Adverse drug reaction monitoring: Doing it the French way – Act II

Soeiro, Thomas; Lacroix, Clémence; Micallef, Joëlle

doi:10.1016/j.therap.2020.11.002

Cited by 6 publications

(8 citation statements)

References 11 publications

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“…For the last criteria related to the occurrence of a congenital anomaly or malformation, there is a need for a multidisciplinary staff to discuss the balance of benefits of treatment for the mother and the foetus. The PV has the responsibility to then analyze the report and investigate the causal correlation between each symptom and each drug administered to the patient, using at least two standardized and harmonized methods of data inputs" [15].…”

Section: Types Of Notification For Consideration In Covid-19 Surveill...mentioning

confidence: 99%

“…The most recognized therapeutic and chemical classification consists of 5 levels: For harmonization of notifications, ADRs are coded in the database according to the Medical regulatory authority (MedRA) classification (Medical Dictionary for Regulatory Activities) [15]. This classification is organized into five levels ranging from the broadest to the most specific.…”

Section: Levels Of Therapeutic and Chemical Classificationmentioning

confidence: 99%

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An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

Tembe-Fokunang

Nyuki²,

Fokam³

et al. 2022

JAMPS

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Once a drug is approved in phase III of clinical trials, pharmacovigilance (PV) becomes very important for the surveillance of drug, vaccine or medical devices. PV constitutes part of the phase IV approval, which involves a study for collecting, detecting, and monitoring adverse events in any population that the drug is used. The adverse events that are reported must be assessed to ascertain the causal effects and prevent or avoid unanticipated side effects on the population. With the advent of the coronavirus disease 2019 (COVID-19) pandemic, vaccination has been the motor for the management of the pandemic, and through intensive health sensitization, more people are vaccinated in a short period leading to greater challenges to the PV taskforce and the PV operating centrers. Global partnerships including the international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and a multitude of others are working in synergy towards putting in place a continuous collaboration work package with many sensitization, education, capacity building, and research initiatives. This is within the framework of identifying the safety and efficacy of vaccines in order to provide solutions to emerging challenging ethical questions. Through PV, signal detection is in progress for the identification of adverse events. The unanticipated emergence and negative impact of COVID-19, caused by the severe acute respiratory syndrome virus 2 (SARS-CoV-2) has significantly compelled global pharmacists and drug actors to collectively play an important role in the management of COVID-19. This has to be done within the framework of therapeutic strategies and guaranteed safety, efficacy and quality of new and old xenobiotics. In the current treatment COVID-19 has created health-related challenges and a shift in paradigm in drug discovery and development of new chemical entities (NCE), for vaccine or drug repurposing for different levels of treatment interventions. The accelerated interest in dynamic research and innovation have led to different approaches of treatment and this has come with potential side effects, which has led to the call for post marketing surveillance and monitory. PV is therefore a key component for phase IV study for the drugs and vaccines approved for global use. This paper gives an insight into the global PV monitoring and surveillance of new chemical entities (drugs and vaccines) and new technologies targeting the management of COVID-19.

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Section: Types Of Notification For Consideration In Covid-19 Surveill...mentioning

confidence: 99%

Section: Levels Of Therapeutic and Chemical Classificationmentioning

confidence: 99%

An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

Tembe-Fokunang

Nyuki²,

Fokam³

et al. 2022

JAMPS

View full text Add to dashboard Cite

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“…French Pharmacovigilance organization for COVID-19 vaccines surveillance is shown in figure 2. The pharmacovigilance of COVID-19 vaccine according to French organization is based on two dimensions: [5,6,7] 1. Individual analysis of all real-time ADRs by regional pharmacovigilance centers (RPVc) 2.…”

Section: French Organisation For the Pharmacovigilance Of Covid-19mentioning

confidence: 99%

A review on vaccine pharmacovigilance during covid-19

Navya¹,

Jaka²,

sujaya³

et al. 2021

J Inn App Pharma Sci

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Pharmacovigilance is important for collecting, detecting, monitoring adverse events which is the main objective. The adverse events reported should be assessed in order to know the casual relationship and avoid unnecessary effects on the recipient. Many people are vaccinating in a short period, so it is becoming much burden to the pharmacovigilance centers. The international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and many others were in continuous collaboration and taking many initiatives to identify the safety and efficacy of vaccines and to provide answers to the raised questions respectively. Through pharmacovigilance, signals were detected, and many adverse events were identified. Pharmacovigilance of BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzevria, Sputnik V, Convidecia are addressed. With BioNTech/Pfizer-m-RNA 12,249 ADRs, with Moderna-mRNA vaccine 577 ADRs, with Covishield 447 ADRs, with Johnson and Johnson 653 ADRs, with Vaxzevria 743 ADRs were reported. These vaccines resulted in immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, deaths, and many other reactions which may be fatal. But the events reported were less compared to the safety of the patients. All these events were maintained by the Uppsala monitoring center.

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“…to determine the incidence of ADRs, nor can it estimate and quantify the risk of the suspected ADRs for a given drug, which is however possible in a pharmaco-epidemiological approach. These two approaches are indeed clearly complementary [26].…”

Section: Introductionmentioning

confidence: 95%

“…These two approaches are indeed clearly complementary. 26 An analysis of the European pharmacovigilance database (Eudravigilance; http://www.adrreports.eu) targeting abiraterone and enzalutamide as suspect drugs from January 2013 to January 2019 suggested different ADR profiles according to age from those identified in Phase III clinical trials. As expected, the analysis showed that several ADRs had not been reported in trials.…”

Section: Introductionmentioning

confidence: 99%

Hospitalization for adverse events under abiraterone or enzalutamide exposure in real‐world setting: A French population‐based study on prostate cancer patients

Scailteux

Despas

Balusson³

et al. 2021

Brit J Clinical Pharma

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Aim. Safety profiles of abiraterone and enzalutamide mainly rely on phase III clinical trials.Our objective was to estimate the incidence rate ratio (IRR) for certain adverse events leading in real life to hospitalization (atrial fibrillation, acute heart failure, ischemic heart disease, acute kidney injury (AKI), ischemic stroke, torsade de pointe / QT interval prolongation, hepatitis, and seizure), comparing abiraterone to enzalutamide. We also set out to discuss previously identified safety signals.Method. Using the French National Health Insurance System database, all patients newly exposed to abiraterone or enzalutamide between 2013 and 2017 and followed until December 31 st , 2018 were targeted. IRR for each event were estimated using a Poisson model in a sub-population of patients without contraindications or precautions for use for either treatment.Results. Among 11,534 new users of abiraterone and enzalutamide, AKI (IRR 1.42, 95% CI:1.01-2.00), liver monitoring suggestive of hepatic damage (IRR 3.06, 95% CI: 2.66 -3.53), and atrial fibrillation (IRR 1.12, 95% CI: 1.05 -1.19) were significantly more often observed with abiraterone than with enzalutamide. Conclusion.Our study provides knowledge on abiraterone and enzalutamide real-life safety profiles, especially for events leading to hospitalisation. Despite several limitations, including the lack of clinical data, the safety signal for AKI under abiraterone is in line with results of an analysis of the French pharmacovigilance database, which requires further specific investigations. Enlightening the clinicians' therapeutic choices for patients treated for prostate cancer, our study should lead to clinicians to be cautious in the use of abiraterone..

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Adverse drug reaction monitoring: Doing it the French way – Act II

Cited by 6 publications

References 11 publications

An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

A review on vaccine pharmacovigilance during covid-19

Hospitalization for adverse events under abiraterone or enzalutamide exposure in real‐world setting: A French population‐based study on prostate cancer patients

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