Valuation of EQ-5D-5L in the Kingdom of Saudi Arabia: A National Representative Study.

OBJECTIVES: To estimate a Saudi-specific value set for the EQ-5D-5L questionnaire using the EuroQol Valuation Technology program and the EuroQol Group's standard protocol. METHODS: Participants were quota-sampled from the Saudi adult population based on residency location, age group, gender, education level, and employment status. The participants were guided through the completion of composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks by trained interviewers using EuroQol Valuation Technology software. Quality control (QC) measures were used to ensure good data quality. Random intercept and Tobit models analyzed the cTTO data, as well as models correcting for heteroskedasticity. DCE data were analyzed using conditional logit models, whereas hybrid models were used to analyze the cTTO and DCE data jointly. To evaluate model performance, prediction accuracy, logical consistency, significance level, and goodness of fit were used. RESULTS: The valuation study included a representative sample of the Saudi population (N = 1000). The hybrid heteroskedastic model without a constant was chosen as the preferred model for generating the value set. The predicted values ranged from -0.683 for the worst health state ("55555") to 1 for the full health state ("11111"). Pain and discomfort had the largest impact on health-state preference values, whereas usual activities had the least. CONCLUSION: The value set for the Kingdom of Saudi Arabia is the first value set for the EQ-5D-5L for any country in the Middle East. The value set can be used in Saudi health system economic evaluations and decision making.

Pharmacy practice in hospital settings in GCC countries: Pharmacists' medication therapy monitoring activities.

Purpose: Our study aims to provide an overview of medication therapy monitoring practices carried out by pharmacists in hospitals across the Gulf Cooperation Council (GCC) countries. Methods: This is a cross-sectional questionnaire-based study of hospitals located in the GCC. Questions were adopted from the American Society of Health-System Pharmacists (ASHP) national survey. Frequency analyses were used to examine the number and percentages of specific responses to the survey questions. Results: A total of 64 hospitals participated in this survey, reflecting an overall response rate of 52.0%. Almost half of participating hospitals (48.4%) were from Saudi Arabia. Among the 64 participating hospitals, 54.7% monitored their patients daily, 40.6% assigned pharmacists to patient care units for at least eight hours per day, and 42.2% held pharmacists accountable for medication-related outcomes. Moreover, the criteria used to identify patients requiring monitoring, 35.9% relied on the list of high-risk medications, 26.5% relied on specific medical services, 21.9% relied on directions from the hospital committee, and 17.2% relied on lab abnormalities. The most frequently utilized method for monitoring adverse drug events (ADEs) was through notifications from nurses or physicians, observed in 60.9% of participating hospitals. Conclusion: The survey emphasizes the need for hospitals in the GCC to promote increased pharmacist accountability for medication-related outcomes, explore technological solutions to enhance monitoring efficiency and extend the presence of pharmacists in patient care units beyond the current level.

The impact of a restricted pregabalin prescription policy on drug utilization: An observational multicenter study.

Background: The Saudi Food and Drug Authority (SFDA) classified pregabalin as a controlled substance in 2018; however, whether this policy change has affected pregabalin use is unclear. This study examined the trends in pregabalin prescriptions before and after the SFDA restriction. In addition, the co-prescription of controlled analgesics and the use of pregabalin for approved indications were also evaluated. Method: A cross-sectional study was conducted on outpatient pregabalin prescriptions from three healthcare centers in Saudi Arabia. Interrupted time series analysis was used to assess changes over time in pregabalin prescriptions and the number of patients receiving pregabalin. June 2016 to June 2017 was identified as the pre-restriction period, and July 2018 to July 2019 as the post-restriction period. Results: In this study, 77,760 pregabalin prescriptions were identified. There were 9,076 patients on pregabalin in the pre-restriction period with 16,875 prescriptions, compared with 7,123 patients and 19,484 prescriptions post-restriction. The total number of pregabalin users decreased by 21.5% post-restriction, and prescriptions increased by 15.5%. There was no significant change in the monthly trends in pregabalin prescriptions before and after the restriction. However, the of tramadol and acetaminophen/codeine prescriptions in patients who were using pregabalin increased in the post-restriction period by 21% and 16.1%, respectively. Conclusion: Pregabalin use was reduced after the SFDA-enforced prescription restriction was implemented. This was accompanied by increased narcotics use in the post-implementation phase.

Pharmacy practice in hospital settings in GCC countries: Dispensing and administration.

Purpose: To outline dispensing and administration practices in hospital pharmacy across the Gulf Cooperation Councils (GCC) countries' hospitals. Paucity of data in appraising hospital pharmacy practice in GCC regions motivated us to conduct this study. Methods: A modified survey questionnaire was prepared from the American Society of Health-System Pharmacist (ASHP) survey questions. Three major domains of questions for general characteristics of the medication use process for dispensing and administration were identified. These were, (1) medication distribution system, and medication distribution technology, (2) technology used to compound sterile preparations, compounding I.V. medication and method of compounding nutrition support preparations, (3) medication administration practices, medication orders, medication administration records (MARs), and technician activities. A list of hospitals was obtained from the Ministry of Health of the targeted GCC countries. A secure invitation link containing a survey questionnaire was sent to the participants directly. Results: Sixty-four hospitals responded to this survey. The overall response rate was 52%. Most surveyed hospitals have centralized inpatient medications distribution system (75.0%). About 37.5% of hospitals used automated dispensing cabinets (ADCs) in their patient care areas. Compounding sterile preparations in the pharmacy, barcode verification technology, workflow management technology, and robotic technology were used by 17.2%, 15.6%, and 4.7% of hospitals, respectively. In using safety technology for medication administration, almost all hospitals have partially or completely implemented an electronic health record (EHR). About 40.6% of hospitals used electronic medication administration records (e-MARs), 20.3% used bar-code-assisted medication administration (BCMA), and 35.9% used smart infusion pumps. Conclusion: The results of this survey revealed an opportunity to improve the medication use management process on dispensing and administration practices in hospitals in GCC countries.

Cost-effectiveness of Favipiravir in moderately to severely ill COVID-19 patients in the real-world setting of Saudi arabian pandemic referral hospitals.

Purpose: We aimed to evaluate the cost effectiveness of Favipiravir treatment versus standard of care (SC) in moderately to severely ill COVID-19 patients from the Saudi healthcare payer perspective. Methods: We used the patient-level simulation method to simulate a cohort of 415 patients with moderate to severe COVID-19 disease who were admitted to two Saudi COVID-19 referral hospitals: 220 patients on Favipiravir and 195 patients on SC. We estimated the incremental cost-effectiveness ratio (ICER) of Favipiravir versus SC in terms of the probability to be discharged alive from hospital and the mean time in days to discharge one patient alive. The model was performed twice: first, using unweighted, and second, using weighted clinical and economic data. Weighting using the inverse weight probability method was performed to achieve balance in baseline characteristics. Results: In the unweighted model, base case (probabilistic) ICER estimates favored Favipiravir at savings of Saudi Riyal (SAR)1,611,511 (SAR1,998,948) per 1% increase in the probability of being discharged alive. As to mean time to discharging one patient alive, ICERs favored Favipiravir at savings of SAR11,498 (SAR11,125). Similar results were observed in the weighted model with savings using Favipiravir of SAR1,514,893 (SAR2,453,551) per 1% increase in the probability of being discharged alive, and savings of SAR11,989 (SAR11,277) for each day a patient is discharged alive. Conclusion: From the payer perspective, the addition of Favipiravir in moderately to severely ill COVID-19 patients was cost-savings over SC. Favipiravir was associated with a higher probability of discharging patients alive and lower daily spending on hospitalization than SC.

Adopting global tools for the advancement of pharmacy practice and workforce in Saudi Arabia.

Background: The continuing expansion of the pharmacist's role necessitates continuous evaluation of current practice to identify strategies for improvements. The International Pharmaceutical Federation (FIP) has developed tools to support stakeholders in identifying development needs and planning advancement strategies. The aim of this research was to utilise the FIP Global Competency Framework, version 2 (GbCF v2), and FIP Development Goals (DGs) to evaluate competencies related to pharmacy practice in Saudi Arabia, and to understand the strategies needed to develop and improve the current practice. Methods: The study involved four phases. Phase 1 involved translation of the FIP GbCF v2 into the Arabic language. Phase 2 was a consensus panel validation to establish the initial relevance of the competencies to current practice. Phase 3 included a national survey distributed to all registered pharmacists in Saudi Arabia. The final phase was conducted through mapping 'not relevant' competencies to FIP DGs to identify priorities. Results: The translation phase yielded a bilingual framework that could be utilized by pharmacists in Saudi Arabia. The initial validation phase identified 61 behavioral statements (from 124 in the GbCF v2) as 'highly relevant' or 'relevant' to pharmacy practice. Findings from the national survey identified a list of 'not relevant' competencies that could highlight gaps in current practice. The final mapping phase generated a list of three FIP DG priorities: DG5 (competency development), DG8 (working with others) and DG11 (impact and outcomes). Conclusion: The study indicated that competencies in the GbCF v2 were relevant to pharmacists practicing in the country. However, some competencies were perceived as 'not relevant' to current practice and these highlighted gaps in the current practice that need attention. Mapping 'not relevant' competencies to FIP DGs should be used as a starting point towards developing strategies, systems, and protocols to advance pharmacy practice in Saudi Arabia.

Association between intention to leave work and quality of work-life of Saudi pharmacists.

Background/Aim: Pharmacists are one of the most essential healthcare professionals, with substantial clinical knowledge and skills in the use of medications. Pharmacists provide patient care services and contribute to the enhancement of health outcomes, which increases their workload. This study was conducted to determine the association between intention to leave work and quality of work life (QWL) of pharmacists in Saudi Arabia. Methods: This cross-sectional study was conducted using a self-administered questionnaire provided as a paper-based survey using two scales (the Work-related Quality of Life [QoL] and Intention to Leave scales). In addition, this was combined with demographics to determine the relationship between intention to leave work and quality of work-life. Data were analyzed using descriptive and analytical statistical tests. Results: A total of 284 (76.5%), out of the 371 surveys distributed, were completed and returned. The average age and annual income of the respondents were 33.4 ± 6.5 years and 196,401 ± 82,306.7 SAR, respectively and 61.2% and 38.9% were male and female, respectively, whereas 62.9% were married and 53.2% reported having children. The multiple linear regression analysis conducted showed a significant negative relationship between QWL and the intention to leave work (ß = -0.131; 95% CI, -0.185 to -0.076). Conclusion: We found a significant association between the QWL and intention to leave. This indicates that a greater intention to leave was associated with a low or lousy QWL among Saudi pharmacists.

Localizing pharmaceuticals manufacturing and its impact on drug security in Saudi Arabia.

Local production of pharmaceuticals plays a vital role in maintaining resilience of national healthcare systems, especially when it comes to facilitating access to needed medicines and decreasing exposure to imports and international supply chains. Pharma is a research-intensive industry and the systemic lack of governance and support to R&D activities in this sector, among other host of related issues such as unsupportive regulatory regimes and human resources capacity limitations, is one of the major impediments to the diversifying of locally produced pharmaceuticals portfolio. In this review, an overview of the current pharmaceutical production system in Saudi Arabia, its major challenges, and proposed remedies to address them will be highlighted.

Developing a multidisciplinary HCV direct-acting antivirals utilization management and assessment program.

BACKGROUND: The introduction of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infections has revolutionized outcomes for patients with HCV. Cost-effective use of these antivirals in addition to ensuring patient adherence is of paramount importance. OBJECTIVES: The goal of this article is to describe the processes by which a tertiary care, multisite institution managed the complexities involved in administering DAA treatment and managing the increased cost of therapy. Specifically, the objectives of this article are to describe the development of a multidisciplinary HCV management program and the role of pharmacists in this program, including formulary management strategies and monitoring of DAAs use in our institution, development of guidelines, electronic prescribing protocols and order sets, and specific outcomes based on a concurrent medication use evaluation. PRACTICE DESCRIPTION: King Faisal Specialist Hospital and Research Centre is a tertiary care referral hospital. As a tertiary referral hospital, it offers primary and highly specialized inpatient and outpatient medical care. The process of selecting and developing institutional HCV management program is described. PRACTICE INNOVATION: This article provides key details regarding how a multidisciplinary HCV program using DAAs can be implemented successfully at a tertiary care facility. Key facets of our innovation include establishing formulary guidelines, setting up eligibility criteria for patients, and establishing an HCV taskforce and multidisciplinary HCV program clinic. EVALUATION: Medication use evaluations were regularly conducted to monitor sustained virologic response rates, adherence to guidelines, adverse reactions, and drug interactions. METHODS: Formulary guidelines, setting up an eligibility criterion for patients, and an HCV taskforce and multidisciplinary HCV program clinic were established. RESULTS: The involvement of pharmacists in a multidisciplinary HCV program in outpatient settings resulted in improved formulary decision making, reduction of costs, and improvement of adherence to institutional guidelines. PRACTICE IMPLICATIONS: The role of a pharmacist in the management of patients with HCV with DAAs is important. Pharmacists play an integral part in medication management and overall reduction in health care expenditure. Many disease management programs can be complemented with pharmacists to improve patient care and reduce cost. CONCLUSION: HCV treatment is challenging, and a multidisciplinary approach to treat HCV is critical. It is a rapidly evolving field; therefore, it requires dynamic formulary management and collaborative practice approaches to monitor pharmacotherapy carefully and efficiently. Clinical pharmacists play a pivotal role within the multidisciplinary team by providing support to both patients and health care providers with regard to the treatment of HCV.

Pharmacy practice in hospital settings in GCC countries: Prescribing and transcribing.

PURPOSE: To outline hospital pharmacy practices across the Gulf Cooperation Councils (GCC) countries' hospitals. METHODS: A modified survey questionnaire was prepared from the original 2019 American Society of Health-System Pharmacist (ASHP) survey questions. Survey details were discussed with some pharmacy directors for clarity and relevance. A list of hospitals were obtained from the Ministry of Health of each of the targeted GCC countries. A secure invitation link containing a survey questionnaire was sent to the participants directly. RESULTS: Sixty four hospitals responded to this survey. The overall response rate was 52%. About 47% of the surveyed hospitals considered their drug formularies as closed, and strict. Additionally, only 44% of hospitals compare the effectiveness of products, when taking formulary decisions for drug inclusion. Forty-four percent of hospitals have computerized prescriber order entry (CPOE / EHR) system functionality for formulary system management. At about 39.1% hospitals, pharmacists have the responsibility for managing medication therapies, majority were engaged in providing anticoagulation therapies. About 61% of hospital pharmacies in GCC countries receive medication orders electronically, through CPOE/EHR. Majority (66%) of the hospitals in GCC countries have an active Antimicrobial Stewardship Program (ASP) while only 40% of pharmacists have a key role in providing clinical support. About 57.8% of hospital pharmacy directors reported that pharmacists do not provide ambulatory care clinical pharmacy services in their hospitals. CONCLUSION: In GCC countries' hospitals, there are major areas for improvement to patient care of which pharmacists are uniquely qualified as the medication experts to have the most meaningful outcomes in all of the domains of safe medication use, medication therapy management, antimicrobial stewardship program and participation in outpatient clinics.

Cancer Management in Saudi Arabia: Recommendations by the Saudi Oncology HeAlth Economics ExpeRt GrouP (SHARP).

Cancer is widely recognized as a major global health problem and is estimated to rank as one of the leading causes of death worldwide. Saudi Arabia has undergone remarkable socioeconomic development in the past 40 years which has contributed to the increase in cancer incidence. The high costs of new oncology medications in combination with uncertainty of long-term effectiveness and safety outcomes highlight the importance of considering value, in terms of clinical outcomes, relative to cost. We convened a group of experts to discuss key factors impacting the current state of cancer management in Saudi Arabia and to agree on a list of recommendations, with a focus on value-based care, considering evidence, patients, and costs.

Clinical pharmacy definition, required education, training and practice in Saudi Arabia: A position statement by the Saudi society of clinical pharmacy.

The Saudi Society of Clinical Pharmacy (SSCP) is a scientific and professional society in the field of clinical pharmacy that operates under the Saudi Commission for Health Specialties governance. The SSCP believes that there is a need to define and describe many aspects related to the clinical pharmacy profession in Saudi Arabia. Moreover, there is an increasing demand for promoting the concept of clinical pharmacy and developing a consensus regarding the scope of practice and clinical pharmacist's required postgraduate education and training in Saudi Arabia. This paper is intended to present several position statements by the SSCP that define the concept of clinical pharmacy, describe the required education and training, and highlight clinical pharmacists' scope of practice in Saudi Arabia. This paper calls for further investigations that examine the impact of clinical pharmacists on individual and population health levels.

Efficacy and safety of three times daily dosing of tacrolimus in pediatric kidney transplantation patients: A single-center comparative study.

BACKGROUND/AIM: Several PK studies have shown that most pediatric patients may require higher doses on a mg/kg basis compared to adults to attain similar therapeutic trough concentrations. The aim of this study was to compare the efficacy and safety of three times daily to twice a day dosing of tacrolimus in pediatric kidney transplant recipients at a major tertiary care transplant center. METHODS AND MATERIALS: Retrospective, single-center, and comparative cohort study. All pediatric kidney transplant recipients received either tacrolimus BID (group 1) or tacrolimus TID (group 2). RESULTS: A total of 87 patients were included in this study; 48 patients received BID tacrolimus (group 1), and 39 patients received TID tacrolimus (group 2). The percentage of patients who achieved therapeutic trough concentrations in group 2 did not significantly differ from those in group 1 at day 7 (84.62% TID vs 83.33% BID; P = .42). The median time to reach therapeutic trough concentrations was three days in group 1 compared to four days in group 2. CONCLUSION: No significant difference was observed between tacrolimus BID and TID dosing in the time to reach therapeutic trough concentration or in the proportion of patients achieving therapeutic trough concentrations at day 7.

Current COVID-19 vaccine candidates: Implications in the Saudi population.

AIM: The purpose of this review is to discuss the current status of local and international efforts undergoing clinical trials aiming at developing a Coronavirus Disease-2019 (COVID-19) vaccine, and to highlight the anticipated challenges of this vaccine globally and in Saudi Arabia. PRESENT FINDINGS: COVID-19 vaccine development efforts started in early January 2020 when Chinese scientists shared the Coronavirus genomic sequence in public domain. Approximately 321 research groups initiated the search for a vaccine, out of which 41 have reached phase I/II trails and 11 reached phase-III clinical trials, including approved vaccines for early to limited use. Out of these projects are two labs in the Kingdom of Saudi Arabia still in early stages of development of a COVID-19 vaccine. Several vaccine attempts are being tested from traditional, attenuated virus methods, to new nucleic acid-based designs. However, no vaccine has yet completed clinical trials and reached public domain.In spite of the challenges faced during previous vaccine trials, researchers have found that Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), the causative agent of COVID-19 is structurally similar to the (SARS-CoV-1) and the Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), which caused epidemics in 2003 and 2012 respectively. Both SARS strains show identical affinity towards the type-II alveolar pneumocytes angiotensin converting enzyme-2 (ACE-2) receptor binding domains and therefore, similar pathogenicity. The race to develop the vaccine is predominantly for individuals at high risk of developing the infection, i.e. population groups who are most susceptible to experiencing fatal symptoms of the coronavirus. These include patients with comorbidities, above the age of 60 years and people at risk of contracting large viral loads, such as healthcare providers caring for critical admissions in in-patient wards, Intensive Care Units and Emergency Room settings. SUMMARY: Many different vaccine strategies are under development throughout different stages of the research timeline; however, it is estimated that none will show favorable results before end of 2020. For any immunization or interventional prevention/therapy system to reach the public and patients at high risk, it needs to undergo multiple phase trials to ensure safety and effectiveness. In this scoping review we aim to map the literature on COVID-19 vaccines and provide recommendations related to gaps in research, applicability and expected challenges for implementation of nationwide vaccination in Saudi Arabia.

Pharmacists roles and responsibilities during epidemics and pandemics in Saudi Arabia: An opinion paper from the Saudi Society of clinical pharmacy.

On the 2nd of March 2020, Kingdom of Saudi Arabia confirmed its first case of the coronavirus's newly emerging strain, causing coronavirus disease 2019 (COVID-19). Soon after, the number of confirmed cases started to increase nationally. In light of the emerging outbreak, all healthcare professionals, including pharmacists, began to function with maximum capacity and efforts. The Saudi Society of Clinical Pharmacy (SSCP) acknowledges the substantial impact pharmacists can play during outbreaks. Based on the existing scientific knowledge during this outbreak, the SSCP established an expert writing task force to conceptualize and draft the proposed recommendations that highlights the roles and responsibilities of pharmacists during epidemics and pandemics. The SSCP writing task force issued 28 recommendations. In addition to the national and institutional guidelines, these recommendations could serve as guidance for the impacted entities.

Comparison of closed system transfer devices for turnaround time and ease of use.

OBJECTIVE/PURPOSE: The primary purpose of this study was to compare three closed-system transfer devices with differing mechanical interfaces for their suitability for adoption into our daily practice. The secondary purpose was to use the results of this study to support the selection of one of the closed-system transfer devices, which would suit both the pharmacy and nursing staff at our institution, furthermore promoting the enculturation of international recommendations into our clinical practice. STUDY DESIGN/METHODS: The hazardous drug preparation process was observed and timed continuously from the moment the technician started compounding until the finished product was handed to the designated checker by raising hands. A self-administered, structured questionnaire was used for data collection looking at ease of use of each of the devices from the perspective of pharmacy technicians and nurses. The questionnaire contained an open-ended 10-point Likert-type scale of eight domains. RESULTS/KEY FINDINGS: An improvement in the compounding efficiency of hazardous drugs using PhaSeal™ ( n = 46), ChemoLock™ ( n = 45), and EquaShield® II ( n = 45), when compared respectively against the historical control ( n = 86), was statistically significant ( p < 0.001). However, no statistically significant difference among the different closed-system transfer devices for preparation of hazardous drugs was observed in our study ( p = 0.1). In terms of ease of use, there was no difference in preference for ChemoLock™ and Equashield®II among the pharmacy technicians with both scoring a mean score of 10 with regard to implementation. While PhaSeal™ scored a mean score of 7.2. Among the nursing staff there was a slight preference for ChemoLock™ over Equashield®II with a mean score of 9.2 and 9, respectively with regard to the recommended product, while PhaSeal™ scored a mean score of 7.4. Both nursing staff and pharmacy technicians had a preference ChemoLock™, with a mean score of 10 and 9.6, respectively in terms of on how easy was each device/system to use and overall impression for pharmacy technicians. This was followed by Equashield®II with a mean score of 9.8 and 8.6, respectively and then PhaSeal™ with a mean score of 7.2 and 6.6, respectively. Pharmacy technicians felt there were more steps, packaging and clutter when using PhaSeal® in comparison to the other devices. With Equashield® II, the estimation of clutter was higher than that of ChemoLock™ despite the number of packages being within a similar range. CONCLUSION/RECOMMENDATIONS: Our study found that with experienced staff, compounding of hazardous drugs with closed-system transfer devices can be as efficient as or even more so than with the traditional needle and syringe method. With the lack of statistically significant difference among the different closed-system transfer devices studied, in addition to the cost, ease of use was one of the factors that decided the products applicability in our institution.

A P&T Committee's Transition to a Complete Electronic Meeting System-A Multisite Institution Experience.

PURPOSE: In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. SUMMARY: We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. CONCLUSION: The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites.

Factors that Influence Healthcare Professionals' Intentions towards Biosimilars.

Background: Physicians often prescribe original biologic products to patients who have not used them before and are reluctant to switch to biosimilars. Biosimilars are highly similar versions of already-approved biologics, but healthcare professionals typically hesitate to transition patients from the original products to biosimilars. This study aims to investigate the factors that influence U.S. healthcare professionals' intentions to use biosimilars. Methods: A cross-sectional study was conducted. 510 participants were eligible healthcare professionals (279 physicians and 231 pharmacists). The theory of planned behavior (TPB) is used to identify which factors affect healthcare professionals' intentions. Descriptive statistics, chi-square, and the logistic regression model tested the TPB constructs as predictors of intentions toward biosimilars. Results: Among 279 physicians, most were aged 61 and above, with high (n = 142) and low (n = 137) intentions. Male physicians constituted 71% of the population. Attending physicians (66.3%) showed consistent perceptions towards biosimilars, primarily in the private sector (76.3%). Pharmacists (n = 231), a higher percentage of females demonstrated higher intentions compared to males (35.5% vs. 28.1%); the majority were community pharmacists. Associations between years of practice and intentions were significant. Positive correlations existed between beliefs and intentions, except for normative beliefs. Conclusions: This study revealed diverse attitudes among healthcare professionals towards biosimilars in the USA. Pharmacists and physicians, especially those with limited experience, require ongoing education on biosimilar manufacturing pathways. This education supports the appropriate use of biosimilars and helps standardize federal and state legislation.

A Step Toward the Development of the First National Multi-Criteria Decision Analysis Framework to Support Healthcare Decision Making in Saudi Arabia.

OBJECTIVES: To assess the feasibility of implementing multi-criteria decision analysis (MCDA) and to select the criteria for preparing a national MCDA framework for health technology assessment of orphan drugs in the Kingdom of Saudi Arabia (KSA). METHODS: The study was conducted in 3 phases. In phase I, a targeted literature review was performed to gather relevant information on the implementation of MCDA in healthcare decision making. Phase II was a cross-sectional survey, conducted to obtain insights from different stakeholders and key opinion leaders on specific topics from the KSA perspective. Phase III included a round-table discussion involving experts to validate the results obtained in the phase II survey and further elaborate on specific requirements that may be critical for developing the first national MCDA framework in the KSA. RESULTS: All the key opinion leaders involved in the study acknowledged the importance of implementing MCDA in the KSA. The Ministry of Health was assigned the responsibility of chairing the MCDA decision process. The experts selected the quantitative, qualitative, and economic criteria to be considered for the MCDA framework. The stakeholders decided to initiate a pilot phase using the deliberative MCDA methodology for the assessment of orphan drugs based on the selected criteria for a period of 1 year and then reevaluate the need to adapt the pragmatic MCDA model. CONCLUSION: This article describes the novel initiative that examined the feasibility and process required for the development of the first MCDA framework in the KSA to support healthcare decision making.

Modeling the Clinical and Economic Burden of Therapeutic Inertia in People with Type 2 Diabetes in Saudi Arabia.

INTRODUCTION: Therapeutic inertia in type 2 diabetes, defined as a failure to intensify treatment despite poor glycemic control, can arise due to a variety of factors, despite evidence linking improved glycemic control with reductions in diabetes-related complications. The present study aimed to evaluate the health and economic burden of therapeutic inertia in people with type 2 diabetes in Saudi Arabia. METHODS: The IQVIA Core Diabetes Model (v.9.0) was used to evaluate outcomes. Baseline cohort characteristics were sourced from Saudi-specific data, with baseline glycated hemoglobin (HbA1c) tested at 8.0%, 9.0%, and 10.0%. Modeled subjects were brought to an HbA1c target of 7.0% immediately or after delays of 1-5 years across time horizons of 3-50 years. Outcomes were discounted annually at 3.0%. Costs were accounted from a societal perspective and expressed in 2023 Saudi Arabian Riyals (SAR). RESULTS: Immediate glycemic control was associated with improved or equal life expectancy and quality-adjusted life expectancy and cost savings in all scenarios compared with delays in achieving target HbA1c. Combined cost savings ranged from SAR 411 (EUR 102) per person with a baseline HbA1c of 8.0% versus a 1-year delay over a 3-year time horizon, to SAR 21,422 (EUR 5291) per person with a baseline HbA1c of 10.0% versus a 5-year delay over a 50-year time horizon. Discounted life expectancy and quality-adjusted life expectancy were projected to improve by up to 0.4 years and 0.5 quality-adjusted life years (QALYs), respectively, with immediate glycemic control. CONCLUSION: Therapeutic inertia was associated with a substantial health and economic burden in Saudi Arabia. Interventions and initiatives that can help to reduce therapeutic inertia are likely to improve health outcomes and reduce healthcare expenditure.