The California Board of Pharmacy is in the discussion of requiring all pharmacies in California to provide translated labels on prescription drug bottles.
Approximately 44 percent of California residents speak a language other than English.
The proposed requlation is similar to a law passed last year in New York that makes labeling easier for non-native English speakers to take their medications properly.
The California board’s executive officer Virginia Herold says the move is very controversial. For starters, there is a concern that bilingual labels would mean larger bottles to fit the text. Patients, she says, don’t like larger bottles.
“They decant the drug out of the large container, put it in a baggie or someplace else,” Herold said. “Now, the instructions on how to take it have been separated,” defeating the purpose of the new labels.
Pharmacists are also concerned that such a requirement puts them at greater liability.
Brian Warren, with the California Pharmacists Association worries, “If the label is translated into Russian and there’s an error, and I’m a pharmacist that does not speak Russian, I cannot verify that that error exists.”
He also added that the labels could increase the cost of malpractice insurance.
“It’s an expense that will ultimately make its way down to consumers, and like all other healthcare costs, will eventually result in higher premiums,” Warren said.
Jon R. Roth, CAE, chief executive officer for the California Pharmacists Association, said the proposed rule presents serious legal liabilities for pharmacists—particularly if they cannot understand the language in either spoken or written form.
“Pharmacists, of course, want to provide the highest level of patient-centered care in as culturally-competent [a] manner as possible,” Roth said in an e-mail to Pharmacy Times. “However, the pharmacist is the last licensed professional that the patient will interact with before they begin their medications. By mandating that a pharmacist dispense a medication with a label that the pharmacist can neither read nor write, we believe is the equivalent of malpractice, and the pharmacist’s personal responsibility and professional license are on the line for an error that could occur with the directions on the translated container.”
Roth also added translating the label only covers a small portion of medication therapy, and does not cover some of the truly important information about correct medication use.
“Ensuring safe, quality medication use is not just about reading the label; it is ensuring that patients understand everything about that medication, such as side effects and what to look for in an adverse reaction,” Roth said. “That information isn’t on a label, but is equal, if not more important, than what is on the label. Engaging the patient in a conversation about their medicines using an interpreter is the most important characteristic for ensuring they will take the medication correctly.”
The discussions of the regulation are in the earliest stages, and if new regulations go forward, many details will need to be worked out, including how many languages are included and who would have responsibility for translation.
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