BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 1329| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: SB 1329 Author: Simitian (D), et al. Amended: 5/14/12 Vote: 21 SENATE HEALTH COMMITTEE : 9-0, 4/11/12 AYES: Hernandez, Harman, Alquist, Anderson, Blakeslee, De León, DeSaulnier, Rubio, Wolk SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 8-0, 5/7/12 AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete McLeod, Vargas, Wyland NO VOTE RECORDED: Strickland SUBJECT : Prescription drugs: collection and distribution program SOURCE : Supporting Initiatives to Redistribute Unused Medication DIGEST : This bill expands the types of entities that can donate and dispense medication in the prescription drug depository and distribution program that provides donated medication to medically indigent patients, includes these additional entities within the immunity from criminal and civil liability contained in existing law, and allows counties to establish a program through an action by the county board or through an action of the public health officer of the county, instead of only through county ordinance under existing law. CONTINUED SB 1329 Page 2 ANALYSIS : Existing law: 1. Authorizes counties, by ordinance, to establish a prescription drug repository and distribution program (program), subject to specified requirements, for medically indigent patients to receive donated prescription drugs free of charge. 2. Allows the following entities to donate medication to a program: a skilled nursing facility (SNF), a SNF designated as an institution for mental disease (IMD), a drug wholesaler or a drug manufacturer. 3. Limits the types of pharmacies that can dispense medication through the program to county-owned pharmacies and pharmacies that contract with the county. 4. Requires a county that elects to establish a program to establish procedures for program eligibility for medically indigent patients, and to ensure proper safety and management of medications, among other requirements. 5. Exempts prescription drug manufacturers, wholesalers, participating pharmacies, SNFs, pharmacists and health care professionals who accept or dispense prescription drugs from criminal or civil liability for injury caused when donating, accepting, or dispensing prescription drugs in compliance the program provisions, except for noncompliance with the program statute, bad faith or gross negligence. Prohibits the program statute from affecting disciplinary actions taken by licensing and regulatory agencies. This bill: 1. Expands the types of entities that are authorized to dispense medication in the program to include two additional entities: a licensed pharmacy that is owned and operated by a licensed primary care clinic, and a licensed primary care clinic that is licensed to CONTINUED SB 1329 Page 3 administer and dispense drugs. 2. Expands the types of facilities authorized to donate medication to include the following: A. A general acute care hospital. B. An acute psychiatric hospital. C. An intermediate care facility (ICF). D. An ICF/developmentally disabled (DD) -habilitative facility. E. A licensed ICF /DD-nursing facility. F. A correctional treatment center. G. A psychiatric health facility. H. A chemical dependency recovery hospital. I. A residential care facility for the elderly (RCFE). J. A RCFE for persons with chronic, life-threatening illness. K. A mental health rehabilitation center. 3. Allows a county public health officer to establish a repository and distribution program, as directed by the county board of supervisors. 4. Requires the additional facilities authorized by this bill to dispense and donate medication to receive the exemption from civil and criminal liability established under existing law when donating, accepting or dispensing drugs in the program, except for noncompliance with the program statute, bad faith or gross negligence. 5. Allows medication donated to the program to be transferred to another entity participating in the program for dispensing to eligible patients. 6. Requires an entity that seeks to participate in the program to inform the county health department in writing of its intent to participate. Prohibits an entity from participating in the program until it has received written or electronic documentation from the county health department confirming that it has received its notice of intent. CONTINUED SB 1329 Page 4 7. Requires an entity participating in the program to disclose to the county health department the name and location of the source of all donated medication it receives, and requires a participating primary care clinic to disclose to the county health department the physician accountable to the Board of Pharmacy (Board) for the clinic's program operations. 8. Requires the county board of supervisors or county public health officer, upon request, to make available to the Board the information in 6) above. 9. Permits the county board of supervisors, the county public health officer, and the Board to prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program. Background According to the 2009 California Health Interview Survey conducted by the University of California Los Angeles, 5.4 million Californians, or 14.5 percent of the state's population, were uninsured. Of the insured in California, seven percent or 2.2 million people did not have coverage for prescription drugs. SB 798 (Simitian), Chapter 444, Statutes of 2005, authorizes the establishment of a program. Under the program, counties can adopt an ordinance to establish such a program, under which SNFs, SNFs that are IMDs, drug wholesalers, and drug manufacturers can donate unused medications to county-owned pharmacies, or pharmacies that contract with the county for dispensing to medically indigent patients free of charge. Prior to the enactment of SB 798, SNFs were required to either destroy the drugs in the presence of a pharmacist or nurse, or return the drugs to the issuing pharmacy (if unopened and in a sealed container) for disposition. To date, two counties (Santa Clara and San Mateo) have established such a program, and Santa Clara indicates it has saved approximately $5,000 through the program as of February 2012. According to an issue brief from the National Conference of State Legislatures, 38 states have enacted laws as of 2010 CONTINUED SB 1329 Page 5 regarding prescription recycling programs for unused medications. Counties establishing a program have to meet certain requirements, including establishing eligibility for medically indigent patients, developing a formulary of medications appropriate for the program, ensuring the privacy of patients donating medication to the program, and ensuring proper safety and medication management. Controlled substances (controlled substances are prescription drugs with the potential for abuse) and medication in the possession of a patient are not eligible for donation. Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet specified standards is eligible for donation. Donated medication cannot have been in the possession of a patient or any individual member of the public, and medication donated by a SNF must have been under the control of the staff of the SNF. Medication that is dispensed under the program is required to be in a new and properly labeled container that is specific to the eligible patient. In addition, medication donated to the program must be segregated from the pharmacy's other drug stock by physical means, for inventory, accounting, and inspection purposes. Pharmacies must also keep complete records of the acquisition and disposition of medication donated to and dispensed under the program. Finally, a participating county-owned or county-contracted pharmacy must follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer. FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local: No SUPPORT : (Verified 5/10/12) Supporting Initiatives to Redistribute Unused Medication (source) Aegis of Corte Madera Alameda County Health Care Services Agency American Cancer Society CONTINUED SB 1329 Page 6 Bethesda Home California Assisted Living Association California Association of Health Facilities California Medical Association California State Association of Counties Californians Against Waste Canyon Manor Children's Recovery Center of Northern California Community Care on Palm County Health Executives Association of California Crestwood Behavioral Health, Inc. Golden Age Convalescent Hospital Golden Empire Nursing and Rehab Center La Casa Mental Health Rehabilitation Center La Casa Psychiatric Health Facility Lincoln Glen Nursing Facility Marin Community Clinics Marlinda-Imperial Convalescent Hospital Masonic Homes of California National Federation of Independent Business ResCare Friendship Developmental Services Royal Oaks Manor - Bradbury Oaks San Francisco Towers Santa Clara County Board of Supervisors Sierra Club California Stanford University School of Medicine Stonebrook Healthcare Center Sunny View Retirement Community Villa Siena ARGUMENTS IN SUPPORT : This bill is sponsored by Supporting Initiatives to Redistribute Unused Medicine (SIRUM) to increase access to necessary, and in many cases life-sustaining, prescription drugs for medically indigent Californians while at the same time reducing the environmental impact of pharmaceutical waste and producing savings for state and local governments. This bill builds upon previous legislation to expand the types of health facilities that can donate unused medicine, allowing California to capture the staggering $100 million in usable medicine from health facilities that ends up destroyed in incinerators, or worse, dumped into our water supply. Additionally, SIRUM states this bill enables non-profit community clinics to receive and dispense donated medicine, CONTINUED SB 1329 Page 7 greatly increasing the number of patients that can access donated medicine. Finally, only two counties currently have overcome the bureaucratic hurdles of establishing redistribution program, and SIRUM states this legislation will streamline the process for counties by removing unnecessary burdens. With shrinking budgets for the health care safety net and rising health care costs for all Californians, SIRUM argues this bill allows California to maximize quality patient care by reducing the financial burden of medicine acquisition and promoting environmentally sustainable health care practices. The California Association of Health Facilities (CAHF) argues this bill would make it easier for counties to approve programs to allow for the redistribution of unused medication from health care providers to the uninsured. CAHF states SNFs are estimated to destroy up to 15 percent of their prescriptions each month, but that an increasing number of SNFs (approximately 79 facilities) are taking advantage of a unique program that allows these facilities to donate surplus medications for redistribution to uninsured residents. The Sierra Club writes in support that this will protect our environment, water supply and people by reducing the amount of prescription drugs and pharmaceutical waste that ends up in our drinking water, lakes and rivers. CTW:do 5/16/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED