RESUMO
The Centers for Disease Control and Prevention's Strategic National Stockpile is a national repository of potentially life-saving medical countermeasures including pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local, regional, and state supplies to run out. Several planning considerations can assist state, local, tribal, and territorial jurisdictions in preparing to receive, distribute, dispense, and administer medical countermeasures from the Strategic National Stockpile. These considerations include, but are not limited to, issues surrounding regulatory requirements, controlled substances, cold chain management, and ancillary supply needs. Multiple aspects to consider for each of these functions are discussed here to assist partners in their planning efforts.
Assuntos
Planejamento em Desastres , Contramedidas Médicas , Estoque Estratégico , Centers for Disease Control and Prevention, U.S. , Humanos , Saúde Pública , Estados UnidosRESUMO
OBJECTIVE: To provide a general description of the roles and contributions of three pharmacists from the Regulatory Affairs program (RA) at the Centers for Disease Control and Prevention (CDC) who are involved in emergency preparedness and response activities, including the 2009 pandemic influenza A (H1N1) public health emergency. SETTING: Atlanta, GA. PRACTICE DESCRIPTION: RA consists of a staff of nine members, three of whom are pharmacists. The mission of RA is to support CDC's preparedness and emergency response activities and to ensure regulatory compliance for critical medical countermeasures against potential threats from natural, chemical, biological, radiological, or nuclear events. CONCLUSION: RA was well involved in the response to the H1N1 outbreak through numerous activities, such as submitting multiple Emergency Use Authorization (EUA) requests to the Food and Drug Administration, including those for medical countermeasures to be deployed from the Strategic National Stockpile, and developing the CDC EUA website (www.cdc.gov/h1n1flu/eua). RA will continue to support current and future preparedness and emergency response activities by ensuring that the appropriate regulatory mechanisms are in place for the deployment of critical medical countermeasures from the Strategic National Stockpile against threats to public health.