The Fix Isn’t In: Why a Safety Device That Can Stop Overdoses by Kids Isn’t Widely Used

by T. Christian Miller and Jeff Gerth ProPublica, Dec. 30, 2013, 9 a.m.

This story was produced in collaboration with Consumer Reports.

Starting in 2007, Dr. Daniel Budnitz, a scientist at the Centers for Disease Control and Prevention’s Medication Safety Program, began tracking an obscure but unsettling statistic about children’s health.

Each year, more and more kids were being rushed to emergency rooms after swallowing potentially toxic doses of medication. By 2011, federal estimates put the figure at about 74,000, eclipsing the number of kids under 6 sent to ERs from car crashes.

In most cases, children experienced no lasting harm from accidentally ingesting pills or liquids from the family medicine cabinet, but about 1 in 5 had to be hospitalized for further evaluation. About 20 children died each year from such accidents, CDC data showed.

As an epidemiologist and the father of two kids, including one who had a penchant for putting things in his mouth, Budnitz became fixated on reducing drug overdoses.

In particular, he saw an easy solution for the roughly 10,000 emergency room visits a year involving liquids, such as over-the-counter pain relievers and prescription cough syrups.

It was a type of safety valve called a flow restrictor. The small plastic device fits into the neck of a medicine bottle and slows the release of fluid, providing a backup if caregivers leave child-resistant caps unfastened or kids pry them off.

In 2008, Budnitz persuaded drug makers, federal regulators and poison experts to come together on an initiative to add flow restrictors, which cost pennies apiece, to medicine bottles.

Today, however, that promise to make medicine safer for kids remains largely unfulfilled, hindered by industry cost concerns and inaction by federal regulators, an examination by ProPublica found.

Honoring a pledge made in 2011, drug makers have added restrictors to infants’ and children’s acetaminophen, the active ingredient in Tylenol. That year, roughly one-quarter of kids’ ER visits for drug accidents involved pediatric or adult formulations of acetaminophen.

But the industry has neither promised nor delivered such protection on other medicines, which account for more than half of kids’ ER visits stemming from drug accidents, including antihistamines, ibuprofen, and cough and cold preparations. ProPublica purchased more than 50 pediatric versions of these products marketed by nine different brands at outlets in California, New York and Washington, D.C., this month. None of the products we bought had flow restrictors.

In some instances, companies that have placed flow restrictors on acetaminophen-only kids’ products have not put them on bottles of pediatric cough and cold syrup that contain the same amount of acetaminophen.

“If flow restrictors work, they should be placed on all liquid products,” said Dr. G. Randall Bond, a pediatrician and poison expert who has consulted with drug makers. “We need a technological change to get us to the next level of safety.”

Industry officials said that they were waiting for better data to quantify the extent to which restrictors mitigate kids’ risk from drug accidents before deciding whether to add the devices to more medicines.

“We will continue to evaluate whether other initiatives or interventions make sense,” said Barbara Kochanowski, the vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association, an industry trade group for over-the-counter drug companies.

Industry leader McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, said it was committed to child safety, but said flow restrictors were only one part of the solution.

“We believe the first line of defense against accidental unsupervised ingestion is secure storage and immediately returning medicines to a high and out-of-sight location following each and every time the product is used,” the company said in a statement.

Makers of liquid acetaminophen started to add flow restrictors in 2011 and, in the absence of any government or industry standards, companies rolled out a variety of designs.

To gauge their effectiveness, Consumer Reports 2013 an independent, nonprofit testing organization 2013 tested the devices found on 31 different products, duplicating the ways a child was most likely to squeeze, shake or suck medicine from the bottle. The results, which were shared with ProPublica, confirmed that all models of flow restrictor reduced the amount of liquid that escaped under these conditions 2013 an outcome Consumer Reports lauded.

This is critical with acetaminophen. While generally safe if taken as recommended, the drug can cause liver damage and death if taken in larger amounts. As ProPublica has reported, about 150 Americans die each year after accidentally overdosing on acetaminophen, and tens of thousands more are hospitalized, the vast majority of them adults.

Products With Preferred Safety Feature (closed flow restrictor)

These products had the flow restrictor type that worked best in Consumer Reports’ tests, which greatly reduced or eliminated the amount of liquid a young child could get from the bottle. Listed alphabetically. Read more about Consumer Reports’ tests »

DG Health (Dollar General)1 Infants’ Pain & Fever Relief 2
Family Wellness (Family Dollar) Infants’ Suspension Liquid 1
Little Remedies Infant Fever/Pain Reliever 2
PediaCare2 Fever Reducer Pain Reliever 2
Safeway1 Infants’ Suspension Drops 2

1 DG Health and Safeway have a syringe that must be snapped into place; in Consumer Reports’ informal usability tests 8 of 9 adults were not able to insert the syringe without instructions.

2 PediaCare also offers liquid acetaminophen products in 0.25 fluid ounce single-dose packets.

Other Products Tests (open flow restrictors)

All of the flow restrictors on these products reduced the amount of liquid released compared to open bottles. But they did not work as well as closed restrictors. Read more about Consumer Reports’ tests »

CVS Infants’ Pain & Fever 1
CVS Infants’ Pain & Fever 2
CVS Children’s Pain & Fever 4
DG Health (Dollar General) Infants’ Pain & Fever 1
DG Health (Dollar General) Children’s Pain & Fever 4
Equaline Infants’ Pain & Fever 2
Equate (Walmart) Infants’ Pain & Fever 1
Equate (Walmart) Infants’ Pain & Fever 2
HEB Pain & Fever Infants 2
Kroger Infants’ Pain & Fever 2
Rite Aid Infants’ Fever Reducer & Pain Reliever 1
Rite Aid Infants’ Fever Reducer & Pain Reliever 2
Rite Aid Children’s Fever Reducer & Pain Reliever 4
Rite Aid Children’s Fever Reducer & Pain Reliever 5
Safeway Infants’ Suspension Liquid 2
Smart Sense (Kmart) Infants’ Pain & Fever 2
Smart Sense (Kmart) Children’s Pain & Fever Oral Suspension 4
Top Care Infants’ Pain & Fever 1
Top Care Infants’ Pain & Fever 2
Tylenol Infants’ 1
Tylenol Infants’ 2
Tylenol Children’s Pain & Fever 4
Up&up (Target) Infants’ Pain and Fever 1
Up&up (Target) Infants’ Pain and Fever 2
Well at Walgreens Infants’ Pain & Fever 1
Well at Walgreens Infants’ Pain & Fever 2

But some of the restrictors used on bottles of liquid acetaminophen work better than others, Consumer Reports found. Bottles with so-called closed restrictors 2013 covers with small holes that open when punctured by a syringe then reseal when it’s removed 2013 outperformed those with open restrictors, hard plastic discs with holes that do not reseal.

PediaCare and store-brand acetaminophen from Safeway, Dollar General and Family Dollar used the better-performing restrictor, tests showed. Many other store brands did not. Consumer Reports also found that McNeil, a company that has long promoted the safety of its products, does not use the “more effective” design. None of McNeil’s products were placed in the “preferred safety feature” category.

Consumer Reports and ProPublica contacted McNeil with questions about the test results. The company would not directly address why it has chosen a less effective flow restrictor. McNeil pointed to a recent study that showed 94 percent of kids tested were unable to empty an uncapped bottle within 10 minutes if it used any design of flow restrictor.

“The issue of accidental ingestion of medicine by young children is one we take very

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