Quality of Life Evaluation in Saudi Arabian Pediatric Patients with Primary Immunodeficiency Diseases Receiving 20% Subcutaneous IgG Infusions at Home.

BACKGROUND AND AIMS: Subcutaneous immunoglobulin (SCIG) home infusion is widely used as an alternative to intravenous immunoglobulin (IVIG). This study aimed to determine the quality of life (QoL) of patients with primary immunodeficiency (PID) after switching to home-based SCIG. METHODS: In this prospective open-label single-center study, QoL was determined using the validated Arabic version of the Child Health Questionnaire at baseline and 3 and 6 months after switching from IVIG to SCIG. RESULTS: Twenty-four patients were recruited from July 2018 to August 2021, including 14 females and 10 males. The median age of the patients was 5 years (range, 0-14 years). The patients' diagnoses included severe combined immunodeficiency, combined immunodeficiency, agammaglobulinemia, Omenn syndrome, immunodysregulation, hyper-IgE syndrome, common variable immunodeficiency, and bare lymphocyte syndrome. The median duration on IVIG before inclusion was 40 months (range, 5-125 months). The QoL score showed a significant improvement in the patients' global health at 3 and 6 months compared with those at baseline and a significant improvement in the patients' general health at 3 and 6 months compared with that at baseline. The mean baseline serum IgG trough level was 8.8 ± 2.1 g/L. The mean serum IgG level was significantly higher on SCIG at both 3 and 6 months (11.7 ± 2.3 and 11.7 ± 2.5 g/L, respectively). CONCLUSIONS: This is the first study involving an Arab population to show improvement in the QoL of patients with PID after switching from hospital-based IVIG to home-based 20% SCIG.

Pharmacy service accreditation: Raising the bar of practice standards.

PURPOSE: To summarize the journey of a tertiary and quaternary care hospital outside the United States in receiving American Society of Health-System Pharmacists (ASHP) accreditation for its pharmacy services. SUMMARY: Tertiary and quaternary care hospitals have gained their reputation owing to the high quality and advanced services that they provide. Our organization, King Faisal Hospital & Research Center (KFSH&RC), Riyadh, Saudi Arabia, is a 1300-bed capacity hospital that serves as a center of excellence in solid organ transplant, genetic and metabolic diseases, hematology and oncology, and cardiology, in addition to a diversity of medical services. Accreditation of the pharmacy services by ASHP represents an important recognition of the quality and breadth of the services performed at KFSH&RC. The process of accreditation and the accreditation standards have also continued to serve as a guide for the hospital to maintain pharmacy service standards as they evolve. CONCLUSION: As the first internationally accredited pharmacy services, KFSH&RC now demonstrates the path forward for other international hospitals seeking to reach the same standards of practice defined by ASHP.

Assessment of foetal risk associated with 93 non-US-FDA approved medications during pregnancy.

Health care practitioners utilize the United States-Food and Drug Administration (US-FDA) pregnancy categorization (A, B, C, D, X) for making decision on the appropriateness of certain medications during pregnancy. Many non US-FDA approved medications are registered and marketed in Saudi Arabia. However, these medications do not have an assigned pregnancy risk categorization like those approved in the US. The objective of this review is to evaluate, report, and categorize the foetal risk associated with non-US-FDA approved medications registered by the Saudi Food and Drug Authority (S-FDA) according to the US-FDA pregnancy risk categorization system. We identified 109 non-US-FDA approved medications in the Saudi National Formulary (SNF) as of October 2007. We searched for data on functional or anatomical birth defects or embryocidal-associated risk using different databases and references. An algorithm for risk assessment was used to determine a pregnancy risk category for each medication. Out of 93 eligible medications, 73% were assigned category risk C, 10 medications (11%) were assigned category risk D, and 12 medications (13%) were assigned category risk B. Only three medications were judged to be safe during pregnancy based on the available evidence and were assigned category risk A. Inconsistencies in defining and reporting the foetal risk category among different drug regulatory authorities could create confusion and affect prescribing. We believe that standardization and inclusion of this information in the medication package insert is extremely important to all health care practitioners.

Utilization and cost of electronic resources in adult cancer center.

OBJECTIVES: This study aims to evaluate the knowledge of healthcare providers and the cost of the current institutional e-resources in an adult oncology setting. To assess the awareness, accessibility, and utilization of the available intranet e-resources, a survey questionnaire was distributed to all oncology healthcare practitioners (physicians, nurses, and pharmacists) in an adult oncology center. The e-resources were divided into two main categories: pre-paid and institution-specific. The cost of the pre-paid e-resources was obtained from the relevant department. The cost of the institution-specific e-resources was calculated based on the human cost spent developing these e-resources; the cost of the information technology (IT) and the organizational overhead were also taken into consideration. RESULTS: Institution-specific e-resources constituted the majority (62%) versus (38%) for pre-paid. The overall awareness, access, and frequent utilization of institution-specific e-resources, as compared to pre-paid e-resources, were low (< 50%). The cost of the institution-specific e-resources was $1,137,196, which was more than ten times higher than the pre-paid e-resources. This study identifies the general lack of awareness and utilization of institutional e-resources. The low utilization coupled with the high cost of the institution-specific e-resources makes pre-paid e-resources an attractive alternative for any institution.

A three-year study of a first-generation chemotherapy-compounding robot.

PURPOSE: Results of a performance evaluation of an automated system for compounding antineoplastic preparations are reported. METHODS: Three years after the pharmacy department of a hospital in Saudi Arabia installed an i.v.-compounding robot (CytoCare, Health Robotics), data captured by the pharmacy information system and the machine's integrated software were analyzed to assess the performance of the robot in terms of compounding accuracy, days of operation, and downtime. RESULTS: The robot was used to prepare 3.82%, 10.80%, and 13.79% of selected antineoplastics compounded in 2010, 2011, and 2012, respectively. The robot failed to meet the specified dose accuracy range of ±5% in compounding 3 of 337 chemotherapy preparations (0.9%) in 2010, 349 of 1516 preparations (23%) in 2011, and 460 of 2993 preparations (15%) in 2012. The robot was operational on 40%, 39%, and 61% of available workdays in 2010, 2011, and 2012, respectively. Robot throughput relative to the pharmacy's manual compounding process was low, with substantial medication waste resulting from dose preparation failures. Implementation challenges included workflow disruptions due to robot downtime, mechanical issues (e.g., robot arm-clamping failures), difficulty obtaining gravimetric data for some drugs, and the need to recalibrate the device to accept i.v. bags, syringes, and medication vials incompatible with manufacturer specifications. CONCLUSION: The introduction of a chemotherapy-compounding robot for preparation of patient-specific i.v. antineoplastic drugs had a limited efficiency impact in practice. This solution, with its numerous limitations and technical difficulties, is not yet mature enough for universal adoption.