Parental Experience of Potential Adverse Drug Reactions Related to Their Oral Administration of Antipyretic Analgesic Medicines in Children in Saudi Arabia.

BACKGROUND: Oral antipyretic analgesic medicines are commonly used in children and have the potential for adverse drug reactions (ADRs). OBJECTIVE: The aim of this study was to explore parental experiences of potential ADRs related to their oral administration of antipyretic analgesics in children in the Kingdom of Saudi Arabia. METHODS: For this cross-sectional survey, a paper-based questionnaire, consent form and information sheet were handed out to 1000 parents who had administered an oral antipyretic analgesic medicine to their children during the previous 3 months. Data were entered and analyzed using SPSS version 21.0 (IBM-SPSS Inc, Armonk, NY). Simple descriptive and inferential statistics were used. Management and ethical approvals were attained. RESULTS: During March to April 2017, 661 parents agreed to participate, giving a response rate of 66.1%. Of the surveyed sample, 208 parents had observed 1 or more potential ADRs (31.5%, n = 208 out of 661). Parents' (n = 208) most commonly reported potential ADRs (n = 523) were loss of appetite (23%, n = 120 out of 523), stomachache (20.3%, n = 106 out of 523), abdominal colic (13%, n = 68 out of 523), and diarrhea (10.3%, n = 54 out of 523). Parents described severity of the ADRs as slight (71.8%, n = 342 out of 476), annoying to the child (7.9%, n = 85 to of 476), significant and affecting daily tasks (3.6%, n = 17 out of 476) and significant and led to the hospital (6.7%, n = 32 out of 476). Fever was the top-ranked reason for using antipyretic analgesic medicines (41.0%, n = 271 out of 661), followed by toothache (25.0%, n = 165 out of 661) and tonsillitis/laryngitis (24.7%, n = 163 out of 661). Among parents, 34.7% (n = 165 out of 476) did not seek medical attention when a potential ADR occurred, whereas 26.3% (n = 125 out of 476) of parents took their children to hospital clinics. CONCLUSIONS: Although the majority of parentally reported (but not proven) ADRs were mild, a number of significant ADRs were reported. Future research should consider whether there is a role for physicians and pharmacists in educating parents in Saudi Arabia, and perhaps more widely, about the optimal use of oral antipyretic and analgesic medicines in children. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX)© 2020 Elsevier HS Journals, Inc.

Practical Management of Castleman's Disease.

Castleman's disease (CD) is a rare lymphoproliferative disorder that is most commonly present in multicentric (MCD) form in association with HIV infection. Interleukin-6 (IL-6) and human herpesvirus-8 (HHV-8) play major roles in MCD pathogenesis. Important treatment options have recently become available, particularly with the introduction of IL-6 and IL-6 receptor inhibitors for the treatment of HIV-negative patients with MCD. Though advances in therapy may improve outcomes in some patients, the prognosis remains guarded, and a stratified approach to the management of MCD is needed.

Opioid Control for Patients With Sickle Cell Anemia in Emergency Departments in the Western Region of Saudi Arabia.

Introduction Sickle cell anemia (SCA) affects the Saudi Arabian population significantly, with 4.2% carriers and 0.26% affected. Vaso-occlusive crises cause severe pain due to blood vessel blockage by sickled cells, leading to frequent emergency visits, where treatment includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs), oxygen, and opioids. This study examines opioid use in managing SCA crises in Saudi emergency departments. Method A retrospective cross-sectional study in western Saudi Arabia surveyed board-certified emergency physicians (consultants, fellows, specialists) via the Sickle Cell Disease Implementation Consortium (SCDIC). Non-board-certified physicians and general practitioners were excluded. Data were gathered through structured surveys and supplemented by interviews. Results The study included 53 emergency physicians, mostly specialists (60.4%), with one to three years' experience, primarily from King Abdul Aziz University Hospital (28.3%) and King Abdullah Medical Complex (22.6%). While more than half of the participants felt adequately trained for SCA management, 20.8% faced challenges referring patients to case management programs. Major barriers included department overcrowding and the opioid epidemic. Conclusion The study reveals challenges in managing SCA in Saudi emergency departments, particularly with opioid use. Despite physician training, gaps in administrative support, medication access, and follow-up care persist. Institutional policies and opioid epidemic concerns restrict Schedule-II opioid prescriptions. Implementing a comprehensive opioid administration tracking system and standardizing protocols are crucial for enhancing patient outcomes. Future efforts should focus on improving resources and inter-institutional collaboration.

End-Stage Kidney Disease Resulting from Atypical Hemolytic Uremic Syndrome after Receiving AstraZeneca SARS-CoV-2 Vaccine: A Case Report.

Hemolytic uremic syndrome (HUS) is classically described as a triad of nonimmune hemolytic anemia, thrombocytopenia, and acute kidney injury. Atypical HUS (aHUS) is a rare variant of the disease, and it accounts for 5-10% of the cases. It has a poor prognosis, with a mortality rate exceeding 25% and a more than 50% chance of progressing into end-stage kidney disease (ESKD). Genetic or acquired dysregulation of the alternative complement pathway is highly implicated in the pathogenesis of aHUS. Multiple triggers for aHUS have been described in the literature, including pregnancy, transplantation, vaccination, and viral infections. Herein, we report a case of a previously healthy 38-year-old male who developed microangiopathic hemolytic anemia and severe kidney impairment one week after receiving the first dose of AstraZeneca SARS-CoV-2 vaccine. A diagnosis of aHUS was made after excluding other causes of thrombotic microangiopathies. Treatment with plasma exchange, prednisone, and rituximab (375 mg/m2) once weekly for four doses resulted in improvement of his hematological parameters. However, he progressed to ESKD.

A Three-Year Experience With Overseas Kidney Transplantation in a Tertiary Transplant Center in Saudi Arabia.

Background Overseas kidney transplantation is known to be associated with adverse outcomes. In this study, we aim to present a detailed analysis of our three years of experience with overseas kidney transplantation at one of the largest kidney transplant referral sites in the Kingdom of Saudi Arabia. Materials and methods A retrospective cohort study included patients who underwent kidney transplantation overseas and were subsequently followed up at King Abdulaziz Medical City from January 2016 to July 31, 2019. In addition, we compared the outcomes of the patients who underwent kidney transplantation overseas with a cohort of patients who were transplanted locally within the same period. Patients in both cohorts had to have at least one year of follow-up post-transplantation. Results We included a total of 51 patients who underwent kidney transplantation overseas. The mean age of the cohort was 44.7 years, and 69% were male. Almost 60% of the cohort had one or no comorbidity prior to transplant, with hypertension (84%) and diabetes mellitus (37%) being the leading comorbidities. The cause of end-stage kidney disease was unknown in 55% of our patients. In those who had an identifiable cause, lupus nephropathy and diabetes were the most common causes of kidney failure. In comparison with the locally transplanted cohort, no difference was detected between these groups in their baseline characteristics, type or number of comorbidities, medical or surgical complications postoperatively, and one-year mortality. However, we found that the graft rejection rate was significantly higher in patients transplanted overseas (OR=5.4, p<0.001). In addition, the proportion of patients who received anti-thymocyte globulin (ATG) induction was also less in the group with overseas kidney transplantation (58% vs. 22%, p<0.001). Conclusion Overseas transplantation is associated with an increased risk for graft rejection. Our study suggests that overseas kidney transplantation is possibly driven by a lack of donors, especially cadaveric. Counseling patients about risks associated with overseas kidney transplantation and encouraging the public to register for organ donation after death may help curb out this practice.

Renal Transplant Experience in a Tertiary Care Center in Saudi Arabia: A Retrospective Cohort Study.

BACKGROUND: Data on outcomes of renal transplantation in the Kingdom of Saudi Arabia (KSA) is limited. We describe renal transplant experience in one of the largest referral centers for renal transplants in KSA. METHODS: This is a retrospective cohort study of patients who underwent kidney transplantation at King Abdulaziz Medical City (KAMC) from January 2016 to July 31, 2019, with at least one year of follow-up post-transplantation. RESULTS: One hundred ninety-four individuals were identified and included in the analysis. The mean age of the renal transplant cohort was 45 years with an average pre-transplant body mass index of 26.1 kg/m2. The most common comorbidities were hypertension (77.3%) and diabetes mellitus (34.5%). The most common etiology of end-stage kidney disease (ESKD) was unknown (49.0%) followed by Lupus nephropathy (16.0%). Central venous catheters were the predominant dialysis access (56.2%). Living-related kidney donation was the commonest source of kidney transplantation (61.3%), followed by deceased donor renal transplantation (22.7%). Anti-thymocytes globulin (ATG) was the predominant induction agent (57.7%) and nearly all patients received tacrolimus-based maintenance immunosuppression. Mean serum creatinine at the time of discharge was 109 umol/l. Delayed graft function was observed in 6.7% of our patients. The most common medical complications were urinary tract infection (26.3%). Post-transplant surgical complications occurred at a low rate. CONCLUSION: Our study demonstrated a successful renal transplant experience among a relatively healthy cohort and identifies potential gaps, particularly the high rate of central venous catheters, the frequent lack of clear etiology of ESKD, the low rate of pre-emptive transplant, and deceased donors. Further studies are needed to evaluate and close these gaps.

IgG4-Related Kidney Disease Associated With End-Stage Kidney Disease, Renal Pseudotumor, and Renal Vein Thrombosis.

IgG4 related disease (IgG4-RD) is a systemic autoimmune disease characterized by tissue invasion with IgG4-producing plasma cells, resulting in tissue dysfunction. IgG4-RD can affect the kidney in various forms, including renal mass, tubulointerstitial disease, and glomerulonephritis. IgG4-RD can mimic other autoimmune diseases and neoplasms, and as such, maintaining a high index of suspicion is the key to timely diagnosis and treatment. In this paper, we present a case of IgG4-RD that presented with pseudotumor and severe renal dysfunction that progressed to end-stage kidney disease (ESKD), associated with a rare finding of renal vein thrombosis (RVT).

Presentation and Outcomes of Patients With End-Stage Kidney Disease Hospitalized With COVID-19 at a Tertiary Center in Riyadh, Kingdom of Saudi Arabia.

Background Patients with end-stage kidney disease (ESKD) are disproportionately vulnerable to COVID-19 and its complications due to the older age and significant burden of comorbid conditions. Data about the impact of COVID-19 on the ESKD population in the Kingdom of Saudi Arabia is scarce, and this study aims to bridge this gap. Method This is a retrospective cohort study that included ESKD patients who were receiving either in-center hemodialysis (HD) or peritoneal dialysis (PD) for at least three months and were hospitalized due to COVID-19 at King Abdulaziz Medical City in Riyadh (KAMC) between March 2020 and March 2021. Of note, the in-center hemodialysis means that the patients come to the dialysis center three times per week to receive their dialysis sessions, as home hemodialysis is not available at our center. Multivariate logistic regression was performed to explore the association of clinical characteristics and laboratory parameters with ICU admission and mortality. Results A total of 104 patients were included in the analysis. The mean age was 62.6 (SD=17.4) years, 101 (97%) were on HD, predominantly through a central venous catheter (72%), and 53 patients (51%) were male. Patients with COVID-19 were either asymptomatic (42%) or had mild symptoms (37%), mainly cough and fever. At the time of admission, 37 patients (36%) had extrapulmonary symptoms, and 13 patients (12%) had altered mental status. Normal chest X-ray (48%), followed by bilateral lung infiltrates (24%), and unilateral lung infiltrate (11%) were the most common radiological findings. We did not observe any thromboembolic events. Twenty patients (19%) required ICU admission and 19 patients (18%) died during hospitalization. Predictors for in-hospital mortality were: 1) the need for inotropes (adjusted OR: 53.01, p=0.006), 2) age (adjusted OR: 1.07, p=0.019), and 3) C-reactive protein (CRP) level on admission (adjusted OR: 1.02, p=0.04). We did not find any strong predictor for ICU admission. Conclusion Our study demonstrated that COVID-19 carries significant mortality and morbidity in the ESKD population. Age, inotropic support requirement and elevated CRP on admission predicted mortality in our population. The high rate of adverse outcomes of COVID-19 among ESRD patients calls for strict implementation of preventive measures, including vaccination, social distancing, and universal masking at the level of both the healthcare providers and patients. Further studies are needed to assess the association of COVID-19 and hypercoagulability ESKD population.

A case report of acquired hemophilia following COVID-19 vaccine.

Acquires hemophilia A (AHA) is rare bleeding condition commonly associated with malignancy, autoimmune disease, or pregnancy. We report a case of a 69-year-old gentleman who developed bleeding symptoms after receiving COVID-19 vaccine. Laboratory testing showed isolated prolongation of the activated partial thromboplastin time, and normal von Willebrand factor. Further testing confirmed the presence of factor VIII inhibitor. To date, no cases of AHA have been reported after exposure to COVID-19 vaccine. There have been two cases of AHA following seasonal flu and H1N1 vaccination, as well as two cases of AHA following COVID-19 infection. We present a summary of these cases and review of literature of autoimmune reactions following vaccination.

A physician survey of perioperative neuraxial anesthesia management in patients on a direct oral anticoagulant.

BACKGROUND: The perioperative management of patients taking a direct oral anticoagulant (DOAC) who require a high-bleed-risk surgery and/or neuraxial anesthesia is uncertain. We surveyed clinician practices relating to DOAC interruption and related perioperative management in patients having high-bleed-risk surgery with neuraxial anesthesia, and assess the suitability of a randomized trial of different perioperative DOAC management strategies. METHODS: We surveyed members of the American Society of Regional Anesthesia and Pain Medicine, the Canadian Anesthesia Society and Thrombosis Canada. We developed four clinical scenarios involving DOAC-treated patients who required anticoagulant interruption for elective high-bleed-risk surgery. In three scenarios, patients were to receive neuraxial anesthesia, and in one scenario they were to receive general anesthesia. We also asked about the merit of a randomized trial to compare a 2-day versus longer (3- to 5-day) duration of DOAC interruption. RESULTS: There were 399 survey respondents of whom 356 (89%) were anesthetists and 43 (11%) were medical specialists. The responses indicate uncertainty about the DOAC interruption interval for high-bleed-risk surgery and/or neuraxial anesthesia; anesthetists favor 3- to 5-day interruption whereas medical specialists favor 2-day interruption. Anesthetists were unwilling to proceed with neuraxial anesthesia in patients with a 2-day DOAC interruption interval, preferring to cancel the surgery or switch to general anesthesia. There is general agreement on the need for a randomized trial in this field to compare a 2-day and a 3- to 5-day DOAC interruption management strategy. CONCLUSIONS: There is variability in practices relating to the perioperative management of DOAC-treated patients who require a high-bleed-risk surgery with neuraxial anesthesia; this variability relates to the duration of DOAC interruption in such patients.

Prevalence of COVID-19 antibodies among operating room and critical care staff at a tertiary teaching hospital: A cross-sectional study.

OBJECTIVES: To identify the prevalence of COVID-19 antibodies among operating room and critical care staff. METHODS: In this cross-sectional study, we recruited 319 Healthcare workers employed in the operation theater and intensive care unit of King Abdulaziz University Hospital (KAUH), a tertiary teaching hospital in Jeddah, Saudi Arabia between August 9, 2020 and November 2, 2020. All participants completed a 20-item questionnaire on demographic data and COVID-19 risk factors and provided blood samples. Antibody testing was performed using an in-house enzyme immunoassay and microneutralization test. RESULTS: Of the 319 participants, 39 had detectable COVID-19 antibodies. Five of them had never experienced any symptoms suggestive of COVID-19, and only 19 were previously diagnosed with COVID-19. The odds of developing COVID-19 or having corresponding antibodies increased if participants experienced COVID-19 symptoms (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.2-7.5) or reported contact with an infected family member (OR, 5.3; 95% CI, 2.5-11.2). Disease acquisition was not associated with employment in the ICU and involvement in the intubation of or close contact with COVID-19 patients. Of the 19 previously diagnosed participants, 6 did not possess any detectable COVID-19 antibodies. CONCLUSIONS: Healthcare workers may have undiagnosed COVID-19, and those previously infected may not have long-lasting immunity. Therefore, hospitals must continue to uphold strict infection control during the COVID-19 pandemic.

Healthcare professionals' views and perceptions of analgesic and antipyretic use in paediatric patients in four major Saudi hospitals.

BACKGROUND: Antipyretics and analgesics, including non-steroidal anti-inflammatory drugs, are medications commonly used in the Kingdom of Saudi Arabia (KSA) and elsewhere to manage fever and pain in the paediatric age group.Research work investigating misuse of these medications in paediatric populations and pertinent healthcare professionals' (HCPs) perceptions as a major determinant of the severity of these errors is scarce. OBJECTIVES: The aim of this study was to explore the perceptions of HCPs about analgesic and antipyretic use in paediatric patients at four major hospitals in Jeddah, KSA. The study also sought to explore factors believed by HCPs to be associated with occurrence of medication errors and adverse drug reactions (ADRs) due to analgesic and antipyretic use. METHODS: A cross-sectional survey employing a pre-piloted online questionnaire with an information sheet was delivered to HCPs in four hospitals in the western region of KSA. The questionnaire comprised a mix of a tick list and open and closed questions with Likert scales for attitudinal statements, and it also comprised items including demographics, healthcare professions and the respondents' work experience, HCPs' views and perceptions relating to occurrence of ADRs and medication errors in children who attended the hospital in the preceding three months and the severity and outcomes of the ADRs. RESULTS: Two-hundred seventy-four HCPs were approached, and 200 agreed to participate, yielding a response rate of 73%, including physicians (50%), nurses (24.5%), and pharmacists (16.5%).The majority of HCPs reported that ADRs could be minimized with appropriate actions. They believed that their lack of experience may have contributed to ADRs. Most HCPs (81%) reported that parental knowledge was a key factor contributing to the decreased occurrence of ADRs in children. They also believed that other factors contributed to the occurrence of ADRs, such as lack of reconciliation (65%), parents' anxiety leading to overmedication (69%) and the easy availability of these medications at home (77%).Twenty-nine respondents (n = 29, 14.5%) reported medication errors related to the use of analgesics or antipyretics. Specifically, they reported that possible contributing factors included poor communication of information (69.5%); interruptions (67.5%) and work pressure (66.0%). CONCLUSION: HCPs reported that ADRs and medication errors related to using analgesics and antipyretics in paediatric patients are not uncommon. In their opinion, several factors were associated with occurrence of these events, including parental knowledge about medications and insufficient training of HCPs.

Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure.

The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) study prospectively evaluated a prespecified periprocedural-interruption strategy of direct oral anticoagulants (DOACs) among patients with atrial fibrillation. Logistic regression analyses were performed to identify clinical parameters associated with residual DOAC levels ≥30 ng/mL or ≥50 ng/mL. Patients undergoing low-bleed-risk procedures were more likely to have residual levels of ≥30 ng/mL and ≥50 ng/mL. For low-risk procedures, age ≥75 years, female sex, a creatinine clearance (CrCl) <50 mL/min, and an interruption of <36 hours were associated with a greater likelihood of levels ≥30 ng/mL, whereas age ≥75 years, female sex, a CrCl of <50 mL/min, and standard DOAC dosing were associated with levels ≥50 ng/mL. For high-risk procedures, weight of <70 kg, CrCl <50 mL/min, and standard DOAC dosing were associated with residual levels ≥30 ng/mL, whereas female sex was associated with levels ≥50 ng/mL. For low-risk procedures, apixaban was associated with a higher likelihood of levels ≥30 ng/mL as compared with dabigatran (P = .0019) and of levels ≥50 ng/mL when compared with rivaroxaban (P = .0003). For high-risk procedures, apixaban was marginally associated with a higher likelihood of residual levels ≥30 ng/mL when compared with dabigatran (P = .05), whereas rivaroxaban was associated with a higher likelihood of levels ≥30 ng/mL as compared with apixaban. Further study is required to determine whether adjustments to perioperative plans based on these clinical parameters could result in a lower risk of residual DOAC levels. The PAUSE trial was registered at www.clinicaltrials.gov as #NCT2228798.

Saudi Lymphoma Group's Clinical Practice Guidelines for Diagnosis, Management and Follow-up of Patients with Various Types of Lymphoma during the Coronavirus Disease 2019 Pandemic.

The Saudi Lymphoma Group had previously published recommendations on the management of the major subtypes of lymphoma. However, the effect the currently ongoing coronavirus disease 2019 (COVID-19) pandemic has on the management of patients with lymphoma has been paramount. Therefore, the Saudi Lymphoma Group has decided to provide clinical practice guidelines for the diagnosis, management and follow-up of patients with various types of lymphoma during the COVID-19 pandemic.

General public's perspectives of issues relating to misuse of medicines: a cross-sectional survey in Jeddah, Saudi Arabia.

Background Misuse of prescription medicines is a global issue potentially resulting in severe consequences including adverse drug reactions, dependence, tolerance, increased healthcare utility and mortality. Objective To assess the public's perspectives of issues relating to medicines misuse. Method A survey of members of the public ( ≥ 18 years) attending medication safety awareness campaigns in Jeddah, Saudi Arabia. The questionnaire comprised: issues relating to misuse of prescription medicines; medicines used without being prescribed by a physician; and suggestions to reduce misuse. Potential participants were approached opportunistically during the campaigns, with those agreeing to participate administered the questionnaire and responses recorded electronically. Results Of the 511 respondents, 59 (11.5%) did not always have their prescription medicines prescribed by a physician, and 196 (38.4%) were uncertain. Commonly cited medicines obtained from sources other than a physician were analgesics (n = 375, 73.2%), antibiotics (n = 57, 11.2%), antipyretics (n = 33, 6.5%) and narcotics (n = 4, 0.8%). More than half (n = 282, 55.2%) claimed to know someone who had misused medicines, some with serious consequences including hospitalization (n = 96, 34.0%) and death (n = 14, 5.0%). Conclusion This general public survey has identified that issues of misuses of medicines in Jeddah, Saudi Arabia persist and may compromise safety and effectiveness of care.