BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 431| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: SB 431 Author: Emmerson (R) Amended: 5/10/11 Vote: 21 SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE : 9-0, 4/25/11 AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete McLeod, Vargas, Walters, Wyland SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 05/04/11 AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe, Lowenthal, Pavley SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 SUBJECT : Pharmacies: regulation SOURCE : Board of Pharmacy DIGEST : This bill expands existing reporting requirements to the Board of Pharmacy when a pharmacy discovers that an employee has been stealing drugs, prohibits a pharmacist whose California license has been revoked from dispensing medication to Californians via mail, and prohibits a reverse distributor from accepting dangerous drugs that have been dispensed to a patient and later returned to the pharmacy unless the drugs were dispensed in a sealed or tampered-evident pack and there is no evidence that the package was opened, damaged or otherwise tampered with. CONTINUED SB 431 Page 2 ANALYSIS : Existing law : 1. Provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA). 2. Defines the following terms: A. "Authorized officers of the law" as inspectors of the Board, inspectors of the Food and Drug Branch of the State Department of Public Health, and investigators of DCA's Division of Investigation or peace officers engaged in official investigations. B. "Designated representative" as an individual to whom a license has been granted to provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer. Specifies that the designated representative shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices. "Designated representative-in-charge" means a designated representative or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the Board as the supervisor or manager responsible for ensuring compliance with all state and federal laws. C. "Pharmacist-in-charge" as a pharmacist proposed by a pharmacy and approved by the Board as the supervisor or manager responsible for ensuring the pharmacy's compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. D. "Reverse distributor" as every person who acts as an agent for pharmacies, drug wholesalers, manufacturers, and other entities by receiving, CONTINUED SB 431 Page 3 inventorying, and managing the disposition of outdated or nonsalable dangerous drugs. 3. Requires pharmacies to keep records of manufacture, sale, acquisition or disposition of dangerous drugs or dangerous devices for three years, and requires these records to be available for inspection by authorized officers of the law. Requires that an inventory be kept by every manufacturer, wholesaler, pharmacy, veterinary food-animal drug retailer, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration who maintains a stock of dangerous drugs or devices. Makes the owner, officer, partner and pharmacist-in-charge or designated representative-in-charge responsible for maintaining records and keeping inventory. Clarifies that the pharmacist-in-charge or designated representative-in-charge are not criminally responsible for the acts of an owner, officer, partner or employee if the pharmacist-in-charge or designated representative-in-charge had no knowledge of the acts. 4. Requires pharmacies to have procedures in place to take action when a licensed individual employed by or with the pharmacy is chemically, mentally, or physically impaired to the extent it affects his or her ability to practice the profession or occupation he or she is licensed to practice, or when a licensed individual has engaged in the theft, diversion, or self-use of dangerous drugs. Requires pharmacies to have written policies and procedures for addressing chemical, mental, or physical impairment, as well as theft, diversion, or self-use of dangerous drugs, among licensed individuals employed by or with the pharmacy. States that anyone making a report has immunity from any civil or criminal liability that might otherwise arise from making of the report. Requires pharmacies to report the following to the Board within 30 days: A. Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice. CONTINUED SB 431 Page 4 B. Any admission by a licensed individual of theft, diversion, or self-use of dangerous drugs. C. Any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his/her ability to practice. D. Any video or documentary evidence demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual. E. Any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it affects his/her ability to practice. F. Any termination of a licensed individual based on theft, diversion, or self-use of dangerous drugs. 5. Requires all records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the Board to be retained on the licensed premises in readily retrievable form. 6. Specifies that a nonresident pharmacy is any pharmacy located outside of California that ships, mails or delivers controlled substances, dangerous drugs, or dangerous devices into California and establishes certain licensing, disclosure and record keeping requirements for these entities. This bill: 1.Clarifies that any record pertaining to the return of dangerous drugs to a wholesaler, or provided to a reverse distributor, must document the quantity or weight of the drugs returned, the date the drugs were returned and the name of the reverse distributor or wholesaler to whom the drugs were provided. Specifies that a reverse distributor must not accept the return of dangerous drugs that have been dispensed to a patient and later returned CONTINUED SB 431 Page 5 by a patient or patient's agent. 2.Clarifies that any record pertaining to the return of dangerous drugs to a hazardous waste hauler must list the volume in weight or measurement of the pharmaceutical waste returned, the date the waste was returned and the name of the hazardous waste hauler to whom waste was provided. Specifies that a pharmacy may furnish dangerous drugs to a hazardous waste hauler for the sole purpose of waste disposal of pharmaceutical waste returned to the pharmacy by a patient or patient's agent. Specifies that only a hazardous waste hauler can pick up or handle dangerous drugs returned by a patient or patient's agent to a pharmacy. 3.Requires a pharmacy, within 14 days, report certain information and evidence about licensees related to chemical, mental, or physical impairment to the extent it affects his or her ability to practice and theft, diversion or self-use of dangerous drugs to the Board. 4.Requires the report required above include sufficient detail to inform the Board of the facts on which the report is based, including an estimate of the type and quantity of all dangerous drugs involved, the timeframe over which the losses are suspected, and the date of the last controlled substances inventory. Requires a pharmacy, upon request of the Board, prepare and submit an audit involving the suspected missing dangerous drugs. 5.Requires the owner, corporate officer, or manager of an entity licensed by the Board, when requested by an authorized officer of the law or by an authorized representative of the Board, to provide the requested records within three business days of the time the request was made. Specifies that the entity may request an extension in writing for up to 14 calendar days, subject to Board approval. Deems an extension approved if the Board fails to deny the request within two business days of the time the extension request was made directly to the Board. 6.Clarifies that a nonresident pharmacy shall not permit a pharmacist whose license has been revoked by the Board to CONTINUED SB 431 Page 6 manufacture, compound, furnish, sell, dispense, or initiate the prescription of a dangerous drug or dangerous device, or to provide any pharmacy-related service, to a person residing in California. 7.Prohibits a reverse distributor from accepting dangerous drugs that have been dispensed to a patient and later returned to the pharmacy unless the dangerous drugs were dispensed in a sealed or tamper-evident package and there is no evidence that the package was opened, damaged or otherwise tampered with. Requires the pharmacy keep records of returned dangerous drugs. Background There are growing concerns about the impact of drugs and pharmaceutical waste based on improper disposal, which in turn leads to contamination of water systems and improper access by potential abusers. The U.S. Geological Survey conducted a study in 2002, sampling 139 streams across 30 states and found that 80 percent had measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones. Exposure, even to low levels of pharmaceuticals, has been shown to have negative effects on fish and other aquatic species and may have negative effects on human health. Proper disposal is believed to decrease the threat of these substances to the environment and waterways. According to recent studies, and data collected by the federal government, prescription drug abuse is the fastest-growing drug problem in the U.S. As prescription drugs are legal, they are easily accessible, often from a home medicine cabinet. Studies show that some individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a health care professional and sold behind the counter. Proper disposal is believed to decrease the availability of expired and unused prescription drugs to abusers. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes CONTINUED SB 431 Page 7 SUPPORT : (Verified 5/23/11) Board of Pharmacy (source) OPPOSITION : (Verified 5/23/11) Bay Area Pollution Prevention Group EXP Pharmaceutical Services Corp. ARGUMENTS IN SUPPORT : According to the author's office, this bill will increase consumer protection as well as better ensure the proper disposal of prescription drugs. The author's office believes that this bill contains consumer protection measures that provide the Board with information it needs to quickly discipline errant licensees by requiring additional reporting on drug loss. Additionally, the author's office notes that ensuring that an individual whose pharmacist license has been revoked in California is not able to dispense medication to Californians via mail supports the Board's public protection efforts. ARGUMENTS IN OPPOSITION : The Bay Area Pollution Prevention Group represents 43 wastewater treatment facilities around the San Francisco Bay and beyond, that work to prevent pollution in San Francisco Bay. They raise several concerns with the bill. They state that the bill could be in conflict with the pending federal regulation and could make it even more difficult and costly for agencies, retailers, and drug manufacturers in California to provide programs for the public to properly dispose of pharmaceuticals. They point to reverse distributors, as well as common carriers, as options that the DEA is looking at as pick-up and transportation services. They claim that reverse distribution is possibly one of the best and most cost-effective tools for residential disposal programs. Reverse distributors already work in pharmacies to dispose of medication that was not sold either due to overstocking, recalls, or expiration. A pharmacy-based residential collection program could utilize their reverse distribution network to remove unwanted residential medication at the same time as these unsold drugs. Also, they point to another option that many public agencies, hospitals, and long-term care facilities would like to consider for CONTINUED SB 431 Page 8 disposal of residential unwanted medication; the use of common carriers to transport pharmaceutical waste to an incineration facility. Currently, United States Postal Service, FedEx, and United Parcel Service deliver medication to end users. They claim that leftover medication could safely be sent by common carrier to a regulated facility for incineration at a significantly lower cost than medical or hazardous waste hauling. JJA:do 5/23/11 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED