The French pharmacovigilance surveys: A French distinctiveness, a real input

Taam, Malak Abou; Jacquot, Baptiste; Ferard, Claire; Thery, Anne-Charlotte; Mounier, Céline; Grandvuillemin, Aurélie; Jonville‐Béra, Annie‐Pierre; Pérault‐Pochat, Marie‐Christine; pharmacovigilance, Réseau français des centres régionaux de

doi:10.1016/j.therap.2020.05.011

Cited by 10 publications

(6 citation statements)

References 20 publications

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“…Furthermore, the contribution of drugs to the occurrence of certain clinical and biological activities seems difficult to understand, the link with the pathology, given the multiple drugs used in combination to treat patients with a serious diagnosed diseased condition. It is therefore proposed that an ADR is considered serious when it is an adverse reaction that is directly life-threatening, or result in a significant long-lasting disability or incapacitation" [1,14].…”

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

confidence: 99%

“…Its purpose is an aid to monitor drug use and for research to improve quality medication use. It does not imply drug recommendation or efficacy [14]. It is controlled by WHO collaborating Centre (WHO-CC) for Drug statistics methodology), and was first published in 1976 [3,9].…”

Section: Drug Classification According To the Anatomical Therapeutic ...mentioning

confidence: 99%

“…This results in bleeding, bruise, petechiae, bleeding gums, or lifethreatening bleeding. This is usually preceded by infection about 7-10 days before the onset of symptoms [13][14][15]. The pathogenesis of ITP is unclear but it may be due to molecular mimicry.…”

Section: Develop Infographics and Provide A Globalmentioning

confidence: 99%

“…hepatitis B, human papillomavirus, varicella, and diphtheria tetanus-pertussis (DPT) vaccines in children and adolescents, other constituents of vaccines like yeast proteins, adjuvants, and preservative diluents. Additives like aluminum [5,[13][14][15][16].…”

Section: Develop Infographics and Provide A Globalmentioning

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: Drug Classification According To the Anatomical Therapeutic ...mentioning

confidence: 99%

Section: Develop Infographics and Provide A Globalmentioning

confidence: 99%

Section: Develop Infographics and Provide A Globalmentioning

confidence: 99%

See 2 more Smart Citations

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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“…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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