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Background: The Yellow Card Scheme was created in 1964 to oversee new and existing medicines and medical devices, and act as an early warning system for unexpected adverse drug reactions (ADRs). Under-reporting within the system is a known issue, estimated to be as high as 94% in a 2006 systematic review. Anticoagulants are often prescribed in the UK to prevent stroke in patients with atrial fibrillation but can be associated with gastrointestinal bleeding as a common ADR. Aim: The study aimed to investigate the incidence of suspected DOAC-related GI bleeds at a North-West England hospital and explore the volume of these incidents reported through the MHRA Yellow Card Scheme, over a 5-year period. Method: Hospital coding data was used to identify patient records with GI bleeding and cross-referenced with electronic prescribing records for anticoagulant usage. Additionally, pharmacovigilance reporting activity for the Trust was obtained from the MHRA Yellow Card Scheme. Results: For the period investigated, the Trust recorded 12,013 GI bleed related emergency admissions. Of these admissions, 1058 patients were taking a DOAC. During the same time period, a total of 6 DOAC-related pharmacovigilance reports were made by the trust. Conclusion: Utilisation of the Yellow Card System for reporting potential ADR is poor, leading to under-reporting of ADRs. [ABSTRACT FROM AUTHOR]

Background: Direct oral anticoagulants (DOACs) can be involved in clinical relevant drug–drug interactions (DDIs) which may compromise safe and effective use. However, assessing the clinical relevance of DDIs with DOACs and managing these interactions optimally, can be challenging in clinical practice. Aim: To develop a practice-oriented list of potentially clinically relevant DDIs with DOACs with corresponding management plans for which it is important to screen in ambulatory care. Method: The RAND/UCLA appropriateness method was used to develop the DOACs DDI list. In a first step a preliminary list was compiled of potentially clinically relevant DDIs per DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) using five reference sources. Subsequently, a two-step modified Delphi process involving a multidisciplinary panel (n = 10) including both pharmacists and physicians with expertise in all decision-making disciplines involved in care for patients using DOACs and with diversity of practice setting, was used to reach expert agreement on a final list of DDIs with corresponding management plans. Results: After a two-step consensus round, 71 DDIs for 20 different interacting drugs were included: five pharmacodynamic, nine pharmacokinetic inhibitor and six pharmacokinetic inducer interacting drugs. Considerations raised and discussed by the panellists were related to (1) the necessity of the interacting drug, (2) the manageability of the DDI (whether there are any alternatives), (3) the (clinical) evidence-base for the DDI and (4) the (potential) consequences of the DDI. Conclusion: We developed a consensus list with specific and straightforward management plans on potentially clinically relevant DDIs with DOACs, for use in ambulatory care. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background There is evidence that direct oral anticoagulants administered as potentially inappropriate medications increase the risk of bleeding and thromboembolic complications, which represent serious threats to human health. Objective To identify direct oral anticoagulants administered as potentially inappropriate medications for hospitalized patients aged ≥ 65 years in our hospital, and to determine associated factors and the correlation between potentially inappropriate medications and adverse reactions. Setting Xi'an Central Hospital, China. Method A retrospective cross-sectional study of elderly hospitalized patients who received either dabigatran or rivaroxaban at Xi'an Central Hospital between June 1, 2018 and June 1, 2019. The evaluation criteria of direct oral anticoagulants were formulated based on drug labels, disease guidelines and the 2019 American Geriatrics Society Beers Criteria, and any non-compliance with the criteria was considered to be potentially inappropriate medications. The Pearson chi-square test and a binary logistic regression model were used. Main outcome measure Factors associated with potentially inappropriate medications and correlation between potentially inappropriate medications and adverse reactions. Results This study analysed 315 patients aged ≥ 65 years. The application of our evaluation criteria identified 155 (49.2%) instances of potentially inappropriate medications, comprising 5 different types of potentially inappropriate medications. Fifteen adverse drug reactions occurred in the study participants. The Pearson chi-square test revealed significant differences in number of medications (p = 0.021) and creatinine clearance rate (p = 0.002) between potentially inappropriate medications and non-potentially inappropriate medications groups. In the binary logistic regression model, potentially inappropriate medications use was associated with creatinine clearance (creatinine clearance < 30: OR = 3.590, 95% CI = 1.214-10.615, p = 0.021), and there was no significant correlation between potentially inappropriate medications and adverse drug reactions after eliminating the confounding factors (age, length of hospitalization, number of disease combined) with p values of less than 0.25 (adjusted OR = 0.372, 95% CI = 0.117-1.182, p = 0.094). Conclusion This study revealed that the incidence of potentially inappropriate medications was relatively high, number of medications and creatinine clearance differed significantly between potentially inappropriate medications and non-potentially inappropriate medications groups, and potentially inappropriate medications was associated with creatinine clearance (creatinine clearance < 30 mL/min), but there was no significant correlation between potentially inappropriate medications and adverse drug reactions after eliminating the confounding factors. [ABSTRACT FROM AUTHOR]

Background Oral anticoagulants are widely used for treatment and prevention of thromboembolic diseases. We set up a pharmaceutical counseling program for both direct oral anticoagulant and vitamin K antagonist drugs in our hospital in 2015. Objective Evaluate patient satisfaction and the evolution of their knowledge throughout the pharmaceutical counseling program on anticoagulants and identify knowledge variability factors. Setting Cardiology Inpatient Unit from the University Antoine Béclère Hospital, France. Methods Evaluation was based on data collection of patients surveyed between 2015 and 2018. Inpatients in the cardiology department on oral anticoagulants were eligible. The learning process was designed to enhance patient knowledge and understanding based on 10 cognitive or self-management skills, relating to the optimization of oral anticoagulant therapy management. It consisted in 2 face-to-face interviews during hospitalization and 2 additional phone interviews one and six months after discharge. The median patient score was evaluated at each step of the process as well as the mean score for each item from the global population. A sub-analysis was run on the less well-acquired skills in order to identify risk factors for limited knowledge. The association between those factors and the level of knowledge (score ≥ 7 or < 7) was assessed using Chi square test followed by multivariate analysis. Main outcome measure Patient knowledge of anticoagulation therapy depending on specific factors. Results Of the 880 patients eligible for pharmaceutical counseling, 319 entered the process and 102 completed it. Median knowledge scores were 8/10 and 9/10 after the first and the final interviews respectively with a significant improvement (p = 0.0003). The least well-acquired items at each step were surveillance and under-dosing management. The sub-analysis showed the use of vitamin K antagonist to be linked to an enhanced understanding related to treatment surveillance (p = 0.029). Patients suffering from atrial fibrillation were found to have a worse understanding of under-dosing management (p = 0.013). Finally, patients evaluated the process as helpful and suitable for their conditions. Conclusion Pharmaceutical counseling is appropriate for patients, improving and maintaining knowledge of oral anticoagulants. Our evaluation highlights the need to focus on patient-specific profiles to reach a satisfactory level of knowledge. [ABSTRACT FROM AUTHOR]

Background For stroke prevention in patients with atrial fibrillation (AF), the decision-making around antithrombotic therapy has been complicated by older age, multiple comorbidities, polypharmacy and the different pharmacological properties of warfarin and the nonvitamin K antagonist oral anticoagulants (NOACs). The complexity of decision-making has been associated with a reluctance by health professionals to use antithrombotic therapy, leading to poor clinical outcomes. In order to improve stroke prevention in patients with AF, the contemporary perspectives of health professionals on the decision-making around antithrombotic therapy needs exploration. Objective To elicit emerging themes describing health professionals' perspectives on the decision-making around antithrombotic therapy for stroke prevention in patients with AF. Setting Sydney metropolitan area of New South Wales, Australia. Method A qualitative study based on face-to-face interviews was conducted from August to October 2014. Seven pharmacists, seven specialists, six general practitioners and six nurses practising in the Sydney metropolitan area and managing antithrombotic therapy for AF were interviewed until theme saturation was achieved in each subgroup. Interview transcripts were analysed using manual inductive coding. Main outcome measure Emerging themes describing health professionals' perspectives on the decision-making around antithrombotic therapy for stroke prevention in patients with AF. Results Three overarching themes emerged. (1) Comprehensive assessment is necessary for decision-making but is not always implemented. Health professionals mostly focused on stroke risk assessment, not on the bleeding risk and medication safety issues. (2) Health professionals from different disciplines have different preferences for antithrombotic therapies. Although the majority of health professionals considered warfarin as the first-line therapy, NOACs were preferred by neurologists and haematologists. (3) Health professionals focused on different aspects of the decision making process: GPs and specialists were concerned about the appropriate prescription of antithrombotics, while pharmacists and nurses focused on daily medication management by patients. Conclusion The decision-making process appears to be partially preference based rather than systematic, and health professionals from various disciplines focus on different parts of the decision-making process. [ABSTRACT FROM AUTHOR]

Background: Non-vitamin K oral anticoagulants (NOACs) became available in the Netherlands in 2008, providing another antithrombotic treatment besides vitamin K antagonists (VKAs) and antiplatelet agents (APAs).Objective: To describe the patterns of antithrombotic drug use between 2008 and 2013 by examination of dispensing data form community pharmacies in the Netherlands; to determine the concomitant use of NOACs with VKAs and APAs and switching between the drug classes; and to compare adherence to NOACs with adherence to APAs.Setting: An observational retrospective study was conducted using routinely collected dispensing data from Dutch community pharmacies.Methods: For each calendar year, the numbers of NOAC, VKA, and APA users were calculated. Adherence was determined for NOACs and APAs by the percentage of days covered by medication (PDC). Information on the prescribed daily dose of VKAs was unavailable.Main Outcome Measures: Comparison of age, sex, and co-medications of users of the three drug classes; concomitant use of different antithrombotic drug classes and switching between these in each year; and mean PDC and percentages of all users with a PDC above 80 %.Results: NOAC use increased during the study period to 29,687 users in 2013. In that year there were 484,024 VKA users and 1313,032 APA users. Compared with users of VKAs, NOAC users were slightly younger and more frequently used antiarrhythmic drugs and beta blockers as co-medications. Substantial numbers of patients were dispensed potentially harmful combinations in 2013: 820 subjects were dispensed NOACs together with VKAs, and 684 subjects were dispensed NOACs, VKAs, and APAs concomitantly. Mean adherence to NOACs was 84.2 % compared with 87.3 % to APA. One in four NOAC users had a PDC lower than 80 % compared with one in five APA users.Conclusion: Our findings show increasing use of NOACs by outpatients. The number of patients taking potentially harmful combinations of antithrombotic drugs was substantial. Adherence to NOACs in daily practice may be suboptimal to prevent thrombotic events. [ABSTRACT FROM AUTHOR]