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Background Antineoplastic monoclonal antibodies (mAbs), such as trastuzumab, bevacizumab, and pertuzumab have been the mainstay of therapy in cancer patients. Despite proven efficacy of the monoclonal antibodies, cardiovascular-induced adverse events such as heart failure, hypertension, ischemic heart disease, arrhythmias, thromboembolic events, and hemorrhage remain a major complication. The European society of cardiology address that concern with antineoplastic monoclonal antibodies issuing a guideline to manage and monitor chemotherapy-induced cardiotoxicity. There is limited evidence of the real-world prevalence of cardiovascular (CV) events induced by monoclonal antibodies among patients with cancer in Saudi Arabia. Objective To evaluate the prevalence of cardiovascular adverse events among patients with cancer treated with monoclonal antibodies in Saudi Arabia. Methods This is a retrospective study conducted in a tertiary care hospital, Riyadh, Saudi Arabia. Data were obtained from an electronic medical record of patients with cancer treated with one of the selected monoclonal antibodies, who met the inclusion criteria between January 2005 until June 2015 and have been followed up for at least one year. Patients were stratified into groups according to monoclonal antibodies treatment: trastuzumab, bevacizumab, pertuzumab, and combined mAbs. Results A total of 1067 patient were included in the study, within the pre-determined study period. The prevalence of cardiovascular disease among patients with cancer treated with monoclonal antibodies was 16.3%. The prevalence of heart failure was relatively higher in the trastuzumab group (46/626 patients, 7.3%). Among 418 patients treated with bevacizumab, hypertension was the most frequent adverse event, reported in 38 patients (9.1%), followed by thromboembolism reported in 27 patients (6.5%). Treatment discontinuation owing to cardiovascular adverse events was reported in 42/1,067 patients (3.9%). Conclusion and relevance Prevalence of antineoplastic monoclonal antibody induced cardiovascular adverse events among patients with cancer is substantially high in Saudi Arabia. There is an urgent need to streamline the practice for identifying high risk patients and flexible referral system for cardio-oncology care.

Antimicrobial stewardship programs (ASPs) have shown to prevent the emergence of antimicrobial resistance associated with an inappropriate antimicrobial use. The primary objective of this study was to compare the prescribing appropriateness rate of the empirical antibiotic therapy before and after the ASP implementation in a tertiary care hospital. Secondary objectives include the rate of Clostridium difficile-associated diarrhea (CDAD), physicians' acceptance rate, patient's intensive care unit (ICU) course, total utilization using defined daily dose, and total direct cost of antibiotics. This is a comparative, historically controlled study. Adult medical ICU patients were enrolled in a prospective fashion under the active ASP arm and compared with historical patients who were admitted to the same unit before the ASP implementation. This study was approved by the institutional review board, and the need for informed consent was waived because the interventions and recommendations were evidence based and considered the standard of care. The study was conducted at KFSHRC, Riyadh. Adult medical ICU patients were enrolled under the active ASP arm if they were on any of the 5 targeted antibiotics (piperacillin/tazobactam, imipenem/cilastatin, meropenem, vancomycin, tigecycline), and had no official infectious disease consultation. The interventions were conducted via prospective audit and feedback. A total of 73 subjects were recruited, 49 in historical control and 24 in the active arm. The appropriateness of empirical antibiotics was improved from 30.6% (15/49) in the historical control arm to 100% (24/24) in the proactive ASP arm (P value < .05). For the ASP group, initially 79.1% (19/24) of the antibiotic uses were inappropriate and diminished by ASPs to 0% on the recommendations implementation. A total of 27 interventions were made with an acceptance rate of 96.3%. The rate of CDAD did not differ between the groups. A reduction in antibiotics utilization and direct cost were also noticed in the ASP arm. A proactive ASP is a vital approach in optimizing the appropriate empirical antibiotics utilization in an ICU setting in tertiary care hospitals. This study highlights the importance of such a program and may serve as a foundation for further ASP initiatives particularly in our region.

The processes by which the pharmacy residency program at King Faisal Specialist Hospital and Research Centre-Riyadh, Saudi Arabia became the first American Society of Health-System Pharmacists (ASHP) accredited program outside the United States is described. This article provides key points for a successful program for other pharmacy residency programs around the world. Additionally, it points out the need for establishing international standards for pharmacy residency programs.

Background Many studies have previously looked at the perceptions, attitude, and use of Evidence-based Practice (EBP) among healthcare providers. However, limited data is available on the implementation of EBP among pharmacists in general, and Saudi Arabia in particular. Objective To evaluate the awareness, attitude, and practice of EBP among hospital practicing pharmacists in Saudi Arabia. Setting Secondary and tertiary care hospitals in Saudi Arabia with a bed capacity of ≥200 Methods This is a cross sectional, survey-based study where a validated selfadministrated questionnaire was utilized. Pharmacists working in secondary and tertiary care hospitals with a bed capacity of ≥200 were targeted. The descriptive data consisted of percentages for discrete and medians for continuous statistics. Results The survey was distributed to a total of 1136 pharmacists. Total number of respondents is 228 which represent a response rate of 20%. Most of them (75% median score = 8) have a positive attitude toward EBP. In addition to clinical expertise, only 48.6% of them were able to identify EBP resource as the second component of EBP concept, while only 1.7% of the respondents were able to identify patient preference as a third component. Lack of personal time, critical appraisal skills, and resources, (40%, 15.6% and 13.9% respectively) are considered as the major barriers to implementing EBP in pharmacy. Conclusion The majority of pharmacists in Saudi Arabia hold a positive attitude of EBP. Unfortunately, most of pharmacists do not consider patients’ values as a component of EBP. The major barriers to practicing EBP are lack of personal time, critical appraisal skills, and resources availability.

There is a paucity of quantitative evidence in the current literature on the incidence of wrong medication and wrong dose administration of intravenous medications by clinicians. The difficulties of obtaining reliable data are related to the fact that at this stage of the medication administration chain, detection of errors is extremely difficult. Smart pump medication library logs and their reporting software record medication and dose selections made by users, as well as cancellations of selections and the time between these actions. Analysis of these data adds quantitative data to the detection of these kinds of errors. We aimed to establish, in a reproducible and reliable study, baseline data to show how metrics in the set-up and programming phase of intravenous medication administration can be produced from medication library near-miss error reports from infusion pumps. We performed a 12-month retrospective review of medication library reports from infusion pumps from across a facility to obtain metrics on the set-up phase of intravenous medication administration. Cancelled infusions and resolutions of all infusion alerts by users were analyzed. Decision times of clinicians were calculated from the time-date stamps of the pumps' logs. Incorrect medication selections represented 3.45% (10,017/290,807) of all medication library alerts and 22.40% (10,017/44,721) of all cancelled infusions. Of these cancelled medications, all high-risk medications, oncology medications, and all intravenous medications delivered to pediatric patients and neonates required a two-nurse check according to the local policy. Wrong dose selection was responsible for 2.93% (8533/290,807) of all alarms and 19.08% (8533/44,721) of infusion cancellations. Average error recognition to cancellation and correction times were 27.00 s (SD 22.25) for medication error correction and 26.52 s (SD 24.71) for dose correction. The mean character count of medications corrected from initial lookalike-soundalike selection errors was 13.04, with a heavier distribution toward higher character counts. The position of the word/phrase error was spread among name beginning (6991/10,017, 69.79%), middle (2144/10,017, 21.40%), and end (882/10,017, 8.80%). The study identified a high number of lookalike-soundalike near miss errors, with cancellation of one medication being rapidly followed by the programming of a second. This phenomenon was largely centered on initial misreadings of the beginning of the medication name, with some incidences of misreading in the middle and end portions of medication nomenclature. The value of an infusion pump showing the entire medication name complete with TALLman lettering on the interface matching that of medication labeling is supported by these findings. The study provides a quantitative appraisal of an area that has been resistant to study and measurement, which is the number of intravenous medication administration errors of wrong medication and wrong dose that occur in clinical settings.

Pharmacoeconomics is a branch of health economics related to the most economical and efficient use of pharmaceuticals. Pharmacoeconomic research identifies, measures and compares the costs and outcomes (clinical, economic and humanistic) of pharmaceutical products and services. Pharmacoeconomic evaluation can play a significant role in the efficient allocation of resources in healthcare systems with constrained budgets. Countries are trying to control the rising costs of health care in their aging population. They are all asking the same question: Is the new drug good value for money; and if so, what is the society willing to pay for it? This article reviews the importance of, and the need for, adaptation of pharmacoeconomic analysis to the conditions in Saudi Arabia. It will shed some light on the important steps for converting the concept into practice, including the need for identifying the willing-to-pay (WTP) or the threshold cutoff, the existence of a real cost for each utility, the nonexistence of an pharmacoeconomic advisory forum, pharmaceutical budget allocation, and the impact of pharmaceutical marketing. It will also provide recommendations for easing any challenges that might jeopardize the conduct of such analysis in Saudi Arabia.

Objectives To develop a database for documenting pharmacist intervention through a web-based application. The secondary endpoint was to determine if the new, web-based application provides any benefits with regards to documentation compliance by clinical pharmacists and ease of calculating cost savings compared with our previous method of documenting pharmacist interventions. Setting A tertiary care hospital in Saudi Arabia. Method The documentation of interventions using a web-based documentation application was retrospectively compared with previous methods of documentation of clinical pharmacists’ interventions (multi-user PC software). Main outcome measure The number and types of interventions recorded by pharmacists, data mining of archived data, efficiency, cost savings, and the accuracy of the data generated. Results The number of documented clinical interventions increased from 4,926, using the multi-user PC software, to 6,840 for the web-based application. On average, we observed 653 interventions per clinical pharmacist using the web-based application, which showed an increase compared to an average of 493 interventions using the old multi-user PC software. However, using a paired Student’s t-test there was no statistical significance difference between the two means ( P  = 0.201). Using a χ 2 test, which captured management level and the type of system used, we found a strong effect of management level ( P  < 2.2 × 10 –16 ) on the number of documented interventions. We also found a moderately significant relationship between educational level and the number of interventions documented ( P  = 0.045). The mean ± SD time required to document an intervention using the web-based application was 66.55 ± 8.98 s. Using the web-based application, 29.06% of documented interventions resulted in cost-savings, while using the multi-user PC software only 4.75% of interventions did so. The majority of cost savings across both platforms resulted from the discontinuation of unnecessary drugs and a change in dosage regimen. Data collection using the web-based application was consistently more complete when compared to the multi-user PC software. Conclusions The web-based application is an efficient system for documenting pharmacist interventions. Its flexibility and accessibility, as well as its detailed report functionality is a useful tool that will hopefully encourage other primary and secondary care facilities to adopt similar applications.

Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch.BACKGROUND AND OBJECTIVESGeneric substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch.Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles, and additional data sources, including the Code of Federal Regulations and Regulatory Guidance from the FDA Center for Drug Evaluation and Research were also reviewed.DATA SOURCESArticles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles, and additional data sources, including the Code of Federal Regulations and Regulatory Guidance from the FDA Center for Drug Evaluation and Research were also reviewed.For most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products cannot be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit.DATA SYNTHESISFor most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products cannot be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit.Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed.CONCLUSIONPerforming the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed.

Experience with alteplase in pediatric patients is limited and recommendations are extrapolated from adult data. Comprehensive guidelines on the management of thromboembolic events in this group are lacking. We assessed the efficacy and safety of alteplase (recombinant tissue plasminogen activator) in the management of intracardiac and major cardiac vessel thrombosis in pediatric patients. All pediatric patients, 14 years of age and younger, with intracardiac or major cardiac vessel thrombus who were treated with alteplase from 1997 to 2004 at our tertiary care institute were identified through the pharmacy database. Patient data were retrospectively evaluated for the efficacy and safety of altepase. Five cases were eligible out of nineteen who received alteplase. Patient ages ranged from 40 days to 13 years. The initial dose of alteplase ranged from 0.3 to 0.6 mg/kg followed by a continuous infusion in three patients with a dosage range between 0.05 and 0.5 mg/kg/hr, while intermittent infusion was used in the other two patients. The duration of therapy ranged from 2 to 4 days. By the end of the treatment, two patients had complete resolution of thrombus and one had partial resolution. Two patients failed to respond and had \"old\" thrombus. Major bleeding events were reported in three patients. The rest had minor bleeding events. Alteplase may effectively dissolve intracardiac thrombi, particularly when freshly formed. Continuous infusion for a long duration appears to be associated with an increased risk of major bleeding. Optimal dose and duration of infusion are still unknown.

IntroductionIn the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.Methods and analysisThe BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged <28 days, maximum of 100 000) will be enrolled across 25 racial, ethnic and ancestry populations and five enrolment site types (high-risk obstetrician offices, labour induction office visits, newborn nurseries, NICUs and well-baby visits). BeginNGS is gNBS for circa 2000 SCGD (currently 508 SCGD). The primary objective of the trial is to generate equitable evidence to support broad implementation of gNBS. Enrolled newborns receive both interventions (BeginNGS and standard of care NBS). Newborns who screen positive receive confirmatory testing and medical follow-up for at least 1 year to obtain outcomes data. The primary outcome measure is clinical utility, defined as the proportion of diagnoses identified by BeginNGS and state NBS during infancy that are likely to benefit (likely to have an improved outcome) from treatment. We hypothesise that BeginNGS has a greater rate of clinical utility than standard NBS. An adaptive design was chosen rather than a traditional, fixed design to allow accumulating results to make the trial more efficient, informative, equitable and ethical by addition or removal of SCGD and genetic variants, population enrichment (for under-represented racial, ethnic and ancestral groups) and sample size re-estimation. Adaptive design will also facilitate meta-analysis with other clinical trials of gNBS, providing greater power to test utility in ultra-rare SCGD. Parents will be approached (in person, via phone or via electronic communication) to provide informed consent to enrol their newborns prenatally, postnatally in newborn nurseries or NICUs or at well baby outpatient visits. This study is part of phase III of the BeginNGS programme. Patient and public voices have been engaged in the design and execution of each BeginNGS phase through individuals and groups joining the BeginNGS consortium and participating in the family and community engagement work group. gNBS has the potential to transform the way we diagnose and treat childhood genetic diseases. Preliminary data suggest that national adoption of BeginNGS for all births has the potential to improve outcomes of >50 000 US children per year.Ethics and disseminationThis study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.Trial registration numberNCT06306521.