Database size and power to detect safety signals in pharmacovigilance

Hammond, Isaac W; Gibbs, Trevor; Seifert, Harry A.; Rich, Donna S

doi:10.1517/14740338.6.6.713

Cited by 28 publications

(15 citation statements)

References 9 publications

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“…The AE database has been approved by and information from it is shared with regulatory agencies. It has been shown to be more comprehensive than both the US Food and Drug Administration and the World Health Organization adverse reaction databases for GSK’s products [11]. Nevertheless, since the data come from voluntary reporting, they are undoubtedly under-reported.…”

Section: Methodsmentioning

confidence: 99%

Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010

Rawson

Terres

2013

BMC Res Notes

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BackgroundWe examined the change in the use of rosiglitazone-containing products (RCPs) Canada-wide between 2004 and 2010 and whether the rates of adverse events in association with RCP therapy in Canadian patients changed in this period to better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline to Health Canada to assess whether there was an impact of a risk communication on cardiac safety.MethodsRCP utilization data were obtained from IMS Brogan’s longitudinal de-identified patient database (known as LRx) that tracks prescription activity using store-based data collection from pharmacies in all Canadian provinces. Adverse events (AEs), serious adverse events (SAEs) and cardiac AEs associated with RCP use in Canadian patients between April 2004 and December 2010 were identified from GlaxoSmithKline’s AE database and, using the LRx data, rates per 100,000 patients were estimated.ResultsA total of 239,184 patients were identified as having received at least one RCP prescription between 2004 and 2010 from the LRx. After excluding those with inconsistent gender or age, only one RCP prescription at the pharmacy, a prescription from a pharmacy that had not consistently reported for the past six years or an unreasonably high number of prescriptions, 180,936 patients remained for the analysis. The number of reports identified from the AE database that occurred between April 2004 and December 2010 was 1,037. The average monthly rates of AEs, SAEs and cardiac AEs decreased by 57%, 43% and 4%, respectively, between the observed periods, April 2004-October 2007 and November 2007-December 2010.ConclusionsThe findings of this analysis demonstrate a significant decrease in RCP use in Canada following a meta-analysis publication suggesting harm, which has been maintained. It is not possible to disentangle whether the continuing decline can be attributed to the meta-analysis, the changes in prescribing guidelines, media attention or a combination of some or all of these factors.

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Section: Methodsmentioning

confidence: 99%

Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010

Rawson

Terres

2013

BMC Res Notes

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“…FDA-AERS and WHO-VigiBase can be considered the largest sources of these data and the additional analysis of published literature incorporates the main strategies to detect an alert signal on the basis of voluntary reports of ADRs. As argued by Hammond et al, the early safety signal detection should involve the use of multiple large global databases because this permits the use of the largest number of reports for a given drug [13]. This approach is appropriate for a rare ADR, such as PML.…”

Section: Discussionmentioning

confidence: 99%

Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents

Piccinni

Sacripanti

Poluzzi

et al. 2009

Eur J Clin Pharmacol

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Aim The aim of the present study was to collect and compare cases of drug-induced PML in order to contribute to the debate about the role of the underlying diseases and/ or drug immunosuppression in PML occurrence. Methods We searched for drug-induced PML cases in two international spontaneous adverse drug reaction (ADR) report databases, FDA-AERS and WHO-VigiBase. From MEDLINE, we retrieved case reports and case series containing the MESH term "leukoencephalopathy, progressive multifocal/chemically induced". In order to assess the PML-drug relationship, we analysed drug-reaction pairs in terms of the patients' underlying diseases and co-suspected drugs. Results Overall, 214 cases in FDA-AERS, 118 in WHOVigiBase and 140 in MEDLINE were collected. Therapeutic groups more frequently involved in PML cases were monoclonal antibodies (MAbs), conventional immunosuppressive drugs and anti-HIV drugs. The most frequent underlying diseases were lymphoproliferative diseases (28%), autoimmune disorders (20%) and transplants (10%). MAbs were more often reported in cases where they were the only suspected drugs, whereas for the other therapeutic groups, concomitant drugs were reported. ConclusionsWe found a strong relationship between PML and MAbs, especially when used in autoimmune diseases. PML is becoming a crucial issue of MAbs, since they can cause severe ADRs through the imbalance of the immune system. Based on these results, patients treated with MAbs should be carefully monitored for early signs and symptoms of PML.

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“…The precise extent of overlap has not been assessed yet and may vary depending on the ADR under investigation. Therefore, combination of different databases has been proposed to achieve the highest statistical power in signal detection [20].…”

Section: Pharmacovigilance Tools: An Overviewmentioning

confidence: 99%

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

Poluzzi¹,

Raschi²,

Piccinni³

et al. 2012

Data Mining Applications in Engineering and Medicine

174

195

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Background: Acute kidney injury (AKI) is associated with signi cant increases in short-and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKIs, along with patients' age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infectives-related AKI-onset pro les. Method: We calculated adjusted reporting odds ratios (RORs) for reports of anti-infectives-related AKIs (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated associations between anti-infectives and age by association rule mining. We evaluated time-to-onset data and hazard types using the Weibull parameter. Results: Among 534,688 reports (submission period: April 2004-June 2018), there were 21,727 AKI events. Anti-infective treatments including glycopeptide antibacterials, uoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were associated with 596, 494, 341, 315, and 313 AKI incidences, respectively. Adjusted RORs of anti-infectives-related AKIs increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 2.75 (2.56-2.95)] than in monotherapies [ROR, 1.52 (1.45-1.61)]. In association rule mining, the number of anti-infectives and age were associated with anti-infectives-related AKI lift values (as consequent). Moreover, 48.1% of AKIs occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation. Conclusion: Thus, adjusted RORs derived from our new SRS analysis indicate potential AKI risks linked to age and number of administered anti-infectives.

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Database size and power to detect safety signals in pharmacovigilance

Cited by 28 publications

References 9 publications

Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010

Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010

Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents

Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)

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