Drug Labels Aren’t Always Translated, Leading to Dangerous Errors

Doreena Wong, project director for Asian Americans Advancing Justice, argues that having access to translated prescription drug labels is a civil rights issue.

Carolina Paniagua knows what it’s like to live in a world that doesn’t make sense.

When the 42-year-old arrived in the United States from Mexico 17 years ago, like many recent immigrants she spoke no English and struggled to understand even the most basic signs and conversations.

Her lack of English proficiency became particularly challenging once Paniagua, who now lives in Ojai, began having children. When her two young sons became sick with the usual childhood illnesses, the new mother found herself frantically trying to figure out what to do with the medications her doctor prescribed. All the instructions on the drug labels came in English, so Paniagua would try to find English-speaking parents at her children’s school who could explain them to her.

“It was a huge frustration not knowing the language,” Paniagua said in an interview in Spanish. “Can you imagine having to give a medicine to your child without knowing if you’re doing it correctly? It was a big worry.”

While some pharmacies in California provide translated instructions with prescriptions, many still do not. That’s a dangerous problem, health-care advocates say. When patients don’t understand how to take their medications, they can misread the instructions and potentially endanger themselves or the people they care for.

More than 15 million people in California, or 44 percent of the population, speak a language other than English at home, according to the most recent census data. Of those, more than half speak little or no English at all.

Today, Paniagua’s English has improved and her sons, now ages 10 and 15, help translate any medication labels she doesn’t understand. Yet the problems she faced as a new immigrant trying to make sense of dosage instructions in a foreign language continue to plague non-English speakers.

State board to discuss issue

The issue is slated for discussion at a meeting of the California Board of Pharmacy, which regulates all pharmacies in the state, at the end of July. It follows action by a state Senate committee that recently amended a bill intended to make prescription-drug-label translations mandatory. The committee removed the requirement from the bill on June 10, dashing the hopes of proponents who have been calling for label translations for years.

“The issue of cultural and linguistic barriers for the limited-English speaking community has been a problem for a long time,” said Doreena Wong, project director for Asian Americans Advancing Justice, a legal and civil-rights organization based in Los Angeles. “If you can’t communicate effectively with your provider or understand how to take medication it doesn’t take much imagination to realize there’s going to be problems.”

Asian Americans Advancing Justice and the advocacy group California Pan-Ethnic Health Network have campaigned extensively on the issue. Cary Sanders, director of policy analysis at the Health Network, said her organization has heard from physicians whose patients took drugs incorrectly because they couldn’t decipher instruction labels.

Stories included a patient who gave a child large doses of Tylenol by mistake. Wong recounted another incident where a mother administered ear drops orally to her child, not realizing they were meant for the ears. Even very simple directions such as “once a day” can be easily misconstrued, Sanders said. “Once” also reads as “eleven” in Spanish, a potentially lethal difference when applied to pharmaceuticals.

“There’s a lot of room for very serious mistakes,” Sanders said.

Quality of translations questioned

The California Board of Pharmacy has made efforts to help pharmacies provide prescription drug label translations. After the passage of a 2007 state bill that required the board to establish patient-friendly labeling rules, the agency began offering standard dosage instructions on its website translated into Spanish, Chinese, Korean, Russian and Vietnamese. However, pharmacies are not mandated to use the translations, and many of them don’t.

Virginia Herold, the Board of Pharmacy’s executive officer, said a survey by her organization of more than 200 pharmacies showed that about 70 percent reported offering some kind of prescription drug label translation. However, the quality of those translations is unknown because very few pharmacies used the phrases on the board’s website, she said. Although the board’s translations have been vetted, some pharmacists have told the board they feel unsure about their accuracy and prefer to use their own, Herold said.

Herold acknowledged that having patients that can’t read their medication instructions is problematic. However, she said the board’s members have been unable to agree on making translations mandatory.

“It’s a thorny issue,” she said.

Jon Roth, CEO for the California Pharmacists Association, agreed that liability concerns are the reason his organization doesn’t support mandated translations. The 5,000-member association represents most pharmacies in the state.

Roth said pharmacies in ethnic neighborhoods such as Los Angeles’ Koreatown often do provide translations because they have staff that speak the predominant language of the area. But pharmacists who don’t speak another language can’t check translated instructions to make sure they’re correct. Although the Board of Pharmacy provides translated phrases, its website still recommends pharmacists confirm the validity of the instructions before they use them.

“It really comes down to that professional liability that would occur and the potential errors that could result from just one small character being off and the pharmacist not being competent in that language to be able to catch that,” Roth said.

Oral interpretation not enough

Limited-English speakers do have the right to free oral interpretation of prescription drug labels under board rules. Since 2011, pharmacies have been required to display a poster informing patients of this right and offer a list of phrases at the counter that patients can point to to request an interpreter in their language. Interpretation can be provided by pharmacy staff or by calling a translation hotline, Herold said.

Wong said the oral interpretation is a good start, but it doesn’t go far enough. Patients need to be able to refer back to written instructions after they leave the pharmacy, she said.

“Even if you had a bilingual pharmacist and they can explain (the label) directly, when you go home there’s a problem of remembering how you’re supposed to take your medication, especially if you have more than one medication,” Wong noted.

Although there are no federal regulations on drug label translations, the state of New York implemented its own law in March 2013. The law requires pharmacy chains that have eight establishments or more to translate labels into languages spoken by at least 1 percent of residents in a particular metropolitan area.

Meanwhile, the Affordable Care Act is making legislation on drug label translations increasingly necessary, Sanders said. The law has brought more than 3 million Californians into the health-care system under Medi-Cal and Covered California, and researchers estimate a third of those will speak limited English, she said.

“We need to start looking at this situation,” Sanders said. “I think there is a sense of urgency that we’re bringing all these folks into the new system, and we need to be able to meet their needs.”

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