Cardiovascular adverse events of antineoplastic monoclonal antibodies among cancer patients: real-world evidence from a tertiary healthcare system.

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.

Performance Assessment of Anti-Xa Assay-Based Heparin Dosing Protocol in Pediatric Patients on Extracorporeal Membrane Oxygenation.

BACKGROUND: The use of extracorporeal membrane oxygenation (ECMO) in the postoperative cardiac critical care setting is evolving. Anticoagulation monitoring is among the most challenging aspects of pediatrics. However, there is no consensus on the optimal dosing and monitoring of unfractionated heparin in this setting. To address this, we developed an anti-Xa assay-based protocol derived from the best available clinical and anecdotal evidence of ECMO use and assessed its effectiveness in achieving the anti-Xa assay therapeutic target. METHODS: This prospective single-arm study was conducted in the pediatric carcardiac-surgery intensive care unit of a large tertiary hospital. We used two different anti-Xa assay intensity levels based on the patients' bleeding status. RESULTS: The median patient age was 7 (interquartile range [IQR]: 5-11.25) months, and the median weight was 5.7 (IQR: 3.8-13.82) kg. The median ECMO duration was 6 (IQR: 4.5-7.5) days. The bleeding protocol was used for most patients. Seventy percent achieved the anti-Xa assay therapeutic target during the study period (median: 75.5 h, IQR: 60.5-117.5 h). Hemorrhagic complications were reported in 40% of the patients, and thrombotic complications were reported in 25%. The median length of stay was 37 (IQR: 22-43) days, with a survival-to-discharge rate of 75%. CONCLUSIONS: Despite a failure to achieve the anti-Xa assay target within the first ECMO days, most patients achieved the target by the median ECMO duration. Moreover, using two different anti-Xa assay levels reduced thrombotic complications.

The clinical and Practice Dilemma of Frequent Switching Among Generic Medications: Magnitude and Patient Safety Prospective.

Objective: To assess the magnitude of generic-generic and brand-generic medication switching and its impact on patients' understanding and the potential risk of medication errors. Methods: The study composed of 2 parts. The first part is a retrospective study to measure the frequency of medications switching in King Faisal Specialist Hospital and Research Centre (KFSH&RC), from 1st of January 2015 to the 31st of December, 2020. Brand medications that were switched to generic medications, generic medications that were switched to brand medications and generic medications that were switched to other generic medications were included. Medications that were switched before or after the study period were excluded. The primary outcomes are the total percentage of switching from brand to generic of all medications in KFSH&RC drug formulary, frequency of generic-generic medications switching and percentage of switching back from generic to brand medications. The second part is a cross sectional survey-based study to assess patients' understanding of their medications and the potential for medication errors by assessing their ability to identify the discrepancies and duplications utilizing a validated questionnaire. Results: Over 5 years, the number of generic medications increased from 553 (35.5%) to 640 (41.1%) out of the 1554 formulary items. Percentage of switching from brand to generic over that 5-year period was 15.9%. Percentage of switching back from generic to brand was 12.8%. Total number of generic medications that had been switched to other generic medications was 256 (16.5%). Out of the 218 patients who had been switched from generic to generic medication, only 43 patients (19.7%) knew the indication for the generic medication they were taking. One hundred forty-six patients (67%) knew the indication of generic medications exclusively by their physical "trademark" characteristics, with 11.5% unrecognized duplication. Conclusion: There is a clear tendency to switch brand medications to generics and to switch between generics. We found the percentage of subsequent switching back to branded products is alarming. Frequent switching between medications negatively impacted patient comprehension and resulted in medication duplication. There is a crucial need for appropriate medication counseling and medication use ecosystem redesign.

Does Secondary Antibiotic Prophylaxis Improve Clinical Outcomes in Adult Rheumatic Heart Disease Patients Post-Valve Replacement?

BACKGROUND: Secondary prevention of recurrent rheumatic fever in individuals with rheumatic heart disease (RHD) requires continuous antibiotic prophylaxis. However, the impact of antibiotic prophylaxis on the outcome of patients with severe RHD who underwent heart valve replacement is unknown. The objective of the study was to assess the relationship between the use of antibiotics as secondary prophylaxis in RHD patients who underwent valve replacement and clinical outcomes including mortality, reoperation, and valve-related hospitalization. METHODS: We retrospectively compared outcomes of adult patients who underwent heart valve replacement for RHD at our institution from 1990 through 2014 and who received secondary antibiotic prophylaxis (prophylaxis group) with those who did not receive prophylaxis (nonprophylaxis group) using propensity score matching analysis. RESULTS: A total of 1094 patients (56% females, median age 40 years, range 31-53 years) were included with a median follow-up of 9.6 years (range 2.9-12.6 years). Antibiotic prophylaxis was prescribed in 201 patients (18%). Propensity score matching analysis demonstrated no significant difference in overall survival (95% [92%-98%] vs 97% [95%-99%], respectively; P = .7), valve-related hospitalization-independent survival (72% [range 65%-78%] vs 81% [range 76%-88%]; P = .25), and redo valve surgery-independent survival [76% [range 70%-83%] vs 75% [range 72%-79%]; P = .41) at 10-year follow-up in the nonantibiotic prophylaxis versus the antibiotic prophylaxis group. CONCLUSION: Secondary antibiotic prophylaxis among adult RHD patients following valve replacement is not associated with improved clinical outcomes.

Clinical pharmacy definition, required education, training and practice in Saudi Arabia: A position statement by the Saudi society of clinical pharmacy.

The Saudi Society of Clinical Pharmacy (SSCP) is a scientific and professional society in the field of clinical pharmacy that operates under the Saudi Commission for Health Specialties governance. The SSCP believes that there is a need to define and describe many aspects related to the clinical pharmacy profession in Saudi Arabia. Moreover, there is an increasing demand for promoting the concept of clinical pharmacy and developing a consensus regarding the scope of practice and clinical pharmacist's required postgraduate education and training in Saudi Arabia. This paper is intended to present several position statements by the SSCP that define the concept of clinical pharmacy, describe the required education and training, and highlight clinical pharmacists' scope of practice in Saudi Arabia. This paper calls for further investigations that examine the impact of clinical pharmacists on individual and population health levels.

Quantifying Clinical Pharmacist Activities in a Tertiary Care Hospital Using Key Performance Indicators.

Background: Key performance indicators (KPIs) are a set of measures used to help an organization in assessing and achieving goals critical to success. The aim of this study was to quantify the clinical pharmacists' contribution to patient care in a tertiary care hospital using predefined clinical pharmacy KPIs. Method: This study was a prospective, observational study conducted by the Pharmaceutical Care Division of a tertiary care hospital. Clinical pharmacy KPIs were submitted by each clinical pharmacist on a monthly basis for 12 months during 2017. All clinical pharmacists up to the managerial level were included in the study. Data were analyzed, stratified, and correlated using Microsoft Excel, JMP statistical software, and Spearman correlation. The study was approved by the hospital's Office of Research Affairs, RAC number 2171-080. Results: A total of 42 clinical pharmacists reviewed 104 728 patient encounters. They performed an adjusted average of 1221 interventions with an acceptance rate of 91.5%, 273 medication reconciliations, 325 discharge consultations, 332 pharmacokinetic consultations, 700 total parenteral nutrition consultations and follow-ups, and 12 688 electronic order verifications per clinical pharmacist per year. These interventions collectively resulted in a cost saving of $316 087.65 per clinical pharmacist per year. Statistical significance with positive correlation was noted for a number of precepted residents/students and clinical pharmacists' experience (R = 0.382, P = .013) and board certification (R = 0.428, P = .0047). Conclusion: Clinical pharmacy KPIs were able to quantify the clinical pharmacists' contributions to patient care and cost savings, which may lead to improve, standardize, and benchmark clinical pharmacy activities in the region.

Clinical Validity Assessment of Integrated Dose Range Checking Tool in a Tertiary Care Hospital Using an Electronic Health Information System.

Background/purpose: The electronic clinical decision support system (CDSS) is mainly used to assist health care providers in their decision-making process. CDSS includes the dose range checking (DRC) tool. This study aims to evaluate the clinical validity of the DRC tool and compare it to the institutional Formulary and Drug Therapy Guide powered by Lexi-Comp. Methods: This retrospective study analyzed DRC alerts in the inpatient setting. Alerts were assessed for their clinical validity when compared to recommendations of the institution's formulary. Relevant data regarding patient demographics and characteristics were collected. A sample size of 3000 DRC alerts was needed to give a margin of error of 1% (using normal approximation to binomial distribution gives 30.26/3000 = 1%). Results: In our cohort, 1659 (55%) of the DRC alerts were generated for adult patients. A total of 1557 (52%) of all medication-related DRC alerts recommended renal dose adjustments, while 708 (24%) needed hepatic dose adjustments. Majority of alerts, 2844 (95%), were clinically invalid. A total of 2892 (96%) alerts were overridden by prescribers. In 997 (33%) cases, there was an overdose relative to the recommended dose, and in 1572 (52%) there was underdosing. Residents were more likely to accept the DRC alerts compared with other health provider categories (P < .001). Conclusion: Using DRC as a clinical decision support tool with minimal integration yielded serious clinically invalid recommendations. This could increase medication-prescribing errors and lead to alert fatigue in electronic health care systems.

The usefulness of an ambulatory care pharmacy performance dashboard during the COVID-19 pandemic in a complex tertiary care system.

PURPOSE: To describe the usefulness of an innovative "semi-real-time" pharmacy dashboard in managing workload during the unpredictable coronavirus disease 2019 (COVID-19) pandemic. SUMMARY: We created a pharmacy dashboard to monitor workload and key performance indicators during the dynamic COVID-19 crisis. The dashboard accessed the prescribing workload from our clinical information system and filled prescriptions from robotic prescription dispensing systems. The aggregated data was visualized using modern tools. The dashboard presents performance data in near real time and is updated every 15 minutes. After validation during the early weeks of the COVID-19 crisis, the dashboard provided reliable data and served as a great decision support aid in calculating the backlog of prescribed but unfilled prescriptions. It also aided in adjusting manpower, identifying prescribing and dispensing patterns, identifying trends, and diverting staff resources to appropriate locations. The dashboard has been useful in clearing the backlog in a timely manner, staff planning, and predicting the next coming surge so that we can proactively minimize accumulation of backlogged prescriptions. CONCLUSION: Developing a dynamic, semi-real-time pharmacy dashboard during unstable circumstances such as those that have arisen during the COVID-19 pandemic can be very useful in ambulatory care pharmacy workload management.

Possible Azithromycin-Induced Life-Threatening Arrhythmia Requiring Extracorporeal Membrane Oxygenation Support: A Case Report.

BACKGROUND Azithromycin is a commonly prescribed antibiotic due to several advantages, including the broad range of indications, spectrum of activity, favorable drug interaction profile, and convenience of dosing. Although azithromycin carries a black-box warning for QTc prolongation and ventricular arrhythmias, these are considered rare adverse effects. CASE REPORT We present the case of a 37-year-old woman who received azithromycin (500 mg) for follicular tonsillitis and was admitted for worsening of symptoms. On the same day of admission to a secondary hospital, she became unresponsive and had cardiac arrest, for which cardiopulmonary resuscitation (CPR) was performed for 26 min. As per the input from the secondary hospital, she had multiple ventricular tachycardia (VT) and ventricular fibrillation, and needed to be transferred to a tertiary care hospital for further management. Veno-arterial extracorporeal membrane oxygenation (ECMO) support was inserted to support her hemodynamics, and serial ECGs showed significant QT interval prolongation up to 600 msec. The QT prolongation resolved over 10 days and she was successfully weaned-off ECMO. CONCLUSIONS Although azithromycin has a relatively safe profile, it is also associated with life-threatening cardiac arrhythmias that may require surgical intervention to stabilize the patient hemodynamically.

Twelve-Month Review of Infusion Pump Near-Miss Medication and Dose Selection Errors and User-Initiated "Good Save" Corrections: Retrospective Study.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Assessment of Late Thromboembolic Complications Post-Fontan Procedure in Relation to Different Antithrombotic Regimens: 30-Years' Follow-up Experience.

Background: The current CHEST guidelines recommend the use of antithrombotic therapy, either aspirin or warfarin, as a primary thromboembolic complications (TECs) prophylaxis in patients who undergo Fontan procedure, without specification on drug selection or duration of therapy. Objective: To investigate the incidence rate of late TECs, occurring after 1-year post-Fontan procedure and to assess the difference in rate of late TECs between warfarin and aspirin. Methods: A retrospective cohort study included patients who had Fontan procedures between 1985-2010 at our institution. Patients were stratified according to the antithrombotic regimen-warfarin, aspirin, or no therapy-at the time of TECs. Results: We screened 499 patients who underwent Fontan procedures; 431 procedures met the inclusion criteria. Over a median follow-up of 13.6 years (IQR= 8.7), freedom from late TECs at 5, 10, 15, and 20 years was 97.54%, 96.90%, 90.78%, and 88.07%, respectively. There was no difference in late TEC incidence rates per 1000 patient-years between warfarin and aspirin: 7.82 and 5.83 events, respectively; rate ratio= 1.34 (95% CI= 0.68-2.60). Warfarin was associated with a higher major bleeding incidence rate per 1000 patient-years: 3.70 versus 2.91 events with aspirin; rate ratio= 1.27 (95% CI= 0.49 to 3.29). Conclusion and Relevance: The incidence rate of late clinical TECs post-Fontan procedure in our population is low. Warfarin was not superior to aspirin for prevention of late TECs. Yet warfarin was associated with a higher rate of bleeding. This finding suggests a simpler antithrombotic regimen for prevention of TEC after 1-year post-Fontan procedure.

Comparison of closed system transfer devices for turnaround time and ease of use.

OBJECTIVE/PURPOSE: The primary purpose of this study was to compare three closed-system transfer devices with differing mechanical interfaces for their suitability for adoption into our daily practice. The secondary purpose was to use the results of this study to support the selection of one of the closed-system transfer devices, which would suit both the pharmacy and nursing staff at our institution, furthermore promoting the enculturation of international recommendations into our clinical practice. STUDY DESIGN/METHODS: The hazardous drug preparation process was observed and timed continuously from the moment the technician started compounding until the finished product was handed to the designated checker by raising hands. A self-administered, structured questionnaire was used for data collection looking at ease of use of each of the devices from the perspective of pharmacy technicians and nurses. The questionnaire contained an open-ended 10-point Likert-type scale of eight domains. RESULTS/KEY FINDINGS: An improvement in the compounding efficiency of hazardous drugs using PhaSeal™ ( n = 46), ChemoLock™ ( n = 45), and EquaShield® II ( n = 45), when compared respectively against the historical control ( n = 86), was statistically significant ( p < 0.001). However, no statistically significant difference among the different closed-system transfer devices for preparation of hazardous drugs was observed in our study ( p = 0.1). In terms of ease of use, there was no difference in preference for ChemoLock™ and Equashield®II among the pharmacy technicians with both scoring a mean score of 10 with regard to implementation. While PhaSeal™ scored a mean score of 7.2. Among the nursing staff there was a slight preference for ChemoLock™ over Equashield®II with a mean score of 9.2 and 9, respectively with regard to the recommended product, while PhaSeal™ scored a mean score of 7.4. Both nursing staff and pharmacy technicians had a preference ChemoLock™, with a mean score of 10 and 9.6, respectively in terms of on how easy was each device/system to use and overall impression for pharmacy technicians. This was followed by Equashield®II with a mean score of 9.8 and 8.6, respectively and then PhaSeal™ with a mean score of 7.2 and 6.6, respectively. Pharmacy technicians felt there were more steps, packaging and clutter when using PhaSeal® in comparison to the other devices. With Equashield® II, the estimation of clutter was higher than that of ChemoLock™ despite the number of packages being within a similar range. CONCLUSION/RECOMMENDATIONS: Our study found that with experienced staff, compounding of hazardous drugs with closed-system transfer devices can be as efficient as or even more so than with the traditional needle and syringe method. With the lack of statistically significant difference among the different closed-system transfer devices studied, in addition to the cost, ease of use was one of the factors that decided the products applicability in our institution.

A P&T Committee's Transition to a Complete Electronic Meeting System-A Multisite Institution Experience.

PURPOSE: In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. SUMMARY: We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. CONCLUSION: The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites.

Impact of a medication reconciliation program on cardiac surgery patients.

Background Cardiac surgery patients are at high risk of medication errors. Resumption of home medications reduces the significance and number of medication errors. This could be achieved by implementing a medication reconciliation program. Patients and Methods Patients were eligible for inclusion in this prospective study if they were admitted, transferred, and/or discharged under cardiac surgery team care from September 2015 to March 2016. The primary outcome was the number and proportion of unintentional medication discrepancies. Secondary outcomes included the number of interventions to resolve discrepancies and their clinical significance, and the medication regimen complexity index and its correlation with discrepancies. Results There were 374 patients included and 1000 encounters tracked. Four-hundred and seventy (47%) of the included encounters were for adult patients. Of the 260 medication discrepancies detected, 181 (69.61%) were detected during admission. Discrepancies among adults were 0.913, 0.307, and 0.176 on admission, transfer, and discharge, respectively. Two-hundred (76.92%) of the interventions recommended by the pharmacy residents were accepted by the medical team, and the remaining were accepted with modifications, with no rejections. One-hundred and sixty-six (83%) of the accepted interventions were of high clinical significance. There was a significant correlation between the number of medication discrepancies and medication regimen complexity index on admission ( p < 0.0001, r = 0.34), transfer, and discharge. Conclusion Implementation of a medication reconciliation program in cardiac surgery units and its step-down units can be a powerful mean of identifying medication errors in post-cardiac surgery patients at admission and throughout the transition of care.

Assessment of evidence-based practice among hospital pharmacists in Saudi Arabia: attitude, awareness, and practice.

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.

Antimicrobial stewardship program implementation in a medical intensive care unit at a tertiary care hospital in Saudi Arabia.

BACKGROUND AND OBJECTIVES: 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. DESIGN AND SETTINGS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Assessment of the standard pediatric unfractionated heparin dosing protocol.

Current dosing guidelines for unfractionated heparin therapy in pediatric patients are based on recommendations of only one study that evaluated a weight-based dosing nomogram. To test the hypothesis that adhering to a strict weight-based nomogram yields better therapeutic results in pediatric patients, we prospectively monitored 25 consecutive pediatric patients who received unfractionated heparin based on the nomogram, and compared them to control patients whose treatment did not follow the standard nomogram. The mean time needed to achieve the target activated partial thromboplastin time was significantly shorter in the study group than the control group (18.32 ± 9.98 vs. 43.8 ± 30 h). A higher proportion of the study group reached the target activated partial thromboplastin time at 12, 24, and 36 h, compared to controls: 44% vs. 6%, 72% vs. 28%, 100% vs. 58%, respectively. Within the study group, patients under 1 year of age needed more time to achieve the target activated partial thromboplastin time than those over 1-year old. The performance of the standard dosing nomogram was excellent with regard to early anticoagulation target achievement, without increasing the risk of bleeding. Further studies are warranted to refine this nomogram for pediatric patients who are less than 1-year old.

The first international residency program accredited by the American Society of Health-System Pharmacists.

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.

Pharmacoeconomic analysis in Saudi Arabia: an overdue agenda item for action.

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.

Documenting clinical pharmacist intervention before and after the introduction of a web-based tool.

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 χ² 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.