[Under-reporting of adverse drug reactions, a problem that also involves medicines subject to additional monitoring. Preliminary data from a single-center experience on novel oral anticoagulants].

G Ital Cardiol (Rome). 2018 Jan;19(1):54-61

Authors: Patrignani A, Palmieri G, Ciampani N, Moretti V, Mariani A, Racca L

Abstract
BACKGROUND: Spontaneous reporting system is the most widely used method by pharmacovigilance centers. Its "voluntary nature" represents the main cause of adverse drug reaction (ADR) under-reporting phenomena. The aim of this study was to point out the issue of ADR under-reporting from doctors, particularly serious ADRs and adverse reactions caused by medicinal products subject to additional monitoring, such as novel oral anticoagulants (NOACs).
METHODS: Only serious ADRs were analyzed, defined as death, life-threatening ADR, hospitalization (initial or prolonged), disability (significant or permanent), congenital anomaly. Firstly, we analyzed suspected adverse reaction alerts to NOACs submitted to the Area Vasta 2 (ASUR Marche) pharmacovigilance center, from June 16, 2013 to January 14, 2017. Then, we examined alerts coming from all over Italy and from the Marche Region in the same time period. Secondly, the analysis was focused on the Senigallia hospital (where we had an easy access to the medical records archive); patients who experienced an ADR in that time period were identified retrospectively and an alert was submitted. Thirdly, from January 15, 2017 to March 15, 2017, suspected ADR alerts were submitted prospectively.
RESULTS: Phase 1: in 43 months, 1625 alerts were submitted from all over Italy, 18 from the Marche Region (one of them from the Senigallia hospital). Phase 2: 8 suspected serious ADRs were collected retrospectively (2 fatal and 3 life-threatening). Phase 3: in only 2 months, 7 serious ADRs were observed prospectively (2 fatal and 1 life-threatening).
CONCLUSIONS: Our study shows that among doctors the under-reporting phenomenon is remarkable and it also involves medicinal products subject to additional monitoring and serious ADRs, including deaths.

PMID: 29451510 [PubMed - indexed for MEDLINE]

Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study.

JAMA Oncol. 2018 Apr 01;4(4):537-544

Authors: Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O'Hear C, Vogelzang NJ

Abstract
Importance: Atezolizumab (anti-programmed death ligand 1) has demonstrated safety and activity in advanced and metastatic urothelial carcinoma, but its long-term clinical profile remains unknown.
Objective: To report long-term clinical outcomes with atezolizumab therapy for patients with metastatic urothelial carcinoma.
Design, Setting, and Participants: Patients were enrolled in an expansion cohort of an ongoing, open-label, phase 1 study. Median follow-up was 37.8 months (range, >0.7 to 44.4 months). Enrollment occurred between March 2013 and August 2015 at US and European academic medical centers. Eligible patients had measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1, Eastern Cooperative Oncology Group performance status 0 to 1, and a representative tumor sample. Programmed death ligand 1 expression on immune cells was assessed (VENTANA SP142 assay).
Interventions: Atezolizumab was given intravenously every 3 weeks until unacceptable toxic effects, protocol nonadherence, or loss of clinical benefit.
Main Outcomes and Measures: Primary outcome was safety. Secondary outcomes included objective response rate, duration of response, and progression-free survival. Response and overall survival were assessed in key baseline subgroups.
Results: Ninety-five patients were evaluable (72 [76%] male; median age, 66 years [range, 36-89 years]). Forty-five (47%) received atezolizumab as third-line therapy or greater. Nine patients (9%) had a grade 3 to 4 treatment-related adverse event, mostly within the first treatment year; no serious related adverse events were observed thereafter. One patient (1%) discontinued treatment due to a related event. No treatment-related deaths occurred. Responses occurred in 26% (95% CI, 18%-36%) of patients. Median duration of response was 22.1 months (range, 2.8 to >41.0 months), and median progression-free survival was 2.7 months (95% CI, 1.4-4.3 months). Median overall survival was 10.1 months (95% CI, 7.3-17.0 months); 3-year OS rate was 27% (95% CI, 17%-36%). Response occurred in 40% (95% CI, 26%-55%; n = 40) and 11% (95% CI, 4%-25%; n = 44) of patients with programmed death ligand 1 expression of at least 5% tumor-infiltrating immune cells (IC2/3) or less than 5% (IC0/1), respectively. Median overall survival in patients with IC2/3 and IC0/1 was 14.6 months (95% CI, 9.0 months to not estimable) and 7.6 months (95% CI, 4.7 to 13.9 months), respectively.
Conclusions and Relevance: Atezolizumab remained well tolerated and provided durable clinical benefit to a heavily pretreated metastatic urothelial carcinoma population in this long-term study.
Trial Registration: clinicaltrials.gov Identifier: NCT01375842.

PMID: 29423515 [PubMed - indexed for MEDLINE]

Adverse drug events in Chinese pediatric inpatients and associated risk factors: a retrospective review using the Global Trigger Tool.

Sci Rep. 2018 02 07;8(1):2573

Authors: Ji HH, Song L, Xiao JW, Guo YX, Wei P, Tang TT, Tian XJ, Tang XW, Jia YT

Abstract
Understanding the epidemiology and risk factors of adverse drug events (ADEs) in pediatric inpatient is essential if we are to prevent, reduce or ameliorate the harm experienced. The Global Trigger Tool (GTT) is a method of retrospective medical record review that measures harm in hospitalized children. We employed a three-stage retrospective chart review of random samples of 1800 pediatric inpatients discharged from January 2013 to December 2015. 31 kinds of pediatric-specific triggers were made based on the previous trigger tool studies developed for use in adult or pediatric. Positive predictive value (PPV) of individual triggers, as well as ADEs detection rates were calculated. Stepwise logistic regression was performed to investigate risk factors associated with ADEs. Of 1746 patients, detected in 221 patients (12.7%) with 247 ADEs. The PPV of the trigger tool was 13.3%. Of the 247 ADEs, 82.6% were identified as category E, 11.7% category F and 5.7% category H. The pediatric-focused trigger tool is a feasible and useful tool for detecting pediatric ADEs. Especially for patients who have had more drugs, more doses or more admissions which needs to be closely monitored as triggers to improve the safety.

PMID: 29416072 [PubMed - indexed for MEDLINE]

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The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial).

BMC Infect Dis. 2019 Sep 06;19(1):780

Authors: Zhou Z, Feng T, Xie Y, Huang P, Xie H, Tian R, Qian B, Wang R

Abstract
BACKGROUND: Sepsis is still a common critical disease with high morbidity and mortality in intensive care unit. Despite published guidelines for sepsis, development of antibiotic therapy and advanced organ support technologies, the mortality of sepsis patients is still 25% or more. It is necessary to distinguish the subtypes of sepsis, and the targeted therapy for the patients need to be explored. Platelets have various biological functions in hemostasis and thrombosis, host defense, inflammatory/immune responses and tissue repair/regeneration. Moreover, severe thrombocytopenia or sustained thrombocytopenia was closely associated with multiply organ dysfunction and higher mortality in sepsis patients. The clinical therapies for thrombocytopenia are platelet transfusion and platelet-elevating drugs. However, platelet transfusion has many defects in clinical practice in sepsis patients, and the impact of platelet-elevating drugs for sepsis patients is still unclear. RESCUE trial is aim to explore the effect of a platelet-elevating drug, recombinant human thrombopoietin (rhTPO), as an effective rescue therapy on sepsis patients with acute severe thrombocytopenia.
METHODS: It is a randomized, open-label, multi-center, controlled trial in 5 tertiary academic hospitals including medical, surgical or general ICUs. In this study, a total of 200 sepsis patients with severe thrombocytopenia will be randomly assigned in a 1:1 ratio to the control and rhTPO group. The patients will be followed up to 28 days after randomization. All patients in two groups receive the same treatment based on the guideline of Surviving Sepsis Campaign. Primary outcome is 28-day mortality. Secondary outcomes are the changes of PCs, blood transfusion, biomarkers of infection and organ function, days free from advanced organ support, drug-related adverse events, the length of ICU and hospital stay.
DISCUSSION: RESCUE trial is the first randomized controlled trial to explore the impact of rhTPO for severe thrombocytopenia in sepsis patients diagnosed by sepsis-3.0 standard. Furthermore, RESCUE trial results will be of significant clinical value on the targeted therapy and add clinical evidence that rhTPO is an effective rescue therapy for these sepsis patients.
TRIAL REGISTRATION: ClinicalTrials.gov : NCT02707497. Registered Date: March 3rd, 2016. Protocol Version 3. Protocol Date: January 25th, 2019.

PMID: 31492102 [PubMed - in process]

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Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

Sleep Breath. 2019 Sep 04;:

Authors: Steffen A, Sommer UJ, Maurer JT, Abrams N, Hofauer B, Heiser C

Abstract
PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years.
METHODS: Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented.
RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively.
CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

PMID: 31485853 [PubMed - as supplied by publisher]

Antipsychotic Polypharmacy in Older Adult Asian Patients With Schizophrenia: Research on Asian Psychotropic Prescription Pattern.

J Geriatr Psychiatry Neurol. 2019 Nov;32(6):304-311

Authors: Dong M, Zeng LN, Zhang Q, Yang SY, Chen LY, Sim K, He YL, Chiu HF, Sartorius N, Tan CH, Chong MY, Shinfuku N, Lin SK, Ng CH, Ungvari GS, Xiang YT

Abstract
BACKGROUND AND OBJECTIVE: Antipsychotic polypharmacy (APP) is a controversial topic in the treatment of older adults with schizophrenia. The objective of this study was to examine the use of APP in older adult Asian patients with schizophrenia and its associated demographic and clinical factors.
METHODS: This study was based on the fourth survey of the consortium known as the Research on Asian Psychotropic Prescription Pattern for Antipsychotics. Fifteen Asian countries/territories participated in this survey, including Bangladesh, Mainland China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Myanmar, Pakistan, Singapore, Sri Lanka, Taiwan, Thailand, and Vietnam. Basic demographic and clinical characteristics were collected using a standardized data collection form.
RESULTS: Among the 879 older adults with schizophrenia included in the survey, the rate of APP was 40.5%. Multiple logistic regression analysis revealed that higher antipsychotic doses (P < .001, odds ratio [OR] = 1.003, 95% confidence interval [CI]: 1.002-1.003), longer duration of illness (P = .02, OR = 1.845, 95% CI: 1.087-3.132), and the prescription of anticholinergics (P < .001, OR = 1.871, 95% CI: 1.329-2.635), second-generation antipsychotics (P = .001, OR = 2.264, 95% CI: 1.453-3.529), and first-generation antipsychotics (P < .001, OR = 3.344, 95% CI: 2.307-4.847) were significantly associated with APP.
CONCLUSION: Antipsychotic polypharmacy was common in older adult Asian patients with schizophrenia. Compared to the results of previous surveys, the use of APP showed a declining trend over time. Considering the general poor health status of older patients with schizophrenia and their increased risk of drug-induced adverse events, the use of APP in this population needs careful consideration.

PMID: 31480982 [PubMed - in process]

State of Art of Idiosyncratic Drug-Induced Neutropenia or Agranulocytosis, with a Focus on Biotherapies.

J Clin Med. 2019 Sep 01;8(9):

Authors: Andrès E, Villalba NL, Zulfiqar AA, Serraj K, Mourot-Cottet R, Gottenberg AJ

Abstract
INTRODUCTION: Idiosyncratic drug-induced neutropenia and agranulocytosis is seldom discussed in the literature, especially for new drugs such as biotherapies outside the context of oncology. In the present paper, we report and discuss the clinical data and management of this relatively rare disorder, with a focus on biotherapies used in autoimmune and auto-inflammatory diseases.
MATERIALS AND METHODS: A review of the literature was carried out using the PubMed database of the US National Library of Medicine. We searched for articles published between January 2010 and May 2019 using the following key words or associations: "drug-induced neutropenia", "drug-induced agranulocytosis", and "idiosyncratic agranulocytosis". We included specific searches on several biotherapies used outside the context of oncology, including: tumor necrosis factor (TNF)-alpha inhibitors, anti-CD20 agents, anti-C52 agents, interleukin (IL) 6 inhibitors, IL 1 inhibitors, and B-cell activating factor inhibitor.
RESULTS: Idiosyncratic neutropenia remains a potentially serious adverse event due to the frequency of severe sepsis with severe deep tissue infections (e.g., pneumonia), septicemia, and septic shock in approximately two-thirds of all hospitalized patients with grade 3 or 4 neutropenia (neutrophil count (NC) ≤ 0.5 × 109/L and ≤ 0.1 × 109/L, respectively). Over the last 20 years, several drugs have been strongly associated with the occurrence of idiosyncratic neutropenia, including antithyroid drugs, ticlopidine, clozapine, sulfasalazine, antibiotics such as trimethoprim-sulfamethoxazole, and deferiprone. Transient grade 1-2 neutropenia (absolute blood NC between 1.5 and 0.5 × 109/L) related to biotherapy is relatively common with these drugs. An approximate 10% prevalence of such neutropenia has been reported with several of these biotherapies (e.g., TNF-alpha inhibitors, IL6 inhibitors, and anti-CD52 agents). Grade 3-4 neutropenia or agranulocytosis and clinical manifestations related to sepsis are less common, with only a few case reports to date for most biotherapies. Special mention should be made of late onset and potentially severe neutropenia, especially following anti-CD52 agent therapy. During drug therapy, several prognostic factors have been identified that may be helpful when identifying 'susceptible' patients. Older age (>65 years), septicemia or shock, renal failure, and a neutrophil count ≤0.1 × 109/L have been identified as poor prognostic factors. Idiosyncratic neutropenia should be managed depending on clinical severity, with permanent/transient discontinuation or a lower dose of the drug, switching from one drug to another of the same or another class, broad-spectrum antibiotics in cases of sepsis, and hematopoietic growth factors (particularly G-CSF).
CONCLUSION: Significant progress has been made in recent years in the field of idiosyncratic drug-induced neutropenia, leading to an improvement in their prognosis (currently, mortality rate between 5 and 10%). Clinicians must continue their efforts to improve their knowledge of these adverse events with new drugs as biotherapies.

PMID: 31480527 [PubMed]

Initial Experiments for Pharmacovigilance Analysis in Social Media Using Summaries of Product Characteristics.

Stud Health Technol Inform. 2019 Aug 21;264:60-64

Authors: Campillos-Llanos L, Grouin C, Lillo-Le Louët A, Zweigenbaum P

Abstract
We report initial experiments for analyzing social media through an NLP annotation tool on web posts about medications of current interests (baclofen, levothyroxine and vaccines) and summaries of product characteristics (SPCs). We conducted supervised experiments on a subset of messages annotated by experts according to positive or negative misuse; results ranged from 0.62 to 0.91 of F-score. We also annotated both SPCs and another set of posts to compare MedDRA annotations in each source. A pharmacovigilance expert checked the output and confirmed that entities not found in SCPs might express drug misuse or unknown ADRs.

PMID: 31437885 [PubMed - indexed for MEDLINE]

An Automated Detection System of Drug-Drug Interactions from Electronic Patient Records Using Big Data Analytics.

Stud Health Technol Inform. 2019 Aug 21;264:45-49

Authors: Bouzillé G, Morival C, Westerlynck R, Lemordant P, Chazard E, Lecorre P, Busnel Y, Cuggia M

Abstract
The aim of the study was to build a proof-of-concept demonstratrating that big data technology could improve drug safety monitoring in a hospital and could help pharmacovigilance professionals to make data-driven targeted hypotheses on adverse drug events (ADEs) due to drug-drug interactions (DDI). We developed a DDI automatic detection system based on treatment data and laboratory tests from the electronic health records stored in the clinical data warehouse of Rennes academic hospital. We also used OrientDb, a graph database to store informations from five drug knowledge databases and Spark to perform analysis of potential interactions betweens drugs taken by hospitalized patients. Then, we developed a machine learning model to identify the patients in whom an ADE might have occurred because of a DDI. The DDI detection system worked efficiently and computation time was manageable. The system could be routinely employed for monitoring.

PMID: 31437882 [PubMed - indexed for MEDLINE]

Development of a list of high-risk perioperative medications for the elderly: a Delphi method.

Expert Opin Drug Saf. 2019 Sep;18(9):853-859

Authors: Wang K, Shen J, Jiang D, Xing X, Zhan S, Yan S

Abstract
Objectives: There is a lack of direct evidence for the management of perioperative medications in elderly patients. Therefore, the authors aimed to develop a list of high-risk medications for the elderly population in China to provide indicators for clinicians to identify medication-related factors contributing to potential adverse events during the perioperative period. Methods: The initial list of high-risk perioperative medications was developed by studying all the publications that described specific high-risk medications and their risk profiles in the elderly. Delphi consultations were performed to form a consensus among the group of experts and the list was finalized. Results: The expert panel consisted of 36 experts from 29 tertiary hospitals and 18 provinces or municipalities. The consensus was reached after two Delphi rounds. Finally, a total of 86 medications of 13 medication classes and 120 screening items were included in the final list, along with perioperative risk profiles and risk aversion recommendations for each drug. Conclusion: This is the first study to establish a high-risk perioperative medication list in China, which can be used as a reference for intervention and evaluation of perioperative medications for the elderly population.

PMID: 31169042 [PubMed - indexed for MEDLINE]

Likelihood-Ratio-Test Methods for Drug Safety Signal Detection from Multiple Clinical Datasets.

Comput Math Methods Med. 2019;2019:1526290

Authors: Huang L, Zalkikar J, Tiwari R

Abstract
Pre- and postmarket drug safety evaluations usually include an integrated summary of results obtained using data from multiple studies related to a drug of interest. This paper proposes three approaches based on the likelihood ratio test (LRT), called the LRT methods, for drug safety signal detection from large observational databases with multiple studies, with focus on identifying signals of adverse events (AEs) from many AEs associated with a particular drug or inversely for signals of drugs associated with a particular AE. The methods discussed include simple pooled LRT method and its variations such as the weighted LRT that incorporates the total drug exposure information by study. The power and type-I error of the LRT methods are evaluated in a simulation study with varying heterogeneity across studies. For illustration purpose, these methods are applied to Proton Pump Inhibitors (PPIs) data with 6 studies for the effect of concomitant use of PPIs in treating patients with osteoporosis and to Lipiodol (a contrast agent) data with 13 studies for evaluating that drug's safety profiles.

PMID: 30915153 [PubMed - indexed for MEDLINE]

Sex Differences in Poisonings Among Older Adults: An Analysis of the Toxicology Investigators Consortium (ToxIC) Registry, 2010 to 2016.

Clin Ther. 2018 08;40(8):1366-1374.e8

Authors: Beauchamp GA, Carey JL, Adams T, Wier A, Colón MF, Cook M, Cannon R, Katz KD, Greenberg MR, Toxicology Investigators Consortium (ToxIC)

Abstract
PURPOSE: Adults aged >65 years are susceptible to intentional and unintentional poisoning, with contributing factors that include polypharmacy, comorbidity, susceptibility to medication error, and gaps in research. Although toxicologists are often tasked with managing and preventing poisoning among older adults, little is known about sex differences in these poisonings. The aim of this study was to review sex differences in poisonings among older adults managed at the bedside by medical toxicologists.
METHODS: All case subjects aged >65 years in the Toxicology Investigators Consortium (ToxIC) registry between January 2010 and December 2016 were reviewed. Data included reasons for exposure and consultation, exposure agents and routes, presenting clinical findings, and treatment provided. Cases missing age, sex, or primary reason for toxicology consultation data were excluded. We used χ2 tests to assess differences in distribution of study variables according to participant sex.
FINDINGS: Among 51,441 total registry cases, 542 (1.05%) were excluded because of missing data. Among the remaining 50,899 cases, 2930 (5.8%) were included for age >65 years; 52.3% of older adults were female. Race was missing or unknown for 49.2% of cases. Adverse drug reactions were more commonly encountered in female subjects than in their male counterparts (9.6% vs 6.4%; P = 0.001). No statistically significant sex differences were observed for total numbers of intentional, unintentional pharmaceutical, and nonpharmaceutical exposures. The most common medications involved were cardiovascular (16.8%) and analgesics/opioids (14.8%). Female subjects were more likely than male subjects to be evaluated by a toxicologist for cardiovascular medications (18.7% vs 14.7%; P = 0.004) and analgesics/opioids (17.6% vs 11.8%; P < 0.001). Male subjects were more likely than female subjects to be evaluated for ethanol toxicity (7.4% vs 1%; P < 0.001) and for envenomations (4.2% vs 1.8%; P < 0.001). The most common route of exposure was oral ingestion (81.3%). Signs/symptoms were noted in 54.8% of cases, with the most common abnormal vital sign being bradycardia (17.2%). Pharmacologic support was the most common intervention and was more common in male subjects than in female subjects (17.7% vs 12.3%; P < 0.001). Deaths were reported in 38 female subjects (2.45%) and 46 male subjects (3.34%); there was no statistically significant difference in death rate according to sex (P = 0.148).
IMPLICATIONS: Older female adults were more commonly evaluated by a medical toxicologist for an adverse drug reaction than older male adults. Female patients were more likely than male patients to be evaluated for poisoning related to analgesic/opioids and cardiovascular medications, and older male patients more frequently received pharmacologic support than older female patients. No significant sex differences were observed in numbers of toxicology consultations for intentional, unintentional pharmaceutical, and nonpharmaceutical exposures.

PMID: 30072041 [PubMed - indexed for MEDLINE]