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Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems

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Abstract

Pharmacovigilance (PV) activities aim to identify potential risks of medicines and vaccines after they have been authorised in the market by collecting and analysing information on suspected adverse events from different stakeholders. These can be captured and transmitted electronically in the form of Individual Case Safety Reports (ICSRs). Hence, up-to-date ICSRs management systems, like VigiFlow and signal detection and management systems as VigiLyze, have an important role in the PV system of a country. In 2019, after various attempts to establish a PV database that could fulfil the needs of the country, Mexico’s National Regulatory Authority, COFEPRIS (Federal Commission for the Prevention against Sanitary Risks) decided to implement these tools. This has been a successful project that is still ongoing, it has involved national and international organisations, and has required the participation and integration of different components of the national PV system. The implementation of these tools has allowed COFEPRIS to increase its reporting trends and quality of reporting, while contributing to make more efficient interactions and processes with PV stakeholders, even during the COVID-19 pandemic. It has also allowed them to strengthen their commitment to the WHO-Programme for International Drug Monitoring, while highlighting opportunities for improvement in the national PV scenario and in the PV tools themselves. The aim of this article is to describe the implementation process, give an overview of current results regarding ICSR data and processes, and highlight the achievements, challenges, and opportunities for improvement after the three years since the beginning of the project.

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Acknowledgements

We would like to externalise our gratitude to the following persons, from COFEPRIS: to former Federal Commissioner Dr José A. Nobelo, Felipe de la Sancha (former employee), Jose Antonio Maza, Rogelio Ríos, Ángel Galván and all members of the national pharmacovigilance system for their support towards the project. To the PAHO-Mexico office for their support in the implementation. To the PAHO-WDC office for the support to the WHO-PIDM and transmission of information. To the MSSO team for the support in MedDRA related matters. To the University of Alcala’s Clinical Pharmacology Unit, Madrid, Spain for their external review. To the UMC for their external review of this paper, and for their support towards the project in Mexico and in many other countries.

Author information

Authors and Affiliations

  1. COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de México, México

    Gandi Rayón-Ramírez, Rosa Camacho-Sandoval, Miriam J. Loera & Alejandro E. Svarch

  2. Master´s graduate from the programme in Pharmacovigilance and Pharmacoepidemiology, Universidad de Alcalá, Madrid, Spain

    Salvador Alvarado-López

  3. CONAHCYT, Consejo Nacional de Humanidades, Ciencias y Tecnologías, Programa Investigadoras e Investigadores por México, Ciudad de México, México

    Rosa Camacho-Sandoval

  4. Secretaria de Salud, Acapulco de Juárez, Guerrero, México

    Jorge Alcocer-Varela

Authors
  1. Gandi Rayón-Ramírez
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  2. Salvador Alvarado-López
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  3. Rosa Camacho-Sandoval
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  4. Miriam J. Loera
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  5. Alejandro E. Svarch
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Corresponding author

Correspondence to Miriam J. Loera.

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Funding

No funding was received for the development of this project.

Conflicts of interest

GRR, is an employee of COFEPRIS and has coordinated the implementation of the systems in Mexico. SAL is an employee of the Uppsala Monitoring Centre where VigiFlow, VigiLyze, VigiBase and the PV methods are produced and maintained. His participation in this project was via personal time and resources and the opinions stated in this manuscript does not necessarily reflect the ones of the Uppsala Monitoring Centre. RCS is an employee of CONAHCYT-COFEPRIS. MJL is the Commissioner of the Evidence and Risk Management department of COFEPRIS. AES is the Federal Commissioner and head of COFEPRIS. JAV is the head of Mexico’s Health Secretariat. The authors have no conflicts of interest to declare.

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Availability of data and material

The data used in this project comes from COFEPRIS’ national safety databases from 1995 until December 2022 and Mexican data extracted from VigiBase. All the analyses and graphs displayed were carried out with permission and in collaboration with COFEPRIS with anonymised aggregated data.

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Authors’ contributions

GRR and SAL made a significant contribution from the conception to write up, design of the manuscript and analysis of data. RCS contributed as reviewer /author of intellectual content of the document. MJL, AES and JAV contributed as reviewers. All authors have read and agreed to the publication of the manuscript.

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Rayón-Ramírez, G., Alvarado-López, S., Camacho-Sandoval, R. et al. Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems. Pharm Med 37, 425–437 (2023). https://doi.org/10.1007/s40290-023-00490-y

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