(2002; 166 pages)
Status of regulation of antimicrobials in Cuba
Dr Rafael Perez Cristia, Cuba
Resistance to antibiotics, and the consequent reduction in their effectiveness in treating infections in humans, constitute a growing problem throughout the world. In order to tackle antimicrobial resistance, the Ministry of Public Health and the National Regulatory Authority in Cuba established an action plan to promote the rational use of antibiotics and adopted strict legislation governing the registration, prescription and use of antibiotics. This plan is in line with the recommendations of World Health Assembly Resolution WHA 51.17, the Pan American Conference on Antimicrobial Resistance in the Americas, and the Guadalajara Declaration to Combat Antimicrobial Resistance in Latin America.
All health institutions, including hospitals and community centres, are involved in the National Programme for Monitoring and Surveillance of Antimicrobial Resistance. This Programme is coordinated by the Institute of Tropical Medicine “Pedro Kuory” in Havana with the participation of the National Network of Microbiological Laboratories.
The main regulations for antibiotic use in Cuba include:
• legislation that establishes the list of antibiotics that can be used only in hospitals and those allowed to be dispensed in community pharmacies,
• sale of antibiotics on medical prescription only,
• establishment of infection control committees responsible for epidemiological surveillance of antimicrobial resistance, and
• establishment of pharmacotherapeutic committees responsible for policies on antibiotic use in each hospital.
The Cuban regulatory authorities also require that data on antimicrobial resistance should be part of any application for approval of a new antibiotic.
The Cuban authorities know that this problem needs to be treated locally, according to the nature and evolution of antimicrobial resistance in the country. Health policies need to promote a better understanding of all aspects related to combating antimicrobial resistance, including intensive surveillance and the rational use of antibiotics.