Evaluation of FDA safety‐related drug label changes in 2010

Lester, J.V.; Neyarapally, George A.; Lipowski, Earlene; Graham, Cheryl Fossum; Hall, Marni; Pan, Gerald J. Dal

doi:10.1002/pds.3395

Cited by 96 publications

(90 citation statements)

References 6 publications

(6 reference statements)

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“…Lester et al [12] found that between 52 and 55 per cent of drug label changes were the result of spontaneous reporting; this demonstrates the significance of spontaneous reporting in PV activities. Spontaneous reporting involves the unsolicited generation of a signal by a healthcare provider or a patient relating to the suspicion of an ADR.…”

Section: Spontaneous Reportingmentioning

confidence: 99%

“…Spontaneous reporting during the post-marketing phase generates the majority of drug safety data, even more so than the clinical trials during the drug development process [12]. Lester et al [12] found that between 52 and 55 per cent of drug label changes were the result of spontaneous reporting; this demonstrates the significance of spontaneous reporting in PV activities.…”

Section: Spontaneous Reportingmentioning

confidence: 99%

“…With 55 per cent of all drug label changes in the United States since 2010 being in direct response to spontaneous reporting of ADRs [12], it is clear that an improved reporting system can benefit proactive drug safety activities such as drug labelling and package inserts. By improving efficiency in ADR reporting, drug safety labels will reflect the latest safety information, allowing HCPs to make more informed therapeutic decisions.…”

Section: Proactive Vs Reactive Systemmentioning

confidence: 99%

“…The likely impact of standardisation on the various stages of the PV reporting system will be discussed in the next section. The most widespread challenge facing PV is a high level of under-reporting ( [15], [16], [17], [18], [12]), typically attributed to a lack of knowledge, time, and incentive ( [19], [16], [20]), which alludes to the lack of standardised reporting protocols and methodologies. PV also faces socio-cultural challenges, such as the existence of a culture of fear surrounding the reporting of ADRs due to a fear of undue disciplinary action being taken against HCPs ( [21], [22], [19]).…”

Section: Effects Of a Lack Of Standardisationmentioning

confidence: 99%

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An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

Schurer

Bam

Kock

2017

SAJIE

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Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised health programmes. The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory bodies, healthcare workers, etc.), and the significant number of dimensions along which the effectiveness and efficiency could be measured, adds to this complexity. Furthermore, the lack of a standardised reporting protocol across the various PV systems hinders efforts to manage PV coherently on a global scale. This paper proposes the value of a standardised global PV reporting system by evaluating the systemic effects of the lack of such a standardised system. OPSOMMINGFarmakologiese waaksaamheid (PV) is gebaseer op die mediese assessering van nadelige mediese gebeure of dwelmverwante probleme wat deur georganiseerde gesondheidsprogramme versamel word. Die groot aantal verskillende PV-sisteme, die ewe groot aantal belanghebbendes in sulke stelsels (farmaseutiese maatskappye, regerings, nasionale en internasionale kliniese reguleringsliggame, gesondheidswerkers, ens.), en die aansienlike aantal dimensies waarvolgens die effektiwiteit en doeltreffendheid gemeet kan word, dra by tot hierdie kompleksiteit. Verder belemmer die gebrek aan 'n gestandaardiseerde rapporteringsprotokol wat oor die verskillende PV-sisteme strek die pogings om PV op 'n wêreldwye skaal konsekwent te bestuur. Hierdie artikel stel die waarde van 'n gestandaardiseerde globale PV rapporteringsprotokol voor deur die sistematiese gevolge van die gebrek aan so 'n gestandaardiseerde stelsel te evalueer

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Section: Spontaneous Reportingmentioning

confidence: 99%

Section: Spontaneous Reportingmentioning

confidence: 99%

Section: Proactive Vs Reactive Systemmentioning

confidence: 99%

Section: Effects Of a Lack Of Standardisationmentioning

confidence: 99%

See 2 more Smart Citations

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

Schurer

Bam

Kock

2017

SAJIE

View full text Add to dashboard Cite

show abstract

“…10 Lester et al evaluated safety-related drug label changes in 2010. 11 In this study, spontaneous reports were associated with 52% and 55% of label changes and anti-infectives and cardiovascular drugs were among the drug classes most frequently affected. The label change initiator was most commonly associated with adverse reactions, precautions, and warnings.…”

Section: Introductionmentioning

confidence: 99%