BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: AB 1073 Hearing Date: July 6, 2015 ----------------------------------------------------------------- |Author: |Ting | |----------+------------------------------------------------------| |Version: |June 9, 2015 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Mason | |: | | ----------------------------------------------------------------- Subject: Pharmacy: prescription drug labels. SUMMARY: Requires a dispenser to use a standardized direction for use on the label of a prescription container for limited English proficient patients in five languages, according to translations provided by the Board of Pharmacy on its website. Authorizes a dispenser to provide his or her own translated directions in any language other than English as an alternative to the translations made available by the Board. Specifies that a dispenser who provides the Board's translated directions for use shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English. Existing law: 1)Under the Pharmacy Law, provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 4000 et seq.) 2)Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian or naturopathic doctor. (BPC § 4059) AB 1073 (Ting) Page 2 of ? 3)Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified, including: a) Unless otherwise ordered by the prescriber, the manufacturer's trade name of the drug or the generic name and the name of the manufacturer, as specified. b) The directions for the use of the drug. c) The name of the patient or patients. d) The name of the prescriber, as specified. e) The date of issue. f) The name and address of the pharmacy, and prescription number or other means of identifying the prescription. g) The strength of the drug or drugs dispensed. h) The quantity of the drug or drugs dispensed. i) The expiration date of the effectiveness of the drug dispensed. j) The condition for which the drug was prescribed if requested by the patient and the condition is indicated on the prescription. aa) The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. (BPC § 4076) 4)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. (BPC § 4076.5 (a)) 5)Requires the Board to hold public meetings statewide in order to seek information on a standardized label from groups representing consumers, seniors, pharmacists, the practice of AB 1073 (Ting) Page 3 of ? pharmacy, other health care professionals, and other interested parties. (BPC § 4076.5 (b)) 6)Requires the Board, when considering the requirements for prescription labels, to consider: (BPC § 4076.5 (c)) a) Medical literacy research. b) Improved directions for use. c) Improved font types and sizes. d) Placement of information that is patient-centered. e) The needs of patients with limited English proficiency. f) The needs of senior citizens. g) Technology requirements necessary to implement the standards. 7)Establishes the Dymally-Alatorre Bilingual Services Act (Act) which requires each state agency to conduct a survey, related to its bilingual services, of each of its statewide offices which render services to the public every two years to determine specified information, and to report results and any additional information requested to the California Department of Human Resources (CalHR). Requires the survey to contain a detailed description of complaints regarding language access received by the agency. The Act also requires each agency that serves a substantial number of non-English-speaking people who comprise 5% or more of the people served to develop an implementation plan, as specified, in every odd-numbered year, and to submit the implementation plan to the department for its review. Additionally, the Act requires CalHR, if it determines that a state agency has not made reasonable progress toward complying with the Act, to issue orders that it deems appropriate to effectuate the purposes of the Act. (Government Code Section 7290 et seq.) 8)Stipulates that, by July 1, 2015, a state agency subject to the Act must translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Also, requires AB 1073 (Ting) Page 4 of ? that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. In addition, requires that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. (GC § 7299.3) This bill: 1) Requires a dispenser to use a standardized direction for use on the label of a prescription container from the list provided in the Board's regulations establishing the patient centered label. 2) Requires the Board to make available translations, in a minimum of five languages other than English of the standardized directions for use. Specifies that the translations must be approved by qualified translators, as determined by the Board and that the Board must post these standardized directions for use on its Internet Web site. Provides the dispenser a period of 180 days from the date of adoption of the Board of any change to the translated standardized directions for use to implement that change. 3) Provides that, upon request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those made available by the Board pursuant to the provisions in 2) above, if available, and append the direction for use to the label on the patient's prescription container or provide it on a supplemental document. 4) Provides that if a translated direction for use appears on a container, the English version of the direction for use shall also appear on the label. Requires the translated direction for use to appear in the patient-centered area of the label in accordance with Board regulations. Authorizes the English version to appear in an area of the label outside the patient-centered area. 5) Authorizes a dispenser to provide his or her own translated directions in any language other than English as an alternative to the translations made available by the Board and procedures outlined above. Requires the translated AB 1073 (Ting) Page 5 of ? direction for use to appear in the patient-centered area of the label in accordance with Board regulations. Requires the English version of the direction to appear on the prescription container if a translated direction for use appears on a container. Authorizes the English version to appear in an area of the label outside the patient-centered area. 6) Provides that a dispenser who provides the Board's translated directions for use shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English. States that this section does not affect existing liability under this division for translated directions not approved by the Board. FISCAL EFFECT: This bill is keyed "fiscal" by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated May 6, 2015, this bill will result in minor and absorbable costs to the Board. COMMENTS: 1. Purpose. The Board of Pharmacy is the Sponsor of this measure. According to the Author, as healthcare for California's diverse population becomes increasingly accessible through Covered California, it is more critical than ever to ensure that all patients receive culturally-competent care. The Author cites the 2010 U.S. Census which found that more than 6.5 million residents of California, one out of every five, speak English "less than very well." Over 44% of Californians speak a language other than English at home. Furthermore, almost half of Medi-Cal enrollees are limited English proficient (LEP), with 3 million more enrollees expected to need language assistance over the next five years as the program expands. According to the Author, research has found that difficulty in understanding instructions results in lack of adherence to a prescribed medication regimen, as well as dangerous and sometimes fatal medical reactions that could have been easily avoided. The Author states that this AB 1073 (Ting) Page 6 of ? problem rings true for all patients, as prescription medication information is complex and cannot be easily imparted during brief consultations with a pharmacist. The risk of falling victim to the problem is particularly high for LEP patients who face communication barriers with health care providers and pharmacists. According to the Author, research published in the Journal of General Internal Medicine found that LEP individuals who received translated standardized directions for use were more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen, and simplify medication use by consolidating when pills should be taken. According to the Author, there is no existing law that requires dispensers to provide patients with translated directions for use. According to the Author, in attempt to address the needs of Limited English Proficient (LEP) patients, Board regulations require pharmacies to provide oral translation services in at least 12 languages via on-site or telephone-based interpretive services, and require the Board to publish on its website standardized and translated directions for use in at least five languages other than English. The Author notes that although translations have been posted in Chinese, Korean, Russian, Spanish, and Vietnamese, they have not been widely adopted by pharmacies. According to the Author, the broad utilization of these translated materials by pharmacies has been impeded by concerns over liability in the event that there are inadvertent errors in materials which pharmacy staff cannot detect. The Author states that this bill would require pharmacists to provide LEP patients with a translated standardized direction for use, and remove barriers for utilization of these translations, bringing the state one big step closer to making patient-centered prescription labels available. 2. Government Agency Efforts to Serve California's LEP Population. The Dymally-Alatorre Bilingual Services Act ensures that all residents, including those who are LEP, AB 1073 (Ting) Page 7 of ? have equal access to public services. The Act requires every state and local agency to have a sufficient number of qualified bilingual staff and translated written materials so that the LEP population they serve are able to effectively access and communicate with government. The Act became law in 1973 with the Legislative intent of ensuring people are not precluded from accessing public services because of language barriers. It requires agencies to provide the same information that is available in English in other languages if the agency services a "substantial number" of non-English speakers. To determine which languages must be included under the defined threshold, agencies are required to conduct surveys every other year to assess their contact with non-English speakers. Then, they must create or update implementation plans to ensure compliance and submit them to CalHR. 3. Medication Errors and Legislative Response. According to the Journal of the American Medical Association, 46 percent of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies indicates that medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90 percent 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 discernable 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 (12 in all) and methods to accomplish each recommendation. The Panel report states that "the information that consumers need to know about regarding AB 1073 (Ting) Page 8 of ? 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." Although the Panel did not come to consensus on the most important subset of consumers that are at "high risk" for medication errors, it did acknowledge that there are a variety of factors which may increase an individual's risk for experiencing a medication error. These include: i) low health literacy; ii) limited English proficiency; iii) cultural incongruence with healthcare providers; iv) physical, cognitive and/or other impairments that make understanding and/or complying with medication instructions difficult; v) age at either end of the age spectrum (the variability of a medication's response, metabolism and dose increases in children and seniors); vi) multiple medications; vii) multiple prescribers; viii) non-prescription medication use (including herbals, dietary supplements, alcohol, and tobacco); and, ix) medication procurement from more than one pharmacy including mail-order. The Panel did state 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 , The California Patient Medication Safety Act, (Corbett, Chapter 470, Statutes 2007) 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 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 AB 1073 (Ting) Page 9 of ? Legislature by January 1, 2010, on its progress in implementing these regulations. 4. Implementation of a Standardized Prescription Drug Label by the Board of Pharmacy. California is 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: 1. Print should be larger or darker = 30.1% 2. Nothing needs to be changed on the label =24.6% 3. Include purpose of drug = 12% The Board concluded that most consumers participating in the survey requested larger and bolder type font on AB 1073 (Ting) Page 10 of ? 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 responded that they want to know "what the drug is for" and suggested that "the 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 percent of the label, using at least 10-point font using sans serif typeface, listing these items in the following order: Name of the patient. AB 1073 (Ting) Page 11 of ? 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.) Directions for use. 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. Since the adoption of the regulation, the Board has continued to evaluate the implementation of the requirements provided under SB 472. When the Board initially promulgated the regulation, a requirement was included for the Board to reevaluate the regulation by December 2013. In April 2013, the Board's Public Education subcommittee began its review of the regulation. As a result of discussions at these subcommittee meetings (which are presented to the full Board for further discussion at Board meetings), in April 2014 the Board initiated a new rulemaking request to change the font size to a minimum of 12-point, rather than the current 10-point. Additionally, the new rulemaking request requires that only four items be clustered into one area of the label that comprises at least 50 percent of the label. The Board continues to discuss the directions for use component of the standardized label at its Public Education subcommittee meetings. 1. Translation Efforts by the Board. The regulation outlining requirements for a patient-centered label also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency and 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. 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 AB 1073 (Ting) Page 12 of ? adjacent to the pharmacy counter. Following the implementation of the patient-centered prescription label requirements, the Board also promulgated a regulation to amend its Notice to Consumers poster which has also been printed in six additional languages: Chinese, Korean, Russian, Spanish, Tagalog, and Vietnamese, and which is available upon request from the Board or available for download from the Board's website. Pharmacies are also authorized to request Board approval of another format or display methodology. The Board also developed a "Point to Your Language" poster, which is required to be posted in pharmacies at or adjacent to the pharmacy counter so that consumers can point to a language to receive interpreter services. The "Point to Your Language" text is printed in 12 languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese. According to the Board, The California Endowment, in an effort to support quality labels for those who do not read English, funded a project with national patient literacy researchers to develop and vet translations of the Board's standardized directions for use as outlined in the patient-centered label regulation. According to information provided to the Board by one of the project leaders, the effort is a very intensive process and, while he would like to include more languages, based on the timeline provided in the regulation, translation of the standard directions for use in five languages is reasonable. The Board determined then that it will not require a pharmacy or pharmacist to provide patients with written translated prescription drug labels but specified that the adopted regulation does not prohibit a pharmacy from providing translated prescription drug labels to patients. The Board determined at the time it provided a final statement of reasons for its proposed regulation that providing fully vetted translations into five languages other than English of the standard directions for use, as well as the oral language interpretive services available, serve the needs of LEP patients. The Board's website provides the following disclosure related to the translated directions for use stemming from the California Endowment project: "While every effort was made AB 1073 (Ting) Page 13 of ? to ensure accuracy and reliability of these translations, the Board cannot ensure that a particular translation is appropriate for a particular patient. The Board recommends that each pharmacy and pharmacist confirm the validity and the medical appropriateness of any given translation for a particular patient before using it for the patient's drug label. 2. Prior Related Legislation. AB 2253 (Ting, Chapter 469, Statutes of 2014) updated the Dymally-Alatorre Bilingual Services Act to require, by July 1, 2015, a state agency subject to the Act to translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Required that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. Required that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. Required CalHR to issue orders that it deems appropriate to effectuate the purposes of the Act if a state agency has not made reasonable progress toward reaching compliance. SB 204 (Corbett) of 2013-14 originally would have required pharmacists to use the translated standard directions for use from the Board's website when providing patients with translated directions in Spanish, Chinese, Vietnamese, Korean, and Russian on their prescription medication labels and would have required pharmacists to use certified translation services if they choose to provide translations in languages other than the five provided on the Board's website. The bill was amended to require the Board to conduct a survey of pharmacists and vendors of electronic health records to gather information about the utilization of, and the obstacles to, the use the Board's standardized directions for use on prescription drug labels. ( Status: The measure was vetoed by Governor Brown who indicated in his veto message that "the Board currently does not have the resources to conduct these surveys.") SB 205 (Corbett) of 2013 would have required the information on the prescription label to be printed in at least a 12-point sans serif typeface. ( Status: The bill was vetoed AB 1073 (Ting) Page 14 of ? by Governor Brown who indicated in his veto message that "the Board of Pharmacy is required to provide an update of its 2010 labeling guidelines to the Legislature next month. I prefer to wait for their findings before mandating such a change.") AB 396 (Fox) of 2013 would have required every prescription to include a legible, clear notice of the condition or purpose for which the drug is prescribed, unless the patient or prescriber requests that this information be omitted. Also, would have required that every prescription container be correctly labeled to include that information, if indicated on the prescription, unless the patient or prescriber requests that this information be omitted. ( Status: The bill was never heard in a policy committee.) AB 1136 (Levine, Chapter 304, Statutes of 2013) required a pharmacist to include a written label on the drug container indicating that the drug may impair a person's ability to operate a vehicle or vessel. SB 1390 (Corbett) of 2010 would have repealed the requirement that the Board promulgate regulations requiring a standardized, patient-centered, prescription drug label on all prescription medications dispensed to patients in California on or before January 1, 2011, and instead established statutory requirements for standardized, patient centered prescription drug labels. ( Status: The bill failed passage in the Assembly Committee on Business, Professions and Consumer Protection.) SB 470 (Corbett, Chapter 590, Statutes of 2009) permitted, if requested by patients, the purpose of the prescribed medication to be listed on prescription drug labels. SB 472 (Corbett, Chapter 470, Statutes of 2007), the California Patient Medication Safety Act, required the Pharmacy Board to promulgate regulations that require a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. Additionally, the Board was required to report to the Legislature by January 1, 2010, on its progress in implementing these regulations. AB 1073 (Ting) Page 15 of ? AB 1276 (Karnette, 2007) would have required medication prescribers to ask a patient if they wanted the intended use on the prescription label. ( Status: The measure failed passage in the Assembly Committee on Business and Professions.) SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) created a panel to study the causes of medication errors and recommend changes in the health care system that reduces errors associated with the delivery of prescription and over the counter medication to consumers. This resolution required the panel to convene by October 1, 2005, and to submit to the Assembly Committee on Health and the Senate Committee on Health, a report on its finding by June 1, 2006. AB 657 (Karnette, 2005) would have required prescription drug labels to include the intended purpose of the drug, if indicated on the prescription, and required prescribers to ask the patient or the patient's authorized representative, if the patient is either incapacitated or a minor who cannot provide informed consent, whether to indicate the intended purpose of the prescription on the label. ( Status: The bill was held in this Committee at the request of the Author.) AB 288 (Mountjoy, 2005) would have amended the prescription labeling requirement to include the condition for which the drug is prescribed unless the patient, physician or legal guardian requested that the information be omitted. ( Status: The measure was held in the Assembly Committee on Business and Professions at the request of the Author.) AB 2125 (Levine, 2004) would have required a physician and surgeon to indicate the patient's diagnosis on each prescription written, unless directed otherwise by the patient and amended the prescription labeling requirement to require that the condition be included on the label unless otherwise directed by the patient. ( Status: The bill was held in the Assembly Committee on Business and Professions at the request of the Author.) SB 292 (Speier, Chapter 544, Statutes of 2003) required AB 1073 (Ting) Page 16 of ? prescription labels to include a physical description of the drug, including the color, shape, and any identification code that appears on the tablet or capsule. AB 2099 (Epple, Chapter 397, Statutes of 1993) required that the condition for which the drug is being prescribed must be included on the label if the patient requests that information on the label. 3. Arguments in Support. Writing in support of the bill, a coalition of groups including the California Pan-Ethnic Health Network , Asian Americans Advancing Justice-Los Angeles , California Immigrant Policy Center , Latino Coalition for a Health California , and Southeast Asia Resource Action Center , states that studies show that a large percentage of patients misunderstand dosage instructions on their labels. The coalition cites The Institute of Medicine estimate that at least 1.5 million Americans are sickened, injured, or killed each year because of medication errors, which are only exacerbated for California's LEP patients. The coalition states that this lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens. These groups support this bills effort to reduce medical errors, increase patient compliance, and meet the needs of LEP patients. Justice in Aging , Asian Health Services , Touro University of California , Greenlining Institute , The City Project , and the California Healthy Nail Salon Collaborative all write in support of the bill, stating that AB 1073 will improve patient access to prescription drug information in their primary languages. According to these organizations, California is the most linguistically diverse state in the nation. The 2010 U.S. Census found over 6.5 million Californians speak English less than "very well," and 44% of Californians speak a language other than English at home. The organizations state that this bill will ensure all Californians, regardless of the language they speak, understand how to safely and correctly take their medication by requiring a dispenser to use a standardized direction for use on the label of the prescription container. According to the American Federation of State, County and Municipal Employees , AB 1073 would help LEP patients across AB 1073 (Ting) Page 17 of ? California by helping them understand prescription drug information in their primary language. The organization states that it can be difficult for proficient English patients to understand complicated medication regimens and cites an article in the Journal of the American Medical Association showing that 46% of adults do not understand the information listed on their prescription drug labels and when factoring in a patient who has LEP, this problem is exacerbated. The California State Board of Pharmacy states that AB 1073 contains important provisions to aid patients in understanding how to take their prescription medications accurately. According to the Board, enactment of this bill will encourage pharmacists to use the translations available from the Board's Web site, when the pharmacist deems it appropriate. The Board states that pharmacists have advised the Board that they are reluctant to use the online translations because they cannot read the language themselves and the waiver of liability for an inadvertent transcription mistake contained in this bill resolves this issue. Health Access California and Rite Aid Pharmacy state that prescription medications are an important element of health care, and AB 1073 recognizes the reality that many Californians need prescription drug labels in languages other than English in order for patient to adhere to medication regimens. 4. Arguments in Opposition. The National Association of Chain Drug Stores (NACDS) , the California Retailers Association , and the California Pharmacists' Association take an oppose unless amended position and state that the bill would impose new translation requirements on pharmacies without providing proper liability protections. According to the organizations, community pharmacies are required, by law, to develop prescription labels that provide information in a manner that is most useful and helpful to patients in addition to providing oral interpreter services to patients. A patient can request these interpreter services and the pharmacy will bring in an interpreter by phone to help in translating all information necessary for patients to properly comply with their medications. The groups note that in 2012, the Board finalized the patient centered labeling AB 1073 (Ting) Page 18 of ? requirements but did not require translated labels due to strong concerns raised by pharmacists about their compromised ability to guarantee accurate information to a patient if a label was in a language they could not read. According to the organizations, AB 1073, while mandating translated labels, does authorize pharmacies to develop and implement their own translation services including translations on the label or on an insert, however it does not provide any liability protection for those pharmacists who work in pharmacies that choose to provide translation services through a different means than the Board's five translations provided on their website. The groups state that in many cases, pharmacies can develop a more sophisticated and comprehensive translation program for their patients without utilizing the more limited Board translations and that these programs should be covered for liability purposes. 5. Proposed Author's Amendments. In response to concerns raised by stakeholders as outlined above, the Author proposes restructuring the bill according to the following: Strike the current provisions of the bill and replace with: (a) Upon the request of a patient or patient's representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. (b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with the requirements of this section. (c) A dispenser shall not be required to provide translated directions for use beyond the languages that the board has AB 1073 (Ting) Page 19 of ? made available or beyond the directions that the board has made available in translated form. (d) Nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form. (e) A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. (f) For purposes of this section, a dispenser does not include a veterinarian. NOTE : Double-referral to Senate Judiciary Committee SUPPORT AND OPPOSITION: Support: American Federation of State, County and Municipal Employees Asian Americans Advancing Justice-Los Angeles California Healthy Nail Salon Collaborative California Immigrant Policy Center California Pan-Ethnic Health Network California State Board of Pharmacy (Sponsor) Greenlining Institute Health Access California Justice in Aging, Asian Health Services Latino Coalition for a Health California Rite Aid Pharmacy Southeast Asia Resource Action Center Touro University of California The City Project Opposition: California Pharmacists' Association California Retailers Association AB 1073 (Ting) Page 20 of ? National Association of Chain Drug Stores -- END --