BILL NUMBER: SB 472 CHAPTERED BILL TEXT CHAPTER 470 FILED WITH SECRETARY OF STATE OCTOBER 11, 2007 APPROVED BY GOVERNOR OCTOBER 11, 2007 PASSED THE SENATE SEPTEMBER 6, 2007 PASSED THE ASSEMBLY SEPTEMBER 5, 2007 AMENDED IN ASSEMBLY AUGUST 30, 2007 AMENDED IN ASSEMBLY JUNE 20, 2007 AMENDED IN SENATE MAY 21, 2007 AMENDED IN SENATE APRIL 30, 2007 AMENDED IN SENATE APRIL 16, 2007 AMENDED IN SENATE APRIL 9, 2007 INTRODUCED BY Senator Corbett (Coauthors: Assembly Members Berg, Karnette, and Ma) FEBRUARY 21, 2007 An act to add Section 4076.5 to the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGEST SB 472, Corbett. Prescription drugs: labeling requirements. Existing law, the Pharmacy Law, provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy in the Department of Consumer Affairs. Existing law prohibits a pharmacist from dispensing a prescription, except in a container that meets certain labeling requirements. This bill would require the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. The bill would require the board to hold special public meetings statewide in order to seek information from certain groups, and would require the board to consider specified factors in developing the label requirements. The bill would require the board to report to the Legislature on or before January 1, 2010, on its progress at the time of the report, and to report to the Legislature on or before January 1, 2013, on the status of implementation of the requirements. Because a knowing violation of the Pharmacy Law constitutes a crime, and because the above-described provisions would impose additional duties under that law, this bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. This act shall be known and may be cited as the California Patient Medication Safety Act. SEC. 2. The Legislature hereby finds and declares all of the following: (a) Health care costs and spending in California are rising dramatically and are expected to continue to increase. (b) In California, prescription drug spending totaled over $188 billion in 2004, a $14 billion dollar per year spending increase from 1984. (c) Prescription drug cost continues to be among the most significant cost factors in California's overall spending on health care. (d) According to the Institute of Medicine of the National Academies, medication errors are among the most common medical errors, harming at least 1.5 million people every year. (e) Up to one-half of all medications are taken incorrectly or mixed with other medications that cause dangerous reactions that can lead to injury and death. (f) Approximately 46 percent of American adults cannot understand the label on their prescription medications. (g) Ninety percent of Medicare patients take medications for chronic conditions and nearly one-half of them take five or more different medications. (h) Nearly six out of 10 adults in the United States have taken prescription medications incorrectly. (i) The people of California recognize the importance of reducing medication-related errors and increasing health care literacy regarding prescription drugs and prescription container labeling, which can increase consumer protection and improve the health, safety, and well-being of consumers. (j) The Legislature affirms the importance of identifying deficiencies in, and opportunities for improving, patient medication safety systems in order to identify and encourage the adoption of structural safeguards related to prescription drug container labels. (k) It is the intent of the Legislature to adopt a standardized prescription drug label that will be designed by the California State Board of Pharmacy for use on any prescription drug dispensed to a patient in California. SEC. 3. Section 4076.5 is added to the Business and Professions Code, to read: 4076.5. (a) The board shall promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. (b) To ensure maximum public comment, the board shall hold public meetings statewide that are separate from its normally scheduled hearings in order to seek information from groups representing consumers, seniors, pharmacists or the practice of pharmacy, other health care professionals, and other interested parties. (c) When developing the requirements for prescription drug labels, the board shall consider all of the following factors: (1) Medical literacy research that points to increased understandability of labels. (2) Improved directions for use. (3) Improved font types and sizes. (4) Placement of information that is patient-centered. (5) The needs of patients with limited English proficiency. (6) The needs of senior citizens. (7) Technology requirements necessary to implement the standards. (d) (1) On or before January 1, 2010, the board shall report to the Legislature on its progress under this section as of the time of the report. (2) On or before January 1, 2013, the board shall report to the Legislature the status of implementation of the prescription drug label requirements adopted pursuant to this section. SEC. 4. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.