysis. They had a mean age of 35.07 (SD 9.61) years, 50.6 % were male (n=132), 45.2% had university-level education (n=118), and 53.3% had at least 1 chronic medical condition (n=139). The model explained 48.9% of the variance in behavioral intention to use the PHR (P=.38). Performance expectancy, effort expectancy, and positive attitude were significantly associated with behavioral intention to use the PHR (P<.05). Prior experience with health apps moderated the relationship between social influence and behavioral intention to use the PHR (P=.04). CONCLUSIONS: This study contributes to the existing literature on PHR adoption broadly as well as in the context of the Kingdom of Saudi Arabia. Understanding which factors are associated with patient adoption of PHRs can guide future development and support the country's aim of transforming the health care system. Similar to previous studies on PHR adoption, performance expectancy, effort expectancy, and positive attitude are important factors, and practical consideration should be given to support these areas.

Liraglutide effects on glycemic control and weight in patients with type 2 diabetes Mellitus: A real-world, observational study and brief narrative review.

BACKGROUND: Glycemic control and weight gain are two essential considerations in the pharmacological management of type 2 diabetes mellitus. Pharmacological agents are effective in lowering blood glucose levels but may result in significant weight gain. Liraglutideeffectively maintains glycemic control while reducingweight. METHODS: This is a real-world study and brief narrative review of the effects of liraglutide on glycemic control and weight in adult patients with type 2 diabetes mellitus. The study uses data extracted from the electronic health record of the Ministry of National Guard-Health Affairs. RESULTS: In this study of 348 subjects, there was a statistically significant reduction in hemoglobin A1c of 0.9% (P < .0001) and weight of 2.3 kg (P < .0001). The majority (77.3%) were on concomitant insulin.Subjects with a baseline hemoglobin A1c greater than 9% had a significantly greater reduction than those below 9% (-0.7%;P < .0001). Those with a weight more than 100 kg had a significantly greater reduction than those below 100 kg (-0.9 kg;P = .0096). CONCLUSION: In this real-world, observational study, liraglutide was shown to be effective in improving glycemic control and reducing weight in adult patients with type 2 diabetes mellitus.

Adoption of a Personal Health Record in the Digital Age: Cross-Sectional Study.

BACKGROUND: As health care organizations strive to improve health care access, quality, and costs, they have implemented patient-facing eHealth technologies such as personal health records to better engage patients in the management of their health. In the Kingdom of Saudi Arabia, eHealth is also growing in accordance with Vision 2030 and its National Transformation Program framework, creating a roadmap for increased quality and efficiency of the health care system and supporting the goal of patient-centered care. OBJECTIVE: The aim of this study was to investigate the adoption of the personal health record of the Ministry of National Guard Health Affairs (MNGHA Care). METHODS: A cross-sectional survey was conducted in adults visiting outpatient clinics in hospitals at the Ministry of National Guard Health Affairs hospitals in Riyadh, Jeddah, Dammam, Madinah, and Al Ahsa, and primary health care clinics in Riyadh and Qassim. The main outcome measure was self-reported use of MNGHA Care. RESULTS: In the sample of 546 adult patients, 383 (70.1%) reported being users of MNGHA Care. MNGHA Care users were more likely to be younger (P<.001), high school or university educated (P<.001), employed (P<.001), have a chronic condition (P=.046), use the internet to search for health-related information (P<.001), and use health apps on their mobile phones (P<.001). CONCLUSIONS: The results of this study show that there is substantial interest for the use of MNGHA Care personal health record with 70% of participants self-reporting use. To confirm these findings, objective data from the portal usage logs are needed. Maximizing the potential of MNGHA Care supports patient engagement and is aligned with the national eHealth initiative to encourage the use of technology for high-quality, accessible patient-centered care. Future research should include health care provider perspectives, incorporate objective data, employ a mixed-methods approach, and use a theoretical framework.

P&T Committee Drug Prioritization Criteria: A Tool Developed by a Saudi Health Care System.

INTRODUCTION: The workflow of a P&T committee can become overwhelming and may be affected by many internal and external factors. Organization, standardization, and an enhanced systematic approach for drug evaluations are necessary to ensure that all requested drugs receive an equal and unbiased evaluation and consideration for addition based on the institution's objectives, priorities, and budget. Our aim was to create a scoring tool that would assist in systematically prioritizing drugs being requested for formulary addition and to eliminate cumbersome evaluations for drugs that clearly do not offer any additional advantage. METHODS: A working group consisting of P&T committee members met with the task of creating initial screening criteria for prioritizing drugs requested for formulary addition. Members conducted independent literature searches and focused meetings to develop a scoring tool that would be piloted on drugs being requested for addition. RESULTS: We developed a scoring tool to prioritize drugs requested for formulary addition. The tool assigns a score for each drug that allows it to be classified into one of three categories: 1) for expedited review, 2) for routine review, or 3) for rejection without the need for a full evaluation. CONCLUSIONS: We believe that this scoring tool will assist in prioritizing drugs requested for formulary addition while allowing for full consideration of the most important decision-making factors. In an era of expected U.S. Food and Drug Administration deregulation and economic constraints, P&T committees must create tools that ease their workflow and organize their priorities.