Prevalence, contributory factors and severity of medication errors associated with direct-acting oral anticoagulants in adult patients: a systematic review and meta-analysis.

PURPOSE: This study aimed to estimate the prevalence, contributory factors, and severity of medication errors associated with direct acting oral anticoagulants (DOACs). METHODS: A systematic review and meta-analysis were undertaken by searching 11 databases including Medline, Embase, and CINHAL between January 2008 and September 2020. The pooled prevalence of errors and predictive intervals were estimated using random-effects models using Stata software. Data related to error causation were synthesised according to Reason's accident causation model. RESULTS: From the 5205 titles screened, 32 studies were included which were mostly based in hospitals and included DOAC treatment for thromboembolism and atrial fibrillation. The proportion of study population who experienced either prescription, administration, or dispensing error ranged from 5.3 to 37.3%. The pooled percentage of patients experiencing prescribing error was 20% (95% CI 15-25%; I2 = 96%; 95% PrI 4-43%). Prescribing error constituted the majority of all error types with a pooled estimate of 78% (95%CI 73-82%; I2 = 0) of all errors. The common reported causes were active failures including wrong drug, and dose for the indication. Mistakes such as non-consideration of renal function, and error-provoking conditions such as lack of knowledge were common contributing factors. Adverse events such as potentially fatal intracranial haemorrhage or patient deaths were linked to the errors but causality assessments were often missing. CONCLUSIONS: Despite their favourable safety profile, DOAC medication errors are common. There is a need to promote multidisciplinary working, guideline-adherence, training, and education of healthcare professionals, and the use of theory-based and technology-facilitated interventions to minimise errors and maximise the benefits of DOACs usage in all settings. PROTOCOL: A protocol developed as per PRISMA-P guideline is registered under PROSPERO ID = CRD42019122996.

Hospital Pharmacists Interventions to Drug-Related Problems at Tertiary Critical Care Pediatric Settings in Jazan, Saudi Arabia.

Background: While drug-related problems (DRPs) have been recognized as a major concern in pediatric wards, the role of hospital pharmacy in improving medication safety has been rarely studied. Objectives: To investigate the frequency, nature, and severity of DRPs and associated pharmacist interventions (PIs). Methods: This is a prospective study carried out using direct observation over a year (2019-2020) in 3 pediatric wards (pediatric emergency department (PED), pediatric intensive care unit (PICU), and neonatal intensive care unit (NICU) in Jazan, Saudi Arabia. A validated data reporting form was developed to include comprehensive clinical data about the prescribed medications, characteristics of patients, and PIs upon DRPs. Clinical significance of DRPs was evaluated by an expert panel, which comprised a clinical pharmacist, a pediatrician, and an internist. Data analysis was conducted using SPSS V26. Results: The overall incidence of DRPs was 6.6%. The highest rate of DRPs 15.2% was detected in the pediatric ICU. Of the 596 DRPs detected, 10.2% were inappropriate drug choice, 5.2% were rated major DRPs, and one-third 33.2% were related to the digestive system and metabolism. Dosing problems were the most predominant DRPs across the included wards. A higher proportion of clinically major and moderate DRPs were detected in pediatric ED. Telephone-delivered interventions [OR: 1.72: 95%CI: 0.78-2.57: P = .001], too high dose [OR: 2.64: 95%CI: 1.33-4.56: P = .01], and major DRPs [OR: 3.21: 95%CI: 2.15-6.42: P = .04] were significant predictors for acceptance of PIs. Conclusion: DRPs are common in Saudi pediatric wards and many of these incidents were clinically major and moderate. Telephone-delivered interventions, too high dose, and major DRPs were major predictors for physician acceptance of PIs.

Patients' views and experiences on the use and safety of directly acting oral anticoagulants: a qualitative study.

BACKGROUND: Direct oral anticoagulants (DOACs) are considered high-risk medications and used to prevent thromboembolic events and stroke. This study aimed to examine patients' views and experiences of DOACs use and factors that can promote safety associated with DOACs. METHODS: In-depth interviews were conducted with adult patients who had been prescribed DOACs, identified and invited by local collaborators in three different tertiary care hospitals in Saudi Arabia. A topic guide developed based on was used to inform the interview. Data were analysed thematically. RESULTS: Data saturation was achieved by the ninth participants. Three major themes were identified: (1) factors affecting DOAC's safety from the patients view; (2) barriers to adherence to DOACs and (3) strategies to promote the safety of DOACs. Lack of knowledge of DOACs, using inappropriate sources of information, lack of communication with HCPs, difficulty in having access to DOACs and lack of monitoring were the main factors affecting the safe use of DOACs. Unavailability of the drugs and difficulty in timely getting to hospitals affected adherence. Patients acknowledged difficulties communicating with healthcare professionals, timely access to anticoagulation clinics and in obtaining their DOACs on time. CONCLUSIONS: There is a need to develop and evaluate theory-based interventions to promote patient knowledge, understanding and shared decision-making to optimise DOACs use and improve their safety.

Risks of Cardiac Arrhythmia Associated with COVID-19 Vaccination: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to summarize the current evidence regarding the association between coronavirus disease 2019 (COVID-19) vaccination and the risk of cardiac arrhythmia. MEDLINE, via PubMed and OVID, Scopus, CENTRAL, and Web of Science were searched using the relevant keywords to identify the relevant citations. Comprehensive Meta-analysis and Review Manager 5.4.1 were used for all the statistical analyses. Seventeen studies (n = 567,033,087 patients) were included. The pooled analysis showed that the incidence of cardiac arrhythmia post-COVID-19 vaccination with Pfizer, Moderna, AstraZeneca, CoronaVac, and Sinopharm was 0.22%, 95% CI: (0.07% to 0.66%), 0.76%, 95% CI: (0.04% to 12.08%), 0.04%, 95% CI: (0.00% to 0.98%), 0.01%, 95% CI: (0.00% to 0.03%), and 0.03%, 95% CI: (0.00% to 18.48%), respectively. Compared to CoronaVac, Pfizer, Moderna, AstraZeneca, and Sinopharm had a higher incidence ratio rate (IRR; 22-times, 76-times, 4-times, and 3-times higher), respectively. Likewise, Pfizer, Moderna, and AstraZeneca showed a higher IRR than Sinopharm (7.3-times, 25.3-times, and 1.3-times higher). The current evidence shows that the incidence rate (IR) of cardiac arrhythmia post-COVID-19 vaccination is rare and ranges between 1 and 76 per 10,000. mRNA vaccines were associated with a higher IR of arrhythmia compared to vector-based vaccines. Inactivated vaccines showed the lowest IR of arrhythmia.

Complementary and alternative medicines use in COVID-19: A global perspective on practice, policy and research.

The COVID-19 pandemic has met international health systems with a low level of preparedness and emergency response. While the emergence of effective vaccines has offered the Governments, scientific communities, and members of the public a possible way out of the pandemic, effective pharmacotherapy, including immunotherapy for COVID-19 prevention and treatment, are yet to be established. Internationally, this has led to a surge in the demand and supply of many complementary and alternative medicines (CAM) and practices. Recent studies have shown increasing CAM information requests made to pharmacists and other healthcare staff from members of public and patients aimed at prevention, symptoms relief or treatment of COVID-19. In this context, it is imperative that healthcare professionals, including pharmacists, are acquainted with current practices, policies, and research in relation to CAM use in COVID-19. This narrative commentary will provide an update on global practices, policies and research in regards to CAM use in the context of COVID-19. Healthcare professionals' understanding of popular CAMs and those tipped for potential benefits in COVID-19, patient and consumer behaviors in relation to CAM use; and healthcare professionals' awareness of cultural, religious, and self-care practices associated with CAM use are imperative to inform effective communication and counselling practices and promote evidence based self-care when patients present for advice. This narrative provides relevant discussions specific to different continents and regions historically linked to diverse CAM practices.

Views, experiences and contributory factors related to medication errors associated with direct oral anticoagulants: a qualitative study with physicians and nurses.

BACKGROUND: Direct oral anticoagulants (DOACs) have become preferable for the management of thromboembolic events. Recent publications have however identified high volume of medication errors related to DOACs. There is limited literature on why and how such errors occur or happen in clinical practice. AIM: This study aimed to explore views, experiences, contributory factors related to DOACs medication errors from the perspectives of healthcare professionals. METHOD: Semi-structured interviews using online videoconferencing were conducted with physicians and nurses from tertiary care hospitals in three different regions in Saudi Arabia. Questions included views, experiences and perceived factors contributing to errors. Interviews were transcribed verbatim and were thematically analyzed using MAXQDA Analytics Pro 2020 (VERBI Software). RESULTS: The semi-structured interviews (n = 34) included physicians (n = 20) and nurses (n = 14) until data saturation was achieved. The analysis identified five themes: Factors related to healthcare professionals (e.g. knowledge, confidence and access to guidelines); Factors related to patients (e.g. comorbidity, polypharmacy, medication review, and communication barriers); Factors related to organization (e.g. guidelines, safety culture and incidents reporting system); Factors related to the DOACs medications (e.g. lack of availability of antidotes and dosing issues); and Strategies for error prevention/mitigation (e.g. the need for professional training and routine medication review). CONCLUSION: Healthcare professionals identified errors in relation to DOACs as multifactorial including their own and patient lack of knowledge, lack of clinical guidelines and organizational factors including safety culture. Medication review and reconciliation on discharge were key strategies suggested to reduce DOACs related errors. These strategies support the role of pharmacists as direct patients care providers to minimize DOACs errors.

Perceived barriers and facilitators to uptake of non-traditional roles by pharmacists in Saudi Arabia and implications for COVID-19 pandemic and beyond: a qualitative study using Theoretical Domain Framework.

BACKGROUND: The COVID-19 pandemic has further strengthened the need for pharmacists to uptake non-traditional roles. Pharmacy practice in Saudi Arabia is emerging in recent years with greater policy emphasis on pharmacists taking new clinical roles. This study aimed to explore the experiences, perceptions and barriers of Saudi pharmacists about their uptake of non-traditional roles using Theoretical Domains Framework (TDF). METHODS: A qualitative semi-structured study using face-to-face or telephone interviews were conducted. Eligible participants included qualified pharmacists from Saudi Arabia. Interviews focused on pharmacist's perceptions, current opportunities and key challenges towards the uptake of non-traditional roles. Interviews were audiotaped and transcribed verbatim. Results were analysed through the framework analysis method and were later mapped with respective domains of TDF. RESULTS: A total of 14 pharmacists completed the interview (9 females and 5 males). Participants showed an overall positive attitude towards the uptake of non-traditional roles. Participants felt that there was wider support available for pharmacists at the policy level to uptake non-traditional roles. However, a need for greater recognition of roles by other healthcare professionals and patients were identified. Participants alluded to reluctance of some physicians to take on board the suggestions from a pharmacist. Key barriers to uptake of non-traditional roles were related to environmental context and resources domain of TDF. For example, participants discussed the need for even further practical experiences during their undergraduate degree to become ready to adopt non-traditional roles in clinical practice. CONCLUSIONS: Participants of this theoretically informed qualitative study showed an overall positive attitude towards the way pharmacy practice is progressing in Saudi Arabia and their uptake of non-traditional roles. However, there is a need to improve interdisciplinary working, patient awareness of pharmacist competencies and their educational preparedness in furthering their uptake of non-traditional roles. Addressing such barriers and promoting uptake of novel roles by pharmacists is imperative in the context of emerging COVID-19 and future pandemics.

Medication errors associated with direct-acting oral anticoagulants: analysis of data from national pharmacovigilance and local incidents reporting databases.

BACKGROUND: For more than a decade, direct oral anticoagulants (DOACs) have been approved in clinical practice for multiple indications such as stroke prevention in non-valvular atrial fibrillation treatment of deep vein thrombosis and pulmonary embolism. This study aimed to explore the nature and contributory factors related to medication errors associated with DOACs in hospital settings. METHODS: Analysis of error reports using data from (a) Saudi Food and Drug Authority pharmacovigilance database and (b) local incidents reporting system from two tertiary care hospitals were included. Errors reported between January 2010 to December 2020 were also included. Statistical analyses were performed using IBM (SPSS) Statistics Version 24.0 software. RESULTS: A total of 199 medication error incidents were included. The mean (range) age of affected patients was 63.5 (19-96) years. The mean reported duration of treatment when incidents happened was 90 days, with a very wide range from one day to 12 months. Prescribing error was the most common error type representing 81.4% of all errors. Apixaban was the most frequent drug associated with error reporting with 134 (67.3%) incidents, followed by rivaroxaban (18.6%) and dabigatran (14.1%). The majority of the patients (n = 188, 94.5%) showed comorbidities in addition to the conditions related to DOACs. Polypharmacy, an indication of treatment and duration of therapy were amongst the important contributory factors associated with errors. CONCLUSIONS: This observational study demonstrates the nature of DOAC related medication errors in clinical practice. Developing risk prevention and reduction strategies using the expertise of clinical pharmacists are imperative in promoting patient safety associated with DOAC use.