Although mostly in line with the European legislation, the new version of the French Good Pharmacovigilance Practices published in February 2018 (1) introduced a few new requirements for Marketing Authorization Holders and “Exploitants”. As specified in article 4.32, these new obligations include the submission of:
- Reports of Medication Errors with no Adverse Reaction to the dedicated ANSM Medication Error Desk,
- Reports of Abuse or Dependence to medicines containing psychoactive substances through the Dependence Evaluation and Information Center (CEIP-A).
Since the reporting of Medication Errors without Adverse Reactions was not required for Marketing Authorization Holders and “Exploitants” prior to February 2018 and no information on the modalities of reporting were provided (i.e. timelines and format), we contacted the French Agency to request some clarifications.
We also asked confirmation regarding the duplicate submission of Reports of Abuse or Dependence to medicines containing psychoactive substances, as those cases are already required to be reported to EudraVigilance (see articles 4.13, 4.14 and 4.15 of the French GVPs).
We have just received a response from the Medication Error Desk, which clarifies that pharmaceutical companies do not have any obligation to report Medication Errors without Adverse Reactions to the ANSM Medication Error Desk. A Questions & Answers Document should be published by the Agency shortly, pending the correction of article 4.32 of the French GVPs. The response included a reminder that confirmed Medication Errors associated or not to an Adverse Reaction must be evaluated in the PSUR, as specified in the EU GVP Module VI (2) (see VI.B.6.3). Medication Errors and the risk of Medication Errors must also be taken into account in the framework of the monitoring of the safe use of medicines and the assessment of risks and benefits.
Below is a copy of the response we received from the ANSM Medication Error Desk (in French !):
“Nous vous remercions pour votre message. Nous tenions à vous préciser que les industriels n’ont pas d’obligation à déclarer les erreurs médicamenteuses sans effet indésirable au Guichet Erreurs Médicamenteuses de l’ANSM.
Une Foire aux questions sera prochainement publiée par l’agence dans l’attente d’un rectificatif de l’article 4.32 du chapitre 4 des BPPV.
Néanmoins, l’ensemble des erreurs médicamenteuses avérées ayant entraîné ou non un effet indésirable doivent être évaluées dans le rapport périodique de pharmacovigilance. Il est important que tout signalement d’erreur ou de risque d’erreur soit pris en compte dans le cadre du suivi de la sécurité d’emploi et de l’évaluation du rapport bénéfice/risque.”
At this time, we have not received a response regarding reports of abuse or dependence cases, and we will update this blog when this information becomes available.
Raphaëlle Kuhn is a Pharmacist with over 9 years of experience in the pharmacovigilance and clinical trial safety area. She has been working as a Pharmacovigilance Consultant within SUNNIKAN Consulting for 6 years where she supports clients in quality management activities and has conducted over 80 audits internationally.
Raphaëlle also contributes to the monthly Pharmacovigilance Regulatory Intelligence service Safety Observer with regards to the French announcements.
