VigiCarib is a voluntary sub-regional system that the Member States of the Caribbean Community (CARICOM) use to report suspected adverse drug reactions (ADRs) and substandard or counterfeit medical products. In 2021, it incorporated the reporting of adverse events following immunisation (AEFIs).
The establishment of VigiCarib stems from the recognition that small States and markets face unique challenges in exercising essential regulatory functions, such as pharmacovigilance. On the one hand, having small populations leads to limited human resources and a smaller group of people with the necessary competence and experience. On the other, small States market a low volume of products that does not generate the commercial incentives to attract companies and manufacturers that can comply with stricter regulatory standards, so the pharmaceutical market in these countries is often dominated by intermediaries. (1)
Given this scenario, in 2011, CARICOM Ministers of Health adopted the Caribbean Pharmaceutical Policy. This policy establishes as one of its objectives the creation of the Caribbean Regulatory System (CRS). The CRS is a regionalization model that mitigates the difficulties of regulatory capacity in these small States by providing a single gateway to the CARICOM market, generating efficiencies by using decisions from other regulatory authorities, work sharing and using modern assessment criteria.
With the creation of the CRS in 2014, the voluntary system VigiCarib emerged with the objective of strengthening capacities to conduct pharmacovigilance in the region. VigiCarib also facilitates reporting to the WHO Global Surveillance and Monitoring System (GSMS) and the WHO Program for International Drug Monitoring (PIDM). This way, VigiCarib helps countries with limited resources to contribute to global surveillance and to receive information on international and regional trends.
VigiCarib provides its Member States electronic reporting forms for ADRs, AEFIs and substandard and falsified medical products. In addition, it coordinates a network of VigiCarib focal points, composed of representatives of CARICOM Member States and partners, which plays a key role in facilitating the exchange of information and experiences, as well as the reporting of ADRs, AEFIs and substandard and falsified medical products.
Between 2017 and 2021, VigiCarib has received 471 reports of suspected ADRs, AEFIs and substandard or falsified products. The majority (75%) are suspected ADRs and AEFIs, followed by substandard or falsified medical products (25%).
Promoting regulatory transparency and generation of information, the CRS periodically publishes a digital newsletter, VigiCarib News. In this newsletter, periodic sub-regional updates on ADRs, AEFIs and substandard and falsified medical products are shared with CARICOM countries.
