BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 204| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: SB 204 Author: Corbett (D) Amended: 5/23/13 Vote: 21 SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 7-2, 4/22/13 AYES: Price, Block, Corbett, Hernandez, Hill, Padilla, Yee NOES: Emmerson, Wyland NO VOTE RECORDED: Galgiani SENATE APPROPRIATIONS COMMITTEE : 4-1, 5/13/13 AYES: De León, Lara, Padilla, Steinberg NOES: Hill NO VOTE RECORDED: Walters, Gaines SUBJECT : Prescription drugs: labeling SOURCE : California Pan-Ethnic Health Network DIGEST : This bill requires, beginning January 1, 2016, translations of the directions for use in non-English languages published on the Board of Pharmacys (Board) Web site to be used, as applicable, when labeling a prescription container; authorizes the directions for use to be translated into additional non-English languages if certified translation services are utilized to complete the additional translations; authorizes a pharmacy to provide its own translations of the directions for use established by Board regulation in the non-English languages published on the Board's Web site; provides that a pharmacist who "reasonably believes" that CONTINUED SB 204 Page 2 translated directions for use contain an error due to software or equipment malfunction, may provide English language directions for use; and states that a pharmacist who "reasonably uses" translations of the direction for use in non-English languages published on the Board's Web site has not breached his/her legal duty if those translations contain an error and the pharmacist did not know, or did not have reason to know, of the error. Senate Floor Amendments of 5/23/13 recast some provisions in this bill; insert language authorizing a pharmacy to provide its own translations of directions for use; state that a pharmacist who "reasonably believes" that translated directions for use contain an error due to software or equipment malfunction may provide English language directions for use; and state that a pharmacist who "reasonably uses" translations for the directions for use that are published on the Board's Web site has not breached their legal duty if those translations contain an error that the pharmacist was not aware of. [Note: According to the author, these amendments are intended to "address opposition's arguments." Specifically, the opposition testified in policy committee that this bill raised significant concerns about pharmacist liability in the event that pharmacists are not able to determine if the translation is correct and thus may provide patients the wrong printed directions for use.] ANALYSIS : Existing law: 1. Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled, as specified. 2. Requires the Board to promulgate regulations on or before January 1, 2011, for a standardized, patient-centered, prescription drug label on all prescription medication dispensed in the state. 3. Requires the Board, when considering the requirements for prescription labels, to consider medical literacy research, improved directions for use, improved font types and sizes, placement of information that is patient-centered, the needs of patients with limited English proficiency, the needs of CONTINUED SB 204 Page 3 senior citizens, and technology requirements necessary to implement the standards. This bill: 1. Provides that, beginning January 1, 2016, translations of the directions for use in non-English languages published on the Board's Web site shall be used, as applicable, when labeling a prescription container. 2. Allows the translation of the directions for use, established by Board regulation, into additional non-English languages if certified translation services are utilized to complete the additional translations. 3. Authorizes a pharmacy to provide its own translations of the direction for use, established by Board regulation, in the non-English languages published on the Board's Web site when labeling a prescription container. 4. States that a pharmacist who "reasonably believes" that translated direction for use contain an error due to software or equipment malfunction, may provide English language directions for use. 5. States that a pharmacist who "reasonably uses" translations of the directions for use in non-English languages published on the Board's Web site has not breached his/her legal duty if the published translations contain an error and the pharmacist did not know or did not have reason to know, of the error. Background Medication errors and legislative response . According to the Journal of the American Medical Association, 46% of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies, medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90% of Medicare patients take medications for chronic conditions with nearly half of them taking five or more medications a day. Given the large numbers of prescriptions that may be prescribed, it is not easily CONTINUED SB 204 Page 4 discernible what the purpose for each of these medications is. This increases the chances that a patient may take the wrong medication increasing the likelihood of serious injury or death. SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) established the Medication Errors Panel (Panel) which published a report in March 2007 entitled "Prescription for Improving Patient Safety: Addressing Medication Errors." The report listed six general goals to reduce medication errors. Under each goal were recommendations and methods to accomplish each recommendation. The Panel report states that "the information that consumers need to know about their medication is often complex and may include unfamiliar language or concepts. Expecting a consumer to retain all the pertinent knowledge from a brief verbal encounter may not be reasonable in many instances." The Panel acknowledged that there are a variety of factors which may increase an individual's risk for experiencing a medication error. These include (1) low health literacy; (2) limited English proficiency; (3) cultural incongruence with healthcare providers; (4) physical, cognitive and/or other impairments that make understanding and/or complying with medication instructions difficult; (5) age at either end of the age spectrum (the variability of a medication's response, metabolism and dose increases in children and seniors); (6) multiple medications; (7) multiple prescribers; (8) non-prescription medication use (including herbals, dietary supplements, alcohol, and tobacco); and (9) medication procurement from more than one pharmacy including mail-order. The Panel stated that these factors must be taken into consideration in the development of any consumer education efforts. One bill was pursued in response to the Panel report SB 472 (Corbett, Chapter 470, Statutes of 2007), the California Patient Medication Safety Act, sought to deal with the lack of uniformity in prescription drug labels throughout the state and the resulting confusion and medication errors that may arise. Much of the conversation during the SB 472 debate focused on the fact that individual pharmacies design and format their own labels, resulting in a lack of standards across all pharmacies which adversely affects medication users who are elderly, suffer from poor vision, have difficulty reading and understanding instructions on labels or have limited English proficiency. The CONTINUED SB 204 Page 5 bill required the Board to promulgate regulations on or before January 1, 2011, that require a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients. Additionally, the Board was required to report to the Legislature by January 1, 2010, on its progress in implementing these regulations. Implementation of a standardized prescription drug label by the Board . California was the first state to require redesigned prescription container labels to emphasize information most important to consumers offering an element of safety and consistency since prescription labels are the key source of patients' reference for information when taking medications in their homes. Part of this current requirement also ensures that oral interpreter services are available to limited English speaking patients in pharmacies, to insure such patients have access to information about how to take their medications. The Board was charged with promulgating regulations that require a standardized, patient-centered prescription drug container label for all prescription drugs dispensed to patients in California. The Board reported on its efforts in a January 2010 report to the Legislature. The Board established a "SB 472 Medication Label Subcommittee" in January of 2008, to conduct public forums and to work with organizations and individuals to develop recommendations to implement the provisions of the law to establish a patient-centered prescription drug label. In May 2008, the Board developed an open-ended prescription label survey for distribution at public outreach events. A total of 606 consumers completed the surveys. When asked what to change on the prescription label, the top responses were: print should be larger or darker (30.1%); nothing needs to be changed on the label (24.6%); and include purpose of drug (12%). The Board concluded that most consumers participating in the survey requested larger and bolder type font on prescription labels to increase readability. Many participants suggested that if a generic drug is provided, the prescription label should state the name of the generic drug name and the brand-name it is generic for. They also noted that color printing and highlighting on labels brings attention to important information. Some participants suggested that the labels themselves be color-coded to help differentiate between multiple medications and family members. Many consumers CONTINUED SB 204 Page 6 responded that they want to know "what the drug is for" and suggested that "purpose of drug" be printed directly on prescription labels. The Board approved a regulation per the requirements set forth in SB 472 after engaging in a lengthy process. The Board conducted outreach, hearings and information gathering sessions throughout 2008, to collect data from the public on prescription labels and standards for those labels. The Board considered testimony and information provided from the public, the pharmaceutical industry, pharmacy professionals and literacy subject matter experts on medical literacy research, improved directions for use, improved font types and sizes, the placement of information that is patient-centered, the needs of patients with limited English proficiency, the needs of senior citizens, and technology requirements necessary to implement the standards developed. Board members were also provided with research articles on designing patient-centered labels. In 2009, the Board discussed the requirements of the regulation at regularly scheduled meetings. Throughout early 2010, the Board held regulation hearings to adopt the proposed regulation, a new section at Title 16 California Code of Regulations Section 1707.5 - "Requirements For Patient-Centered Prescription Container Labels." The regulation outlines that the following items must be clustered into one area of the label that comprises at least 50% of the label, using at least a 10-point font sans serif typeface, listing these items in the following order: (1) name of the patient; (2) name of the drug and strength of the drug ("name of the drug" means either the manufacturer's trade name, or the generic name and the name of the manufacturer); (3) directions for use; and (4) purpose or condition, if entered onto the prescription by the prescriber, or otherwise known to the pharmacy, and its inclusion on the label is requested by the patient. The regulation also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency, understand the information on the label in the patient's language. The pharmacy's policies and procedures must be specified in writing, and must include, at minimum, the selected means to identify the patient's language, and to provide interpretive services in the patient's language. CONTINUED SB 204 Page 7 Pharmacies must provide, at minimum, interpretive services in the patient's language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee, there are potential one-time costs of about $75,000 to adopt regulations by the Board (Pharmacy Board Contingent Fund). SUPPORT : (Verified 5/6/13) (Unable to reverify at time of writing) California Pan-Ethnic Health Network (source) Asian American Center for Advancing Justice Asian Americans for Civil Rights and Equality Asian Law Alliance Asian Pacific American Legal Center Asian Pacific Community in Action Asian Pacific Islander Caucus for Public Health California Alliance for Retired Americans California Communities United Institute California Health Advocates California Immigrant Policy Center California State Retirees, Chapter 1 Health Through Action Arizona Latino Coalition for a Healthy California Paramedics Plus Southeast Asia Resource Action Center California Street Level Health Project Visión y Compromiso Western Center on Law and Poverty Worksite Wellness LA OPPOSITION : (Verified 5/29/13) California Grocers Association California Korean American Pharmacists Association California Pharmacists Association California Retailers Association CONTINUED SB 204 Page 8 National Association of Chain Drug Stores Rite Aid ARGUMENTS IN SUPPORT : According to the author's office, existing regulations provide for interpretation services at a pharmacy, but neither existing law, nor existing regulations, provide for translated directions on prescription medication container labels. The author states that "It is troubling that studies show about 1/3 of California pharmacies are not providing translated directions in the patient's preferred language, upon request. Patients cannot follow directions if they cannot read them. This large population of Californians is in danger of misusing their prescription medications and suffering an adverse drug event because the directions are provided in a language they cannot read." According to the author's office, adverse drug events cause over 700,000 emergency room visits around the country every year, and every year almost 120,000 patients are hospitalized after an emergency room visit for adverse drug events. The bill's sponsor, California Pan-Ethnic Health Network (CPEHN), writes that "for prescription drug labels to meet the needs of California's limited English proficient patients, pharmacies should utilize the translated instructions provided by the Board of Pharmacy. This will provide limited English patients with prescription instructions that they will understand which helps increase patient compliance and reduce medical errors." CPEHN states that in California, 40% of individuals speak a language other than English at home and an estimated six to seven million are limited English proficient. The Asian Law Alliance, California Health Advocates, California Immigrant Policy Center, and Street Level Health Project state that millions of Californians will have increased access to health care coverage and prescription medications with the implementation of the federal Patient Protection and Affordable Care Act, among them patients with limited English proficiency who will benefit from a translated label. They believe that this bill will finally provide these patients prescription drug instructions that they understand which will help reduce medical errors and improve quality of care. ARGUMENTS IN OPPOSITION : The California Grocers Association (CGA) is concerned that the requirements in this bill are CONTINUED SB 204 Page 9 unworkable and could lead to additional confusion for patients and providers. CGA points out that some pharmacies already provide oral or written translation services based on community needs, and that requiring pharmacies to use rigid pre-set use translations will disrupt those pharmacies' practices despite the fact that there is no evidence the system is failing to meet consumer safety needs. The California Retailers Association (CRA) cites that this bill may be premature. "The current regulation for the label just became effective less than two years ago, after the Board and stakeholders went through a lengthy rule-making process. CRA believes that before we adopt changes to the current label standard, it is important to determine whether there is a need for these changes and whether these changes would provide consumers with added benefit." CRA also expresses concern that patient safety may be jeopardized by improper translations, and cites the difficulty of providing accurate written translations, as demonstrated by the Board's struggle to adopt standard translations for the five languages currently translated. Many languages have different dialects and some languages have multiple ways of stating the same thing. This bill may do a disservice to limited English proficient individuals throughout the state if they are provided with translation that is wrong, faulty, or does not match with their specific understanding or ability to read the dialect used on the label. CRA states that allowing a patient to communicate with a live translator over the phone will enable a dialogue, and should provide the patient with more accurate instructions, the opportunity to ask questions in their primary language, and greater assistance than a translated label would provide. CRA also points out that many pharmacies have invested in labeling software that does not have the flexibility to accommodate incorporating different languages into the label. Many pharmacies would have to bear significant costs to purchase software enhancements that would be necessary for them to comply with the translation requirements of this bill. The California Pharmacists Association (CPhA) cites the reasonable balance that was struck during the Board's exhaustive, collaborative rulemaking process to implement a standardized label and lack of data indicating that the existing regulations are insufficient to protect patients. CPhA believes that pharmacists would lose their ability to verify the accuracy CONTINUED SB 204 Page 10 of directions printed in a language other than English and notes the risk of patient harm, as discussed during the rulemaking process that can result from misinterpretation of directions printed in a non-English language. Rite Aid states that there is no need for the requirements imposed by this bill and that there is no evidence that the current practice of pharmacies providing live translation services involving a three-way consultation between the patient, pharmacist and translator over the phone is not working effectively. MW:k 5/29/13 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED