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Conversations with the Director: Dan Budnitz, MD, MPH

April 17, 2014

Capping Medication Overdoses

Photo: Dan Budnitz, MD, MPH

Dan Budnitz, MD, MPH (Capt, USPHS), who directs the Medication Safety Program in the Division of Healthcare Quality Promotion, says about 1 in 7 children will be taken to an emergency room by age 5 for swallowing too much medicine on their own or unintentionally being given too much medicine.

About 70,000 children are taken to the emergency room for medication overdoses every year. Sharply reducing that tragic number is a top priority of Dan Budnitz, MD, MPH (Capt, USPHS), who directs the Medication Safety Program in the Division of Healthcare Quality Promotion.

When Budnitz met recently with CDC Director Thomas Frieden, MD, MPH, for a Conversation with the Director, Frieden started with the basics, “What does the Medication Safety Program do?” “We count stuff,” Budnitz said. But his reply conceals the complexities of the program’s work. Much of what Budnitz and his team count are adverse drug events—harm caused by taking a medicine, whether as prescribed or not.

But how do you define “medicine?” Do dietary supplements count? And what is meant by “adverse” or “drug event?” Does this include side-effects and intentional overdoses? Is a mild rash caused by a topical cream adverse? Does a car accident after taking sleeping medicine qualify as a drug event or merely an unfortunate choice? Might the answer depend on a coroner’s report or death certificate? And how do you get hold of all this information? Maybe counting isn’t so simple…

“Among children, a big hunk of these adverse events are antibiotic reactions,” Budnitz explained, pointing to paper charts and graphs. “But most of them, about 60-odd percent, are unintentional overdoses, mostly related to kids getting into medicines. Meaning, it’s not abuse. Most of these kids are under the age of 5.”

Budnitz said about 1 in 67 children will be taken to an emergency room by age 5 for swallowing too much medicine on their own or unintentionally being given too much medicine.

When he began this kind of work about 10 years ago, there was almost no national data on the number of adverse drug events. Budnitz helped to gather the data for the first time. He noticed that about the same number of young children were being taken to emergency rooms for medication overdoses as were being taken for motor vehicle crash injuries. But while the number of kids’ ER visits after vehicle crash injuries has dropped by 20 percent in the past several years, the number of kids showing up after medication overdoses has increased by the same 20 percent in the same period. Budnitz attributes much of the reduction in crash injuries to transportation safety regulations requiring seatbelts and child safety seats and engineering improvements in automobile and safety seat design. And he thinks lessons can be learned from the automobile safety successes.

Photo: Dan Budnitz, MD, MPH, and CDC director Tom Frieden

With a constant smile and infectious enthusiasm, Budnitz conducted an old-fashioned show-and-tell session with CDC Director Tom Frieden, pulling out one prop after another, rarely pausing for breath while he pointed out the problems: inappropriate units of measure, easy-to-open child safety caps, and unclear dosage instructions.

Earlier in his career, Budnitz investigated a spike in poisonings related to methadone overdoses among adults. “I don’t know if I can solve that problem,” he said, “but I think I can outwit a 2-year-old. I think!” And yet, Budnitz knows there is no easy way to dissuade toddlers from putting things in their mouths. “They’re going to do it,” he said. “But maybe we can put in an extra barrier.”

With a constant smile and infectious enthusiasm, Budnitz conducted an old-fashioned show-and-tell session with Frieden, pulling out one prop after another, rarely pausing for breath while he pointed out the problems: inappropriate units of measure, easy-to-open child safety caps, and unclear dosage instructions. Then, he showed some simple solutions, like flow restrictors on liquid medicine bottles.

As he talked, it was easy to see Budnitz is enthusiastic about the work his team does—especially its impact on child safety in settings ranging from supermarket aisles to emergency rooms. For example, all infants’ liquid acetaminophen products and some children’s products now use flow restrictors.

“Walmart has said they are going to start putting flow restrictors on all the liquid medications they dispense,” Budnitz said.

“Not just liquids for kids?” Frieden asked. “You mean liquid drugs for adults, that kids might get into?”

“Yes, Walmart says for all liquids,” Budnitz said. However, he pointed out that some manufacturers are resisting this idea because they believe adults don’t want to be hampered by flow restrictors and would rather use spoons than syringes. So getting more manufacturers to alter medicine containers for adults remains a challenge.

Medication Safety Team research shows that about 10 to 15 percent of the medicines children get into are liquids, and almost all are over-the-counter medicines. Although over-the-counter medicines might be the most frequent route to medication overdoses among children, Budnitz pointed to a recent article about a 2-year-old boy dying of liquid methadone meant for an adult.

Holding up a flow restrictor, Budnitz said, “There’s no doubt in my mind that liquid methadone should have this.” Frieden wanted to know how to make this happen. For example, could states make pharmacies use flow restrictors by refusing to pay Medicaid bills until they do?

But there is no standard defining exactly what a flow restrictor is, what it should look like, how it should work, how much it should restrict the flow of a liquid, or what drugs should be required to have them. The states might come up with 50 different standards, with no guarantee that any would be adequate for the task. Budnitz said his team is working with the American Society for Testing and Materials to develop testing standards for flow restrictors.

Flow restrictors are fine for liquid medicines, but what about pills and capsules? Budnitz pointed to a chart showing the most severe cases of pediatric medicine overdoses came from young children getting into buprenorphine (an opiod pain drug) and clonidine (for high blood pressure, ADHD and other disorders). Both are prescription medicines in solid forms. Neither is prescribed as often as narcotic pain medicines like hydrocodone and oxycodone, for example, but buprenorphine and clonidine send children to the hospital for unsupervised ingestions. Budnitz and his team have suggested that if manufacturers offered these medicines in blister packs rather than pill bottles, many of these overdoses could be prevented every year.

The Medication Safety Team is also concerned with the safety of older adults. Because of their poorer general health, older adults often need to take medicines that require careful dosing and monitoring to avoid adverse effects. Budnitz suggested that improving the use of a handful of medications that most commonly cause harm, such as blood thinners and diabetes medicines, is a way to target safety interventions, but solving these problems will require more time.

“All the adult issues are far more complicated than the issues with kids,” Budnitz said, but the Medication Safety Program is working with other agencies and helped develop a new National Action Plan for Adverse Drug Event Prevention to coordinate federal activities.

While they still have much work to do, it’s clear that the Medication Safety Program is well on its way to putting better caps on all those medicine bottles, not to mention caps on overdose rates.

This Inside Story by Luis M. Luque

CDC Connects Story Manager: Kathy Chastney

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