A Tragic Lesson in Drug Safety

David B. Troxel, MD, Medical Director, Board of Governors.

A four-year-old female with a history of asthma presented with her mother to our insured pediatrician for treatment of a barky cough (croup). The pediatrician prescribed Tussionex, one-half teaspoon once a day. The following day at 6:30 PM, the office nurse telephoned the residence and spoke with the mother, who reported the child was much better and was running around. The next day, the mother found the child unresponsive and summoned the emergency squad. They administered CPR and transported the child to the hospital, where she was pronounced dead. An autopsy revealed the child had toxic blood levels of hydrocodone and chlorpheniramine (components of Tussionex) and diphenhydramine (an active ingredient of Benadryl).

It was alleged the insured pediatrician failed to heed the warnings and recommendations of the manufacturer of Tussionex, including explicit warnings against its administration to children under the age of six; that he failed to heed the warnings of the Food and Drug Administration (FDA) and the American Academy of Pediatrics against prescribing Tussionex to children under the age of six; and that he prescribed an excessive dose of Tussionex based on the child’s age and weight.

Defense Experts

A pediatrician expert stated he had no issue with the insured prescribing Tussionex to a child this age. He said the FDA Alert regarding Tussionex was released just a week before this event occurred, and he felt it was understandable that the insured was not aware of it. He also did not believe the standard of care required the insured to be aware of the FDA press release on Tussionex (released three months before this event) or the notice posted on the FDA website. However, he believed the insured was responsible for knowing the contents of the FDA “Dear Provider” letter that had been sent within a week of this prescribing event. He also questioned whether a physician is responsible for reviewing each medication he prescribes when a new edition of the Physicians’ Desk Reference (PDR) is released.

A toxicology expert stated that both the Benadryl and the antihistamine in the hydrocodone are inhibitors of metabolism of hydrocodone. The toxicologist concluded the amount of hydrocodone found in the blood meant that the child had 3.4 doses in her body at the time of death, which is more than would be expected based on the dosage prescribed. He made similar calculations with regard to chlorpheniramine and concluded there were approximately 4.8 doses at death. Chlorpheniramine has a longer half-life than hydrocodone, which could account for the difference.

A pediatric neonatologist felt it was a breach of the standard of care to prescribe Tussionex to this child. He said slow-release narcotics can accumulate in the system and lead to respiratory depression, which is aggravated by the child’s age, by other drugs in the mixture, and by Benadryl. There is no safe amount to prescribe. The specific drug for croup (when it is very bad) is a corticosteroid; otherwise a vaporizer and observation are the standard of care.

The pharmacy that filled the prescription was a co-defendant. Its pharmacist received an electronic Drug Utilization Review (DUR) Alert requiring him to contact the physician regarding the safety of the prescription. He entered “prescriber contacted, prescribe as is” to override the Alert and filled the prescription without calling the insured.

Plaintiff’s Experts

A forensic pathologist and a toxicologist from the coroner’s office believed there were toxic-to-lethal blood levels of the components of Tussionex, which caused the child’s death.

A pediatrician opined that the insured should never have prescribed Tussionex to this child, adding that this drug should never be considered for any child under six years of age. He could not say if the proper dose was one-quarter teaspoon rather than one-half teaspoon, but he opined that the insured prescribed twice as much as he should have based on the child’s weight. He added that it was not appropriate to recommend using Benadryl as a sleeping aid in a child. (Our insured did not remember ever making this recommendation, while the parents alleged that he did.)

Should This Case Be Tried?

The death of a four-year-old child is tragic and would be viewed as such by a jury. While there was one expert to support the insured’s lack of knowledge of the multiple warnings against using Tussionex in children, the plaintiff’s counsel had multiple experts to state the contrary. Furthermore, the PDR in the insured’s office contained the warning, and a jury would likely expect a physician to be fully knowledgeable about medications being prescribed and the dangers contained therein. The insured would be susceptible to the question, “Doctor, who is responsible for knowing about a medication that is prescribed to a patient?” Clearly, the correct answer is the physician who is prescribing it. With the insured’s consent, the case was settled.


Each year, almost 25 percent of drugs have clinically relevant changes made to their FDA-approved labels. FDA-approved labeling is often the standard to which physicians are held in claims involving medication errors. An analysis of all claims closed at The Doctors Company in 2010 revealed that 6.1 percent contained medication errors. The most prevalent claims in this category included giving the wrong medication (18 percent), failing to follow guidelines or protocols (16 percent), giving the wrong dosage (13 percent), errors in drug administration (12 percent), and ordering errors (5 percent). It is likely that some of these errors could have been prevented by keeping current on FDA-approved drug labeling.

We encourage our members to join the Health Care Notification Network (PDR Drug Alert Network) to receive their FDA Drug Alerts via e-mail. Physicians who participate are less likely to overlook an important FDA Alert, and they can earn continuing medical education (CME) credits for reading the Alert and taking a short online test on its content.

PDR Network hosts the CME programs, and The Doctors Company provides the CME credits to all U.S. physicians at no charge. These CME courses are available for physicians who are registered PDR.net users. For more information on this free service, visit www.PDR.net.

Implications for E-Prescribing Liability

The pharmacist overrode the DUR Alert and filled the prescription without calling the insured. This may be a harbinger of electronic health record e-prescribing liability risk, because there is a danger that doctors may suffer “alert fatigue”—and ignore, override, or disable alerts, warnings, reminders, and clinical decision support guidelines. If following an alert or guideline would have prevented an adverse patient event, the physician may be found liable for ignoring it.

This article originally appeared in The Doctor’s Advocate, third quarter 2011 (www.thedoctors.com/advocate).

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

J8355F 09/11

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