Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?

TrifirÃ2, Gianluca; Pariente, Alexandre; Coloma, Preciosa M.; Kors, Jan A.; Polimeni, Giovanni; Miremont-SalamÃ©, Ghada; Catania, Maria Antonietta; Salvo, Francesco; David, Anaëlle; Moore, Nicholas; Caputi, Achille P.; Sturkenboom, Miriam; Molokhia, Mariam; Hippisley‐Cox, Julia; Acedo, Carlos Diaz; Lei, Johan van der; Fourrier‐Réglat, Annie

doi:10.1002/pds.1836

Cited by 156 publications

(111 citation statements)

References 43 publications

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“…Possible contribution of pharmacovigilance in DILI research: Pharmacovigilance, namely post-marketing phase of drug development, represents the mainstay to evaluate the safety of recently marketed drugs or to monitor high-priority adverse events [36] . On one hand, data in these fields were not considered).…”

Section: Data Selection and Analysismentioning

confidence: 99%

Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database

Raschi¹,

Poluzzi²,

Koci³

et al. 2014

WJH

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AIM: To inform clinicians on the level of hepatotoxic risk among antimycotics in the post-marketing setting, following the marketing suspension of oral ketoconazole for drug-induced liver injury (DILI). METHODS:The publicly available international FAERS database (2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011) was used to extract DILI cases (including acute liver failure events), where antimycotics with systemic use or potential systemic absorption were reported as suspect or interacting agents. The reporting pattern was analyzed by calculating the reporting odds ratio and corresponding 95%CI, a measure of disproportionality, with time-trend analysis where appropriate. RESULTS:From 1687284 reports submitted over the 8-year period, 68115 regarded liver injury. Of these, 2.9% are related to antimycotics (1964 cases, of which 112 of acute liver failure). Eleven systemic antimycotics (including ketoconazole and the newer triazole derivatives voriconazole and posaconazole) and terbinafine (used systemically to treat onychomicosis) generated a significant disproportionality, indicating a post-marketing signal of risk. CONCLUSION:Virtually all antimycotics with systemic action or absorption are commonly reported in clinically significant cases of DILI. Clinicians must be aware of this aspect and monitor patients in case switch is considered, especially in critical poly-treated patients under chronic treatment.

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Section: Data Selection and Analysismentioning

confidence: 99%

Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database

Raschi¹,

Poluzzi²,

Koci³

et al. 2014

WJH

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show abstract

“…In Europe, the EU-ADR project has begun to allow signal detection using multinational clinical information databases 25) . In Japan, the Pharmaceuticals and Medical Devices Agency announced a new initiative to computerize information on adverse drug reactions, such as drug use-result survey, and by 2014 to build databases to provide for the use of centralized electronic data for the development of safety measures 26) .…”

Section: Discussionmentioning

confidence: 99%

Integration of Drug Use-Results Survey (DUS) Data of a Pharmaceutical Manufacturer

Matsushita

Sugihara

Kawasugi

2010

Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

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Objective: Pharmaceutical manufacturers conduct drug use-results surveys（DUSs）for drug reexamination applications in Japan. However, most DUSs are single-cohort studies to confirm drug safety; therefore little information is obtained from a DUS for safety comparison with other drugs. Integrating DUS data is a novel method to compare drug safety profiles among drugs. This study examined the usefulness of integrating DUS data. Design: Active surveillance Methods: We integrated DUS data obtained from two DUSs of antihypertensive drugs-a calcium channel blocker（CCB), azelnidipine（Calblock® ), and an angiotensin-receptor blocker（ARB), olmesartan medoxomil（Olmetec® )-with similar study protocols. Both studies were conducted by the same pharmaceutical company. Matching patients using propensity scores, we examined whether the DUS results could be applied to pharmacoepidemiology data resources for hypothesis strengthening. Safety outcomes included vasodilation-related events, which are typical adverse drug reactions（ADRs）to CCB. The incidence of safety outcomes was compared by conditional logistic regression models. Two definitions for safety outcomes were employed: definition 1, physician-reported adverse events; and definition 2, physicianreported ADRs. Results: In a total of 7196 patients included in the analysis, the propensity-matched patients were well balanced. Most safety outcomes were detected in the CCB group including a significant increase in vasodilation-related events（odds ratio for definition 1 versus ARB group, 1.75; 95％ confidence interval, 1.01-3.03). Conclusion: Integrated DUS data collated by pharmaceutical manufacturers following clear criteria are potentially useful to commence pharmacoepidemiology studies designed to strengthen hypotheses.

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“…From the therapeutic target, clinical trials are designed to sift possible chemical compounds and determine its value. [9,20,22,23] …”

Section: Quiñonez World Journal Of Pharmacy and Pharmaceutical Scienmentioning

confidence: 99%

Pharmacokinetics Surveillance on Drugs- A Review

Palacio¹

2017

WJPPS

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All drugs can have negative effects. When they reach the market, there are reasonably safe, yet remain in surveillance by pharmacovigilance.Pharmacokinetics plays a very important role in this because we can have monitored the ranges of concentrations of pharmacologic active principles. With these results, we calculate pharmacokinetic parameters and ranges of concentrations and with this information, we can determinate if the treatment is ineffective and above. It is frequent that toxic effects are observed. However, there are patients who respond to levels below this range and others need levels above this.For the determination of serum levels of a drug is justified it is necessary that there is a reliable analytical method that allows its determination, that there is a poor relationship between administered doses and levels and that there is a good relationship between the serum levels of the drug and its therapeutic or toxic effects i.e., an optimal interval.Variability in the response to drugs depends on multiple pharmacokinetic factors, which modify the plasma levels, and pharmacodynamic factors that alter the sensitivity to a certain level. In addition, the prescribed dose may be different from the taken by the patient by errors in the administration or therapeutic non-compliance.

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Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?

Abstract: A ranked list of 23 adverse drug events judged as important in pharmacovigilance was created to permit focused data mining. The list will need to be updated periodically as knowledge on drug safety evolves and new issues in drug safety arise.

Cited by 156 publications

References 43 publications

Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database

Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database

Integration of Drug Use-Results Survey (DUS) Data of a Pharmaceutical Manufacturer

Pharmacokinetics Surveillance on Drugs- A Review

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