Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug;77(8):1235-1246.
doi: 10.1007/s00228-021-03109-w. Epub 2021 Feb 17.

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

Loubna Alj  1   2 , Raja Benkirane  3 , Amina Tebaa  4 , Ghita Benabdallah  4 , Alem Zekaria  5 , Asmae Khattabi  6   3 , Rachida Soulaymani Bencheikh  4
Affiliations

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

Loubna Alj et al. Eur J Clin Pharmacol. 2021 Aug.

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.

Keywords: Medication errors; Medication safety; Pharmacovigilance; Risk minimization action; Root cause analysis; Signal detection.

PubMed Disclaimer

References

    1. European Medicines Agency. Good practice guide on recording, coding, reporting and assessment of medication errors. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/g... (2015). Accessed 18 June 2020.
    1. Elliott RA, Camacho E, Campbell F, Jankovic D, Martyn-St James M, Kaltenthaler E and al. Prevalence and economic burden of medication errors in the NHS in England: rapid evidence synthesis and economic analysis of the prevalence and burden of medication error in the UK. Policy Research Unit in Economic Evaluation of Health and Care Interventions (EEPRU), 2018. 174 p. https://pure.york.ac.uk/portal/en/publications/prevalence-and-economic-b... . Accessed 7 May 2020.
    1. Kohn LT, Corrigan JM, Donaldson MS (2000) To Err is human: building a safer health system. Institute of Medicine (US) Committee on Quality of Health Care in America National Academy. National Academies Press (US), Washington (DC). https://doi.org/10.17226/9728 - DOI
    1. Aitken M, Gorokhovich L (2012) Advancing the responsible use of medicines: applying levers for change. September 17. https://doi.org/10.2139/ssrn.2222541 . Accessed 7 May 2020.
    1. Walsh EK, Hansen CR, Sahm LJ, Kearney PM, Doherty E, Bradley CP (2017) Economic impact of medication error: a systematic review. Pharmacoepidemiol Drug Saf 26(5):481–497. https://doi.org/10.1002/pds.4188 - DOI - PubMed

LinkOut - more resources