Pandemic flu plan calls for massive data collection

HHS Pandemic Influenza Plan

The Bush administration's national Pandemic Influenza Plan calls for a potentially massive effort by state and local health departments to collect data on antiviral medications, which state public officials say is a daunting task.

Under the plan, state and local public health departments will have to collect data on the distribution of antiviral medication. The plan also calls for them to collect information about adverse reactions to antiviral drugs, effectiveness of treatment and development of drug resistance.

Dr. C. Mack Sewell, state epidemiologist at New Mexico’s Department of Health, said the data collection requirement is a tall order, which New Mexico cannot meet at this time. Sewell added that he doubts that many other state and local health departments are ready to meet the data collection mandate.

Sewell said the data collection requirement will impose another burden on already financially strapped state and local health departments. The administration cut much of their federal funding in the 2006 budget, although President Bush restored $100 million in public health preparedness funds in the National Strategy for Pandemic Influenza Preparedness and Response, which he released Nov.1.

According to the plan, released by the Department of Health and Human Services and part of the administration’s larger strategy, public health departments would report adverse reactions to antiviral drugs through the Food and Drug Administration’s MedWatch program. MedWatch requires clinicians to submit an online or paper form for all adverse drug events, which would become a time-consuming exercise during a pandemic.

State and public health departments are expected to encourage hospitals to download, print and distribute MedWatch forms for distribution to patients. The FDA’s Adverse Events Reporting System collates and analyzes adverse events reported MedWatch.

The plan also calls for active monitoring of adverse events in emergency rooms through the Centers for Disease Control and Prevention’s National Electronic Injury Surveillance System -- Cooperative Adverse Drug Event (NEISS-CADE) system.

But the NEISS-CADE system collects data from only 68 hospitals nationwide, according to the CDC. The pandemic plan also states that CDC, the FDA and HHS’ Agency for Healthcare Research and Quality will “explore the use of existing drug-monitoring systems that have access to individual utilization records that may allow population-based surveillance for adverse events.” The plan did not detail those systems.

Dr. Robert Stroube, Virginia’s State Health Commissioner, told HHS last year in his comments on a draft HHS pandemic plan that CDC “should develop some databases in advance so consistent data collection will be assured." Stroube added that "clearly, a lot of data needs have been identified. The development of tools to meet these needs would aid public health capacity to respond and document critical information."