Pediatric Anesthesiology 2018 Reviews
Saturday Session I: The Buck Stops Here: Perioperative Economics
Reviewed by Erin Williams, MD, FAAP
Texas Children’s Hospital
Baylor College of Medicine
Houston, TX
The FDA: Your Tax Dollars at Work
If I were to poll pediatric anesthesiologists across the country, most anesthesiologists do not have an in-depth understanding of the history and intricacies of the Food and Drug Administration (FDA). Renowned Dr. Victor Baum of the U.S. Food and Drug Administration as well as Adjunct Professor of Anesthesiology and Pediatrics at George Washington University provided a high-yield yet thorough lecture detailing the road to this very necessary American institution on Saturday morning in Session I: The Buck Stops Here: Perioperative Economics. After attending Dr. Baum’s excellent lecture, the audience was able to master the following objectives:
- Understand the historical context of drug regulation in the U.S., including pediatric drug regulation,
- Recognize the routine pathway of drug development from "good idea" to approved product, and
- Differentiate the regulatory processes for drugs versus devices.
First, Dr. Baum reminded the audience of the FDA’s history. The FDA has not always been in existence. In fact, it was not until 1902 that the Biologics Control Act was passed by Congress. Prior to this, there was no regulatory entity for drugs in the United States. The 1902 Biologics Control Act came about after an unfortunate incident in 1901 where 13 children with diphtheria died from being treated with contaminated antitoxin that was derived from horse blood serum. It was that tragedy that led to the Biologics Control Act, the very first regulatory entity for vaccine and antitoxin production. A similar calamity occurred around the same time in Camden, NJ involving the deaths of nine children who received smallpox vaccine contaminated with tetanus. Thus, the regulation of drugs and biologics was born.
Biologics is defined as any medical product that is made from a living organism such as humans, animals, or plants. Four years later, in 1906 the Pure Food and Drug Act was developed. Then, in 1938 President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FD&C Act). Once again, tragedy was the impetus for development of this regulatory act; previously more that 100 people had died due to an apparent sulfa wonder drug known as Elixir Sulfanilamide. This drug was found to be an extremely toxic chemical equivalent of antifreeze. It was given to many children who ultimately lost their lives. Such a tragedy left the public outraged and pushed the government to focus on the “safety” of drugs. The FD&C Act was updated in 1962, to not only look at the “safety” of drugs in the US, but also the “efficacy” of medications.
Even with the development of drug regulatory Acts, there still remained a lack of regulations regarding the safety and efficacy of pediatric drugs. Most recently in 2002 the Best Pharmaceuticals Act for Children was developed. To ensure adequate research for drugs for the pediatric population, the Pediatric Research Equity Act was developed.
After discussing the historical timeline of drug regulation, Dr. Baum further discussed concepts involved with drug development. In short, Dr. Baum stated that drug development “is not easy, it’s not rapid.” It takes approximately 10 years to go from clinical trial to approval for patient care which can cost upwards of 1 billion dollars.
Because the steps to drug approval can be quite exhaustive, the FDA developed the Amendments Act of 1997, which allowed for some flexibility in interpreting clinical data and for allowing a single clinical trial.
As Dr. Baum eloquently discussed the tedious route to drug approval, he also explained how waiting patients can have access to unapproved drugs. This expanded access (EA) can have pros and cons. Some of the Pros include; access for the patient, quick approval over the phone, no cost to the patient and 99% of requests are approved. Some of the Cons include; lack of clinician knowledge to navigate the FDA and 70% of the drugs offered under EA are never approved, making one wonder what our patients are really getting.
Similar to drug regulation, medical devices require some form of quality control. Devices are divided into three categories: Class I, Class II, or Class III. Class I devices are considered low risk while Class III are the highest risk. Of note, anesthesia machines are Class II. The indication for the device and whether or not there was a predicate will determine the extent of monitoring.
In summary, there are a multiplicity of steps involved with drug and device approval. Without such safety, careless mistakes are made leading to lives lost as occurred in the past. Thus, the FDA performs a challenging yet necessary balancing act that allows drug approval while ensuring their safety and efficacy for the public.
The Economics of Anesthetics: How to Reduce Costs in the OR
Many Pediatric Anesthesiologists focus solely on patient care and leave the business aspect of medicine for someone else to master. While that may be fine, it is better for the physician anesthesiologist to have an understanding of the financial aspects of the day-to-day economics in the operating room (OR), and thus Dr. Franklin Dexter, Director of the Division of Management and Consulting and Professor of the Department of Anesthesia at the University of Iowa gave the audience a power-packed lecture regarding the economics of anesthetics.
After attending this lecture, the audience was able to master the following objectives:
- Apply the definitions of under-utilized operating room time, over-utilized operating room time, and the efficiency of use of operating room time for making decisions to reduce operating room costs,
- Discuss the economic valuation of increases in anesthesia-controlled time that occur when anesthesiologists supervise additional operating rooms, and
- Apply simply screening methods for economic analyses associated with small changes in operating room time.
Understanding the difference between over-utilized time and under-utilized time was a key concept that Dr. Dexter shared. An example of under-utilized time occurs if the work day is scheduled from 7AM-3PM. However, if the last case of the day finishes at 1PM, there are 2 hours of under-utilized time that day.
An example of over-utilized time occurs when OR staffing is scheduled from 7AM-3PM and if the last case of the day ends at 5PM there are two hours of over-utilized time. By understanding this essential concept, the coordinating anesthesiologist should always focus his or her attention on the operating room that has over-utilized time.
Dr. Dexter went on to describe how to maximize efficiency of OR time. He presented the following formula regarding the inefficient use of OR time:
Inefficiency of use of OR time ($) = (Cost per hour of under-utilized OR time) ´ (hours of under-utilized OR time) + (Cost per hour of over-utilized OR time) ´ (hours of over-utilized OR time).
To drive home the point that we should always put our energy into the over-utilized OR, Dr. Dexter emphasized “on the day of surgery, the cost of an hour of under-utilized OR time is negligible relative to the cost of an hour of over-utilized OR time.” Thus, over-utilized time being more expensive must be our target of attack. The overall implication is that we can maximize OR efficiency on the day of surgery by minimizing hours of over-utilized OR time.
When trying to understand how to improve efficiency, Dr. Dexter used the following example. On the day of surgery staffing is scheduled from 7AM-3PM. The cases finished at 3PM rather than an expected late finish at 4PM. If anesthesia time is decreased by decreasing OR turnover times, we increased OR efficiency by preventing 1 hour of over-utilized time (the most expensive component of our formula for inefficiency).
Dr. Dexter also explained that the common desire to make sure all first cases start on time may not always increase OR efficiency. It depends on whether there is one OR or multiple ORs being staffed by the same anesthesiologist. Ideally, it is imperative to inform the surgeons in the appropriate manner so that those with the later start times are not waiting in the ORs.
In summary, there are multiple facets to consider when trying to increase OR efficiency. These can include under-utilized time, over-utilized time, first case starts, and staffing. By far the most pressing area to focus on should be reducing the most expensive component which is over-utilized time.
For further information and readings on operating room management Dr. Dexter directed the audience to the following websites: http://www.franklindexter.net/education.htm or http://www.franklindexter.net/.
