CQ (10/2) reported that a new study released Thursday from the National Committee for Quality Assurance (NCQA) found that “the quality of healthcare across the United States improved in 2007 despite rising health costs and a sluggish economy,” although “the quality of healthcare people received varied greatly depending on where they lived.”

According to the report, “people in New England were much more likely to receive quality care than those living in the deep South,” and the “difference…has cost about 88,000 lives a year.” Furthermore, “the quality of healthcare improved the most for people who are enrolled in commercial healthcare plans instead of government programs Medicare and Medicaid.” While “the commercial plans improved in 44 of 54 measures of healthcare quality,” the “private healthcare providers within the Medicare system showed improvement in only 24 of 45 measures of quality care, and most gains were small.” Furthermore, “for the second year in a row, the study also found that Medicaid quality has not improved.” In response, “NCQA suggests all insurance firms — public and private — should be required to measure their quality of care and report it publicly. This move would be especially helpful in eliminating waste from the ‘uneven’ Medicaid program, the study says.”

AP, 10/2/08: 

Medtronic has warned physicians about issues with some of its implantable drug pump systems that have been linked to one patient death and dozens of other problems.

The Food and Drug Administration on Thursday posted a notice about problems with the tubing connecting the company’s catheters to its drug pumps. The pumps are implanted in the abdomen to deliver drugs to treat chronic pain. Minneapolis-based Medtronic warned physicians of the problem in late June.

Medtronic said the misconnections could block the flow of drugs, cause overdoses and other potentially fatal complications. The company said in a statement last week it has received 83 reports of problems with the systems, including one death.

A spokeswoman stressed on Thursday that Medtronic is not recalling the products, which were manufactured according to company standards. Medtronic’s letter to physicians provided guidance on how to make sure the devices are functioning properly.

Modern HealthCare (10/3, Robeznieks) reports that “hospitals may have an incentive to under-report their healthcare-associated infections (HAIs) and states lack the ability to find out if the number of infections hospitals report is accurate,” according to a study by the Government Accountability Office (GAO).

The report indicates the “problem is that — as the foundation of their reporting programs — states are using a system developed by the Centers for Disease Control and Prevention for hospitals to use for their own internal measurement of healthcare-associated infections. The CDC’s National Healthcare Safety Network system relies on self-reported data.”

The GAO report concludes that this “may be giving hospitals ‘an incentive to minimize the number of HAI cases they identify and report.’” According to the report, “using these data ‘raises concerns about the lack of established mechanisms to check the completeness and accuracy of the data submitted by hospitals.’”

FDA Press Release, 10/3/08

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food

The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.

The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China,  was conducted by scientists from FDA’s Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.  The FDA reviewed scientific literature on melamine toxicity.

Infant Formula

FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.  In large part, this is because of gaps in our scientific knowledge about the toxicity of melamine and its analogues in infants, including:

1. the consequences of the continuous use of infant formulas as the sole source of nutrition;
2. the uncertainties associated with the possible presence and co-ingestion of more than one melamine analogue; and
3. for premature infants with immature kidney function, the possibility that they may be  fed these formulas as the sole source of nutrition and thus on  a body weight basis experience greater levels of intake for a longer time than is experienced by term infants.

There is too much uncertainty to set a level in infant formula and rule out any public health concern.  However, it is important to understand that this does not mean that any exposure to any detectable level of melamine and melamine–related compounds in formula will result in harm to infants.

Other Food Products

In food products other than infant formula, the FDA concludes that levels of melamine and melamine-related compounds below 2.5 parts per million (ppm) do not raise concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for any uncertainties. The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk. 

FDA continues to screen products, collaborate with foreign governments and their regulatory agencies, and monitor reports of contamination from international sources to help ensure that potentially contaminated products from foreign sources are examined if imported into the United States. If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce.

Finelli, Lyn et al.  Pediatrics. 2008 Oct; 122(4); 805-811.  Available at http://pediatrics.aappublications.org/cgi/content/abstract/122/4/805.

Abstract
OBJECTIVE. Pediatric influenza-associated death became a nationally notifiable condition in the United States during 2004. We describe influenza-associated pediatric mortality from 2004 to 2007, including an increase of Staphylococcus aureus coinfections. 

METHODS. Influenza-associated pediatric death is defined as a death of a child who is younger than 18 years and has laboratory-confirmed influenza. State and local health departments report to the Centers for Disease Control and Prevention demographic, clinical, and laboratory data on influenza-associated pediatric deaths. 

RESULTS. During the 2004–2007 influenza seasons, 166 influenza-associated pediatric deaths were reported (n = 47, 46, and 73, respectively). Median age of the children was 5 years. Children often progressed rapidly to death; 45% died within 72 hours of onset, including 43% who died at home or in an emergency department.
Of 90 children who were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. Reports of bacterial coinfection increased substantially from 2004–2005 to 2006–2007 (6%, 15%, and 34%, respectively). S aureus was isolated from a sterile site or endotracheal tube culture in 1 case in 2004–2005, 3 cases in 2005–2006, and 22 cases in 2006–2007; 64% were methicillin-resistant S aureus. Children with S aureus coinfection were significantly older and more likely to have pneumonia and acute respiratory distress syndrome than those who were not coinfected. 

CONCLUSIONS. Influenza-associated pediatric mortality is rare, but the proportion of S aureus coinfection identified increased fivefold over the past 3 seasons. Research is needed to identify risk factors for influenza coinfection with invasive bacteria and to determine the impact of influenza vaccination and antiviral agents in preventing pediatric mortality.

CDC Press Release, 10/2/08:

“…each year, health care providers in the U.S. prescribe tens of millions of antibiotics for viral infections.

To bring attention to this increasing problem, the Centers for Disease Control and Prevention (CDC) will be observing the Get Smart About Antibiotics Week October 6-10, 2008. The campaign will highlight the coordinated efforts of the agency, states, non-profit partners, and for-profit partners to educate the public about antibiotic resistance and the importance of appropriate antibiotic use.

“Antibiotic overuse is a serious problem and a threat to everyone′s health,” says Dr. Lauri Hicks, medical director of CDC′s Get Smart: Know When Antibiotics Work program. Over-prescribing antibiotics, using a broad-spectrum therapy when a more specific drug would be better, starting and stopping medications, giving leftover medications to a friend who appears to have the same ailment you had, all contribute to the problem of antibiotic drug resistance, according to Hicks.

“As we enter this year′s cold and flu season, we ask parents to not insist on getting antibiotics when a health care provider says they are not needed,” says Hicks. “If you have a cold, or the flu, antibiotics won’t work for you.”

According to Hicks antibiotics kill bacteria, not the viruses that cause colds or flu, most coughs and bronchitis, sore throats not caused by strep, and runny noses. Taking antibiotics when you don′t need them or not as prescribed increases your risk of getting an infection later that resists antibiotic treatment. If the health care provider’s recommendation is to wait- wait. People need to be patient and let the body do its work.

Hicks also asks health care providers to take the time to educate their patients about antibiotic resistance and the possibility of having serious side effects. For example, allergic reactions to antibiotics, such as rash and anaphylaxis, send thousands of patients to the emergency room each year, according to a recent study published in the Clinical Infectious Diseases Journal.

To help prevent illness, Hicks encourages people to wash their hands frequently, get the flu vaccine and avoid close contact with people who are sick.

The campaign will reach out to parents and health care providers through advertisements, fact sheets, brochures, posters, radio and print public service announcements, podcasts, and mainstream media interviews.”

For more information or to download free campaign materials, visit www.cdc.gov/getsmart.

Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk

Contact:
Tristar Food Wholesale Co Inc.
(201) 938-2590

FOR IMMEDIATE RELEASE — October 3, 2008 — Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.

Consumers who have the product which is being recalled should stop using it immediately. If consumers have questions about possible health risks, they should contact their doctor.

Product was distributed nationwide in Asian grocery stores.

The product comes in 100 ml plastic bottles package with a BESTBEFORE date. There are four (4) flavors (see below) printed in Chinese. All packaging has a logo of blue cat on the back of the bottle and the word “blue cat” (in Chinese) on the front.

1. Strawberry, with red strawberry picture on the bottle.
2. Sweet Orange, with orange picture on the bottle
3. Pineapple, with green pineapple picture on the bottle
4. Peach, with pink peach picture on the bottle

No illnesses associated with this product have been reported to date.

The recall was initiated after FDA testing discovered that product was found to contain Melamine.
Consumers who have purchased Blue Cat Flavor Drink (Lanmao) are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201-938-2590, Monday to Friday, 8:30 to 5:00, Eastern Standard Time.

NY Times, 10/4/08 (http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=1&th=&oref=slogin&emc=th&pagewanted=print)