Revitalizing oncology medications access in Saudi Arabia: Current challenges and recommendations by the Saudi Oncology Pharmacy Assembly.

BACKGROUND: Cancer care is posing immense challenges to healthcare systems globally. Advances in screening, monitoring, and treating cancer improved patient outcomes and survival rates yet amplified the disease burden. Multiple barriers might impede early access to innovative therapies. We thoroughly examined the current challenges in oncology medication access in Saudi Arabia and provided consensus recommendations to revitalize the process. METHODS: A focus group discussion was conducted. Expert healthcare providers (pharmacists and physicians) were invited to participate based on prespecified criteria. The research team conducted a qualitative analysis of the discussion to identify themes and formulate recommendations. RESULTS: Fourteen experts were equally distributed into two groups, limiting the number in each group to 7. Pharmacists were 12 (∼86%), and physicians were 2 (∼14%). Ten were practicing in governmental hospitals, four representing different sectors; regulatory bodies, including Ministry of Health, National Unified Procurement Company, and Saudi Food and Drug Authority. Five themes were identified: national cancer burden, local data availability, pharmacoeconomic evaluation, patients reported outcomes, administration, and procurement. Consensus recommendations were formulated to optimize the formulary management process, enabling informed decision-making and facilitating early medication access for cancer patients. CONCLUSIONS: The formulary management process can be enhanced by addressing the national cancer burden, promoting local data availability, conducting pharmacoeconomic evaluations, focusing on patient outcomes, and improving administration and procurement procedures. Implementing these recommendations can improve access to oncology medications and improve patient care outcomes in Saudi Arabia.

Practical strategies to manage cancer patients during the COVID-19 pandemic: Saudi Oncology Pharmacy Assembly Experts recommendations.

PURPOSE: During COVID-19 pandemic, cancer patients are considered one of the most vulnerable to infection since they tend to have advanced age, multiple comorbidities, and are often immunosuppressed by their cancer or therapy. Hence, the Saudi Oncology Pharmacy Assembly has issued recommendations to reduce the frequency of cancer patients' visits to oncology centers during the pandemic while maintaining the access to cancer therapy and minimize the risk of exposure to coronavirus disease. MATERIALS AND METHODS: A qualitative methodological approach was conducted in April 2020 using a virtual panel discussion for collection of recommendations. RESULTS: A total of 12 expert oncology pharmacy practitioners shared their knowledge and experiences in managing oncology patients during the COVID-19 pandemic. The participants recognized many fundamental recommendations that were already applied in many cancer centers since the start of the COVID-19 outbreak. On that basis, the panelists developed eight practice-related recommendations for action, with a main focus on cancer treatment modification. CONCLUSIONS: In conclusion, delivering cancer care during the COVID-19 pandemic carries significant challenges. This paper addressed suggestions to properly manage cancer patients during difficult times. Implementing changes in practice mandates a national collaborative effort from different sectors to guarantee the quality and continuity of care. The SOPA expert panel developed these recommendations, to ultimately contribute in maintaining access to cancer therapy while minimizing the risk of COVID-19 exposure.

Perceptions regarding antimicrobial use and resistance among adult hospital patients in Saudi Arabian Ministry of Health (MOH) hospitals.

BACKGROUND: Education, a key strategy within antimicrobial stewardship programmes (ASPs), has been mainly directed towards healthcare professionals and prescribers more than hospitalised patients. AIM: To examine patients' knowledge and perceptions of antibiotic use and resistance, while evaluating the institutional role of patient education on antibiotic use in two Saudi Arabian hospitals, one with an implemented ASP and one without an ASP. METHOD: A cross-sectional self-administered survey was developed and piloted. A total of 400 surveys were distributed, 200 within the hospital with an ASP and another 200 within the hospital without an ASP. Data were coded and analysed. Ethical approval was obtained before the start of the study. FINDINGS: 176 patients responded to the survey with 150 surveys completed and analysed. 78% of patients agreed that they should only take an antibiotic when prescribed by the doctor, however they still tended to keep left over antibiotics for future use. 84% of patients were unaware 'antibiotic resistance', with 48% believing that antibiotics help them get better quicker when they had a 'cold'. Information on antibiotic use and resistance were provided to patients in the hospital with an ASP in contrast to the hospital without an ASP. CONCLUSION: Overall there are poor perceptions regarding antibiotic use and resistance among hospital patients in Saudi Arabia. Patients in the hospital with ASP demonstrated greater knowledge during their hospitalisation. ASPs should not only focus on educating healthcare professionals but should involve the patients and seize the opportunity to educate them while hospitalised.

Implementing Oncology Pharmacy Boot Camp for Advanced Pharmacy Practice Experience Students at a Regional Conference in Saudi Arabia.

Background Upon graduation, pharmacy students are expected to possess a diverse array of knowledge, skills, and attitudes. A subject-specific boot camp may support bridging the gap between the information and skills gained during clerkships, courses required for pharmacy school after graduation, and skills needed for the job market, as well as the gap between pharmacy school and residency. This research aimed to determine whether an integrated boot camp increased Advanced Pharmacy Practice Experience (APPE) student self-confidence and enhanced students' knowledge in oncology pharmacy. Method APPE students who attended the annual meeting of the Saudi Oncology Pharmacy Assembly (SOPA)/International Society of Oncology Pharmacy Practitioners (ISOPP) Regional Conference 2021 were voluntarily enrolled in a three-hour oncology-focused boot camp consisting of interactive lectures. Pre- and post-intervention examinations were used to evaluate student learning outcomes and their experience feedback. Result Of 118 students who attended the boot camp, 80 students who met the criteria were included in the study. The pre- and post-intervention examinations were completed by the 80 APPE students. The pre-intervention test results (mean: 66%, standard deviation (SD): 16%) increased by 21.5% after the boot camp (mean: 87.5%, SD: 12%, p = 0.001). Students scored better on each of the 10 test questions, with nine questions demonstrating a statistically significant result. Conclusion The results of this research showed that interns who participated in an oncology boot camp had a higher level of knowledge and confidence in applying key oncology concepts. Interns were satisfied with the chance to engage in the activity, and they agreed to adding boot camps to future conferences would be valuable. This research shows that it is possible to hold a transitional boot camp during conferences to better prepare students for their fields of study and increase their participation in oncology conferences.

Assessing Adherence to Cardiac Monitoring Guidelines in Trastuzumab-Treated Breast Cancer Patients: Insights From a Tertiary Hospital.

INTRODUCTION: Breast cancer is a global health concern, with a significant portion of patients exhibiting human epidermal growth factor receptor 2 (HER2) overexpression. Trastuzumab is one of the pivotal therapies for HER2-positive breast cancer, but it carries the risk of cardiotoxicity. Guidelines for cardiac monitoring are essential to detect early signs of cardiotoxicity. However, adherence to these guidelines remains uncertain. METHOD: In this single-center retrospective cohort study, we analyzed data from 167 female patients diagnosed with HER2-positive breast cancer who were treated with trastuzumab. We meticulously assessed the level of adherence to cardiac monitoring guidelines and determined the incidence of trastuzumab-induced cardiotoxicity (TIC). Factors affecting adherence were subsequently investigated using appropriate statistical methods. RESULTS: Adherence to monitoring guidelines was only 31.7%. TIC incidence was 7.8%. Patients with concurrent use of cardiotoxic medications demonstrated higher adherence. A significant association was found between the number of trastuzumab doses and adherence. CONCLUSION: Adherence to monitoring guidelines was suboptimal. Those at a higher risk of cardiac issues showed greater adherence. Improved risk assessment methods are needed to individualize monitoring and intervention. Future research should focus on patient-centered, evidence-based monitoring to optimize the balance between cancer therapy and cardiac safety in the field of cardio-oncology.

Adherence to Hormonal Therapy in Breast Cancer Patients in Saudi Arabia: A Single-Center Study.

Breast cancer is one of the most common types of cancer in women. Approximately three-quarters of all breast cancer patients have estrogen and/or progesterone receptor positivity. As a result, the majority of patients receive hormonal treatment for between five and 10 years. Long-term use of hormonal therapy reduces the recurrence rate and the risk of death. In Saudi patients, adherence to hormonal therapy is not adequately assessed. The primary objective of this study is to determine the clinical outcomes associated with hormonal therapy adherence in breast cancer patients. This is a retrospective cohort study of patients who received adjuvant hormonal therapy for hormone-receptor-positive breast cancer. Patients were included if they had received at least two prescription refills following their breast cancer diagnosis. The primary outcome measure was mortality and disease progression in relation to hormonal therapy adherence. Progression of disease is defined as local recurrence or radiographic evidence of metastatic disease. The secondary outcome measure was the study population's adherence to hormonal therapy. The proportion of days covered during hormonal therapy was used to assess adherence (PDC). PDC was calculated as the number of days in the prescription period divided by the total number of days in the prescription period. Patients are considered adherent if their PDC value is greater than 0.8. The mortality and disease progression curves were generated using the Kaplan-Meier method. The proportion of patients adhering to hormonal therapy was determined using descriptive analysis. The IRB granted approval. A total of 121 patients were included in the study from the 380 patients screened. Tamoxifen, letrozole, and anastrozole were administered to 58%, 27%, and 14% of patients, respectively. The median age was 53 years. Women who were postmenopausal constituted 52.3% of the study population. The majority of patients were in Stages II and I (56.2% and 16.53%, respectively). The majority of the tumors were Grade II (58.68 %). Adherence was not associated with disease progression (HR, 0.66; 95% CI, 0.25-1.72) or mortality (HR, 1.391; 95 percent CI, 0.33-5.82). Disease progression and mortality were not found to be significantly associated with hormonal therapy adherence in this study. A larger study is required to confirm the findings of our study.

Antimicrobial Stewardship Program Implementation in a Saudi Medical City: An Exploratory Case Study.

Antimicrobial stewardship programs (ASPs) in hospitals have long been shown to improve antimicrobials' use and reduce the rates of antimicrobial resistance. However, their implementation in hospitals, especially in developing countries such as Saudi Arabia, remains low. One of the main barriers to implementation is the lack of knowledge of how to implement them. This study aims to explore how an antimicrobial stewardship programme was implemented in a Saudi hospital, the challenges faced and how they were overcome, and the program outcomes. A key stakeholder case study design was used, involving in-depth semi-structured interviews with the core members of the ASP team and analysis of 35 ASP hospital documents. ASP implementation followed a top-down approach and involved an initial preparatory phase and an implementation phase, requiring substantial infectious diseases and clinical pharmacy input throughout. Top management support was key to the successful implementation. ASP implementation reduced rates of multi-drug resistance and prescription of broad-spectrum antimicrobials. The implementation of ASPs in hospital is administrator rather than clinician driven. Outsourcing expertise and resources may help hospitals address the initial implementation challenges.

Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia.

Lay abstract Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia: Immune Checkpoint Inhibitors (ICIs) are rapidly growing and changing cancer care. With introduction of ICIs the landscape for cancer treatment has changed significantly. ICIs are known to induce immune-related adverse effects. This research is intended to shed light on ICIs and describe our safety experience with these agents. This study is a retrospective cohort study aimed to determine the safety of ICIs and its related adverse events at a tertiary hospital in Saudi Arabia. The study was conducted in the oncology center at King Abdulaziz Medical City, Riyadh. We identified study participants by using electronic health care system (BestCare)® to involve patients who received ICIs treatment during the study period from January 2016 up to December 2018, to include a total of 53 patients. Most of our patients were on nivolumab (37 patients) followed by atezolizumab (10 patients), and pembrolizumab (6 patients). The average number of emergency room visits after receiving treatment was three visits per patient. Renal adverse events occurred following ICIs use in nine patients, and none of the reported cases experienced a grade ≥3 event. Moreover, 13 patients experienced a hepatic adverse event, of whom only 1 patient experienced a grade ≥3 event leading to treatment discontinuation. As for diarrhea, among all patients who received ICIs, 14 patients experienced diarrhea, and 5 of them had grade ≥3 events. Also, thyroxine abnormalities occurred in seven patients. While, Pneumonitis occurred in four patients following ICIs use. In addition, we noticed other adverse events with ICIs including (skin reaction, nausea, vomiting, thrombocytopenia, neutropenia, and neurological adverse events). Furthermore, 17 patients required steroids to manage ICIs adverse events. And, no patients in our study required additional management with other immunosuppressive agents.Immunotherapies are rapidly growing and changing cancer care. Immune Checkpoint Inhibitors (ICIs) have the ability to block inhibitory checkpoints and restore the functions of the immune system. ICIs are used for the treatment of several types of cancer, and nowadays, many studies are ongoing in order to get approvals for newer indications. ICIs are known to induce immune-related adverse effects. The safety of ICIs and the most common immune-related adverse events are not yet well recognized for our population since this class of medications is lately introduced in our region, where only limited studies in our population are available in the literature. This research is intended to shed light on ICIs and describe our safety experience with these agents. This study is a retrospective cohort study aimed to determine the safety of ICIs and its related adverse events at a tertiary hospital in Saudi Arabia. The study was conducted in the oncology center at King Abdulaziz Medical City, Riyadh. Study participants were identified by using the electronic health care system (BestCare)® to include patients who were treated with ICIs during the study period from January 2016 up to December 2018. A total of 53 patients were included. Most of our patients were on nivolumab (37 patients) followed by atezolizumab (10 patients), and pembrolizumab (6 patients). The average number of emergency room visits after receiving ICIs was three visits per patient. Renal adverse events occurred following ICIs use in nine patients, and none of the reported cases experienced a grade ≥3 event. Moreover, 13 patients experienced a hepatic adverse event, of whom only 1 patient experienced a grade ≥3 event leading to treatment discontinuation. As for diarrhea, among all patients who received ICIs, 14 patients experienced diarrhea, and 5 of them had grade ≥3 events. Also, thyroxine abnormalities occurred in seven patients. While, pneumonitis occurred in four patients following ICIs use. In addition, we noticed other adverse events with ICIs, including (skin reaction, nausea, vomiting, thrombocytopenia, neutropenia, and neurological adverse events). Furthermore, 17 patients required steroids to manage ICIs adverse events. And, no patients in our study required additional management with other immunosuppressive agents. Patients treated with immune checkpoint inhibitors could have a variety of adverse drug events that might lead to treatment discontinuation and increase overall emergency room visits. This study highlights the most common adverse drug events associated with ICIs use at a tertiary care center in Saudi Arabia.