Monitoring drug safety in Astrakhan, Russia

Kirilochev, O.O.; Дорфман, И. П.; Умерова, А. Р.

doi:10.3233/jrs-150680

Cited by 8 publications

(6 citation statements)

References 1 publication

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“…It is particularly concerning that the international organization pharmacovigilance database has never received any report on clozapine ADRs from Russia 69 . This is not unusual since pharmacovigilance in Russia is very limited 70 . This lack of tradition of pharmacovigilance extends to all drugs, 70 not only to clozapine.…”

Section: Discussionmentioning

confidence: 99%

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Can Slow Personalized Titration Using C-Reactive Protein Monitoring Decrease the High Rates and Mortality of Clozapine-Associated Myocarditis Seen in Some Countries? A Call for Research

de Leon

2024

J Clin Psychopharmacol

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Purpose/Background The hypothesis that slower personalized titration may prevent clozapine-associated myocarditis and decrease the disproportion incidence of 3% found in Australia was not described in a recent Australian article in this journal. Methods Six countries in addition to Australia have published information suggesting a similar incidence of clozapine-associated myocarditis. On September 19, 2023, PubMed searches were updated for articles from the United States, Korea, Japan, Canada, New Zealand, and Turkey. Findings/Results An incidence of 3.5% (4/76) was found in a US hospital, but US experts were the first to propose that clozapine-associated myocarditis may be a hypersensitivity reaction associated with rapid titration and possibly preventable. Koreans and Japanese are of Asian ancestry and need lower minimum therapeutic doses for clozapine than patients of European ancestry. A 0.1% (2/1408) incidence of myocarditis during clozapine titration was found in a Korean hospital, but pneumonia incidence was 3.7% (52/1408). In 7 Japanese hospitals, 34% (37/110) of cases of clozapine-associated inflammation were found during faster titrations (based on the official Japanese titration) versus 13% (17/131) during slower titrations (based on the international titration guideline for average Asian patients). Recent limited studies from Canada, New Zealand, and Turkey suggest that slower personalized titration considering ancestry may help prevent clozapine-associated myocarditis. Implications/Conclusions Other countries have very limited published data on clozapine-associated myocarditis. Based on a recent Australian case series and these non-Australian studies, the author proposes that Australia (and other countries) should use slow personalized titration for clozapine based on ancestry and c-reactive protein monitoring.

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Section: Discussionmentioning

confidence: 99%

“…69 This is not unusual since pharmacovigilance in Russia is very limited. 70 This lack of tradition of pharmacovigilance extends to all drugs, 70 not only to clozapine.…”

Section: Clozapine-associated Myocarditis In Russia and Eastern Europementioning

confidence: 99%

Can Slow Personalized Titration Using C-Reactive Protein Monitoring Decrease the High Rates and Mortality of Clozapine-Associated Myocarditis Seen in Some Countries? A Call for Research

de Leon

2024

J Clin Psychopharmacol

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“…Прогнозирование НПР -сложный процесс, включающий полноценное и объективное обследование пациента (клинические, лабораторные и инструментальные методы, консультации специалистов) до начала терапии, требующий от врача знаний клинической фармакологии ЛС [33]. Реакции типа А проявляются токсическими симптомами со стороны различных органов и систем и связаны с фармакологическим действием ЛС, они прогнозируемы и их можно предупреждать.…”

Section: прогнозирование и профилактика развития нежелательных побочнunclassified

Principles of Rational Chemotherapy for Tuberculosis

Краснова¹,

Kravchenko²,

Val³

2019

EPh

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e key reasons for development of drug-resistant M. tuberculosis are prescription of inadequate chemotherapy regimens, early discontinuation and/or interruptions of chemotherapy, lack in both range and amounts of necessary drugs, use of the drugs of substandard quality. is article highlights basic principles of rational chemotherapy for TB, including adherence to clinical guidelines, prescription of drugs with due regard to information in package lea ets.

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“…Currently, PMS studies focusing on the assessment of DI reports worldwide are scarce and similarly PMS studies on those reports that are received by the Saudi NPC are lacking. One of the earliest studies focusing on the adverse event reports received by the regional Center for Drug Safety Monitoring (CDSM) in Astrakhan, Russia for the period of 2010 to 2014 found that 1% of ADEs were associated with ineffectiveness of drugs [23]. In 2018 Misu et.al reported that DI (6.4%) was the most frequently reported ADE through the United States Food & Drug Administration Adverse Reporting System (FAERS) database [24], and in South Korea, DI constituted about 1.0 to 1.3% of the ADEs reported to the Korean Adverse Event Reporting System (KAERS) database between 2013 to 2016 [4].…”

Section: Introductionmentioning

confidence: 99%

Assessment of the Post-Marketing “Drug Ineffective” Reports Received by the Saudi Vigilance System

Khabbaz,

Alsoaiby,

Alolayet

2023

J. Pharm. Res. Int.

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Aim: Drug Ineffective (DI) reports are Adverse Drug Events (ADE) important for post-marketing surveillance (PMS). Currently drug safety information from the DI reports received by the Saudi Food and Drug Authority (SFDA) via the Saudi Vigilance System (SVS) is undetermined. The study aims to describe the DI reports received by the SVS from different stakeholders. Methods: DI reports received by the SVS between January 2020 to December 2021 were retrieved and characterized based on patients’ demographics, reporter type and suspected drug type and group in comparison to non-DI reports. Potential determinants of the DI reports were screened to estimate odds ratios (OR) and the 95% confidence intervals (CI) for these reports. Results: The total number of DI reports was 1885. Adults constituted the major age group (67.6 %), and male gender dominated most DI reports (80.2%) compared to equal percentages of males and females in non-DI reports. Most of the DI reports were reported by pharmacists (68.9%), and the most frequently reported drugs associated with DI and non-DI reports were Metformin (16.3%) and Atorvastatin (5.30%) respectively. Adjustment of potential confounding variables showed that gender (AOR = 2.285, 95% CI = 1.921–2.719) and age (AOR = 1.005, 95% CI = 1.002– 1.007) were significantly associated with the DI reports. Conclusion: DI reports were frequently associated with adult male patients, and were more frequently reported by pharmacists. Most of the DI reports did not indicate the seriousness criteria, and the most frequently reported drug associated with DI reports was Metformin.

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Monitoring drug safety in Astrakhan, Russia

Abstract: The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis.

Cited by 8 publications

References 1 publication

Can Slow Personalized Titration Using C-Reactive Protein Monitoring Decrease the High Rates and Mortality of Clozapine-Associated Myocarditis Seen in Some Countries? A Call for Research

Can Slow Personalized Titration Using C-Reactive Protein Monitoring Decrease the High Rates and Mortality of Clozapine-Associated Myocarditis Seen in Some Countries? A Call for Research

Principles of Rational Chemotherapy for Tuberculosis

Assessment of the Post-Marketing “Drug Ineffective” Reports Received by the Saudi Vigilance System

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