An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance

Candore, Gianmario; Zaccaria, Cosimo; Slattery, Jim; Arlett, Peter

doi:10.1002/pds.4344

Cited by 11 publications

(10 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Since the introduction of mandatory reporting of ICSRs to EudraVigilance in the European Economic Area, on 20 November 2005, the EMA has used the data held in EudraVigilance to detect safety signals and, incidentally, to determine if these signals were due to quality defects or medication errors. 49 Since the release of MedDRA version 19.0 in March 2016, a 27th MedDRA System Organ Class (SOC) ‘Product issues’ has been introduced. The LLTs of this SOC can be used to code ICSRs, in addition to ADR terms, and to send them to EudraVigilance.…”

Section: Eudravigilance As a Useful Source Of Data For The Identifica...mentioning

confidence: 99%

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

Sardella¹,

Belcher

Lungu

et al. 2021

Therapeutic Advances in Drug Safety

View full text Add to dashboard Cite

The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation. Society assumes that unexpected adverse reactions causally related to pharmacological activity are very unlikely to be detected for such well-established medicines, but important risks can still occur. For these products, a change in the safety profile which is brand or source specific and usually local in nature, associated with failures with the adequate control of quality of manufacturing or distribution are important safety issues. These may be the consequence of manufacturing and pharmacovigilance quality systems that are not fully integrated over the product life cycle (e.g. inadequate control of quality defects affecting one or multiple batches; inadequate impact assessment of change/variation of manufacturing, quality control testing, storage and distribution processes; inadequate control over the distribution channels including the introduction of counterfeit or falsified products into the supply chain). Drug safety hazards caused by the above-mentioned issues have been identified with different products and formulations, from small molecules to complex molecules such as biological products extracted from animal sources, biosimilars and advanced therapy medicinal products. The various phases of the drug manufacturing and distribution of pharmaceutical products require inputs from pharmacovigilance to assess any effects of quality-related issues and to identify proportionate risk minimisation measures that often have design implications for a medicine which requires a close link between proactive vigilance and good manufacturing practice. To illustrate our argument for closer organisational integration, some examples of drug safety hazards originating from quality, manufacturing and distribution issues are discussed. Plain language summary Monitoring the manufacturing and quality of medicines: the fundamental task of pharmacovigilance Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products. The collection and assessment of adverse reactions are particularly important in the first decade after marketing authorisation of a drug as the information gathered in this period could help, for example, to identify complications from its use which were unknown before its commercialization. However, when it comes to medicines that have been on the market for a long time there is general acceptance that their safety profile is already well-established and unknown adverse reactions unlikely to occur. Nevertheless, even older medicines, such as generic drugs, can generate new risks. For these drugs a change in the safety profile could be the result of inadequate control of their quality, manufacturing and distribution systems. To overcome such an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality systems in the medicine life-cycle. This could help detect safety hazards and prevent the development of new complications which may arise due to the poor quality of a drug. Pharmacovigilance activities should indeed be included in all phases of the drugs’ manufacturing and distribution process, regardless of their chemical complexity to detect quality-related matters in good time and reduce the risk of safety concerns to a minimum.

show abstract

Section: Eudravigilance As a Useful Source Of Data For The Identifica...mentioning

confidence: 99%

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

Sardella¹,

Belcher

Lungu

et al. 2021

Therapeutic Advances in Drug Safety

View full text Add to dashboard Cite

show abstract

“…Case-based argumentation strategies for estimating clinical outcomes and resource consumption indicate how case-based argumentation approaches may drastically enhance patient care in ICUs. Pinheiro, Candore, Zaccaria, Slattery and Arlett [4] describe a CDSS that incorporates both case-oriented and rule-oriented and operates effectively with generated and actual ICU datasets. A computer amber alert intended to detect adverse drug events in medical settings is described by the authors.…”

Section: Emergency Medication and Intensive Care Unit (Icu)mentioning

confidence: 99%

A Survey on Biomedical Informatics for Computer-Aided Decision Support System

Gray

2021

JBSHA

View full text Add to dashboard Cite

Biomedical computing for computer-aided biomedical diagnostics and the decision support system has developed a platform for the biomedical setting during the last few decades. As early as 1971, there were elaborate and basic applications of management information systems driven by biomedical informatics. According to a 1994 assessment, this field's literature stretches back to the 1950s. Medical decision is more challenging than ever for doctors and other caregivers due to the amount and complexity of contemporary patient information. This circumstance necessitates the application of medical computing technologies to evaluate data and formulate suggestions and/or forecasts to aid decision makers. Over the past two decades, healthcare informatics tools, such as computer-aided decision support, have grown indispensable and extensively employed. This article gives a quick overview of such technologies, their productivity applications and methodology, as well as the problems and directions they imply for the future.

show abstract

“…EMA applies an algorithm that screens the data in EudraVigilance for duplicate reports, but not all will be captured. The results of this analysis, therefore, might contain a small amount (in the order of 10%) of duplicates [19,20].…”

Section: Databasementioning

confidence: 99%

Differences between paediatric and adult suspected neuropsychiatric adverse drug reactions of Melatonin reported to the European Medicines Agency

Bakalov

Gateva

Tafradjiiska-Hadjiolova

2021

Biotechnology & Biotechnological Equipment

View full text Add to dashboard Cite

Melatonin has been approved as a sleep medication in Europe since 2007. The pharmacological dosages of this substance are much higher than the physiological ones, so it is no surprise that it has potential for many adverse effects. In children melatonin has been used for many years off-label, but in 2018 the Committee for Medicinal Products for Human Use (CHMP) granted paediatric-use marketing authorization for melatonin. We used the European Medicines Agency (EMA) database to compare the distribution of melatonin adverse drug reaction (ADRs) between the pediatric and the adult population. The results will serve as a basis for future research involving melatonin use in specific populations. All ADR reports received in EMA up to 23.03.2019 were analyzed for overall numbers, age and gender. The nature of the ADRs and the most frequently reported drug substances and drug event combinations were evaluated using MedDRA 21.0. As of 27th March 2019, EudraVigilance contained 1061 spontaneous reports. After excluding all the cases with other suspected or concomitant drugs, we are left with 177 cases. In children ADRs were generally associated with central nervous system (CNS) excitability, whereas in adults there was mainly inhibition. The present study focused on the ADR reports of melatonin in one of the largest databases. Future research of melatonin in the pediatric population is needed, because the current SmPCs lack such information, and in the cases of melatonin use in children are increasing in recent years.

show abstract

An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance

Cited by 11 publications

References 11 publications

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

A Survey on Biomedical Informatics for Computer-Aided Decision Support System

Differences between paediatric and adult suspected neuropsychiatric adverse drug reactions of Melatonin reported to the European Medicines Agency

Contact Info

Product

Resources

About