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.

Exploring factors influencing patient activation in Saudi rheumatoid arthritis patients: A Nationwide Cross-Sectional Survey-Results from the COPARA study.

OBJECTIVES: To evaluate patient activation in rheumatoid arthritis (RA) patients using patient activation measure 13 (PAM-13) on a national level in Saudi Arabia. METHOD: A national survey was administered across multiple centers in Saudi Arabia. Patient activation was assessed using the PAM-13. The Compliance Questionnaire for Rheumatology (CQR) and the RA Impact of Disease (RAID) tool were also administered. The data from the survey were analyzed, and the results were stratified based on activation level. All factors affecting patient activation were explored and reported. RESULTS: A total of 1241 participants were included. Most of the patients were females (85%), the mean age was 47 (±14), and most patients lived in the central region (47%). The mean (±standard deviation) patient activation score was 578.7 (±13.0). Patient activation was affected by multiple factors: demographic characteristics, such as education, with a beta value of 1.11 (95% confidence interval [CI] 0.64 ̶1.58, p < .001). Higher CQR scores were associated with higher activation levels, with a beta value of 2.61 (95% CI 0.80 ̶4.44, p = .005), and higher RAID scores were associated with lower activation levels, with a beta value of 3.13 (95% CI 1.36 ̶4.91, p = .001). CONCLUSIONS: Patient activation was affected by several demographic characteristics and the impact of RA. A higher activation may improve compliance. Future longitudinal studies are required to confirm these findings and should explore the underlying mechanism of these effects.

Exploring Impact of Multidisciplinary Care on Patient Activation in Saudi Rheumatoid Arthritis Patients: A Cross-Sectional Survey-Extended Results from the COPARA National Project.

Introduction: Multidisciplinary setting in healthcare provide positive patient outcomes. Objective: To evaluate the impact of specialized rheumatology clinics (multidisciplinary settings) on the activation and engagement of rheumatoid arthritis (RA) patients. Material and Methods: This cross-sectional survey assessed patient activation using the patient activation measure-13. Participants attending Specialized Rheumatology Clinics (SRC multidisciplinary clinics) were compared with age- and sex-matched patients attending Standard of Care (SOC). The study was observational in nature, assessing several demographic and therapeutic options and their relation to the clinical setting and patient activation. Results: This study included 117 SRC matched RA patients with 117 SOC. The majority of the included patients were female (n=211, 90.2%), >40 years of age (n=177, 75.6%), and had intermediate-to-high education (n=147, 62.8%). Patients in the SRC were also more likely to have activation levels 3 and 4 with an odds ratio of 3.194 (95% confidence interval [CI] 1.835-5.562, p<0.001). In addition, SRC participants were more likely to be in levels 3 and 4 activation, even after adjustment for confounding variables, with an adjusted odds ratio of 2.401 (95% CI 1.121-4.758, p=0.012) and 2.175 (95% CI 1.127-4.196, p=0.020), respectively. Conclusion: Establishing SRC for RA patients seems to have a positive impact on patient activation and engagement and adds to the previously explored benefits of multidisciplinary care in chronic disease management.

Comparison of medical documentation between pharmacist-led anticoagulation clinics and physician-led anticoagulation clinics: A retrospective study.

Background and objectives: High-quality documentation is critical in medical settings for providing safe patient care. This study was done with the objective of assessing the standard of medical records in anticoagulation clinics and investigating the distinctions between notes written by pharmacists and physicians. Methods: A retrospective cross-sectional analysis of data from electronic health records (EHRs) was performed on patients who received anticoagulation and were observed at anticoagulation clinics from October to December 2020. Patients were monitored in two anticoagulation clinics, one administered by pharmacists and the other by physicians. The quality of the documentation was assessed using a score, and the note was assigned one of five categories according to its score: very good, good, average, poor, and very poor. The data was analyzed using Stata/SE 13.1. P value<0.05 was considered significant in all analytical tests. Results: A total of 331 patients were included. While 160 patients (48.3%) were followed by the physician-led clinic, 171 (51.6%) were by the pharmacist-led clinic. The average age of the patients was 54 ± 15. 60.73% of them were female, and 90.3% of them were Saudi nationals. Warfarin was the most widely used anticoagulant (70%), followed by rivaroxaban (15.7%). Compared to physicians, pharmacists demonstrated very strong documentation (54% vs. 18%). The examination of the variables considered in the study revealed that physicians had significantly less drug-drug interaction documentation (17 vs. 71 times) or drug-food interaction documentation (23 vs. 71 times) than pharmacists. In terms of follow-up frequency, pharmacists were found to adhere to the clinic protocol (150 times) more frequently than physicians (104 times). However, there was no significant difference in therapeutic plan documentation between the two groups. (p = 0.416). Conclusion: Pharmacists were more comprehensive in their documentation than physicians in anticoagulation clinics. Unified clinic documentation can ensure consistent documentation within EHRs across all disciplines.

The Patient Activation Measure in Patients with Rheumatoid Arthritis: A Systematic Review and Cross-Sectional Interview-Based Survey.

Introduction/Objective: The patient activation measure (PAM) is considered a reliable tool for measuring patient activation. This study aimed to systematically review the scientific literature regarding the use of PAM -13 in rheumatology patients and to compare PAM scores in patients with rheumatoid arthritis (RA) following two different practices at a single institution with previously published studies. Methods: The study consisted of a systematic review of articles reporting the PAM-13 in patients with RA, followed by a cross-sectional study evaluating PAM scores between standard rheumatology clinics and specialized rheumatology clinics (SRCs). The correlation between PAM levels and other variables, such as demographics, disease characteristics, and treatment, was assessed. Results: Nineteen studies, published between 2012 and 2022, met the inclusion criteria. The studies in this review had inconsistent results and quality, with patient activation in RA ranging from 29 to 76. A total of 197 patients with confirmed RA diagnoses were interviewed (response rate, 88%). Most were female (n=173, 88%) and older than 40 years (n=150, 76%). The average patient activation score was 64.9 (standard deviation, 15.7). Most participants had level 3 and 4 patient activation measures (n=71 [36%] and n=72[37%], respectively). Patients who were attending SRCs also had borderline higher PAM levels. Patients with high PAM scores tended to be older, have active disease, and were taking corticosteroids. Conclusion: Adequate activation of patients was observed from our center, which was higher than that reported in most published literature. The PAM of patients with RA was variable according to the systematic review. Longitudinal interventional studies should be considered to improve activation in patients with low scores.

Exploring Factors Influencing Medication Compliance in Saudi Rheumatoid Arthritis Patients: A Nationwide Cross-Sectional Survey - Results from the COPARA Study.

Purpose: Compliance is essential to achieve treatment goals in rheumatoid arthritis (RA) patients. The current study evaluated compliance and related factors in a large and diverse population. Patients and Methods: Patients with RA who received active treatment were invited to participate in an online survey. The Arabic versions of the 5-Item Compliance Questionnaire for Rheumatology (ACQR-5) and the RA Impact of Disease (RAID) were used to measure compliance and disability, respectively. The patients were sub-grouped based on background disease-modifying anti-rheumatic drugs (DMARDs). Variables associated with high compliance were selected for the logistic regression analysis. Results: A total of 1241 patients completed the survey and were included in the final analysis. Of those, 1055 (85%) were females with a mean (±SD) age and disease duration of 47.14 ± 13.71 and 8.77 ± 7.43 years, respectively. The mean RAID was 4.4±2.58, with 980 (79%) having an unacceptable level state. Patients with an unacceptable RAID level had a lower compliance rate (78.8% vs 85.8%, p = 0.001). Demographics associated with high compliance were female sex and increased age, with reported odds ratios of 1.018 (95% CI: 1.007-1.028) and 1.464 (95% CI: 1.016-2.108), respectively. Compliance was similar between patients on Janus kinase inhibitors or biological DMARDs (88.14% vs 80.83%, p = 0.17), between monotherapy, double therapy, or triple therapy recipients (80% vs 82.23% vs 81.32%, p = 0.665), and between patients receiving injectable and oral therapy (77.32% vs 81.14%, p = 0.246). Conclusion: A high compliance level was observed in this population, with patient demographics influencing compliance rather than the medication type or route of administration. Interventional studies should focus on the of high-risk patients identified in this study.

Examining bedtime procrastination, study engagement, and studyholism in undergraduate students, and their association with insomnia.

Introduction: Compulsive overstudying, known as studyholism, is an emerging behavioral addiction. In this study, we examine the prevalence of, and the relationships between, insomnia, study engagement, studyholism, bedtime procrastination among undergraduate students. Methods: The Studyholism (SI-10), Athens Insomnia (AIS), and bedtime procrastination scales were administered to a convenience sample of 495 university students. Results: Our findings indicate that the prevalence of insomnia was 75.31%, high studyholism was found in 15.31% of the sample, and increased study engagement was detected in 16.94%. Gender differences analysis revealed that females reported higher studyholism and bedtime procrastination than males. Fifth-year students had higher levels of studyholism than internship (p < 0.001), first-year (p < 0.01), and sixth-year students (p < 0.05). Insomnia was positively related to studyholism and bedtime procrastination. Furthermore, insomnia can be positively predicted by studyholism and bedtime procrastination. Participants with a medium level of studyholism were twice as likely to experience insomnia as those with a low level. Studyholics were six times more susceptible to insomnia than students with low studyholism levels. Compared to individuals with low bedtime procrastination levels, those with medium and high bedtime procrastination were twice as likely to report insomnia. Conclusion: Our study highlights the interplay between insomnia, studyholism, and bedtime procrastination. Further, the findings indicate the need to increase awareness of insomnia.

Categorizing and understanding medication errors in hospital pharmacy in relation to human factors.

BACKGROUND: Medication errors (MEs) in hospital settings are attributed to various factors including the human factors. Human factors researches are aiming to implement the knowledge regarding human nature and their interaction with surrounding equipment and environment to design efficient and safe systems. Human Factors Frameworks (HFF) developed awareness regarding main system's components that influence healthcare system and patients' safety. An in-depth evaluation of human factors contributing to medication errors in the hospital pharmacy is crucial to prevent such errors. OBJECTIVE: This study, therefore, aims to identify and categorize the human factors of MEs in hospital pharmacy using the Human Factors Framework (HFF). METHOD: A qualitative study conducted in King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. Data collection was carried out in two stages; the first stage was the semi-structured interview with the pharmacist or technician involved in the medication error. Then, occupational burnout and personal fatigue scores of participants were assessed. Data analysis was done using thematic analysis. RESULTS: A total of 19 interviews were done with pharmacists and technicians. Themes were categorized using HFF into five categories; individual, organization and management, task, work, and team factors. Examples of these themes are poor staff competency, insufficient staff support, Lack of standardization, workload, and prescriber behaviour respectively. Scores of fatigue, work disengagement, and emotional exhaustion are correlating with medium fatigue, high work disengagement, and high emotional exhaustion, respectively. CONCLUSIONS: The study provided a unique insight into the contributing factors to MEs in the hospital pharmacy. Emotional stress, lack of motivation, high workload, poor communication, and missed patient information on the information system, are examples of the human factors contributing to medication errors. Our study found that among those factors, organizational factors had a major contribution to medication safety and staff wellbeing.

Medication safety problems priorities in community pharmacy in Saudi Arabia: a multi-stakeholder Delphi study using the human factors framework.

AIM: To achieve multi-stakeholder consensus and prioritisation of medication safety problems in community pharmacies in Saudi Arabia. DESIGN AND INTERVENTION: A theoretically-underpinned, three-round Delphi study. SETTING: Saudi Arabia. PARTICIPANTS: Patients and public (pharmacy users), pharmacy-related professionals (policymakers, academics, medication safety officers and pharmacy owners) and community pharmacists. METHODS: Round 1 comprised 84 statements derived from a qualitative study. The items were grouped according to the Human Factors Framework (HFF). Rounds 1 and 2 aimed to achieve consensus, 6-point Likert response scale (agreement/disagreement) was used. Round 3 aimed to prioritise the items for which consensus was achieved in Rounds 1 and 2 indicated on a 5-point scale (very important to unimportant). Consensus was predefined as any item that achieved ≥70%. RESULTS: The number of respondents in Rounds 1, 2 and 3 was 161, 120 and 112, respectively. In all three rounds, the majority of respondents were pharmacy users (Round 1 77% (n=124), Round 2 74% (n=89), Round 3 72% (n=81)). Consensus was achieved with 28/84 items. The top five medication safety priorities were: lack of pharmacy facilities such as counselling area, lack of communication between pharmacists and physicians, lack of patient databases, lack of post-registration pharmacist education and pharmacists' long working hours. The professional and pharmacy user groups achieved consensus on similar items through different categories of the HFFs. Community pharmacists had the highest percentage of consensus among the three groups for factors related to work, such as high workload and low salaries. CONCLUSION: This multi-stakeholder study used the HFF to identify and prioritise the main medication safety challenges facing community pharmacy in Saudi Arabia. It indicates the need for changes to practice and policy and further research to address these priorities and promote medication safety at an individual, pharmacy and population level.

Using the Human Factors Framework to understand the origins of medication safety problems in community pharmacy: A qualitative study.

BACKGROUND: Community pharmacy practice in the Kingdom of Saudi Arabia (KSA) faces many challenges. In KSA, there is a lack of empirical research about medication safety in this setting. OBJECTIVE: To explore the safety problems associated with medication supply from community pharmacies in KSA and compare different stakeholder perspectives. METHODS: Four focus groups and individual interviews were conducted in Riyadh, KSA, in February-May 2013. All group discussions were recorded, transcribed and translated from Arabic into English, except the professional group, which was conducted in English. Thematic analysis was performed using the Human Factors Framework (HFF). RESULTS: The groups comprised "professionals" (n = 8; one female), community pharmacists (n = 4; all male) and two pharmacy user groups (females, n = 11 and males, n = 8). Medication safety problems identified were categorised into nine categories representing the HFF. Seven main themes were identified from these categories: commercial pressure on community pharmacy; illegal supply of prescription medication; lack of enforcement of regulations; the healthcare system; self-medication; patient trust in pharmacists: and communication failure. Themes that emerged only from the "professionals" and community pharmacists were the different role of the regulatory organisations and the reasons behind lack of enforcement, while the community pharmacist group focused on the relationship between owners and managers. Pharmacy users expressed a need for information about medication and that the primary role of the pharmacist should be as an information provider. Furthermore, they perceived pharmacists to be vendors rather than healthcare professionals. CONCLUSION: Many medication safety problems were identified, attributable to individuals (patient, pharmacist), pharmacy and organisational factors. These results will be used to develop interventions to improve medication safety.