So Far, So Good: Flu Vaccine Supply Appears Adequate

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Public Health Feature - March 2008

 

By  Crystal Conde
Associate Editor

Physicians often are plagued by significant challenges in vaccinating their patients, placing the public at risk of contracting a preventable disease. One of those challenges in recent years has been the availability of vaccine to immunize patients against the flu, a disease that puts 200,000 people in the hospital and takes some 36,000 lives annually. Flu vaccines arrived late, or the supply was so scarce physicians couldn't order enough. This flu season, however, doctors tell a different story.

The U.S. Centers for Disease Control and Prevention (CDC) estimates a record 132 million doses of flu vaccine are available this year. Public health officials credit the increase to collaboration with vaccine manufacturers by the National Influenza Vaccine Summit, as well as federal approval of expanded use of FluMist for children aged 2 to 5 years and Afluria for adults over 18. They also cite the entrance of an Australian manufacturer into the market. As a result, physicians have an opportunity to expand the traditional vaccination season and to reach more patients than ever.

Jack Sims, manager of the Texas Department of State Health Services (DSHS) Immunization Branch, says vaccine production and delivery went according to schedule this flu season.

"Large amounts of vaccine were available early; they were equitably distributed to the public and private sectors and among different health care provider types," he said. "I believe those two things made it a successful vaccine season."

In addition, preservative-free vaccine for infants was available early this year for the first time. Children aged 6 to 59 months also received flu vaccine, a new CDC recommendation.

Pediatrician Molly Droge, MD, touts the expanded use of FluMist to children aged 2 to 5 years as a positive development this season. She says the vaccine nasal spray is more acceptable to patients who don't want another shot.

Last season, Dr. Droge's practice received its vaccine shipment late, leaving her stuck with leftover doses and unable to recoup the cost of the vaccine. When she couldn't immunize patients, they went to pharmacies, employers, and public health clinics, which she says undermines the concept and benefits of the medical home.

The Texas Medical Association is working to ensure physicians are able to vaccinate patients in the medical home, while educating the public about the need for influenza vaccination. (See " TMA Vaccine Advocacy .")

 

The Summit Helps

Last year's availability problems were not the first time vaccine shipment and delivery didn't go according to plan.

Influenza vaccine supply shortage and inequitable distribution outraged physicians and public health officials in 2004, a low point in supply since 2000. (See " Influenza Vaccine Production for the U.S. Market, 2000-07 .") The situation was so critical that in October of that year, CDC advised healthy people aged 2 to 64 to delay or forego vaccination altogether.

The 2007-08 season is a much different story. In fact, it has been a banner season for vaccine supply and production, according to Litjen (L.J.) Tan, MS, PhD, director of infectious disease, immunology, and molecular medicine at the American Medical Association.

Physician offices and state health departments are not only getting their vaccine on time, they're also able to order plenty of it. That success is due in large part, he says, to the work of the National Influenza Vaccine Summit, cosponsored by AMA and CDC and established in 2000.

The annual summit consists of more than 400 participants representing more than 100 stakeholder organizations, which include health care and public health professionals, vaccine manufacturers and distributors, consumers, federal agencies, and others interested in warding off vaccine-preventable diseases.

But stabilizing the influenza vaccine supply didn't happen overnight.

"Any kind of change takes time," Dr. Tan said. "It has taken about five years for the summit to get where it is today. The goal of stabilizing the influenza vaccine supply is all about increasing demand for immunization and then increasing manufacturers of vaccine."

Indeed, AMA and CDC have made progress in drawing more vaccine manufacturers to the U.S. market. In 2004, there were two manufacturers; this season, six are in production mode. CSL Biotherapies, an Australian manufacturer, entered the market and infused 3 million doses of Afluria into the vaccine supply this year.

Dr. Tan says CSL can potentially produce 25 million to 30 million doses. By 2010, he estimates, as many as 300 million doses of vaccine could be available if each manufacturer functions at full capacity. The question is, will manufacturers produce that much vaccine?

"They'll have to decide if they want to. It's a tricky balance," Dr. Tan said. "The beauty is now we have six manufacturers, which means we have some stability in the system. If one goes out, we still have five. However, the disadvantage of a free-market system is that they're all competing and they have to figure out how to get a return on investment and balance out how many doses of vaccine to produce."

He says 111 million of the doses produced this season have been distributed, meaning that 19 million doses will be destroyed. Until manufacturers receive reassurance that producing more vaccine won't result in a loss, Dr. Tan says, the companies likely won't choose to operate at full capacity. He predicts manufacturers will take a gamble and push to 150 million doses next season. He bases his assertion on manufacturers' willingness to commit to the enterprise and interest in working with the summit to stabilize the vaccine supply and increase use of the vaccine to protect more people.

 

Reimbursement Improves

Andrew Eisenberg, MD, MHA, family physician and a member of TMA's Council on Public Health, says physicians became leery of ordering vaccine they might need because they couldn't afford to have unused vaccine left over.

In 2007, two manufacturers implemented innovative vaccine-return policies to reduce physicians' financial risk. ASD Healthcare announced it would allow customers to return up to 25 percent of flu vaccine ordered through CertiFlu, ASD's flu program. And FFF Enterprises accepted return of 100 percent of Novartis Vaccines Fluvirin Influenza Virus Vaccine 10-dose vials and prefilled syringes.

Improvements have been made in vaccine administration reimbursement, as well. Dr. Eisenberg, who has represented TMA as a member of the National Influenza Vaccine Summit since 2004, recognizes that cost is an overwhelming concern for family medicine practices and small practice groups. He and other summit members worked to make it possible for these groups to immunize patients without stressing over the financial components.

"Through the summit, manufacturers and distributors have gotten a better understanding of the problems physicians face and the risks they assume," he said.

In 2005, the Centers for Medicare & Medicare Services increased the resource-based relative value scale (RBRVS) for administering vaccines. The summit and TMA have advocated for recognition of the work involved in physician vaccine administration services. (See " Flu Vaccine Reimbursement .")

With improved reimbursement, vaccine-return policies, adequate supply, and equitable delivery in place, CDC and AMA urge medical professionals to vaccinate patients throughout the full influenza season, including March. Dr. Tan says the recommendation represents a "huge cultural shift" in the way many physicians have been instructed to immunize for influenza. Previously, the message was to focus on high-risk populations: infants, the chronically ill, pregnant women, and the elderly. This season's flu vaccine supply gives physicians an opportunity to immunize more patients.

"Physicians need to do more than just immunize the standard population," he said. "They need to think about how to immunize everyone who walks into the office. A family physician, for example, should look at the whole family and not just focus on the grandmother."

He also suggests physicians think ahead to next year.

"They should order vaccine now from multiple suppliers. They should try to split their orders among manufacturers and spread out orders. That way, if there's an unforeseen production problem with a manufacturer, doctors will get most of their vaccine," he said.

Dr. Tan says instead of potentially losing business to grocery stores and other retailers that offer flu vaccines, physicians should consider competing with them by running their own immunization clinics. And, there may be opportunities to attract new patients to the practice.

The vaccine summit promotes on its Web site,  www.preventinfluenza.org , the American Lung Association's Flu Clinic Locator, a national directory patients can use to find vaccination sites. Dr. Tan says physician offices aren't present on the list, causing them to miss out on a valuable opportunity to vaccinate more of the public. If physicians were willing to offer public clinics, the summit would assist them with being included on the Flu Locator Web site.

Physicians can be more involved at the state level, as well. Although influenza isn't a reportable illness at the federal level (except for pediatric deaths), measures are being taken to help track cases of influenza-like illnesses in Texas through CDC's U.S. Influenza Sentinel Provider Surveillance Network. (See " Program Tracks Flu Statewide .")

Despite the success of this flu season, Dr. Tan says medical professionals must expand vaccination coverage rates, educate the public about the need for influenza vaccination, and reduce vaccine waste to prevent some manufacturers from pulling out of the market or reducing the amount of vaccine they produce.

"Just because we've had one good year doesn't guarantee it will continue, unless we raise the bar," he said. "Manufacturers will work with the influenza vaccine summit but may only go so far. After three or four years of throwing out vaccine, it's likely they'll say enough is enough."

Crystal Conde can be reached at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at  Crystal Conde .

 

 

SIDEBAR

TMA Vaccine Advocacy

Acting on several recommendations to improve immunization rates and ensure an adequate vaccine supply in Texas made by William Paul Glezen, MD, a Houston pediatrician representing TMA, the 2007 Texas Legislature passed several bills aimed at increasing immunization awareness and participation among parents of children in child care facilities. They also initiated a study on giving health care professionals priority in distributing influenza vaccine.

House Bill 3184 orders the Texas Health and Human Services Commission to study the wholesale distribution of influenza vaccine in the state. The goal is to decide if it's feasible to give first priority to physicians and other licensed health care professionals authorized to administer influenza vaccine. Retail establishments would have a lower priority. The commission may implement such a system if it's found to be feasible. The bill also calls on the Texas Department of State Health Services (DSHS) to promote the benefits of annual immunization against influenza for children aged 6 months to 5 years on its Web site.

House Bill 1059 requires school districts to post the following on their Web sites in English and in Spanish:

  • Required vaccinations for school entry, including the influenza vaccine;
  • Recommended vaccinations for public school students;
  • Health districts that offer the influenza vaccine; and
  • A link to the DSHS Web site for exemption procedures.

The bill also instructs DSHS to prepare a list, suitable for posting on schools' Web sites, of required and recommended immunizations for school-age children.

House Bill 532 allows each health care professional to select the specific influenza vaccine to be used under the Vaccines for Children program from a list of approved vaccines.

Senate Bill 140 requires DSHS and the Texas Higher Education Coordinating Board to study the feasibility of providing immunizations without charge or at a discount to economically disadvantaged students enrolled in college health profession degree programs. The study must examine potential methods of providing those immunizations.

Senate Bill 204 requires electronic medical record vendors in Texas to provide the ability to connect with the ImmTrac Texas Immunization Registry.

Finally, legislators allocated $11 million to purchase flu antiviral in the event of a pandemic flu outbreak.

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SIDEBAR

Mar 08 PH vaccine chart

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SIDEBAR

Flu Vaccine Reimbursement

In 2005, Medicare significantly increased the resource-based relative value scale (RBRVS) values for the service of administering vaccines.

The following chart shows geographically adjusted Medicare payment amounts for administering influenza vaccine in Texas counties for 2007. These are the most recent figures available.

Texas Areas

Healthcare Common Procedure Coding System (HCPCS) Code G0008

Brazoria County

$19.06

Dallas County

$20.24

Galveston County

$18.82

Harris County

$19.74

Jefferson County

$17.60

Tarrant County

$19.23

Travis County

$19.95

Rest of Texas

$17.60

Source: American Medical Association

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SIDEBAR

Program Tracks Flu Statewide

The Texas Department of State Health Services (DSHS) implements the Centers for Disease Control and Prevention's (CDC's) U.S. Influenza Sentinel Provider Surveillance Network. Participants provide data on influenza-like illnesses each week to help CDC monitor the impact of influenza and guide prevention and control activities, vaccine strain selection, and patient care.

Currently, 120 Texas health care professionals report influenza-like illness data to CDC every week. CDC compares the percentage of patient visits reported to sentinel providers for influenza-like illness with the national baseline of 2.2 percent. This allows the center to survey influenza activity around the nation.

Participation in the program involves reporting the total number of patient visits for influenza-like illness by age group (0-4, 5-24, 25-64, older than 65), along with the total number of patient visits. Physicians submit the data once a week to CDC via the Internet or fax.

DSHS says a majority of participants report that the entire process takes less than 20 minutes each week. In addition, sentinel providers can submit specimens from a subset of patients for virus isolation, free of charge. And they receive feedback on the data submitted, summaries of regional and national influenza data, and free subscriptions to CDC's Morbidity and Mortality Weekly Report and Emerging Infectious Diseases journal.

Physicians interested in enrolling in the program can request a form from Irene Brown, sentinel influenza coordinator in the DSHS Infectious Disease Control Unit, by calling (512) 458-7111, ext. 6878, or e-mailing  irene.brown@dshs.state.tx.us .

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