Vial T. French pharmacovigilance: Missions, organization and perspectives. Therapies. 2016;71:143–50.

Article  Google Scholar 

Moore N, Berdaï D, Blin P, Droz C. Pharmacovigilance – The next chapter. Therapies. 2019;74:557–67.

Article  Google Scholar 

Faillie J-L. Case-non case studies: Principles, methods, bias and interpretation. Therapie. 2018;73:247–55.

Article  PubMed  Google Scholar 

Hazell L, Shakir SAW. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29:385–96.

Article  PubMed  Google Scholar 

Costa C, Abeijon P, Rodrigues DA, Figueiras A, Herdeiro MT, Torre C. Factors associated with underreporting of adverse drug reactions by patients: a systematic review. Int J Clin Pharm. 2023;

García-Abeijon P, Costa C, Taracido M, Herdeiro MT, Torre C, Figueiras A. Factors associated with underreporting of adverse drug reactions by health care professionals: A systematic review update. Drug Saf. 2023;46:625–36.

Article  PubMed  PubMed Central  Google Scholar 

Raschi E, Poluzzi E, Salvo F, Pariente A, De Ponti F, Marchesini G, et al. Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: What a clinician should know on disproportionality analysis of spontaneous reporting systems. Nutr Metab Cardiovasc Dis NMCD. 2018;28:533–42.

Article  CAS  PubMed  Google Scholar 

Mouly S, Roustit M, Bagheri H, Perault-Pochat M-C, Molimard M, Bordet R. The French Levothyrox® crisis: We did the best we could but…. Therapie. 2019;74:431–5.

Article  PubMed  Google Scholar 

Langlade C, Gouverneur A, Bosco-Lévy P, Gouraud A, Pérault-Pochat M-C, Béné J, et al. Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. Br J Clin Pharmacol. 2019;85:2126–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf. 2007;30:891–8.

Article  PubMed  Google Scholar 

Arnaud M, Salvo F, Ahmed I, Robinson P, Moore N, Bégaud B, et al. A Method for the Minimization of Competition Bias in Signal Detection from Spontaneous Reporting Databases. Drug Saf. 2016;39:251–60.

Article  CAS  PubMed  Google Scholar 

Caster O, Juhlin K, Watson S, Norén GN. Improved statistical signal detection in pharmacovigilance by combining multiple strength-of-evidence aspects in vigiRank. Drug Saf. 2014;37:617–28.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lacroix C, Salvo F, Gras-Champel V, Gautier S, Massy N, Valnet-Rabier M-B, et al. French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge. Therapie. 2021;76:297–303.

Article  PubMed  PubMed Central  Google Scholar 

Khouri C, Revol B, Lepelley M, Mallaret M, Cracowski J-L. Impact of the “French Levothyrox crisis” on signal detection in the World Health Organization pharmacovigilance database. Pharmacoepidemiol Drug Saf. 2018;27:1427–8.

Article  PubMed  Google Scholar 

Viard D, Parassol-Girard N, Romani S, Van Obberghen E, Rocher F, Berriri S, et al. Spontaneous adverse event notifications by patients subsequent to the marketing of a new formulation of Levothyrox® amidst a drug media crisis: atypical profile as compared with other drugs. Fundam Clin Pharmacol. 2019;33:463–70.

Article  CAS  PubMed  Google Scholar 

MedDRA | [Internet]. [cited 2019 Jan 23]. Available from: https://www.meddra.org/

Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299–309.

Article  CAS  PubMed  Google Scholar 

Jandoc R, Burden AM, Mamdani M, Lévesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations. J Clin Epidemiol. 2015;68:950–6.

Article  PubMed  Google Scholar 

Micallef B, Dogné J-M, Sultana J, Straus SMJM, Nisticò R, Serracino-Inglott A, et al. An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance. Drug Saf. 2023;

Vidlin S. Unmasking data in the COVID-19 vaccine era [Internet]. Upps. Rep. 20230201 [cited 2023 Sep 21]. Available from: https://www.uppsalareports.org/articles/unmasking-data-in-the-covid-19-vaccine-era/

Harpaz R, DuMouchel W, Van Manen R, Nip A, Bright S, Szarfman A, et al. Signaling COVID-19 Vaccine Adverse Events. Drug Saf. 2022;45:765–80.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Adopo D, Daynes P, Benkebil M, Debs A, Jonville-Berra AP, Polard E, Patient involvement in pharmacovigilance: determinants and evolution of reporting from, et al. to 2020 in France. Eur J Clin Pharmacol. 2011;2022:1–8.

Google Scholar 

Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis. Drug Saf. 2017;40:607–14.

Article  PubMed  PubMed Central  Google Scholar 

Patt D, Gordan L, Diaz M, Okon T, Grady L, Harmison M, et al. Impact of COVID-19 on Cancer Care: How the Pandemic Is Delaying Cancer Diagnosis and Treatment for American Seniors. JCO Clin Cancer Inform. 2020;4:1059–71.

Article  PubMed  Google Scholar 

Mathieu C, Pambrun E, Bénard-Laribière A, Noize P, Faillie J-L, Bezin J, et al. Impact of the COVID-19 pandemic and its control measures on cardiovascular and antidiabetic drugs use in France in 2020: a nationwide repeated cohort study. Eur J Epidemiol. 2022;37:1049–59.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mathieu C, Bezin J, Pariente A. Impact of COVID-19 epidemic on antihypertensive drug treatment disruptions: results from a nationwide interrupted time-series analysis. Front Pharmacol. 2023;14:1129244.

Article  PubMed  PubMed Central  Google Scholar 

Hauben M, Hung E. Effects of the COVID-19 Pandemic on Spontaneous Reporting: Global and National Time-series Analyses. Clin Ther. 2021;43:360-368.e5.

Article  CAS  PubMed  Google Scholar 

Dörks M, Jobski K, Hoffmann F, Douros A. Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system. Pharmacoepidemiol Drug Saf. 2021;30:707–15.

Article  PubMed  PubMed Central  Google Scholar