Medication incidents and pharmacist interventions in relation to directly acting oral anticoagulants in hospital settings: evaluation using Reason’s Accident Causation Theory

2021 ◽  
Author(s):  
Hazera Haque ◽  
Abdulrhman Alrowily ◽  
Zahraa Jalal ◽  
Bijal Tailor ◽  
Vicky Efue ◽  
...  
Keyword(s):  
Renal Function ◽  
Improve Patient Safety ◽  
Oral Anticoagulants ◽  
Patient Discharge ◽  
Incident Type ◽  
Pharmacist Interventions ◽  
Wrong Drug ◽  
Accident Causation ◽  
Wrong Dose ◽  
Medication Incidents

Abstract BackgroundDirect oral anticoagulants (DOACs) have revolutionised anticoagulant pharmacotherapy. However DOACs medication incidents are known to be common.ObjectiveTo assess medication incidents associated with DOACs using an error theory and to analyse pharmacists’ contributions in minimising medication incidents in secondary care settings.SettingA large University tertiary academic hospital in the West Midlands of England.MethodsMedication incident data from the incident reporting system (48-months period) and pharmacist interventions data from the prescribing system (26-month period) were extracted. Reason’s Accident Causation Model was used to identify potential causality of the incidents. Pharmacists’ intervention data was thematically analysed.Main outcome measure(a) Frequency, type and potential causality of DOACs incidents, (b) Nature of pharmacists’ interventions.ResultsA total of 812 DOACs reports were included in the study (124 medication incidents and 688 intervention reports). Missing drug/omission was the most common incident type (26.6%,n = 33) followed by wrong drug (16.1%,n = 20) and wrong dose/strength (11.3%,n = 14). A high majority (89.5%,n = 111) of medication incidents were caused by active failures. Patient discharge without anticoagulation supply and failure to restart DOACs post procedure/scan were commonly recurring themes. The majority of (38.1%,n = 262) the pharmacist interventions were related to pharmacological strategy (i.e., drug or dose changes or discontinuation). Impaired renal function was the most common reason for dose adjustments.ConclusionPrescribers’ active failure rather than system errors (i.e. latent failures) are contributing to DOACs incidents. Rreinforcement of guideline adherence, prescriber education, harnessing pharmacists’ roles and mandating renal function information in prescriptions are likely to improve patient safety.

scholarly journals Appropriateness of Dabigatran and Rivaroxaban Prescribing for Hospital Inpatients

2016 ◽  
Vol 69 (3) ◽  
Author(s):  
Unnum Chowdhry ◽  
Amanda Jacques ◽  
Alan Karovitch ◽  
Pierre Giguère ◽  
My-Linh Nguyen
Keyword(s):  
Renal Function ◽  
Improve Patient Safety ◽  
Oral Anticoagulants ◽  
Inappropriate Prescribing ◽  
Ideal Body Weight ◽  
Educational Interventions ◽  
Prescribing Practices ◽  
Inappropriate Use ◽  
Tertiary Teaching ◽  
Fonction Rénale

<p><strong>ABSTRACT</strong></p><p><strong>Background: </strong>Recent approval of the new oral anticoagulants dabigatran and rivaroxaban has led to rapid changes in anticoagulant prescribing practices. Postmarketing reports have highlighted safety concerns with these agents, and their use outside of evidence-based recommendations was noted at the authors’ centre.</p><p><strong>Objectives: </strong>To determine the incidence of and risk factors associated with inappropriate prescribing of dabigatran and rivaroxaban.</p><p><strong>Methods:</strong>This retrospective cohort study investigated randomly selected dabigatran or rivaroxaban prescriptions for patients admitted to a tertiary teaching hospital between January 2010 and December 2012. Appropriateness of prescribing was determined from the documented indication, drug dosage, patient’s renal function, and presence of drug interactions, if applicable.</p><p><strong>Results: </strong>Among a total of 321 medication orders reviewed, the incidence of inappropriate use was 31.2% (34/109) for dabigatran and 26.9% (57/212) for rivaroxaban. Of the 97 reasons for inappropriate use that were identified, the most common were prescribing for an unapproved indication (49/97 [50.5%]), concomitant prescribing of another anti -coagulant (22/97 [22.7%]), and high prescribed dose (9/97 [9.3%]). The prescribing service was found to be an independent risk factor for inappropriate prescribing (<em>p </em>= 0.041). Corrections were made to 23.1% (21/91) of the incorrect regimens before hospital discharge. In a sensitivity analysis using calculated ideal body weight to estimate renal function, the overall incidence of inappropriate prescribing increased to 31.5% (101/321).</p><p><strong>Conclusions: </strong>The proportion of patients with inappropriate prescribing of dabigatran or rivaroxaban in clinical practice was higher than expected. Educational interventions and pharmacy-led initiatives with a focus on appropriate indications, concomitant anticoagulant prescribing, and review of dosage regimens are recommended to improve patient safety.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte : </strong>La récente approbation de deux nouveaux anticoagulants oraux, le dabigatran et le rivaroxaban, a mené à de rapides changements dans les habitudes de prescription pour l’anticoagulothérapie. Des rapports de pharmacovigilance ont relevé des risques pour la santé relativement à ces agents. De plus, on a noté au centre où travaillent les auteurs que ces médicaments n’étaient pas toujours utilisés selon les recommandations fondées sur des données probantes.</p><p><strong>Objectifs : </strong>Déterminer quelle est l’incidence des prescriptions inadéquates de dabigatran et de rivaroxaban et quels sont les facteurs de risque qui y sont associés.</p><p><strong>Méthodes : </strong>La présente étude de cohorte rétrospective a examiné des ordonnances choisies au hasard de dabigatran ou de rivaroxaban, lesquelles étaient destinées à des patients admis dans un hôpital universitaire de soins tertiaires entre janvier 2010 et décembre 2012. La pertinence des prescriptions était établie à l’aide des informations consignées sur l’indication, la posologie, la fonction rénale du patient et la presence d’interactions médicamenteuses, le cas échéant.</p><p><strong>Résultats : </strong>Parmi l’ensemble des 321 ordonnances analysées, l’incidence d’utilisation inadéquate était de 31,2 % (34/109) pour le dabigatran et de 26,9 % (57/212) pour le rivaroxaban. Des 97 raisons d’utilisation ina- déquate qui ont été recensées, les plus fréquentes étaient : la prescription pour une indication non approuvée (49/97 [50,5 %]), la prescription concomitante d’un autre anticoagulant (22/97 [22,7 %]) et la prescription d’une dose élevée (9/97 [9,3 %]). Le service auquel appartenait le prescripteur s’est révélé être un facteur de risque indépendant de prescription inadéquate (<em>p </em>= 0.041). Des corrections ont été apportées à 23,1 % (21/91) des schémas erronés avant que le congé ne soit donné. Dans une analyse de sensibilité qui s’appuyait sur le calcul du poids idéal pour estimer la fonction rénale, le taux global d’incidence de prescription inadéquate augmentait à 31,5 % (101/321).</p><p><strong>Conclusions : </strong>La proportion de patients pour qui la prescription de dabigatran ou de rivaroxaban était inadéquate dans la pratique Clinique était plus élevée que prévu. Afin d’améliorer la sécurité des patients, on recommande l’adoption d’interventions éducatives et d’initiatives dirigées par les services de pharmacie qui porteront sur les indications adéquates, la prescription concomitante d’anticoagulants et la révision des schémas posologiques.</p>

scholarly journals Understanding safety in healthcare: the system evolution, erosion and enhancement model

2013 ◽  
Vol 2 (3) ◽  
pp. 25 ◽  
Author(s):  
Jane Carthey
Keyword(s):  
Patient Safety ◽  
Complex Systems ◽  
Human Error ◽  
Improve Patient Safety ◽  
New Model ◽  
System Evolution ◽  
Accident Causation ◽  
System Migration ◽  
Improve Patient

The paper summarises previous theories of accident causation, human error, foresight, resilience and system migration. Five lessons from these theories are used as the foundation for a new model which describes how patient safety emerges in complex systems like healthcare: the System Evolution Erosion and Enhancement model. It is concluded that to improve patient safety, healthcare organisations need to understand how system evolution both enhances and erodes patient safety.

scholarly journals Adverse outcomes after worsening renal function in patients with atrial fibrillation: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Ogawa ◽  
Y An ◽  
S Ikeda ◽  
Y Aono ◽  
K Doi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Oral Anticoagulants ◽  
Adverse Outcomes ◽  
Funding Source ◽  
Worsening Renal Function ◽  
Gault Formula ◽  
Bayer Healthcare ◽  
Artery Disease

Abstract Background Patients with atrial fibrillation (AF) commonly coexist with chronic kidney disease (CKD). Non-vitamin K antagonist oral anticoagulants (NOAC) are recommended for stroke prevention in patients with non-valvular atrial fibrillation (AF), and worsening renal function (WRF) as well as CKD is an important issue in using NOAC. However, little is known about the clinical outcomes of patients after WRF. Purpose We aimed to investigate outcomes after WRF in AF patients. Methods The Fushimi AF Registry is a community-based prospective survey of the AF patients in our city. Follow-up data including prescription status were available for 4,441 patients. Of them, 1,890 patients who have baseline and at least 1 follow-up creatinine clearance (CrCl) measurements, estimated by the Cockcroft-Gault formula, were analyzed in the present study. WRF was defined as a decrease of ≥20% from baseline CrCl measurement at any time point during follow-up. We evaluated demographics and outcomes after WRF in AF patients. Results During the median follow-up period of 2,194 days, mean CrCl decrease of 2.2 ml/min/year was observed and WRF occurred in 981 patients (51.9%). Patients with WRF were significantly more often female (with vs. without WRF; 40.3% vs. 35.4%; p=0.03), older (73.4 vs. 71.1 years of age; p&lt;0.01), more often paroxysmal type (49.9% vs. 47.1%; p&lt;0.01), and more likely to have prior stroke (17.9% vs. 12.7%; p&lt;0.01), heart failure (30.8% vs. 24.8%; p&lt;0.01), diabetes (31.7% vs. 27.1%; p=0.03), and coronary artery disease (19.9% vs. 12.1%; p&lt;0.01) than those without WRF. Co-existing of CKD and mean CrCl at baseline were comparable (37.4% vs. 36.9%; p=0.82, 65.3 vs. 63.5 ml/min; p=0.66, respectively). Mean CHA2DS2-VASc score was significantly higher in WRF patients (3.55 vs. 3.03; p&lt;0.01). On landmark analysis, all-cause mortality occurred in 135 patients (8.6 /100 person-years) after WRF and 82 patients (1.7 /100 person-years) without WRF, with an adjusted hazard ratio (HR) of 6.33 (95% confidence interval [CI], 4.33–9.50; p&lt;0.01), adjusted by sex, age, body weight, serum creatinine, type of AF, oral anticoagulant prescription and comorbidities. Stroke or systemic embolism occurred in 45 patients after WRF (3.0 /100 person-years) and 78 (1.7 /100 person-years) patients without WRF (adjusted HR 1.60 [95% CI, 1.04–2.49; p=0.03]) (Figure). Conclusions AF patients after WRF had higher incidence of various adverse events. Incidence of Adverse Outcomes Funding Acknowledgement Type of funding source: Other. Main funding source(s): The Practical Research Project for Life-Style related Diseases including Cardiovascular Diseases and Diabetes Mellitus from Japan Agency for Medical Research and Development. Boehringer Ingelheim, Bayer Healthcare, Pfizer, Bristol-Myers Squibb, Astellas Pharma, AstraZeneca, Daiichi-Sankyo, Novartis Pharma, MSD, Sanofi-Aventis, and Takeda Pharmaceutical.

Meta-analysis comparing impact of age, sex and renal function on the efficacy and safety of new oral anticoagulants vs. vitamin K antagonists for the treatment of acute venous thromboembolisms

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J She ◽  
B.Z Zhuo
Keyword(s):  
Renal Function ◽  
Venous Thromboembolism ◽  
Creatinine Clearance ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Acute Venous Thromboembolism

Abstract Background New direct oral anticoagulants (NOACs), as a preferable treatment option for acute venous thromboembolism (VTE) have been recommended with practical advantages as compared to Vitamin K antagonists (VKAs) in clinical practice. Purpose In our study, we performed a meta-analysis to determine the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE. Methods Electronic databases (accessed October 2019) were systematically searched to identify RCTs evaluating apixaban, dabigatran, edoxaban, and rivaroxaban versus VKAs for the treatment of acute venous thromboembolism. Results NOACs was associated with a borderline higher efficacy in female (OR 0.79, 95% CI 0.62–1.02), and a significantly higher efficacy in patients with age more than 75 (OR 0.51, 95% CI 0.32–0.80) and creatinine clearance less than 50 mL/min (OR 0.57, 95% CI 0.32–0.99). NOACs also show advantage in terms of major or clinically relevant non-major bleeding in male (OR 0.72, 95% CI 0.60–0.86), and patients with creatinine clearance more than 50 mL/min (OR 0.75, 95% CI 0.67–0.84). Conclusions NOACs have exhibited clinical preference among patients with acute VTE as compared to VKA with significantly decreased thrombosis events and lower bleeding complications, especially in patients with age more than 75 and creatinine clearance less than 50 mL/min. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): This study was supported by the National Natural Science Foundation of China (81800390) and the Natural Science Foundation of Shaanxi province (2018KW067).

P3472Modifications of renal function in atrial fibrillation patients treated with different oral anticoagulants: a multicentre cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Pastori ◽  
G Y H Lip ◽  
A Sciacqua ◽  
F Perticone ◽  
F Melillo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Cohort Study ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Forest Plot ◽  
Multicentre Cohort Study ◽  
Egfr Decline ◽  
Multicentre Cohort

Abstract Background A decline of estimated glomerular filtration rate (eGFR) has been described in atrial fibrillation (AF) patients on Vitamin K antagonists (VKAs). Few real-world data on the modifications of eGFR in AF patients treated with non-vitamin K antagonist oral anticoagulants (NOACs) do exist. Purpose To evaluate changes of renal function in AF patients treated with VKAs or NOACs. Methods Multicentre prospective cohort study including 1,667 patients with non-valvular AF from 5 clinical centres of Internal Medicine and Cardiology in Italy. Renal endpoints were: 1) median annual decline of eGFR; 2) transition to eGFR <50 ml/min/1.73 m2; 3) eGFR class worsening according to KDIGO 2012 classification. The eGFR was assessed by the CKD-EPI formula at baseline and during follow-up. Results Median age was 73.7±9.1 years and 43.3% were women. 743 patients were on VKAs and 924 on NOACs (Dabigatran, Rivaroxaban e Apixaban). Median annual eGFR decline was −2,11 (Interquartile Range [IQR] −5,68/−0,62] in patients on VKAs, −0,27 [IQR −9,00/4,54] with Dabigatran (p<0.001 vs. VKAs), −1,21 [IQR −9,98/4,02] with Rivaroxaban (p=0.004 vs. VKAs) and −1,32 [IQR −8,7/3,99] with Apixaban (p=0.003, vs. VKAs). Use of Dabigatran and Apixaban was associated to a lower transition to eGFR <50 mL/min/1.73 m2, compared to VKAs: adjusted Odds Ratio (aOR) 0.492, 95% Confidence Interval (CI) 0.298–0.813, p=0.006 for Dabigatran; aOR 0.449, 95% CI 0.276–0.728, p=0.001 for Apixaban). Regarding the eGFR class worsening, Dabigatran (aOR 0.70, 95% CI 0.503–0.975, p=0.035), Rivaroxaban (aOR 0.591, 95% CI 0.423–0.825, p=0.002), and Apixaban (aOR 0.591, 95% CI 0.429–0.815, p=0.001) were all associated to a lower rate of eGFR class worsening compared to VKAs. Forest plot Conclusions In this prospective multicentre cohort study, NOACs use was associated with a lower decline of renal function compared to VKAs. Patients on Dabigatran showed the lowest annual rate of eGFR decline and those on Apixaban and Rivaroxaban a lower eGFR class worsening. Acknowledgement/Funding None

scholarly journals High-risk medications identified from the Danish Patient Safety Database and the challenge of dissemination

2018 ◽  
Vol 24 (1) ◽  
pp. 7-12 ◽  
Author(s):  
Pia Knudsen ◽  
Lena Graversen ◽  
Torsten Larsen
Keyword(s):  
Patient Safety ◽  
High Risk ◽  
Improve Patient Safety ◽  
Healthcare Staff ◽  
Safety Database ◽  
Danish Patient ◽  
National Patient ◽  
Medication Incidents ◽  
Patient Safety Incidents ◽  
Improve Patient

Since 2004, patient safety incidents in Denmark have been reported to a national patient safety reporting system – the Danish Patient Safety Database. The goal of the system is to improve patient safety. In 2011, a decision was made to develop a national list of high-risk medications based on the medication incidents reported to the Danish Patient Safety Database. The high-risk medications are defined as medications that have been involved in medication errors and have caused harm to patients. The purpose is to identify medications that posed a particular and preventable risk for patients. It became clear through updates that there was a group of medications that caused severe harm to the patients more frequently than others. Based on the list, the Danish Patient Safety Authority in 2015 identified seven groups of medications that require special attention from healthcare staff: antidiabetic medications, anticoagulants, low-dose methotrexate, concentrated potassium, opioids, gentamicin and digoxin. Better handling of these seven types of medication could improve patient safety significantly. For many years, Danish Patient Safety Authority has distributed tables and booklets about these high-risk medications. In addition, ‘patient safety warnings’ are issued when it is considered necessary. In spite of this, many patient safety incidents involving these medications still occur. This points to the fact that disseminating knowledge from a government level all the way to frontline healthcare staff poses a challenge. On that background, Danish Patient Safety Authority is exploring new ways to disseminate knowledge to frontline healthcare staff about patient safety incidents.

scholarly journals 122 Are We Effective Prescribers? A Retrospective Audit of DOAC Prescribing Post Embolic Stroke for Non Valvular Atrial Fibrillation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Karen Dennehy ◽  
Joseph Morris ◽  
Diarmaid Hughes ◽  
Kate Donlon ◽  
Thomas Walsh
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Embolic Stroke ◽  
Haemorrhagic Transformation ◽  
Retrospective Audit ◽  
Online Laboratory ◽  
Number Of Patients

Abstract Background Direct oral anticoagulants (DOAC) are indicated for stroke prophylaxis in non-valvular atrial fibrillation, which is responsible for up to 20% of all ischaemic strokes(1). We performed a retrospective audit of all consecutive stroke patients in an Irish teaching hospital over a 1-year period to investigate the rate of incorrect dosing and any risk factors for this occurring. Methods We assessed our hospital stroke database from January to December 2017. Our research focused on DOAC prescribing in non valvular atrial fibrillation post embolic stroke. We collected data on baseline characteristics, choice of anticoagulation, dosing, and assessment of renal function, with follow up renal function if available. We reviewed electronic discharge summaries, online laboratory systems and completed a chart review. Results There was a total of 116 people with atrial fibrillation who developed an embolic stroke in our centre, of which 68 were eligible for anticoagulation using a DOAC (59). The main reasons for omission were CKD and haemorrhagic transformation. Patients were discharged on either Apixaban (32 patients), Rivaroxoban (32 patients), or Dabigatran (4 patients). Following our review, we established that 54/68 (79%) of patients were correctly anticoagulated. Over 20% of patients were incorrectly dosed and there was a clear tendency to under-dose 13/14 (93%). There were significant differences between the correct and incorrect dosing groups, with the latter group of patients being older and more at risk of polypharmacy. Renal function did not differ significantly between the groups at discharge or follow up and none of the incorrectly dosed patients were on a concurrent anti platelet. Conclusion A significant number of patients prescribed DOAC in hospital were not appropriately anticoagulated (21%), a majority of which were under-dosed. The patients who were under-dosed were older and more likely to be on 5 or more medications.

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