Cover Story - December 2006
Earlier this fall, the U.S. Centers for Disease Control and Prevention (CDC) said the mid-range and long-term outlooks for the influenza vaccine supply for this year's flu season "appear very positive." It projected that more than 110 million doses of vaccine would be available this year, 16 percent more than last year. If those estimates hold, said CDC Director Julie Gerberding, MD, MPH, "more people than ever before will be able to protect themselves and their loved ones from influenza this year."
Tell that to the Dallas County Health and Human Services Department (DCHHS).
DCHHS received an initial shipment of 2,500 of the 15,000 doses originally ordered from Sanofi Pasteur in September, but a second shipment scheduled for early October was delayed. DCHHS ran out of adult vaccine and had to tell people at high risk to get their flu shots elsewhere. Things ended well, however, when DCHHS secured 400 additional doses from a third-party vendor and resumed offering flu shots to the public.
Still, the situation frustrated DCHHS medical director John T. Carlo, MD.
"Seasonal influenza happens every year. It's as predictable as the winter weather. We don't know how strong the flu virus will be or how many people will get sick, but we know flu will occur sometime between November and March. CDC indicated there would not be a shortage this year, and I admit we were looking forward to a smooth season. Now, DCHHS is experiencing the opposite."
DCHHS isn't the only one having problems.
Dr. Carlo says he has heard of other public health departments across the state receiving restricted shipments, regardless of how much they ordered. Media outlets in Austin, El Paso, Abilene, and Houston have reported that doctors are experiencing delays in receiving their full vaccine orders.
"This year we're experiencing a three-week delay in the delivery of the vaccine, and that's why people are thinking there's a shortage," said Austin Regional Clinic marketing manager Heidi Shaley. "We expect to receive all the shipments and have ordered more vaccine this year than ever before. Distribution varies every year. Some years we get it early, some late. Last year we received vaccine early and had it before anyone else."
The Washington Post said in mid-October that delays in shipping vaccine "are causing sporadic shortages and forcing some doctors to postpone clinics or serve only high-risk patients. Some 26 million doses were distributed across the country in September, and federal officials expected that three times that many would be on their way by the end of this month."
CDC blames the delays on the small number of vaccine makers and the short window between identification of this year's expected flu strain and the beginning of shipments to doctors.
During an Oct. 18 media briefing on influenza vaccine supply and distribution, the agency said, "Because the U.S. influenza vaccine manufacturers are currently producing vaccine at or near full capacity, it isn't possible for all of the doses to be produced and distributed before the vaccination season begins. Efforts have been made by the manufacturers and major influenza vaccine distributors to ensure that all providers have at least some vaccine to begin vaccination, but it is CDC's expectation that doses will be distributed over the next two months to support ongoing vaccination in October, November, and beyond."
Dr. Carlo says delayed shipments may not be a big issue for smaller counties or agencies, "but for Dallas, with our population, it's a huge concern."
For many Dallas residents, he points out, DCHHS is the provider of last resort for flu shots. He says many of these individuals are uninsured and cannot afford to get the vaccination elsewhere.
"Not having the vaccine before November leads to us not being able to vaccinate residents before the flu season officially starts," he said. "Frankly, I feel it's a disservice to the community DCHHS serves. It's aggravating when grocery and drug stores have vaccines, while DCHHS and physicians' offices don't. Why are we once again in this position?"
The CDC announcement regarding the flu vaccine supply was contained in a statement on its Web site at www.cdc.gov/flu/about/qa/vaxsupply.htm. It paints a rosy picture of improved supply this year and next year, thanks to efforts by vaccine manufacturers to expand their production capabilities and the possibility of two additional manufacturers coming online next year. CDC officials also posted a lengthy list of questions and answers about the flu vaccine in which they said they cannot control vaccine distribution so that physicians seeing priority patients receive their orders first.
The statement also attempts to explain why physicians often have to wait for their vaccine, while retail stores appear to have adequate supplies.
"Based on information CDC has collected from manufacturers, distributors, physicians, community vaccination providers, and others, no particular category of provider is favored over any other in vaccine distribution," the agency said. "In 2005, many companies that offer vaccine in commercial settings such as grocery, drug, or department stores were unable to obtain all the vaccine they wanted and had to cancel many of their scheduled clinics. Nevertheless, because these community-based clinics are so visible, observers may incorrectly conclude that they can obtain as much vaccine as they want. Data generated recently by CDC's Behavioral Risk Factor Surveillance System suggest that between 6 and 7 percent of total influenza doses are given in commercial settings, translating to between 4 and 6 million doses in 2005."
Supply and Demand
The basic economic theory of supply and demand has always explained market behavior. Although its everyday application often is discussed in classrooms, Paul Glezen, MD, an epidemiologist at the Influenza Research Center at Baylor College of Medicine, suggests it can be used to both understand and improve current influenza vaccine supply and distribution. In fact, he encourages all physicians to use every last drop of this year's flu shots.
"Supply follows demand, and it is imperative that physicians use all of their supplies," he said. "Because the influenza virus changes each year, vaccine is only good for one season. In the past, manufacturers produced millions of doses that weren't used. Those doses were thrown away eventually, costing the manufacturers large sums of money. They lost interest in the business, they left, and their number decreased. At one time, more than a dozen companies made flu shots, but in 2004 there were just two," he said.
That year Chiron Vaccines (now Novartis Vaccines, Inc.) a California-based biotechnology company that produces influenza vaccine, lost its license because of contamination problems at its plant in England. Nearly 50 million doses were destroyed, causing a vaccine shortage that panicked the public. The company's license was reinstated in October 2005.
The other manufacturer, Sanofi Pasteur, continues to be the largest manufacturer of influenza vaccine. In 2005, two other companies entered the market, GlaxoSmithKline and MedImmune Vaccines, Inc.
CDC says that in the past six years physicians' access to flu vaccine has depended upon which brand of vaccine they ordered and from which supplier. Because some manufacturers have had difficulty with production (like Chiron in 2004), vaccine providers have received delayed or limited quantities of their orders. By comparison, CDC says, companies experiencing good production were likely to ship full orders or a substantial portion of their orders.
This year, the American Academy of Family Physicians (AAFP) recommended that its members split their total vaccine order among the various vaccine manufacturers. Doing so is precautionary in case one of the manufacturers experiences production difficulty.
In a letter to members, AAFP President Larry Fields, MD, of Ashland, Ky., said physicians "should understand that because of the uncertainty inherent in manufacturing a biological product, acceptance of a prebooked order cannot guarantee delivery of the final product. Prospective vaccine buyers can maximize their chances of getting the vaccine they need by splitting their total order among various vaccine sources. That doesn't mean physicians should book more vaccine than they expect to use; it simply means purchasers can spread their risk by booking vaccine from more than one manufacturer/distributor."
Besides ordering from more than one manufacturer, Dr. Glezen stresses that physicians must place their orders as soon as possible for each season. Most of the vaccine for the 2006-07 season was prebooked at the start of this year.
"The longer physicians wait to place the order, the longer they'll wait to receive the vaccine," he said. "Physicians know flu is coming; they must be proactive in ordering. My hope is for more physicians to order early, use up those supplies, and cause more companies to become interested in manufacturing the vaccine. If there had been more companies, the situation in 2004 wouldn't have happened. Physicians should have other options when it comes time to ordering. The influenza vaccine market should be more buyer friendly than seller friendly."
The second National Influenza Summit, cosponsored by CDC and the American Medical Association, was held in Chicago last summer to address and attempt to resolve influenza and influenza vaccine issues.
Participants agreed that extensive interaction was needed among vaccine providers, manufacturers, and distributors. Topics requiring more communication were the manufacturers' vaccine production process, their total production projections, how they prebook vaccine, the timing of vaccine distribution, and how vaccine is divided among different providers and tiered to certain population groups. Summit participants also recommended establishing a special preordering period for physicians in small office-based practices. Although that proposal was well received by physician organizations, they were concerned that a preordering period would favor one customer segment over another.
CDC also said it would send specific summary reports of influenza vaccine distribution data to state and local public health officials. The agency is working with manufacturers and seven major distributors to provide information on a weekly basis throughout the flu season.
The first report was made available in September, but AMA says access to the information is currently restricted because many distributors and manufacturers believe their sales data (including where their sales are doing best) would be exposed if the information was public. The manufacturers and distributors share the information with CDC only so the agency can identify where shortages exist in the event of another vaccine supply crisis.
Dr. Glezen thinks the issues surrounding influenza vaccination will eventually disappear. For him the most important thing is patient vaccination. He acknowledges that vaccine distribution needs improvement, along with public education about flu shots. A recent survey by the National Foundation for Infectious Diseases found many Americans forego annual vaccination because they do not recognize the severity of influenza or the risk of transmitting it to loved ones. The survey also found that many Americans think December is too late to be protected by the annual vaccination.
"In an ideal world, every person would get a flu shot before Thanksgiving," Dr. Glezen said. "In Texas, we've had influenza epidemics in November in three out of the last six years. The manufacturers need to work on new methods to speed up production, and, in turn, physicians need to support the market so there will be more interest in that production. Right now, more money is being put into tissue culture technology, which if successful will significantly speed up the production process. Manufacturing the vaccine is under control; physicians need to be educated about the distribution system and to push for improvements."
At the June 2006 AMA meeting, the AMA House of Delegates approved a Texas delegation resolution calling on AMA to seek appropriate action to make sure an enforceable and efficient distribution system is devised so that physicians and other health care professionals who care for high-risk populations may receive priority each year in early shipments of the vaccine.
Erin Prather can be reached at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by email at Erin Prather.
Doc, Stick Out Your Arm
Beginning Jan. 1, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will require its accredited organizations to offer influenza vaccinations to staff (including physicians) with close patient contact and to volunteers.
"Preventing the spread of the flu protects patients and saves lives. Encouraging health care workers to be vaccinated can play a vital role in stopping the transmission of this potentially fatal infection," said Robert Wise, MD, vice president of the JCAHO Division of Standards and Survey Methods.
JCAHO developed the requirement after the Centers for Disease Control and Prevention (CDC) made reducing flu transmission from health care professionals to patients a top priority. CDC says vaccination rates among health care professionals remain low, even though it has recommended since 1981 that they be immunized. Typically, fewer than 40 percent of health care workers are immunized each year, CDC said, adding that "health care-associated transmission of influenza has been documented among many patient populations in a variety of clinical settings, and infections have been linked epidemiologically to unvaccinated health care workers."
The Healthcare Infection Control Practices Advisory Committee and the Advisory Committee on Immunization Practices urge all health care personnel to be vaccinated annually against influenza. To read the recommendations, go online to www.cdc.gov/MMWR/preview/mmwrhtml/rr5502a1.htm.
State Law Requires Vaccination
Under a new state law that took effect in September, the Texas Medical Board requires physicians who provide ongoing care for elderly patients to offer them pneumococcal and influenza vaccinations unless the physician determines it is not feasible. If it isn't feasible due to vaccine shortages, the physician must give the patient information on other options.
The TMF Health Quality Institute says hospitals are required to comply with the law by making the vaccine available. A physician's order for a vaccination is no longer required if the hospital medical staff approves a standing policy for nurses to administer vaccinations to eligible patients before discharge.
"Statistics show that when it's not given in the hospital, 50 to 60 percent of the time, it's not done in the outpatient office either," said Adonica Benesh, TMF's director of hospital quality improvement.
Be Wise - Immunize Helps Improve Kids' Immunization Rates
Texas Medical Association's Be Wise - Immunize SM program, along with an executive order from Gov. Rick Perry directing the Texas Department of State Health Services to implement a comprehensive plan to increase immunization rates statewide, has helped Texas improve its immunization rate for children. Texas now ranks 24th in the nation, the U.S. Centers for Disease Control and Prevention (CDC) said in September. That's a vast improvement over the previous ranking of 41st in 2004.
Be Wise - Immunize is one of the most ambitious public health programs in TMA's 152-year history. The purpose of this joint initiative of TMA and the TMA Alliance, funded through a grant from the TMA Foundation, is to substantially increase statewide immunization rates. Using education, communication, and action, Be Wise - Immunize promotes immunizations to the public as important, effective, and safe.
The CDC's National Immunization Survey, which tracks immunization rates among preschool children, found that the Texas rate for a key vaccine series was 76.8 percent in 2005, compared with 69.3 percent in 2004, and it's the first time since the survey's inception in 1995 that Texas ranked above the national average.
The National Immunization Survey provides vaccination coverage estimates for children aged 19 through 35 months. State rankings are based on the percentage of children completing the 4:3:1:3:3:1 series of immunizations. That series includes four doses of diphtheria, tetanus, and pertussis, three doses of polio vaccine, one dose of measles-containing vaccine, three doses of Hib vaccine, three doses of hepatitis B vaccine, and one dose of varicella vaccine.
Physicians can participate in Be Wise - Immunize by adopting best practices, using the ImmTrac Vaccine Registry, joining the Texas Vaccines for Children program, and employing TMA's many free Be Wise - Immunize educational and support materials. TMA also encourages member physicians to become immunization spokespeople in their communities by serving as Be Wise immunization advocates. To sign up for the physician advocate listserv and get the latest information on immunization advocacy, e-mail firstname.lastname@example.org and type in the body: subscribe "bwiadvocate" firstname lastname.
The TMA Alliance and medical student chapters provide grassroots ground support for the program, spearheading Be Wise - Immunize efforts in communities across Texas. These include organizing immunization clinics, creating public awareness through presentations to PTA and civic organizations, and getting the word out through the local media. TMA provides statewide media campaigns and support materials.
To sign up for the Be Wise Buzz listserv and get the latest information on the program, email email@example.com and type in the body: subscribe "bewise" firstname lastname.
In addition, TMA's Immunization Resource Center provides access to Be Wise program information, as well as information on immunization schedules and standards, vaccine safety, and the conscientious objection law; statistics and reports; news alerts; health tips; and links to related immunization Web sites. Log on to www.texmed.org/bewise.
For more information, email firstname.lastname@example.org, or call (800) 880-1300, ext. 1470, or (512) 370-1470.
ACIP Recommendations for the 2006-07 Influenza Season
The Advisory Committee on Immunization Practices (ACIP) now recommends annual influenza vaccination for the following groups at increased risk for severe complications from influenza or because of an increased risk for influenza-associated clinic, emergency department, or hospital visits:
- Children aged 6-59 months;
- Women who will be pregnant during the influenza season;
- People aged 50 years and older;
- Children and adolescents (aged 6 months-18 years) who receive long-term aspirin therapy and might be at risk for Reye syndrome after influenza virus infection;
- Adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma (hypertension is not considered a high-risk condition);
- Adults and children who required regular medical follow-up or hospitalization in the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunodeficiency (including immunodeficiency caused by medications or by HIV);
- Adults and children who have any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration; and
- Residents of nursing homes and chronic-care facilities that house persons of any age with chronic medical conditions.
ACIP also recommends vaccination for people who live with or care for persons at high risk, including healthy household contacts and caregivers of children aged 0-59 months and people at high risk for severe complications, and health care workers.
The complete recommendations are posted at http://www.cdc.gov/vaccines/pubs/ACIP-list.htm#flu.
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