Anesthesia Billing & Management

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.

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.