by Gary N. McAbee, D.O., J.D., FAAP, and
Steven M. Donn, M.D., FAAP
Rita Agarwal, M.D., FAAP, chair of the
AAP Section on Anesthesiology and Pain Medicine executive committee and Constance S.
Houck, M.D., FAAP, chair of the AAP Surgical Advisory Panel, contributed to this article.
In December 2016, the Food and Drug
Administration (FDA) issued a drug safety communication ( https://www.fda.gov/
Drugs/DrugSafety/ ucm532356.htm) warning about the potential negative e;ects of
anesthesia and sedatives on the neurodevelopmental and behavioral outcome in children under age 3 years.
;e FDA notice indicated that animal
studies, and some human studies, have
demonstrated that general anesthesia and
sedative drugs used for more than three
hours, or repeated use of anesthetics, may
be associated with resultant developmental/
learning and behavioral disorders. ;e alert
advised health professionals to “balance the bene-
fits of appropriate anesthesia in young children and
pregnant women against the potential risks, especial-
ly for procedures that may last longer than 3 hours
or if multiple procedures are required in children
under 3 years.”
;is will result in a labeling change for 11 com-
monly used anesthetic and sedating agents, includ-
ing propofol, ketamine, phenobarbital and benzodi-
azepines. Currently, there is no black box warning.
;is action precipitated controversy not only because of the underlying science upon which it was
based but also because of concern that necessary procedures and surgery that younger children require
may be delayed because of the FDA alert. Others
cited more widespread concern for delays not only in
surgery but for delays in procedures such as imaging
studies that require anesthesia or sedation for less
than three hours.
In response to these concerns, the FDA published
a communication on April 27 ( https://www.fda.gov/
Drugs/DrugSafety/ ucm554634.htm) stating that
“surgeries or procedures in children younger than 3
years should not be delayed or avoided when med-
ically necessary. Consideration should be given to
delaying potentially elective surgery in young chil-
dren where medically appropriate.”
An editorial in the New England Journal of Med-
icine noted that the studies upon which the FDA
relied had methodological flaws, including other
confounding factors (such as the underlying med-
ical condition for which the procedure is needed)
that may have adversely impacted developmental
and behavioral outcomes (Andropoulos DB, Green
MF. N Engl J Med. 2017;376:905-907). ;e authors
of the editorial cited more recent studies that refut-
ed any adverse cognitive e;ect from anesthesia. ;e
recent General Anesthesia vs. Spinal/Regional study
and the Pediatric Anesthesia and Neurodevelopment
Assessment study demonstrated that a single, brief
exposure to general anesthesia was not associated
with poor developmental outcome.
Such an alert might subject clinicians to an increased malpractice risk for failure to timely refer
because of concern for adverse developmental outcome, or conversely, risk for adverse developmental
or behavioral outcome secondary to the anesthesia/
sedation that was given to a young child. ;is issue
relates to two broader issues of pediatric malpractice
risk: cases associated with the use of drugs and cases
involving a failure to refer.
Problems with medication account for approximately 4%-10% of medical malpractice lawsuits
against pediatricians. A 2008 pediatric study found
that 11% of hospitalized children had problems secondary to medication and that 22% were avoidable
(Otero P, et al. Pediatrics. 2008;122:e737-e743).
;e Physician Insurers Association of America
(PIAA), the largest independent malpractice claims
database, analyzed pediatric claims over a 10-year period. Although only one out of four closed medication
claims resulted in a payout, the average indemnity was
over $200,000. ;e top classes of pharmaceuticals
relating to medication errors involved those used for
heartburn, esophageal disorders, viral illness (likely
due to inappropriate antibiotic prescribing), epilepsy,
asthma and attention-deficit/hyperactivity disorder/
hyperkinetic syndrome. When there was a major permanent injury or a grave outcome, the average indemnity paid was $322,000 and $466,000, respectively.
Claims regarding asthma drugs
resulted in the highest average
Problems with a failure or
delay in referral also can be a
malpractice risk for pediatricians. From the PIAA database, 4% of the top 10 causes
of malpractice cases against pediatricians involved this allegation. However, 41% of closed
claims resulted in a payout for
an average indemnity payment
of nearly $330,000. When
there was a significant permanent injury, major permanent
injury or a grave outcome, the
average indemnity payments
were $292,000, $309,000 and
$450,000, respectively (PIAA.
A Risk Management Review of
Pediatricians should have an open and reasoned
discussion with parents, surgeons and anesthesiologists about procedures (including imaging studies)
that may require anesthesia or sedation. ;e discussion should include the potential risks and benefits
of deferring the procedure until the child is older or
proceeding right away.
Regional anesthesia may be an alternative for
some procedures, although not for all. As of now,
briefer periods of exposure to general anesthesia do
not appear to be problematic. Further studies are
in progress to help clarify these issues. Until then,
thorough documentation of indications, risk/benefit
analysis and informed consent is strongly advised.
Drs. McAbee and Donn
are former members and
chairs of the AAP Committee on Medical Liability and Risk Management.
FDA warning on anesthesia calls attention to malpractice risks
associated with medications, failure to timely refer
Clinicians might face an increased malpractice risk if they delay referring a patient
who needs surgery because they are concerned about an adverse developmental-behavioral outcome from anesthesia/sedation.
Dr. McAbee Dr. Donn
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