Life is unpredictable, and influenza is no different. With every new flu season, influenza virus presents unique challenges based on the strains circulating that year, time of circulation and a host of other factors.
The 2009-10 influenza season is a perfect example. When the CDC first recognized a new flu strain-influenza A H1N1, also known as "swine flu" because initial tests showed genetic similarities to the genes of North American swine-in April 2009, the agency immediately started work on a vaccine.
But the process to produce vaccine takes about 6 months, said Tom Skinner, CDC public affairs officer. The FDA first decides which viruses will go into the vaccine, the CDC then prepares the viruses for flu manufacturers, and the FDA approves the vaccine prior to mass production/distribution. By mid-fall 2009, flu activity and demand for H1N1 vaccine were high. So when the season peaked unexpectedly early-in late October, and vaccine had just become widely available, the CDC faced particular challenges.
"While we got a lot of people vaccinated, close to 81 million people, I think we could have gotten more people vaccinated had we had the vaccine prior to activity peaking," Skinner added. "That just goes back to the fact that flu really is unpredictable."
In addition to vaccination, lab testing was an immediate priority. As patients began trudging into hospital emergency departments with influenza-like symptoms (e.g., fever, malaise, respiratory symptoms) in greater-than-usual numbers in April/May of 2009, Yvette McCarter, PhD, clinical microbiology laboratory director at Shands Jacksonville, knew the flu season was going to be different from past seasons.
Her county health department initially asked the lab to send (at no charge) all positive specimens to the state lab for confirmation/classification. (Later, in the summer, the county health department required only specimens meeting specific criteria to be tested by the state lab.) By the time the H1N1 pandemic was in full swing, Shands Jacksonville was running about 400 tests a month--eight times what it would normally see.
"The biggest influx for us was in our molecular area, and essentially we just ended up having to assign more technologists to perform that testing," Dr. McCarter said. "We were doing it at least once a day if not more, including the weekends."
Shands Jacksonville offers commercially available antigen and molecular polymerase chain reaction (PCR) tests. Dr. McCarter noted it became clear the molecular test was better at detecting H1N1 and seasonal influenza and was "a lot more sensitive" than the antigen test. This season, the lab will rely on its PCR test from Prodesse Inc. (now Gen-Probe) with high hopes for an even more rapid molecular test that may hit the market.
Several hospital representatives say they did not experience a severe influx of 2009-2010 seasonal flu or H1N1 cases. However, Jeffrey Canose, MD, MHA, president of Texas Health Presbyterian Hospital-Plano, experienced a 28 percent increase in emergency room visits in October 2009 over 2008.
Though the Greenwich Hospital Infectious Diseases department has been preparing for an influenza pandemic for years-stockpiling supplies and setting policies/procedures, it wasn't prepared for the surge of requests for information from staff members, patients and family members or volume of people showing up with flu-like and respiratory symptoms, said Lillian A. Burns, MT, MPH, CIC, infection control and prevention coordinator in the Infectious Diseases department. "So we had to work in a timely fashion with various departments and physicians' offices, giving them guidance, helping them set up a system where specimens could be obtained at the various laboratories in the surrounding areas."
Trying to minimize unnecessary hospital visits, Amir Dan Rubin, chief operating officer, UCLA Medical Center and Hospital System, used an information-distribution approach. "We did a lot of proactive communications with our patients, ambulatory environments and community about what to do in terms of calling your physician office, when to test or when not to," Rubin said.
Frank Corvino, president and CEO, Greenwich (CT) Hospital, said his institution was able to pay overtime within the normal budgetary process to cover additional staff hours since the institution is financially strong, but it is uncertain how other institutions fared.
Many hospital officials implemented new policies pertaining to employees, patients and visitors. Infection control precautions were especially focused on vulnerable populations.
Hospital officials strongly encouraged sick employees to stay home and offered flu vaccinations as a precaution, often requiring signatures to decline the vaccination. The state of New York attempted to make vaccines mandatory, but a lawsuit resulted in a state Supreme Court judge issuing a restraining order in October 2009 against the state.
Employees who wanted the vaccine sometimes had difficulty getting it. H1N1 vaccine shortages meant most facilities were forced to rank employees based on their associated patient populations. Corvino estimates 85-90 percent of all employees got both seasonal and H1N1 flu shots.
On August 10, World Health Organization (WHO) Director-General Dr. Margaret Chan announced "the new H1N1 virus has largely run its course" effectively ending the 2009 H1N1 influenza pandemic. Most experts agree the 2009 H1N1 won't have the same impact this season, Skinner says. The FDA has included the virus in the 2010-11 vaccine so individuals who get flu shots will be protected if circulation continues.
The CDC has a new recommendation that all people over the age of six months get vaccinated, while in years past it targeted vaccination at those at high risk for serious flu complications and their close contacts.
"The main lesson is to continuously push the importance of vaccination," Skinner said. "That is the single most important thing that people can do to protect themselves."
Dr. McCarter is relieved about Dr. Chan's announcement. She was starting to see seasonal influenza activity in late August but was encouraged by last season's widespread vaccination efforts. "Hopefully we won't have a resurgence, and we'll just see a very calm influenza season this year," Dr. McCarter said.
If not, hospitals such as UCLA Medical Center and Hospital System are ready to unsheath their new, accurate, in-house-developed lab tests that can be run in a single day-for a little certainty in an uncertain flu world.
Jill Hoffman is on staff at ADVANCE.