Posaconazole versus voriconazole as antifungal prophylaxis for invasive fungal diseases in patients with hematological malignancies.

INTRODUCTION: The incidence of invasive fungal diseases (IFDs) has risen in hematologic malignancy patients due to neutropenia. While posaconazole is recommended as the first-line antifungal prophylaxis in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients and voriconazole is an alternative, there is currently no direct comparison data available to assess their relative effectiveness. METHOD: We retrospectively reviewed eligible patient charts from January 2017 to February 2019 to identify breakthrough IFD rates, drug adverse event frequency, and drug acquisition cost in AML/MDS patients. RESULTS: Forty-eight patients received 130 chemo cycles, with 50 (38%) cycles prescribed posaconazole and 80 (62%) prescribed voriconazole as primary IFD prophylaxis. The incidence rates of IFD in the posaconazole group were 8% (4 out of 50), of which two were probable and two were possible infections, while 6.26% (5 out of 80) of patients in the voriconazole group developed IFD, with four possible infections and one probable infection (p = 0.73). A higher percentage of patients in the voriconazole group discontinued prophylaxis due to adverse events, with six patients compared to two patients in the posaconazole group (p = 0.15). The drug acquisition cost of posaconazole is 5.62 times more expensive than voriconazole. CONCLUSION: The use of voriconazole instead of posaconazole for 130 chemo cycles would save $166,584.6. Posaconazole and voriconazole have comparable efficacy and safety in preventing IFD in AML and MDS patients receiving chemotherapy. However, posaconazole is more costly than voriconazole.

Safety and discontinuation rate of immune checkpoint inhibitors used in patients with solid and hematological malignancies. A population based retrospective analysis.

BACKGROUND: The discovery of immune checkpoint inhibitors caused a paradigm shift in cancer treatment and led to a major improvement in clinical outcomes. However, they may induce inflammatory side effects that are known as immune-related adverse effect (iRAE). This study aimed to assess the safety profile and discontinuation rate of immune checkpoint inhibitors in cancer patients. METHODS: Adult cancer patients ≥18 years who received at least one dose of immune-checkpoint inhibitor (ICI) were included. The primary endpoint was the rate of permanent discontinuation of immune checkpoint inhibitors due to immune-related adverse effects. The secondary endpoints were rate and type of specific organ iRAEs, interventions used to treat specific organ iRAEs, and discontinuation rate of immune checkpoint inhibitors due to disease progression. RESULTS: A total of 75 patients were included in the study with a median age of 60 years [IQR: 46-72 years]. Of 75 patients, 7 patients (9.33%) have permanently discontinued ICIs due to immune-related adverse effects. Seven iRAEs occurred in the 7 patients who have permanently discontinued ICIs. Steroids were the main treatment used for 8 patients, followed by levothyroxine for 2 patients and one patient did not receive any medication. The discontinuation rate due to disease progression was reported in 32 patients (42.66%). CONCLUSION: Immune checkpoint inhibitors were well tolerated in the majority of our patient population with a comparable rate of immunerelated adverse effects in comparison to the published data. Corticosteroids were fundamentally used to treat immune-related adverse effects.

Characteristics of the ideal clinical pharmacy residency candidate: A survey of residency program directors and preceptors in Saudi Arabia.

OBJECTIVE: Residency positions are highly competitive. Pharmacy students who are familiar with the ideal qualities of residency candidates and the expectations of residency programs may be more likely to obtain one of these coveted positions. This study identifies the characteristics that residency program directors (RPDs) and preceptors use to define an ideal residency candidate. METHODS: This is a cross-sectional, descriptive study that surveyed pharmacy RPDs and preceptors across the Kingdom of Saudi Arabia. The questionnaires are comprised of two sections: demographic information and characteristics of the residency candidates. Over a five-month period (May 1, 2020 - September 30, 2020), the survey was sent electronically to the participants. RESULTS: Of the 78 surveys returned, 68 surveys were included (RPDs: 36, Preceptors: 32) and 12 surveys (15.17%) were excluded due to incompleteness. Number of RPDs responded to the survey represents (65%) of the total RPDs in Saudi Arabia. The mean response scores from the results of the Likert scale [strongly agree (1) - strongly disagree (5)] - suggest that a candidate's performance during the interview (mean score = 1.5), their professional appearance (1.5), an alignment between a candidate's interests and the program focus (1.6), and previous hospital experience (1.8) mattered most. While being from the same region (3.4), having an advanced degree (2.8) and the cumulative Grade Point Average (2.7) mattered the least. We find that previous hospital experience (29%), familiarity with the program (16%), research experience (15%), Saudi Commission for Health Specialists aggregate score (10%), and letters of recommendation (4%) are considered the top five factors. CONCLUSION: Residency candidates should focus on training in clinical settings. Offering mock interviews and Saudi Pharmacist Licensure Examination practice tests and involving pharmacy students in clinical research may increase their chance in securing a residency position.

Evaluation of a pharmacist vs. Haematologist-managed anticoagulation clinic: A retrospective cohort study.

INTRODUCTION: Warfarin is the core component in the management of various thromboembolic disorders, which requires specialized expertise to optimize outcomes. There is limited data comparing a pharmacist vs. a haematologist-managed anticoagulation clinic in our setting, and in the Middle East. We aimed to evaluate the effectiveness and safety of a pharmacist vs. a haematologist-managed anticoagulation clinic in the Ambulatory Care Center at King Abdulaziz Medical City, Jeddah, Saudi Arabia. METHODS: A retrospective cohort study was conducted from 2016 to 2018, which included adult patients who have been followed-up for at least six months and who received warfarin for an extended period. The primary outcome was the proportion of time the patients in the two arms were in the therapeutic range. The secondary outcomes were the differences in expanded time in the therapeutic range, as well as the frequency of bleeding and thromboembolic events between the two arms. RESULTS: We enrolled 104 and 124 patients in the pharmacist and haematologist arms respectively. The median time in the therapeutic range for the pharmacist arm was 71.4%, IQR (60.8-83.8) vs. 65%, IQR (43.5-79.1), in the haematologist arm (p = 0.0049). The median expanded time in the therapeutic range was 86.4%, IQR (77.5-95.3) vs. 81.21%, IQR (67.1-93.3) in the pharmacist vs. haematologist arm (p = 0.015) respectively. Major bleeding events occurred in 5.7 % vs. 3.2 %, and thromboembolic events in 5.7% vs. 4%, in the pharmacist vs. haematologist arm respectively. CONCLUSIONS: Our results demonstrated that the time in the therapeutic range was significantly higher in the pharmacist arm, with no significant difference in bleeding and thromboembolic events compared to the haematologist arm.

High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1-infected patients with severe chronic kidney disease.

BACKGROUND & AIMS: Limited data have shown high efficacy of co-formulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in the treatment of hepatitis C virus (HCV) genotype (GT)-4, and combined with dasabuvir (DSV) in GT1 patients, with chronic kidney disease (CKD) stages 4-5 (<30 mL/min/1.73 m2 ). We assessed real-world safety and efficacy of OBV/PTV/r ± DSV in GT1- and 4-infected patients. METHODS: In this observational cohort (n = 67), we enrolled stages 4-5 CKD treatment-naïve or Peginterferon/RBV-experienced GT4-infected patients (n = 32) treated for 12-24 weeks with OBV/PTV/r ± RBV, and plus DSV in GT1 patients (n = 35, including 3 with GT1/4 co-infection). RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily. Primary endpoints were SVR12, calculated on intention-to-treat (ITT) basis, and occurrence of serious adverse events. RESULTS: The mean age of the cohort was 45.7 ± 12.7 years, 50.7% were females, 20.9% had cirrhosis, 35.8% were treatment-experienced and 97% were on haemodialysis. Three patients (F4) received 24-week treatment, 2 with GT4, and 1 with GT1a; and 19.4% were treated without RBV, including 9 GT1, and 4 GT4. Overall, 65 (97.1%) patients achieved SVR12, including 100% of those with a post-treatment follow-up (modified ITT analysis). Of the two patients without SVR12, one died from sepsis-related complications and the other from a myocardial infarction 2 weeks after completing therapy. Grades 3-4 anaemia occurred in 8.9%. CONCLUSION: A 12-week regimen of OBV/PTV/r ± DSV with or without RBV is highly effective with a favourable safety profile amongst GT4 and GT1 patients with CKD stages 4-5. SVR12 rates were high regardless of patient characteristics.

The impact of the implementation of computerized insulin order sets for the control of hyperglycemia in hospitalized cardiac patients.

Background: Glycemic control is crucial in managing hospitalized patients with type II diabetes (T2DM), and it presents as a clinical challenge in the cardiac population. Therefore, we aimed to evaluate the impact of computerized insulin order sets in T2DM hospitalized cardiac patients. Methods: A quasi-experimental, pre- and post-study design. We included T2DM patients who were hospitalized for at least 3 days. Patients undergoing cardiac surgery were excluded. The primary endpoint was the mean difference in random blood glucose level (BGL) before and after the implementation of insulin order sets. While the secondary endpoints were to compare the median differences in fasting BGLs and the number of hyperglycemic and hypoglycemic episodes during the first 7 days. The study consisted of three phases: pre-implementation, intervention and post-phase. In the intervention phase, insulin order sets were integrated into the electronic prescribing system, and education was provided to the cardiology department. The post-phase included the patient's post-implementations. Results: A total of 194 patients were enrolled during the study period. The mean random BGL was 11.17 mmol/L, 95% CI, 10.6-11.7 in the pre-phase and 9.5 mmol/L, 95% CI, 9-1 -9.9 mmol/L in the post-phase (P < 0.001). The median fasting BGL was 9.2 mmol/L (7.4-11.8, IQR) in the pre-phase and 8.5 mmol/L (6.6-10.3, IQR) in the post-phase (P = 0.027). The number of hypoglycemic episodes was 24 in pre-phase and 33 in post-phase (P = 0.13). Conclusion: The use of computerized insulin order sets was associated with potential improvements in random and fasting glycemic control without increasing the risk of hyperglycemia or hypoglycemia.

A retrospective review of antiemetic use for chemotherapy-induced nausea and vomiting in pediatric oncology patients at a tertiary care center.

BACKGROUND: Chemotherapy-induced nausea and vomiting are the most dreaded and distressing side effects for cancer patients undergoing chemotherapy treatment. These side effects have a significant impact on the patients' quality of life and can interfere with their ability to receive intensive chemotherapy regimens. With the recent advances in antiemetic pharmacotherapy and supportive care, the current treatments for chemotherapy-induced nausea and vomiting, when used appropriately, have become highly effective in mitigating these adverse effects. OBJECTIVE: The aim of this study was to evaluate the current practice involving antiemetic treatment in newly diagnosed pediatric oncology patients at our center. METHODS: This was a retrospective cohort study of newly diagnosed pediatric oncology patients who were less than 14 years of age receiving their first cycle of inpatient chemotherapy. The data abstracted included the following: age, gender, type of cancer, chemotherapy regimen, emetogenic risk and level, prescribed prophylactic antiemetic regimen, incidence of breakthrough emesis, and breakthrough antiemetic medications used. Emetogenic risk was classified based on published guidelines into low, moderate, or high emetogenic chemotherapy, and a scoring system to determine the emetogenic level of combined chemotherapy agents was followed to monitor the efficacy of the antiemetic regimens. Clinical effectiveness was assessed based on breakthrough emesis. RESULTS: A total of 49 patients were eligible for the study. High emetogenic chemotherapy was administered in 28/49 (57.1%) and moderate emetogenic chemotherapy was administered in 21/49 (42.9%) patients. Only 10/49 (20.4%) received appropriate antiemetic prophylaxis, whereas 39/49 (79.6%) received inadequate antiemetic prophylaxis; 14/49 (28.6%) patients experienced breakthrough emesis. Breakthrough emesis occurred in 11/28 (39.3%) patients receiving high emetogenic chemotherapy and 3/21 (14.3%) patients receiving moderate emetogenic chemotherapy. The use of an inadequate antiemetic regimen was found in 14/14 (100%) patients with breakthrough emesis. Thus, inadequate prophylaxis resulted in a 35.9% (14/39) risk of breakthrough emesis. This risk was higher in patients receiving high emetogenic chemotherapy versus those receiving moderate emetogenic chemotherapy (39.3% versus 14.3%). CONCLUSION: Inadequate antiemetic prophylaxis is associated with a high risk of breakthrough emesis particularly with high emetogenic chemotherapy regimens. Standardizing antiemetic prophylaxis based on emetogenic level could reduce breakthrough emesis and improve the quality of life in pediatric oncology patients.

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.

Epidemiology and potential associated risk factors of drug-related problems in hospitalised children in the United Kingdom and Saudi Arabia.

AIM: Drug-related problems (DRP) are "an event or circumstance involving drug therapy that actually or potentially interferes with the desired health outcome". The extent and characteristics of DRPs in children in the UK and the Kingdom of Saudi Arabia (KSA) are unknown. Our aim was to determine the epidemiology of and identify risk factors for DRPs in hospitalised children. METHODS: A prospective cohort study was carried out in children aged 0-18 years, admitted to the medical ward, paediatric intensive care unit (PICU) and neonatal intensive care unit (NICU) during a 3-month period in two hospitals. Patients' charts, medical records and laboratory data were reviewed daily to identify DRPs; their preventability and severity were assessed. Logistic regression was used to analyse the potential risk factors associated with DRP incidence. RESULTS: Seven hundred and thirty-seven children (median age 2.3 years, interquartile range 6 months to 8 years, 58.1% male) were included. Three hundred and thirty-three patients suffered from 478 DRPs. Overall DRP incidence was 45.2% (95% CI, 41.5-48.8); KSA (51.1%; 95% CI, 45.8-56.3), UK (39.4%; 95% CI, 34.4-44.6). Incidence was highest in the PICU (59.7%; 95% CI, 47.0-71.5). Dosing problems were the most frequently reported DRPs (n = 258, 54%). 80.3% of DRP (n = 384) cases were preventable; 72.2% (n = 345) of DRPs were assessed as minor; 27% (n = 129) as moderate. Number of prescriptions and type of admission (transferred) were potential risk factors for DRP occurrence in children. CONCLUSIONS: Drug-related problems were common in the hospitalised children in this study; the most frequent were dosing problems and drug choice problems; the majority of them were preventable. Polypharmacy and transferred admission (another hospital or ward) were potential risk factors. To improve prescribing practices and minimise the risk of DRPs in hospitalised children, paediatric pharmacology and pharmacotherapy are important in medical education.

Comparing the Efficacy and Safety of Apixaban Versus Warfarin in Morbidly Obese Patients.

This study was conducted to evaluate the efficacy and safety of apixaban versus warfarin in morbidly obese patients. A total of 250 morbidly obese patients with a body mass index (BMI) higher than 40 kg/m2 or a body weight higher than 120 kg who were on anticoagulation therapy with either apixaban or warfarin for over one month were included in the study. This retrospective cohort, multicenter study was executed using the medical records of 125 morbidly obese patients treated with apixaban, while patients on warfarin were selected using a systemic random sampling to match the sample size of the apixaban group. There was no significant difference between apixaban and warfarin in the development of thromboembolic events and major bleeding. However, incidences of minor bleeding significantly decreased in the apixaban group compared to patients treated with warfarin. This difference was overcome by controlling serum creatinine and nonsteroidal anti-inflammatory drugs (NSAIDs). In conclusion, apixaban efficacy and safety are nearly the same as that of warfarin in morbidly obese patients with a lower incidence of minor bleeding with apixaban. Controlling serum creatinine and NSAIDs use may improve warfarin safety and decrease its complications.

Real-World Experience of Monitoring Practice of Endocrinopathies Associated with the Use of Novel Targeted Therapies among Patients with Solid Tumors.

BACKGROUND: Cancer treatments have gradually evolved into targeted molecular therapies characterized by a unique mechanism of action instead of non-specific cytotoxic chemotherapies. However, they have unique safety concerns. For instance, endocrinopathies, which are defined as unfavorable metabolic alterations including thyroid disorders, hyperglycemia, dyslipidemia, and adrenal insufficiency necessitate additional monitoring. The aim of this study was to assess the prevalence of monitoring errors and develop strategies for monitoring cancer patients who receive targeted therapies. METHOD: A retrospective chart review was used to assess the prevalence of monitoring errors of endocrinopathies among cancer patients who received targeted therapies over one year. All of the adult cancer patients diagnosed with a solid tumor who received targeted therapies were included. The primary outcome was to determine the prevalence of monitoring errors of endocrinopathies. The secondary outcomes were to assess the incidences of endocrinopathies and referral practice to endocrinology services. RESULTS: A total of 128 adult patients with solid tumors were involved. The primary outcome revealed a total of 148 monitoring errors of endocrinopathies. Monitoring errors of the lipid profile and thyroid functions were the most common error types in 94% and 92.6% of the patients treated with novel targeted therapies, respectively. Subsequently, 57% of the monitoring errors in the blood glucose measures were identified. Targeted therapies caused 63 events of endocrinopathies, hyperglycemia in 32% of the patients, thyroid disorders in 15.6% of them and dyslipidemia in 1.5% of the patients. CONCLUSION: Our study showed a high prevalence of monitoring errors among the cancer patients who received targeted therapies which led to endocrinopathies. It emphasizes the importance of adhering to monitoring strategies and following up on the appropriate referral process.

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.

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.

Impact of Drug Use Policy on the Appropriate Use of Direct Acting Antiviral Agents for Hepatitis C in Saudi Arabia.

BACKGROUND: Ministry of National Guard-Health Affairs in Saudi Arabia developed a new policy for the use of direct antiviral agents (DAAs) for hepatitis C. The present study was conducted to evaluate prescribers' compliance and the impact of the policy on DAAs appropriate use. MATERIALS AND METHODS: This study was conducted at King Abdul Aziz Medical City in Jeddah, Saudi Arabia. The study compares patients' data during 1 year before and 1 year after policy initiation. The primary outcomes were compliance to monitoring parameters, appropriateness of treatment and treatment eligibility. Secondary outcomes included sustained virologic response at 12 weeks, documentation of potential drug-drug interactions and treatment costs. Independent samples t-test and Chi-square test were used when applicable. A P < 0.05 was considered statistically significant. RESULTS: One hundred and three patients were included in analysis (46 before and 57 after policy). Prescriber compliance to baseline monitoring parameters was 67.4% before policy and 82.5% after-policy (P = 0.076). International normalized ratio (INR) was requested in 84.8% of cases before policy compared to 96.5% after-policy (P = 0.036). Treatment options offered to patients were appropriate in 52.2% of cases before policy and in 82.5% after-policy (P = 0.001). CONCLUSION: There is a significant improvement in the baseline monitoring of INR. Treatment options offered after policy implementation were significantly more appropriate.

A cross-sectional study comparing variation in body surface area and chemotherapy dosing in pediatric oncology using two different methods.

PURPOSE: Standardizing body surface area (BSA) determination is essential for avoiding variation in chemotherapy dosage calculations. In this study, we compared variation in BSA calculation using weight and height by the Mosteller formula with weight alone using recently adapted table at a local oncology center. METHODS: Cross-sectional study of pediatric oncology patients presenting to a pediatric oncology clinic over a week period of time. RESULTS: One-hundred consecutive pediatric oncology patients presented to the clinic. The mean BSA calculated by the Mosteller formula was 0.83 m(2) (SD 0.24) and the mean BSA determined by the table (based on weight alone) was 0.82 m(2) (SD 0.25). The mean variation in dosing between the two methods was 1.64% (SD 3.4). Only 13 out of 100 patients (13%) had equal dosing using both methods and 21 out of 100 patients (21%) had dosing variation greater than 5%. When comparing both methods, using paired t-test, the difference was statistically significant (t((99)) = 3.99 and p < 0.001). CONCLUSION: Significant differences in BSAbased chemotherapy dosing exist in our center. The Mosteller method should remain the standard until prospective studies are performed to determine the significance of this dosing variability on toxicity and survival outcome.

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.

Evaluation of Medication Error Incident Reports at a Tertiary Care Hospital.

Background: Medications errors (MEs) have been a major concern of healthcare systems worldwide. Voluntary-based incident reporting is the mainstay system to detect such events in many institutions. However, the number of reports can be highly variable across institutions depending on their adoption of the safety culture. This study aimed to evaluate and analyze medication error incidents that were submitted through the hospital safety reporting system in 2015 at a tertiary care center in the western region of Saudi Arabia, and to explore the most common types of harmful MEs in addition to the risk factors that led to such harmful incidents. Methods: This is a descriptive study that was conducted utilizing 624 medication error reports extracted from the hospital safety reporting system. Reports were analyzed based on the medication name, event type, event description, nodes of the medication use process, harm score (adapted from the National Coordinating Council for Medication Error Reporting and Prevention harm index), patients' age/gender, incident setting, and time of occurrence as documented in the Safety Reporting System (SRS). Furthermore, all errors that resulted in injury or harm to patients had a deeper review by two senior pharmacists to find contributing factors that led to these harmful incidents and recommend system-based preventive strategies. Results: This study showed that most reported incidents were near misses (69.3%). The pediatric population was involved in 28.4% of the incident reports. Most of the reported incidents were categorized as occurring in the inpatient setting (57.4%). Medication error incidents were more likely to be reported in the morning shift versus evening and night shift (77.4% vs. 22.6%). Most reported incidents involved the dispensing stage (36.7%). High-alert medications were reported in 281 out of 624 events (45%). Conclusions: The hospital medication safety reporting program is a great tool to identify system-based issues in the medication management system. This study identified many opportunities for improvement in the medication use system, especially in management of chemotherapy and anticoagulant agents.

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.

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.