Archive for March, 2011

Panel Studies Potential Health Risks of Anesthesia Use in Young Children

31 Mar

Earlier this month an FDA advisory panel met regarding a very important topic: whether or not anesthesia poses cognitive and learning disability risks when used in young children. Since this involves millions of medical procedures, the importance of this topic is pretty obvious.

There have been a number of animal studies on the subject which have led to this meeting. According to Dr. Bob Rappaport, the Food and Drug Administration’s director of the division of anesthesia and analgesia products, these studies have suggested that there may be a correlation between anesthesia exposure and brain cell death or learning problems.

The FDA panel will evaluate this research, consider what further research may be needed, and decide what if anything parents should be presented if their children will be going into surgery.

“How do we communicate what we do know at this point without causing undue concern in parents and in physicians?", asked Dr. Rappaport.

Taking a look at the animal studies more closely, rodents and monkeys that were exposed to anesthesia at an age that is roughly equivalent to children under the age of four experienced brain cell death. An additional study, one done by the FDA, found that exposing newborn rhesus monkeys to 24 hours of anesthesia resulted in poorer tests performances for memory, attention and learning.
"We don’t know what this means for children at this time," said Dr. Rappaport. "That’s exactly why it’s so critical that we get all of the necessary information."

It’s difficult to do similar controlled studies with children, so when examining humans, experts look to children who have learning disabilities and trace back to see if they had anesthesia when they were younger. However, this method is not considered very reliable.

In the absence of absolutely certain evidence, ultimately the dilemma is this: most young children who are being given anesthesia absolutely need the surgery performed on them. So, what do you do?

“What we know is that not giving anesthesia and appropriate medication to manage a child’s pain during surgery does have long-term adverse affects on a child – physical as well as emotional,” said Dr. Jayant Deshpande, another committee member, pediatrician and anesthesiologist who is a senior vice president at Arkansas Children’s Hospital. “So because the child needs surgery today, we are going to use the best information that we have and use the anesthetics.”

Most of the studies so far the studies have involved the common anesthetic, ketamine. Some of the questions experts still have involve dose, age or length of exposure, and how each may relate to the risks.


Death Sentences Postponed Over Anesthesia Drug Shortage?

08 Mar

We recently told you about the concerns over pain killng drug shortages. The issue is serious enough to have been addressed in Congress. Senator Amy Klobuchar of Minnesota and Bob Casey of Pennsylvania introduced legislation that would give the FDA the ability to require early notification from pharmaceutical companies when an issue may arise that could cause a shortage.

The next development continues to grow dire as 13 states are jointly requesting help from the federal government on how to acquire the anesthetic sodium thiopental. However, the states’ requests aren’t based on saving lives; it’s for ending them. Sodium thiopental is used as part of a lethal execution drug, however it is also used for brief surgical procedures. The shortage may force states to postpone executions. There have also been situations where states have sought alternatives, such as in Oklahoma where they used an anesthetic commonly used to euthanize animals to execute a prisoner.

Oregon is one of the 13 states that is signing the letter to the federal government. The other states signing the letter are Alabama, Colorado, Delaware, Florida, Idaho, Mississippi, Missouri, Nevada, Tennessee, Utah, Washington and Wyoming.

While the headlines are being dominated by the need for this drug in the justice system, what can’t be lost is that a shortage of anesthesia drugs has serious life-changing implications in the medical world.

"Never before have the shortages of key drugs been so prevalent," says Sheldon S. Sones, RPh, FASCP, president of Sheldon S. Sones and Associates, a pharmacy and accreditation consulting firm based in Newington, Connecticut. "While the best strategy is to keep as far ahead of anticipated supply needs as possible, borrowing non-controlled drugs may be an option."

Sometimes shortages are sudden and unpredictable, which is all the more reason that the drug shortage needs to be addressed on a national level, whether through legislation or other means.

Another reason is that, while some states are importing drugs like thiopental, there is uncertaintly about its safeness. Unfortunately, the messenger of this concern right now is a group of death row inmates who are suing to have the imported drugs halted. While the messengers may not be popular, the message is something worth considering.


American Academy of Professional Coders Launches ICD-10 Resource

07 Mar

Last week, The American Academy of Professional Coders unveiled an ICD-10 resource on its website to help payers and providers comply with the mandated code sets.

“Our message is simply that ICD-10 will change everything,” said AAPC CEO Deborah Grider.

The United States will begin to officially use ICD-10 on October 1, 2013. While that is still a few years away, it is AAPC’s intent to educate and raise awareness with healthcare professionals in plenty of time before the October 1, 2013 compliance deadline.

The ICD-10 resource page on AAPC’s website includes a code conversion tool, an online application for tracking and measuring the progress of ICD-10 implementation, and interactive floor plans to show how ICD-10 affects different aspects of a doctor’s practice or health plan. Among other features is also a collection of articles discussing ICD-10.

The page also comes with interactive graphics to illustrate how the changes in coding standards will affect different aspects of a health care practice or health plan.

If you are in the medical billing industry or are part of a medical practice, the ICD-10 revisions will be about more than just coding changes. It’s going to change everything about your practice. However, if you do want to concentrate on how it will alter the coding aspect of the game that is certainly a daunting challenge. The number of diagnostic codes under ICD-10-CM will more than quadruple, going from 13,500 to 69,000. And for inpatient procedures, the number jumps from 4,000 codes to 71,000 codes.

That’s a lot of catching up to do. All of this underscores how important it is not to delay in prepping for the changes: 2013 will be here before you know it! For more on all the tools available go to the AAPC’s website.


Johnson & Johnson Medical Device Rejected by FDA

01 Mar

Johnson & Johnson is at odds with the Food & Drug Administration over the government agency’s rejection of the company’s medical device which administers a propofol-containing drug. Sedasys, which must be administered by an anesthesiologist, is a medical device that uses a mild sedative during routine medical tests for patients.
After the FDA rejected Johnson & Johnson’s request for approval, the agency requested more data involving anesthesiologists in the control group. According to the Wall Street Journal, the FDA said that it asked Johnson & Johnson for the information before the trial began, something that Johnson & Johnson denies.
"We did everything that we were asked to do," says Mike Gustafson, who oversees the Sedasys program at J&J’s Ethicon Endo-Surgery unit.
The percentage of applications for new devices to be approved by the FDA without delay dropped to 56 percent in 2009 from 74 percent five years previous. Companies pulled 17 percent of applications for new versions of devices in 2009, which was up from nine percent five years earlier. According to AdvaMed, a trade group for the medical-device industry, this was sometimes due to the fact that the FDA sought more information.
"It’s never been as bad as this," says David Nexon, senior executive vice president at AdvaMed.

People in the business community have criticized the FDA for changing their requirements in the middle of the approval process. This is not disputed by the government agency, which says that it does so due to the evolution of scientific findings in the years of the approval process, which may bring to light new questions.

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