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Braille in Pharma: Differing Views in the U.S. and Europe: Unlike all of the European Union countries where braille is mandatory on pharmaceutical packaging, the U.S. still considers it to be an optional guideline.

The United States has been at the forefront when it comes to most rules and regulations designed to help the handicapped.

The Americans with Disabilities Act (ADA) prohibits employment discrimination, and governs a host of regulations aimed at providing public accommodations, commercial facilities, public transportation, and telecommunications access for the disabled.

Federal laws protect the rights of disabled voters, require access and accommodation for passenger air travel, provide free individualized public education for eligible disabled students, and mandate that buildings and facilities designed, constructed, or altered with federal funds, or leased by a federal agency, comply with federal standards for physical accessibility.

In essence, the U.S. has taken more steps than most other nations of the world when it comes to protecting disabled individuals, removing barriers to accommodations, and ensuring a safe environment for all.

EU Sparks Brief U.S. Frenzy

So, it may seem a bit odd that, unlike every nation in the European Union, the U.S. still does not require braille labeling on pharmaceutical product packaging to aid the visually impaired.

When the EU stepped forward last decade to order mandatory braille packaging on a host of products, including drugs, there was a flurry of activity throughout the pharma supply chain in the U.S. as manufacturers, packagers, distributors, and dispensaries began putting plans in place to bring equipment capabilities onboard to handle braille, expecting the U.S. to follow the European model.

But, the FDA did not issue mandatory requirements, and a committee of the United States Access Board issued guidelines instead, encouraging but not requiring the addition of braille, a move that industry sources welcomed since a government mandate likely would have presented regulatory challenges, but associations representing the blind saw as a missed safety opportunity and potential health risk for those affected.

An FDA spokesman, responding to an information request from Pharmaceutical Processing, said that the agency "would be open to reviewing braille labeling on a drug product if a sponsor were to submit for review," pointing to the drug Hetlioz that was "previously approved by the FDA with braille labeling for brand name and strength."

Industry and Trade Groups Step In

Despite the regulatory inaction by the FDA, groups like the American Council of the Blind (ACB) and the International Association of Diecutting and Diemaking (IADD) stepped in and took action to help industry include braille on packaging and set standards that are consistent across the U.S. and Canada.

The IADD, working with the. Braille Authority of North America, diemakers, converters, and pharmaceutical representatives, got involved shortly after the EU began moving from a temporary standard toward its current EIN standard prior to 2007, Stephen Brighton, vice president of Die-X Limited in Ontario, Canada, and chairman of the IADD Braille Task Force, told Pharmaceutical Processing. The association took a look at what Europe was doing and began holding hearings

Wary of Government Action

"People were saying, it probably would be better if the industry took a leading roll doing something about braille in North America," Brighton said. "If it's going to become mandatory, the biggest concern was that some government official would try to put a mandatory braille standard in place that may not be achievable."

Brighton, who had two aunts that were blind from birth, became personally involved in the project and included one of his aunts in initial testing for a new standard for industry in the U.S. and Canada to follow.

In 2009, the IADD Can-Am Braille Standards were introduced, updated in 2012, and remain the key guideline for braille pharmaceutical packaging in North America to this day. The standards closely align with the EU's early standards in place prior to adoption of the EIN standards, which added restrictions not considered necessary in the U.S. and Canada. Companies that produce cartons for use in Europe adhere to the EU EIN regulations.

As industry began setting its own standards, advocates for the visually impaired moved forward with efforts aimed at pharmaceutical prescription labeling, meeting with success largely through cooperation from big pharmacy chains like CVS, Walgreens, and Rite-Aid where braille instructions generally are made available by their local pharmacists.

While the advocacy groups generally are satisfied with the progress they've made with braille labeling on prescription drugs at the pharmacy level, there's still work to be done on over-the-counter (OTC) medication, where braille labeling is rarely found.

No Federal Traction

"As a blindness advocacy community we couldn't get any traction (with the FDA) to get something moving," Kim Charlson, president of the American Council of the Blind, said. There's been little, if any, momentum since 2012 toward developing braille requirements for drugs at the federal level.

"In Europe it's all over," Charlson said, adding that the braille inclusion goes well beyond prescription and (OTC) drugs. "You can go into a store and pick up a package and it will say, in braille, 'chocolate chip cookies,' another will say 'Band Aid' on it, while a different package might spell out `Crest Toothpaste.' In Europe, it's ubiquitous ... they just do it."

Not so here in the U.S.

"Certainly we couldn't go to every different manufacturer and say, 'would you put braille on your boxes?' It has to be some uniform consumer protection or driven by the FDA, something more national," Charlson said. "It hasn't risen to a level where we got any kind of response from anybody at the FDA. But, it has been on our radar." The lack of U.S. momentum toward increased use of braille in U.S. pharmaceutical packaging since the FDA chose not to enact mandatory regulations can be seen via a simple Google search of the words: 'braille pharmaceutical packaging.'

A Stagnant Market

Results produce current news regarding EU labeling, but barely a mention regarding U.S. efforts over the past five years until a manufacturer of finishing equipment recently announced a new braille initiative.

"The market will be stuck right where it is until some kind of a formal mandate is made that insists that all pharmaceuticals are embossed with the name of the drug and its dosage," Patrick O'Leary, sales manager for WSI Global, said in an interview with Pharmaceutical Processing. "Until that happens here in the States, I think it's a stagnant market."

WSI Global, a Grand Junction, CO-based manufacturer of finishing equipment for the carton converting, liquid packaging, and corrugated industries, in May announced new braille capabilities using either its TaskMaster infeed system or with a standalone unit that can be integrated into any folder gluer. Since braille is embossed prior to reaching the folder gluer, the WSI system doesn't require the purchase of a new gluer.

"The TaskMaster was originally designed to emboss braille," O'Leary said. "Due to the whole European mandate for the braille embossment on all pharmaceutical cartons, that was the entire reason we developed that piece of machinery. We were expecting the same mandate to move to the United States and I'm sure a lot of other people were too, but that mandate never happened."

A Push for OTC Labeling?

"There probably are a handful of companies here in this country that are embossing braille (in pharmaceuticals), but it's on a fairly small scale compared with what's going on in Europe at the moment. In Europe it's across the board."

In the meantime, ACB's Charlson said her organization will remain proactive in the effort to expand braille packaging and labeling in the U.S.

"I am definitely going to make it a priority to make a push for labeling on non-prescription related products--toothpaste, hand cream," Charlson said, adding that it's also time to tackle OTC medications. "It won't take a lot of space. We're not looking for every word on the box to be put in braille. There's no reason they can't be doing it."

Editor's Note

Pharmaceutical Processing reached out to the FDA for background on its decision not to enact mandatory braille requirements following the EU mandates last decade. An FDA spokesman said that the prescription drug 2012-13 labeling guidance for 'pharmacy best practices' was crafted by the United States Access Board, a coordinating body among federal agencies representing people with disabilities. The board did not recommend mandatory requirements for the industry. There was no word as to whether the FDA would consider establishing mandatory braille packaging requirements across the industry going forward.

By Mike Botta, Contributing Editor
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Title Annotation:Feature
Author:Botta, Mike
Publication:Pharmaceutical Processing
Date:Sep 1, 2017
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