scholarly journals Distant Supervision with Transductive Learning for Adverse Drug Reaction Identification from Electronic Medical Records

2017 ◽  
Vol 2017 ◽  
pp. 1-21 ◽  
Author(s):  
Siriwon Taewijit ◽  
Thanaruk Theeramunkong ◽  
Mitsuru Ikeda
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Multiple Instance Learning ◽  
Semisupervised Learning ◽  
Drug Event ◽  
Model Parameters ◽  
Transductive Learning ◽  
Automatic Data ◽  
Event Pair ◽  
Distant Supervision

Information extraction and knowledge discovery regarding adverse drug reaction (ADR) from large-scale clinical texts are very useful and needy processes. Two major difficulties of this task are the lack of domain experts for labeling examples and intractable processing of unstructured clinical texts. Even though most previous works have been conducted on these issues by applying semisupervised learning for the former and a word-based approach for the latter, they face with complexity in an acquisition of initial labeled data and ignorance of structured sequence of natural language. In this study, we propose automatic data labeling by distant supervision where knowledge bases are exploited to assign anentity-levelrelation label for each drug-event pair in texts, and then, we use patterns for characterizing ADR relation. The multiple-instance learning with expectation-maximization method is employed to estimate model parameters. The method applies transductive learning to iteratively reassign a probability of unknown drug-event pair at the training time. By investigating experiments with 50,998 discharge summaries, we evaluate our method by varying large number of parameters, that is, pattern types, pattern-weighting models, and initial and iterative weightings of relations for unlabeled data. Based on evaluations, our proposed method outperforms the word-based feature for NB-EM (iEM), MILR, and TSVM with F1 score of 11.3%, 9.3%, and 6.5% improvement, respectively.

scholarly journals Classification and applying pharmacovigilance principles to study adverse drug reaction and its management

2017 ◽  
Vol 6 (11) ◽  
pp. 2537
Author(s):  
Srihitha Pendota ◽  
Sre Akshaya Kalyani Surabhineni ◽  
Abhinay Sharma Katnapally ◽  
Dharanija Porandla ◽  
Sandeep Kumar Beemreddy
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Causality Assessment ◽  
Causal Relation ◽  
Drug Event ◽  
Multiple Drug ◽  
Different Types ◽  
Multiple Drug Therapy ◽  
Assessment Scales ◽  
Reason For Admission

Adverse drug reaction (ADR) is an unwanted, undesirable effect of medication resulting in mild to severe effect on the patient. This review explains definitions of ADR and it differentiation with adverse drug event, medication error. ADRs may cause increased length of stay or initial reason for admission and are major cause of morbidity and mortality worldwide. Risk factors for ADR occurrence include age, gender, patients with multiple diseases and multiple drug therapy (polypharmacy). ADRs are classified into different types based on the mechanism and onset of reaction. The causal relation between suspected drug and reaction can be assessed by using causality assessment scales. The severity and preventability of ADR can be assessed by severity assessment scale and preventability scale respectively. Clinical Pharmacists play an important role in monitoring and management of ADRs.

scholarly journals High-quality reports and their characteristics in the Japanese Adverse Drug Event Report database (JADER)

2021 ◽  
Vol 24 ◽  
pp. 161-173
Author(s):  
Masami Tsuchiya ◽  
Taku Obara ◽  
Makoto Miyazaki ◽  
Aoi Noda ◽  
Takamasa Sakai ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Anticancer Drugs ◽  
Adverse Drug Event ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Drug Event ◽  
Event Report ◽  
High Quality ◽  
Grade 3

Purpose: Spontaneous adverse drug reaction reporting is the foundation of postmarketing drug safety monitoring. The present study aimed to analyze and clarify the quality and characteristics of the Japanese Adverse Drug Event Report database (JADER) using the World Health Organization (WHO) documentation grading scheme and the vigiGrade completeness score. The characteristics of reports were described using both schemes simultaneously. The way of proper use of these two schemes was explored. Methods: The WHO documentation grading scheme and the vigiGrade completeness score were applied to the same dataset (JADER202001 dataset). Reports classified as high-quality under both assessment criteria were extracted, and the characteristics of these reports were analyzed. Results: Of the 607,361 adverse drug reaction reports analyzed, 52.8% were ‘well-documented reports’ with a vigiGrade completeness score >0.8. Under the WHO documentation grading scheme, 328,702 reports (54.1%) were Grade 2 and 5,178 (0.9%) were Grade 3 (including rechallenge information). Among well-documented Grade 3 reports, classified as the highest quality, a high proportion of the adverse drug reaction reports were related to disorders of hematopoietic function resulting from anticancer drugs. Because a high proportion of the reports with rechallenge information were for anticancer drugs as suspect drugs, the WHO documentation grading scheme tended to extract reports regarding anticancer drugs as high quality. Conclusions: We conclude that the two schemes need to be used appropriately, depending on the purpose of analysis, the target adverse drug reactions, and suspect drugs.

scholarly journals P015 Yellow cards are still not on everyone’s to do list

2019 ◽  
Vol 104 (7) ◽  
pp. e2.18-e2
Author(s):  
Emily Horan ◽  
David Tuthill
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Drug Event ◽  
Yellow Card ◽  
Reporting Scheme ◽  
Know How ◽  
Learning Module ◽  
Yellow Card Scheme ◽  
E Learning

AimTo look at how the Yellow Card Scheme is used by health care professionals (HCPs) in child health.MethodsAn online SurveyMonkey questionnaire was devised to look at how healthcare professionals (HCPs) have used the Yellow Card Scheme in clinical practice. It comprised of 10 questions (9 multiple choice and 1 freestyle text). What type of healthcare professional are you? Are you aware of the Yellow Card reporting scheme? Have you ever used the Yellow Card Scheme to report an adverse drug reaction? If yes, how did you make the report? (If no, select N/A) If you haven’t ever reported a reaction, would you know how to? Have you ever completed an e learning module about the Yellow Card Scheme? Are you aware that parents can report adverse drug reactions using the Yellow Card Scheme? Have you ever been aware of an adverse drug reaction but decided not to report it? If yes, what was the reason you chose not to report it? (If no, select N/A) Can you think of any ways to make the Yellow Card Scheme more accessible to healthcare professionals? It was piloted on 5 HCPS and minor textural revisions made. The questionnaire was then undertaken via face-to-face interviews during June 2018.Results50 healthcare professionals completed the questionnaire: 16 doctors, 13 nurses, 8 pharmacists, 9 medical students, 2 nursing students and 2 pharmacy technicians. 43/50 were aware of the Yellow Card Scheme (10 undergraduates and 33 postgraduates). 18 participants had used the Yellow Card whilst 32 had not reported an adverse drug event. Out of the 32 respondents who had never reported a reaction, 13 (7 undergraduates and 6 postgraduates) said that they would not know how to report a reaction if required. Only 9 had completed an online e learning module about the Yellow Card scheme. 30 participants were aware that parents could report using the scheme. 10 participants had been aware of an adverse drug reaction but decided not to report it. The most common reason for this was being too busy. The most common suggestion on how to improve accessibility to the Yellow Card Scheme was the implementation of a mobile phone application.ConclusionMost participants were aware of the Yellow Card scheme although undergraduates less so. Many had reported, although some had chosen not to report because they were: too busy; not being concerned enough; not knowing how to; having forgotten. An app already exists, but awareness of this appears low, as it was the commonest suggestion to aid the low reporting.

A Data Driven Approach to Profile Potential SARS-CoV-2 Drug Interactions Using TylerADE (Preprint)

2020 ◽  
Author(s):  
Robert P Schumaker ◽  
Michael A Veronin ◽  
Trevor Rohm ◽  
Matthew C Boyett ◽  
Rohit R Dixit
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Event ◽  
Treatment Guidelines ◽  
Drug Efficacy ◽  
Drug Combinations ◽  
Data Driven ◽  
Drug Event ◽  
Data Driven Approach ◽  
Reaction Severity

UNSTRUCTURED We use a data driven approach on a cleaned FAERS database to determine the adverse drug reaction severity of several covid-19 drug combinations and further investigate their safety for vulnerable populations such as individuals 65 years and older. Our key findings include 1. hydroxychloroquine/chloroquine is associated with increased adverse drug event severity versus other drug combinations already not recommended by NIH treatment guidelines, 2. hydroxychloroquine/azithromycin is associated with lower adverse drug event severity among older populations and 3. lopinavir/ritonavir has lower adverse reaction severity among toddlers. While this approach does not consider drug efficacy, it can help prioritize clinical trials for drug combinations by focusing on those combinations with decreased adverse drug reaction severity.

scholarly journals A study to determine the knowledge of pharmacovigilance among pharmacy students from Mumbai university

2018 ◽  
Vol 6 (8) ◽  
pp. 2621
Author(s):  
Dnyanesh Limaye ◽  
Purav Shah ◽  
Akhil Shah ◽  
Ragini Pillay ◽  
Viraj Modak ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reaction Reporting ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Pharmacy Students ◽  
Drug Event ◽  
Eligibility Criterion ◽  
Cross Sectional ◽  
Pharmacy Council

Background: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students. 

scholarly journals Spontaneous Reporting of Adverse Drug Reactions

2018 ◽  
Vol 2 (1) ◽  
pp. 3
Author(s):  
Jagminder Kaur Bajaj ◽  
Satinder Jeet Singh
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Drug Event ◽  
Drug Reactions ◽  
Comprehensive Health Care ◽  
Unexpected Event ◽  
Comprehensive Health

Drugs are used for the benefit of the patient however drugs also produce adverse drug reactions. Adverse drug reaction is an adverse drug event that results in undesirable or unexpected event that requires some changes in the clinician's care of the patient, modifying a dosage, prolonging hospitalization or administering supportive treatment. Monitoring and Reporting of adverse drug reaction should be a part of comprehensive health care provided to the patients. This letter stresses on the need for the health care professional to report and monitor the adverse drug reactions.

scholarly journals Standard-based comprehensive detection of adverse drug reaction signals from nursing statements and laboratory results in electronic health records

2017 ◽  
Vol 24 (4) ◽  
pp. 697-708 ◽  
Author(s):  
Suehyun Lee ◽  
Jiyeob Choi ◽  
Hun-Sung Kim ◽  
Grace Juyun Kim ◽  
Kye Hwa Lee ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Electronic Health Record ◽  
Adverse Event Reporting System ◽  
Drug Event ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Laboratory Test Results ◽  
Electronic Health ◽  
Medical Dictionary

Abstract Objective. We propose 2 Medical Dictionary for Regulatory Activities–enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. Matrials and methods. This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)–based pharmacovigilance method, called CLEAR. Adverse drug reaction (ADR) signals from 117 laboratory abnormalities and 1357 standard nursing statements for all precautionary drugs (n  = 101) were comprehensively detected and validated against SIDER (Side Effect Resource) by MetaLAB and MetaNurse against 11 817 and 76 457 drug-ADR pairs, respectively. Results. We demonstrate that MetaLAB (area under the curve, AUC = 0.61 ± 0.18) outperformed CLEAR (AUC = 0.55 ± 0.06) when we applied the same 470 drug-event pairs as the gold standard, as in our previous research. Receiver operating characteristic curves for 101 precautionary terms in the Medical Dictionary for Regulatory Activities Preferred Terms were obtained for MetaLAB and MetaNurse (0.69 ± 0.11; 0.62 ± 0.07), which complemented each other in terms of ADR signal coverage. Novel ADR signals discovered by MetaLAB and MetaNurse were successfully validated against spontaneous reports in the US Food and Drug Administration Adverse Event Reporting System database. Discussion. The present study demonstrates the symbiosis of laboratory test results and nursing statements for ADR signal detection in terms of their system organ class coverage and performance profiles. Conclusion. Systematic discovery and evaluation of the wide spectrum of ADR signals using standard-based observational electronic health record data across many institutions will affect drug development and use, as well as postmarketing surveillance and regulation.

Efavirenz-Induced Vanishing Bile Duct Syndrome: A Case Report

2019 ◽  
pp. 089719001986835
Author(s):  
Angela Shogbon Nwaesei ◽  
Pamela M. Moye-Dickerson ◽  
Robin Henry Dretler
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Bile Duct ◽  
Drug Event ◽  
Vanishing Bile Duct Syndrome ◽  
Dark Urine ◽  
Potential Adverse Drug Event ◽  
End Stage ◽  
Vanishing Bile Duct ◽  
Duct Syndrome

Background: Efavirenz (Sustiva®) is used for the treatment of human immunodeficiency virus (HIV) type 1 infection. Hepatoxicity is a known potential adverse drug event with efavirenz; however, to our knowledge, vanishing bile duct syndrome (VBDS), a type of liver injury, has not been reported with this therapy. Case Presentation: We report the case of a 48-year-old male with HIV and VBDS secondary to antiretroviral therapy. The patient was started on efavirenz, emtricitabine, and tenofovir disoproxil fumarate (Atripla®). Four weeks later, the patient presented with complaints of poor appetite, nausea with emesis, dark urine, and malaise. Labs obtained supported the diagnosis of acute hepatitis, and a liver biopsy confirmed a diagnosis of VBDS. The Naranjo adverse drug reaction probability scale showed that it was probable (score of 7) that the VBDS was related to drug therapy. Efavirenz was assessed to be the most likely cause of VBDS, end-stage liver disease, and the eventual need for liver transplantation. Conclusion: To our knowledge, this is the first reported case of probable efavirenz-induced VBDS in a patient living with HIV. Recognition and awareness of this adverse drug reaction by clinicians for quick diagnosis, discontinuation of therapy, and management are important in patients receiving this regimen.

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