Введение. Антикоагулянты (АК) являются лекарственными средствами (ЛС) высокого риска причинения вреда пациенту. Безопасность применения АК во многом зависит от соблюдения врачами клинических руководств и инструкций по медицинскому применению ЛС. Цель. Проанализировать выполнение врачами стационара клинических рекомендаций и инструкций по медицинскому применению АК у пациентов с фибрилляцией предсердий (ФП) и тромбозом глубоких вен (ТГВ). Материал и методы. В ретроспективное когортное исследование включено 100 пациентов с ФП или ТГВ, пролеченных в 2016-2017 гг. в многопрофильном стационаре г. Москвы. С помощью системы поддержки принятия решения (СППР) лекарственные назначения в историях болезни сопоставлялись с клиническими руководствами и инструкциями по медицинскому применению АК для выявления отклонений от рекомендаций по назначению АК (соблюдение показаний/противопоказаний и режима дозирования АК). Результаты. Из 50 пациентов с ФП антикоагулянтная терапия в стационаре была назначена 43 (86%) пациентам, включая 20 (46,5%) назначений прямых оральных антикоагулянтов (ПОАК), 17 (39,5%) варфарина и 6 (14%)-низкомолекулярных гепаринов (НМГ). Для пациентов с ТГВ структура назначений АК в качестве основной терапии составила: 39,5% ПОАК, 33,5% НМГ и 27% варфарин. Уровень приверженности врачей рекомендациям по назначению АК пациентам с ФП и ТГВ (соблюдение показаний и противопоказаний) был равен 88%. При несоблюдении рекомендаций по назначению АК частота нежелательных лекарственных событий была статистически значимо выше, чем при соблюдении рекомендаций (34% против 11%, соответственно; отношение шансов (ОШ) 3,9; 95% доверительный интервал (ДИ) 0,9-15,3; p=0,045). Врачи соблюдали рекомендации по режиму дозирования АК в 63,5% случаях. При несоблюдении рекомендаций по дозированию АК прямые затраты в стационаре на терапию АК были статистически значимо выше, чем при соблюдении: 4,04 тыс руб (интерквартильный размах, interquartile range, IQR=7,501 тыс руб) против 1,13 тыс руб (IQR=5,911 тыс руб), соответственно; p=0,02. Заключение. Несоблюдение клинических рекомендаций и инструкций по медицинскому применению АК может повышать риск развития нежелательных лекарственных событий и увеличивать стоимость антикоагулянтной терапии. СППР является перспективным инструментом как для клинического аудита антикоагулянтной терапии, так и для повышения приверженности врачей клиническим рекомендациям при назначении АК пациентам с ФП и ТГВ. Ключевые слова: антикоагулянты, фибрилляция предсердий, тромбоз глубоких вен, нежелательные лекарственные события, приверженность клиническим рекомендациям.
Background. Failure of continuity at care transitions results in 50% of all medication errors and up to 20% of adverse drug events (ADEs). In surgical patients medication errors occur more often than in medical patients due to perioperative corrections of medications and greater number of in-hospital transitions. The frequency of ADE in surgical patients varies from 2.3 to 27.7%. Aims to determine the prevalence and structure of unintentional discrepancies (UDs) in medications at admission to and discharge from surgery departments, report their potential clinical impact and analyse possible risk factors. Methods. Retrospective observational study was conducted in a general hospital in Russia. The study included patients hospitalized for elective surgery in Surgical Departments from January to June 2019. The pre-admission Best Possible Medication History (BPMH) for every patient was obtained. The BPMHs were compared with admission medication orders and hospital discharge prescriptions to identify UDs. Detected UDs were analysed for potential ADE with severity evaluation. Results. 206 patients were included, 55.83% were female, mean age 63.85 (9.38), median of chronic medications was 3 drugs. At least one UD was detected in 70.87% of patients at admission and in 92.72% at discharge, respectively, with averages of 1.30 and 2.81 discrepancies per patient. Cardiovascular drugs were the most frequent class involved at both admission (72.2%) and discharge (68.05%) in UDs. The most often UDs at both admission (51.68%) and discharge (94.65%) were omissions, incorrect dose (22.47% and 2.25%), and additional medications (11.6% and 1.55%). UDs had the potential to cause significant ADEs in 81.27%, serious ADEs in 18.35% of cases. Only 0.37% of UDs could contribute to life-threatening ADEs. The relative risk of discrepancies in patients of 60 years and older was 1.292-fold higher; three and more chronic medications increase risk 1.565-fold; diabetic or thyroid medications increase risk 1.932-fold. Conclusions. We reported on the first study of medication discrepancies conducted in Russian hospital. Estimated frequency, structure and risk factors of UDs in medications at admission to and discharge from surgery departments are similar to those from other countries. To decrease UDs in medications, implementation of medication reconciliation is needed.
Background: Physicians adherence to recommendations for appropriate antithrombotic therapy of venous thromboembolism (VTE) can reduce the risk of recurrent VTE, pulmonary hypertension, bleeding and other adverse events. Clinical decision support systems (CDSS) are shown to increase physicians adherence to clinical guidelines. Aims: To assess effectivenes and safety of CDSS for anticoagulant prescribing for inhospital patients with VTE. Methods: A prospective cohort study was conducted in a Moscow general hospital from 06.30.2017 to 06.23.2018 to compare physicians compliance with clinical guidelines for DVT anticoagulant therapy, the rate of drug errors and direct costs of anticoagulant therapy before and after CDSS implementation (55 patients in control group and 49 in experimental group). Results: The rate of anticoagulant prescribing for patients with DVT did not alter significantly after CDSS implementation (96% compared with 91% before CDSS), but physicians compliance with recommendations on anticoagulant dosage increased from 32.7% to 73.5% (p = 0.0003) with corresponding decrease in the rate of anticoagulant prescribing errors from 1.35 to 0.65 per 1 patient (p = 0.0005). The length of stay and hemorrhagic complication rate did not differ between control and experimental groups. LMWH replacement with new oral anticoagulants has reduced the cost of anticoagulant therapy for 1 patient from 11.800 rubles (IQR = 7000) to 5.430 rubles (IQR = 5700) (p 0.005). Conclusions: СDSS can increase physicians adherence to recommended anticoagulant therapy for patients with DVT: to prevent unreasonable under-/overdosing or prolongation of anticoagulant therapy. CDSS for DVT drug therapy can be economically feasible.
Surgical care is associated with a high risk of complications. In 2014 the updated joint ESC/ESA guidelines on preoperative assessment and perioperative management of patients were published to improve patient safety in non-cardiac surgery. The increase in the adherence to clinical guidelines promotes the improving of the healthcare quality and safety improvement.Aim. To study physicians' level of adherence to ESC/ESA clinical guidelines for preoperative assessment and perioperative management of patients.Material and methods. A retrospective observational study included 102 patients admitted to Moscow general hospital from 01.03.2019 to 30.06.2018 for elective surgery. All of them underwent preoperative examination in outpatient department of the hospital and had at least one concomitant disease requiring drug therapy. The medical records data on the preoperative examination and perioperative treatment with beta-blockers, HMG CoA reductase inhibitors and angiotensin-converting-enzyme (ACE) inhibitors/ angiotensin receptor blockers (ARBs) were analyzed for compliance with the ESC/ESA guidelines.Results. A standardized cardiac risks assessment was not documented in the results of preoperative examination. Electrocardiography (ECG), echocardiography and non-invasive stress tests were performed according to clinical guidelines in 100%, 77.8% and 25% of cases, respectively. Unnecessary ECG and echocardiography were prescribed in 50.5% and 72% of cases, respectively. Appropriate correction of ACE inhibitors/ARBs therapy was performed in 66.7% patients with congestive heart failure and only in 2.7% with arterial hypertension. In 19 patients with ischemic cardiac disease, 13 (84.2%) patients received HMG CoA reductase inhibitors and 16 (68.4%) ones received beta-blockers during hospitalization. Inappropriate omission of statins, beta-blockers and ACE inhibitors (ARBs) during hospitalization was registered in 22.2%, 11% and 4.9% patients, respectively.Conclusion. The number of inappropriate ECGs and echocardiographies, as well as incorrect treatment with beta-blockers, HMG CoA reductase inhibitors and ACE inhibitors (ARBs) in perioperative period evidence that the adherence of physicians to the clinical guidelines on preoperative assessment and perioperative management of patients remains low.It is reasonably to develop risk-based interdisciplinary protocols for preoperative examination, algorithms for interdisciplinary communication and interaction between specialists and the healthcare levels, as well as physicians' education for better adherence to clinical guidelines.
Aim. To study the structure of anticoagulant prescription in a general hospital to identify trends and contributing factors.Materials and methods. The study was conducted in an urban general hospital. According to retrospective retrieval from electronic health records, total 17,129 patients received anticoagulants from 2008 to 2018. Formal appropriateness of oral anticoagulants (OАС) prescriptions for 6,638 patients with atrial fibrillation (AF) was analyzed with CHA2-DS2-VASc score.Results. Appearance of recommendations for the direct oral anticoagulants (DOAC) prescription in clinical guidelines for venous thromboembolism (VTE) and AF management contributed to steady increase in the DOAC taking and decrease in the proportion of warfarin prescription. From 2011 to 2018, the proportion of patients with DOACs prescription increased from 1.7% to 81.5%. The most common indications for anticoagulant were ischemic stroke prevention in AF and VTE with mean rate 75.3% and 23.2%, respectively for the 2011-2018 period. Steady increase in low-molecular-weight heparin (LMWH) prophylactic prescriptions was also shown (Chi-square for linear trend=1340, df=1, p<0.0001). Since 2014, the prescription of LMWH in prophylactic doses increased dramatically, probably related to implementation of computerized decision support system (CDSS) for VTE prevention in the hospital.Conclusion. The study showed that in a general hospital anticoagulants were prescribed in 19% of hospitalized patient. Not only the new clinical recommendations based on the results of the recent studies on anticoagulants efficacy and safety (external factors), but also implementation standard operating protocols and CDSS, providing physicians current information about the relevant clinical recommendations (internal changes), could influence the appropriateness of anticoagulants prescription.
Background. Medication errors and resultant adverse drug events (ADEs) often occur during transitions of care. Up to 67% of in-patients prescriptions have at least one unintentional medication discrepancy with previously prescribed therapy. The proportion of clinically significant medication discrepancies is 1159%. Studies from the developed countries demonstrated the effectiveness of medication reconciliation in reducing medication errors, ADEs and healthcare resource utilization. There is a necessity to conduct medication reconciliation studies within Russian current clinical practice to develop effective medical care quality and patients safety programs. Aims to evaluate the impact of pharmacologist-led medication reconciliation on the frequency and structure of unintentional medication discrepancies and potential ADEs at hospital admission and discharge. Methods. Standard care was compared to medication reconciliation led by a clinical pharmacologist in a prospective randomized trial of 410 elective surgical patients. Medication discrepancies at hospital admission and discharge were identified and reconciled. Clinical outcomes were evaluated by reviewing electronic health records. Results. In the intervention group the frequency of unintentional discrepancies at hospital admission decreased from 32.68 to 16.86%, the proportion of patients with at least one unintentional discrepancy decreased from 64.9 to 44.9%, the number of discrepancies per patient decreased from 1.5 to 0.66. The incidence of discrepancies at hospital discharge decreased from 82.90 to 43.29%, the proportion of patients with discrepancies decreased from 95.61 to 52.68%, the average number of discrepancies per patient decreased from 2.79 to 1.67. Medication reconciliation led by clinical pharmacologist decreased the frequency of unscheduled out-patient visits after discharge from 7.32 to 2.93%. The determined risk factors for unintentional discrepancies at hospital admission were: prescribing of cardiovascular, endocrine drugs and those affecting the central nervous system. Both at admission and discharge medication reconciliation was the significant factor reducing the risk of unintentional discrepancies. Conclusions. Medication reconciliation at hospital admission and discharge reduces the frequency of unintentional discrepancies in drug prescriptions by 16 and 40%, respectively. The implementation of medication reconciliation into clinical practice reduces unscheduled out-patient visits after hospital discharge.
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