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

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 »

Brand	Product Name	Size, Fluid Oz.
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 »

Brand	Product Name	Size, Fluid Oz.
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 – covers with small holes that open when punctured by
a syringe then reseal when it’s removed – 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 seriously,” said the company, which provided
information on its product specifications for the study. “Each manufacturer
makes its own decisions about safety designs that work best with its bottles
and existing manufacturing process.”

The U.S. Consumer Product Safety Commission has the power to
set standards for flow restriction but, by law, must start by working toward
voluntary guidelines. Though commission officials have participated in
Budnitz’s initiative for years, the agency never instigated the standard-making
process.

Instead, Budnitz did so. In early 2013, he contacted ASTM
International, a leading standard-setting body.

“It is an active process that’s moving in a positive
direction,” said Scott Wolfson, a spokesman for the CPSC. (Commission officials
serve on the ASTM committee that is considering flow-restrictor standards.)

Officials with the U.S. Food and Drug Administration, which
oversees drug safety, have long voiced support for flow restrictors, publicly
urging companies to use them.

“Tens of thousands of children still overdose each year, and
yet the technology used to prevent accidental ingestion has hardly changed for
decades,” FDA Commissioner Margaret Hamburg told pharmaceutical company executives at an over-the-counter drug conference in Florida in 2010. “New tools—such as
single-dose packs and flow restrictors—must be explored for their
potential to prevent unnecessary suffering.”

But the FDA has not moved to require the devices; agency
officials have offered differing opinions as to whether it has the power to do
so. In a statement to ProPublica, the FDA said it “encourages companies to
continuously improve the safety of their products and encourages discussions
with manufacturers on measures that will help in this regard.”

The hands-off approach of the FDA and CPSC has left it
largely to Budnitz to continue the campaign for flow restrictors. Trim and
balding, with an abhorrence of confrontation, he has doggedly pressed forward,
even though his own agency, the CDC, has no funding for his initiative and no
regulatory authority over the products he is determined to make safer.

“This could be a win for everyone,” he said. “No one wants
kids to be harmed.”

* * *

For public health experts, the recent rise in pediatric drug
accidents was an unexpected development.

Child poisonings, of which drug accidents are a subset, had
been falling since the 1970s, when manufacturers introduced child-resistant
caps. Poisoning deaths among children had dropped
from more than 200 a year in 1972 to 28 by 2000.

But over the next decade, Budnitz and others saw the total number
of childhood accidents start heading back up, though poisoning deaths held
relatively constant.

Budnitz analyzed federal data based on a sample from about
60 emergency rooms to generate an estimate of how many children were taken to
ERs nationwide each year after drug accidents. He found that ER visits jumped
by about 32 percent between 2004 and 2011. (Budnitz is studying the data more
closely to determine if the increase is statistically significant and not the
result of chance.)

Similarly, a
2012 study co-authored by G. Randall Bond, based on data from the
American Association of Poison Control Centers, found that the number of
children evaluated at health care facilities for drug overdoses increased
sharply between 2001 and 2008. The preponderance of cases involved children
getting into drugs unsupervised.

Both Budnitz and Bond found evidence that at least some
accidental ingestions result in harm.

Budnitz’s analysis showed that in 2011 about 15,000 of the
74,000 children who went to the emergency room after a drug accident were
admitted for further evaluation or treatment.

The poison control center data showed that of 450,000
children evaluated, more than 25,000 exhibited symptoms ranging from a faster
heart rate to brief seizures to liver damage, a life-threatening condition.

Even in cases in which children suffer no ill effects,
pediatric drug accidents have other costs, from the anxiety experienced by
panicked parents to the expense of unnecessary trips to the ER, medical experts
said.

Researchers suggest the increase in drug accidents might be
tied to several factors, including that families have more, and more powerful,
medicines in their homes. Most of the accidents involved pills, such as
painkillers.

Though fewer accidents involved liquids, Budnitz focused on
them because – inspired by automakers, which improved safety with
seatbelts, improved car frames and airbags – he thought it might be
possible to make medicine bottles safer with better engineering.

He started Googling for ideas and came across an ad for flow
restrictors.

The devices had mostly been used on prescription medications
as a way to improve dosing accuracy. By sticking a syringe into a small
opening, or self-sealing cap, a person could withdraw the exact amount of
medicine required instead of relying on a teaspoon or cup.

Budnitz thought the devices could help with safety, too,
slowing the flow of medicine and making it more difficult for a child to ingest
a dangerous amount.

In 2008, when the Consumer Healthcare Products Association
approached him for help with a campaign to teach parents to administer cold and
cough medicines properly, Budnitz had a counterproposal: Gather officials from
industry, government and science to discuss safer packaging.

“I didn’t want to publish a paper just to publish a paper,”
he said. “I wanted to do something.”

These groups were unlikely candidates to join forces –
they often took opposite sides on regulatory matters.

But then Budnitz found an influential ally: Dr. Edwin
Kuffner, the medical director of McNeil, whose flagship brand, Tylenol, had
long been the market leader in over-the-counter pain relievers.

“It’s hard to move the industry,” Budnitz said. But “Kuffner
said, ‘I want to make this happen.’” (Kuffner declined comment, referring
questions to McNeil’s corporate spokeswoman.)

Thus was born what came to be known as the Preventing
Overdoses and Treatment Errors in Children Taskforce – the PROTECT
Initiative.

* * *

In some ways, Kuffner’s backing reflected McNeil’s history.

The company’s very first product was a liquid medication for
children called Tylenol Elixir. From that, McNeil built Tylenol into a
billion-dollar brand, principally by marketing
its safety. The company was often an innovator on this front,
developing tamper-proof pills and spending millions to help fund poison control
centers and develop an antidote to acetaminophen poisoning.

Still, over time, regulators and researchers became
increasingly concerned with the drug’s risks. In the mid-1990s, the FDA raised
questions about the safety of acetaminophen for children.

In 1999, McNeil launched an early experiment in flow
restriction, introducing a new cap for Infants’ Tylenol called the SAFE-TY-LOCK.

A dropper was slotted into a hole at the top of the bottle.
Even with the dropper gone, the liquid would drip out through the hole slowly,
reducing the chance that a child could swallow a toxic dose.

Anthony Temple, McNeil’s longtime medical director and
Kuffner’s predecessor in that position, later testified at a trial that McNeil
had a patent on SAFE-TY-LOCK, but the company offered to give it away to
generic competitors to make all acetaminophen products safer.

Though generic drug makers often follow McNeil’s lead, few,
if any, added SAFE-TY-LOCK.

Still, there were early signs that the device could make a
difference. In 2002, McNeil provided the FDA with a company analysis showing
that the number of consumer calls about mistakes made in dosing infants had “declined notably” since SAFE-TY-LOCK’s
introduction. In a later presentation, Kuffner included a slide that said “flow restrictors will
reduce accidental unsupervised ingestion for infants’ concentrated drops.”

McNeil stuck with its restrictor design even as other, more
advanced models became available.

Dr. Abner Levy, an inventor and the president of Los
Angeles-based Andwin Corp., had developed a resealing restrictor after having a
frightening experience while babysitting his granddaughter. He’d taken the cap
off a bottle of medicine, then left it to answer the phone. When he turned
around, he saw the little girl had managed to drink some of the liquid. It
wasn’t enough to harm her, but it could have been, he realized.

“I imagined, ‘What if she had drank the whole bottle?’ ”
said Levy, now 85. “She was absolutely in danger of her life.”

Levy’s flow restrictor allowed users to withdraw medicine by
poking a syringe through an opaque, flexible protective seal over the bottle’s
opening; when the syringe was withdrawn, the rubber would reseal.

In February 2008, he visited McNeil’s headquarters in Fort
Washington, Pa., hoping to persuade the company to buy his invention. The pitch
seemed to go well enough, he recalled, but follow-up conversations went
nowhere.

McNeil did not respond to questions about its dealings with
Andwin.

Andwin received a similar response from most other drug
makers. In the end, it managed to persuade only one company to use its
restrictor: Prestige Brands, which makes PediaCare and Little Remedies.

“Even though you can show that it can help save lives, the
pharmaceutical companies are looking at the bottom line,” said Ryan Smith,
Andwin’s general manager.

“Change is driven by consumers or requirements set by the
federal government,” he added. “Nobody wanted to be the first to do it.”

The experience left Levy bitterly disappointed.

“I have a belief: If you gain an understanding of a problem,
then automatically you have a responsibility to fix the problem,” Levy said. “I
had a responsibility to fix the problem.”

* * *

Budnitz convened the first PROTECT meeting in November 2008
in a modern conference center with high windows at the CDC’s headquarters in Atlanta.

There were more than 30 participants, including executives
from all the major over-the-counter drug manufacturers as well as experts in
toxicology and public health. Bond, the pediatrician who later authored the 2012
study based on poison control center data, said attendees were
initially wary.

“There were different perspectives on the size and causes of
the problem, there were different ideas on the priorities for change and on
which changes might work,” Bond said. “That made trust difficult.”

Flow restrictors were just one of three items on the agenda.
Two initiatives rapidly gained support: a public-private educational
campaign and a move to standardize bottle measurements.

Then Budnitz shared the eye-opening federal data on the rise
of pediatric drug accidents and showed a slide about ketchup bottles, based on
a Harvard Business
Review case study.

Ketchup makers had moved from glass bottles that would not
pour, to plastic containers that made an embarrassing noise when squeezed, to
plastic bottles designed to be stored upside down to prevent noise and ensure
an easy flow. If ketchup manufacturers could make a better bottle, why couldn’t
the drug industry?

“I am not a packaging expert. I don’t know how production
lines really work,” Budnitz recalled telling the group. “But I think there is
something that can be better.”

Some drug makers voiced concern that consumers might resist packaging changes, especially if they had to use syringes instead of pouring liquid into cups.

Budnitz’s appeal resonated. One company, New Jersey-based Comar
Inc., said it would begin work immediately to develop a safety valve for
medicine bottles.

Momentum grew over the next few years. At one PROTECT
meeting, Kuffner said McNeil was moving ahead with putting flow restrictors on
its pediatric Tylenol products and was assessing specific design options,
Budnitz recalled.

With the leading marketer of acetaminophen on board, the
initiative had a place to start. Attention focused on the liquid forms of the
drug and turned to the logistics of testing bottle designs and changing
production lines.

But for McNeil, the linchpin of the push, this stage was
complicated by a massive manufacturing disruption.

In April 2010, the company announced it was pulling 136
million children’s products from store shelves – the largest pediatric
recall in history. The FDA had found minute traces of metal shavings and other
contaminants during an inspection of the company’s manufacturing plants. The
company was forced to shut down much of its production line.

Progress on flow restrictors didn’t resume until the
following year, when it was nudged forward by the FDA scheduling a meeting of
outside advisers on pediatric acetaminophen for May.

An analysis prepared for the meeting noted that 20 percent of 630 adverse medical reactions involving acetaminophen reported to the FDA over the course of a
decade were the result of kids getting into medicine by mistake. The percentage
was “alarming,” the analysis said.

A month before the meeting, McNeil announced it would put
flow restrictors on Infants’ and Children’s Tylenol. A few weeks later, the
industry group representing McNeil and other over-the-counter drug makers
unveiled an agreement to do the same on all brands of pediatric acetaminophen.

“These enhancements are intended to help reduce the incidence
and magnitude of accidental acetaminophen exposures in cases of unsupervised
ingestions,” Kuffner said in a letter
McNeil sent to health care professionals.

The companies made no public commitment to add safety valves
to other liquid medications.

As it turned out, there was little pressure from federal
regulators to do even as much as the industry had promised, let alone more.

FDA experts had recommended that manufacturers use flow
restrictors, or similar barriers, to prevent accidental acetaminophen overdoses
since at least 2001, according to a report obtained through the Freedom of
Information Act. In 2011, in a summary of a decade’s worth
of studies, the agency urged drug makers to investigate flow restrictors as
among the measures “likely to have the greatest impact on patient safety.”

Yet when the FDA’s advisory committee met in May 2011,
agency officials expressed caution about mandating flow restrictors and
disagreed openly over whether they had the authority to require such a step.

Dr. Scott Furness, then director of the FDA division that
regulates over the counter drugs, said they didn’t: “The short answer is, we
cannot really make these restrictions,” he said.

Dr. Sandy Kweder, deputy director of the FDA’s Office of New
Drugs, said the agency could set standards to slow the flow of medicine from
bottles, but it shouldn’t do so, because establishing such regulations was so
cumbersome.

“You have to remember, as has been pointed out adequately
and then some, how long this process takes,” Kweder said. “The last thing we
want is to be tied down.”

The advisory committee recommended that the agency look into whether
drug makers should do what they’d already promised to do – use
restrictors, or similar devices, on pediatric acetaminophen.

Two and a half years later, the FDA said it is studying the
issue.

“These new strategies must be rigorously tested to show they
work, and do so reliably,” the agency said in a statement. “The FDA believes the addition of accurate, well-tested flow restrictors should help make products safer by
reducing the incidence of accidental pediatric ingestion.”

* * *

Drug makers started installing flow restrictors on bottles
of pediatric liquid acetaminophen later in 2011.

The devices were a small added expense, with basic models
costing 2 to 3 cents apiece when purchased in bulk, manufacturers said. More
advanced resealing designs cost 8 to 10 cents apiece.

But companies also had to update production lines to put
restrictors in bottles, said James Medford, until recently the owner and chief
executive of Aaron Industries, which makes and packages acetaminophen for store
brands. Medford said his company, which makes products that use both open and
closed restrictors, invested more than $1 million on a new manufacturing line
after the Consumer Healthcare Products Association announced the restrictor
pact. (Aaron was recently purchased by PL Developments.)

These expenditures influence manufacturers’ decisions to
expand the use of flow restrictors, Medford said.

“The next step is moving to other children’s products,”
he said. “It’s going to be costly and time-consuming to do that.”

McNeil developed a restrictor system called SimpleMeasure.
But in early 2012, it had to issue a recall for 574,000
bottles of Infants’ Tylenol that employed the system; some users had pushed the restrictor into the
medicine bottle when applying pressure with the syringe.

When Infants’ Tylenol came back on the market in July 2013,
McNeil chose to use older, open flow restrictors made by Comar, the company
that began developing devices after the 2008 PROTECT meeting, rather than
Comar’s newer resealing restrictor, which was advertised for sale earlier in
the year.

In its statement, McNeil noted that each company had the
freedom to pick a restrictor based on its manufacturing processes and bottle
designs.

Walgreens and other store brands said they were using open
restrictor designs in part because industry leader McNeil does so.

“Walgreens and its suppliers strive to offer products that
are comparable to national brands. In this case, the national brand uses
the earlier generation of flow-restrictor,” Walgreens spokesman Phil Caruso
said in a statement.

When the drug companies announced they would install flow
restrictors on pediatric acetaminophen products, they did not set a deadline. Manufacturers
have deployed flow restrictors on infants’ acetaminophen, but some have not yet
done so for children’s products, according to the Consumer Healthcare Products
Association.

“While the vast majority of CHPA members’ children’s single
ingredient products on the market also have incorporated the flow restrictors,
some store brands of liquid children’s acetaminophen are in the process of the
conversion now,” the organization said in a statement. “We understand that it
should be another six to nine months until that happens.”

After completing its tests this fall, Consumer Reports
recommended that drug makers both expand the use of restrictors to all adult
and children’s liquid medications and switch to resealing flow restrictors.

McNeil said it was examining whether to use flow restrictors
on its other pediatric medicines, such as Benadryl, an antihistamine, Sudafed
PE, a decongestant, and Motrin, its brand with ibuprofen.

“McNeil continues to evaluate feedback and data on the effectiveness
of flow restrictors and, based on the results of this data, will determine
whether to extend the use of flow restrictors beyond Infants’ and Children’s
TYLENOL,” the company said in a statement.

Those familiar with the industry said extending the use of
the devices may be a tough sell, however, especially for store brands, which
have less ability to pass on costs to consumers.

“Ultimately, it’s about making a profit,” said Clay
Robinson, a packaging expert whose company tests safety devices for drug
makers. “If it’s going to add cost, it’ll be hard to get industry interested.”

At the most recent PROTECT Initiative meeting in September
2013, Budnitz unveiled the 2011 pediatric drug accident data, charting another
rise in ER visits.

The group agreed to continue working with ASTM International
to develop voluntary standards for flow restrictors. (Consumer Reports has also
joined the task group focused on this.) It remains unclear how long the process
will take or how the Consumer Product Safety Commission will enforce them.

Budnitz – the doctor and the parent – wants to
pick up the pace. His children are now 9 and 12.

“I want to believe that before my kids have kids of their
own, we will have made more progress to improve child safety packaging,” he
said. He shook his head ruefully.

“More can be done. More can be done.”