Is pharmacovigilance ready to take a look at itself? Results from a quality auto-challenge

Mme Fatma MARZOUGUIa, Mme Fanny ROCHERa, M. David KOENIGa, Dr. Isabelle LERAISa, M. Thibaut LAVRUTb, Dr. Christiane KOUJIa, Mme Catherine BERNARDa, Dr. Bernadette BALDINa, Dr. Anne SPREUXa, Pr. Milou DRICIa

a CRPV de nice, b Service de Pharmacologie du CHU de Nice

The benefits of quality management systems (accreditation), are improving confidence in our public services or help to demonstrate that our analysis process is fit for purpose. Little has been implemented in pharmacovigilance, although its Centers might some day undergo a certification process to assess the quality of their task and effectiveness.

Aims :

To ensure the reliability of our pharmacovigilance activities, we adapted current guidelines of existing accreditation processes to the Centre Regional de Pharmacovigilance de Nice.


The CRPV recruited a quality assessment engineer for 6 months (april-september 2011) in order to audit our daily practice, assess a necessary qualifications framework and identify which urgent tasks should be undertaken. We urgently had to:

-         Adapt to the CRPV the document managing software (validation groups, addition of follow up criteria and indicators, Ennov®) of the Nice Medical Center

-         Evaluate our “customer” degree of satisfaction (or complaint) : all of our regional medical referees (>2800 health professionals from departments 06, 05 and 83)  have been contacted for a survey (e-mail).

-         Conducting and internal Management Review in order to evaluate the improvement in predefined chosen indicators as compared to the end of the 6 months period.

Results :

-         By October, 70% of operating procedures have been created or implemented (according to French end European directives), transferred onto the hospital managing software, and validated.

-         13% of our survey correspondents replied within a week. From this small but representative sample, the answers were overwhelmingly satisfied (> 90%: concerning rapidity, quality specificity and relevance of the responses provided by the CRPV).

-         The Management Review gathered all causes of non conformities, took corrective actions to avoid their recurrence,  pointed out new areas for improvement, and solutions to complete the remaining procedures.

Discussion and conclusion:

Quality management is a new process that  must be adopted in Pharmacovigilance which still is under intense public scrutinization. Such an independent process can easily be adapted from what exists in laboratories undergoing ISO 15189 accreditation process. Continually monitoring, measuring and improving the effectiveness of its quality management system should help current  problems to occur again.

Keywords : Pharmacovigilance, Quality