Dermatol Ther (Heidelb). 2021 Dec 29. doi: 10.1007/s13555-021-00666-x. Online ahead of print.

ABSTRACT

INTRODUCTION: In 2018, ixekizumab (80 mg every 2 weeks [Q2W] beyond Week 12) received approval in Japan for patients with generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP). This open-label study evaluated the efficacy and safety of ixekizumab (80 mg Q2W from Week 12 to Week 20) in Japanese patients with GPP and EP.

METHODS: Seven patients with GPP and five patients with EP were enrolled. An initial dose of 160 mg (subcutaneous [SC] injection) was followed by 80 mg Q2W SC until Week 12. Primary endpoint assessed global improvement score (GIS) by comparing psoriatic findings, Static Physician Global Assessment, Psoriasis Area and Severity Index score, and other evaluations with those at the baseline and were graded as 1 = resolved, 2= improved, 3 = unchanged, and 4 = worsened. Patients who showed GIS = 1 (resolved) at Week 12 completed the study. Patients with GIS ≥ 2 continued to receive ixekizumab 80 mg Q2W until Week 20.

RESULTS: At Week 12, four of seven patients with GPP showed "resolved," two showed "improved," and one showed "worsened." Of five patients with EP, one showed "resolved" and four showed "improved." Two patients with GPP and four patients with EP continued ixekizumab treatment until Week 20. At Week 20, one of the two patients with GPP showed "resolved" and one patient showed "improved." All four patients with EP showed "improved." One non-drug related serious adverse event was reported by one patient with EP at Week 12. From Week 12 to Week 20, no adverse events (AEs) were reported in patients with GPP, but two mild AEs were reported in one of the four patients with EP.

CONCLUSIONS: This study indicates that ixekizumab continuous Q2W dosing is efficacious and safe for patients with GPP and EP.

CLINICAL TRIAL REGISTRATION: NCT03942042.

PMID:34967916 | DOI:10.1007/s13555-021-00666-x

Pediatrics. 2022 Jan 1;149(1):e2020034371. doi: 10.1542/peds.2020-034371.

ABSTRACT

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior.

METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported.

RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician).

CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers.

PMID:34957504 | DOI:10.1542/peds.2020-034371

J Thorac Oncol. 2021 Dec 24:S1556-0864(21)03403-1. doi: 10.1016/j.jtho.2021.11.025. Online ahead of print.

ABSTRACT

INTRODUCTION: This integrated analysis of a phase 1/2 study (NCT03046992) assessed the efficacy and safety of lazertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with advanced EGFR T790M-positive non-small cell lung cancer (NSCLC) after prior EGFR TKI therapy.

METHODS: Adults with EGFR mutation-positive NSCLC that progressed after prior EGFR-directed TKIs received once-daily oral lazertinib 240 mg continuously until disease progression. Prior TKIs to treat T790M-positive NSCLC were prohibited. Primary endpoints were safety and objective response rate (ORR). Secondary endpoints included progression-free survival, overall survival, and intracranial ORR.

RESULTS: Seventy-eight patients received lazertinib 240 mg at 17 centers in South Korea. Among patients with T790M-positive tumors at baseline (n=76), 1 (1.3%) had a complete response and 41 (53.9%) had partial responses, giving an ORR of 55.3% (95% CI, 44.1-66.4). Median progression-free survival was 11.1 months (95% CI, 5.5-16.4). Median overall survival was not reached (median follow-up 22.0 months). In patients with measurable intracranial lesions (n=7), 1 (14.3%) had a complete intracranial response and 5 (71.4%) had partial responses, giving an intracranial ORR of 85.7% (95% CI, 59.8-100.0%). The most common treatment-emergent adverse events were rash (37.2%), pruritus (34.6%), and paresthesia (33.3%); most were mild to moderate in severity. Serious drug-related adverse events occurred in 3 patients (gastritis, pneumonia, pneumonitis). The major mechanism of resistance was EGFR T790M loss.

CONCLUSIONS: Lazertinib 240 mg/day has a manageable safety profile with durable antitumor efficacy, including brain metastases, in patients with advanced T790M-positive NSCLC after prior EGFR TKI therapy.

PMID:34958928 | DOI:10.1016/j.jtho.2021.11.025

Telemed J E Health. 2021 Dec 24. doi: 10.1089/tmj.2021.0288. Online ahead of print.

ABSTRACT

Introduction: Older people living in nursing homes (NH) are at a higher risk of preventable drug-related adverse events because of age-related physiological changes, polypathology, and polypharmacy. NH residents are particularly exposed to potentially inappropriate medications (PIMs). Many strategies have been developed to improve the quality and the safety of drug prescription in NH, including medication reviews (MRs). Methods: In the context of the application of telemedicine, we developed and are currently implementing a novel hospital expert-based MRs through tele-expertise (or "telemedication review," telemedication reviews hereafter [TMR]) in French NH residents. The impact of these TMR on unplanned hospitalizations 3 months after implementation is assessed. TMR consider all available sociodemographic, clinical, biological, and pharmaceutical data pertaining to the patient and are performed in accordance with their health care objectives. Results: The preliminary results for the 39 TMRs performed to date (September 2021) showed that a total of 402 PIMs were detected, and all residents had at least one PIM. We also present the feasibility and the usefulness of this novel TMR for NH, illustrating these preliminary results with two concrete TMR experiences. Among the 39 TMR performed, the average acceptance rate of expert recommendations made to general practitioners (GP) working in NH was ∼33%. Discussion and Conclusions: The success of this novel TMR depends on how the proposed prescription adjustments made by the hospital expert team are subsequently integrated into health care practices. The low acceptance rate by GP highlights the need to actively involve these professionals in the process of developing TMR, with a view to encouraging them to act on proposed adjustments.

PMID:34958258 | DOI:10.1089/tmj.2021.0288

Australas J Dermatol. 2021 Dec 27. doi: 10.1111/ajd.13780. Online ahead of print.

ABSTRACT

Anecdotal evidence suggests that selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) cause cutaneous adverse drug reactions (CADRs). However, there is limited information on the factors associated with these occurrences. In this study, we aimed to describe the demographic, clinical and pharmacological characteristics associated with CADRs encountered by patients administered SSRIs and/or SNRIs for psychiatric diagnoses and to compare the differences in these factors between severe and non-severe CADRs. A protocol was developed a priori (PROSPERO: CRD42020204830) in line with the PRISMA guidelines. We searched PubMed/Medline, PsycINFO and SCOPUS from inception to October 2020 to identify case reports and/or case series of SSRI and SNRI associated CADRs. Additional cases were obtained from the retrieved articles' bibliography. A total of 141 articles were included in the study, documenting 173 CADRs. Females accounted for 128 (74.0%) of the analysed CADRs. The median age of the cases was 42 IQR (27; 53) with no statistically significant differences in age between males and females (P = 0.542). A total of 157 (90.8%) of the reported CADRs were associated with SSRIs, particularly fluoxetine 68 (39.5%), sertraline 30 (17.4%) and paroxetine 25 (14.5%). Non-severe CADRs and severe CADRs accounted for 23 (13.4%) and 149 (86.6%) reports respectively. No statistically significant differences were observed for gender (P = 0.616), age at onset (P = 0.493) and time to onset (P = 0.105) between non-severe CADRs and SCARs. In conclusion, CADRs following SSRIs and SNRIs disproportionately affect females in the reproductive age group compared to males and are mostly associated with SSRIs.

PMID:34958129 | DOI:10.1111/ajd.13780

Braz J Anesthesiol. 2021 Dec 23:S0104-0014(21)00409-7. doi: 10.1016/j.bjane.2021.10.010. Online ahead of print.

ABSTRACT

INTRODUCTION: Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events.

METHODS: MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity.

RESULTS: The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable.

CONCLUSION: There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.

PMID:34954261 | DOI:10.1016/j.bjane.2021.10.010

J Manag Care Spec Pharm. 2022 Jan;28(1):16-25. doi: 10.18553/jmcp.2022.28.1.16.

ABSTRACT

BACKGROUND: Therapy with angiotensinconverting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) requires laboratory monitoring to avoid hyperkalemia and acute kidney failure. OBJECTIVE: To assess the frequency of recommended annual serum potassium and creatinine monitoring and determine potential factors associated with care gaps among adults dispensed an ACEI or ARB. METHODS: This mixed-methods study integrated findings from a retrospective cohort study and individual patient interviews. Adults aged 21 years and over within Kaiser Permanente Southern California with at least 180 treatment days of an ACEI and/or ARB in 2015 were included. Patients invited for qualitative interviews included those who did and did not complete the recommended laboratory tests. We assessed the proportion of patients completing both recommended laboratory tests, factors associated with not receiving laboratory monitoring, and patients' insights into barriers and facilitators of recommended monitoring. RESULTS: Of 437,544 patients who received an ACEI or ARB, 9.0% did not receive both a serum potassium and creatinine laboratory test during treatment (defined as a care gap). Lower risk of a care gap was observed for patients with increasing age (rate ratio [RR] per 10-year increase = 0.78, 95% CI = 0.77-0.79); diabetes mellitus (RR = 0.62, 95% CI = 0.60-0.64); hypertension (RR = 0.71, 95% CI = 0.71-0.74); Charlson Comorbidity Index score of at least 2 (RR = 0.62, 95% CI = 0.60-0.64); those who changed medication classes (RR = 0.53, 95% CI = 0.51-0.56); and patients with a cardiologist (RR = 0.81, 95% CI = 0.73-0.90) or nephrologist (RR = 0.60, 95% CI = 0.52-0.69) as their prescribing provider. Twenty-five patients completed the qualitative interviews. Patients often lacked knowledge about the need for laboratory monitoring, cited logistical barriers to accessing the laboratory, and deemed the reminders they received through an outpatient safety program as a facilitator to completing tests. CONCLUSIONS: Given the large patient population on ACEI and ARB medications, monitoring and support strategies such as electronic clinical surveillance could be important in addressing care gaps and potentially reducing adverse drug effects. DISCLOSURES: This project was supported by grant number R01HS024437 from the Agency for Healthcare Research and Quality. The funder had no role in the design of the study; collection, analyses, or interpretation of the data, or decision to submit this manuscript for publication. Harrison, Reynolds, Hahn, Munoz-Plaza, Yi, Fischer, Luong, Sim, Brettler, Handler, and Mittman are employees of the Southern California Permanente Medical Group. Danworth was employed by the Southern California Permanente Medical Group at the time of this study. Singh was partially supported by the Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (CIN13-413). Reynolds reports grants from Novartis, Amgen Inc., and Vital Strategies, Resolve to Save Lives, unrelated to this work. Yi reports grants from Novartis unrelated to this work. Kanter has nothing to disclose.

PMID:34949121 | DOI:10.18553/jmcp.2022.28.1.16

J Manag Care Spec Pharm. 2022 Jan;28(1):58-68. doi: 10.18553/jmcp.2022.28.1.58.

ABSTRACT

BACKGROUND: Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and epilepsy, and are one of the most frequently prescribed medication classes. This class of medication has important safety considerations, including an increased risk of dependence and addiction, falls, and death from opioid overdose. Although benzodiazepine safety and prescribing encompasses a rich and important research area, there is a lack of pharmacoepidemiologic literature addressing benzodiazepine dosing intensity in real-world settings. OBJECTIVE: To develop and apply a standardized benzodiazepine milligram equivalency conversion algorithm and assess the dose intensity of benzodiazepine use in Rhode Island (RI) in 2018. METHODS: A systematic literature review was conducted to identify the most commonly used benzodiazepine equivalency values. We then conducted a cross-sectional analysis of 2018 data from the RI Prescription Drug Monitoring Program (PDMP) to calculate the mean daily diazepam milligram equivalency (DME) based on a patient's most recent dispensing. A multivariable logistic regression analysis was conducted to determine the association between higher benzodiazepine doses (≥ 15 DME/day) and recipient characteristics, including concurrent use of opioids or stimulants. RESULTS: We identified 143,026 patients who received at least 1 prescription for a benzodiazepine in RI in 2018. The mean (SD) daily DME was 10.60 (9.05), and 26.2% of individuals had a mean DME per day of at least 15. Approximately 14% (n = 20,168) of patients prescribed a benzodiazepine had concurrent use with a prescription opioid, and 6.7% (n = 9,547) had concurrent use with a prescription stimulant. Females had a 28% lower adjusted odds of receiving a benzodiazepine dose of at least 15 DME per day compared with males (adjusted odds ratio [aOR] = 0.72, 95% CI = 0.70-0.73). The adjusted odds of receiving a benzodiazepine prescription of at least 15 DME per day was lower among the younger (aged 18-34 years) and older age groups (aged 65 years and older) compared with patients aged 35-64 years. Compared with commercial insurance, all other forms of payment had significantly higher adjusted odds of a daily benzodiazepine dose of at least 15 DME per day. The adjusted odds receiving a daily DME of at least 15 was 67% higher among those who also received a concurrent pharmacy dispensing for an opioid and 84% higher among those who also received a concurrent dispensing for a stimulant drug (aOR = 1.67, 95% CI = 1.61-1.72; aOR = 1.84, 95% CI = 1.76-1.93, respectively). CONCLUSIONS: Individuals aged 35-64 years with Medicaid insurance and those aged under 65 years with Medicare were more likely to be prescribed a benzodiazepine of at least 15 DME per day. Higher benzodiazepine DMEs were also dispensed to patients who concurrently used prescription opioids or stimulants who may be at increased risk of medication-related harm. We advocate for routine measurement of benzodiazepine dose intensity as a risk reduction strategy. DISCLOSURES: No funding supported this study. The authors have no conflicts of interest to disclose. The content and results of this study are solely the responsibility of the authors and do not necessarily represent the official views of the Rhode Island Department of Health. Kogut is partially supported by Institutional Development Award Numbers U54GM115677 and P20GM125507 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR) and the RI Lifespan Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose, respectively. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contents of this study were presented as a poster presentation at AMCP 2019 Nexus; October 29-November 1, 2019; National Harbor, MD.

PMID:34949119 | DOI:10.18553/jmcp.2022.28.1.58

Int J Environ Res Public Health. 2021 Dec 8;18(24):12936. doi: 10.3390/ijerph182412936.

ABSTRACT

Peripheral vestibular disease can be treated with several approaches (e.g., maneuvers, surgery, or medical approach). Comorbidity is common in elderly patients, so polytherapy is used, but it can generate the development of drug-drug interactions (DDIs) that play a role in both adverse drug reactions and reduced adherence. For this reason, they need a complex kind of approach, considering all their individual characteristics. Physicians must be able to prescribe and deprescribe drugs based on a solid knowledge of pharmacokinetics, pharmacodynamics, and clinical indications. Moreover, full information is required to reach a real therapeutic alliance, to improve the safety of care and reduce possible malpractice claims related to drug-drug interactions. In this review, using PubMed, Embase, and Cochrane library, we searched articles published until 30 August 2021, and described both pharmacokinetic and pharmacodynamic DDIs in patients with vestibular disorders, focusing the interest on their clinical implications and on risk management strategies.

PMID:34948545 | PMC:PMC8701970 | DOI:10.3390/ijerph182412936

Int J Mol Sci. 2021 Dec 10;22(24):13302. doi: 10.3390/ijms222413302.

ABSTRACT

Adverse drug reactions (ADRs) rank as one of the top 10 leading causes of death and illness in developed countries. ADRs show differential features depending upon genotype, age, sex, race, pathology, drug category, route of administration, and drug-drug interactions. Pharmacogenomics (PGx) provides the physician effective clues for optimizing drug efficacy and safety in major problems of health such as cardiovascular disease and associated disorders, cancer and brain disorders. Important aspects to be considered are also the impact of immunopharmacogenomics in cutaneous ADRs as well as the influence of genomic factors associated with COVID-19 and vaccination strategies. Major limitations for the routine use of PGx procedures for ADRs prevention are the lack of education and training in physicians and pharmacists, poor characterization of drug-related PGx, unspecific biomarkers of drug efficacy and toxicity, cost-effectiveness, administrative problems in health organizations, and insufficient regulation for the generalized use of PGx in the clinical setting. The implementation of PGx requires: (i) education of physicians and all other parties involved in the use and benefits of PGx; (ii) prospective studies to demonstrate the benefits of PGx genotyping; (iii) standardization of PGx procedures and development of clinical guidelines; (iv) NGS and microarrays to cover genes with high PGx potential; and (v) new regulations for PGx-related drug development and PGx drug labelling.

PMID:34948113 | PMC:PMC8704264 | DOI:10.3390/ijms222413302

Zhongguo Zhong Yao Za Zhi. 2021 Nov;46(21):5456-5461. doi: 10.19540/j.cnki.cjcmm.20210413.501.

ABSTRACT

The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts. A variety of methods are employed for the mining of risk signals or analysis and screening of relevant signals to accurately determine the correlation between medication and adverse reactions. The safety signal acquisition and mining techniques are the technical basis for the safety risk management of medicine products after Chinese medicines are marketed, which is critical in drug safety alerts. To accurately collect the safety signals of Chinese medicines and effectively and rapidly track, determine, and assess the sources of signals are important technical links in drug risk management. The ultimate purpose of safety signal discovery is to achieve normalized risk management through downgrading drugs from a high-risk level to a low-risk level.The five main steps in the standard drug risk management are listed below: to extensively collect predicted risk signals; to accurately identify drug risks by the techniques such as data mining; to evaluate the risks with process-based quality risk control; to employ management measures minimizing the impact of drug risks for risk management; to update and apply risk assessment to clinical evaluation after medication.

PMID:34951196 | DOI:10.19540/j.cnki.cjcmm.20210413.501

Zhongguo Zhong Yao Za Zhi. 2021 Nov;46(21):5450-5455. doi: 10.19540/j.cnki.cjcmm.20210918.501.

ABSTRACT

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.

PMID:34951195 | DOI:10.19540/j.cnki.cjcmm.20210918.501

Eur J Radiol. 2021 Dec 10;146:110101. doi: 10.1016/j.ejrad.2021.110101. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the incidence and risk factors of late adverse reactions (ARs) to non-ionic low-osmolar contrast media (LOCM).

METHODS: The occurrence of late AR was monitored on day 1 and from day 7 to day 28 in all patients who received enhanced computed tomography using LOCM during a 5-week study period in a single tertiary hospital. Patients who experienced late AR were followed up for three years.

RESULTS: Among the total 10,540 LOCM exposures, 315 ARs (3.0%) were reported; acute ARs occurred in 108 LOCM exposures (1.0%) and late ARs occurred in 207 LOCM exposures (2.0%) (90.9% within one week, 9.1% developed afterwards by day 20). Previous history of drug allergy (odds ratio [OR] = 4.59; 95% confidence interval [CI] 2.17-9.71) and allergic diseases (OR = 2.54; 95% CI 1.32-4.91) were risk factors of late ARs to LOCM. Although the recurrence rate was lowered with premedication from 8.5% to 1.7% (8/94 vs. 3/178; p = 0.016), LOCM change did not make difference compared to reuse of the culprit LOCM (2/38 vs. 9/234; p = 0.655). In patients with a history of late AR to LOCM, the risk of recurrent reactions decreased with longer time intervals between exposures (OR = 0.86; 95% CI: 0.77-0.97; p = 0.025) and with the use of antihistamine premedication (OR = 0.27; 95% CI: 0.06-0.99; p = 0.049).

CONCLUSIONS: Late ARs to LOCM occurred mostly within one week. The use of premedication may be helpful in reducing the recurrence of late ARs.

PMID:34952368 | DOI:10.1016/j.ejrad.2021.110101

Ann Intensive Care. 2021 Dec 24;11(1):182. doi: 10.1186/s13613-021-00968-5.

ABSTRACT

BACKGROUND: Major therapeutic advances including immunotherapy and targeted therapies have been changing the face of oncology and resulted in improved prognosis as well as in new toxic complications. The aim of this study is to appraise the trends in intensive care unit (ICU) admissions and outcomes of critically ill patients with solid malignancies. We performed a retrospective single-centre study over a 12-year period (2007-2018) including adult patients with solid malignancies requiring unplanned ICU admission. Admission patterns were classified as: (i) specific if directly related to the underlying cancer; (ii) non-specific; (iii) drug-related or procedural adverse events.

RESULTS: 1525 patients were analysed. Lung and gastro-intestinal tract accounted for the two main tumour sites. The proportion of patients with metastatic diseases increased from 48.6% in 2007-2008 to 60.2% in 2017-2018 (p = 0.004). Critical conditions were increasingly related to drug- or procedure-related adverse events, from 8.8% of ICU admissions in 2007-2008 to 16% in 2017-2018 (p = 0.01). The crude severity of critical illness at ICU admission did not change over time. The ICU survival rate was 77.4%, without any significant changes over the study period. Among the 1279 patients with complete follow-up, the 1-year survival rate was 33.2%. Independent determinants of ICU mortality were metastatic disease, cancer in progression under treatment, admission for specific complications and the extent of organ failures (invasive and non-invasive ventilation, inotropes/vasopressors, renal replacement therapy and SOFA score). One-year mortality in ICU-survivors was independently associated with lung cancer, metastatic disease, cancer in progression under treatment, admission for specific complications and decision to forgo life-sustaining therapies.

CONCLUSION: Advances in the management and the prognosis of solid malignancies substantially modified the ICU admission patterns of cancer patients. Despite underlying advanced and often metastatic malignancies, encouraging short-term and long-term outcomes should help changing the dismal perception of critically ill cancer patients.

PMID:34951668 | DOI:10.1186/s13613-021-00968-5

J Patient Saf. 2022 Jan 1;18(1):e343-e350. doi: 10.1097/PTS.0000000000000784.

ABSTRACT

BACKGROUND OBJECTIVES: Adverse drug events (ADEs) present the greatest risk of harm to patients in hospitals, especially those receiving neuropsychiatric treatment. The objective of the present record-based study was to test the appropriateness of the neuropsychiatry trigger tool (NPTT) to identify and measure harm due to adverse events (AEs).

METHODS: A total of 1324 clinical case notes of discharged patients from 2017 to 2018 with a hospital stay >24 hours to <70 days were examined.

RESULTS: One hundred forty-four (10.88%) patients experienced 166 AEs. A total of 854 triggers (range, 1-12 triggers per patient) were identified in 296 (22.36%) and 39 (2.94%) patients presented with triggers at admission. The overall AE rate per 1000 patient days was 12.73 (intensive care unit, 21; inpatient department, 11.54). Triggers at admission were altered sensorium and abnormal behavior followed by headache, ataxia, and aspiration pneumonia. A small number of triggers accounted for most AEs (laxative, rising liver function test (LFT), hypokalemia, hyponatremia, health care-associated infections, intubation, abnormal behavior/sensorium, hepatic encephalopathy, antiemetics), although type of AE reported differed by level of care. Most AEs caused minor harm, and relatively fewer patients experienced temporary harm requiring intervention (110; 8.29%), permanent harm (45; 3.39%), harm requiring initial/prolonged hospitalization (10; 0.75%), interventions to sustain life (24; 1.81%), and death (109; 8%). The higher the number of AEs, the longer was the length of stay (average increased from 9.32 to 17.33 days). The NPTT identified 30 times more AEs compared with 5 AEs reported by voluntary method. Medication-related ADEs were found in 130 (90%) of 144 patients who experienced AEs. Antitubercular drugs caused most ameliorable AEs (visual disturbance, drug-induced vomiting, deranged LFT, constipation). Care is needed in attributing harm because some triggers (abnormal sensorium/behavior, intubation, headache/dizziness, laxatives) may overlap with neurological illnesses (cerebrovascular accident [CVA]/meningitis/stroke). If the triggers are identified early, harm/discomfort to the patients can be reduced. The NPTT can be used in patient safety improvement projects. Harm occurred in 296 (22.28%) patients (temporary, 120 [9%]; permanent, 178 [13%]). Adverse events prolonged hospital stay (14.29 days) compared with 9.32 days in patients without AEs.

CONCLUSIONS: A higher number of triggers per patient (≥5), trigger nature (intubation, cardiac arrest/shock), or the presenting illness (CVA/neuroinfections/status epilepticus/prolonged seizures) were correlated with the highest harm, that is, death. Because some triggers (abnormal sensorium/behavior, headache/dizziness, laxatives, intubation) may overlap with neurological illness (CVA/meningitis/stroke), care is needed in attributing harm. The NPTT identified 30 times more AEs compared with 5 AEs reported by voluntary method. Antitubercular drugs caused ameliorable AEs (visual disturbance, drug-induced vomiting, deranged LFT, constipation) and, if identified early, can reduce harm/discomfort to the patients.

PMID:34951611 | DOI:10.1097/PTS.0000000000000784

Drug Ther Bull. 2022 Jan;60(1):6. doi: 10.1136/dtb.2021.000070.

ABSTRACT

Overview of: Khatter A, Moriarty F, Ashworth M et al Prevalence and predictors of potentially inappropriate prescribing in middle-aged adults: a repeated cross-sectional study. Br J Gen Pract 2021;71:e491-e497.

PMID:34949665 | DOI:10.1136/dtb.2021.000070

Drug Ther Bull. 2022 Jan;60(1):5. doi: 10.1136/dtb.2021.000069.

ABSTRACT

Overview of: Murray S, Augustyniak M, Murase JE, et al Barriers to shared decision-making with women of reproductive age affected by a chronic inflammatory disease: a mixed-methods needs assessment of dermatologists and rheumatologists. BMJ Open 2021;11:e043960.

PMID:34949664 | DOI:10.1136/dtb.2021.000069

Drug Ther Bull. 2021 Dec 23:dtb-2021-000071. doi: 10.1136/dtb.2021.000071. Online ahead of print.

ABSTRACT

Overview of: Henderson JT, Vesco KK, Senger CA, et al Aspirin use to prevent preeclampsia and related morbidity and mortality: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA 2021;326:1192-1206.

PMID:34949585 | DOI:10.1136/dtb.2021.000071

Life (Basel). 2021 Nov 29;11(12):1316. doi: 10.3390/life11121316.

ABSTRACT

Psoriasis is a chronic inflammatory, autoimmune-mediated disease that affects millions of individuals worldwide. Advances in treatment with biological agents represented by monoclonal antibodies, such as TNF-α inhibitors (TNFI), IL-17A and IL-12/23 antagonists have not only benefited from outstanding clinical efficacy with lower side effects compared to conventional systemic therapy, but also raised the standards towards therapeutic success, fact reflected in the greater Psoriasis Area and Severity Index (PASI) response rates. However, due to their relatively recent introduction in clinical practice, and despite their proven superior efficacy, further research is needed for monitoring the eventual changes in treatment-induced parameters, especially of metabolic origin. In this respect, initial reports stress on one particular comorbidity associated with psoriasis-obesity-which seems to be not only a risk and result of the disease, but also an adverse effect of long-term therapy with some biologics. The consequent drug-induced increase in body mass index (BMI) of patients suffering from psoriasis undergoing biological treatment appears to contribute to the progression of the disease, promote drug discontinuation and reduce overall clinical efficacy of monoclonal antibodies. Therefore, we review herein the impact of body weight (BMI) increase on the biological treatment of psoriasis, to further investigate on its relationship with the disease and aid on the management of treatment schemes that take into account individual characteristics of patients, such as body mass, for a more efficient and personalized therapy approach.

PMID:34947847 | DOI:10.3390/life11121316

J Pers Med. 2021 Dec 2;11(12):1279. doi: 10.3390/jpm11121279.

ABSTRACT

Early detection and prompt treatment of psychosis is of the utmost importance. The great variability in clinical onset, illness course, and response to pharmacological and psychosocial treatment is in great part gender-related. Our aim has been to review narratively the literature focusing on gender related differences in the psychoses, i.e., schizophrenia spectrum disorders. We searched the PubMed/Medline, Scopus, Embase, and ScienceDirect databases on 31 July 2021, focusing on recent research regarding sex differences in early psychosis. Although women, compared to men, tend to have better overall functioning at psychotic symptom onset, they often present with more mood symptoms, may undergo misdiagnosis and delay in treatment and are at a higher risk for antipsychotic drug-induced metabolic and endocrine-induced side effects. Furthermore, women with schizophrenia spectrum disorders have more than double the odds of having physical comorbidities than men. Tailored treatment plans delivered by healthcare services should consider gender differences in patients with a diagnosis of psychosis, with a particular attention to early phases of disease in the context of the staging model of psychosis onset.

PMID:34945748 | DOI:10.3390/jpm11121279