Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study.

Investigating pharmacovigilance (PV) practices among oncology healthcare providers (HCPs) is crucial for patient safety in oncology settings. This study aimed to assess the awareness, attitudes, and practices towards PV and identify barriers to effective adverse drug reaction (ADR) reporting for HCPs working in oncology-related settings. Employing a cross-sectional survey design, we collected data from 65 HCPs, focusing on their experiences with ADR reporting, education on ADR management, and familiarity with PV protocols. The results showed that about half of the responders were pharmacists. Around 58.9% of the respondents reported ADRs internally, and 76.9% had received some form of ADR-related education. However, only 38.5% were aware of formal ADR review procedures. Methotrexate and paclitaxel emerged as the drugs most frequently associated with ADRs. The complexity of cancer treatments was among the common reasons for the low reporting of ADRs by the study participants. The findings highlight the need for enhanced PV education and standardized reporting mechanisms to improve oncology care. We conclude that reinforcing PV training and streamlining ADR-reporting processes are critical to optimizing patient outcomes and safety in oncology, advocating for targeted educational interventions and the development of unified PV guidelines.

Evaluation of factors affecting pharmacists and pharmacy technicians' satisfaction towards practicing CE activities in Saudi Arabia.

Background: Continuing education (CE) is an essential requirement for pharmacy professionals to stay abreast with the evolving knowledge and skills of the practice and meet the regulatory mandate. The purpose of this research is to assess factors affecting the satisfaction of pharmacists and pharmacy technicians towards CE practices in Saudi Arabia. Material and methods: A self-administered survey instrument was developed following an extensive literature search. The questionnaire consisted of three sections: participants' demographics, data on CE activities over the past year and overall satisfaction, and statements of barriers (14 items) and facilitators (12 items) for participation in CE activities (scored on a 5-point Likert scale (5 = always, 1 = never)). The survey was piloted and then distributed as a link through the Saudi Commission for Health Specialties and Saudi Pharmaceutical Society (SPS) between Jan 2018 and Feb 2019. Results: Data was available on 398 pharmacists and 40 pharmacy technicians (completion rate was 55 %). The majority were practitioners, male, working in a hospital setting and had more than five years of practice experience. Half of the participants were from the Central Region and about one-third were non-Saudi. Only a quarter of the participants were satisfied/very satisfied with the current CE practices in Saudi Arabia. Job constraints (62.7 %), cost (55.9 %), schedule of CE activities (55.4 %), lack of information on CE opportunities (53 %) and professional burnout (49.7 %) were the top barriers. There was a significant level of dissatisfaction among pharmacy technicians when compared to pharmacists (p = 0.003), as well as among Saudi pharmacists when compared to non-Saudi pharmacists (p = 0.002). Lack of relevant CE activities (p = 0.05), lack of quality activities (p = 0.002), lack of recognition (p = 0.013) and lack of internet access (p = 0.006) were significantly more barriers for pharmacy technicians compared to pharmacists. The most identified facilitators to engage in CE activities were a personal desire to learn (78.4 %), the requirement to maintain a professional license (73.8 %) and relaxation provided by learning (58.5 %) and networking opportunities (53.4 %). The majority of the participants preferred conferences or interactive workshops, short CE over half a day or less, and the topic of disease management/drug therapy. Conclusion: The findings of the study highlight the need for a partnership strategy that includes various stakeholders to improve CE program quality and accessibility that supports and promotes the professional development of pharmacists and pharmacy technicians in Saudi Arabia. It also underscores the importance of meeting the preferences of pharmacy practitioners when designing CE programs and aligning such activities with their practices.

Impact of Educational Intervention on Compliance of Health Care Workers Towards Chemotherapy Handling Guidelines.

Background: Chemotherapy safety guidelines have been enacted to minimize their side effects on healthcare providers when handling medications. The aim of this study is to assess the impact of an educational intervention on healthcare workers' compliance with chemotherapy safety guidelines. Methods: In this study, we used a quasi-experimental, pre-post testing design. It was conducted in the Oncology center at King Saud University Medical City (KSUMC) in Riyadh, Saudi Arabia. All healthcare workers involved in the preparation and administration of chemotherapy medications in KSUMC were invited. We evaluated Educational intervention to ensure the compliance of healthcare workers with standard safety guidelines through a questionnaire with 29 questions in total. Results: Fifty-two participants were eligible in this study. Overall, the score for mean compliance with workplace guidelines among the participants increased from 17.62∓0.78 to 18.17∓0.80 out of 19. Multiple liner regression indicates that there are no variables among the included variables predicting a change in post-intervention. Conclusion: This study indicates that educational intervention is the only effect of compliance in the included sample. Education safety training could improve healthcare workers' knowledge and consequently improve their compliance in the preparation and administration of chemotherapy medication.

Assessing Nontechnical Skills in Senior Pharmacy Students Using an Innovative Simulation Setting.

OBJECTIVES: To evaluate pharmacy students' nontechnical skills in a simulated session by assessing their teamwork skills and ability to identify patient safety priorities. METHODS: This study involved 2 phases. Phase I was a simulated case with a total of 23 errors. Students were divided into groups and instructed to identify errors in the setting. Teamwork skills were assessed using the Individual Teamwork Observation and Feedback Tool. Phase II was a debriefing and reflection session. Quantitative data were generated using the number of errors and Individual Teamwork Observation and Feedback Tool domain scores, while qualitative data were obtained using thematic analysis. RESULTS: The study participants were 78 female PharmD students who were divided into 26 groups. The average number of errors identified was 8 (range: 4-13), and the most identified error was using the wrong drug (96%). The teamwork skills displayed by most groups were shared decision-making, participating in discussions, and demonstrating respect and leadership in ways that were sensitive to the needs of the team. The students described the activity as fun and novel as it encouraged them to be more detail oriented. CONCLUSION: The designed simulation setting is an innovative tool to assess students' understanding of patient safety priorities and teamwork skills.

Health-Related Quality of Life in Women With Breast Cancer Undergoing Treatment With Hormonal Therapy - A Review Study.

This review aimed to analyze the significance and impact of health-related quality of life (QoL) in women with breast cancer undergoing treatment with hormonal therapy. This study developed a comprehensive, structured, systematic search strategy to identify literature related to health and QoL in breast cancer patients undergoing treatment with hormonal therapy. The search was conducted for published literature indexed in PubMed (Medline), Cancer Lit, CINAHL, Google Scholar, and Web of Science between 2010 and 2020. Patients associated with the study of QoL reported some difficulties in terms of depression, anxiety, chronic fatigue, sleep problems, pain, sexual dysfunction and sleep disorders. Endocrine-related symptoms did not fluctuate between interventions and remained unchanged in all groups. The evaluation of FACT-G scores (physical well-being subscale) showed statistically significant differences among participants receiving anastrozole versus tamoxifen and exemestane. It can be concluded that the QoL of postmenopausal women with breast cancer is affected by the long-term use of adjuvant endocrine therapy, with difference reported associated with the different therapies. However, further efforts are required to improve QoL instruments and the quantitative evaluation of QoL data for patients receiving adjuvant ET.

The prevalence of drug-drug interactions in cancer therapy and the clinical outcomes.

BACKGROUND: When a patient concomitantly uses two or more drugs, a drug-drug interaction (DDI) may occur, and patients with cancer are at high risk of DDIs because they commonly receive multiple medications. However, data on the prevalence of DDIs are scarce, especially in Saudi Arabia. OBJECTIVE: Our aim was to evaluate the occurrence of DDIs in patients with cancer and identify risk factors for these DDIs and the clinical outcomes. METHOD: A retrospective cross-sectional study was conducted in KFMC. Data were collected from the medical records and phone calls, and the patient's drugs were screened for interactions using Micromedex and Lexi-Comp. The data were statistically analysed using IBM SPSS version 24 statistical program. RESULTS: In 72 patients (mean age of 47 years; 11 medications), the prevalence of DDIs was 60 %, and 2 potential DDIs were identified. According to Lexi-Comp, 137 (51.8 %) were categorized as pharmacodynamics interactions. In Micromedex, 94 potential DDIs were identified, 68.1 % were categorized as pharmacokinetic interactions, the comparison between the interaction of Lexi-Comp and Micromedex for 9 drugs. Eight drug pairs showed statistically significant difference in category of interaction (P < 0.05). Six pair of drugs showed statistically significant difference in mechanism of action (p < 0.05). Number of drugs was reported as significant risk factor (p = 0.007), type of treatment such as chemotherapy (p = 0.0000) and inpatient admission in terms of length of stay in hospital was also found significant risk factor (p = 0.031). CONCLUSION: To prevent DDIs, Physicians and pharmacists should be more aware of these potential interactions to prevent DDIs.

Assessing System Thinking in Senior Pharmacy Students Using the Innovative "Horror Room" Simulation Setting: A Cross-Sectional Survey of a Non-Technical Skill.

System thinking is an important competency for all healthcare professionals as it is a required skill to provide safe patient care. However, the literature does not describe how students gain such a skill or the manner in which it is assessed. Purpose: This study aimed to assess pharmacy students' non-technical skills in the form of system thinking and error detection in a simulated setting. Results were correlated with the number of errors students were able to identify in a team-based simulation activity called the "horror room." Patients and methods: A cross-sectional survey was administered after completion of the "horror room" simulation activity to identify elements of system thinking and error detection. Survey respondents were senior students enrolled in a patient safety course. System thinking elements identified in the survey were then linked to the number of errors reported. Results: Sixty-six students participated in the activity. Their mean grade point average (GPA) was 4.72 (standard deviation (SD) 0.22), and the mean number of errors detected was 8 (SD 2). The average total system thinking score (STS) was 68 (SD 8.4). There was no association between the number of errors detected and STS; however, a positive association was found between GPA and STS (Spearman's correlation coefficient = 0.27, p = 0.030). The most common type of error detected was a medication safety error (100%). Conclusions: High STS showed that teaching theory is important for students to learn concepts; however, knowing the ideas associated with system thinking does not necessarily translate into practice, as evidenced by the low number of errors students were able to detect.

Evaluation and pharmacists perspective of repeat prescribing process in refill clinics.

INTRODUCTION: Repeat prescription refers to a re-prescribed medications list issued by a refill clinic, commonly for stable chronic illnesses. The issues regarding repeat prescriptions have garnered increasing important in recent years, as no general agreement about a standardized protocol exists between organizations. Due to the importance of pharmacists' involvement and intervention in the process of repeat prescription and the lack of local studies discussing this topic, the aim of this study was to assess pharmacists' perspectives toward the repeat prescription process and identify the issues related to repeat prescriptions in refill clinics at tertiary hospitals. METHODOLOGY: A self-developed questionnaire was used to assess outpatient pharmacists' perspectives toward the repeat prescription process. This was followed by a comprehensive review of the electronic health records (EHR) of patients who requested repeat prescriptions to identify related issues. The study was conducted at a tertiary teaching hospital from September 2019 to January 2020. RESULTS: Based on the questionnaire, 34 pharmacists reported receiving less than 10 repeat prescriptions per week (82.35%); nevertheless, around 88.24% of pharmacists have faced issues with the repeat prescription process, and only 15.65% of the issues got resolved. Most of the pharmacists (88.24%) showed a proactive attitude toward modifying the work process to reduce issues. Further, the review of the patients' EHR identified 1766 prescriptions with related issues in 617 (14.02%) patients' profiles. Most of these issues were seen in the elderly (46.7%). The most common issue encountered was "Patients came too early to request," which accounted for 986 (55.8%) of the total issues, followed by the issue of "Refilling a restricted medication" reported at 247 (14%). Only 11% of these issues were completely resolved by pharmacists. CONCLUSION: The repeat prescription service might be associated with issues that lead to preventable adverse effects, especially among the elderly who are prone to such effects. Comprehensive reviews of patients' profiles are necessary to assess their needs and avoid such issues.

Cancer Impacts on Out-of-Pocket Expenses, Income Loss, and Informal (Unpaid) Care: A Cross-Sectional Study of Patient Perspective.

A paper-based questionnaire was used to measure out-of-pocket expenses, income loss, and informal (unpaid) care from the cancer patient's perspective. A total of 181 adult solid cancer patients on chemotherapy for at least 3 months were recruited from 1 teaching hospital in Riyadh, Saudi Arabia. The majority were female (66%) and 41% were 60 years of age or older. A total of 107 respondents used their own car for transport to and from the hospital to receive chemotherapy (median distance 42 km). Over the last 4 weeks, 21% purchased medications, 18% visited a physician, and 8% visited a physiotherapist, spending a median amount of $47, $220, and $793, respectively. A total of 47 participants were employed at the time of their cancer diagnoses, and 32% of them reported some loss of income. A total of 85% of respondents were escorted by a carer during chemotherapy sessions. Approximately 64%, 31%, 61%, 43%, and 28% reported getting help from a carer for housework, child care, shopping, medicine taking, and personal care, respectively. The carer spent on average 50 h per week looking after the patient.

Assessment of knowledge among caregivers of diabetic patients in insulin dosage regimen and administration.

BACKGROUND: Inadequate production of Insulin can lead to a complex metabolic disorder named Diabetes Mellitus that is characterized by hyperglycaemia. Diabetes is leading metabolic disease that causes major disability and increased death-rate world-wide. Diabetes can cause neuropathy, blindness, ischaemic heart disease, peripheral vascular disease, increased risk of stroke, and renal diseases. Since the management of diabetes mellitus is complex, the reliance of some patients on their caregivers has increased. In this study, a caregiver is a family member or a paid helper who is willing to provide long-term assistance to a child, an older adult, or a person with a disability. AIM: The knowledge of caregivers about insulin doses (administration and adjustment) is determined and to study the correlation between the demographic data (age, gender, and marital status) and the knowledge of caregivers. METHODOLOGY: This is a cross sectional type of descriptive study. A questionnaire was built based on literature review and was reviewed and validated by 17 arbitrators and modified accordingly. A pilot study was performed on 5 people of the targeted population to assess the feasibility, duration, and clarity of the data collection tool. The questionnaire was distributed online and had some extra questions to exclude non-relevant responses. RESULTS: A total of 819 participants filled the online questionnaire. Out of these, 83.6% were female and 16.4% were male. The good knowledge was significantly associated with caregivers who had patients diagnosed with diabetes since less than 6 months when compared with others. CONCLUSION: Caregivers who reported that they do not live with the healthcare receiver had less knowledge compared with those they live, and it is statically significant association. 55% were satisfied with their level of knowledge about insulin doses management. This study indicates who lives with patient has caregiver's knowledge on inulin dosages administration 1.766 times from who don't have.

Cardiotoxicity and Cardiac Monitoring Among Anthracycline-Treated Cancer Patients: A Retrospective Cohort Study.

PURPOSE: Cardiotoxicity is a common complication associated with anthracyclines. Little is known regarding the rate of anthracyclines-related acute and chronic cardiotoxicity and adherence to cardiac monitoring recommendations among cancer patients. PATIENTS AND METHODS: A single-centre retrospective cohort study was conducted from 2015 to 2018 on patients with cancer, 18 years of age and older, on anthracyclines without a history of cardiovascular diseases. Data on demographic information, comorbidities, cardiovascular events, monitoring parameters, and treatment details were obtained. The primary outcome was the incidence of anthracyclines-related cardiotoxicity both acute and chronic. The secondary outcome was to determine adherence to guideline recommendations for monitoring anthracyclines-related cardiotoxicity based on the American Society of Clinical Oncology clinical practice guidelines. Analyses included descriptive statistics and logistic regression. Institutional review board approval was obtained. RESULTS: In 235 patients identified, 28.9% developed cardiotoxicity, of which 27.2% were acute, while chronic cardiotoxicity was observed in 8.9% of subjects. Patients who received optimal cardiac monitoring had a statistically significant higher odds of developing cardiotoxicities (odds ratio=2.65, confidence interval=1.32-5.33). The risk of cardiotoxicity was higher in subjects with a history of diabetes mellitus, those using daunorubicin, and concomitant filgrastim use. Adherence to guideline recommendations was only achieved in 25.1% of the population. Echocardiography was the most common monitoring method used. CONCLUSION: In this study, there was a high incidence of anthracyclines cardiotoxicity and poor compliance with cardiac monitoring recommendations for cancer patients on anthracyclines, which underscores acute and chronic cardiotoxicity in this population.

Risk Factors Associated with Methotrexate Intolerance in Rheumatoid Arthritis Patients.

BACKGROUND: Methotrexate (MTX) Intolerance Severity Score (MISS) has been previously validated in the Arabic language and has helped to detect high levels of intolerance in rheumatoid arthritis (RA) patients. The aim of the current study was to evaluate patient and disease characteristics associated with a high risk of MTX intolerance. MATERIALS AND METHODS: A cross-sectional interview-based survey was conducted using adult RA patients as a study group, who were visiting a specialized rheumatology clinic at King Saud University Medical City. The Arabic MISS was used in this survey. Statistical analyses were performed to understand associations between MTX-intolerant and MTX-tolerant patients. RESULTS: A total of 117 patients were involved in this study. Of those, 101 (86.3%) were females with a mean (SD) disease duration of 6.6 (5.7) years. The median (interquartile range (IQR)) Disease Activity Score-28 (DAS28) was 3.6 (3.6-4.1). MTX intolerance was observed in 55 (47%) patients. The most predominant component in patients with a positive test was the behavioral component. Intolerant patients had a higher median of pain (47.3 vs. 50.0; P = 0.010) and patient global assessment (50.0 vs. 60.0; P = 0.004) scales compared to those in tolerant patients. Additionally, MTX intolerance was associated with the female gender (adjusted odds ratio (AOR) 6.724; 95% CI 1.420, 31.843, P = 0.016), marital status (AOR 2.549; 95% CI 1.037, 6.270, P = 0.042) and DAS28 (AOR 1.612; 95% CI 1.032, 2.517, P = 0.036). There was no significant difference between the two groups in the remaining disease activity parameters, background therapies, seropositivity, and smoking status (P > 0.05). CONCLUSION: Patient characteristics, rather than disease activity, significantly impact MTX intolerance. Behavioral component is the main driver of intolerance. Intolerant patients have higher patient-reported outcomes. Qualitative studies are needed to explore causes and potential solutions to MTX intolerance.

Evaluation Breast Cancer Information on The Internet in Arabic.

Nowadays, medical information regarding various diseases and disorders is available online. The Internet has become the first choice for the patient when it comes to gathering detailed information about a disease or problem. Therefore, in view of this frequent occurrence, the information that is provided online needs to be accurate; providing comprehensive facts, transparency, and quality. A study was carried out to determine the accuracy of information related to breast cancer on various websites. Websites which share information online about breast cancer, in the Arabic language, were selected. The quality of the websites was to be evaluated; however, there is no standard method for evaluating the quality of health websites. Hence, a rating form was developed for this study, to determine the completeness and transparency of a specific number of websites using three popular search engines. A 16-item questionnaire was prepared and validated to determine the quality of individual websites in addition to using the DISCERN instrument for assessing consumer health information. Most of the websites (approximately 47%) were deemed to be commercial in nature. Thirty-three percent were developed by non-profit organizations. They disseminated information concerning the risk factors (93%), screening, mammography (93%), surgical treatment (93%), chemotherapy (89%), radiotherapy (93%), and complementary medicine (0%) surrounding the treatment of breast cancer. About 67% of the websites were estimated to give completely correct information. Incidentally, only five websites had a healthcare professional or expert as the author, while nine of them had no author. Although numerous breast cancer-related websites exist, most do a poor job in providing Arabic-speaking women with comprehensive information about breast cancer surgery. Providing easily-accessible, high-quality online information has the potential to significantly improve patients' experiences.

Therapeutic drug monitoring of cancer chemotherapy.

Therapeutic drug monitoring is not routinely used for chemotherapy agents. There are Several reasons, but one major drawback is the lack of established therapeutic Concentration ranges. Combination chemotherapy makes the establishment of Therapeutic ranges for individual drugs difficult, the concentration-effect relationship for a single drug may not be the same as when that drug is used in a drug combination. Pharmacokinetic optimization protocols for many classes of cytotoxic compounds exist in specialized centers, and some of these protocols are now part of large multicentre trials. Nonetheless, TDM clearly has the potential to improve the clinical use of chemotherapy gents, most of which have very narrow therapeutic indices and highly variable pharmacokinetics. A substantial body of literature accumulating during the past 15 years demonstrates relationships between systemic exposure to various chemotherapy agents and their toxic or therapeutic effects. This article reviews TDM concepts in addition to tools based on pharmacokinetic modeling of chemotherapy agents. The administered dose of chemotherapy agents is sometimes adjusted individually using either a priori or a posteriori methods. These models can only be applied by using the same dose and schedule as the original study. Bayesian estimation offers more flexibility in blood sampling times and, owing to its precision and to the amount of information provided is the method of choice for ensuring that a given patient benefits from the desired systemic exposure. Moreover, the role and application of Pharmacogenetics as a tool for individualizing chemotherapy is discussed highlighting the agents and mechanisms that have been well studied and defined and their relevance to clinical practice. Finally, this paper address issues critical to the optimal use of TDM in a clinical setting, and the role of clinical pharmacist in this regard. In addition, it discusses future developments in this field that can contribute to improving cancer chemotherapy In terms of patient outcome and survival.

Effects of fluconazole on the pharmacokinetics and pharmacodynamics of antimony in cutaneous leishmaniasis-infected hamsters.

Pentavalent antimony (Sb(V)) compounds are the drugs of choice for the treatment of all forms of leishmaniasis. For 20 years there has been an interest in antifungal azoles for treating leishmaniasis, with variable success. In the current study, we examined the effects of co-administration of fluconazole (FLZ) on the pharmacokinetics and pharmacodynamics of Sb(V) in cutaneous leishmaniasis-infected hamsters. Hamsters were divided into four groups. All hamsters were injected with 0.1 mL of 1x10(8)promastigotes/mL into the right foot on Day 1. Treatment was started 5 days after the infection. The antimony group received 80 mg/kg/day of Pentostam intramuscularly whilst the FLZ group received FLZ 20 mg/kg/day orally for 14 days. The combination group received both Pentostam and FLZ at the above mentioned doses for 14 days. Animals in the control group received no treatment. The infected footpads were measured on Days 1 and 14. A pharmacokinetic study was conducted on Days 1 and 14 of treatment, representing single- and multiple-dose pharmacokinetics, respectively. Blood samples were collected at different time intervals up to 24h. Sb(V) was determined using flameless atomic absorption spectrophotometry. Pharmacokinetic parameters were calculated using a non-compartmental analysis. In the single-dose study, there was no statistically significant difference in any of the pharmacokinetic parameters of Sb(V) when given alone or with FLZ. However, on Day 14 a significant increase in peak plasma concentration (C(max)) (three-fold) and area under the concentration-time curve (AUC) (four-fold) of antimony was observed when Sb(V) was co-administered with FLZ. A statistically significant prolongation of the terminal half-life from 1.63 to 8.67 h (P<0.05) was also observed. A significant reduction in clearance was detected. However, FLZ had no effect on the pharmacodynamics of Sb(V) as measured by footpad sizes. In conclusion, FLZ did not improve the therapeutic effect of Sb(V) when given concomitantly despite the significant increase in blood concentration and prolongation of the elimination half-life of Sb(V).