Loubna Alj1,2, Raja Benkirane3, Amina Tebaa4, Ghita Benabdallah4, Alem Zekaria5, Asmae Khattabi6,3, Rachida Soulaymani Bencheikh4. 1. Centre Anti Poison et de Pharmacovigilance du Maroc, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP: 6671, Rabat, Morocco. naloub20@yahoo.fr. 2. Field Epidemiology Training Program, Ecole Nationale de Santé Publique, Ministry of Health, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP: 6329, Rabat, Morocco. naloub20@yahoo.fr. 3. Ecole Nationale de Santé Publique, Ministry of Health, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP: 6329, Rabat, Morocco. 4. Centre Anti Poison et de Pharmacovigilance du Maroc, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP: 6671, Rabat, Morocco. 5. Uppsala Monitoring Center, Bredgränd 7b, 753 20, Uppsala, Sweden. 6. Field Epidemiology Training Program, Ecole Nationale de Santé Publique, Ministry of Health, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP: 6329, Rabat, Morocco.
Abstract
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.
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.
Authors: Franca Davanzo; Laura Settimi; Felice Giordano; Maria Luisa Casini; Fernanda Ferrazin Journal: Pharmacoepidemiol Drug Saf Date: 2015-02-02 Impact factor: 2.890
Authors: Elaine K Walsh; Christina Raae Hansen; Laura J Sahm; Patricia M Kearney; Edel Doherty; Colin P Bradley Journal: Pharmacoepidemiol Drug Saf Date: 2017-03-13 Impact factor: 2.890