Pharmacovigilance Systems in Latin America

Pharmacovigilance in Latin America has had one of its most significant challenges in developing the sensitivity and willingness of the population, health professionals, and patients to report adverse effects, so in these areas of the COVID-19 pandemic, where vaccination has been one of the key instruments to deal with this health emergency, the question arises how suitable are pharmacovigilance systems to positively influence the population to be an active part of the surveillance of these vaccines? To confirm whether what had been identified in the clinical development of these vaccines in terms of safety is like what in “real life,” it is being observed if there is new information that demands actions that emanate from Pharmacovigilance: analyze, understand, communicate and mitigate risks.

Four vaccines are being applied until the beginning of August 2022; about 465.8 million doses have been used. Its National Drug Monitoring Center, part of the regulatory agency, ANVISA, began operations in 2001.

Surveillance of COVID-19 vaccines is based on five pillars:

• Daily evaluation of notifications received

• Signal detection

• Monthly Executive Summary of Adverse Events

• Periodic quarterly reports on the assessment of benefits and risks

• Risk Management Plan

The individual reports are collected through VigiMed/Vigiflow for evaluation by the Pharmacovigilance team at ANVISA, and this information is then shared in the WHO database, VigiBase. There is also another platform for collecting individual reports, the E-SUS Notifica. At the beginning of August, around 20 thousand notifications had been registered in VigiMed and about 135 thousand in E-SUS Notifica (Sep-2021). Descriptive statistics of these data are available in the Pharmacovigilance section of the regulatory agency’s website. Access to VigiMed is public on the ANVISA homepage.

In June, a campaign in Pharmacovigilance was launched to the public, which included graphic materials such as videos; this campaign was carried out on social networks. In addition, the medical societies have signed a letter of commitment to exalt and corroborate their commitment to Pharmacovigilance and patient safety. As part of the activities of the regulatory agency, several communiqués have also been published to inform the population of the known and new risks with these vaccines available in the country against COVID-19. For example, information on the risk of Guillain-Barré Syndrome was published on July 26, 2021.

Four vaccines are applied; by February 2022, about 41.6 million doses have been used. In 2010 the Pharmacovigilance regulations were published for the first time; the team responsible for coordinating Pharmacovigilance activities is part of the Chilean regulatory agency, ISP.

As a result of the pandemic, in an approach similar to that made by the EMA, a specific document for the execution of Pharmacovigilance in vaccines against COVID-19 was published in December 2020, called “Implementation of Pharmacovigilance for SARS-CoV-2 vaccines in Chile”, in this document the following pillars are described:

• Legal basis for case reporting

• Prioritization, Research, and Evaluation of reports

• Risk Management Plans

• Monthly Periodic Reports

In addition to this framework of activities, a stimulated passive surveillance system was implemented, which consisted of conducting virtual surveys of patients vaccinated against COVID-19. The strategy is to send a message to the vaccinated person’s registered email three times after administering each dose of the SARS- CoV-2 vaccine, that is, 48 hours after inoculation, then at seven days, and the last one is sent 42 days after vaccination.

The individual reports are collected through 2 main channels: ESAVI online and RAM Network; there is also the possibility of manually notifying the mail: esavi@ispch. cl for evaluation by the team of the Subdepartment of Pharmacovigilance (SDFV) in ISP and then proceeds to share this information in the WHO database, VigiBase. Between December 2020 – February 2022, about 15 thousand notifications were recorded. The ISP also publishes periodic reports that include statistics on the cases collected about severity, gender, age, nature of the event, number of reports per vaccine, and number of reports per number of doses applied, among other elements.

As part of the regulatory agency’s activities, communications have also been made to the population regarding the safety and benefit of COVID-19 vaccines, both on its website and its other social networks, for example, Twitter.

Three are the available vaccines; at the beginning of April 2022, about 10.5 million doses have been applied. In 1998 the National Center for Pharmacovigilance was created, and in 2005, it was incorporated into the Ministry of Health of Costa Rica.

In response to the pandemic, a National Technical Labor Committee was created, composed of the Costa Rican Social Security Fund, the Ministry of Health (including the representation of the National Center for Pharmacovigilance), and Specialists, to identify possible risks that may be associated with vaccination against COVID-19. The COVID-19 vaccine surveillance scheme consists of the following elements:

• Spontaneous notification

• Risk Management Plans

• Monthly security reports

Spontaneous reports are collected through 4 main channels: a) Noti-Facedra: Regional Database, b) Yellow Card, c) CCSS Notification Form, and d) telephone line. In the period of 24 Dec. 2020 - 02 Apr. 2022, about 7 thousand notifications were recorded. The ISP also publishes periodic reports that include statistics on the cases collected about severity, gender, age, nature of the event, and the number of reports per vaccine, among other elements.

Eight vaccines are being applied; as of May 2022 cutoff, about 113.9 million doses have been used. Its National Pharmacovigilance Center was integrated into the national regulatory agency, COFEPRIS, in 2001.

Surveillance of COVID-19 vaccines is based on three pillars:

• Evaluation of notifications received

• Signal detection

• Risk Management Plan

Individual reports are collected through “e-Reporting vaccines,” “e-Reporting Industry,” “Vigiflow,” and the website “vacunacovid. gob.mx” for evaluation by the team of the National Center for Pharmacovigilance at COFEPRIS. This information is then shared in the WHO database, VigiBase. By the end of May 2022, around 38,000 notifications had been registered; from the notifications collected between December 2020 and May 2022, a monthly report was published, including statistics regarding severity, gender, age, locality, and nature of the event. Access to the different reporting platforms is available on the COFEPRIS website.

As part of the activities of the regulatory agency, various health alerts have also been published to inform the population about the illegal sale and falsifications of COVID-19 vaccines.

Sources:

1. https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoesanaliticas/notificacoes-de-farmacovigilancia

2. https://www.ispch.cl/isp-covid-19/informes-estadisticos-de-esavi-de-vacunas-sarscov-2/

3. https://www.ministeriodesalud.go.cr/index.php/biblioteca-de-archivos-left/ documentos-ministerio-de-salud/regulacion-de-la-salud/farmacovogilancia/ informe-de-sospecha-de-reacciones-adversas-a-medicamentos/informesacumulados-esavi-covid-19

4. https://www.gob.mx/salud/documentos/reporte-mensual-esavi-por-vacunacontra-covid19

5. https://www.gob.cl/coronavirus/

6. https://www.minsal.cl/wp-content/uploads/2020/12/ IMPLEMENTACI%C3%93N-DE-LA-FARMACOVIGILANCIA-PARA-vacunas- SARS-Cov-2-VF.pdf

7. https://www.ispch.cl/noticia/isp-y-hospital-digital-realizan-encuesta-parapacientes-vacunados-por-covid-19-para-fortalecer-vigilancia-de-posibles-efectosadversos/

8. https://www.ispch.cl/isp-covid-19/informes-estadisticos-de-esavi-de-vacunas-sarscov-2/

9. https://twitter.com/ispch

10. https://www.notificacentroamerica.net

11. https://www.ministeriodesalud.go.cr/index.php/formularios-de-notificacion-rams

12. https://www.ccss.sa.cr/web/coronavirus/assets/materiales/personal/ lineamientos/652.pdf

13. https://www.presidencia.go.cr/comunicados/tag/linea-telefonica-1322/