scholarly journals Adverse medication events in a psychiatric practice: a naturalistic study

2013 ◽  
Vol 37 (12) ◽  
pp. 395-397
Author(s):  
Eugene G. Breen
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Drug Events ◽  
Psychiatric Training ◽  
Clinical Implications ◽  
Naturalistic Study ◽  
Near Misses ◽  
Significant Events ◽  
Core Module ◽  
Sector Service

Aims and methodTo document the number and type of adverse medication events in a psychiatric sector service. Significant new adverse events were collated by the author and team over 30 months. Intervention to prevent any adverse event was enacted as soon as any were noticed or anticipated.ResultsThirty-six significant events occurred including three deaths and nine near misses. Corrective action was taken immediately any adverse event occurred. Inadequate communication between various hospital clinics, general practitioner practices, psychiatric clinics and pharmacies was the biggest avoidable cause of adverse events.Clinical implicationsAwareness of adverse drug events is essential in psychiatry. Clear, transparent pathways of prescribing are a key requirement to reduce avoidable adverse medication events. Psychopharmacology is a core module for psychiatric training.

Adverse Events and Patient Safety in the Operating Theatre: Perspectives of 549 Surgeons

2010 ◽  
Vol 92 (6) ◽  
pp. 1-4 ◽  
Author(s):  
C Pritchard ◽  
J Brackstone ◽  
J MacFie
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Operating Theatre ◽  
Near Misses ◽  
The Uk

The Chief Medical Officer's recent report, 'Making surgery safer', was a response to widespread concern about patient safety in the operating theatre. Annually there are an estimated 129,416 'untoward events' in the UK. These range from 'near misses' (NM), in which a patient is 'nearly harmed', to an 'adverse event' (AE), usually defined as 'an unintended injury or complication, including death'.

The Safety of Acupuncture – Evidence from the Uk

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 53-57 ◽  
Author(s):  
Adrian White
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Serious Adverse Events ◽  
Positive Evidence ◽  
Safe Treatment ◽  
Significant Events ◽  
The Uk

Background Patients are attracted to acupuncture partly by its reputation for having low risks. The safety of acupuncture should be established by positive evidence. Methods Two prospective surveys were conducted among different groups of professionals in the UK, including doctors, physiotherapists and practitioners primarily trained in acupuncture. Participants monitored adverse events over a defined period of time, and reported minor and significant events on purpose designed forms. Results A total of 652 acupuncturists reported 6733 adverse reactions including tiredness in 66 229 patients, an adverse event rate of 10.2%. The most common events were tiredness (3%) bleeding or bruising (3%), aggravation of symptoms (2%) and pain at the needling site (1%). There were no serious adverse events. A total of 86 (0.1%) of the treatments was associated with an event that the practitioner judged to be significant though without persistent consequences for the patient's health. Conclusion The risks associated with acupuncture can be classified as negligible, and acupuncture is a very safe treatment in the hands of competent practitioners.

scholarly journals An Assessment of an Educational Intervention on Resident Physician Attitudes, Knowledge, and Skills Related to Adverse Event Reporting

2010 ◽  
Vol 2 (2) ◽  
pp. 188-194 ◽  
Author(s):  
Barbara G. Jericho ◽  
Rosalie F. Tassone ◽  
Nikki M. Centomani ◽  
Jennifer Clary ◽  
Crescent Turner ◽  
...  
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Educational Intervention ◽  
Adverse Event Reporting ◽  
Physician Attitudes ◽  
Event Reporting ◽  
Near Misses ◽  
Knowledge And Skills ◽  
Process Improvements

Abstract Objective Reporting and learning from events linked to patient harm and unsafe conditions is critical to improving patient safety. Programs that engage resident physicians in adverse event reporting can enhance patient safety and simultaneously address all 6 Accreditation Council for Graduate Medical Education competencies. Yet fewer than 60% of physicians know how to report adverse events and near misses, and fewer than 40% know what to report. Our study evaluated the effect of an educational intervention on anesthesiology residents' attitudes, knowledge, and skills related to adverse event reporting and the associated follow-up. Methods In a prospective study, anesthesiology residents participated in a training program focused on the importance of reporting methods and on reporting adverse events for patient safety. Quarterly adverse event reports were analyzed retrospectively for 2 years before the intervention and prospectively for 7 quarters after the intervention. Residents also completed a survey, before and 1 year after the intervention, that evaluated their attitudes, experience, and knowledge regarding adverse event reporting. Results After the intervention, the number of adverse event reports increased from 0 per quarter to almost 30 per quarter. We identified several categories of harm events, near misses, and unsafe conditions, including reports of disruptive providers. Of the harm events associated with invasive procedures, more than half were associated with lack of attending physician supervision. We also observed significant progress in the residents' ability to appropriately file a report, improved attitudes regarding the value of reporting and available emotional support, and a reduction in the perceived impediments to reporting. Conclusions An educational intervention increased the number of adverse event reports submitted by anesthesiology residents, improved their attitudes about the importance of reporting, and produced a source for learning opportunities and process improvements in the delivery of anesthesia care.

scholarly journals A Survey of the Impact of Patient Adverse Events and near Misses on Anaesthetists in Australia and New Zealand

2018 ◽  
Vol 46 (5) ◽  
pp. 510-515 ◽  
Author(s):  
R. Harrison ◽  
H. Lee ◽  
A. Sharma
Keyword(s):  
Adverse Event ◽  
New Zealand ◽  
Adverse Events ◽  
Incident Reporting ◽  
Near Miss ◽  
Near Misses ◽  
Incident Reporting Systems ◽  
Safety Incident ◽  
Reporting Systems ◽  
The Impact

We conducted a cross-sectional online survey of members of the Australian and New Zealand College of Anaesthetists to investigate their experiences of adverse patient safety events and near misses, including their use of incident reporting systems and the organisational support available. There were 247 respondents. Of the 243 anaesthetists whose patients had an adverse event or near miss, 199 reported this had affected them personally or professionally; 177 reported stress, 153 anxiety, 109 sleep disturbance, and 127 lower professional confidence. Of 188 who had reported an adverse event using their local incident reporting systems, 68 were satisfied with this process, 136 received useful feedback, 114 saw local improvements, and 104 saw system changes. Two hundred and thirty-four reported feeling determined to improve, and 228 were anxious about the potential for future errors. Seventy-five anaesthetists admitted not reporting a safety incident that they knew they should have. Reasons for not reporting included an impression that nothing would improve from incident reporting, that reporting was onerous, or fears of punitive action. These findings should spur anaesthetists, anaesthetic departments and professional organisations across Australia and New Zealand to examine their support mechanisms in relation to adverse events and errors and their incident reporting mechanisms, and to attempt to improve these services where necessary.

scholarly journals Gydytojų ir slaugytojų požiūris į nepageidaujamų įvykių ir neatitikčių valdymą lietuvos bendrojo pobūdžio ligoninėse

2015 ◽  
Vol 1 (8) ◽  
pp. 29
Author(s):  
Loreta Marmienė ◽  
Ramunė Kalėdienė
Keyword(s):  
Health Care ◽  
Adverse Event ◽  
Adverse Events ◽  
Health Care Professionals ◽  
Work Experience ◽  
Near Miss ◽  
General Hospitals ◽  
Near Misses ◽  
Preventive Actions

Adverse events and near-miss management in Lithuanian general hospitals is analyzed in this article. The aim of the paper is to evaluate the attitudes of physicians and nurses towards adverse events and near-miss management. 1020 general hospitals health care professionals took part in the anonymous survey, which was performed during the period of June - December, 2014. The results suggested that 9.9% of the respondents did not know what adverse event is, and 10.7% did not know the meaning of near-miss. Nurses compared to physicians knew much more about the process of what and where to register the adverse event or near-miss. Most of the respondents declared that it is useful to register adverse events and near-misses. Older health care professionals with longer work experience were considerably more active in this process. Most of the respondents declared that after the near-miss happens, the efforts are put to examine causes of the event, but only half of them knew further near-miss investigation steps and were instructed about the adjustment and preventive actions.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

Adverse Effects of Natural Products: A Brief Pre-Systematic Review

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Natural Products ◽  
Adverse Events ◽  
In Vitro Study ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

scholarly journals Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

2021 ◽  
Vol 18 (5) ◽  
pp. 2546
Author(s):  
Noriko Morioka ◽  
Masayo Kashiwagi
Keyword(s):  
Adverse Event ◽  
Patient Safety ◽  
Adverse Events ◽  
Home Care ◽  
Process Of Care ◽  
Related Factors ◽  
Cross Sectional ◽  
Home Care Nursing ◽  
Number Of Patients ◽  
Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

scholarly journals The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 24
Author(s):  
Gerald McGwin
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Large Body ◽  
Science Research ◽  
Gastrointestinal System ◽  
Gastrointestinal Cancers ◽  
H2 Antagonists ◽  
Study Results ◽  
Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

scholarly journals Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

2021 ◽  
Vol 12 ◽  
pp. 204209862110128
Author(s):  
Hanan Khalil ◽  
Dimi Hoppe ◽  
Nabil Ameen
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Neuroleptic Malignant Syndrome ◽  
Antipsychotic Drug ◽  
Antipsychotic Drugs ◽  
Common Adverse Event ◽  
Drug Misuse ◽  
Large Databases ◽  
Chi Squared

Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

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