Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience.

BACKGROUND In the Middle East, there is lack of data on peripheral blood CD34+stem cells mobilization by using biosimilar filgrastim. We have been using both Neupogen and a biosimilar G-CSF) Zarzio® (as a mobilizing agent since February 2014 for both allogenic and autologous stem cell transplantations. MATERIAL AND METHODS This was a single-center retrospective study. All patients and healthy donors who received either the biosimilar G-CSF (Zarzio®) or original G-CSF (Neupogen®) for mobilization of CD34+ stem cells were included in the study. The primary goal was to determine and compare the rate of successful harvest and amount of CD34+ stem cells collected in either adult cancer patients or healthy donors between Zarzio® and Neupogen® groups. RESULTS A total of 114 patients, including 97 cancer patients and 17 healthy donors, underwent successful CD34+ stem cell mobilization using G-CSF with chemotherapy (35 with Zarzio® +chemotherapy, 39 with Neupogen® +chemotherapy) or G-CSF as monotherapy (14 with Zarzio®, 9 with Neupogen®) in autologous transplantation. In an allogeneic stem cell transplantation, successful harvest was achieved by using G-CSF monotherapy (8 with Zarzio®, 9 with Neupogen®). There was no difference between Zarzio® and Neupogen® in the amount of CD34+ stem cells collected at leukapheresis. There was no difference with regards to secondary outcomes between the 2 groups. CONCLUSIONS Our study showed that biosimilar G-CSF (Zarzio®) has comparable efficacy to the original G-CSF (Neupogen®) when used for mobilization in both autologous and allogenic stem cell transplantation and was associated with significant cost saving.

The Impact of Role of Pharmacists in Renal Dosage Adjustment Program on Renal Drug Dosing Errors: A Quasi-Experimental Study.

Studies have reported high prevalence of inappropriate dosing in patients with renal impairment, which was significantly reduced with pharmacists' interventions. The objective of this study was to assess the proportions of renal drug dosing errors following the implementation of pharmacists-led renal drug dosing adjustment program. This was a quasi-experimental study conducted at the King Abdul Aziz Medical City, a tertiary teaching hospital, Jeddah, Saudi Arabia. The study comprised of 3 phases. The pre-phase and post-phase evaluated drug orders for dosing appropriateness. During the intervention phase, a renal drug dosing adjustment program was implemented, which included educational sessions on dosing in renal insufficiency and a renal drug dosing guidance. The primary outcome was to assess the change in the proportions of dosing errors following the intervention. In the pre-phase, inappropriate dosing was noted in 20.1% (70/348) of orders that required dosing adjustment. Among the total dosing errors, 44.2% (31/70) were further corrected, and pharmacists have documented intervention in 48.3% (15/31) of the corrected orders. In the post-phase, inappropriate dosing was noted in 21.9% (76/346) of orders that required dosing adjustment. Among the total dosing errors, 39.4% (30/76) were further corrected, and pharmacists have documented intervention in 66.6% (20/30) of the corrected orders. There was no statistically significant difference in inappropriate drug dosing between pre-phase and post-phase with a P = 0.56. The intervention was not associated with significant reduction in renal dosing errors, although pharmacist involvement in the corrected orders orders increased after the implementation of the intervention. This may indicate the need to integrate renal dosing guidance into the hospital prescribing system to optimize drug dosing in renal patients.

Prescriber behaviours that could be targeted for change: An analysis of behaviours demonstrated during prescription writing in children.

BACKGROUND: The prescribing process for children with cancer is complex, and errors can occur at any step. As a result, many interventions have been used to reduce errors. However, few of them have been designed based on an understanding of the prescriber behaviour that can lead to errors. In order to design effective behaviour change interventions, it is important first to understand the prescribing process and identify prescriber behaviours that could be targeted for change. OBJECTIVES: To describe the prescribing process in a paediatric oncology ward and to identify prescriber behaviours during prescription writing that could be targeted to reduce errors. METHODS: This study employed two sequential phases. First, the prescribing process was observed and then described using the hierarchical task analysis (HTA) method. Second, prescriber tasks identified from the HTA were analysed using the behaviour change wheel (BCW) approach to identify promising behaviours for change. These identified behaviours were prioritised based on information collected from four focus groups with prescribers and chart review of errors made in the ward. RESULTS: The prescribing process was complex and involved multiple tasks performed in varying orders. Applying the BCW identified thirty-two candidate behaviours for potentially reducing prescribing errors. However, after prioritization, only two emerged as promising candidate behaviours for intervention: writing drug indications at the time of prescribing and using a pre-written order when ordering medications through electronic prescribing. CONCLUSIONS: This research suggests that two behaviours could be promising in reducing errors. Having identified these behaviours, future work could explore what needs to change with respect to individuals and their work environments to achieve the desired change in these identified behaviours.

Medication-Use Evaluation of Recombinant Human Factor VIIa.

Introduction: Medication-use evaluation (MUE) is a performance improvement method used to achieve optimal patient outcomes. The recombinant human factor VIIa (rFVIIa) (NovoSeven) is an expensive agent approved by the U.S. Food and Drug Administration (FDA) for specific indications. However, in clinical practice, rFVIIa is often used for conditions unrelated to the one approved, with limited evidence. The use of rFVIIa has been associated with expenditures of more than Saudi riyal (SR)30 million ($8 million) annually at King Abdul-Aziz Medical City-Western Region (KAMC-WR). Therefore, we planned a MUE of rFVIIa. The primary purpose was to determine the off-label use of rFVIIa, and the secondary purpose was to evaluate the cost impact of off-label use of rFVIIa at KAMC-WR. Methods: This was an observational retrospective cohort study conducted to assess the off-label usage pattern and the direct cost of rFVIIa for one year. Results: A total of 27 patients who received rFVIIa were included. Two out of the 27 patients had hemophilia A with inhibitors (7%), and 23 of the 27 patients received rFVIIa with off-label indications (85%). The total cost associated with the use of rFVIIa was SR18.61 million ($4.96 million). The cost of the rFVIIa used for the appropriate purpose was SR17.83 million ($4.75 million), which represented 95.8% of the expenditures. Conclusions: Recombinant FVIIa is one of the most expensive medications in our hospital. It has been used mostly in patients having hemophilia A with inhibitors.

Emerging Role of Biosimilars in Oncology-Hematology in Saudi Arabia: A Practical Perspective.

Biologics are significant drivers of globally escalating healthcare costs. Biosimilars have potential to offer cost savings with comparable efficacy and safety to innovator products and increase the access of treatment to more patients. This study aimed to increase understanding and perception of biosimilars concept. It also described the pharmacoeconomic impact of biosimilar in oncology and formulary consideration of oncology biosimilars substituting with their originators in major oncology centers in the Saudi Arabia. A biosimilar is a biological product that is similar to a reference biopharmaceutical product. As the manufacturing process hinders the ability to identically replicate the structure of the original product, biosimilar cannot be described as an absolute equivalent of the original medication. Different regulatory agencies such as United States Food and Drug Administration, European Medicines Agency, and Saudi Food and Drug Authority have approved several biosimilars of oncology biologics. The experience of biosimilar use in Europe and USA provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving access without compromising patient outcomes. There is a need for increasing awareness about biosimilars to improve acceptance rates. The use of biosimilar filgrastim in Ministry of National Guard Health Affairs, Saudi Arabia, has resulted in a significant cost saving annually. It was proposed that further substitution and switching to biosimilars in oncology would lead to major savings in resources.

Systematic review and meta-analysis of the safety of erythromycin compared to clarithromycin in adults and adolescents with pneumonia.

Macrolides are recommended for the treatment of community-acquired pneumonia (CAP). It is debatable whether erythromycin is associated with more adverse drug reactions (ADRs) compared to clarithromycin, and both are recommended in clinical practice guidelines. This meta-analysis aim is to compare ADRs in CAP patients treated with erythromycin versus clarithromycin. Two investigators independently searched PubMed, EMBASE and Cochrane Library databases through Feb 07, 2019. Randomized-controlled trials (RCTs) comparing ADRs of monotherapy with erythromycin versus with clarithromycin in adults or adolescents with CAP were included. We estimated risk ratios (RRs) with 95% confidence intervals (CIs) using random-effects models and evaluated heterogeneity (I2). Bias risk was assessed using the Cochrane risk of bias tool for RCTs. Five RCTs (total of 693 patients) were included. A significantly higher discontinuation rate due to ADRs was found with erythromycin compared with clarithromycin (RR, 4.347; 95% CI, 2.506-7.539; p < 0.001; I2=0%). Overall, ADRs occurred more significantly with erythromycin compared with clarithromycin (RR, 1.773; 95% CI, 1.423-2.209; p < 0.001; I2=0%). Gastrointestinal (GI) ADRs were higher with erythromycin (RR, 2.678; 95% CI, 1.791-4.006; p < 0.001; I2=5.835%). Restriction of analyses to double-blind RCTs did not change our findings. Based on meta-analysis of RCTs in adults and adolescents with CAP, erythromycin results in more overall ADRs and GI ADRs, as well as a higher rate of discontinuation due to ADRs. Therefore, given that erythromycin is not more effective than clarithromycin, erythromycin should not be selected unless other macrolides cannot be used.

Incidence of diabetic ketoacidosis in newly diagnosed type 1 diabetes children in western Saudi Arabia: 11-year experience.

Background A wide range of reports on the incidence of diabetic ketoacidosis (DKA) at the onset of type 1 diabetes mellitus (T1DM) in children have been published worldwide. Reports from Saudi Arabia are limited. The aim of this study was to assess the incidence, clinical pattern and severity of DKA in children with newly diagnosed T1DM and the association of autoimmune conditions with initial DKA occurrence at King Abdulaziz Medical City - Jeddah. Methods This retrospective chart review was conducted during the period 2005-2015. All newly diagnosed T1DM children during the study period were investigated (n = 390). Data were collected on the demographic characteristics, body mass index (BMI), DKA severity, length of hospital stay and follow-up data on the type of diabetes therapy. Results The incidence of DKA among newly diagnosed T1DM pediatric patients was 37.7% (n = 147). Moderate and severe DKA cases were significantly higher among female children (p = 0.04). Patients diagnosed with DKA had lower BMI (20.87 ± 5.21) than their counterparts (p = 0.03). The median length of hospital stay was higher among severe DKA compared to moderate and mild cases (5.0, 4.5 and 4.0 days, respectively). Conclusions The incidence of DKA among newly diagnosed T1DM is still high compared to developed countries; however, it is relatively lower than previous reports in Saudi Arabia. Immediate interventions, such as awareness campaigns, are vital to reduce the burden of this preventable health sequela among children with DM.

Understanding the causes of prescribing errors from a behavioural perspective.

INTRODUCTION: While many attempts have been made to reduce prescribing errors (PEs), they persist. PE is not in itself a behaviour, but a consequence of a prescribing behaviour. Interventions aimed at prescribers should focus on understanding prescribers' behaviours. OBJECTIVES: The aim of this study was to use the capability, opportunity, motivation - behaviour (COM-B) model to explore the behaviours that could have caused PEs made by senior doctors in a speciality paediatric inpatient ward. METHODS: A qualitative approach was used to investigate prescribers' behaviours in a 26-bed paediatric oncology ward. Error data were collected over a two-month period and were presented during focus groups with prescribers, which were audio-recorded and transcribed verbatim. Thematic analysis was used to identify contributory factors to errors, which was used to identify sources of behaviours using the COM-B model. RESULTS: Behaviours related to prescribers' capabilities were: prescribers' improper use of the software because of insufficient skills, and prescribers' inability to prescribe correctly because of lack of knowledge. Behaviours related to opportunities in the environment were: prescribers' inability to make an informed decision because of poor access to patient information, inability to properly complete a task because of heavy workload and interruption, and having to re-check doses frequently because of frequent change in patients' weight and surface area. Those related to motivation were: prescribers unquestioningly following recommendations and not communicating with other specialists because they over-trusted them or feared a negative reaction, and prescribers inability to complete a task because of other competing and preferable tasks at the same time. CONCLUSION: Employing COM-B helped in identifying causes of PEs from a new perspective. Future work could focus on mapping identified sources of behaviour and errors against appropriate intervention functions and policies in order to design more successful interventions.

Prescribing Empiric Antibiotics for Febrile Neutropenia: Compliance with Institutional Febrile Neutropenia Guidelines.

Background: Febrile neutropenia (FN) is an oncologic emergency which should be treated immediately with empiric antibiotics. Different institutions observe different antibiograms and use different FN management guidelines. Our center implemented FN management guidelines for adult cancer patients in 2009. Hence, we decided to assess compliance with FN management guidelines and to describe the pattern of bacterial infections. Method: We conducted a cross-sectional study on all adult cancer patients admitted with FN. Data were collected from electronic medical records between January and December 2014. Results: One hundred FN episodes met the study inclusion criteria. The mean age of the patients was 41 ± 17 years; 52% (52 patients) were women. The most common diagnosis was lymphoma (33%). In terms of compliance to institutional FN guidelines, 55% of patients received guideline non-compliant treatment. The most common non-compliant treatment was incorrect amikacin dosing in 31% of patients, followed by incorrect vancomycin dosing in 20%, incorrect piperacillin/tazobactam dosing in 19%, inappropriate use of carbapenems in 18%, and non-compliant vancomycin use in 12% of patients. Bacterial isolates were only observed in 19% of the FN episodes. Among these 19 episodes of FN, Gram-negative pathogens were predominant and were identified in 74% of the episodes, followed by Gram-positive pathogens in 16% and polymicrobial pathogens in 10%. The mean time to defervescence was 2.21 ± 2 days. Conclusion: Our study concluded that there was a high percentage of non-compliance with our institutional FN management guidelines. We recommend following appropriate empiric antibiotic doses and indications as per institutional guidelines.

The impact of pharmacist-led medication reconciliation during admission at tertiary care hospital.

Background Medication errors represent the most common type of error that compromises patient safety, with approximately 20% believed to result in harm. Over 40% of these errors are believed to result from inadequate medication reconciliation during admission, transfer, and discharge of patients and many of these errors could be prevented if adequate medication reconciliation processes were in place. In an effort to minimize adverse events caused during these care transitions, the Joint Commission has stated medication reconciliation as one of its National Patient Safety Goals and health care providers and organizations are encouraged to perform the process at various patient care transitions. Objective Identify the types of medication discrepancy that occurred during medication reconciliation performed by a pharmacist gathering the best possible medication history (BPMH). Estimate the potential for harm with each medication discrepancy using the severity rating methods developed by Cornish et al. (Arch Intern Med 165(4):424-429, 2005). Setting Tertiary care hospital in Jeddah, Saudi Arabia. Method Prospective 3-month study on 286 adult patients, admitted for at least 24 h and regularly taking at least four chronic prescription medications. Medication histories taken by physicians and by a pharmacist gathering the BPMH were compared. Identified discrepancies were reviewed by a panel of clinical pharmacists to assess the potential to cause patient harm with these errors. Main Outcome measure Number and types of medication discrepancies recorded by the pharmacist. Results Total number of medications recorded by physicians was 2548, versus 3085 by the pharmacist. 48.3% of patients had at least one unintended medication discrepancy by physicians. 537 medication discrepancies were reported (17.4% of number of medication discrepancies recorded by pharmacist). Types of medication discrepancies included, omissions (77% of discrepancies), commissions (13%), dosing errors (7%), and frequency errors (3%). 52% of the identified medication discrepancies had the potential to cause moderate to severe patient discomfort. Conclusion Patient medication histories are frequently recorded inaccurately by physicians during admission of patients which results in medication-related errors and compromises patient safety. Medication reconciliation is crucial in reducing these errors. Pharmacists can help in reducing these medication-related errors and the associated risks and complications.

The impact of a pediatric antibiotic standard dosing table on dosing errors.

OBJECTIVE: The goal of this study was to compare the rate of dosing errors for antibiotic orders in pediatric patients before and after the implementation of an antibiotic standard dosing table with precalculated dosage for different weight ranges at a tertiary care hospital. METHODS: A retrospective study of 300 antibiotic prescriptions for pediatric patients in three different settings (ambulatory care, inpatient, and emergency department) at a tertiary care hospital assessed the appropriateness of antibiotic dosing. The need for an antibiotic dosing standardization policy was identified after finding that more than 30% of patients experienced a dose variation of ±10% of the recommended daily dose. An antibiotic dosing standardization policy was implemented with an antibiotic standard dosing table for different weight ranges, and a hospital wide-education program was conducted to increase awareness of this new practice and its benefits. Three months after implementation, a random sampling of 300 antibiotic prescriptions collected from the same settings as the pre-intervention period was evaluated for compliance with the new policy and its effect on the number of antibiotic dosing errors. RESULTS: Six hundred prescriptions were included in this study (300 in the pre-implementation phase and 300 in the post-implementation phase). Patient characteristics were similar in both groups in terms of sex, age, and weight. Physician compliance with the antibiotic dosing standardization policy after its implementation was 62%. The dosing standardization policy reduced the rate of dosing errors from 34.3% to 5.06% (p=0.0001), and weight documentation on the antibiotic prescription improved from 65.8% to 85.7% (p=0.0001). CONCLUSIONS: Implementation of an antibiotic dosing standardization policy significantly reduced the incidence of dosing errors in antibiotics prescribed for pediatric patients in our hospital.