scholarly journals Minireview of drug safety and pharmacovigilance

2021 ◽  
Vol 1 (1) ◽  
pp. 10-13
Author(s):  
Nawaf Almuntashiri

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.

Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek

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.


Methods ◽  
2016 ◽  
Vol 110 ◽  
pp. 14-25 ◽  
Author(s):  
Yuxiang Tan ◽  
Yong Hu ◽  
Xiaoxiao Liu ◽  
Zhinan Yin ◽  
Xue-wen Chen ◽  
...  

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

2020 ◽  
Author(s):  
Hong Wu ◽  
Jiatong Ji ◽  
Haimei Tian ◽  
Yao Chen ◽  
Weihong Ge ◽  
...  

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.


Author(s):  
Hani Gh. Jawad ◽  
Eman S. Saleh ◽  
Manal M. Younus

Medication safety is an important part of the comprehensive patient safety term. Medication safety is gaining more attention as the World Health Organization set the goal of decreasing medication harm by (50%) for the next 5 years when launching the third global challenge. Studying medication safety in the risk groups such as young ages, children are crucial to learn more about the effect of medicines in this risk group since they are not included in the clinical trials. Adverse drug reaction is defined as any harm resulted from the drug itself during medical process journey, while medication errors are any harm resulted from the treatment process rather than the drug or it is the result of the failure in a step of the treatment process and by that it came clear that adverse drug reaction in non-preventable event while medication error is preventable one. The objectives of this study are to find the preventable medication errors from the Iraqi database of Adverse drug events in ages from neonatal to adolescent age. This study is a retrospective descriptive study conducted using the Iraqi pharmacovigilance center database. The study included reports that were received by the Iraqi pharmacovigilance center from 1st of January 2014 until the 1st of January 2020. In this study, the total number of reports included was 2344. The type of medication involved, type of adverse event, type of error and


Author(s):  
R Sai Priya ◽  
R Vidya ◽  
Dr. M. Robinson Joel

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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