Recent Developments in EU and US Pharmacovigilance Legislation

Montanari-Vergallo, Gianluca

doi:10.4172/2329-6887.1000e105

Cited by 1 publication

(3 citation statements)

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“…It is an important and sometimes avoidable cause for hospital admissions, adding to the social and financial burden of healthcare (Patel, Bell, & Molokhia, 2007). In Europe ADRs are responsible for 5% of all hospital admissions causing on average 1.91 extra hospital days (Montanari-Vergallo, 2013). In the USA, ADRs are among the top 10 leading causes of death (Montanari-Vergallo, 2013).…”

Section: Introductionmentioning

confidence: 99%

“…In Europe ADRs are responsible for 5% of all hospital admissions causing on average 1.91 extra hospital days (Montanari-Vergallo, 2013). In the USA, ADRs are among the top 10 leading causes of death (Montanari-Vergallo, 2013). Over a 10 year period (1999e2009) the number of hospital admissions associated with ADRs in England increased by 76.8% (Wu et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

“…The definition has since been extended to include all aspects of medicine development, manufacturing, registration, warehousing, logistics, prescribing, dispensing, use and the destruction of expired medicine stock e spanning the complete product life cycle. Many countries, notably in Europe and the USA, formalised PV risk-benefit legislation to be enforced by their medicine regulatory authorities (Montanari-Vergallo, 2013).…”

Section: Introductionmentioning

confidence: 99%

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Knowledge, perceptions and practices of pharmacovigilance amongst community and hospital pharmacists in a selected district of North West Province, South Africa

Joubert

Naidoo

2016

Health SA Gesondheid

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Background: Pharmacovigilance (PV) as a means of ensuring drug safety is an essential component of the process ensuring that the risk of drug use does not outweigh the benefit. Pharmacists are valuable in collecting PV information, but not many studies explored the knowledge, perceptions and practices of both community and hospital pharmacists towards the practice of PV.Objectives: The aim of the study was to explore the knowledge, perceptions and practise of PV amongst the pharmacists in a selected district of North West Province, South Africa.Method: A cross sectional study was conducted amongst pharmacists in a selected district of the North West province, using a pre-tested questionnaire. Descriptive statistics were used to analyse the results including ANOVA testing.Results: One hundred and two pharmacists (68.9%) completed the questionnaire. Although familiar with the concept of PV, pharmacists knowledge scores were low. Pharmacists agreed that PV is a useful tool, but perceived the PV authorities to be distant and remote. Although more than 90% indicated that all adverse drug reactions should be reported, only 44.1% indicated that they have reported adverse drug reactions (ADRs). Only 6.7% of pharmacists were satisfied with feedback received from authorities after reporting an ADR. Barriers were cited that prevented them from reporting ADRs. Over 80% indicated they would participate in further PV training.Conclusion: The majority of pharmacists are familiar with the concept of PV, but less than half reported any ADR. They are willing to participate in PV processes but are unsure what their exact role playing should be. More than half indicated that they would like to see improvements to the current PV system in South Africa. The majority are prepared to undergo further education to improve their PV knowledge.

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Section: Introductionmentioning

confidence: 99%