Abstract

The World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse drug effects. The aim is to promote the safety and effective use of medicines through an early detection and evaluation of drug safety risks. The pharmacovigilance system is essentially based in spontaneous reports of Adverse Drug Reactions (ADR). ADR can be associated with severe outcomes and significant mortality, besides, most of them are deemed to be preventable events. Globally, antibiotics are among the most widely prescribed medications and their extensive use is linked to antibiotic-associated ADR. This chapter aims to summarize available epidemiological data concerning antibiotic use related ADR and analyze the reports received by the EudraVigilance system regarding the exclusive usage of antibiotics.

Highlights

  • The history of antibiotics and its use can be dated back to the previous century [1]

  • A study based on data from the European Antimicrobial Resistance Surveillance Network (EARS-Net) during 2015 estimated that, annually, around 670 thousand infections occur in the European Union (EU) due to antibiotic-resistant bacteria, with approximately 33 thousand people dying as a direct outcome of these types of infection [6]

  • These have shown to effectively impact antibiotic resistance (ABR) and comprise bacterial infection regulatory programs to limit the transmission of resistant microorganisms, antibiotic stewardship courses based on the adherence to awareness guidelines and approaches to increase the judicious antibiotic prescription, educational interventions among health professionals to improve prudent antibiotic prescription and vaccination programs [20, 29, 32–35]

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Summary

Introduction

The history of antibiotics and its use can be dated back to the previous century [1]. The appropriate use of antibiotics is safe, effective and has few adverse effects When these medicines are improperly prescribed, bacterial resistance may arise. This problem, commonly known as antibiotic resistance (ABR), is one of the major public health threats of the 21st century worldwide [4, 5]. The appropriate use of antibiotics is essential to prevent ABR and reduce the risk of adverse reactions. Pharmacovigilance systems are essential to enhance patients’ care and safety, being responsible for the monitoring of pre-market review and post-market surveillance processes. They provide reliable and balanced information for an effective evaluation of the benefits and risks of available medical drugs [12]. To analyze the reports received by the EudraVigilance system regarding the exclusive usage of antibiotics

Antibiotics
Main challenges with antibiotic use
Epidemiological data
Adverse drug reactions associated with antibiotics
ADR analysis in Europe
Special populations: children, pregnant women and older adults
Children
Pregnant women
Older adults
Findings
Conclusions
Full Text
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