On December 20, 2017, the Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) launched VigiCarib, a voluntary regional system for CARICOM states to report medicines related adverse events (adverse drug reactions (ADRs)) and substandard and falsified (SF) products. Medicines safety and monitoring systems are often limited in the individual small states of CARICOM, and the rationale for a regional approach is that with pooling of resources, sharing of information, and coordination of activities, there will be efficiencies of scale that can lead to stronger systems overall.
VigiCarib is endorsed by Ministers of Health in CARICOM states and allows health professionals, the public, and other stakeholders to report to the CRS for regulatory analysis and action. The CRS may share information about problematic products with CARICOM states, pool data to identify signals, and make recommendations to governments about regulatory actions. The program will help to protect patients and bolster their confidence in health care, as well as send a signal to manufacturers and distributors that their products are being monitored for safety and quality.
Stakeholders can report via the VigiCarib word form, or online form but if pressed for time, can also work with the CRS to flag issues through abbreviated methods, such as taking photos and/or sending short recorded messages via email, that capture essential information, while the CRS works with the stakeholder to complete the necessary information on the case.
Information and reports should be sent to the CRS through the dedicated email: Vigicarib@carpha.org
Note that reports received will be copied to the government focal points and the national centers. The CRS will keep reporter identities anonymous at their request.
VigiCarib now has the ability to report into World Health Organization (WHO) programs including the Program for International Drug Monitoring (PIDM) and Global Surveillance and Monitoring System (GSMS) on behalf of governments. This means that governments can send reports to the CRS to input into these systems if they do not have time to enter them on their own or have a backlog of reports.
More detailed procedures for using VigiCarib can be found HERE.
WHO has developed guidance for identifying SF products as well as managing SF incidents.
VIGICARIB REPORTING FORM:
Aide Memoire 2018 Managing SF Medical Products
Identifying Suspect SF Medical Products
VigiCarib Reporting Guidelines for Focal Points 8 7 18
WHO Global Surveillance and Monitoring System
WHO Program for International Drug Monitoring