Some Unused Narcotics Should Go Down the Drain, FDA Says

[December 1, 2009, AJHP News]

Kate Traynor

BETHESDA, MD 13 November 2009—FDA in October highlighted a small but serious public health risk by asking consumers to remove certain leftover narcotics from the household by flushing them away or pouring them down a sink.

The request applies mostly to products containing high-potency opioids that can cause serious harm or death if a single dose is taken by someone other than the person for whom the drug was prescribed.

Flushing the medications or pouring them down the sink is intended "to immediately and permanently remove this threat from the home" once the medicines are no longer needed, said Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, during an October 14 media briefing.

Most other medications should be disposed of be mixing them with an "unpalatable" substance and then putting them in household trash, according to FDA.

FDA toxicologist Tim Kropp said he suspects that just over 100 children die each year after ingesting someone else's leftover medicine, but he said FDA has no true estimate of the magnitude of the problem.

Karen Simone, director of the Northern New England Poison Center, said she probably has taken calls about children exposed to leftover medication on FDA's list, but she does not recall any specific cases. She said the poison control center does not routinely collect data on whether an exposure resulted from a medication that remained in the home after it was no longer needed.

Simone said maintenance medications that are necessary for a family member's health need to remain in the household. But that isn't the case with leftover or expired medications.

"It's a question of risk," Simone said. "I think that the risk associated with something that you really aren't taking and have no use for anymore is a less acceptable risk" than that posed by maintenance medications.

"Maybe we should ask ourselves, how do we prevent so much extra medicine from being in the home to begin with?" she said. "Patients may not take their medicines because they're not compliant, or they don't work out. And then they're left with a very large supply of medication, which is expensive, and now it's a potential hazard to the environment and the household."

More than 500,000 pharmaceutical exposures in children under the age of five years were reported to poison control centers in 2007, according to Jessica Wehrman, communications manager for the American Association of Poison Control Centers.

Wehrman said an informal scan of the database turned up about 2000 reports of young children exposed to drugs FDA has recommended for flushing. More than half of the reports involved oxycodone or oxycodone combination products.

Throckmorton said FDA encourages the development of so-called take-back programs that allow consumers to bring their unneeded medications to designated sites for safe disposal. He said that drugs other than controlled substances can be "sent back and disposed of properly through a variety of channels."

For controlled substances, Throckmorton said it is "very difficult or impossible" to develop take-back programs because of limitations posed by state and federal laws.

"It's not possible to have a take-back program or a program where someone could send their medicines back to the manufacturer or distributor or something like that," he said.

The Texas Poison Center Network and the Amarillo Independent School District held a take-back event at two locations in September and collected 870 lbs of medications, including 70 lbs of controlled substances, said Jeanie Jaramillo, the network's managing director.

Dubbed Medication Cleanout, the project was a way for private citizens to anonymously turn in unneeded medications and for the poison control center to gather a variety of data about those drugs.

"It was unbelievable," Jaramillo said about the four-hour drive-through event. "We got everything you can imagine, Rolaids to Oxycontin."

On average, each participant brought 21 medication containers to the take-back program, she said.

Jaramillo said the program was designed with input from the local police department, and officers were at the drop-off sites. She said the controlled substances were inventoried and turned over to the police, and everything else was given to a medical waste management company for incineration.

She said the police involvement was necessary to ensure that the transfer of narcotics complied with the Controlled Substances Act. "Basically, if you hold a take-back event, you cannot take controlled substances unless you have law enforcement participating," she said.

Jaramillo said the take-back program took about four years to organize and cost about $15,000, most of which went to advertising. Disposal of the medications cost about $500, paid to the contractor that incinerates medicines for the Texas Tech University Health Sciences Center, where Jaramillo is an assistant professor of pharmacy practice.

An anonymous survey of participants revealed that 55% would have kept the medications in their home if the take-back program had not been held, Jaramillo said. Sixteen percent would have put the medicines in the trash, and 9% would have flushed them.

Jaramillo agreed with FDA about the need to immediately and permanently remove unneeded narcotics from homes, but she had reservations about the list of medications recommended for flushing.

"My concern with the recommendations is that they imply that those are the only medications that pose such risks," she said. "There are a lot medications out there that aren't even controlled that are also of immediate risk to life, and they're not on the list."

She said Tessalon Perles, a benzonatate-containing prescription cough suppressant that is meant to be swallowed whole, can cause seizures and suppress breathing in small children who chew the soft capsules.

"We have had two children within about the last year and a half who have gotten into these and have nearly lost their lives," she said.

Jaramillo said common medications that affect the heart, such as calcium-channel blockers and beta-blockers, are also "extremely risky particularly, for small children," and deserve a place on FDA's list.