The California Board of Pharmacy’s plan to make prescription drug labels easier for patients to read via a process that’s workable for pharmacies can move forward with the defeat this week of a proposal in the California legislature to upend that agreement and impose expensive mandates on community pharmacies, such as translation services.
At issue is S.B. 1390, a proposal by State Senator Ellen Corbett, that would have particularly burdened independent pharmacies. As Lynn Rolston, Chief Executive Officer of the California Pharmacists Association, said in an email after the vote:
“This bill spelled disaster for pharmacies, especially independents, in that it included requirements that would be impossible to implement! It was also duplicative of recently passed new Board of Pharmacy regulations and would have added an impossible requirement that all pharmacies provide translated labels in many, many languages requested. That would have been costly. But far more important is the fact that most pharmacists only read one or two languages, not hundreds! This would have caused situations where pharmacists dispense prescriptions with labels that they could not guarantee accurately reflected the physician’s instructions. This could also have been very dangerous for patients and created a huge liability for pharmacists!”
Independent pharmacist Gary Thomas told CalWatchdog.com prior to the vote that “the change in size of font size on the prescription labels most likely will require pharmacies to go to larger pill bottles. Thomas said that translators are very expensive and not something most small independent pharmacies will be able to afford.”
NCPA also opposed the legislation. On the eve of the key committee vote, we wrote to Assemblymember Mary Hayashi, Chair of the Committee on Business, Professions and Consumer Protection. Fortunately, that panel voted against the legislation, 7-2.
Excerpts of NCPA’s letter follow:
“In 2008, the California Legislature passed SB 472 that directed the State Board of Pharmacy to survey consumers and stakeholders on prescription labels and then to draft regulations that would create a standardized, patient-centered prescription label. The Board of Pharmacy recently completed this process with its vote on the final regulations. The Board’s regulations would require key provisions of the label to be in 10-point type and 12-point type upon patient request as well as other formatting requirements. The regulation would require oral translation services if available in the patient’s language and that the label be translated using translations that would be posted on the Board of Pharmacy website. The pharmacy community has been supportive of the efforts of the Board throughout the regulatory process and recognizes the expertise of the Board in weighing potential patient protections with practitioner liability and expense.
“S.B. 1390 would essentially overturn the efforts of the Board of Pharmacy and instead mandate that all parts of the label be printed in 12-point type. This requirement would necessitate the use of larger prescription drug bottles which may result in consumers taking their medication out of the larger, unwieldy bottle and putting it into a smaller, unlabeled bottle—which may result in an increase in medication errors. Board of Pharmacy regulations would require 10-point type (and 12-point if requested) for specified elements of a prescription label—well in excess of the current industry standard of 8.5. There are no states that currently require a 12-point font and only one other state (TX) mandates even a 10-point font size for prescription labels.
“In addition, S.B. 1390 would impose unrealistic requirements for translated labels that could subject individual pharmacists to increased liability and ultimately jeopardize patient safety. S.B. 1390 would ultimately require that pharmacies provide non-English speaking patients with prescription labels ‘and any other written information relevant to the prescription drug in the language of the LEP (limited English proficient) patient.’ At the present time, there are no standardized medical translation services that will guarantee the accuracy of translated labels. This would place individual pharmacists in an untenable situation in which they would be required to deliver drug information and instructions in a language that they do not understand and have no way to verify the accuracy of the translation. An incorrect label in a patient’s native language is highly likely to result in a medication error and could subject the pharmacist to legal liability and jeopardize his/her professional license.
“In light of the significant legal and patient safety concerns raised by the bill, NCPA strongly opposes S.B. 1390 and urges the Committee on Business, Professions and Consumer Protection to endorse the California State Board of Pharmacy Regulations on Patient-Centered Prescription Labels.”