Medication-related Adverse Events Research Articles

Continuities and discontinuities in pharmaceutical treatment and medication use among older chronically ill patients of Turkish descent in Germany: a qualitative structuring content analysis.

Polypharmacy occurs frequently among older adults and is associated with an increased risk of falls and medication-related adverse events. In particular, people with a history of migration may receive inappropriate medication due to language barriers or discrimination in healthcare. This study aims to assess the continuities, discontinuities and barriers to drug therapy in older migrants of Turkish descent in Berlin, Germany. Eleven problem-centered qualitative interviews with chronically ill older persons of Turkish descent and family caregivers were conducted and analyzed qualitatively by means of structuring content analysis. The chronically ill participants of Turkish descent predominantly take more than 5 types of medication per day and aim to take them regularly. Discontinuities emerge when medication is forgotten or intentionally omitted due to side effects. Frequent changes in medication and physicians' lack of time are relevant barriers to drug treatment plans. To avoid language barriers and disinterest on the part of professionals, respondents prefer Turkish-speaking physicians.

Antibiotic Diversity Index: A novel metric to assess antibiotic variation among hospitalized children.

Despite nationally endorsed treatment guidelines and stewardship programs, variation and deviation from evidence-based antibiotic prescribing occur, contributing to inappropriate use and medication-related adverse events. Measures of antibiotic prescribing variability can aid in quantifying this problem but are not adequate. The objective of this study is to develop a standardized metric to quantify antibiotic prescribing variability (diversity) within and across children's hospitals, and to examine its association with outcomes. We performed a cross-sectional study of empiric antibiotic exposure among children hospitalized during 2017-2019 with one of 15 common pediatric infections using the Pediatric Health Information System database. Encounters for children with complex chronic conditions, transfers in, and birth hospitalizations were excluded. Using the Shannon-Weiner entropy index, we quantified antibiotic diversity for each infection type using the d-measure of diversity. Generalized linear mixed-effects models were used to examine the association between hospital-level antibiotic diversity and risk-adjusted length of stay and costs. A total of 79,515 hospitalizations for common pediatric infections were included. Antibiotic diversity varied within and across hospitals. Infections with low mean antibiotic diversity included appendicitis (mean diversity [mDiv] = 4.9, SD = 2.5) and deep neck space infections (mDiv = 5.9, SD = 1.9). Infections with high mean antibiotic diversity included pneumonia (mDiv = 23.4, SD = 5.6) and septicemia/bacteremia (mDiv = 28.5, SD = 12.1). There was no statistically significant association between hospital-level antibiotic diversity and risk-adjusted LOS or costs. We developed and applied a novel metric to quantify diversity in antibiotic prescribing that permits comparisons across hospitals and can be leveraged to identify high-priority areas for local and national stewardship interventions.

Eighteen-Month Real-World Experience Using Mavacamten for Treatment of Obstructive Hypertrophic Cardiomyopathy in a Racially Diverse Population.

Patients with obstructive hypertrophic cardiomyopathy have increased symptomatic burden. Mavacamten was recently approved for treatment of obstructive hypertrophic cardiomyopathy based on 2 randomized controlled trials. However, its use under real-world conditions and in diverse populations is under-studied. This was a prospective observational cohort study of patients seen at the Johns Hopkins HCM center and prescribed mavacamten for obstructive hypertrophic cardiomyopathy between July 7, 2022 and January 6, 2024. Patients were followed longitudinally, with serial echocardiography and clinical evaluation as mandated by the risk evaluation and mitigation strategy program. Sixty-six patients received mavacamten (mean age 59 years, 47% male, 29% non-White [Black, Hispanic/Latino, Asian, Native Hawaiian or Pacific Islander], 47% obese). Before treatment, all patients had New York Heart Association class II (51.5%) or III (48.5%) heart failure symptoms. Initial maximum peak left ventricular outflow tract gradient was 107±46 mm Hg. Median treatment duration was 9 months. For patients on mavacamten after ≥6 months (n=43), symptoms improved by ≥1 New York Heart Association class in 72% of patients, and peak left ventricular outflow tract gradient decreased by 80±46 mm Hg, eliminating hemodynamically significant left ventricular outflow tract obstruction in 79.1% of patients. Mavacamten was temporarily discontinued in 3 patients due to left ventricular ejection fraction decrease <50%. There were no medication-related adverse events. Effectiveness and safety were similar between White and non-White patients, but symptomatic relief was attenuated in patients with body-mass index ≥35 kg/m2. Mavacamten was effective and safe when used under real-world conditions in a racially diverse population of symptomatic patients with obstructive hypertrophic cardiomyopathy. Patients with comorbid obesity were less likely to experience symptomatic improvement while on mavacamten.

Prescription and Dispensation of QT-Prolonging Medications in Individuals Receiving Hemodialysis

Individuals with dialysis-dependent kidney failure have numerous risk factors for medication-related adverse events, including receipt of care by multiple clinicians and initiation of some QT-prolonging medications with known risk of torsades de pointes (TdP), which is associated with higher risk of sudden cardiac death. Little is known about the prescription and dispensation patterns of QT-prolonging medications among people receiving dialysis, hindering efforts to reduce drug-related harm from these and other medications in this high-risk population. To examine prescription and dispensation patterns of QT-prolonging medications with known TdP risk and selected interacting medications prescribed to individuals receiving hemodialysis. This cross-sectional study included patients 60 years or older who were enrolled in Medicare Parts A, B, and D receiving in-center hemodialysis from January 1 to December 31, 2019. Analyses were conducted from October 20, 2022, to June 16, 2023. New-user prescriptions for the 7 most frequently filled QT-prolonging medications characterized by the timing of the new prescription relative to acute care encounters, the type of prescribing clinician and pharmacy that dispensed the medication, and concomitant use of selected medications known to interact with the 7 most frequently filled QT-prolonging medications with known TdP risk. The main outcomes were the frequencies of the most commonly filled and new-use episodes of QT-prolonging medications; the timing of medication fills relative to acute care events; prescribers and dispensing pharmacy characteristics for new use of medications; and the frequency and types of new-use episodes with concurrent use of potentially interacting medications. Of 20 761 individuals receiving hemodialysis in 2019 (mean [SD] age, 74 [7] years; 51.1% male), 10 992 (52.9%) filled a study drug prescription. Approximately 80% (from 78.6% for odansetron to 93.9% for escitalopram) of study drug new-use prescriptions occurred outside of an acute care event. Between 36.8% and 61.0% of individual prescriptions originated from general medicine clinicians. Between 16.4% and 26.2% of these prescriptions occurred with the use of another QT-prolonging medication. Most potentially interacting drugs were prescribed by different clinicians (46.3%-65.5%). In this cross-sectional study, QT-prolonging medications for individuals with dialysis-dependent kidney failure were commonly prescribed by nonnephrology clinicians and from nonacute settings. Prescriptions for potentially interacting medications often originated from different prescribers. Strategies aimed at minimizing high-risk medication-prescribing practices in the population undergoing dialysis are needed.

Safety Profile of Seven-Day Intra-articular Antibiotic Irrigation for the Treatment of Chronic Periprosthetic Joint Infection: A Prospective Randomized Phase II Comparative Study

BackgroundSystemic intravenous antimicrobials yield poor outcomes during treatment of periprosthetic joint infection due to the inability to obtain minimum biofilm eradication concentrations. This study evaluated the safety of a novel method of optimized local delivery of intra-articular antibiotics (IAAs). MethodsThis was a Phase II, multicenter, prospective randomized trial evaluating safety of a rapid (seven-day) two-stage exchange arthroplasty with IAA irrigation compared to standard two-stage exchange. The Experimental Group received irrigation using 80 mg tobramycin daily with a 2-hour soak, followed by hourly irrigation using 125 mg vancomycin with a 30-minute soak via an intramedullary irrigation device. The Control Group received an antibiotic-loaded cement spacer with vancomycin (average 8.4 g) and tobramycin (average 7.1 g, total 16 g antibiotics). Both groups received 12 weeks of systemic antibiotics following Stage 2. Safety measures included adverse events, peak vancomycin/tobramycin serum concentrations (Experimental Group), blood transfusion, and mortality. There were thirty-seven patients randomized to the Experimental Group and 39 to control. There was no difference in baseline demographics or comorbidities. ResultsThere were no antibiotic medication-related adverse events and 2 serious adverse events related to antibiotic instillation. Of 188 vancomycin peak measurements, 69% had detectable serum level concentrations, with all concentrations well below the maximum acceptable trough threshold of 20 μg/mL. Of the 103 tobramycin peak measurements, 45% had detectable levels, with all below the maximum acceptable peak threshold of 18 to 24 μg/mL. There was no difference in blood transfused per subject (Experimental: 655 mL versus Control: 792 mL; P = .4188). There were two (2) deaths in the Experimental Group and four (4) in the control. ConclusionsThe use of IAA is safe with minimal systemic antibiotic exposure. There was no difference in the rates or severity of serious adverse events between groups. Further research is being conducted to examine treatment efficacy.

"Should We Phenobarb-it-All?" A Phenobarbital-Based Protocol for Non-Intensive Care Unit Trauma Patients at High Risk of or Experiencing Alcohol Withdrawal.

Alcohol use is frequent in trauma patients and alcohol withdrawal syndrome (AWS) is associated with significant morbidity. Benzodiazepines are commonly used for AWS, but may cause neurologic and respiratory adverse events (AEs). The objective was to evaluate the effectiveness and safety of a phenobarbital-based protocol for the treatment of AWS in non-intensive care unit (ICU) trauma patients. Adult non-ICU trauma patients at high risk of or experiencing AWS PRE and POST implementation of a phenobarbital-based protocol were included. Outcomes were AWS-related complications (AWS-RC), benzodiazepine use, adjunctive medication use, hospital length of stay (HLOS), and medication-related AEs. Subgroup analyses were performed on patients with traumatic brain injury (TBI), rib fractures, and at high risk of severe AWS. Overall, 110 patients were included (51 PRE, 59 POST). AWS-RC developed in 17 PRE patients compared to 10 POST patients (33% vs 17%; P = .05). PRE patients were more likely to receive benzodiazepines (88% vs 42%, P < .0001) and higher total dose (11 vs 4mg lorazepam equivalent; P = .001). No difference noted in HLOS (8 vs 8 days, P = .27), adjunctive medication use (49% vs 54%, P = .60), or AEs (57% vs 39%, P = .06). There was no difference in AWS-RC in the TBI subgroup (P = .19), less AEs in the rib fracture POST subgroup (P = .04), and less AWS-RC in the high risk of severe AWS POST subgroup (P = .03). A phenobarbital-based protocol in trauma patients is effective in preventing AWS-RC and decreasing benzodiazepine use without increasing AEs.

Unraveling the Enigma: Understanding Adverse Drug Reactions and its Impact in Medical Care

Adverse drug reactions, also known as medication-related adverse events, are harmful occurrences caused on by medication. ADRs may increase the pressure on the healthcare system and have a significant negative impact on patients' quality of life. With the increasing complexity of medications used to treat a wide range of diseases in an aging society, adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality on a global scale and will remain a major public health concern. ADRs are largely determined by a variety of factors, some of which are social, pharmacological, or patient-related. For example, age plays a significant role in the incidence of adverse drug reactions (ADRs); patients in the highest age groups are more susceptible to these reactions than those in lower age groups. The impact of specific factors on adverse drug reaction (ADR) occurrence, the pharmacovigilance process, and reporting were covered in this study. Medical literature has extensive documentation of these factors' impacted on adverse drug reactions. During medical evaluation, medical professionals can select the most effective medication regimen by taking these factors into account.

Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study

IntroductionTopical non-steroidal anti-inflammatory drugs (NSAIDs) are useful for a variety of musculoskeletal injuries. It is not known whether topical NSAIDs should be used for patients presenting with acute non-radicular musculoskeletal low back pain (LBP). MethodsWe conducted a randomized, placebo-controlled double-blind study in which ED patients 18-69 years with acute, non-traumatic, non-radicular, musculoskeletal LBP were randomized at the time of discharge to treatment with oral ibuprofen 400mg orally + placebo topical gel, 1% diclofenac topical gel + oral placebo, or ibuprofen 400mg + 1% diclofenac topical gel. We measured outcomes using the Roland Morris Disability Questionnaire (RMDQ), a 24-item yes/no instrument about the impact of back pain on a respondent’s daily activities. The primary outcome was change in RMDQ between ED discharge and two days later. Medication related adverse events were elicited by asking whether the study medications caused any new symptoms. Results3281 patients were screened for participation and 198 were randomized. Overall, 36% of the population were women, the mean age was 40 years (SD 13), and the median RMDQ score at baseline was 18 (25th, 75th percentile: 13, 22) indicating substantial low back related functional impairment. 183 (92%) participants provided primary outcome data. By two days after the ED visit, the ibuprofen + placebo group had improved by 10.1(95%CI 7.5 to 12.7), the diclofenac gel + placebo group by 6.4(95%CI 4.0 to 8.8), and the ibuprofen + diclofenac gel by 8.7(95%CI 6.3 to 11.1). The 95%CI for between group differences were as follows-- ibuprofen versus diclofenac: 3.7 (0.2, 7.2); ibuprofen versus both medications 1.4 (-2.1, 4.9); diclofenac versus both medications -2.3 (-5.7, 1.0). Medication related adverse events were reported by 3/60 (5%) ibuprofen patients, 1/63 (2%) diclofenac patients, and 4/64 (6%) patients who got both. ConclusionsAmong patients with non-traumatic, non-radicular acute musculoskeletal low back pain discharged from an ED, topical diclofenac was probably less efficacious than oral ibuprofen. It demonstrated no additive benefit when co-administered with oral ibuprofen.

Effect of Sirolimus on Vascular Malformations in Adult Populations

Introduction: Vascular anomalies encompass a wide spectrum of disorders defined by abnormal development/growth of blood and/or lymphatic vessels. Medical treatment for vascular malformations has focused mostly on pathways that are involved in abnormal vascular proliferation. Sirolimus, a mTOR inhibitor that is regulated by the PI3K/AKT signaling pathway has been studied as an off-label treatment modality for vascular anomalies, with most studies being centered on the effect of sirolimus in pediatric populations. Few studies have evaluated the safety and efficacy of sirolimus use in treating vascular malformations in adult populations. We developed a single center study to look at adults diagnosed with vascular malformations and the effect of sirolimus. Methods: In this retrospective study, we included all adult patients diagnosed with a vascular malformation and prescribed sirolimus for their malformation from January 2000 to July 2023 at Oregon Health &amp; Science University (OHSU). We received IRB approval (OHSU IRB Number: STUDY00025570) to collect patient demographics, pertinent medical history, laboratory values, response to sirolimus, side effects from sirolimus, use of other medications while taking sirolimus, and reasons for discontinuation of sirolimus through individual chart review. Patients were identified by using OHSU's Oregon Clinical and Translational Research Institute Cohort Discovery Tool using the search terms: sirolimus, age &amp;gt;18, and vascular malformations. Additional patients were identified by assessing referrals to the OHSU Hematology Clinic to capture patients not identified with the cohort discovery tool. Results: Seventeen patients were identified that met study criteria. The median age was 35 years, with ages ranging from 18-56 years. 23.5% of the patients (n=4) were male and 76.5% (n=13) were female. Of the 17 patients, 10 stopped sirolimus within one year. One patient continued sirolimus for 1.8 years with four patients continuing sirolimus indefinitely. The median time taking sirolimus was 217 days. All patients were started on a dose of 0.8mg/m2 twice daily, with a goal trough level of 8-15mg. Thirteen (76.4%) patients experienced side effects. The most common side effects were mucositis (41.1%, n=7) and GI side effects (17.6%, n=3) such as nausea and/or vomiting. All patients who experienced an adverse event, experienced a CTCAE Grade 3 or less adverse event attributed to sirolimus. Eleven patients (64.7%) experienced a Grade 1 or 2 adverse event and two patients (11.8%) experienced a Grade 3 adverse event. The Grade 3 adverse events included one patient who developed a pulmonary embolism and one patient who developed significant allergy-related angioedema while on sirolimus, which lead to prompt discontinuation. Eleven patients (64.7%) did not perceive any benefit from sirolimus, which eventually lead to discontinuation of sirolimus. Fifteen patients (88%) were followed symptomatically and two patients (11.8%) were followed on imaging. One patient who received MRI imaging after a 9 month course of sirolimus showed interval improvement of their vascular malformation. Conclusions: Sirolimus has been suggested to be beneficial to patients who have vascular malformations, although the majority of data has been accrued in pediatric cohorts. Our findings demonstrate that sirolimus is a relatively well tolerated medication in adults, with minimal severe medication related adverse events with only 11.8% of patients experiencing a CTCAE Grade 3 adverse event. However, most adults in our study (64.7%) did not perceive a benefit from sirolimus for their vascular malformations and 58.8% of patients stopped sirolimus within one year. It is still unclear the efficacy of sirolimus for the treatment of vascular malformations in an adult population and more research is needed to fully elucidate the benefits and risks of sirolimus for patients with vascular malformations.

The impact of outpatient pharmacological optimization on echocardiographic parameters in heart failure with reduced ejection fraction

Abstract Background The 2022 landmark STRONG-HF study demonstrated that aggressive uptitration of guideline directed medical therapy (GDMT) in patients recently hospitalized for heart failure leads to a reduction in the composite endpoint of heart failure hospitalization and mortality. However, the impact of optimization of GDMT on echocardiographic parameters in heart failure with reduced ejection fraction (HFrEF) is unknown. Purpose This goal of this study was to determine the impact of a virtual HFrEF optimization program for achieving GDMT uptake and its impacts of echocardiographic parameters. Methods We conducted a single center study at a Canadian community cardiovascular centre using a prospective pre-post design. NYHA class II/III HFrEF patients referred from inpatient and outpatient settings were enrolled in our virtual 3-month HFrEF optimization program. All participants underwent an initial consult with a nurse and cardiologist. After this, all patients were seen remotely by a nurse every two weeks for adjustment of HFrEF medications with the goal of maximally tolerated GDMT dosing within 3 months was. Transthoracic echocardiograms were performed prior to participation in the program &amp; after completion. Results Over 9 months, 284 NYHA class II/III HFrEF patients enrolled in the virtual HFrEF optimization program. Mean age was 67 and 70% were male. Mean ejection fraction was 34% and 54% had New York Heart Association Class II symptoms. At intake, the proportion of patients prescribed each class of GDMT was: 69% for Beta-blockers, 23% for Mineralocorticoid Receptor Inhibitors (MRA), 16% for Valsartan-Sacubitril and 7% for SGLT2 inhibitors. At 3-month follow-up, rates of GDMT prescription were improved: 90% for beta-blockers (p&amp;lt;0.01), 71% for MRA (p&amp;lt;0.01), 95% for ARNI (p&amp;lt;0.01) and 79% for SGLT2i (p&amp;lt;0.01). From baseline to follow-up echocardiogram, mean Left Ventricular End Diastolic Diameter improved from 5.51 to 5.13 cm (p&amp;lt;0.01). Mean Left Ventricular End Systolic Diameter improved from 4.33 to 3.75 cm (p&amp;lt;0.01). Mean Left Ventricular Mass Index was improved from 112.5 to 102.5 g/m2 (p&amp;lt;0.01). Mean Left Ventricular Ejection Fraction improved 34.4% to 49.8% (p&amp;lt;0.01). No hospitalizations due to medication-related adverse events were reported and 18 patients were hospitalized for HF exacerbation during study follow-up. Mean serum creatinine increased from 97.4 to 104.5 µmol/L (p&amp;lt;0.01); mean serum potassium increased from 4.48 to 4.58 (p&amp;lt;0.01). Conclusions This study demonstrates that a virtual program for GDMT optimization can safely and rapidly promote uptake of therapy in HFrEF patients. Furthermore, medical optimization was associated with significant reductions in left ventricular size, mass and ejection fraction. This provides a structural explanation for reductions in morbidity and mortality seen in STRONG-HF. Future studies should examine the effect of similar interventions on patient outcomes in a randomized setting.

Frailty and Its Implications in Heart Failure with Reduced Ejection Fraction: Impact on Prognosis and Treatment.

Frailty affects half of all patients with heart failure with reduced ejection fraction (HFrEF) and carries a ∼2-fold increased risk of mortality. The relationship between frailty and HFrEF is bidirectional, with one condition exacerbating the other. Paradoxical to their higher clinical risk, frail patients with HFrEF are more often under-treated due to concerns over medication-related adverse clinical events. However, current evidence suggests consistent safety of HF medical therapies among older frail patients with HFrEF. A multidisciplinary effort is necessary for the appropriate management of these high-risk patients which focuses on the optimization of known beneficial therapies with a goal-directed effort toward improving quality of life.

Transgastric Jejunostomy (PEG-J) for Continuous Infusion of Levodopa-Carbidopa Intestinal Gel: An Approach for Parkinson's Disease Treatment.

BACKGROUND Parkinson's disease (PD) is a neurodegenerative disorder that often requires long-term management of motor symptoms. Continuous infusion of levodopa-carbidopa intestinal gel (LCIG) has shown promising results in alleviating motor fluctuations and improving quality of life. This study aimed to evaluate the efficacy and safety of transgastric jejunostomy (PEG-J) as a delivery method for LCIG in a cohort of 43 PD patients. MATERIAL AND METHODS Forty-three PD patients who were candidates for LCIG therapy underwent transgastric jejunostomy to facilitate continuous infusion of LCIG. The primary outcomes assessed were motor symptom improvement, reduction in motor fluctuations, and medication-related adverse events. Secondary outcomes included changes in quality of life, dyskinesia severity, and healthcare resource utilization. RESULTS The results of this study demonstrated significant improvements in motor symptoms, reduction in motor fluctuations, and enhanced quality of life following PEG-J for LCIG infusion. The treatment was generally well-tolerated, with a low incidence of procedure-related complications. Notably, the use of PEG-J allowed for precise and continuous delivery of LCIG, minimizing variations in drug absorption and ensuring consistent therapeutic levels. CONCLUSIONS Transgastric jejunostomy (PEG-J) offers an effective approach for the continuous infusion of LCIG in Parkinson's disease treatment. This method provides a stable and reliable delivery system, leading to improved symptom control and enhanced quality of life for PD patients.

Identification of Medication Prescription Errors and Factors of Clinical Relevance in 314 Hospitalized Patients for Improved Multidimensional Clinical Decision Support Algorithms.

Potential medication errors and related adverse drug events (ADE) pose major challenges in clinical medicine. Clinical decision support systems (CDSSs) help identify preventable prescription errors leading to ADEs but are typically characterized by high sensitivity and low specificity, resulting in poor acceptance and alert-overriding. With this cross-sectional study we aimed to analyze CDSS performance, and to identify factors that may increase CDSS specificity. Clinical pharmacology services evaluated current pharmacotherapy of 314 patients during hospitalization across three units of two Swiss tertiary care hospitals. We used two CDSSs (pharmaVISTA and MediQ), primarily for the evaluation of drug-drug interactions (DDI). Additionally, we evaluated potential drug-disease, drug-age, drug-food, and drug-gene interactions. Recommendations for change of therapy were forwarded without delay to treating physicians. Among 314 patients, automated analyses by both CDSSs produced an average of 15.5 alerts per patient. In contrast, additional expert evaluation resulted in only 0.8 recommendations per patient to change pharmacotherapy. For clinical pharmacology experts, co-factors such as comorbidities and laboratory results were decisive for the classification of CDSS alerts as clinically relevant in individual patients in about 70% of all decisions. Such co-factors should therefore be used for the development of multidimensional CDSS alert algorithms with improved specificity. In combination with local expert services, this poses a promising approach to improve drug safety in clinical practice.

Human Error Analysis and Modeling of Medication-Related Adverse Events in Taiwan Using the Human Factors Analysis and Classification System and Logistic Regression.

Medical institutions worldwide strive to avoid adverse medical events, including adverse medication-related events. However, studies on the comprehensive analysis of medication-related adverse events are limited. Therefore, we aimed to identify the error factors contributing to medication-related adverse events using the Human Factors Analysis and Classification System (HFACS) and to develop error models through logistic regression. These models calculate the probability of a medication-related adverse event when a healthcare system defect occurs. Seven experts with at least 12 years of work experience (four nurses and three pharmacists) were recruited to analyze thirty-seven medication-related adverse events. The findings indicate that decision errors, physical/mental limitations, failure to correct problems, and organizational processes were the four factors that most frequently contributed to errors at the four levels of the HFACS. Seven error models of two types (error occurrence and error analysis pathways) were established using logistic regression models, and the relative probabilities of failure factor occurrences were calculated. Based on our results, medical staff can use the error models as a new analytical approach to improve and prevent adverse medication events, thereby improving patient safety.

Medication-Related Adverse Events and Discordancies in Cystatin C–Based vs Serum Creatinine–Based Estimated Glomerular Filtration Rate in Patients With Cancer

Serum creatinine-based estimated glomerular filtration rate (eGFRcr) may overestimate the glomerular filtration rate (GFR) in patients with cancer. Cystatin C-based eGFR (eGFRcys) is an alternative marker of GFR. To determine whether the therapeutic drug levels and adverse events (AEs) associated with renally cleared medications were higher in patients with cancer whose eGFRcys was more than 30% lower than their eGFRcr. This cohort study analyzed adult patients with cancer at 2 major academic cancer centers in Boston, Massachusetts. These patients had their creatinine and cystatin C measured on the same day between May 2010 and January 2022. The date of the first simultaneous eGFRcr and eGFRcys measurement was considered to be the baseline date. The primary exposure was eGFR discordance, defined as an eGFRcys that was more than 30% lower than the eGFRcr. The primary outcome was risk of the following medication-related AEs within 90 days of the baseline date: (1) supratherapeutic vancomycin trough level greater than 30 μg/mL, (2) trimethoprim-sulfamethoxazole-related hyperkalemia (>5.5 mEq/L), (3) baclofen toxic effect, and (4) supratherapeutic digoxin level (>2.0 ng/mL). For the secondary outcome, a multivariable Cox proportional hazards regression model was used to compare 30-day survival of those with vs without eGFR discordance. A total of 1869 adult patients with cancer (mean [SD] age, 66 [14] years; 948 males [51%]) had simultaneous eGFRcys and eGFRcr measurement. There were 543 patients (29%) with an eGFRcys that was more than 30% lower than their eGFRcr. Patients with an eGFRcys that was more than 30% lower than their eGFRcr were more likely to experience medication-related AEs compared with patients with concordant eGFRs (defined as eGFRcys within 30% of eGFRcr), including vancomycin levels greater than 30 μg/mL (43 of 179 [24%] vs 7 of 77 [9%]; P = .01), trimethoprim-sulfamethoxazole-related hyperkalemia (29 of 129 [22%] vs 11 of 92 [12%]; P = .07), baclofen toxic effects (5 of 19 [26%] vs 0 of 11; P = .19), and supratherapeutic digoxin levels (7 of 24 [29%] vs 0 of 10; P = .08). The adjusted odds ratio for vancomycin levels more than 30 μg/mL was 2.59 (95% CI, 1.08-7.03; P = .04). Patients with an eGFRcys more than 30% lower than their eGFRcr had an increased 30-day mortality (adjusted hazard ratio, 1.98; 95% CI, 1.26-3.11; P = .003). Results of this study suggest that among patients with cancer with simultaneous assessment of eGFRcys and eGFRcr, supratherapeutic drug levels and medication-related AEs occurred more commonly in those with an eGFRcys more than 30% lower than their eGFRcr. Future prospective studies are needed to improve and personalize GFR estimation and medication dosing in patients with cancer.

Improving inpatient discharge workflows through pharmacist pending discharge medication orders.

Hospital discharge represents a difficult care transition for patients, with the potential for medication-related problems (MRPs) and adverse events. Medication reconciliation is widely accepted as a best practice to minimize MRPs at the time of discharge. Pharmacists can play a key role in identification and resolution of MRPs, although pharmacist reconciliation usually occurs after provider medication reconciliation. This workflow is often inefficient and results in duplication of work within the care team. A prospective pharmacist-led pilot program with preparation of discharge medication orders for provider review, also known as pended medication orders, was investigated to determine its impact on MRPs and discharge processing time. Patient discharges from February through April 2022 were compared for 2 hospital medicine services at a large academic medical center. One group participated in the pilot workflow, while the other used standard discharge workflows. The pilot group had a significant decrease in the average number of clinical interventions made by a pharmacist after provider orders were placed (52.4% decrease; P = 0.03) and a nonsignificant reduction in the time from provider order entry to completion of the final pharmacist medication reconciliation (47.6% reduction; P = 0.18) compared to the group using standard workflows. Pharmacist-led, prospective discharge medication reconciliation with pending of medication orders for provider review increases overall discharge efficiency. Data from this project and previous studies support an expanded pharmacist role in the discharge process and continued high-level collaboration between pharmacists and providers.

Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial.

Aged care residents are vulnerable to the harmful effects of medicines; however, data on the prevalence and preventability of adverse medicine events in aged care residents are scarce. To determine the prevalence and preventability of adverse medicine events in Australian aged care residents. A secondary analysis of data from the Reducing Medicine-Induced Deterioration and Adverse Reactions (ReMInDAR) trial was conducted. Potential adverse medicine events were identified and independently screened by two research pharmacists to produce a short-list of potential adverse medicine events. An expert clinical panel reviewed each potential adverse medicine to determine the likelihood that the event was medicine related (based on the Naranjo Probability Scale criteria). The clinical panel assessed preventability of medicine-related events using Schumock-Thornton criteria. There were 583 adverse events due to medicines, involving 154 residents (62% of the 248 study participants). There was a median of three medication-related adverse events (interquartile range [IQR] 1-5) per resident over the 12-month follow-up period. The most common medication-related adverse events were falls (56%), bleeding (18%) and bruising (9%). There were 482 (83%) medication-related adverse events that were preventable, most commonly falls (66% of preventable adverse medicine events), bleeding (12%) and dizziness (8%). Of the 248 residents, 133 (54% of the cohort) had at least one preventable adverse medicine event, with a median of 2 (IQR 1-4) preventable adverse medicine events per resident. In total, 62% of aged care residents in our study had an adverse medicine event and 54% had a preventable adverse medicine event in a 12-month period.

Perceptions of Indian Physicians towards Deprescribing of Medications for Chronic Diseases in Elderly: A Questionnaire-based Study

Abstract: Deprescribing is the process of reconstructing multiple medications use by review and analysis, which concludes with the modification, replacement or elimination of drugs. Medications that were once appropriate may become inappropriate due to age-related physiological changes that increase the risk of harm from medications eliminated by the liver and kidneys and other co-morbidities. In India, with a steadfast rise in the elderly population paralleled with an augmented necessity for chronic disease management, the essence of deprescribing is rarely known and less practiced by physicians. Hence, a questionnaire-based interventional study was conducted to assess their perception and attitude towards implementing the deprescribing process. The study included 75 physicians from the departments of General Medicine and Nephrology, who were initially educated on deprescribing through a self-developed and validated educational video of three minutes duration, following which they were asked to fill the Perceptions, Attitudes and Challenges of Physicians towards Deprescribing Questionnaire. About 76% of the physicians felt that deprescribing was needed to reduce medication-related problems in older patients. Involvement of multiple prescribers (54.6%) was the main challenge stated by physicians; 92% stated deprescribing to be beneficial in current clinical scenario, and 85.3% showed a positive attitude towards integrating deprescribing into their day-to-day clinical practice. Physicians below 40 years with an experience of 0 to 10 years had a significantly positive perception and attitude towards deprescribing. In view of reducing potential medication-related adverse events in the elderly, daily practice of the deprescribing process should become a norm, thereby improving the quality of life. Keywords: Comorbidities, Polypharmacy, Deprescribing, Elderly patients.

The UK psychiatrists' experience of rationalising antipsychotics in adults with intellectual disabilities: A qualitative data analysis of free-text questionnaire responses.

Overprescribing of off-licence psychotropic medications, particularly antipsychotics, for challenging behaviours in people with intellectual disabilities without a psychiatric disorder is a significant public health concern. In the United Kingdom, the National Health Service England launched an initiative in 2016, 'STopping Over-Medication of People with learning disabilities, autism or both (STOMP)', to address this concern. STOMP is supposed to encourage psychiatrists in the United Kingdom and elsewhere to rationalise psychotropic medication use in people with intellectual disabilities. The current study aims to gather UK psychiatrists' views and experience of implementing the STOMP initiative. An online questionnaire was sent to all UK psychiatrists working in the field of intellectual disabilities (estimated 225). Two open-ended questions allowed participants to write comments in response to these questions in the free text boxes. One question asked about the challenges psychiatrists faced locally to implement STOMP, and the other asked for examples of successes and positive experiences from the process. The free text data were analysed using a qualitative method with the help of the NVivo 12 plus software. Eighty-eight (estimated 39%) psychiatrists returned the completed questionnaire. The qualitative analysis of free-text data has shown variation within services in the experience and views of the psychiatrists. In areas with good support for STOMP implementation provided through adequate resources, psychiatrists reported satisfaction in the process with successful antipsychotic rationalisation, betterlocal multi-disciplinary and multi-agency working, and increased awareness of STOMP issues among the stakeholders such as people with intellectual disabilities and their caregivers and multidisciplinary teams, and improved quality of life caused by reduced medication-related adverse events in people with intellectual disabilities. However, where resource utilisation is not optimum, psychiatrists seemed dissatisfied with the process with little success in medication rationalisation. Whereas some psychiatrists are successful and enthusiastic about rationalising antipsychotics, others still face barriers and challenges. Much work is needed to achieve a uniformly positive outcome throughout the United Kingdom.

P523 Quality, safety and equity of care outcomes for inflammatory bowel disease patients at four tertiary referral centres in Australia using a cloud based management system Crohn’s Colitis Care (CCCare): A real world observational study.

Abstract Background Inflammatory bowel disease (IBD) is a global problem and Australia has amongst the highest prevalence rates. This study looked to assess the quality, safety and equity of care across four specialised IBD centres in Australia over a 12-month period using the cloud-based IBD clinical management system called Crohn’s Colitis Care (CCCare). This study aimed to define existing care at each centre and the range of performance across each centre to propose potential benchmarks for optimal quality IBD care. Methods The study was conducted across four tertiary IBD centres in Australia (Centres A, B, and C were public hospitals and D was a private centre). De-identified data within the backend CCCare research registry was audited between 1st of July 2021 to 31st August 2022. People with IBD who had a clinical assessment documented within the platform during this 12-month period were included. We assessed quality of IBD care using disease activity based on patient reported outcome measures (PROMs), biomarkers and endoscopy; surgery rates; health maintenance indicators including vaccination and skin cancer screening rates and; key performance indicators including steroid use, smoking rates and current opioid use. Safety of care was assessed using adverse events from therapy and hospital admission due to therapeutic complications. Equity of care examined education levels and ethnicity. Results A total of 1889 patients were included. 63% had Crohn’s disease and 37% had ulcerative colitis. 51% of the cohort was female. The median age was 39 years (IQR 30-53) and the median disease duration was 8.4 years (IQR 3.3-15.7) (Table 1). Current steroid use was between 6% to 15.4%. Faecal calprotectin (FCP) remission rates (250μg/mg) were between 65-84% and patient reported outcome (PRO-2) remission rates were between 76-88% with the highest rates observed at Centre D (Figure 1). 74 patients underwent a surgical procedure. COVID-19 vaccination rates were between 40.1% to 88.8% with the highest rates once again observed at Centre D. 3% of the cohort was documented as currently using opioid medications. 12.2% were recorded as currently smoking at Centre A compared to 2.6% at Centre D. 55 medication related adverse events were recorded and 94 patients had a hospital admission during the study period. Conclusion This study showcases how CCCare can readily provide researchers with granular, real-world data to audit the quality of IBD care at 4 specialised centres in Australia over a 12-month period. While there were some differences (higher vaccination rates, lower smoking and steroid use rates at Centre D), quality and safety of care was still fairly uniform across the various sites and can serve as a standard of care for IBD patients in Australia.