H1N1 Update: Key Facts and Resources for Counseling Patients

Pharmacists can expect to be asked lots of questions about H1N1 when classes resume and the flu season kicks into high gear this fall, if the drumbeat of news and information about the government's preparedness efforts for the pandemic is any indication. The government is closely monitoring local outbreaks and groups most affected, ratcheting up testing and production of an H1N1 vaccine, and spearheading a massive public information effort. Through it all, patients will be seeking guidance-and reassurance-on how to protect themselves and their families.

Centers for Disease Control and Prevention (CDC) surveillance figures through the end of July show 5514 hospitalized cases of H1N1 and 353 deaths in 47 states and territories. The federal government has directed $1 billion toward the development of an H1N1 vaccine, and clinical trials involving an estimated 2400 participants are expected to begin next week at 8 study sites across the country.

CDC is projecting a vaccine for H1N1 will be available by mid-October. Initial studies are looking at whether one or two 15-mcg doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers (aged 18 to 64) and elderly people (aged 65 and older). Researchers also will assess whether one or two 30-mcg doses are needed. The doses will be given 21 days apart, testing 2 manufacturers' vaccines (Sanofi Pasteur and CSL Biotherapies). If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin. More information on these trials can be found at www.clinicaltrials.gov.

Demand for antiviral drugs also has spiked worldwide. The CDC is reporting that this fall, antivirals may need to be prioritized for persons with severe illness or those at higher risk for flu complications. One group of particular concern is pregnant women. Cases of severe illness with H1N1 have been reported among pregnant women and infants, and evidence from past influenza pandemics reveals flu can be more severe in this population.

In response, the CDC has issued updated, interim guidance on the use of influenza antiviral treatment of pregnant women who are sick with H1N1. The agency stresses that pregnant women with influenza-like illness should be treated as soon as possible and that treatment should not be withheld pending results of testing for influenza, if testing is done. More information on this topic can be found at www.cdc.gov/h1n1flu/clinician_pregnant.htm.

Another population of concern is infants and children younger than 5 years of age. Based on past pandemics and seasonal flu patterns, within this age group, those under 2 are most at risk for influenza-related complications; for CDC's prevention and treatment guidance for clinicians for this population, go to www.cdc.gov/h1n1flu/childrentreatment.htm.

On top of all this, health officials increasingly are worried that all the attention on H1N1 will overshadow the need for individuals to get vaccinated for seasonal flu. CDC's Advisory Committee on Immunization Practices is now recommending that annual vaccination be administered to all children aged 6 months to18 years. The FDA recently announced the approval of 6 vaccines for 2009-2010 seasonal influenza: Afluria (CSL Limited); Fluarix (GlaxoSmithKline Biologicals); FluLaval (Biomedical Corporation); Fluvirin (Novartis Vaccines and Diagnostics Limited); Fluzone (Sanofi Pasteur Inc); and FluMist (MedImmune Vaccines Inc).

A wide range of flu information resources for patients and health professionals are available at the government's central Web site, www.flu.gov, including advice for patients on what to do if they get flulike symptoms, proper use of antiviral drugs, and how to care for a sick person at home. The site also offers state-by-state breakdowns on numbers of reported cases of H1N1, as well as information on each state's flu preparedness plans and activities.