Lost in Translation: Drug Labeling Law is Improvement, but Not a Panacea

Drug labels can pose a huge challenge for non English-speakers. According to advocates, the inability to read labels can put them at risk of taking the wrong medicine or dosage, of failing to adhere to instructions that minimize side effects, and may even lead them to give up taking needed medications altogether. Photo by Thinkstock.

When she’s out of town, pharmacist Isabel Fong worries about her Chinese-speaking mother taking prescription medications.

On more than one occasion her mom – who lives in San Francisco – has taken medicines incorrectly because the label wasn’t fully translated into Chinese, Fong said. Once, she took too many antibiotics for a stomach infection because she couldn’t read the English instructions telling her to stop after two weeks. Another time, she mistook an anti-spasmodic medication for a painkiller because of a non-translated label, risking dangerous side effects.

“I wasn’t home to help her, so she thought it was another medication that she took,” said Fong, a former University of California, San Francisco (UCSF) student and currently a pharmacy resident in San Diego. “Now I have to write it on the bottle in Chinese that this is not for pain.”

Drug labels can pose a huge challenge for non English-speakers. Inability to read labels can put them at risk of taking the wrong medicine or dosage, of failing to adhere to instructions that minimize side effects, and may even lead them to give up taking needed medications altogether, according to advocates who track this issue. Often, these patients ask for help from family members –frequently children – who may not be capable of translating the labels accurately.

In California, where as many as two in 10 residents have limited English skills, several legislative efforts have moved to improve drug labeling for non-native speakers. Since 2011 pharmacies have been required to offer free oral translation services into 12 languages to patients who request it, either through a staff member or by calling a translation hotline. And in late 2015, Gov. Jerry Brown signed a new law urging pharmacies to provide basic written drug label translations in one of five languages if a patient asks for the service and if the pharmacist deems it necessary.

These requirements are big steps forward, said Kimberly Chen, government affairs manager for the California Pan-Ethnic Health Network (CPEHN), which supported the 2015 bill. The new law on written translations emerged after years of debate, failed legislative attempts, and resistance from some in the pharmaceutical industry who feared such translations would be onerous and possibly inaccurate, she said.

“I think folks finally realized that enough of the large chains and enough people had already been doing this,” said Chen. “We were just elated that this would finally become a requirement across the state, especially for folks who live in regions where they may not have access to those larger pharmacies.”

Translated written instructions are important for non-English speakers, even when they receive oral interpretation on how to take a drug, said Fong. That’s because they may have difficulty remembering the instructions once they get home, especially if they’re taking multiple medications.

But there are limitations to the most recent law. Pharmacists are only asked to translate instructions into five languages – Chinese, Korean, Russian, Spanish, and Vietnamese – although they can go beyond that if they choose. Likewise, the law requests translations of 15 basic directions provided on the California Board of Pharmacy website, but not of more complicated instructions. For example, the board provides directions for “Take 1 pill in the morning” and “Take 2 pills in the morning and 2 pills at bedtime,” but not for how to use an asthma inhaler, or administering insulin injections.

Additionally, Virginia Herold, the Board of Pharmacy’s executive officer, insisted it’s still ultimately up to a pharmacist to decide whether any written translation is appropriate.

“There’s not a specific requirement that they have to do it in every case,” she said. “(The law) gave the authority and the encouragement to use these (translations) when appropriate.”

It’s also unclear how effective the 2015 bill has been in pushing more pharmacists to translate labels. Chen said CPEHN has not tracked the issue since the law passed. Herold said the California Board of Pharmacy has no way of assessing compliance. She said the board has received five complaints related to written drug label translation since the law took effect. That pales in comparison to the approximately 2,400 other types of complaints the board receives each year, she said.

One researcher who has attempted to assess translation offerings is pharmacist Fong herself. In February, 2016, in collaboration with Kirby Lee, a UCSF associate professor in clinical pharmacy, Fong began interviewing pharmacists in the Bay Area, asking them whether and how they provided translations, and what obstacles they faced in complying with translation requirements. The yet-to-be-published research was designed to identify challenges pharmacists face and identify possible solutions, rather than to criticize non-compliance, Lee explained.

In all, Fong interviewed 10 pharmacy retail chains, eight hospital pharmacies and eight independent pharmacists. She found that a few pharmacies, including a couple of large chains, still did not provide written translations, and some independent pharmacies also struggled to provide them. Those that did translate labels often used computer software to do it since the translations offered by the Board of Pharmacy are limited, but they worried about the accuracy of the translations. Some also complained about the additional time it took to provide written translations, and the difficulty of fitting both English and translated instructions on a drug bottle.

“All pharmacists pretty much agreed that translation services are important,” Lee said. “But they have legitimate barriers to doing it well, and that is first and foremost, having accurate translation, and second, having software to help.”

To ameliorate the situation, Lee suggested the creation of a certification process for bilingual staff to ensure accuracy of translation, improving translation software so it can screen for dialect and cultural differences, and using pre-printed labels. Fong said the Board of Pharmacy should also expand the translations available on its website to include more complex instructions. And greater efforts are needed to inform patients of their right to seek written translations, she said.

The California Pharmacists Association, the largest state organization representing pharmacists, did not respond to a request for comment.

Meanwhile, Chen at CEPHN acknowledged imperfections with the current law, including its limitation to just five languages, but said it’s a step in the right direction.

“I think it made a tremendous difference to move the ball forward,” she said. “Implementation is a long process and there are definitely points to be improved upon, but we’re just happy to see that at least now with the state law we have something to point to, to continue improving the efforts.”



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