We noted this Newsday story with pleasure: “2 drug chains to provide Rx translation services,” about an agreement between NY Attorney General Andrew Cuomo and the pharmacy chains CVS (NYSE:CVS) & Rite-Aid (NYSE:RAD). Says the article:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations in Spanish, Chinese, Italian, Russian, French and Polish, Cuomo said in a news release.

Cuomo’s office launched an undercover investigation after a Brooklyn-based nonprofit, Make the Road by Walking New York, complained that pharmacies “routinely fail to advise non-English-speaking customers in a language that allows them to understand the purpose, dosage and side effects of their medications,” according to the release.

State law requires pharmacists to “personally provide information about prescription drugs to all patients, orally and in writing,” the release said.

This is great news, given that patients whose first language is not English face major obstacles to getting adequate health care. Recognizing this problem, there are state and federal laws requiring that health care providers (and pharmacies, at least in NY) ensure language access for all their patients/customers.

A patient who can’t read or understand the instructions for a prescription drug can’t take it correctly. They may not understand how often to take it, what time of day to take it, whether to take it with food or not, and whether it has any dangerous drug interactions.

Failing to ensure that the millions of such patients can understand how to take their drugs isn’t just important for them individually and their families — it’s important for the health care system as a whole. Patients who can’t comply with their prescription drug regimen because of language barriers are more likely to have their chronic conditions not controlled. This can lead to a worsening of those conditions (e.g. heart disease, high blood pressure, diabetes), putting them at an increased risk of complications and even death. It also puts them at an increased risk of injury caused by their drugs — because of accidental overdosing and drug interactions.

There’s one thing in particular that jumped out while reading the Newsday story:

CVS and Rite-Aid, will advise pharmacy customers about prescriptions with spoken and written translations
[emphasis added]

If this means that CVS and Rite-Aid will be translating a drug’s official FDA-approved label, who is responsible for the content and accuracy of the translated label? Is it the drug store, which translated it? Or the manufacturer, which wrote the original? Manufacturers would argue, understandably, that they’re not responsible for something they didn’t write/translate.

Medical translation is a delicate art, and minor changes in translation can have major consequences for the meaning of the text once it’s translated. Who does the translating is key. There are translators, and then there are translators. Nuances of meaning and idiom are notoriously tricky, yet are key to adequate understanding. PAL’s parent organization, Community Catalyst, learned this while translating its Generics are Powerful Medicine materials into Spanish (those Spanish-language consumer materials about generic drugs are here.

Some other questions came to mind:

  • How will these written translations be done? They can’t be done on an as-needed basis – you can’t exactly translate a drug’s label, or even the instructions for taking it, on the spot in the pharmacy. If they’re done prospectively, what drugs will they be done for? There are tens of thousands of prescription medications on the market in the U.S. Yet a huge percentage of dispensed prescriptions are concentrated in a very small number of best-selling drugs. CVS and Rite-Aid aren’t going to translate the label of every drug on the market, so how do they decide which to do?
  • What if there are changes to the drug’s label? Is there an ongoing obligation for CVS and Rite-Aid to update the translations? What if, for instance, new risk information is added to a drug’s label and the pharmacy doesn’t add that to the translation? This could present a liability risk to the pharmacy.
  • What if there’s a discrepancy between the original label and the translation? Another possible liability risk for the pharmacy
  • How do small independent and community pharmacies fulfill this obligation? They don’t have the resources and the staff to do such translations that chains like CVS and Rite Aid do. Does this place them at an even greater competitive disadvantage than they already are?
  • If drug manufacturers know that their drugs’ labels have been translated, do they have an obligation to ensure that those translations are accurate? On the one hand, you can’t make a drug maker responsible for every mis-translation of things they write. But on the other hand, if they know a major chain has translated their materials, do they have a responsibility to check the accuracy?
  • How do you guard against differing translations? No two translators will translate the same item the same way. Will there be uniformity throughout, say, all of CVS’s stores? What if CVS’s translation differs from Rite-Aid’s? Consumers change pharmacies at times — this can create patient confusion.

The growth of the number of patients in the U.S. who are not fluent or literate in English suggests that translation of prescription drug instructions and labels is going to be an increasing need. The problems above suggest that there’s a need for uniformity. Perhaps drug manfacturers should proactively translate their materials and labels to ensure accuracy and uniformity. The question arises whether a translated label would require the same FDA approval as the original label, and whether FDA has (a) the capacity to review translations and (b) the regulatory or statutory power to do so.

This is an issue that pharmacists, manufacturers, regulators and advocates for improved language access in health care need to address.

We’d be very interested in pharmacists’ take on this issue. How have you dealt with this in your pharmacy? What do you think needs to be done to ensure that non-English speakers understand their medications? How do we take these steps without overburdening pharmacists, particularly those in small independent and community pharmacies?