U.S. -- shortage of adult tetanus/diphtheria toxoid ("Td vaccine")

greenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread

Morbidity and Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention

MMWR dated November 17, 2000 – volume 49, number 45, pages 1029-1030

[ http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4945a3.htm ]

Notice to Readers: Shortage of Tetanus and Diphtheria Toxoids

A temporary shortage of adult tetanus and diphtheria toxoids (Td) in the United States has resulted from two coincident situations: 1) a decrease in the number of lots released by Wyeth Lederle (Pearl River, New York), and 2) a temporary decrease in inventory of vaccine following routine maintenance activities at the production facilities by Aventis Pasteur (Swiftware, Pennsylvania) that lasted longer than anticipated. Approximately one half of the usual number of Td doses has been distributed this year. Although there have been no decreases in production of tetanus toxoid (TT), availability is low because of increased use during the Td shortage.

On the basis of information provided by Aventis Pasteur, the Public Health Service expects vaccine supplies to be restored early in 2001. Until then, Aventis Pasteur will be limiting orders to assure the widest possible distribution of available doses.

The shortage will only impact persons aged >7 years who 1) require tetanus prophylaxis in wound management, 2) have not completed a primary series (three doses) of vaccine containing Td, or 3) have not been vaccinated during the preceding 10 years with Td, diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) or diptheria and tetanus toxoids (DT) (1). This shortage will not affect vaccination of children aged <7 years who require additional doses of a vaccine-containing TT; they should receive DTaP or pediatric DT (2), which are not in short supply. Td is preferred to TT because Td provides protection against both tetanus and diphtheria (1). However, during this shortage, if Td is not available, TT can be used as an alternative for persons aged >7 years who require immediate boosting with TT (e.g., wound management), or who are unlikely to return to a clinic if vaccination is delayed. If TT is administered, patients and health-care providers must weigh risks and benefits of subsequent vaccination with Td. Arthus-type reactions may occur among persons who receive multiple doses of TT, especially within short intervals (<10 years). However, if vaccination with Td is delayed for >10 years following their last Td administration, persons may be protected inadequately against diphtheria.

Clinics experiencing shortages of Td may need to prioritize their use of available supplies. If administration of Td is delayed, clinics should implement a call-back system when vaccine is available. Recommendations for use (highest to lowest priority) of Td are:

1. Persons traveling to a country where the risk for diphtheria is high*.

2. Persons requiring tetanus vaccination for prophylaxis in wound management.

3. Persons who have received <3 doses of vaccine containing Td.

4. Pregnant women and persons at occupational risk for tetanus-prone injuries who have not been vaccinated with Td within the preceding 10 years.

5. Adolescents who have not been vaccinated with a vaccine containing Td within the preceding 10 years.

6. Adults who have not been vaccinated with Td within the preceding 10 years.

References

1. Immunization Practices Advisory Committee. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures---recommendations of the Immunization Practices Advisory Committee. MMWR 1991;40(no. RR-10).

2. Advisory Committee on Immunization Practices. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children---recommendations of the Advisory Committee on Immunization Practices. MMWR 1997;46(no. RR-7).

3. CDC. Recall of Tripedia™ Vaccine. MMWR 1999;48:146--7.

* Travelers to certain countries may be at substantial risk for exposure to toxigenic strains of C. diphtheriae, especially with prolonged travel, extensive contact with children, or exposure to poor hygiene. On the basis of surveillance data and consultation with the World Health Organization, countries with highest risk are in Africa (Algeria, Egypt, and sub-Saharan Africa); the Americas (Brazil, Dominican Republic, Ecuador, and Haiti); Asia/Oceania (Afghanistan, Bangladesh, Cambodia, China, India, Indonesia, Iran, Iraq, Laos, Mongolia, Myanmar, Nepal, Pakistan, Philippines, Syria, Thailand, Turkey, Vietnam, and Yemen); and Europe (Albania and all countries of the former Soviet Union) (3).

Disclaimer: All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.



-- Andre Weltman (aweltman@state.pa.us), November 21, 2000

Answers

1) a decrease in the number of lots released by
Wyeth Lederle (Pearl River, New York), and 2) a
temporary decrease in inventory of vaccine
following routine maintenance activities at the
production facilities by Aventis Pasteur
(Swiftware, Pennsylvania) that lasted longer than
anticipated.

It would be interesting to get more information
on this extended maintenance activity.

-- spider (spider0@usa.net), November 21, 2000.


Tetanus vaccine shortage worsens Many Valley hospitals, clinics have only few days' supply

Hernán Rozemberg The Arizona Republic March 05, 2001

A shortage of tetanus vaccine shots has worsened, leaving many hospitals and clinics across the country with only a week-to-week supply.

Though no Arizona medical center has yet run out of the tetanus vaccine, the shortage has many doctors biting their nails as they await the next small shipment.

In mid-January, Wyeth-Ayerst, one of the nation's two tetanus manufacturers, announced that it was stopping production of both child and adult versions of the vaccine.

"It caught us all by surprise," said Len Lavenda, spokesman with Aventis Pasteur, the Pennsylvania-based company now responsible for developing the vaccine for the entire country. "We never thought they were making a permanent exit from the market."

It is estimated the shortage could continue for up to 18 months. Lavenda said it will take at least until the end of the year before supply meets demand for the adult brand - more commonly known as "10- year booster shots."

Until then, orders are being "rationed," meaning, for example, that a hospital asking for 1,000 doses will get only 100 doses.

It also will take several months before the children's version, a series of five shots given between birth and age 5, is no longer on back order, said Lavenda, who pointed out that it takes nearly a year to grow the bacteria to make the vaccine.

The Centers for Disease Control and Prevention in Atlanta, the U.S. government's health monitor, doesn't see a need to panic. But "spot shortages" may be worse in parts of the country that are further down on the waiting list, spokeswoman Barbara Reynolds said.

Lavenda also sees no need to worry. If hospitals or doctors run out, all they need to do is ask for help - an emergency supply is always kept handy, he said.

Even so, Arizona health officials would like to prevent such a scenario. They're calling for temporary changes until the shortage ends.

"When you have to be putting new orders in every week and you're used to a regular three-month supply, it makes everyone nervous," said Kathy Frederickson, who runs Arizona's Immunization Program. The program is the vaccine distributor for nearly 800 public hospitals and clinics across the state.

Frederickson's office dispatched a memo to all medical centers in the state saying they may keep only up to one month's reserve of the children's version. They also must list how many shots were given the previous month and their current stock or they won't be given more.

The memo also asks that the last shot kids get before entering kindergarten be delayed until they're 5 to 6 years old - many children get this shot when they're 4.

The 10-year boosters are required to attend school, but due to the shortage, school nurses are being told to let students in even if they haven't had them.

"We're being told to use it only for students with injuries," Mesa High School nurse Marilyn Brown said.

Medical workers are nervous but aren't sounding the alarm - at least not yet.

"It's a big change in practice for us," said Marcia Dern, a Phoenix Children's Hospital nurse who serves many low-income, uninsured children that depend on free shots. "Normally, if I have a 4-year-old in the office, I don't have to think about not giving a tetanus shot."

Gary Baker, pharmacy director for the privately run Scottsdale Healthcare hospitals, has nightmares of having to turn people away.

"We haven't run bone-dry yet, but we've often been down to our last vial," he said. "It'll be a really big deal when a patient shows up and cannot be served."

According to the Centers for Disease Control, tetanus is a potentially fatal disease that stiffens the body's muscles and produces spasms, usually starting with the jaw area. The bacterium that causes tetanus usually comes from the soil and enters through a wound.

Elderly people are most vulnerable, primarily because they haven't had tetanus shots in many years. During the 1990s, a larger number of younger people became infected, mostly through the use of drug needles.

The number of cases has dramatically dropped. While as many as 600 people in the United States died of tetanus in the late 1940s, an all- time low of 33 deaths was reported in 1999.

Reach the reporter at hernan.rozemberg@arizonarepublic.com or (602) 444-8480.

http://www.arizonarepublic.com/arizona/articles/0305tetanus05.html



-- Martin Thompson (mthom1927@aol.com), March 05, 2001.


Headline: Hospitals say shortages of drugs are increasing -- Small and large hospitals have been hurt

Source: Wall Street Journal, 6 Mar 2001

URL: http://www.msnbc.com/news/539787.asp?cp1=1

Hospitals in several areas of the country are experiencing dire shortages of some anesthetics and other drugs used during surgery, forcing some to reschedule medical operations.

In the latest stage of a widening pharmaceutical shortage in the country, the American Society of Anesthesiologists, which represents more than 36,000 physicians nationwide, said its members are reporting that painkillers and other medications that were in “limited supply” only two months ago are now experiencing “critical shortages” in both urban and rural areas. The group has asked the Food and Drug Administration and the Drug Enforcement Administration, which regulate the types of drugs used in surgery, as well as drug makers, to meet with the anesthesiologists to help ease the shortages.

‘CRITICAL’ SHORTAGES

The group says member anesthesiologists in 14 areas of the country reported “critical” drug shortages, including Minnesota, Illinois, Washington state, Michigan and Texas. Dr. Bruce Cullen, an anesthesiologist in Seattle and an official with the national group, said he has been practicing medicine for about 35 years and, “I’ve never seen this before.”

“We just never used to talk about this,” Dr. Cullen said. “It’s something new.” One drug he regularly uses in his practice — a muscle relaxant used to help insert a breathing tube into a patient — was in short supply about three weeks ago. His hospital was down to a single bottle and had to call all over the city to find more; it was able to secure an overnight shipment from a manufacturer, he said.

The anesthesiologists’ group is particularly concerned about shortages of fentanyl, a powerful opioid used as the principal anesthetic in hospitals and surgical centers. The group said that many anesthesiologists are being required to use second-choice drugs for surgery — including morphine, which depresses a patient’s breathing for hours longer than does fentanyl. The group said that periodic shortages are having an impact on the way hospitals schedule surgeries, and some are rescheduling elective operations. Small and large hospitals have been hurt, the group said.

Joseph Deffenbaugh, an official with the American Society of Health- System Pharmacists, said it is difficult to quantify the absolute number of shortages, since they are often regional and fleeting. But evidence from hospitals and physicians nationwide suggests that “the numbers of shortages are substantially greater than they were two or three years ago,” he said. “There’s been a gradual increase over the last two years, one that’s been exacerbated in the last six months.”

DETERMINING THE CAUSES

What officials don’t have a handle on are the causes. The FDA said that the shortage of fentanyl, which is made by various manufacturers, is due to an “unexpected increase in demand.”

Other drugs have been short because of manufacturing problems or because manufacturers stopped making them. Mr. Deffenbaugh also said that as hospitals have moved toward just-in-time inventory of their drugs they have kept smaller supplies on hand and been more susceptible to shortages.

A FDA spokeswoman said officials “are concerned about the anesthesiology drug shortages and are seriously looking into the situation.”

-- Andre Weltman (aweltman@state.pa.us), March 06, 2001.


Moderation questions? read the FAQ