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INTRODUCTION: Efficient epidemiological monitoring of virus diseases is crucial in evaluating general public health, the prevalence of specific diseases, the pattern of spread, and implementing preventative and control strategies into action. METHODS: This study analyzed data obtained from the Field Epidemiology Program (FETP) which is part of the Ministry of Health (MOH) in Saudi Arabia, which contained reported cases of infectious diseases over four years, from January 2018 to December 2021, to investigate and highlight the significant trend and incidence rate for each viral infectious disease. RESULTS: Of the reported viral infectious diseases, hepatitis B and C, dengue fever (DF), influenza, chickenpox, and measles were the highest reported viral cases over four years. For the aforementioned diseases, males were often more susceptible to viral infections than females. Except for DF, this viral infection was more common in Saudi citizens. Viral illnesses like hand, foot, and mouth disease were less prevalent, while neurological viral disorders such as acute flaccid paralysis were rarely detected. There was an overall reduction in viral cases recorded during 2020-2021, which may be attributed to the implementation of preventive measures during the Coronavirus Disease 2019 (COVID-19) pandemic or an underreporting of cases during the lockdown of that time. CONCLUSION: The prevalence of these common viral infections in the Saudi population suggests that understanding the mechanisms influencing changes in these viruses, methods of transmission, and the burden of these diseases is a priority for health policy. This understanding is necessary to develop effective intervention and preventive strategies.
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The Hajj is an annual mass gathering of people in Makkah, Saudi Arabia. Respiratory infections are common due to their potential for rapid spread in crowded settings. There is a lack of data regarding the effectiveness of face masks in preventing respiratory tract infections (RTIs), specifically during Hajj. We systematically searched PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials until July 3, 2023 for studies comparing the incidence or prevalence of RTIs in those who used any face mask during Hajj compared with no mask. Risk ratio (RRs) and 95% CIs were calculated using either a fixed or random-effect model, depending on the heterogeneity. A comprehensive analysis encompassed 10 studies involving 5007 participants. The overall RR favored wearing masks over not wearing masks regarding the incidence of RTIs; however, the difference was not statistically significant (RR = 0.78; 95% CI = 0.55-1.10; P = 0.16). A significantly lower incidence of RTIs was found in those wearing masks most of the time versus intermittently (RR = 0.59; 95% CI = [0.38-0.94; P = 0.02). In subgroup analyses, there was no difference between wearing masks and not wearing masks across different study designs (cohort/case-control), different groups (pilgrims/healthcare workers), and different years of Hajj, except from 2000 to 2008, when there was a significant difference favoring wearing face masks. This meta-analysis found wearing masks most of the time was associated with significantly lower risk of RTIs than wearing it intermittently.
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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.
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OBJECTIVE: To provide evidence-based clinical practice recommendations for managing Systemic Lupus Erythematosus (SLE) in Saudi Arabia. METHODS: This EULAR-adapted national guideline in which a multidisciplinary task force utilized the modified Delphi method to develop 31 clinical key questions. A systematic literature review was conducted to update the evidence since the EULAR publication. After reaching a consensus agreement, two rounds of voting and group discussion were conducted to generate consolidated recommendations/statements. RESULTS: A significant number of patients in Saudi Arabia experience delays in accessing rheumatologists, highlighting the significance of timely referral to SLE specialists or rheumatologists to ensure accurate diagnosis and prompt treatment. The primary goal of Glucocorticoid (GC) therapy in SLE patients is to establish disease control with a minimum dose and duration. Steroid-sparing agent utilization facilitates steroid-sparing goals. Hydroxychloroquine is recommended for all SLE patients, though physicians must carefully monitor toxicity and prioritize regular medication adherence assessment. SLE management during pregnancy starts from preconception time by assessing disease activity, major organ involvement, hypercoagulability status, and concomitant diseases that may negatively impact maternal and fetal outcomes. Multidisciplinary care with close monitoring may optimize both maternal and fetal outcomes. For patients with antiphospholipid antibodies, low-dose aspirin prophylaxis is recommended. Also, Long-term anticoagulant medications are fundamental to prevent secondary antiphospholipid syndrome due to high thrombosis recurrence. CONCLUSION: This Saudi National Clinical Practice guidelines for SLE management provide evidence-based recommendations and guidance for healthcare providers in Saudi Arabia who are managing patients with SLE. These guidelines will help to standardize healthcare service, improve provider education, and perhaps lead to better treatment outcomes for SLE patients.
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INTRODUCTION: The emergence of the COVID-19 pandemic has served as a call for enhanced global cooperation and a more robust pandemic preparedness and response framework. As a result of this pressing demand, dialogues were initiated to establish a pandemic treaty designed to foster a synchronized global strategy for addressing forthcoming health emergencies. In this review, we discussed the main obstacles to this treaty. RESULTS: Among several challenges facing the pandemic treaty, we highlighted (1) global cooperation and political will, (2) equity in access to resources and treatments, (3) sustainable financing, (4) compliance and enforcement mechanisms, (5) sovereignty concerns, and (6) data sharing and transparency. CONCLUSION: Navigating the hurdles facing the development of the pandemic treaty requires concerted efforts, diplomatic finesse, and a shared commitment to global solidarity. Addressing challenges in global cooperation, equitable access, transparency, compliance, financing, and sovereignty is essential for forging a comprehensive and effective framework for pandemic preparedness and response on the global stage.
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INTRODUCTION: Bacterial infections have a significant impact on human health; they can cause severe morbidity and mortality, particularly in susceptible populations. Epidemiological surveillance is a critical tool for monitoring the population's health and facilitate the prevention and control of infectious disease outbreaks. Knowing the burden of bacterial communicable diseases is an initial core step toward public health goals. METHODS: Saudi epidemiology surveillance data were utilized to depict the changing epidemiology of bacterial infectious diseases in Saudi Arabia from 2018 to 2021. The cumulative numbers of cases, demographics, and incidence rates were analyzed and visualized. Parametric tests were used to compare the difference in the mean values between categorical variables. Regression analysis was employed to estimate trends in disease rates over time. Statistical significance was set at p value ≤ 0.05. RESULTS: The results revealed that brucellosis, tuberculosis, and salmonellosis were the most frequently reported bacterial infectious diseases in Saudi Arabia. Males were more significantly affected by brucellosis and tuberculosis infections than females. Salmonellosis infections were more significant among Saudi citizens, while pulmonary tuberculosis was more significant in non-Saudis. Interestingly, there was a decline in the incidence rates of numerous bacterial infectious diseases during the Coronavirus Disease 2019 (COVID-19) pandemic and COVID-19 restrictions. Some bacterial infectious diseases were rarely reported in Saudi Arabia, including syphilis and diphtheria. CONCLUSIONS: The future perspective of this research is to enhance disease surveillance reporting by including different variables, such as the source of infection, travel history, hospitalization, and mortality rates. The aim is to improve the sensitivity and specificity of surveillance data and focus on the mortality associated with bacterial pathogens to identify the most significant threats and set a public health priority.
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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.
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Decision Making , Decision Support Techniques , Technology Assessment, Biomedical , Saudi Arabia , Humans , Cross-Sectional Studies , Technology Assessment, Biomedical/methods , Delivery of Health Care , Orphan Drug Production , Surveys and QuestionnairesABSTRACT
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.
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Health Status , Quality of Life , Humans , Saudi Arabia , Male , Female , Adult , Middle Aged , Surveys and Questionnaires , Young Adult , Aged , Choice Behavior , AdolescentABSTRACT
Psoriatic arthritis (PsA) is a complex inflammatory disease characterized by musculoskeletal and non-musculoskeletal manifestations. It is a distinct disease entity at the interface between rheumatology and dermatology, making it challenging to manage. The diverse clinical presentation and severity of PsA require a multidisciplinary approach for optimal care. Early diagnosis and management are necessary to improving quality of life for patients. In Saudi Arabia, there is currently no unified national consensus on the best practices for managing PsA. This lack of consensus leads to debate and uncertainty in the treatment of the disease, resulting in over or under prescribing of biological agents. To address this issue, a multidisciplinary work group was formed by the Saudi Ministry of Health. This group, consisting of dermatologists, rheumatologists, and pharmacists, aimed to develop evidence-based consensus recommendations for he use and monitoring of biological therapy in PsA management. The work group conducted five consensus workshops between December 2021 to March 2022. Using the nominal group technique, they discussed various aspects of PsA management, including eligibility criteria for biological treatment, monitoring of disease activity, treatment goals, screening, precautions, and management of PsA with biologic therapies. The group also considered special considerations for patients with comorbidities, pregnant and lactating women, as well as pediatric and adolescent populations. The resulting consensus document provides recommendations that are applicable to the Saudi setting, taking into account international guidelines and the specific needs of PsA patients in the country. The consensus document will be regularly updated to incorporate new data and therapeutic agents as they become available. Key Points ⢠In Saudi Arabia, there is a lack of unified national consensus on the optimal management of PsA, therefore, this article aims to provide up-to-date evidence-based consensus recommendations for the optimal use and monitoring of biologic therapy in the management of PsA in Saudi Arabia. ⢠The consensus development process was undertaken by a multidisciplinary work group of 13 experts, including two dermatologists, six rheumatologists, and five pharmacists. ⢠There is more than one disease activity tool used in PsA disease, depending on the disease domain - peripheral arthritis Disease Activity Index in Psoriatic Arthritis (DAPSA) or Minimal Disease Activity (MDA), axial PsA Ankylosing Spondylitis Disease Activity Score (ASDAS), and dactylitis and enthesitis MDA. ⢠The main goal of therapy in all patients with PsA is to achieve the target of remission, or alternatively, low disease activity in all disease domains and improve quality of life (QoL).
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Arthritis, Psoriatic , Male , Humans , Female , Child , Adolescent , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/drug therapy , Consensus , Quality of Life , Lactation , Saudi ArabiaABSTRACT
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.
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Antiviral Agents , Hepatitis B, Chronic , Tenofovir , Humans , Cost-Benefit Analysis , Hepatitis B, Chronic/drug therapy , Hepatitis B, Chronic/epidemiology , Saudi Arabia/epidemiology , Tenofovir/analogs & derivatives , Tenofovir/therapeutic use , Alanine/therapeutic use , Antiviral Agents/therapeutic use , Guanine/analogs & derivatives , Guanine/therapeutic useABSTRACT
INTRODUCTION: Type 2 diabetes mellitus (T2DM) is associated with huge clinical and economic burden in the Kingdom of Saudi Arabia (KSA) which can be curtailed by efficacious treatment. In order to achieve this, current treatment pathways for T2DM and associated costs need to be assessed. METHODS: A longitudinal cohort review was conducted to collect country-specific and patient-specific clinical data, over a minimum observation period of 5 years in the KSA. Patient demographics, clinical characteristics and treatment patterns were recorded. The IQVIA Core Diabetes Model (CDM) version 9.5 Plus was used to assess the burden of illness, which included long-term projections of clinical (life expectancy [LE], quality-adjusted life-years [QALYs], event rates of diabetes-related complications) and direct medical cost (per-patient annual or lifelong [50 years]) outcomes of the most commonly used first-line (1st-line) regimens for T2DM from a payer perspective in the KSA. RESULTS: Data were collected from a subpopulation of 638 patients from 15 participating centres. There was an equal gender representation with a majority of the patients belonging to Arabian/Saudi ethnicity (71.0%). Biguanides (81.5%), sulfonylureas (51.6%), dipeptidyl peptidase 4 (DPP4) inhibitors (26.2%) and fast-acting insulins (17.2%) were the most prescribed 1st-line agents. The most frequently used 1st-line regimens resulted in an estimated LE of 25-28 years, QALYs of 18-21 years and lifelong total cost of illness of 201,377-437,371 Saudi Arabian riyal (53,700-116,632 US dollars). CONCLUSION: Our study addresses gaps in the current research by providing a complete landscape of baseline demographic, clinical characteristics and treatment patterns from a heterogeneous group of patients with T2DM in the KSA. Additionally, the burden of illness analysis using CDM showed substantially higher cost of T2DM care from a payer perspective in the KSA.
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Diabetes Mellitus, Type 2 , Dipeptidyl-Peptidase IV Inhibitors , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Saudi Arabia/epidemiology , Longitudinal Studies , Insulin/therapeutic use , Dipeptidyl-Peptidase IV Inhibitors/therapeutic use , Cost of IllnessABSTRACT
BACKGROUND: Hajj is the largest mass gathering worldwide that takes place every year in Makkah, Saudi Arabia. This paper aims to provide a comprehensive guide and expectations for delivering and optimizing clinical pharmacy services during one of the largest mass gatherings in the world, Hajj pilgrimage METHODS: A task force initiated and included members of clinical pharmacists who previously participated in delivering clinical pharmacy services during the Hajj pilgrimage, members of the Saudi Society of Clinical Pharmacy (SSCP), and policymakers from different sectors and representatives from pharmaceutical care of the Ministry of Health (MOH). The members established an expert task force to conceptualize and draft the proposed suggestions highlighting the roles and responsibilities of clinical pharmacists during the annual Hajj season. RESULTS: The task force determined the following key domains 1) pharmaceutical care (administration and strategic plan, resources, formulary management); 2) pharmacists' activities (clinical pharmacy services and documentation, professional training and development, and staff credentials, and qualifications); 3) challenges and proposed solutions. The task force was divided into groups to draft each domain and provide suggested statements and insights for each section. Finally, the group members of the task force issued 15 opinion statements. CONCLUSION: Mass gatherings such as Hajj pilgrimage, represent a unique opportunity to demonstrate the value of pharmacists in advancing health care delivery within a multidisciplinary team. These suggestions and insights could guide the implementation of clinical pharmacy services in acute settings during mass gatherings (Hajj). Future studies should focus on assessing the applicability and the impact of the provided suggestions.
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Mass Gatherings , Pharmacy Service, Hospital , Humans , Travel , Islam , Saudi ArabiaABSTRACT
BACKGROUND: Infection is the second-leading cause of death among cancer patients, but there have been few studies on the effectiveness of novel antimicrobial agents to treat carbapenem-resistant Enterobacterales in cancer patients. OBJECTIVE: Evaluate the mortality and clinical outcomes of ceftazi-dime-avibactam for OXA-48- and/or New Delhi metallo-ß-lactamase (NDM)-producing Enterobacterales infection in cancer patients. DESIGN: Retrospective observational cohort study. SETTING: Tertiary academic medical center in Riyadh, Saudi Arabia. SUBJECTS AND METHODS: This study included patients who had cancer and received ceftazidime-avibactam for at least 72 hours for infections caused by OXA-48- and/or NDM-producing Enterobacterales. We excluded patients who died within 72 hours of treatment, patients with polymicrobial infections, and patients who did not receive appropriate antimicrobial therapy. MAIN OUTCOMES AND MEASURES: Primary outcomes were 30-day mortality and hospital mortality. Secondary outcomes included clinical cure, relapse, and reinfection. SAMPLE SIZE: 32 cancer patients. RESULTS: The 30-day mortality among all patients was 15/32 (47%), clinical cure was achieved in 19/32 (59%) of the patients, and the relapse and reinfection rates were 2/19 (10.5%) and 4/17 (23.5%), respectively. CONCLUSION: This is the largest study to evaluate clinical outcomes associated with infections caused by OXA-48- and/or NDM-producing Enterobacterales in cancer patients. The mortality rate remains high; however, ceftazidime-avibactam is an encouraging alternative for treating severe infections in cancer patients. LIMITATIONS: Small sample size and single center.
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Ceftazidime , beta-Lactamases , Humans , Ceftazidime/therapeutic use , Reinfection , Retrospective Studies , Neoplasms/drug therapyABSTRACT
ABSTRACT: The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.
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BACKGROUND: The Kingdom of Saudi Arabia (KSA) has embarked on a Health Sector Transformation Program as part of the Kingdom's Vision 2030 initiatives with the facilitation of access to healthcare services for the millions in KSA with diabetes an essential part of the Program. Decision-making tools, such as budget impact models, are required to consider the addition of new medications like oral semaglutide that have multifaceted health benefits and address barriers related to therapeutic inertia to reduce diabetes-related complications. OBJECTIVE: To determine the financial impact of the introduction of oral semaglutide as a treatment option for people with type 2 diabetes mellitus (T2DM) in KSA. METHODS: From the public payer's perspective, the budget impact model estimates the costs before and after the introduction of oral semaglutide over a 5-year time horizon. The budget impact of introducing oral semaglutide (primary comparator) compared with three different classes of diabetes medicines: glucagon-like peptide-1 receptor agonists (GLP-1), sodium-glucose transport protein 2 inhibitors (SGLT 2i) and dipeptidyl peptidase 4 inhibitors (DDP-4i) have been calculated based on the projected market shares. The model includes the cost of care through the incorporation of health outcomes that have an impact on the national payer's budget in Saudi Riyals (SAR). RESULTS: The budget impact over the five-year time horizon indicates a medication cost increase (17,424,788 SAR), and cost offsets which include a difference in diabetes management costs (-3,625,287 SAR), CV complications costs (-810,733 SAR) and weight loss savings of 453,936 SAR. The cumulative total cost difference is 12,427,858 SAR (0.66%). CONCLUSION: The introduction of oral semaglutide 14 mg as a second-line treatment option after metformin is indicated as budget-neutral to slightly budget-inflating for the public pharmaceutical formulary of KSA. The price difference is offset by positive health outcomes and costs. This conclusion was confirmed through a probabilistic sensitivity analysis.
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Diabetes Mellitus, Type 2 , Drug Costs , Glucagon-Like Peptides , Hypoglycemic Agents , Humans , Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptides/therapeutic use , Hypoglycemic Agents/therapeutic use , Saudi ArabiaABSTRACT
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.
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The indications of direct oral anticoagulants (DOACs) have expanded over the past 15 years. DOACs are effective and safe oral anticoagulants associated with lower bleeding risks and mortality than vitamin K antagonists. However, DOAC users are prone to a considerable bleeding risk, which can occur at critical sites or lead to severe life-threatening conditions. Recent statistics indicated that major bleeding occurs in up to 6.62 DOAC users per 100 treatment years. With the increased use of DOACs in clinical practice, DOAC-associated major bleeding is expected to be encountered more frequently in the emergency department. The current international guidelines recommend specific reversal agents for the management of DOAC users with severe bleeding to reverse the anticoagulant effect and restore normal hemostasis. An individualized assessment was incorporated in specific clinical situations to guide the decision pathway of major bleeding management. However, specific reversal agents are unavailable or have limited availability in many countries, which is expected to negatively impact the clinical outcomes of DOAC-associated major bleeding. Limited real-world evidence is available from these countries regarding the clinical outcomes of patients with DOAC-associated major bleeding. This narrative review provided an updated assessment of the evidence-based approaches for the management of major bleeding in DOAC users. We also explored the clinical outcomes of patients with major bleeding from clinical settings where specific reversal agents are unavailable.
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Anticoagulants , Hemorrhage , Humans , Hemorrhage/chemically induced , Anticoagulants/adverse effects , Administration, Oral , Dabigatran/adverse effectsABSTRACT
Alopecia areata (AA) is a complex autoimmune disease manifesting as a chronic inflammatory disease characterized by non-scarring patches of hair loss over the face, scalp, and body. Several treatments have been proposed for AA, but none are curative nor achieve a state of remission. The present consensus statement aims to present the evidence- and experience-based recommendations on the diagnosis and management of AA in Saudi Arabia. The Ministry of Health in Saudi Arabia has opted to initiate a meeting of a multidisciplinary group to discuss and concede on this topic. Eight dermatology experts and clinical pharmacists convened in eight consensus meetings. All content presented in this document was agreed upon by this working group, including diagnosis and severity assessment, prognostic indicators, and therapeutic options for AA. Special consideration was given to special patient populations including pediatric patients and patients with less frequent presentations of AA. Updates of the current recommendations will take place as new evidence evolves in the treatment of AA.
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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.