Abstract
During the post-marketing period, when medicines are used by large population contingents and for longer periods, unexpected adverse events (AE) can occur, potentially altering the drug's risk-benefit ratio enough to demand regulatory action. AE are health problems that can occur during treatment with a pharmaceutical product, which in the drug's post-marketing period can require a significant increase in health care and result in unnecessary and often fatal harm to patients. Therefore, a key objective for the health system is to identify AE as soon as possible in the post-marketing period. Some countries have pharmacovigilance systems responsible for collecting voluntary reports of post-marketing AE, but studies have shown that social networks can be used to obtain more and faster reports. The current project's main objective is to build a totally automated system using Twitter as a source to detect both new and previously known AE and conduct the statistical analysis of the resulting data. A system was thus built to collect, process, analyze, and assess tweets in search of AE, comparing them to U.S. Food and Drug Administration (FDA) data and the reference standard. The results allowed detecting new and existing AE related to the drug doxycycline, showing that Twitter can be useful in pharmacovigilance when employed jointly with other data sources.
Highlights
During the post-marketing period, when medicines are used by large population contingents and for longer periods, adverse events (AE) can occur that can alter the drug’s risk-benefit ratio enough to require regulatory action
AE are defined as health problems that can emerge in a user or patient during treatment with a pharmaceutical product, potentially resulting from medication errors, deviation in the drugs’ quality, adverse drug reactions (ADR), drug-drug interactions, and intoxications 1
Due to limitations on the number of words that can be searched for in Twitter, this study focused on ADR from drugs for malaria, which was the neglected disease with the most tweets in 2014
Summary
During the post-marketing period, when medicines are used by large population contingents and for longer periods, adverse events (AE) can occur that can alter the drug’s risk-benefit ratio enough to require regulatory action. According to the World Health Organization (WHO), pharmacovigilance is defined as “as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” 2. Pharmacovigilance is responsible for identifying, assessing, and monitoring the occurrence of drug-related AE, with the aim of guaranteeing that the benefits outweigh the risks caused by them 1. To achieve this objective, the main instrument in pharmacovigilance is spontaneous reporting, informing government agencies on AE that have occurred with the drugs’ use. In Brazil, pharmacovigilance activities are shared by the state and municipal health surveillance agencies and the Brazilian Health Regulatory Agency (Anvisa) 2,3. It is necessary to use other sources to detect AE
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