Construction and analysis of a database for medication errors in a pharmacovigilance centre-the Moroccan experience.

PURPOSE

The study aimed to describe the epidemiological profile of medication errors (MEs) reported to the Moroccan Pharmacovigilance Center (MPVC), to determine factors associated with serious MEs, and to describe signals related to them.

METHODS

We carried out a retrospective descriptive analysis of MEs reported to the MPVC from 2006 to 2016 and a secondary analysis of the seriousness of MEs with adverse drug reactions (ADRs). The reports were sorted by demographic profile and by ME and ADR characteristics. For signal detection, a quantitative approach was adopted, and the root cause analysis was completed. Epi info 7 software was used to perform descriptive and analytical statistics. The statistical significance level was set at p < 0.05.

RESULTS

A total of 1618 ME reports were retrieved. The proportion of MEs associated with serious ADRs was 23.9%. The factors statistically associated with serious MEs were as follows: (i) the age group 16 years old and less (p < 0.001), (ii) the gender (p = 0.01), (iii) the administration and the prescription stages (p < 0.001), and (iv) the ME types related to inappropriate schedule of drug administration, drug prescribing error (p < 0.001), and incorrect drug administration dosage form (p = 0.04). Fourteen signals related to MEs were detected, for which risk minimization actions were implemented.

CONCLUSION

The establishment of a ME unit within the MPVC was an opportunity to further improve the pharmacovigilance centre performance and consequently its contribution to medication safety. The lessons learned from MEs should be shared through pharmacovigilance networks and with institutions involved in medication safety for synergistic results to achieve patient safety worldwide.