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Using data from the UK National Reporting and Learning System and the National Health Service Litigation Authority, this paper assesses trends in patient safety incidents and litigation in relation to ophthalmic surgery generally ...
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Using data from the UK National Reporting and Learning System and the National Health Service Litigation Authority, this paper assesses trends in patient safety incidents and litigation in relation to ophthalmic surgery generally and vitreoretinal (VR) surgery in particular. Examples of human error and equipment-related incidents in VR surgery are discussed. Data from incident reporting and litigation should be interpreted with care as these are influenced by many factors. An open culture, improved reporting and prioritisation of patient safety will help provide further insight into the prevalence and causes of patient safety incidents in VR surgery.
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Background The advance of medical treatment in renal cell carcinoma (RCC) has fostered the development of diverse continuous oral therapies with tyrosine kinase inhibitors (TKI), among these sunitinib remains the mainstay of thera...
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Background The advance of medical treatment in renal cell carcinoma (RCC) has fostered the development of diverse continuous oral therapies with tyrosine kinase inhibitors (TKI), among these sunitinib remains the mainstay of therapy for most of the patients. Based on its clinical activity, disease control over a period of 11 months can be expected with sunitinib treatment. Given this prolonged period of exposure to sunitinib, adverse events tend to reoccur and can possibly decrease the quality of life in our patients. Hence, development of modalities to detect, treat and cope with such adverse events has become a major focus for physicians and patients. Today, numerous publications address these questions and offer advice from experienced centers. However, these reviews summarize single or oligo-center experiences.
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Regorafenib is the first tyrosine kinase inhibitor approved for metastatic colorectal cancer. In 2 phase III trials, regorafenib significantly improved progression-free and overall survival in patients who had been previously trea...
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Regorafenib is the first tyrosine kinase inhibitor approved for metastatic colorectal cancer. In 2 phase III trials, regorafenib significantly improved progression-free and overall survival in patients who had been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor therapy, and, if (K)RAS wild type, an anti-epidermal growth factor receptor therapy. Its safety profile is in line with other multikin ase and/or tyrosine kinase inhibitors approved for different indications. Commonly reported adverse events specifically associated with regorafenib include hand-foot skin reaction and hypertension, whereas others such as fatigue, diarrhea, and liver dysfunction may occur during both targeted and cytotoxic treatments. These adverse events frequently occur within the first cycles of treatment, are transient, and decrease in incidence over time. Patient selection, education, and management, as well as close communication between oncologists or trained nurses and patients, are essential for prevention and mitigation of treatment toxicity as is rapid implementation of dose modifications and temporary discontinuations. Effective management of adverse events enables patients who are responding to stay on treatment for a substantial period of time and thereby receive the full benefit of regorafenib therapy. This review aims to provide guidance around prophylaxis and management of regorafenib-associated adverse events.
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Abstract Lenvatinib is an oral multikinase inhibitor approved for use as first‐line treatment for patients with advanced hepatocellular carcinoma (HCC). However, like other agents in this drug class, lenvatinib is associated with...
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Abstract Lenvatinib is an oral multikinase inhibitor approved for use as first‐line treatment for patients with advanced hepatocellular carcinoma (HCC). However, like other agents in this drug class, lenvatinib is associated with clinically important adverse events (AEs) that could adversely affect patient outcomes. Hypertension, diarrhea, decreased appetite/weight, hand–foot skin reaction, and proteinuria are among the most common AEs associated with lenvatinib therapy. This article provides strategies for the effective management of lenvatinib‐associated AEs based on the expert opinion of authors and currently available literature. Due to the high risk of AEs in patients receiving lenvatinib, prophylactic measures and regular monitoring for AEs are recommended. Lenvatinib dose interruption, adjustment, or discontinuation of treatment may be required for patients who develop AEs. For grade 1 or 2 AEs, dose interruption is generally not required. For persistent or intolerable grade 2 or 3 AEs, lenvatinib treatment should be interrupted until symptoms improve/resolve to grade 0–1 or baseline levels. Thereafter, treatment should be resumed at the same or a lower dose. Disease progression may occur in patients who do not initially respond to treatment or receive a suboptimal lenvatinib dose following dose reduction, resulting in lack of efficacy. Therefore, to derive maximum treatment benefit and ensure long‐term disease control, lenvatinib should be maintained at the highest possible dose when managing AEs. To conclude, lenvatinib‐associated AEs can be managed with prophylactic measures, regular monitoring and symptomatic management, which can ensure continued treatment and maximum survival benefit in patients with advanced HCC receiving first‐line lenvatinib therapy.
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IMPORTANCE Most adults 65 years or older have multiple chronic conditions. Managing these conditions with prescription drugs can be costly, particularly for older adults with limited incomes. OBJECTIVE To estimate hypothetical out...
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IMPORTANCE Most adults 65 years or older have multiple chronic conditions. Managing these conditions with prescription drugs can be costly, particularly for older adults with limited incomes. OBJECTIVE To estimate hypothetical out-of-pocket costs associated with guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases among older adults with Medicare prescription drug plans (PDPs). DESIGN, SETTING, AND PARTICIPANTS This retrospective cross-sectional study used 2009 and 2019 Medicare prescription drug plan formulary files to estimate annual out-of-pocket costs among hypothetical patients enrolled in Medicare Advantage or stand-alone Medicare Part D plans. A total of 3599 PDPs in 2009 and 3618 PDPs in 2019 were included after inclusion and exclusion criteria were applied. Costs associated with guideline-recommended medications for 8 of the most common chronic diseases (atrial fibrillation, chronic obstructive pulmonary disease [COPD], heart failure with reduced ejection fraction, hypercholesterolemia, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes), alone and in 2 clusters of commonly comorbid conditions, were examined. MAIN OUTCOMES AND MEASURES Annual out-of-pocket costs for each chronic condition, inflation adjusted to 2019 dollars. RESULTS Among 3599 Medicare PDPs in 2009, 1998 were Medicare Advantage plans and 1601 were stand-alone plans; among 3618 Medicare PDPs in 2019, 2719 were Medicare Advantage plans and 899 were stand-alone plans. For an older adult enrolled in any Medicare PDP in 2019, the median annual out-of-pocket costs for individual conditions varied, from a minimum of $32 (IQR, $6-$ 48) for guideline-recommended management of osteoporosis (a decrease from $128 [IQR, $102-$183] in 2009) to a maximum of $1579 (IQR, $1524-$2229) for guideline-recommended management of atrial fibrillation (an increase from $91 [IQR, $73-$124] in 2009). For an older adult with a cluster of 5 commonly comorbid conditions (COPD, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes) enrolled in any PDP, the median out-of-pocket cost in 2019 was $1999 (IQR, $1630-$2564), a 12% decrease from $2284 (IQR, $1920-$3107) in 2009. For an older adult with all 8 chronic conditions (atrial fibrillation, COPD, diabetes, hypercholesterolemia, heart failure, hypertension, osteoarthritis, and osteoporosis) enrolled in any PDP, the median out-of-pocket cost in 2019 was $3630 (IQR, $3234-$5197), a 41% increase from $2571 (IQR, $2185-$3719) in 2009. CONCLUSIONS AND RELEVANCE In this cross-sectional study, out-of-pocket costs for guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases varied by condition. Although costs generally decreased between 2009 and 2019, particularly with regard to conditions for which generic drugs were available, out-of-pocket costs remained high and may have presented a substantial financial burden for Medicare beneficiaries, especially older adults with conditions for which brand-name drugs were guideline recommended.
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ObjectiveThe aim of this study was to determine if emergency medicine specific triggers for completing an incident form could be agreed and if a common definition for contributory factors could be achieved. Such definitions could ...
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ObjectiveThe aim of this study was to determine if emergency medicine specific triggers for completing an incident form could be agreed and if a common definition for contributory factors could be achieved. Such definitions could be used to improve safety within the emergency department (ED) and share learning across the specialty.Participants and methodsOne hundred and fifteen ED safety leads in the UK and Ireland were invited to participate in a Delphi study. This process took 1 year to complete. In the first round, participants listed 20 events that should be reported as an adverse event and 20 contributory factors that could contribute to risk or harm. An 80% concordance level was sought for both aspects.ResultsEighty-four per cent of safety leads participated in the first round, although this decreased over subsequent rounds to 43%. Four hundred and eighty-five triggers were initially suggested; eventually, 27 triggers that should always or usually be reported achieved 80% concordance. Sixty-eight contributory factors were initially identified with eventual agreement being reached on 27 remediable contributory factors.ConclusionThe process demonstrated agreement amongst emergency physicians in the UK and Ireland on the type of events that should be formally reported. The lists emerging from this process should not be viewed as exhaustive; rather they should be used to encourage the reporting of incidents and designing safer systems and processes within the ED.
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Abstract The outcome of lupus nephritis (LN) has changed since the introduction of glucocorticoids (GCs), which dramatically reduced the mortality related to one of the most severe complications of systemic lupus erythematosus (SL...
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Abstract The outcome of lupus nephritis (LN) has changed since the introduction of glucocorticoids (GCs), which dramatically reduced the mortality related to one of the most severe complications of systemic lupus erythematosus (SLE). Since the 1950′s, other immunosuppressants, including biologic drugs (i.e. rituximab) have aided in maintaining remission, preserving kidney function, but not preventing treatment-related toxicity. GCs still remain the cornerstone in the treatment of SLE, including LN, and they are widely used in clinical practice. However, GC administration represents a double-edged sword. Indeed, from one side they allow a fast and effective control of disease activity by dampening inflammation; from the other side, they have many and severe side effects leading to organ damage. In this paper, we will discuss pros and cons of the chronic use of GCs, especially focusing on LN.
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Objective The objective of this article is to review the current supporting literature for the use of oral oncolytics in chronic lymphocytic leukemia, consideration for their use and management of adverse drug events that may limi...
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Objective The objective of this article is to review the current supporting literature for the use of oral oncolytics in chronic lymphocytic leukemia, consideration for their use and management of adverse drug events that may limit use. Data Sources NCCN guidelines were utilized to determine available oral options for treatment of chronic lymphocytic leukemia. A literature review was carried out through PubMed to find relevant clinical trials that evaluated the efficacy and safety of Bruton's tyrosine kinase inhibitors, BCL-2 inhibitors and PI3K-δ inhibitors. Medication package inserts and primary literature regarding toxicity were used to determine appropriate adverse drug event management. Data Summary A total of 7 clinical trials were found for the evaluation the efficacy and safety of burton tyrosine kinase inhibitor, 1 clinical trial for the BCL-1 inhibitor venetoclax and 4 trials were for PI3K-δ inhibitors. The data from these studies suggest that ibrutinib can be used first line in previously untreated patients and relapsed/refractory patients as well as acalabrutinib. The data also support the use of venetoclax, idelalisib, and duvelisib in relapsed/refractory chronic lymphocytic leukemia patients. Conclusions The use of oral-only oncolytics could be a viable option for reducing the risk of infection due to limiting exposure to healthcare settings. Current literature suggests oral oncolytics may be an option, but there are several considerations to evaluate including medication adherence, drug-drug interactions, adverse events, and financial toxicity.
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Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic ne...
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Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic neurotoxicity has been identified.
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