Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

Weaver, Joyce; Willy, Mary E.; Avigan, Mark

doi:10.1208/s12248-007-9004-5

Cited by 40 publications

(22 citation statements)

References 11 publications

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“…[48] One of the best-known examples was the identification of increased coronary symptoms associated with cyclo-oxygenase (COX)-2 selective NSAIDs in the early 2000s. Epidemiological studies of large retrospective databases led to further study, and eventually the withdrawal of valdecoxib (Bextra®) and refocoxib (Vioxx®) from the US market.…”

Section: Discussionmentioning

confidence: 99%

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Nutrition Therapy Cost Analysis in the US

Turpin

Canada

Liu

et al. 2011

Applied Health Economics and Health Policy

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BackgroundBloodstream infections (BSI) occur in up to 350 000 inpatient admissions each year in the US, with BSI rates among patients receiving parenteral nutrition (PN) varying from 1.3% to 39%. BSI-attributable costs were estimated to approximate $US12000 per episode in 2000. While previous studies have compared the cost of different PN preparation methods, this analysis evaluates both the direct costs of PN and the treatment costs for BSI associated with different PN delivery methods to determine whether compounded or manufactured pre-mixed PN has lower overall costs.ObjectiveThe purpose of this study was to compare costs in the US associated with compounded PN versus pre-mixed multi-chamber bag (MCB) PN based on underlying infection risk.MethodsUsing claims information from the Premier Perspective™ database, multivariate logistic regression was used to estimate the risk of infection. A total of 44 358 hospitalized patients aged ≥18 years who received PN between 1 January 2005 and 31 December 2007 were included in the analyses. A total of 3256 patients received MCB PN and 41 102 received compounded PN. The PN-associated costs and length of stay were analysed using multivariate ordinary least squares regression models constructed to measure the impact of infectious events on total hospital costs after controlling for baseline and clinical patient characteristics.ResultsThere were 7.3 additional hospital days attributable to BSI. After adjustment for baseline variables, the probability of developing a BSI was 30% higher in patients receiving compounded PN than in those receiving MCB PN (16.1% vs 11.3%; odds ratio= 1.56; 95% CI 1.37, 1.79; p<0.0001), demonstrating 2172 potentially avoidable infections. The observed daily mean PN acquisition cost for patients receiving MCB PN was $US164 (including all additives and fees) compared with $US239 for patients receiving compounded PN (all differences p < 0.001). With a mean cost attributable to BSI of $US16 141, the total per-patient savings (including avoided BSI and PN costs) was $US1545.ConclusionIn this analysis of real-world PN use, MCB PN is associated with lower costs than compounded PN with regards to both PN acquisition and potential avoidance of BSI. Our base case indicates that $US1545 per PN patient may be saved; even if as few as 50% of PN patients are candidates for standardized pre-mix formulations, a potential savings of $US773 per patient may be realized.

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Section: Discussionmentioning

confidence: 99%

“…Epidemiological studies of large retrospective databases led to further study, and eventually the withdrawal of valdecoxib (Bextra®) and refocoxib (Vioxx®) from the US market. [48,49]…”

Section: Discussionmentioning

confidence: 99%

Nutrition Therapy Cost Analysis in the US

Turpin

Canada

Liu

et al. 2011

Applied Health Economics and Health Policy

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“…Two different methods of collecting ADE reports are available [11]. One is traditional ADE reporting, which is called "spontaneous reporting."…”

Section: Introductionmentioning

confidence: 99%

A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital

Yun

Koo

Park

et al. 2012

Korean J Intern Med

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Background/AimsSpontaneous reporting systems have several weak points, such as low reporting rates and insufficient clinical information. Active surveillance programs, such as ward rounds and a clinical data repository (CDR), may supplement the weak points of such systems. We developed active surveillance programs and compared them with existing spontaneous reporting.MethodsWe collected adverse drug event (ADE) cases, which comprised 1,055 cases of spontaneous reporting, 309 reported by ward rounds, and 229 found using a CDR. The clinical features and causative drugs were evaluated.ResultsActive surveillance programs detected additional serious ADEs compared to those of spontaneous reporting programs. The ADEs identified by CDR (22.9%) were more likely to be classified as "serious" than those reported spontaneously (5.2%) or identified during ward rounds (10.3%). Causative drugs also differed. Opioids, antibiotics, and contrast media were the most common drugs causing ADEs in the spontaneous reporting system, whereas the active surveillance programs identified antibiotics as the most common causative drug. Clinical features also differed. ADEs with gastrointestinal manifestations were reported most frequently by spontaneous reporting programs. ADEs reported from active surveillance more reliably identified events associated with changes in laboratory values, such as hepatobiliary toxicity, hematologic manifestations, and nephrologic manifestations, compared with spontaneous reporting programs.ConclusionsOur findings suggest that active surveillance programs can supplement spontaneous reporting systems in hospitals. ADEs related to laboratory abnormalities were monitored more closely by active surveillance programs and may be useful for identification of serious ADEs.

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“…Mini-Sentinel, a pilot project of the FDA's Sentinel Initiative, uses a distributed data approach with a centralized portal to collect aggregated de-identified results and to distribute manually coded packages. 16,17 There have been efforts to leverage the ''big data'' potential of Mini-Sentinel, but these had notable limitations, in part because of the closed nature of the data. Seeking to obtain insight into the risks associated with dabigatran, one of the new generation of anticoagulant medications, the FDA deployed Mini-Sentinel to compare the incidence of hemorrhage between patients on dabigatran and patients on the more widely used and much cheaper warfarin.…”

Section: Observational and Open Data Approaches To Pharmacovigilancementioning

confidence: 99%

From Pharmacovigilance to Clinical Care Optimization

et al. 2014

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In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of individuals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general. Limitations of Clinical TrialsIn the quest for the safe and effective use of pharmaceuticals, there is a pressing need for improved surveillance to reduce the risk of preventable morbidity and mortality after products are released. Clearly, such pharmacovigilance represents a form of care optimization as postrelease safety cannot be maximally assured even by excellent premarket studies. This is particularly so because these agents are prescribed to patient populations that are often not completely represented in the original studies required for market approval. Randomized controlled trials (RCTs), the gold standard for defining drug efficacy and safety profiles, are often of inadequate duration, are too narrow in indication and scope, and consist of relatively few test subjects.1 Therefore, RCTs are ill-equipped to fully unravel heterogeneity of treatment

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Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

Cited by 40 publications

References 11 publications

Nutrition Therapy Cost Analysis in the US

Nutrition Therapy Cost Analysis in the US

A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital

From Pharmacovigilance to Clinical Care Optimization

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