Patient Dies After Physician, Pharmacist Miss Important Drug Alert
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.