California Assembly Bill AB1458 Amended / Bill

 BILL NUMBER: AB 1458AMENDED BILL TEXT AMENDED IN ASSEMBLY APRIL 2, 2009 INTRODUCED BY Assembly Member Davis FEBRUARY 27, 2009 An act  relating to care facilities   to add Article 7 (commencing with Section 111657.10) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to public health  . LEGISLATIVE COUNSEL'S DIGEST AB 1458, as amended, Davis.  Assisted living for seniors.   Drugs: adverse effects: reporting.   Existing law establishes various programs for the prevention of disease and the promotion of health to be administered by the State Department of Public Health, including, but not limited to, a program for the licensing and regulation of health facilities and clinics. Existing law requires certain health facilities to report adverse events, as defined, relating to patient care. Existing law requires the department to regulate the manufacture, sale, labeling, and advertising activities related to food, drugs, devices, and cosmetics in conformity with the federal Food, Drug, and Cosmetic Act. A violation of these provisions is a crime.   This bill would require clinics, health facilities, and health professionals to report serious adverse drug events to the federal Food and Drug Administration and would exempt violations from related criminal provisions.   Under existing law, the State Department of Social Services licenses and regulates community care facilities, residential care facilities for the elderly, and other facilities that serve older adults.   This bill would state the intent of the Legislature to enact legislation that would make assisted living services more affordable to seniors.  Vote: majority. Appropriation: no. Fiscal committee:  no   yes  . State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:  SECTION 1.   The Legislature finds and declares all of the following:   (a) The federal Food and Drug Administration (FDA) operates a voluntary reporting system for adverse drug reactions known as the MedWatch system.   (b) The FDA currently estimates that only 10 percent of the adverse drug reactions or events that occur each year are reported to the FDA.   (c) Given the prevalence of pharmaceuticals and their use for treatment of hundreds of chronic diseases and conditions, and given recent highly publicized instances of commonly used prescription drugs being taken off the market due to safety concerns that were discovered after the drugs were approved for use, the systematic underreporting of adverse drug events represents a serious public health problem.   (d) Requiring licensed health professionals and health facilities to report adverse drug events to the FDA would increase the amount of data available to the FDA about adverse drug reactions, thereby enabling the FDA to discern problems with drugs that arise after they are approved and to take action to protect the public health in a more timely manner.   SEC. 2.   Article 7 (commencing with Section 111657.10) is added to Chapter 6 of Part 5 of Division 104 of the   Health and Safety Code   , to read:   Article 7. Adverse Event Reporting 111657.10. (a) A licensed health professional, including, but not limited to, a physician and surgeon, dentist, or pharmacist, a health facility as defined in Section 1250, or a clinic as defined under Chapter 1 (commencing with Section 1200), shall report all suspected serious adverse drug events that are spontaneously discovered or observed in medical practice to MedWatch, the drug safety information and adverse event reporting program operated by the federal Food and Drug Administration (FDA). (b) For purposes of this section, serious adverse drug events shall include adverse health outcomes involving patients that result in death, life-threatening conditions, hospitalization, disability, congenital anomaly, or that require intervention to prevent permanent impairment or damage. (c) Any health professional, health facility, or clinic that is required to report an adverse drug event pursuant to this section shall do so in addition to reporting requirements pursuant to Section 1279, and shall use the FDA 3500 Voluntary form developed by the FDA for MedWatch. 111657.15. A licensed health professional, health facility, or clinic that violates any provision of this article shall not be subject to the penalties and remedies outlined in Chapter 8 (commencing with Section 111825) or any other provision of law. Nothing in this section affects otherwise existing duties, rights, or remedies under the law.   SECTION 1.   It is the intent of the Legislature to enact legislation that would make assisted living services more affordable to seniors.