Cost effectiveness of rivaroxaban versus warfarin among nonvalvular atrial fibrillation patients in Saudi Arabia: A Single-Center retrospective cohort study.

Background: Rivaroxaban is a novel oral anticoagulant (NOAC) that is commonly used for stroke prevention among patients with atrial fibrillation (AF). However, its cost effectiveness in reducing the risk of hospitalization and mortality in comparison to warfarin among nonvalvular AF patients in Saudi Arabia is largely unknown. Methods: This was a single-center retrospective chart review of adult patients (≥18 years) with nonvalvular AF who were treated with warfarin or rivaroxaban for at least 12 months. Patients with mitral valve stenosis were excluded from the study. Multiple logistic regression was conducted to examine the risk of hospitalization and mortality as a composite outcome, and all annual healthcare costs were captured. Inverse probability treatment weighting with bootstrapping was conducted to determine the mean costs and effectiveness rates. Results: Two-hundred and twenty-six patients (142 on rivaroxaban and 84 on warfarin) met the inclusion criteria and were included in the analysis. Most of the patients were females (65.91 %), had diabetes (50.57 %) and hypertension (73.76 %), and with a mean age of 68.95 ± 12.55 years. No significant difference in the odds of the composite outcome for rivaroxaban versus warfarin was found (OR = 0.785, 95 % CI = [0.427-1.446], p = 0.443). Rivaroxaban resulted in a mean annual cost saving of $13,260.79 with an 87.65 % confidence level that it would be more effective than warfarin with a mean difference in effectiveness rate of 0.168 % (95 % CI [-5.210-18.36]). Conclusion: Rivaroxaban was associated with lower direct medical costs and non-inferior effectiveness among nonvalvular AF patients in comparison to warfarin.

The Impact of Patient Access to Their Electronic Health Record on Medication Management Safety: A Narrative Review.

Introduction: As the American's Federal Health Insurance Portability and Accountability Act (HIPAA) stated that patients should be allowed to review their medical records, and as information technology is ever more widely used by healthcare professionals and patients, providing patients with online access to their own medical records through a patient portal is becoming increasingly popular. Previous research has been done regarding the impact on the quality and safety of patients' care, rather than explicitly on medication safety, when providing those patients with access to their electronic health records (EHRs). Aim: This narrative review aims to summarise the results from previous studies on the impact on medication management safety concepts of adult patients accessing information contained in their own EHRs. Result: A total of 24 studies were included in this review. The most two commonly studied measures of safety in medication management were: (a) medication adherence and (b) patient-reported experience. Other measures, such as: discrepancies, medication errors, appropriateness and Adverse Drug Events (ADEs) were the least studied. Conclusion: The results suggest that providing patients with access to their EHRs can improve medication management safety. Patients pointed out improvements to the safety of their medications and perceived stronger medication control. The data from these studies lay the foundation for future research.

Identification and Characterization of Preventable Adverse Drug Events in Family Medicine Clinics from Central Saudi Arabia.

Background: Medication errors can result in adverse drug events (ADEs) and cause considerable patient harm. Limited data are available from Saudi Arabia and the Middle East regarding the prevalence of preventable adverse drug events (pADEs) in primary care settings. Objectives: To estimate the period prevalence of pADEs and assess the medication error severity in primary care setting in Saudi Arabia. Methods: This retrospective study is a continuation of a previous study where 117 of 2000 adult patients managed at the Family Medicine clinics of King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, were identified to have had least one medication error in the past 15 months. The electronic health records of these 117 patients were analyzed for a 3-month post-medication error period to explore the presence of pADE. Medication errors were categorized according to the National Coordinating Council for Medication Error Reporting and Prevention index (NCC MERP) and the occurrence of pADE was assessed using the NCC MERP scheme. Results: Of the included 117 patients, 9 (7.7% [95% confidence interval (CI): 2.79-12.59]) experienced pADE (Category E), while 108 (92.3% [95% CI: 87.97-98.35]) did not (Category C). All patients who experienced pADE were using over-the-counter medications and were on polypharmacy. Outcomes 2a and 2b (asthma and ß-blocker) accounted for two and four cases, respectively, while Outcomes 6 (warfarin and international normalized ratio), 7 (lithium and lithium level), 16 (new oral anti-coagulant or warfarin and antiplatelet), and 17 (acetylsalicylic acid [aspirin] and antiplatelet) each accounted for one case. Conclusions: This study provides the period prevalence of patients with pADEs from Family Medicine clinics at a major tertiary hospital of Saudi Arabia, and highlights the need for a multicenter study of clinically important medication errors at the prescribing and monitoring stages for the development of quality improvement programs.

Fibromyalgia Rapid Screening Tool (FiRST): Arabic Translation and Cross-Cultural Adaptation and Validation.

Background: Fibromyalgia (FM), a complex neurological disorder, has multiple consequences for the patient. To diagnose patients, healthcare practitioners use multiple diagnostic questionnaires. However, Arabic translated or validated tools are lacking. This study aimed to translate and validate the Fibromyalgia Rapid Screening Tool (FiRST) into the Arabic language. Methods: Forward and backward translations of the FiRST were conducted by two Arabic translators and two English-certified translators. The survey was piloted (n = 5) and subjected to cognitive interviews and psychometric analysis. Patients were recruited from a university hospital in Riyadh and an FM support group in Saudi Arabia. The internal consistency, factor analysis, and test-retest correlations were evaluated. Results: This study included 46 patients. The stepwise translation process resulted in minor edits related to the use of synonyms to the survey items. The translated survey had a good internal consistency and test-retest correlation, with a Cronbach's alpha of 0.7 and Pearson's correlation coefficient of 0.79 (p-value < 0.001), respectively. The survey was factorable into two themes: generalized symptoms and more specific sensations. Conclusions: The Arabic FiRST is a simple, valid, and reliable tool to diagnose patients with FM in different settings.

The Prevalence of High-Risk Prescribing of Oral Non-Steroidal Anti-Inflammatory Drugs in Primary Healthcare: A Single-Centre Retrospective Chart Review Study.

The quality and safety of prescribed drugs can be assessed using prescribing safety indicators (PSIs). This study aimed to estimate the prevalence of PSIs of oral non-steroidal anti-inflammatory drugs (NSAIDs) at primary care clinics of a tertiary care hospital in Saudi Arabia and to identify the risk factors associated with positive PSIs for patients. In this retrospective chart review study, data from the medical records of 450 patients aged ≥18 years, who were prescribed oral NSAIDs, were reviewed and collected manually. Seven PSIs were chosen and defined as follows: prescription of an oral NSAID to any patient with a peptic ulcer; aged ≥75 years; aged ≥65 years with a glomerular filtration rate <60; heart failure; co-prescribed warfarin; co-prescribed aspirin or clopidogrel; or co-prescribed angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker and a diuretic. Patients with positive indicators are at risk of harm from high-risk prescribing. The overall period prevalence of PSIs is 153/450 (34%; 95% CI 29.60−38.39). The overall proportion of PSIs is 202/431 (46.9%; 95% CI 42.12−51.61). The most common safety indicators were for NSAIDs prescribed to patients with heart failure and patients aged ≥65 years with a glomerular filtration rate <60. The elderly and patients using polypharmacy are at increased risk of having at least one positive PSI (OR 5.22; 95% CI 3.32−8.21, p-value < 0.001 and OR 2.97; 95% CI 1.17−7.55, p-value 0.022, respectively). Patients at risk of harm from high-risk NSAID prescriptions are common in primary care. The elderly and patients on polypharmacy are at increased risk of having at least one positive PSI. Therefore, when NSAIDs are prescribed, it is recommended to weigh the benefits versus the risks for high-risk patients, such as the elderly and those with multiple-drug therapy.

The Contraindications to Combined Oral Contraceptives among Reproductive-Aged Women in an Obstetrics and Gynaecology Clinic: A Single-Centre Cross-Sectional Study.

This study aimed to determine the estimated proportion of contraindications among women taking combined oral contraceptives (COCs) and to assess the risk factors associated with their contraindications. This study was cross-sectional. Reproductive-aged women (18-49 years) on any COCs between 2018 and 2020 were recruited from one obstetrics-gynaecology clinic in a university-affiliated hospital and were included. Contraindications were defined using the World Health Organization (WHO) Medical Eligibility Criteria (MEC) for Contraceptive Use. Data were collected from electronic medical records for all included women, as well as a standardised, pretested, structured survey for one-third of the women. In this cross-sectional study, 380 women using COCs were included. Their mean age was 31.645 ± 7.366 years. Among them, 131 (34.5%) participated via a survey and electronic records, while the other 249 (65.5%) participated via electronic records only. The majority of the participants had a Bachelor's degree (59.0%) and were married (62.1%). The overall estimated proportion of patients with at least one contraindication to COCs according to category 3 (relative contraindications) or 4 (absolute contraindications) was 31.3% (95% CI 26.63-35.99). The most common contraindications observed were controlled hypertension, category 3 (12.1%); major surgery with prolonged immobilisation, category 4 (4.7%); migraine with aura at any age, category 4 (4.2%); breastfeeding from six weeks to less than six months postpartum, category 3 (4.0%); and diabetes mellitus with complications, category 4 (3.2%). Significant factors associated with contraindications to COCs were married women (OR 2.19, 95% CI 1.38-3.46), those aged 35 years or more (OR 2.33, 95% CI 1.49-3.66), and those with one or more live births (OR 2.19, 95% CI 1.38-3.46). Ensuring proper assessment prior to prescribing and considering alternatives suitable for long-term use among women taking an oral contraceptive regularly is recommended.

Relationship of Body Adiposity with Platelet Function in Obese and Non-obese Individuals.

Background Adiposity is firmly linked to a higher incidence of various cardiovascular and metabolic morbidities, including diabetes, hypertension, and thromboembolism. This research study was aimed to verify the association of increased adiposity and hyperreactivity of platelets in obese and non-obese individuals. Methods This cross-sectional study was conducted on 42 subjects aged 18 years and above. Subjects were divided into obese and non-obese groups based on their body mass index (BMI). The data was collected through self-administered questionnaires. All participants underwent body composition analysis. Blood samples were collected from all subjects and taken to the Pharmacology Department for the preparation of platelet-rich plasma (PRP) and poor platelet plasma (PPP). Platelet aggregation was induced by arachidonic acid and was monitored with a Bio/Data multichannel aggregation profiler (Bio/Data Corp., Horsham, PA, USA). Results Significant differences were observed in most parameters, such as fat mass, body fat percentage, free fat mass (FFM), the percentage of trunk fat, total body water, waist-hip ratio (WHR), and basal metabolic rate (BMR) of obese and non-obese subjects. The average percent of platelet aggregation in obese and non-obese subjects was 56.33 ± 15.62 and 59.38 ± 12.62, respectively. The average area under the curve (AUC) for platelet aggregation for both groups was 339.33 ± 191.55 and 342 ± 146.68, respectively. Platelet function was not significantly different and didn't positively correlate with most parameters of the body composition, except WHR, which positively correlated with AUC for platelet function.  Conclusion There was no significant direct correlation between adiposity and platelet activation in obese subjects. However, a significant positive correlation of AUC for platelet aggregation with WHR was observed (resistance (r)-value: 0.307, p < 0.05). These findings suggest that WHR could be an effective determinant to assess the risk of thromboembolism in obese individuals.

The Impact of Direct-to-Consumer Pharmaceutical Advertising on Public Knowledge of Gastroesophageal Reflux Disease: A Study on Over-the-Counter Proton Pump Inhibitors.

BACKGROUND: The use of direct-to-consumer advertising (DTCA) to promote sales of over-the-counter (OTC) pharmaceuticals used to manage common medical conditions, such as gastroesophageal reflux disease (GERD), is increasing. However, the educational value of these advertisements as well as the public perceptions of this type of advertising remain largely unknown among non-English speaking populations. OBJECTIVE: The aim of this study was to explore the public perceptions and educational value of a short motion graphic video documenting the lifestyle of person with GERD and presenting a brief introduction to the role of proton pump Inhibitors (PPIs) in relieving the symptoms. METHODS: This was a prospective quasi-experimental study in which a short mock advertising motion graphic video was shown to a sample of adult individuals in malls and shopping centers in different cities across Saudi Arabia. Participants were required to express their levels of agreement with six statements concerning their perceptions of DTCA of OTC drugs, and answer a quiz consisting of three questions and enquiries about their knowledge of GERD and the OTC drugs used in its treatment. RESULTS: Two hundred and ninety-five participants were involved in this study, the majority of whom were female (55.30%). After watching the video, the percentages of participants who strongly agreed or agreed that DTCA is a credible source of information and encourages them to purchase the marketed drug have increased significantly (P<0.05). With regard to the quiz, the percentages of participants with correct answers regarding the definition of GERD, knowledge of OTC drugs for GERD, and awareness of the common side effects of PPIs increased from 81.69% to 95.93%, 69.83% to 96.27%, and 46.44% to 91.53%, respectively (P<0.0001). CONCLUSION: DTCA of OTC drugs for GERD, particularly if the content complies with the regulatory requirements, can promote the public knowledge of the disease and treatment options.

Investigating the epidemiology of medication errors in adults in community care settings. A retrospective cohort study in central Saudi Arabia.

OBJECTIVES: To investigate the period prevalence and risk factors for clinically important prescription and monitoring errors among adults managed in community care in Saudi Arabia (SA). METHODS: This retrospective cohort study used electronic health record (HER) data. A random sample comprising of 2,000 adults (≥18 years old) visiting Family Medicine clinics in King Faisal Specialist Hospital and Research Center (KFSH & RC), Riyadh, SA, was selected. Data collection took 3 months (October December 2017).  Descriptive analyses and logistic regression modeling were performed using STATA (version 14) statistical software. Results: The overall period prevalence of medication errors over 15 months was 8.1% (95% confidence interval [CI] 6.5-9.7). Risk factors that significantly predicted overall risk of patients experiencing one or more medication errors were: age ≥65 years, male gender, Saudi nationality, and polypharmacy (defined as the concurrent use of ≥5 drugs). CONCLUSIONS: Clinically important medication errors were commonly observed in relation to both drug prescription and monitoring.

What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of the international literature.

OBJECTIVE: To investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients' homes. DESIGN: Systematic review. DATA SOURCE: Six international databases were searched for publications between 1 January 2006 and 31 December 2015. DATA EXTRACTION AND ANALYSIS: Two researchers independently extracted data from eligible studies and assessed the quality of these using established instruments. Synthesis of data was informed by an appreciation of the medicines' management process and the conceptual framework from the International Classification for Patient Safety. RESULTS: 60 studies met the inclusion criteria, of which 53 studies focused on medication errors, 3 on error-related adverse events and 4 on risk factors only. The prevalence of prescribing errors was reported in 46 studies: prevalence estimates ranged widely from 2% to 94%. Inappropriate prescribing was the most common type of error reported. Only one study reported the prevalence of monitoring errors, finding that incomplete therapeutic/safety laboratory-test monitoring occurred in 73% of patients. The incidence of preventable adverse drug events (ADEs) was estimated as 15/1000 person-years, the prevalence of drug-drug interaction-related adverse drug reactions as 7% and the prevalence of preventable ADE as 0.4%. A number of patient, healthcare professional and medication-related risk factors were identified, including the number of medications used by the patient, increased patient age, the number of comorbidities, use of anticoagulants, cases where more than one physician was involved in patients' care and care being provided by family physicians/general practitioners. CONCLUSION: A very wide variation in the medication error and error-related adverse events rates is reported in the studies, this reflecting heterogeneity in the populations studied, study designs employed and outcomes evaluated. This review has identified important limitations and discrepancies in the methodologies used and gaps in the literature on the epidemiology and outcomes of medication errors in community settings.

Investigating the epidemiology of medication errors and error-related adverse drug events (ADEs) in primary care, ambulatory care and home settings: a systematic review protocol.

INTRODUCTION: There is a need to better understand the epidemiology of medication errors and error-related adverse events in community care contexts. METHODS AND ANALYSIS: We will systematically search the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, Eastern Mediterranean Regional Office of the WHO (EMRO), MEDLINE, PsycINFO and Web of Science. In addition, we will search Google Scholar and contact an international panel of experts to search for unpublished and in progress work. The searches will cover the time period January 1990-December 2015 and will yield data on the incidence or prevalence of and risk factors for medication errors and error-related adverse drug events in adults living in community settings (ie, primary care, ambulatory and home). Study quality will be assessed using the Critical Appraisal Skills Program quality assessment tool for cohort and case-control studies, and cross-sectional studies will be assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Descriptive Studies. Meta-analyses will be undertaken using random-effects modelling using STATA (V.14) statistical software. ETHICS AND DISSEMINATION: This protocol will be registered with PROSPERO, an international prospective register of systematic reviews, and the systematic review will be reported in the peer-reviewed literature using Preferred Reporting Items for Systematic Reviews and Meta-Analyses.