Misoprostol-Induced Fever and Unnecessary Antibiotic Prescribing: A Retrospective Study.

INTRODUCTION: Misoprostol is widely used for medication abortion and postpartum hemorrhage. However, it has been associated with the adverse effect of fever, which can pose challenges in management and potentially contribute to unnecessary antibiotic use. The incidence of misoprostol-induced fever in the context of medical abortion has not been extensively studied. METHODS: This retrospective cohort study aimed to determine the incidence of fever following misoprostol administration at a tertiary care hospital in Saudi Arabia. The study included female patients who received misoprostol for pregnancy termination or management of missed or incomplete abortion between January 2017 and December 2019. Data on demographics, misoprostol dosage and route, fever characteristics, outcome of abortion, and antibiotic use were collected. Statistical analysis was preformed using appropriate tests. RESULTS: A total of 213 patients were included in the study. The incidence of fever post-misoprostol administration was 8%. Patients who developed fever had a higher gestational age and received higher doses of misoprostol. However, no significant associations were found between other patient variables and fever incidence. Antibiotic therapy was administered to a almost half of the patients who developed fever post-misoprostol but was determined to be unnecessary in all cases. CONCLUSION: This study contributes to the understanding of misoprostol-induced fever in the context of medical abortion. Further research is needed to explore strategies for reducing unnecessary antibiotic use in this population.

Trends in antidote utilization at a tertiary care hospital in Saudi Arabia: A 6-year retrospective study.

Antidote stocking has been described in several studies from many countries to be problematic and constantly insufficient. During our institution's previous experience with a medication event that resulted from lack of antidote stocking, we initiated a review of all our antidotes and realized the lack of data on utilization in the literature that would help us in planning for our stocks. Therefore, we conducted this retrospective review of antidotes utilized at a large tertiary care hospital over a period of 6 years. The paper describes the types of antidotes and toxins involved, together with important patient characteristics and antidote utilization data that can be useful to other healthcare institutions in planning for their antidote stocks.

Humanistic and Economic Burden of Atopic Dermatitis for Adults and Adolescents in the Middle East and Africa Region.

INTRODUCTION: Atopic dermatitis (AD) is a chronic skin disease that poses a significant burden on both patients and the society. AD causes the highest loss in disability-adjusted life years compared with other skin diseases. This study aimed to estimate the economic and humanistic burden of AD in adults and adolescents in seven countries in the Middle East and Africa region (Egypt, Lebanon, Saudi Arabia, Kuwait, Algeria, South Africa, and United Arab Emirates). METHODS: We conducted a literature review to identify country-specific data on this disease. Subsequently, meetings were organized with experts from each country to complete the missing data. The data were aggregated and calculation models were created to estimate the value of the humanistic and economic burden of the disease in each country. Finally, we conducted meetings with local experts to validate the results, and the necessary adjustments were made. RESULTS: On average, a patient with AD loses 0.19 quality-adjusted life years (QALYs) annually owing to this disease. The average annual healthcare cost per patient is highest in the United Arab Emirates, with an estimated value of US $3569 and a population-level indirect cost of US $112.5 million. The included countries allocated a range of 0.20-0.77% of their healthcare expenditure to AD-related healthcare services and technologies. The indirect cost of AD represents approximately 67% of the total disease cost and, on average, approximately 0.043% (range 0.022-0.059%) of the gross domestic product (GDP) of each country. CONCLUSION: Although the humanistic and economic burdens differ from country to country, AD carries a significant socioeconomic burden in all countries. The quality of life is severely affected by the disease. If AD is controlled, the costs, especially indirect costs, could decrease and the disease burden could be alleviated significantly.

Atopic dermatitis is a chronic condition characterized by inflamed and itchy skin. The prevalence and symptoms of atopic dermatitis are observed to increase in dry weather. Owing to its high prevalence in children, the majority of studies on atopic dermatitis are in children. Although it is also prevalent in adults and adolescents, its burden on adults has not been sufficiently studied, especially in Africa and the Middle East. This study quantified the burden of atopic dermatitis in adults and adolescents in seven countries in the Middle East and Africa. We estimated the economic and humanistic burden of this disease. We conducted a literature review and expert interviews to determine the effects on patients and caregivers. We created mathematical models to calculate the disease burden in each country, and local experts in each country validated the data. The study results showed that atopic dermatitis significantly affects the quality of life of patients. The direct medical costs of treatment in each country were calculated. The management of atopic dermatitis consumes around 0.20­0.77% of the healthcare expenditure in a country. The indirect cost of atopic dermatitis represents 0.022­0.059% of the gross domestic product (GDP) of a country. The country-specific burden data are essential to guide decision-makers in arriving at evidence-based decisions and efficiently allocating available resources. This study focused on the significant indirect economic burden of the disease, which can sometimes be underestimated because the disease is not fatal.

Can't find the antidote: A root cause analysis.

Background: In a series of cases that came to be recognized as a national methanol outbreak, an incident of delay in allocation and treatment with the antidote fomepizole is described with aim of sharing a learning experience. Method: A team of 16 members was formed to conduct a Root Cause Analysis (RCA), which included multiple individual interviews with the stakeholders and inspection visits to the area. Results: Root causes: The restocking process was unclear and inconsistent and specifically lacked a restocking policy for antidotes, inappropriate labeling and area design, and a sound-alike between fomepizole and omeprazole. Contributing factors included: unsuitable restocking practice and lack of training in using the pharmaceutical electronic inventory system. Corrective actions were recommended and implemented. Conclusion: Management of antidotes in large healthcare systems requires a team effort to ensure appropriate and timely availability in emergency poisoning cases. This RCA identified important areas for improvement that could be insightful to other institutions in preventing similar vulnerabilities and is unique in describing the details of system improvements that can have a large impact on patient safety.

Apixaban Use in Patients with Protein C and S Deficiency: A Case Series and Review of Literature.

Background: Historically, warfarin was the mainstay anticoagulant agent to manage patients presenting with thrombotic disorders caused by Protein C or S deficiency. Several direct oral anticoagulants (DOACs) were introduced over the past decade. They showed superiority over warfarin in patients with venous thromboembolism in many landmark trials. Insufficient data are available that examine the outcome of utilizing apixaban in patients with protein S deficiency induce thrombosis. Cases Presentation: We reported the clinical outcomes of utilizing apixaban in four patients with systemic thrombosis caused by protein C or S deficiency who presented to a tertiary hospital in Riyadh, Saudi Arabia. Four patients exhibited typical features of thrombotic events. After confirming the diagnosis, one patient was initially started on apixaban, and the other three patients were converted from warfarin to apixaban. Three of the four patients tolerated the apixaban during the follow-up period. Additionally, they did not have any bleeding or thrombotic complications. However, one patient developed recurrent thrombotic events despite switching to different type of DOAC and was ultimately transitioned back to warfarin. Conclusion: Based on the available emerging evidence and our case series, the use of apixaban could be effective in preventing recurrent thrombotic events in patients with inherited thrombophilia without safety concerns. Further, large studies are warranted to investigate the safety and efficacy of apixaban in these population.

Antimicrobial-associated anaphylaxis at a tertiary care medical city.

BACKGROUND: Antimicrobial-associated anaphylaxis occurs at different rates and can lead to worsening infection-related outcomes, we sought to describe the incidence and complications of such episodes at a tertiary care hospital. METHOD: A retrospective cohort study was conducted between January 2016 and December 2019. Cases of antimicrobial-associated anaphylaxis were identifiedusing the hospital's electronic healthcare records. Outcomes included: mortality related to anaphylaxis, infection-related mortality, hospitalization and impact on antimicrobial prescribing. RESULTS: The estimated rate of antimicrobial-associated anaphylaxis was 18.6 (95% CI: 11.8-29.5) cases per 100,000 exposures, which required hospitalization in 23.8% of the cases and ICU admission in 19% of the cases. CONCLUSION: Implications from antimicrobial-associated anaphylaxis is beyond the episode itself, and can be associated with poor clinical outcomes such as infection-related mortality and hospitalization.

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.

Ibuprofen and NSAID Use in COVID-19 Infected Patients Is Not Associated with Worse Outcomes: A Prospective Cohort Study.

INTRODUCTION: Ibuprofen disappeared from the pharmacy shelves during the 2019 coronavirus (COVID-19) pandemic. However, a while later, information circulated that ibuprofen should be avoided as it could worsen COVID-19 symptoms. The aim of our study was to assess the association of acute and chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) with worse COVID-19 outcomes. METHODS: We did a prospective cohort study between April 12 and June 1, 2020. Adults consecutively diagnosed with COVID-19 were included. Information on NSAID use was collected through a telephone questionnaire, and patients were followed up for COVID-19 infection outcomes, including death, admission, severity, time to clinical improvement, oxygen requirement and length of stay. RESULTS: Acute use of ibuprofen was not associated with a greater risk of mortality relative to non-use (adjusted hazard ratio [HR] 0.632 [95% CI 0.073-5.441; P = 0.6758]). Chronic NSAID use was also not associated with a greater risk of mortality (adjusted HR 0.492 [95% CI 0.178-1.362; P = 0.1721]). Acute ibuprofen use was not associated with a higher risk of admission compared to non-NSAID users (adjusted odds ratio OR 1.271; 95% CI 0.548-2.953). NSAID users did not have a significantly longer time to clinical improvement or length of stay. CONCLUSION: Acute or chronic use of ibuprofen and other NSAIDs was not associated with worse COVID-19 disease outcomes.

Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented.

WHAT IS KNOWN: Limitations of clinical trials in determining all safety concerns related to a drug are well recognized. Monitoring spontaneous adverse drug reaction (ADR) reports remains an easy and relatively inexpensive method for overseeing that a drug remains a safe and effective option for patients. OBJECTIVE: To characterize and describe ADR reports at one of the largest healthcare institutions in the region and share the measures implemented by the team. METHODS: We conducted a retrospective analysis of all ADRs submitted by healthcare providers in a tertiary healthcare system in Saudi Arabia between January 2016 and December 2019. The main outcome measures included reporting rate, patient characteristics, suspected drugs involved, seriousness and reporting specialities. RESULTS AND DISCUSSION: Throughout this study, 1156 ADR reports were submitted. The top reported ADR was immune system disorders (87.8%). The most represented class were antimicrobials (56.8%), followed by analgesics (11.4%) and diagnostic agents (5.1%). The ADRs were deemed definitely avoidable in 11.4% (132/1156) of the cases, and 24.2% (280/1156) were deemed possibly avoidable. Reporting ADRs has steadily increased over the years at our institution, but there continues to be a lack of reporting by physicians. Almost one-third of the reported ADRs were considered to be avoidable or possibly avoidable, which is a driver to continue pharmacovigilance activates on an institutional level and provide specific and tailored preventative measures guided by the specific types of ADRs reported. WHAT IS NEW AND CONCLUSION: This is the first study to report trends of ADRs spontaneously reported at one of the largest healthcare institutions in the Middle East. It shows similar trends to what has been reported by other institutions, with mainly immediate immunological ADRs being the top reported ADRs, which could be explained by the immediate onset which simplifies the temporal association. Every institution should support and maintain an active ADR team, with responsibilities of evaluating incidents, monitoring trends and most importantly identifying opportunities to improve medication and patient safety. We share here our workflow and hope it serves as a guide for other institutions.

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.

Pharmacy and Therapeutics Committee Preparedness Plan for COVID-19.

As the Pharmacy and Therapeutics (P&T) committee acts as an advisory committee on therapeutic options, it is important during pandemics, such as the current Coronavirus disease 2019 pandemic, to quickly search the evidence, be able to select the most appropriate therapies despite the limited evidence, and make appropriate decisions related to which drugs to procure and stock. Potential therapies and recommendations to the P&T committee at a large healthcare institution as means of a preparedness plan are reviewed here.