How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers

2002 ◽  
Vol 11 (1) ◽  
pp. 37-44 ◽  
Author(s):  
P. Fleuranceau-Morel
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Pharmaceutical Companies

scholarly journals Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Safety Data ◽  
Regulatory System ◽  
Basic Structure ◽  
Reaction Reporting ◽  
Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

scholarly journals Improving drug safety: From adverse drug reaction knowledge discovery to clinical implementation

Methods ◽  
2016 ◽  
Vol 110 ◽  
pp. 14-25 ◽  
Author(s):  
Yuxiang Tan ◽  
Yong Hu ◽  
Xiaoxiao Liu ◽  
Zhinan Yin ◽  
Xue-wen Chen ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Knowledge Discovery ◽  
Drug Safety ◽  
Clinical Implementation

scholarly journals Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

2013 ◽  
Vol 5 (4) ◽  
pp. 116-120 ◽  
Author(s):  
Manjunath Ajanal ◽  
Shradda Nayak ◽  
Buduru Sreenivasa Prasad ◽  
Avinash Kadam
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety

Radical embedding combined dynamic embedding based BERT in Bi-LSTM-CRF model for Chinese named entity recognition from Adverse Drug Event records (Preprint)

2020 ◽  
Author(s):  
Hong Wu ◽  
Jiatong Ji ◽  
Haimei Tian ◽  
Yao Chen ◽  
Weihong Ge ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Information Extraction ◽  
Drug Safety ◽  
Named Entity Recognition ◽  
Entity Recognition ◽  
Named Entity ◽  
Related Information ◽  
Post Marketing ◽  
Radical Model

BACKGROUND With the increasing variety of drugs, the incidence of Adverse Drug Events (ADEs) is increasing year by year. Massive ADEs are recorded in Electronic Medical Records and Adverse Drug Reaction (ADR) reports which are important source of potential ADRs information. OBJECTIVE Meanwhile, it is essential to make latent ADR information to be available automatically for better post-marketing drug safety reevaluation and pharmacovigilance. This present study describes how to identify ADR-related information from Chinese ADE reports. METHODS Our study established an efficient automated tool, named BBC-Radical (BBC-Radical is model that consists of three components – Bidirectional Encoder Representations from Transformers (BERT), Bidirectional Long-Short Term Memory (Bi-LSTM), and Conditional Random Field (CRF)) model to identify ADR-related information from Chinese ADR reports. Token features and radical features of Chinese characters are used to represent the common meaning of a group of words. BERT and Bi-LSTM-CRF were novel models combined these features to conduct Named Entity Recognition (NER) tasks in the free-text section of 24,890 ADR reports of Jiangsu Province Adverse Drug Reaction Monitoring Center from 2010 to 2016. Moreover, the Man-Machine comparison experiment on the ADE records of Drum Tower hospital was designed to compare the NER performance between BBC-Radical model and manual method. RESULTS The NER model achieved relatively high performance of Precision of 96.41%, Recall of 96.03%, and F1 score of 96.22%. It was indicated the performance of the BBC-Radical model (Precision: 87.17%, Recall: 85.69%, and F1 score: 86.43%) is much better than that of the manual method (Precision: 86.1%, Recall: 73.8%, and F1 score: 79.5%) in the recognition task of each kind of entity. CONCLUSIONS The proposed model shows competition in ADR related information extraction from ADE reports and the results suggested that the application of our method in the information extraction of ADR related information is of great significance in improving the quality of ADR reports and post-marketing drug safety evaluation.

scholarly journals A pharmacovigilance study of adverse drug reactions in a tertiary care hospital in Haryana

2019 ◽  
Vol 8 (10) ◽  
pp. 2184
Author(s):  
Manmeet Kaur ◽  
Tirthankar Deb ◽  
Jayant Kairi ◽  
Ankit Arora
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Large Scale ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Pharmaceutical Companies ◽  
Care Hospital ◽  
Dermatology Department ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College

Background: Adverse drug reaction (ADR) is an inevitable risk associated with all the prescribed medicines. They vary in severity & duration in any population. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance programme of India through adverse drug reaction monitoring centres. This study was taken to assess the pattern of ADR reported in a tertiary care hospital in Haryana.Methods: This study was conducted in the Kalpana Chawla Government Medical College, Karnal, Haryana from January 2018 to June 2019. ADRs were collected from different departments and were analysed according to gender, age, department wise distribution, drugs class involved and ADR that was reported.Results: A total of 233 ADRs were reported in the above mentioned period. Females were affected more than males, maximum number reported in the age group of 21-60 years. The maximum number of ADRs reported was from Dermatology department. Antimicrobials were the class of drugs that were responsible for the maximum number of ADRs reported. Skin manifestations of various types were the most reported ADRs.Conclusions: By keeping a careful and timely watch majority of the ADRS can be prevented by early intervention. There is also a need to ensure timely check on the drugs supplied by the various pharmaceutical companies who get the contract for government supply. This will be a step towards improving patient safety.

scholarly journals Minireview of drug safety and pharmacovigilance

2021 ◽  
Vol 1 (1) ◽  
pp. 10-13
Author(s):  
Nawaf Almuntashiri
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Animal Experiments ◽  
Medical Conditions ◽  
Insufficient Evidence ◽  
Extrinsic Factors ◽  
Intrinsic Factors ◽  
Pharmacovigilance Center ◽  
Harmful Effects

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. ADR causing intrinsic factors include the active ingredients in the drug itself. In Saudi Arabia, the National Pharmacovigilance Center (NPC) was established in March, 2009 as a semi-autonomous department of Saudi Food and Drug Authority (SFDA). The purpose of NPC was to perform early detection of ADR and safe use of drugs. We need pharmacovigilance because animal experiments and clinical trials performed before marketing are insufficient evidence of drug safety.

scholarly journals Mining of ADR And Symptoms for Immediate Patient Treatment

2019 ◽  
pp. 178-182
Author(s):  
R Sai Priya ◽  
R Vidya ◽  
Dr. M. Robinson Joel
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
High Probability ◽  
Statistical Data ◽  
Critical Issue ◽  
Patient Treatment ◽  
Medical Field ◽  
Key Factor ◽  
Post Marketing

Adverse Drug Reaction is the most critical issue in the medical field. The importance of chemical drug reaction is severe and spreading easily. It causes severe major problem in hospitalization. Here it gives you a detailed view of ADR effects and it mines the data to get instantaneous treatment for the patients. Adverse drug reaction is an cause of harm which affects the patient by taking a medicine. When a person intake a capsule without prescribed by a doctor then it has a high probability of ADR in it. So, it is the important issue in the drug safety. Many ADR are found after post-marketing clinical trials so identifying ADR in pre-marketing trial is more important rather than post trials. Statistical data is the main key factor in mining concept to detect the ADR as early as possible in the drug safety.

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