Abstract:Chronic kidney disease (CKD) confers a higher risk of adverse safety events as a result of many factors including medication dosing errors and use of nephrotoxic drugs, which can cause kidney injury and renal function decline. CKD patients may also have comorbidities such as hypertension and diabetes for which they require more frequent care from different providers, and for which standard, but countervailing treatments, may put them at risk for adverse safety events. Areas covered: In addition to the well-kno… Show more
“…In the present surveillance, the incidences of overall ADRs, particularly for ADRs related to renal impairment, and serious ADRs were numerically greater in the G4 and G5 subgroups than in the G1 subgroup. Patients with renal impairment are generally more prone to AEs due to multiple factors including comorbidities and the need for polypharmacy [51]. Indeed, in RUBY, the rate of comorbidities was higher in patients with advanced renal impairment.…”
Section: Safety In Patients With Renal Impairmentmentioning
Introduction: Teneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term postmarketing surveillance (RUBY) to obtain realworld evidence regarding the safety and efficacy of teneligliptin in Japan. Methods: This 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1-G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years. Results: Of 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin's package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24-7.14% and 0.65-5.36% in G1-G5, and 4.49% and 1.92% in patients on Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11298191.
“…In the present surveillance, the incidences of overall ADRs, particularly for ADRs related to renal impairment, and serious ADRs were numerically greater in the G4 and G5 subgroups than in the G1 subgroup. Patients with renal impairment are generally more prone to AEs due to multiple factors including comorbidities and the need for polypharmacy [51]. Indeed, in RUBY, the rate of comorbidities was higher in patients with advanced renal impairment.…”
Section: Safety In Patients With Renal Impairmentmentioning
Introduction: Teneligliptin is a dipeptidyl peptidase 4 inhibitor that was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. We performed a long-term postmarketing surveillance (RUBY) to obtain realworld evidence regarding the safety and efficacy of teneligliptin in Japan. Methods: This 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs) and laboratory variables. Data were evaluated in all patients and in patients divided according to baseline renal function across categories of estimated glomerular filtration rate (G1-G5) and dialysis. Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years. Results: Of 11,677 patients registered, 10,696 and 10,249 were evaluable for safety and efficacy analyses, respectively. The median duration of exposure was 1096 days. ADRs occurred in 412 patients (3.85%) and were serious in 117 patients (1.09%). The most frequent ADR class was gastrointestinal disorders (0.68%), which included constipation. There were no new ADRs warranting attention beyond those already described in teneligliptin's package insert. ADRs and serious ADRs in renal function subgroups occurred in 3.24-7.14% and 0.65-5.36% in G1-G5, and 4.49% and 1.92% in patients on Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11298191.
“…The complexity of this disease and its medical management predispose individuals to further complications of the cardiovascular and renal systems [3,4]. Underrecognition of impaired kidney functioning [5][6][7][8][9], presence of multiple comorbid conditions [3,5,10], and polypharmacy associated with management of comorbidities [6] often culminate in frequent hospital admissions. In a population of pre-dialysis patients with CKD in the Safe Kidney Care (SKC) Cohort Study, Ginsberg et al [4] reported that 70 % experienced at least one adverse safety incident or actionable safety finding, while over one-third had two or more.…”
Background
People living with chronic kidney disease (CKD) require complex medical management and may be frequently hospitalized. Patient safety incidents during hospitalization can result in serious complications which may negatively affect health outcomes. There has been limited examination of how these patients perceive their own safety.
Objectives
This study compared the safety perceptions of patients hospitalized with CKD using two approaches: (a) the Patient Measure of Safety (PMOS) questionnaire and (b) qualitative interviews. The study objectives were to: (1) assess concordance between qualitative and quantitative data on safety perceptions and (2) better understand safety as perceived by study participants.
Methods
A cross-sectional convergent mixed methods design was used. Integration at the reporting level occurred by weaving together patient narratives and survey domains through the use of a joint display. Interview data were merged with results of the PMOS on a case-by-case basis for analysis to assess for concordance or discordance between these approaches to safety data collection.
Results
Of the 30 inpatients with CKD, almost one quarter (23.3 %) of participants reported low levels of perceived safety in hospitals. Four major themes emerged from the interviews: receiving safe care; expecting to be taken care of; expecting to be cared for; and reporting safety concerns. Suboptimal communication, delays in care and concerns about technical aspects of care were common to both forms of data collection. Concordance was noted between qualitative and quantitative data with respect to communication/teamwork, respect and dignity, staff roles, and ward type/lay-out. While interviews allowed for participants to share specific concerns related to safety about quality of interpersonal interactions, use of the questionnaire alone did not capture this concern.
Conclusions
Safety issues are a concern for in-patients with CKD. Both quantitative and qualitative approaches provided important and complementary insights into these issues. Narratives were mostly concordant with questionnaire scores. Findings from this mixed methods study suggest that communication, interpersonal interactions, and delays in care were more concerning for participants than technical aspects of care. Eliciting the concerns of people with CKD in a systematic fashion, either through interviews or a survey, ensures that hospital safety improvement efforts focus on issues important to patients.
“…Acetaminophen was the most usually used pain-relieving (34% of the entire CKD cohort), although the higher doses of acetaminophen used chronically have been accompanied by analgesic nephropathy (96). To avoid toxicity, it is proposed to not exceed 3 g/day of acetaminophen (97). For moderate pain, tramadol is preferred, given its low risk of direct nephrotoxicity (98).…”
Section: Opioidsmentioning
confidence: 99%
“…For moderate pain, tramadol is preferred, given its low risk of direct nephrotoxicity (98). The use of fentanyl, alfentanil, and hydromorphone is relatively safe in dialysis patients, but doses should be adjusted to minimize the risk of respiratory depression (97). However, adjuvant medications are useful for improving pain scores, decreasing opioid doses, and treating neuropathic components of pain in dialysis patients (99).…”
: Chronic kidney disease (CKD) is a global public health problem. Pain is one of the most generally experienced symptoms by CKD patients. Pain management is a key clinical activity; nonetheless, insufficient pain management by health professionals keeps it up. Opioids as pain relievers are a class of naturally-derived and synthetic medications. They act through interactions with receptors in peripheral nerves. Numerous pharmacokinetic alterations happen with aging that influence drug disposition, metabolism, and quality of life. Acetaminophen alone, or combined with low-potency opioid does is regarded as the safest pain-relieving choice for CKD. Morphine and codeine are probably eluded in renal impairment patients and used with excessive carefulness. Tramadol, oxycodone, and hydromorphone can be used by patient monitoring, while methadone, transdermal fentanyl, and buprenorphine seem to be safe to use in older non-dialysis patients with renal impairment. Consistent with the available literature, the main aim of this review was to explore the occurrence of chronic pain and its opioid treatment in CKD patients. Ac-cording to this review, more and well-made randomized controlled trials are necessary to find appropriate opioid doses and explore the occurrence of side effects.
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