scholarly journals Incident adverse drug reactions in geriatric inpatients: a multicentred observational study

2017 ◽  
Vol 9 (1) ◽  
pp. 13-23 ◽  
Author(s):  
Amanda Lavan ◽  
Joseph Eustace ◽  
Darren Dahly ◽  
Evelyn Flanagan ◽  
Paul Gallagher ◽  
...  
Keyword(s):  
Observational Study ◽  
Adverse Drug Reactions ◽  
Feasibility Study ◽  
Median Number ◽  
Economic Consequences ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
P Value ◽  
Drug Reactions ◽  
Monitoring Centre

Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions ( r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

scholarly journals Pharmacovigilance programme of India: revival of the renaissance

2018 ◽  
Vol 7 (11) ◽  
pp. 2281
Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Family Welfare ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

scholarly journals Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders

2021 ◽  
Vol 2 (2) ◽  
pp. 27-32
Author(s):  
Rani Kumari ◽  
Rachna Gupta ◽  
Manjeet Singh Bhatia ◽  
Suresh Kumar Gupta
Keyword(s):  
Psychiatric Disorders ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Improve Patient Care ◽  
Assessment Method ◽  
Uppsala Monitoring Centre ◽  
Drug Reactions ◽  
Mortality And Morbidity ◽  
Monitoring Centre ◽  
Common Diagnosis

Introduction: Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity. Objectives: The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders. Methods: This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital,  between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed. Results: Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable. Conclusions: Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.

scholarly journals Inter-rater and intra-rater agreement in causality assessment of adverse drug reactions: a comparative study of WHO-UMC versus Naranjo scale

2017 ◽  
Vol 5 (10) ◽  
pp. 4389 ◽  
Author(s):  
Sushil Sharma ◽  
Ajay Kumar Gupta ◽  
G. Jyothi Reddy
Keyword(s):  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Assessment System ◽  
Uppsala Monitoring Centre ◽  
Rater Agreement ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Common Category ◽  
Kappa Value ◽  
Mean Time

Background: The causality assessment system proposed by the WHO collaborating centre for international drug monitoring, the Uppsala monitoring centre (WHO-UMC) and the Naranjo probability scale are the generally accepted and most widely used methods for causality assessment. Both these scales are structured, transparent, consistent, and easy to apply with distinct advantages. The PvPI recommends use of WHO-UMC scale while many clinicians prefer Naranjo scale for its simplicity. As both these scales are used very widely in practise, it is important to study the level of agreement among them, to ensure proper interpretation of the causality assessment of the drugs. Objective was to study the inter-rater and intra-rater agreement in causality assessment of adverse drug reactions between WHO-UMC and Naranjo scale.Methods: A total of 200 cases were analyzed by three raters. Each ADR reporting form was analyzed by the raters independently using both the Naranjo scale and the WHO-UMC scale. The inter-rater and Intra-rater agreement of all the three raters was analyzed using kappa statistics.Results: The most common category of causality assessment was ‘possible’ which was around 73%, while the probable, definite and unlikely accounted for 23%, 3% and 1% respectively. The inter-rater agreement for the various categories of causality assessment when using Naranjo scale ranged from “very good to excellent” (Kappa value 0.95) while the same ranged from “good to very good” when the WHO-UMC scale was used (Kappa value 0.89) while the Intra-rater agreement for the three raters ranged from good to very good. The mean time (in minutes) taken for assessing the suspected adverse drug an ADR was 8. 26±2.53 for WHO-UMC scale while it was 14.18±3.44 when Naranjo scale was used.Conclusions: Both the WHO-UMC scale and Naranjo scale are reliable and valid tools for causality assessment but the Inter-rater agreement was slightly better with Naranjo as compared to WHO-UMC scale.

scholarly journals Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Süsskind ◽  
P. A. Thürmann ◽  
C. Lüke ◽  
E. Jeschke ◽  
M. Tabali ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Community Hospital ◽  
Safety Data ◽  
Uppsala Monitoring Centre ◽  
Anthroposophic Medicine ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Medical Wards ◽  
Design And Methods ◽  
Uppsala Monitoring

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use.Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3n=191, 90.5%, CTCAE grade 4/5n=20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2).Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Suspected Adverse Drug Reaction ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Risk Minimization ◽  
Drug Reactions ◽  
Medicinal Products

Abstract Background: Signals of adverse drug reactions are the basis of some regulatory risk-minimization actions in pharmacovigilance, such as changes to the section of undesirable effects in Summaries of Products Characteristics (SmPCs). Reviews of the evidence of signals have highlighted that these are mostly supported by reports of adverse drug reactions or multiple types of evidence, but have so far been limited to specific medicinal products, time intervals, groups of adverse drug reactions and specific countries. The time that elapses between a report of a suspected adverse drug reaction and the communication of a signal has not been systematically investigated. Furthermore, difficulties in causally linking medicinal products to adverse events have been highlighted, but the elements of reports of suspected ADRs that authors used to support putative causal relationships have been rarely characterized.Methods: We plan a scoping review to chart the evidence underpinning signals in pharmacovigilance and the time that it takes to communicate a signal. We shall retrieve records from electronic databases, without language or publication restrictions; we shall apply backward and forward citation to adjust for variations in database indexing. We shall also hand-search the websites of 35 regulatory agencies/authorities, restricted publications from Uppsala Monitoring Centre, and drug bulletins in the list of International Society of Drug Bulletins. If websites do not report signals, signals will be requested from the competent stakeholder. We shall use the Oxford Centre for Evidence-Based Medicine Levels of Evidence to chart and summarize evidence. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the date of reporting for reports of adverse drug reactions. Plots, or pictograms (if appropriate), will be used to represent the time from the first report of a suspected adverse drug reaction to a signal.Discussion: We expect that the findings from this exploratory investigation will be useful in better understanding global patterns of similarities or differences in regulatory decision-making in terms of evidence and timing of communications, and in identifying relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals Drug Utilisation Pattern and Adverse Drug Reactions in Stage II Breast Cancer Patients in a Tertiary Care Centre of Odisha- An Observational Study

2021 ◽  
Author(s):  
Anima Rout ◽  
Priti Das ◽  
Ratikanta Tripathy ◽  
Dillip Kumar Agarwalla ◽  
Vedvyas Mishra
Keyword(s):  
Breast Cancer ◽  
Observational Study ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Stage Ii ◽  
World Health ◽  
Combination Regimen ◽  
Breast Cancer Patients ◽  
Drug Reactions

Introduction: Breast cancer is the most common cancer occurring in women with an estimated prevalence of 28.94% in Cuttack, Odisha, India. Adverse Drug Reactions (ADRs) associated with the use of anticancer drugs is a worldwide problem which needs further attention. Aim: To know about treatment regimens, premedications used for toxicity amelioration or any associated ADRs occurring during treatment of stage II breast cancer patients. Materials and Methods: This was a prospective observational study carried out in the Department of Pharmacology in collabo- ration with Acharya Harihar Regional Cancer Center (AHRCC), SCB Medical College and Hospital, Odisha, India. A total of 181 female breast cancer patients of stage II were finally analysed about their treatment protocol pattern including premedication, chemotherapy regimen, associated ADRs and their treatment. Different outcomes measured were Absolute Neutrophil Count (ANC), febrile neutropenia, anaemia, thrombocytopenia. ADRs were analysed by using World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) Scale and Hartwig-Siegel Scale. All analysis was performed using Statistical Package For the Social Sciences (SPSS) version 18.0. Results: Most common chemotherapy combination regimen used was cyclophosphamide+doxorubicin+paclitaxel+trastuzumab in 30.9% of patients, out of which 28.7% showed ADRs. Ondansetron and aprepitant were commonly used as premedication in 96% of patients. Most commonly reported ADR was Chemotherapy Induced Nausea and Vomiting (CINV) in 43.6% patients and Chemotherapy Induced Neutropenia (CIN) (34.8%). Fifty percent ADRs were mild and 3.3% ADRs were severe in nature. A 64% ADRs were possible and 23% ADRs were probable according to WHO-UMC causality assessment scale. Grade 4 Neutropenia was present in 1.3% patients. Mild haematological problems were treated by blood transfusion while severe cases by additional growth factor support like Granulocyte Colony Stimulating Factor (G-CSF). In this study, mean age of presentation was found to be 44.6 years. Conclusion: Despite use of drugs for toxicity amelioration, some grade four life threatening ADRs were observed. Mostly ADRs were missed and under-reported. Regular monitoring, increased care and patient compliance was needed to detect new ADRs and to reduce the morbidity as well as burden on the patients.

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reactions ◽  
Systematic Reviews ◽  
Scoping Review ◽  
Data Retrieval ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Data Repository ◽  
Supporting Evidence ◽  
Causal Relationships ◽  
Drug Reactions

Abstract Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. . The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither have the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting signals, and the time that it takes to communicate a signal.Methods: . We shall retrieve records from PubMed, EMBASE, Web of Science, PsycINFO (from inception onwards), without language/design restrictions and apply backward citation screening . We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the dates on which ADRs were reported . We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal.Discussion: We expect the findings from this review will allow better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications, and identify relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

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