BILL ANALYSIS Ó AB 1136 Page 1 Date of Hearing: April 23, 2013 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Richard S. Gordon, Chair AB 1136 (Levine) - As Amended: April 15, 2013 SUBJECT : Pharmacists: drug disclosures. SUMMARY : Requires a pharmacist after July 1, 2014 to include a written warning label on a prescription drug if the pharmacist determines that the drug may impair a person's ability to operate a vehicle or vessel. Specifically, this bill : 1)Requires, after July 1, 2014, a pharmacist to include a written label on a drug container indicating that the drug may impair a person's ability to operate a vehicle or vessel if the pharmacist determines that the drug may have that effect. 2)Permits this warning to be printed on an auxiliary label that is added to the prescription container. 3)Makes other technical and clarifying changes. 4)States that no reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. EXISTING LAW : 1)Provides for the practice of pharmacy and the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy (BOP) within the Department of Consumer Affairs. (Business and Professions Code (BPC) Section 4000 et seq.) 2)Requires a pharmacist to inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription if the drug poses substantial risk to the person consuming the drug when taken in combination with alcohol or if the drug may AB 1136 Page 2 impair a person's ability to drive a motor vehicle, if the drug is determined by BOP to be a drug or drug type for which this warning shall be given. (BPC 4074 (a)) 3)Permits BOP to develop regulations requiring additional information or labeling. (BPC 4074 (b)) 4)Requires a health facility to establish and implement a written policy to ensure that each patient receives information, as specified, regarding each medication given at the time of discharge. This information shall include the use and storage of each medication, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse, unless already provided by a patient's prescriber, and the written policy shall be developed in collaboration with a physician, a pharmacist, and a registered nurse. The written policy shall be approved by the medical staff. Nothing in existing law shall be construed to require that only a pharmacist provide this consultation. (BPC 4074 (d)). 5)Requires that each prescription dispensed by a pharmacist must be in a container meeting state and federal specifications 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 AB 1136 Page 3 dispensed; j) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription; and, 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) FISCAL EFFECT : Unknown COMMENTS : 1)Purpose of this bill . This bill requires a pharmacist to include a written warning label on a prescription drug if the pharmacist determines the drug may impair a person's ability to operate a vehicle or vessel. This practice is already permitted under current law, and is done voluntarily in many pharmacies. This bill is author sponsored. 2)Author's statement . According to the author, "In California there is no requirement to include a warning label or sticker on prescription medication which BOP identifies as capable of impairing a person's ability to drive. Current law only requires that a pharmacist inform a patient orally or in writing? AB 1136 combats the growing epidemic of drugged driving by mandating best practices among California pharmacies to ensure that warning labels are included on dangerous drugs." 3)Current prescription drug labeling requirements . Current regulations developed by BOP require each prescription dispensed by a pharmacist to be in a container that meets state and federal specifications. Labels must already include: 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; AB 1136 Page 4 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 or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription; and, aa) The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. Current law also requires a pharmacist to inform a patient orally or in writing of the harmful effects of a drug if the drug poses substantial risk to the person when taken in combination with alcohol or if the drug may impair a person's ability to drive a motor vehicle. According to the California Pharmacists Association, the use of warning labels that caution patients about driving while using dangerous medications is already standard practice in most pharmacies. This bill may also be read to permit a pharmacist to identify drugs in addition to those drugs identified by BOP for this additional warning. 4)Related legislation . SB 204 (Corbett) would require a pharmacist to use translations of the directions for drug use in non-English languages published on the Board's Internet Web site, as applicable, when labeling a prescription container and authorizes a pharmacist to translate the directions for drug use into additional non-English languages if certified translation services are utilized to complete the additional translations. SB 204 is pending in Senate Business, Professions and Economic Development Committee. AB 1136 Page 5 SB 205 (Corbett) would require the information on a prescription label to be printed in at least a 12-point sans serif typeface. SB 205 is pending in Senate Business, Professions and Economic Development Committee. SB 289 (Correa) would make it unlawful for a person to drive a motor vehicle if his or her blood contains any detectable amount of a drug classified in Schedules I, II, III, or IV of the California Uniform Controlled Substance Act, unless the drug was consumed in accordance with a valid prescription issued to the person by a licensed health care practitioner. SB 289 is pending in Senate Public Safety Committee. 5)Previous legislation . SB 472 (Corbett), Chapter 470, Statutes of 2007, requires BOP 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. AB 1276 (Karnette) of 2007 would have required prescribers of medications to ask the patient whether to indicate the intended purpose of the prescription on the prescription's label. AB 1276 died in the Assembly Business and Professions Committee. AB 657 (Karnette) of 2005 would have required prescription labels to include the intended purpose of the drug, if indicated on the prescription, and would have required a physician, dentist, optometrist, podiatrist, or other specified drug prescriber to ask the patient or patient's representative whether to indicate the intended purpose of the prescription on the label. AB 657 died in the Senate Business, Professions and Economic Development Committee. AB 288 (Mountjoy) of 2005 would have required the prescription container to be labeled with the condition for which the drug was prescribed, unless the patient, physician, or a parent or legal guardian of a minor patient requests that the information be omitted. AB 288 died in the Assembly Health Committee. AB 2125 (Levine) of 2004 would have required a physician and surgeon to indicate a patient's diagnosis on each prescription, as specified, and required the prescription label to include the condition for which the drug was AB 1136 Page 6 described, unless the patient directs the pharmacist not to include this information on the label. AB 2125 died in the Assembly Health Committee. SB 292 (Speier), Chapter 544, Statutes of 2003, required 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. 6)Double referred . This bill is double-referred, having been previously heard by the Assembly Health Committee on April 2, 2013 and approved on an 11-1 vote. REGISTERED SUPPORT / OPPOSITION : Support California Narcotic Officers' Association California Senior Legislature California State Sheriffs' Association Opposition None on file. Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301