Drug-induced Adverse Events

Using Follow-Up Telephone Calls to Identify Obstacles to Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting

Mon, 2023-11-27 06:00

Clin J Oncol Nurs. 2023 Nov 16;27(6):644-652. doi: 10.1188/23.CJON.644-652.

ABSTRACT

BACKGROUND: Despite advances in antiemetic regimens, uncontrolled chemotherapy-induced nausea and vomiting (CINV) remains a problem for patients receiving oncology treatment, leading to decreased quality of life and worse treatment outcomes.

OBJECTIVES: The purpose of this pilot project was to use follow-up telephone calls to identify barriers related to successful management and prevention of CINV on a single-center outpatient chemotherapy infusion unit.

METHODS: A mixed-methods descriptive design was used for this project. Quantitative data were used to assess barriers to management and prevention of CINV. Secondary multiple regression analysis was used to determine whether barriers could predict CINV. Qualitative data were used to analyze common barriers and themes.

FINDINGS: Of the patients called (N = 132), 50% identified a barrier to managing and treating CINV, with the most common barrier being knowledge gaps related to proper use of antiemetics.

PMID:38009878 | DOI:10.1188/23.CJON.644-652

Categories: Literature Watch

Validation of the French version of the Assessment Tool for Hospital Admissions Related to Medications (AT-HARM10) to detect drug-related hospitalizations

Sun, 2023-11-26 06:00

Therapie. 2023 Nov 17:S0040-5957(23)00183-X. doi: 10.1016/j.therap.2023.10.015. Online ahead of print.

ABSTRACT

Admissions of the elderly related to medication errors are frequent in hospital, more than half would be avoidable, but there is currently no validated method in French to identify them. The objective of this work was to validate the French version of the AT-HARM10 tool in order to use it for patients admitted in our healthcare facilities. The tool has 10 questions. A positive response to any of the first 3 questions identify admissions that are unlikely to be drug-related. A positive response to one of the following 7 questions identify possible medication-related admissions. For semantic and linguistic validation, we performed cross-validation with forward-backward translation. To clinically validate the method, we conducted a retrospective study including patients over 65 admitted to short-stay units (UHCD) and to orthopedic surgery units in two French hospitals. Two hundred and sixty-six (266) patients were included ; 166 patients admitted to UHCD (mean age 86.0±5.7 years; sex ratio 0.66; mean number of drugs prescribed 7.7±3.8) and 100 patients admitted to orthopedic units (mean age 85.2±6.1 years; sex ratio 0.43; mean number of prescribed drugs 6.4±3.6). We identified 55 % of admissions probably related to medication in UHCD and 76 % in orthopedic units (p<0.05). The most represented item was P5 in both groups (Might [side] effects of the medications the patient was taking [prescribed or not prescribed] prior to hospitalization have caused the admission [including over-treatment] ? The validated AT-HARM10 tool is now integrated into our clinical pharmacy practices and medication reviews are offered as a priority to patients admitted for iatrogenic reasons.

PMID:38008600 | DOI:10.1016/j.therap.2023.10.015

Categories: Literature Watch

Effectiveness of mud-pack therapy and mud-bath therapy in osteoarthritis. A systematic review

Sun, 2023-11-26 06:00

Complement Med Res. 2023 Nov 24. doi: 10.1159/000535437. Online ahead of print.

ABSTRACT

Background Osteoarthritis has a tremendous socioeconomic impact in terms of drug spending, hospital admissions, work productivity and temporary or permanent incapacity. Mud therapy has been discussed as a potential conservative treatment options for osteoarthritis. However, findings from several trials still remain controversial. Methods We conducted a systematic review of the literature on mud-therapy in the treatment of osteoarthritis in order to investigate the evidence of efficiency of this treatment. Results Of the 19 studies included, 15 examined the effects of mud-bath therapy in knee osteoarthritis treatment. We finally systematically reviewed the data obtained from literature and summarized the results on the basis of the main outcomes. The results show significant improvements in function, quality of life and perceived pain for patients with osteoarthritis. Conclusion Results of randomized controlled trials suggest that mud therapy is part of a promising integrated and synergistic multidisciplinary approach in combination with other treatment forms like pharmacotherapy or physiotherapy. Impressing drug- reduction of conventional treatment dosage was reported, possibly resulting in lesser costs and drug-related adverse events.

PMID:38008065 | DOI:10.1159/000535437

Categories: Literature Watch

Renal Side Effects of Novel Molecular Targeted Oncologic Agents

Sun, 2023-11-26 06:00

G Ital Nefrol. 2023 Oct 3;40(Suppl 81):2023-S81.

ABSTRACT

The introduction of innovative therapies has changed the scenario of complications. The delay in the recognition of kidney adverse effects is partly due to the timing of the development of the kidney damage which occurs later than the observation period of registration studies, and partly to the exclusion of patients with known kidney impairment from registration trials. Renal disease has a significant impact on the management of cancer patients and often leads to discontinuation of therapy. Histological evaluations of kidney disorders induced by targeted/immunotherapy are very limited. Renal biopsy is critical for the management of renal toxicities and should be especially encouraged for patients showing adverse renal effects to novel cancer agents. We recently examined the histological features of patients treated with new cancer agents who underwent renal biopsy for new onset renal failure and/or urinary abnormalities. The cohort included 42 patients. The most frequently administered therapies were immunotherapy (54.8%) and anti-angiogenic treatments (45.2%). The most common adverse effect was tubular interstitial nephritis in the first group and thrombotic microangiopathy in the second one. Based on histological findings, definitive discontinuation of treatment could be restricted to a very limited number of patients. All of them had anti-VEGF-related TMA. Treatment discontinuation was unneeded in patients treated with ICIs. In patients treated with multidrug therapy, the histological findings made it possible to identify the weight of drug-related specific injury. Based on this data, renal biopsy should be considered in every cancer patient who develops urinary abnormalities or shows a worsening of renal function during treatment with immunotherapy or targeted therapy.

PMID:38007829

Categories: Literature Watch

Side effects of chronic systemic glucocorticoid therapy: what dermatologists should know

Sat, 2023-11-25 06:00

An Bras Dermatol. 2023 Nov 24:S0365-0596(23)00242-8. doi: 10.1016/j.abd.2023.05.005. Online ahead of print.

ABSTRACT

In dermatologists' clinical practice, the use of systemic glucocorticoids is recurrent for the management of different comorbidities that require chronic immunosuppression. The prescription of this medication requires caution and basic clinical knowledge due to the several adverse effects inherent to the treatment. However, different doubts may arise or inappropriate conduct may be adopted due to the lack of objective and specific guidelines for the screening, prophylaxis and management of complications from chronic corticosteroid therapy. Considering this problem, the authors carried out a narrative review of the literature to gather up-to-date data on adverse effects secondary to the chronic use of systemic glucocorticoids. The broad approach to this topic made it possible to review the pathophysiology and risk factors for these complications, as well as to develop updated orientation that can be used as a learning tool and quick reference for dermatologists during their clinical practice with glucocorticoids.

PMID:38007314 | DOI:10.1016/j.abd.2023.05.005

Categories: Literature Watch

Impact of Pharmacogenomics in Clinical Practice

Sat, 2023-11-25 06:00

Pharmaceuticals (Basel). 2023 Nov 13;16(11):1596. doi: 10.3390/ph16111596.

ABSTRACT

Polymorphisms of genes encoding drug metabolizing enzymes and transporters can significantly modify pharmacokinetics, and this can be associated with significant differences in drug efficacy, safety, and tolerability. Moreover, genetic variants of some components of the immune system can explain clinically relevant drug-related adverse events. However, the implementation of drug dose individualization based on pharmacogenomics remains scarce. In this narrative review, the impact of genetic variations on the disposition, safety, and tolerability of the most commonly prescribed drugs is reported. Moreover, reasons for poor implementation of pharmacogenomics in everyday clinical settings are discussed. The literature analysis showed that knowledge of how genetic variations can modify the effectiveness, safety, and tolerability of a drug can lead to the adjustment of usually recommended drug dosages, improve effectiveness, and reduce drug-related adverse events. Despite some efforts to introduce pharmacogenomics in clinical practice, presently very few centers routinely use genetic tests as a guide for drug prescription. The education of health care professionals seems critical to keep pace with the rapidly evolving field of pharmacogenomics. Moreover, multimodal algorithms that incorporate both clinical and genetic factors in drug prescribing could significantly help in this regard. Obviously, further studies which definitively establish which genetic variations play a role in conditioning drug effectiveness and safety are needed. Many problems must be solved, but the advantages for human health fully justify all the efforts.

PMID:38004461 | DOI:10.3390/ph16111596

Categories: Literature Watch

Therapeutic Dosage of Antipsychotic Drug Aripiprazole Induces Persistent Mitochondrial Hyperpolarisation, Moderate Oxidative Stress in Liver Cells, and Haemolysis

Sat, 2023-11-25 06:00

Antioxidants (Basel). 2023 Oct 30;12(11):1930. doi: 10.3390/antiox12111930.

ABSTRACT

Aripiprazole has fewer metabolic side effects than other antipsychotics; however, there are some severe ones in the liver, leading to drug-induced liver injury. Repeated treatment with aripiprazole affects cell division. Since this process requires a lot of energy, we decided to investigate the impact of aripiprazole on rat liver cells and mitochondria as the main source of cellular energy production by measuring the mitochondrial membrane potential, respiration, adenosine triphosphate (ATP) production, oxidative stress, antioxidative response, and human blood haemolysis. Here, we report that mitochondrial hyperpolarisation from aripiprazole treatment is accompanied by higher reactive oxygen species (ROS) production and increased antioxidative response. Lower mitochondrial and increased glycolytic ATP synthesis demand more glucose through glycolysis for equal ATP production and may change the partition between the glycolysis and pentose phosphate pathway in the liver. The uniform low amounts of the haemolysis of erythrocytes in the presence of aripiprazole in 25 individuals indicate lower quantities of the reduced form of nicotinamide adenine dinucleotide phosphate (NADPH+H+), which is in accordance with a decreased activity of glucose 6-phosphate dehydrogenase and the lower dehydrogenase activity upon aripiprazole treatment. The lower activity of glucose 6-phosphate dehydrogenase supports a shift to glycolysis, thus rescuing the decreased mitochondrial ATP synthesis. The putative reduction in NADPH+H+ did not seem to affect the oxidised-to-reduced glutathione ratio, as it remained equal to that in the untreated cells. The effect of aripiprazole on glutathione reduction is likely through direct binding, thus reducing its total amount. As a consequence, the low haemolysis of human erythrocytes was observed. Aripiprazole causes moderate perturbations in metabolism, possibly with one defect rescuing the other. The result of the increased antioxidant enzyme activity upon treatment with aripiprazole is increased resilience to oxidative stress, which makes it an effective drug for schizophrenia in which oxidative stress is constantly present because of disease and treatment.

PMID:38001783 | DOI:10.3390/antiox12111930

Categories: Literature Watch

When I use a word . . . Medicines regulation-poisons

Fri, 2023-11-24 06:00

BMJ. 2023 Nov 24;383:2784. doi: 10.1136/bmj.p2784.

NO ABSTRACT

PMID:38000791 | DOI:10.1136/bmj.p2784

Categories: Literature Watch

Deprescribing: A Prime Opportunity to Optimize Care of Cancer Patients

Fri, 2023-11-24 06:00

Curr Oncol. 2023 Nov 2;30(11):9701-9709. doi: 10.3390/curroncol30110704.

ABSTRACT

Patients with incurable cancers have an increasing number of comorbidities, which can lead to polypharmacy and its associated adverse events (drug-to-drug interaction, prescription of a potentially inappropriate medication, adverse drug event). Deprescribing is a patient-centered process aimed at optimizing patient outcomes by discontinuing medication(s) deemed no longer necessary or potentially inappropriate. Improved patient quality of life, risk reduction of side effects or worse clinical outcomes, and a decrease in healthcare costs are well-documented benefits of deprescribing. Deprescribing and advance care planning both require consideration of patients' values, preferences, and care goals. Here, we provide an overview of comorbidities and associated polypharmacy risks in cancer patients, as well as useful tools and resources for deprescribing in daily practice, and we shed light on how deprescribing can facilitate advance care planning discussions with patients who have advanced cancer or a limited life expectancy.

PMID:37999124 | PMC:PMC10670366 | DOI:10.3390/curroncol30110704

Categories: Literature Watch

Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study

Wed, 2023-11-22 06:00

Sci Rep. 2023 Nov 22;13(1):20498. doi: 10.1038/s41598-023-47271-w.

ABSTRACT

Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study aimed to compare the safety and efficacy of remimazolam with those of midazolam for bronchoscopy. This prospective randomized parallel-group study was conducted at a single institution. The primary outcome was the time from the end of the procedure to full alertness. Other procedural time parameters, satisfaction profiles, and adverse effects were thoroughly evaluated. The time taken to reach peak sedation and the time from the end of the procedure to full alertness was significantly shorter in the remimazolam group than in the midazolam group (median [interquartile range], 2 min [1-4] vs. 3 min [2-5], P = 0.006; and median, 2 min [1-5] vs. 5 min [1-12], P = 0.035, respectively). In patients with non-biopsy procedures (n = 79), participant satisfaction was significantly higher in the remimazolam group than in the midazolam group (median rated scale, 10 vs. 7, P = 0.042). Physician satisfaction and willingness to repeat the procedure were similar between groups. Although the incidence of adverse effects was similar between the groups and there was no significant difference, the midazolam group had a higher antidote administration rate than the remimazolam group (15.7% vs. 4.1%, P = 0.092). Remimazolam is effective and safe for achieving adequate sedation, with a shorter onset time and faster neuropsychiatric recovery than midazolam. It may be a new option for sedation during bronchoscopy.Trial registration: The trial registration number is NCT05994547, and the date of first registration is 16/08/2023.

PMID:37993525 | PMC:PMC10665376 | DOI:10.1038/s41598-023-47271-w

Categories: Literature Watch

The impacts of economic policy uncertainty on firm cash holding in China

Wed, 2023-11-22 06:00

PLoS One. 2023 Nov 22;18(11):e0293306. doi: 10.1371/journal.pone.0293306. eCollection 2023.

ABSTRACT

Cash holding is an important strategic decision of enterprises. As a macro-level factor, economic policy uncertainty causes risks, affecting enterprises' cash holdings. Taking the quarterly financial data of China's A-share non-financial listed firms for 2010-2020 as a sample, this study adopts the OLS and fixed effect models to investigate how corporate cash holdings are affected by economic policy uncertainty. The findings indicate that economic policy uncertainty is directly proportional to the level of cash that listed corporations hold. The higher the uncertainty, the more cash the company holds. Among them, state-owned enterprises and the manufacturing industry are more significantly affected by economic policy uncertainty. Finally, considering the regional marketization level and the differences in financing constraints enterprises face, it is concluded through grouping empirical studies that enterprises located in regions with lower marketization levels are more susceptible to policy uncertainty, while financially constrained enterprises are more susceptible to economic policy uncertainty. The study of economic policy uncertainty is helpful to guide enterprises to realize the importance of coping strategies in advance under the background of intensifying economic policy uncertainty. Therefore, this paper proposes to introduce policies on the premise of fully considering the smoothness of the economy and the differences in the conditions of firms of different natures, as well as some proposals to alleviate financing constraints, reduce the adverse effects of uncertainty on firms, and bolster the marketization process.

PMID:37992087 | PMC:PMC10664914 | DOI:10.1371/journal.pone.0293306

Categories: Literature Watch

Study on the association between adverse drug reactions to opioids and gene polymorphisms: a case-case-control study

Wed, 2023-11-22 06:00

BMC Pharmacol Toxicol. 2023 Nov 21;24(1):64. doi: 10.1186/s40360-023-00708-4.

ABSTRACT

OBJECTIVE: Adverse drug reactions (ADRs) caused by opioid drugs show individual differences. Our objective was to explore the association between gene polymorphism and ADRs induced by opioid drugs.

METHODS: Evidence-based medical data analysis was conducted for genes related to ADRs induced by opioid drugs to select target genes. Sixty patients with cancer pain who had ADRs after taking opioid drugs (morphine, codeine, oxycodone) and 60 patients without ADRs after taking opioid drugs were used as the experimental group and control group, respectively. Then, we used polymerase chain reaction (PCR) or in situ hybridization to detect target genes. By combining with clinical data such as age, sex, dosage and duration of medication, the effect of gene polymorphism on the ADR of patients after taking opioid drugs was statistically analysed.

RESULTS: Based on a database search and evidence-based medical data, we identified CYP2D6*10, CYP3A5*3, ABCB1, and OPRM1 as target genes for detection. The results of statistical analysis showed no significant difference in genotype distribution between the experimental group and the control group (p > 0.05). However, if 32 patients with ADRs after taking oxycodone and 32 controls were selected for comparison, the SPSS22.0 and SNPStats genetic models showed that the ABCB1 (062rs1045642) CT and TT genotypes correlated with the occurrence of ADRs (p < 0.05): the total number of CT + TT genotypes in the experimental group was 29 (90.62%), with 11 (34.37%) CT + TT genotypes types in the control group.

CONCLUSION: Polymorphism of ABCB1 (062rs1045642) is related to ADRs caused by oxycodone, and the incidence of ADRs is higher with the allele T. Polymorphism of ABCB1 is expected to become a clinical predictor of ADRs to oxycodone, and attention should be given to the occurrence of serious ADRs in patients with ABCB1 (062rs1045642) CT and TT genotypes.

PMID:37990344 | DOI:10.1186/s40360-023-00708-4

Categories: Literature Watch

Hyperleptinemia contributes to antipsychotic drug-associated obesity and metabolic disorders

Wed, 2023-11-22 06:00

Sci Transl Med. 2023 Nov 22;15(723):eade8460. doi: 10.1126/scitranslmed.ade8460. Epub 2023 Nov 22.

ABSTRACT

Despite their high degree of effectiveness in the management of psychiatric conditions, exposure to antipsychotic drugs, including olanzapine and risperidone, is frequently associated with substantial weight gain and the development of diabetes. Even before weight gain, a rapid rise in circulating leptin concentrations can be observed in most patients taking antipsychotic drugs. To date, the contribution of this hyperleptinemia to weight gain and metabolic deterioration has not been defined. Here, with an established mouse model that recapitulates antipsychotic drug-induced obesity and insulin resistance, we not only confirm that hyperleptinemia occurs before weight gain but also demonstrate that hyperleptinemia contributes directly to the development of obesity and associated metabolic disorders. By suppressing the rise in leptin through the use of a monoclonal leptin-neutralizing antibody, we effectively prevented weight gain, restored glucose tolerance, and preserved adipose tissue and liver function in antipsychotic drug-treated mice. Mechanistically, suppressing excess leptin resolved local tissue and systemic inflammation typically associated with antipsychotic drug treatment. We conclude that hyperleptinemia is a key contributor to antipsychotic drug-associated weight gain and metabolic deterioration. Leptin suppression may be an effective approach to reducing the undesirable side effects of antipsychotic drugs.

PMID:37992151 | DOI:10.1126/scitranslmed.ade8460

Categories: Literature Watch

Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers

Tue, 2023-11-21 06:00

Drug Saf. 2023 Dec;46(12):1363-1379. doi: 10.1007/s40264-023-01355-8. Epub 2023 Nov 21.

ABSTRACT

INTRODUCTION: Adverse drug reactions (ADRs) can be reported by Health Care Professionals (HCPs; e.g., physicians, pharmacists) and non-Health Care Professionals (non-HCPs; e.g., consumers). Previous studies investigating differences between reports from HCPs and non-HCPs rarely considered the completeness of information provided. In addition, they mostly did not distinguish between physicians and pharmacists or were performed years ago. The aim of our study was to analyse and compare the completeness of information provided in reports from physicians, pharmacists and consumers from Germany in a more recent dataset.

MATERIALS AND METHODS: We analysed all spontaneous reports from Germany received between 2018 and 2021 in the ADR database EudraVigilance exclusively reported by physicians (n = 69,976), pharmacists (n = 42,396) or consumers (n = 121,144). Demographical parameters of the patients were analysed descriptively. Completeness of reports was evaluated applying an established score (vigiGrade). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using logistic regression analysis in order to identify report, patient, drug or ADR-specific information provided more often in reports from physicians, pharmacists or consumers.

RESULTS: Within the study period the number of reports per year by physicians and pharmacists decreased steadily, while an opposite trend was observed for consumer reports. The proportion of female patients was higher in reports from pharmacists (64.4%) and consumers (64.8%) compared to those from physicians (55.3%). On average, patients in reports from pharmacists (58.7) were older compared to those from physicians (53.5) and consumers (52.6). As an example for the presence of specific information, the time to onset of the ADR could be calculated more often in consumer compared to physician (OR 1.9 [1.8-1.9]) and pharmacist reports (OR 1.7 [1.6-1.7]). In contrast, pharmacist (OR 0.5 [0.4-0.5]) and consumer (OR 0.5 [0.5-0.5]) reports included the indication of the suspected drug less often than physician reports. Physician reports on average (mean = 0.5) were slightly more complete according to the vigiGrade score compared to reports from consumers (mean = 0.4) and pharmacists (mean = 0.4).

CONCLUSION: The ADR reports from consumers were comparable with regard to the completeness score with those from physicians and pharmacists underlining their value. Differences in completeness of specific information between the reporter types were found, suggesting that a common reporting of interactions between the three reporters may further improve the completeness of ADR reports. Furthermore, stratified analysis of ADR reports per reporter type may be helpful for certain objectives in scientific research.

PMID:37987966 | DOI:10.1007/s40264-023-01355-8

Categories: Literature Watch

Preexposure Prophylaxis for HIV Prevention in the United States: An Overview and Update

Tue, 2023-11-21 06:00

Am J Nurs. 2023 Dec 1;123(12):54-62. doi: 10.1097/01.NAJ.0000997216.21988.19.

ABSTRACT

There were 36,136 new HIV diagnoses in the United States and dependent areas in 2021, despite a 12% reduction in estimated HIV incidence from 2017 to 2021. The burden of HIV remains disproportionately high among certain populations, including gay and bisexual men, Black/African American individuals, and Hispanic/Latino individuals, and racial and ethnic health care disparities persist. The Ending the HIV Epidemic initiative aims to significantly reduce new infections, with a focus on HIV prevention, particularly the use of preexposure prophylaxis (PrEP). However, challenges remain in achieving equitable PrEP distribution. As frontline health care providers, nurses play a pivotal role in this battle against HIV. This article provides an update on PrEP screening recommendations, the types of PrEP available, dosing, adverse effects, and the role of nurses in patient support and monitoring.

PMID:37988020 | DOI:10.1097/01.NAJ.0000997216.21988.19

Categories: Literature Watch

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience

Tue, 2023-11-21 06:00

J Int Med Res. 2023 Nov;51(11):3000605231211402. doi: 10.1177/03000605231211402.

ABSTRACT

OBJECTIVE: To explore the effects of oral semaglutide on glycaemic parameters, body weight, and satisfaction in the first recipient patients with type 2 diabetes mellitus in Slovenia, in a real-world clinical practice setting.

METHODS: The first consecutive adult patients with type 2 diabetes who were eligible for oral semaglutide treatment were included in this prospective, open-label interventional study. Patients received increasing doses of oral semaglutide and were evaluated at inclusion, at 1 month, then 3-5 months after starting treatment. Fasting blood glucose, glycosylated haemoglobin (HbA1c), body weight, patient satisfaction with oral semaglutide treatment (using the validated Treatment Satisfaction Questionnaire for Medication), and adverse effects, were analysed. Statistical analyses were performed using one-way analysis of variance, and, when significant interactions were found, Bonferroni post-hoc test. A P-value <0.05 was considered statistically significant.

RESULTS: Twenty patients (11 male: 9 female; mean age, 59.9 ± 1.5 years; mean diabetes duration, 8.5 ± 1.4 years) were included. Oral semaglutide (7 and 14 mg) significantly decreased HbA1c (from 9.4 ± 0.3% to 8.2 ± 0.2% and 7.8 ± 0.2%, respectively) and fasting plasma glucose (from 11.2 ± 0.5 mmol/L to 9.2 ± 0.7 mmol/L and 8.9 ± 0.4 mmol/L, respectively). Oral semaglutide (14 mg) significantly decreased body weight (from 100.9 ± 2.7 kg to 92.7 ± 2.4 kg). Patients reported that treatment was easy to use and expressed high global satisfaction. Mild and transient, mostly gastrointestinal, adverse effects were reported in 10 patients.

CONCLUSIONS: Oral semaglutide, the first oral glucagon-like peptide 1 receptor agonist, was effective and safe, and associated with high patient satisfaction, in its first recipients in Slovenia. The results are important for daily clinical practice involving patients with type 2 diabetes, however, due to the small study population, lack of placebo control, and short exposure to oral semaglutide, the effectiveness of oral semaglutide in clinical practice requires further investigation.

PMID:37987649 | DOI:10.1177/03000605231211402

Categories: Literature Watch

Adverse drug reactions as cause of nonspecific symptoms in patients in the emergency department

Fri, 2023-11-17 06:00

Anaesthesiologie. 2023 Dec;72(12):887-893. doi: 10.1007/s00101-023-01355-4. Epub 2023 Nov 17.

ABSTRACT

BACKGROUND: In a large proportion of patients admitted to the emergency department (ED), the initial main symptom is nonspecific. One possible reason for this, especially in older patients, may be adverse drug reactions (ADR) due to their frequent polypharmacy.

AIM: To illustrate the incidence of ADRs, the affected patient population including risk factors, and drug classes with ADRs leading to nonspecific symptoms. To provide practice recommendations for the management of ADRs in the ED.

MATERIAL AND METHODS: Presentation of the pharmacological principles on ADRs, statistics of pharmacovigilance centers as well as original literature including experiences from clinical practice and own projects.

RESULTS: In 10% of patients with nonspecific symptoms an ADR is responsible for presentation in the ED. In 60% of cases these ADRs are not correctly identified in the ED setting. A small number of drug classes are responsible for most of these referrals. Databases, risk stratification, clinical pharmacists, or clinical decision support systems are available to improve ADR identification and management. As these options are partly associated with considerable costs or the validation for German EDs is missing, a widespread application does not take place.

CONCLUSION: Correct identification of ADRs in patients with nonspecific symptoms in the ED is necessary to initiate adequate treatment. These ADRs are often overlooked because processes and tools for identification and management are not applied in the ED, leading to a lack of awareness. For high-risk patients in the ED, the focus should be on drug history, ideally considering patient-specific risk factors and specific drug classes.

PMID:37978070 | DOI:10.1007/s00101-023-01355-4

Categories: Literature Watch

Identifying the data elements and functionalities of clinical decision support systems to administer medication for neonates and pediatrics: a systematic literature review

Fri, 2023-11-17 06:00

BMC Med Inform Decis Mak. 2023 Nov 16;23(1):263. doi: 10.1186/s12911-023-02355-5.

ABSTRACT

BACKGROUND: Patient safety is a central healthcare policy worldwide. Adverse drug events (ADE) are among the main threats to patient safety. Children are at a higher risk of ADE in each stage of medication management process. ADE rate is high in the administration stage, as the final stage of preventing medication errors in pediatrics and neonates. The most effective way to reduce ADE rate is using medication administration clinical decision support systems (MACDSSs). The present study reviewed the literature on MACDSS for neonates and pediatrics. It identified and classified the data elements that mapped onto the Fast Healthcare Interoperability Resources (FHIR) standard and the functionalities of these systems to guide future research.

METHODS: PubMed/ MEDLINE, Embase, CINAHL, and ProQuest databases were searched from 1995 to June 31, 2021. Studies that addressed developing or applying medication administration software for neonates and pediatrics were included. Two authors reviewed the titles, abstracts, and full texts. The quality of eligible studies was assessed based on the level of evidence. The extracted data elements were mapped onto the FHIR standard.

RESULTS: In the initial search, 4,856 papers were identified. After removing duplicates, 3,761 titles, and abstracts were screened. Finally, 56 full-text papers remained for evaluation. The full-text review of papers led to the retention of 10 papers which met the eligibility criteria. In addition, two papers from the reference lists were included. A total number of 12 papers were included for analysis. Six papers were categorized as high-level evidence. Only three papers evaluated their systems in a real environment. A variety of data elements and functionalities could be observed. Overall, 84 unique data elements were extracted from the included papers. The analysis of reported functionalities showed that 18 functionalities were implemented in these systems.

CONCLUSION: Identifying the data elements and functionalities as a roadmap by developers can significantly improve MACDSS performance. Though many CDSSs have been developed for different medication processes in neonates and pediatrics, few have actually evaluated MACDSSs in reality. Therefore, further research is needed on the application and evaluation of MACDSSs in the real environment.

PROTOCOL REGISTRATION: (dx.doi.org/10.17504/protocols.io.bwbwpape).

PMID:37974195 | PMC:PMC10652533 | DOI:10.1186/s12911-023-02355-5

Categories: Literature Watch

Severe acute drug-induced dystonia in the post-operative period requiring tracheal re-intubation

Fri, 2023-11-17 06:00

Anaesth Rep. 2023 Nov 15;11(2):e12258. doi: 10.1002/anr3.12258. eCollection 2023 Jul-Dec.

ABSTRACT

Ondansetron is a highly selective 5-hydroxytryptamine receptor antagonist and the most commonly used anti-emetic for the prevention of postoperative nausea and vomiting. Ondansetron has a low affinity for dopamine receptors and so extrapyramidal side effects are rare. Here, we present the case of a 14-year-old girl who developed a severe post-operative acute dystonic reaction which included oculogyric crisis. We believe that ondansetron was the most likely cause, although propofol may have been a synergistic or alternative causative agent. The patient had no significant past medical history and had previously undergone two uneventful general anaesthetics which included both ondansetron and propofol. The prolonged duration and severity of the reaction and failure to fully respond to specific treatments resulted in the need for tracheal intubation and transfer to a paediatric intensive care unit. She subsequently recovered uneventfully with no ongoing neurological sequalae. Ondansetron-induced dystonic reactions are rare and unpredictable and can occur in patients who have previously received the drug without complication. They are thought to be caused by an imbalance between inhibitory and excitatory neurotransmitters in the extrapyramidal system. Specific treatments include anticholinergics, antihistamines and benzodiazepines.

PMID:37974908 | PMC:PMC10646813 | DOI:10.1002/anr3.12258

Categories: Literature Watch

Opioid Tapering in Older Cancer Survivors Does Not Increase Psychiatric or Drug Hospitalization Rates

Thu, 2023-11-16 06:00

J Natl Cancer Inst. 2023 Nov 16:djad241. doi: 10.1093/jnci/djad241. Online ahead of print.

ABSTRACT

BACKGROUND: Opioid tapering in the general population is linked to increases in hospitalizations or emergency department visits related to psychiatric or drug-related diagnoses. Cancer survivors represent a unique population with different opioid indications, prescription patterns, and more frequent follow-up care. This study sought to describe patterns of opioid tapering among older cancer survivors, and to test the hypothesis of whether older cancer survivors face increased risks of adverse events with opioid tapering.

METHODS: Using the Surveillance, Epidemiology and End Results Medicare-linked database we identified 15,002 Medicare-beneficiary cancer survivors diagnosed between 2010 and 2017 prescribed opioids consistently for at least 6-months after their cancer diagnosis. Tapering was defined as a binary time-varying event occurring with any monthly oral morphine equivalent reduction of 15% or more from the previous month. Primary diagnostic billing codes associated with emergency room or hospital admissions were used for the composite endpoint of psychiatric or drug-related event(s).

RESULTS: There were 3.86 events per 100 patient-months, with 97.8% events being mental health emergencies, 1.91% events being overdose emergencies and 0.25% involving both. Using a generalized estimating equation for repeated measure time-based analysis, opioid tapering was not significantly linked to acute events in the 3-month post-taper period (odds ratio 1.02; p = .62), nor at any point in the future (odds ratio 0.96; p = .46).

CONCLUSIONS: Opioid tapering in older cancer survivors does not appear to be linked to a higher risk of acute psychiatric or drug-related events, in contrast to prior research in the general population.

PMID:37971959 | DOI:10.1093/jnci/djad241

Categories: Literature Watch

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