Medication errors through a national pharmacovigilance database approach: A study for Malta

Tanti, Amy; Camilleri, Miriam; Bonanno, Patricia Vella; Borg, John-Joseph

doi:10.3233/jrs-120582

Cited by 8 publications

(4 citation statements)

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“…Thus member states and MAHs must report ADRs related to MEs to EudraVigilance, which subsequently could be upgraded to be able to better handle these ME reports. This is because different information is required to be captured in an ME report to be able to carry out imputability assessment for MEs compared with causality assessment for adverse events with medicinal products [Tanti et al . 2013].…”

Section: Resultsmentioning

confidence: 99%

“…2013]. It is interesting to note that the EU Directive (2001/83/EC) does not codify that near misses of medication errors need to be reported [Tanti et al . 2013].…”

Section: Resultsmentioning

confidence: 99%

“…It is easily understandable that the legislative change meant a significant increase in workload within pharmacovigilance departments across all sectors, with some postulating that the industry expected a 2030% increase alone in case volume [Borg et al 2011; Garattini and Bertele, 2011; Tanti et al . 2013].…”

Section: Introductionmentioning

confidence: 99%

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European Union pharmacovigilance capabilities: potential for the new legislation

Borg¹,

Tanti²,

Kouvelas

et al. 2015

Therapeutic Advances in Drug Safety

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European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

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Section: Resultsmentioning

confidence: 99%

“…2013]. It is interesting to note that the EU Directive (2001/83/EC) does not codify that near misses of medication errors need to be reported [Tanti et al . 2013].…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

European Union pharmacovigilance capabilities: potential for the new legislation

Borg¹,

Tanti²,

Kouvelas

et al. 2015

Therapeutic Advances in Drug Safety

Self Cite

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“…Similar to ADRs, MEs are also a cause of high morbidity, mortality, and economic burden worldwide ( Segal et al, 2019 ). The data reported in previous reports show that up to 56% of ADEs were attributed to MEs ( Bates et al, 1995a , Kunac and Tatley, 2011 , Tanti et al, 2013 ). A Japanese study reported that of all the 103 ADE cases that received traditional Japanese Kampo medication in one hospital, 99 were MEs and only 4 were ADRs ( Shimada et al, 2017 ).…”

Section: Introductionmentioning

confidence: 86%

Investigation of the characteristics of medication errors and adverse drug reactions using pharmacovigilance data in China

Tan

Lin³

et al. 2020

Saudi Pharmaceutical Journal

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The aim of this study was to investigate the characteristics of medication errors (MEs) and adverse drug reactions (ADRs) using data from the spontaneous reporting system, which is helpful to understand the actual situation of MEs in China. Data from 2015 in a south distinct in Shanghai were gathered from the spontaneous reporting system and analyzed. The general information, cause of errors, severity, primary diseases, involved system and organs, symptoms, and suspected drugs were investigated. A total of 1290 adverse drug events (ADEs), including 1079 ADRs and 211 MEcs (MEs causing ADE), were reported. Older patients suffered from both ADRs and MEcs (age distribution and dosage form were different between ADRs and MEcs). The main causes of errors were inappropriate usage and dosage of drugs and inappropriate indication selection. Most ADR and MEc cases were mild; the possibility of developing a severe adverse event was quite low. The distribution of the top 10 system and organs, and symptoms involved was significantly different between ADRs and MEcs, with J01 drugs (antibacterials for systemic use) being the leading cause in both. Our results suggested that a direct analysis of data from the spontaneous reporting system is a reliable, and convenient method to investigate MEs and ADRs, despite the existing limitations, and contributes to further understanding the current situation of MEs and ADRs in China.

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Construction and analysis of a database for medication errors in a pharmacovigilance centre—the Moroccan experience

Alj

Benkirane

Tebaa³

et al. 2021

Eur J Clin Pharmacol

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Medication errors through a national pharmacovigilance database approach: A study for Malta

Cited by 8 publications

References 0 publications

European Union pharmacovigilance capabilities: potential for the new legislation

European Union pharmacovigilance capabilities: potential for the new legislation

Investigation of the characteristics of medication errors and adverse drug reactions using pharmacovigilance data in China

Construction and analysis of a database for medication errors in a pharmacovigilance centre—the Moroccan experience

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