This month’s case looks at the very important issue of drug information – specifically what should health care practitioners know about a medication before it is prescribed to a patient.

Dr. Z, 72, was a pediatrician who had his own solo practice for almost his entire career. Two years earlier he had stopped taking on new patients, as he began to plan for retirement.

Dr. Z’s private office was lined with books. He preferred letters to email, calls to texts. He got his news from the newspaper, didn’t own a smart phone, and although he could use his computer, he mainly left that to the office staff. In spite of, or perhaps because of his old-fashioned ways, he was a beloved fixture in his community, and had taken care of several generations of local children.

One day a 4-year old female patient with a history of asthma was brought into the physician’s office by her mother, Mrs. C. The child was exhibiting a barky cough and was diagnosed with croup. The physician prescribed one-half teaspoon once a day of an extended-release oral suspension that contained chlorpheniramine and hydrocodone.

The next day, Dr. Z’s office nurse called Mrs. C to find out how the patient was feeling. The mother reported that the child was much better and was running around. The nurse told the mother to call if she had any questions or if the child got worse.

The following morning, the mother found the child unresponsive and called 911. The emergency medical technicians performed CPR and transported the child to the hospital, where she was pronounced dead. An autopsy revealed that the child had toxic blood levels of hydrocodone and chlorpheniramine.

Unbeknownst to Dr. Z, the FDA had issued a press release three months before this incident warning about prescribing this medication to children under the age of 6. A notice was also posted on the FDA website. An FDA Alert, warning against use in children under age 6, and noting that the FDA had received reports of death in children less than 6 years of age who were prescribed the medication, had been released the week before this event. And finally, an FDA “Dear Provider” letter had been sent within a week of the prescribing event. Dr. Z did not see any of these, and was unaware of the FDA warning.

To make matters worse, when the mother went to get the medication from the pharmacy, a DUR (drug utilization review) alert popped up, advising the pharmacist to call the doctor to double check the prescription. Instead, the pharmacist overrode the alert, and filled the script without consulting with the physician.

The child’s family sued Dr. Z, as well as the pharmacy. Dr. Z felt terrible about the child’s death. He became very depressed, and decided to retire earlier than planned. But he still had to deal with the lawsuit, and so he met with the defense attorney provided by his insurance.

The attorney hired several experts to go over the records and events and to provide some insight in order to help the attorney decide on the right course of action in his defense of Dr. Z. The first expert was a pediatrician. She informed the attorney about the FDA Alert, FDA press release and “Dear Provider” letter. This expert believed that it was understandable that Dr. Z was unaware of the FDA Alert released the week prior to the incident. She also did not believe that the standard of care required Dr. Z to be aware of the FDA press release (published three months earlier) or the notice on the FDA’s website. However, the expert opined that Dr. Z was responsible for knowing the contents of the “Dear Provider” letter. 

The second expert, a pediatric neonatologist, felt it was a breach of the standard of care to prescribe the medication to this child. “Slow-release narcotics can accumulate in the system and lead to respiratory depression, which is aggravated by the child’s age,” he said. “There is no safe amount to prescribe for a child that age.” He went on to report to the attorney that the specific drug for croup (when it is very bad) is a corticosteroid, otherwise a vaporizer and observation are the standard of care.

After consulting with the experts, and reading the reports from a forensic pathologist and a toxicologist from the coroner’s office who believed that toxic-to-lethal blood levels of the active ingredients caused the child’s death, the attorney recommended that Dr. Z settle the case rather than go to trial. Both Dr. Z and the pharmacy settled this case out of court. 

Legal Background

In this case, both the doctor and the pharmacist made an error. Had the pharmacist heeded the alert which required him to contact the physician regarding the safety of the prescription, it is possible that Dr. Z might have double-checked the current prescribing information, and changed the prescription.

The pharmacist’s contributing negligence in this case, might have reduced the monetary amount that Dr. Z would have had to pay had he lost at trial, but it would not have absolved the doctor of his own negligence.

Protecting Yourself

As prescribers, it is essential to know about the medications you are prescribing. Recalls, labeling changes, black box warnings… changes to medication information happen on a daily basis. This is why the FDA uses so many different communication vehicles to get this information out, including its website, MedWatch Safety Alerts, FDA Updates for Health Professionals, and numerous e-mail newsletters that clinicians can subscribe to online. In addition, the FDA now tweets out important safety information on medications from its @FDAMedWatch Twitter account.

In addition, there are numerous online drug references to use as resources. There are references that work as apps on a smartphone. In this case, Dr. Z had prescribed this medication in the past with no issue, and assumed he could continue to do so. However, his assumption couldn’t be further from the truth – often the longer a drug is on the market, the more likely it is that a safety issue will be identified. You can never simply assume that prescribing information remains the same indefinitely. It does not.

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Protect yourself by staying up to date on drug information.