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.

Efficacy of forskolin as a promising therapy for chronic olfactory dysfunction post COVID-19.

PURPOSE: Olfactory dysfunction is increasingly common among COVID-19 patients, impacting their well-being. Reports have demonstrated decreased levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate among patients with chronic olfactory dysfunction. A prospective randomized clinical trial was developed to demonstrate the efficacy of an oral forskolin regimen treatment, an adenylyl cyclase activator that raises intracellular levels of cyclic adenosine monophosphate, for the treatment of olfactory dysfunction following COVID-19, compared to placebo regimen. METHODS: The study enrolled 285 participants with persistent olfactory dysfunction post COVID-19 infection, randomly assigning them to receive either placebo capsules (n = 120) or oral forskolin capsules (n = 165). Follow-up was conducted to track progress, with 18 participants from the placebo group and 12 from the forskolin group lost during this period. Olfactory function was assessed using the "Sniffin' Sticks" test, measuring threshold, discrimination and identification scores before and after treatment. RESULTS: Subjects administered forskolin capsules demonstrated a significant enhancement in their composite TDI (threshold, discrimination and identification) score, suggesting a notable amelioration in olfactory functionality. Moreover, the discrimination and identification scores notably improved within the forskolin group. Conversely, no significant alterations were observed in the threshold scores. CONCLUSION: This study suggests that forskolin can contribute potentially to improve chronic olfactory dysfunction post COVID-19. TRIAL REGISTRATION: DFM-IRB00012367-23-10-001.

Healthcare Providers' knowledge, attitudes and practice in relation to drug hypersensitivity reactions at King Abdulaziz Medical City in Riyadh.

Background: Drug hypersensitivity reactions (DHRs) are immune-mediated responses triggered by exposure to a drug. DHRs are responsible for serious adverse drug reactions (ADRs) and are considered the fifth leading cause of death. This study aims to assess and evaluate the knowledge, practice, and attitudes of healthcare providers (HCPs) towards DHRs. Methods: A cross-sectional survey was conducted at King Abdulaziz Medical City (KAMC) in Riyadh, Saudi Arabia. Healthcare providers, including pharmacists, physicians, and nurses, were recruited using a convenience sampling method to complete the survey. The survey comprised three domains: knowledge (14 items), attitudes (5 items), and practices (6 items), utilizing a standardized self-administered questionnaire. Results: The survey was completed by 373 healthcare providers. The respondents were predominantly female (72.1 %) with a mean age of 33.8 ± 7.8 years. Of the respondents, 64 % were nurses, 25 % pharmacists, and 11.3 % physicians. Educational levels varied, with 53 % holding a bachelor's degree, 22 % an associate degree, and 25 % a master's degree or higher. The median knowledge score was 48. Female healthcare providers, those with advanced levels of education, and physicians had higher knowledge scores compared to male and nurse participants (p < 0.05). One-third of the respondents (33 %) were satisfied with their knowledge of DHRs, and 42 % believed HCPs should receive more advanced training in DHR management. Less than a quarter of HCPs reported inquiring about patients' histories of hypersensitivity reactions. Conclusions: The study revealed that healthcare workers had a relatively low level of knowledge about drug hypersensitivity reactions and lacked a consensus on DHR management. While displaying a positive attitude towards DHRs, they often did not translate this attitude into consistent clinical practice.

Assessing oncology providers attitudes and practices toward nonformulary drugs and mapping current obstacles in Saudi Arabia.

Introduction: Formulary drug list is a continually updated list of medications routinely stocked by hospitals and other healthcare facilities and deemed effective, safe, and cost saving. Non-formulary drug (NFD) refers to medications not on the formulary, due to cost or lack of clinical data. This study aimed to examine the processing of NFD requests by oncology providers (OPs) in Saudi Arabia. Method: A cross-sectional survey in Saudi oncology centers gathered perspectives of healthcare practitioners, mainly oncology pharmacists and physicians, on NFDs and request processes, aiming to understand variations, reasons for NFDs, and suggestions for an improved, unified NFDs request algorithm. Result: A total of 93 physicians and pharmacists responded, 57 % were pharmacists, 43 % were physicians, and 94.6 % worked in the governmental sector. Around 31.2 % reported that it takes one week to receive a decision on their NFD request, while 28 % reported it takes two weeks to one month. Furthermore, 35.5 % of participants reported that the complete NFD process, from the initial order placement to the receipt of medications, spans a duration of 2-4 months, while 8.6 % noted a longer duration exceeding six months. The participants reported that the most common obstacles while requesting NFD were procurement delays and lengthy processing times. Additionally, 26.9 % agreed that formulary restrictions hindered medical care and 40.3 % reported delays in patient care. While 33.8 % were forced to use fewer effective options, and 22.1 % referred patients to palliative care. Conclusion: The current practice of NFDs has negative consequences on cancer patient outcomes due to delays in patient care or the use of less effective drugs. Thus, we recommend having a national NFD access program.

Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union.

INTRODUCTION: Pharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, including licensing, registration, manufacturing, marketing, and labeling. Among these, the USFDA plays a crucial role in upholding public health. The pharmaceutical industry contributes significantly to well-being by developing and distributing therapeutic agents. The journey of evaluating new pharmaceuticals involves meticulous examination through several phases, from safety and efficacy assessments to toxicity evaluation. Drug approval involves submitting New Drug Applications (NDAs) to regulatory agencies like the USFDA and EMA. However, disparities in durations contribute to the phenomenon known as "drug lag." This lag refers to delays in a pharmaceutical product's availability in one market compared to another. Addressing this issue is crucial, given its impact on patient access to treatments. METHOD: This study aims to analyze the extent of drug lag, focusing on newly approved oncology targeted therapies in Saudi Arabia, the United States, and the European Union. Data for cancer treatments authorized by the USFDA, EMA, and SFDA from January 1, 1997, to December 31, 2022, were collected from regulatory agency websites. The data sources included authorization letters, prescription information, and evaluation documents. We conducted a comparative assessment of drug lag for approved oncology targeted therapies between Saudi Arabia, the US, and the EU. RESULT: Our analysis identified 135 newly approved oncology-targeted drugs within the specified timeframe. Of these, 71 received approval in all three regions, while disparities were evident in others. The USFDA consistently had the highest number of approved drugs, with 98.5% of drugs initially approved there. In contrast, Saudi Arabia had the lowest number of approved drugs and a significantly longer median drug lag, indicating substantial delays in drug availability. CONCLUSION: This study highlights the significance of mitigating drug lag to enhance global healthcare outcomes and patient access to innovative therapies. Further research and collaborative efforts are essential to bridging these disparities and promoting equitable healthcare worldwide.

Case Series: Sacubitril/Valsartan Role for Chemotherapy-Induced Cardiotoxicity: An in-Depth Investigation in Saudi Arabia.

Background: Chemotherapy-induced cardiotoxicity is a significant problem, ranking as the second most frequent cause of mortality in cancer patients. This adverse outcome encompasses many cardiovascular problems, such as heart failure. Sacubitril/valsartan has shown potential in the management of heart failure, however, its effectiveness in treating chemotherapy-induced heart failure has not been extensively explored. We performed a case series to investigate the safety and effectiveness of sacubitril/valsartan in treating chemotherapy-induced cardiomyopathy in Saudi Arabia. Methods: The case series was conducted at a single medical center in Makkah, Saudi Arabia. The data gathered included patient demographics, clinical features, laboratory results, echocardiographic findings, and medication information. The data underwent analysis using descriptive statistics. Results: Out of the total of eight patients who were part of the investigation, a notable majority of six individuals exhibited substantial enhancements in their ejection fraction (EF) after receiving sacubitril/valsartan medication. Conclusion: Our case series provides significant insights by revealing improvements in ejection fraction (EF) in six out of eight patients who had chemotherapy-induced cardiomyopathy after receiving sacubitril/valsartan treatment.

Exploring Entrepreneurship in Pharmacy: Attitudes and Perceptions Among Saudi Pharmacists and Students.

Introduction: Entrepreneurship has recently become a focus in community development, innovation, and economic growth, including within pharmaceutical organizations. However, it remains a relatively new aspect of pharmacy education. For the effective incorporation of entrepreneurship in this field, a robust educational foundation is critical, one that emphasizes risk-taking, strategic planning, competitive spirit, and a sense of social responsibility. This study aims to evaluate Saudi pharmacists' attitudes towards entrepreneurship in their practice. Methods: A cross-sectional survey design to assess the attitudes of pharmacists and pharmacy students in Saudi Arabia towards entrepreneurship. The study sample consisted of 302 individuals, selected through convenience sampling, all of whom were either licensed pharmacists or pharmacy students in Saudi Arabia. The survey was conducted electronically and disseminated online throughout the duration of January 2023, spanning a one-month period. The research sought to provide a deeper understanding of how entrepreneurship is perceived within the pharmacy field. Results: The study involved 302 pharmacists in Saudi Arabia, with the majority being pharmacy students and Doctor of Pharmacy holders. Over 60% of the participants worked for the government sector. Results showed a strong interest in entrepreneurship, with nearly 80% expressing interest and believing in the entrepreneurial potential of pharmacists. However, there was a knowledge gap, as only 52% were familiar with entrepreneurship concepts, and most had not taken entrepreneurship courses. More than half of the participants reported insufficient institutional support for entrepreneurship. Remarkably, only 1% had started a pharmaceutical business. Conclusion: In conclusion, this study emphasizes the interest in entrepreneurship among pharmacists, highlighting the need for raising familiarity and formal education in the field. Factors such as working in the government sector were associated with higher willingness to become entrepreneurs, while the lack of awareness and institutional support hindered the entrepreneurial mindset.

Evaluating Adherence to Therapeutic Drug Monitoring Guidelines for Gentamicin in Neonatal Care: A Retrospective Study at the Maternity and Children's Hospital in Makkah.

In this study, we assess healthcare providers' adherence to therapeutic drug monitoring (TDM) guidelines for gentamicin in neonates. Conducted at the Maternity and Children's Hospital in Makkah, Saudi Arabia, from July 2020 to July 2022, it retrospectively analyzed the compliance of healthcare workers in managing neonates treated with gentamicin. Covering 410 neonates, primarily diagnosed with respiratory distress (56%) and sepsis (32%), the study revealed that while a majority of trough and peak levels conformed to guidelines, substantial deviations were noted in cases of respiratory distress. This underlines the necessity for targeted TDM strategies, particularly in managing respiratory distress in neonates, to ensure optimal treatment efficacy and safety. The findings urge stringent compliance with TDM guidelines, emphasizing personalized approaches in neonatal gentamicin therapy for improved healthcare outcomes.

Awareness and attitudes of oncology specialists toward dihydropyrimidine dehydrogenase testing in Saudi Arabia.

BACKGROUND: Fluoropyrimidines (FP) are among the most common class of prescribed anti-neoplastic drugs. This class has severe to moderate toxicity in around 10%-40% of those who take 5-fluorouracil (5-FU) or capecitabine for the treatment of cancer. In practice many patients with severe toxicities from FP use had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. Several studies have proposed DPD screening before treatment with 5-fluorouracil (5-FU) and capecitabine or other drugs belonging to the FP group. This study aims to assess the level of awareness and attitudes of oncology specialists in Saudi Arabia toward genetic screening for DPD prior to giving FP. This highlights the importance of health guidelines required for implementation in our health care system, as a framework to adopt testing as a regular practice in clinical care. Based on the findings in this study, guidelines have been suggested for the Middle East North Africa region. METHODS: A cross-sectional survey study was conducted during 2021 targeting oncologists and clinical pharmacists working in the oncology departments across Saudi Arabia. RESULTS: A total of 130 oncologists and pharmacists completed the questionnaire representing a response rate of 87%. Most of the respondents indicated that they prescribe FP in clinical practice, but 41% of respondents reported that they have never ordered a specific molecular test during their practice. Only 20% of respondents reported that they often screen for DPD deficiency prior to prescribing FP. Significantly higher rates of awareness of potential dihydropyrimidine dehydrogenase gene (DPYD) mutation were observed among respondents in governmental hospitals (81.1% vs. 47.4% in private hospitals), and among those with more years of practice (80.6% if 5 or more years of practice vs. 59.3% if less than 5 years of practice). Also, higher rates of observing the impact of DPD testing were present among respondents with a PharmD (35% vs. 11% for oncologists and 18% for other professions) and among those with 5 or more years of practice (24.6% vs. 7.7% among those with less than 5 years). CONCLUSION: While in some institutions there is a high level of awareness among oncology specialists in Saudi Arabia regarding the effect of the potentially serious DPD enzyme deficiency as a result of gene mutations, screening for these mutations prior to prescribing FP is not a routine practice in hospitals across the country. The findings of this study should promote personalized medicine with recognition of interpatient variability via DPD testing to manage the risks of FP prescribing more effectively in the Kingdom of Saudi Arabia.

Humoral and Cellular Immunity following Five Doses of COVID-19 Vaccines in Solid Organ Transplant Recipients: A Systematic Review and Meta-Analysis.

Solid organ transplant (SOT) recipients are at increased risk of COVID-19 infection because of their suppressed immunity. The available data show that COVID-19 vaccines are less effective in SOT recipients. We aimed to assess the cellular and humoral immunogenicity with an increasing the number of doses of COVID-19 vaccines in SOT recipients and to identify factors affecting vaccine response in this population. A systematic review and meta-analysis were conducted to identify ongoing and completed studies of humoral and cellular immunity following COVID-19 vaccines in SOT recipients. The search retrieved 278 results with 45 duplicates, and 43 records did not match the inclusion criteria. After title and abstract screening, we retained 189 records, and 135 records were excluded. The reasons for exclusion involved studies with immunocompromised patients (non-transplant recipients), dialysis patients, and individuals who had already recovered from SARS-CoV-2 infection. After full-text reading, 55 observational studies and randomized clinical trials (RCTs) were included. The proportion of responders appeared higher after the third, fourth, and fifth doses. The risk factors for non-response included older age and the use of mycophenolate mofetil, corticosteroids, and other immunosuppressants. This systematic review and meta-analysis demonstrates the immunogenicity following different doses of COVID-19 vaccines among SOT patients. Due to the low immunogenicity of vaccines, additional strategies to improve vaccine response may be necessary.

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.

Risk of Lichen Sclerosus and Lichen Planus in Patients Receiving Immune Checkpoint Inhibitors.

INTRODUCTION: Immune checkpoint inhibitors (ICIs) are recommended for various types of cancer. On the other hand, these ICIs may cause immune-related adverse events (irAEs). Lichen sclerosus (LS) and lichen planus (LP) are two distinct phenotypes of irAEs that occur in a subset of patients treated with ICIs. These adverse effects have a detrimental effect on the patient's quality of life and treatment phases; however, the clinical evaluation and assessment of LS and LP remain uncertain. This study aims to assess and evaluate the risk of LS and LP associated with the use of ICIs via a systematic review of the literature and the USA FDA Adverse Events FAERS database. METHOD: The study searched electronic databases such as PubMed, Medline, Cochrane, and Google Scholar for case reports on immune-checkpoint-inhibitor-associated lichen sclerosus and lichen planus published in English between inception and 31 December 2021. The FDA's adverse event reporting system (FAERS) database was also analyzed. RESULTS: Thirty-eight case reports and two retrospective studies with a total of 101 patients, in addition to the FAERS data, were evaluated. More cases involved lichen planus (78.9%) than lichen sclerosis (21%). Nivolumab and pembrolizumab were most frequently reported with LS and LP, among other ICIs. Thirty-six out of thirty-eight patients with LS or LP experienced complete remission, while two patients experienced partial remission. Most of the cases had an excellent response to corticosteroids (92.1%), while the remainder had moderate (5.2%) and poor (2.6%) responses. Additionally, the reporting odds ratio (ROR) of the FAERS database indicated a favorable association for ICIs, the risk of LP, and LS. A stronger association was uniquely found between nivolumab and pembrolizumab. CONCLUSION: There have been published case reports for these adverse events. Healthcare providers should be aware of the possibility of lichen sclerosis and lichen planus developing in patients receiving ICIs which could necessitate hospitalization or discontinuation. Regulatory agencies are advised to monitor the risks as a potential safety signal.

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.

What Is the Current State of Awareness, Knowledge, and Attitudes Toward Breast Cancer? A Cross-Sectional Survey Among Health and Non-health College Students.

Objective: To document breast cancer (BC) knowledge, awareness, and attitudes among female undergraduate students studying at health and non-health colleges. Methods: A 3-month cross-sectional study was conducted among female undergraduate students studying at health and non-health subject colleges affiliated to a public university. Convenience sampling was employed, and a previously validated questionnaire available in English and Arabic languages was used. Multiple linear regression was used to report the predictors of BC knowledge. A two-tailed p-value of < 0.05 was considered significant. The study was approved by an ethics committee. Results: A total of 506 responses were analyzed. The mean knowledge score was 13.98 ± 4.1. The findings of the surveyed students suggested that more than 55% of the students had an acceptable level of knowledge. By education sector, approximately 70% and 40% of health and non-health college students, respectively, had an acceptable level of knowledge. The mean difference in knowledge scores between students of health and non-health colleges was significant (p < 0.001) as students at health colleges had a higher score. Age, college type and the presence of the disease in family/relatives were significant predictors of students' BC knowledge (p < 0.05). Conclusion: By comparing it with previous evidence, the knowledge of BC has improved. The role of awareness campaigns as an information medium for students from non-health backgrounds is greatly appreciated. Moreover, the internet and electronic media have emerged as new sources of information for non-health college students, and therefore, more efforts are needed to utilize this medium in empowering this student population in understanding of this disease.