AB 1073: Pharmacy: prescription drug labels.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2015-10-11
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requires the board to 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. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.
This bill would require a pharmacist to use professional judgment to provide a patient with directions for use of a prescription that enhance the patients understanding of those directions, consistent with the prescribers instructions. The bill would also require a dispenser, excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requires the board to 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. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.
This bill would require a pharmacist to use professional judgment to provide a patient with directions for use of a prescription that enhance the patients understanding of those directions, consistent with the prescribers instructions. The bill would also require a dispenser, excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requires the board to 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. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.
This bill would require a pharmacist to use professional judgment in determining the content of the to provide a patient with directions for use of a prescription. prescription that enhance the patients understanding of those directions, consistent with the prescribers instructions. The bill would also require a dispenser, excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requires the board to 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. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.
This bill would require a pharmacist to use professional judgment in determining the content of the directions for use of a prescription. The bill would also require a dispenser, excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to 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. Existing regulations of the board implement that requirement. requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.
This bill would require a dispenser, in his or her professional judgment, to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its Internet Web site. This bill would require the board to allow a dispenser 180 days to implement changes to translated standardized directions as may be adopted by the board. The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patients prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translated directions, in any language other than English, as an alternative to the translations made available by the board and the above-described procedure. excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to 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. Existing regulations of the board implement that requirement. A violation of that law is a crime.
This bill would require a dispenser, in his or her professional judgment, to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its Internet Web site. This bill would require the board to allow a dispenser 180 days to implement changes to translated standardized directions as may be adopted by the board. The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patients prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translated directions directions, in any language other than English, as an alternative to the translations made available by the board and the above-described procedure. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to 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. Existing regulations of the board implement that requirement. A violation of that law is a crime.
This bill would require a dispenser dispenser, in his or her professional judgment, to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its Internet Web site. The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patients prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translated directions as an alternative to the above-described procedure. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to 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. Existing regulations of the board implement that requirement. A violation of that law is a crime.
This bill would remove that obsolete date. require a dispenser to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its Internet Web site. The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patients prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translated directions as an alternative to the above-described procedure. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
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 Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to 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. Existing regulations of the board implement that requirement.
This bill would remove that obsolete date.
(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
(e)A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions, consistent with the prescribers instructions.
SEC. 2.Section 4076.6 is added to the Business and Professions Code, to read:4076.6.(a)Upon the request of a patient or patients representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b)A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispensers existing responsibility to correctly label a prescription pursuant to Section 4076.
(f)For purposes of this section, a dispenser does not include a veterinarian.
SEC. 3.Section 4199 of the Business and Professions Code is amended to read:4199.(a)Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076, 4076.6, and 4077.
(b)All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
SEC. 4.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.
(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
(e)A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions, consistent with the prescribers instructions.
SEC. 2.Section 4076.6 is added to the Business and Professions Code, to read:4076.6.(a)Upon the request of a patient or patients representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b)A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispensers existing responsibility to correctly label a prescription pursuant to Section 4076.
(f)For purposes of this section, a dispenser does not include a veterinarian.
SEC. 3.Section 4199 of the Business and Professions Code is amended to read:4199.(a)Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076, 4076.6, and 4077.
(b)All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
SEC. 4.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.
(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
(e)A pharmacist shall use professional judgment in determining the content of the to provide a patient with directions for use. use that enhance the patients understanding of those directions, consistent with the prescribers instructions.
SEC. 2.Section 4076.6 is added to the Business and Professions Code, to read:4076.6.(a)Upon the request of a patient or patients representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b)A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispensers existing responsibility to correctly label a prescription pursuant to Section 4076.
(f)For purposes of this section, a dispenser does not include a veterinarian.
SEC. 3.Section 4199 of the Business and Professions Code is amended to read:4199.(a)Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076, 4076.6, and 4077.
(b)All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
SEC. 4.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.
(a)A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturers trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturers trade name or the commonly used name or the principal active ingredients.
(2)The directions for the use of the drug.
(3)The name of the patient or patients.
(4)The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)The date of issue.
(6)The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)The strength of the drug or drugs dispensed.
(8)The quantity of the drug or drugs dispensed.
(9)The expiration date of the effectiveness of the drug dispensed.
(10)The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)(A)Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)Prescriptions dispensed by a veterinarian.
(ii)An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)Dispensed medications for which no physical description exists in any commercially available database.
(B)This paragraph applies to outpatient pharmacies only.
(C)The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice.
(e)A pharmacist shall use professional judgment in determining the content of the directions for use.
SECTION 1.SEC. 2.Section 4076.6 is added to the Business and Professions Code, to read:4076.6.(a)Upon the request of a patient or patients representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b)A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)Nothing A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispensers existing responsibility to correctly label a prescription pursuant to Section 4076.
(f)For purposes of this section, a dispenser does not include a veterinarian.
SEC. 2.SEC. 3.Section 4199 of the Business and Professions Code is amended to read:4199.(a)Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076, 4076.6, and 4077.
(b)All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
SEC. 3.SEC. 4.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.
(a)For all dangerous drugs dispensed to patients in this state, when applicable and in the professional judgment of the dispenser, a dispenser shall use a standardized direction for use on the label of the prescription container from the list in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(b)The board shall make available translations, in a minimum of five languages other than English, of the standardized directions for use that are listed in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. These translations shall be approved by qualified translators, as determined by the board. The board shall post these translated standardized directions for use on its Internet Web site. The board shall allow a dispenser a period of 180 days from the date of adoption by the board of any change to the translated standardized directions for use to implement that change.
(c)Upon the request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those established in accordance with subdivision (b), if available, and append it to the label on the patients prescription container or provide it on a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the container. The translated direction for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. The English version may appear in an area of the label outside the patient-centered area.
(d)A dispenser may provide his or her own translated directions, in any language other than English, as an alternative to the translations made available by the board and the procedure established in subdivisions (a) to (c), inclusive. The translated directions for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations or a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the container. The English version may appear in other areas of the label outside the patient-centered area.
SEC. 2.Section 1714.20 is added to the Civil Code, immediately following Section 1714.2, to read:1714.20.(a)A dispenser who complies with subdivision (c) of Section 4076.6 of the Business and Professions Code shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
(b)This section does not affect existing liability under this division for translated directions not approved by the California State Board of Pharmacy.
SECTION 1.Section 4076.6 is added to the Business and Professions Code, to read:4076.6.(a)Upon the request of a patient or patients representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document.
(b)A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)Nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient.
(f)For purposes of this section, a dispenser does not include a veterinarian.
SEC. 2.Section 4199 of the Business and Professions Code is amended to read:4199.(a)Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food producing animals from a veterinary food-animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076 4076, 4076.6, and 4077.
(b)All prescriptions filled by a veterinary food-animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333.
SEC. 3.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.
(a)For all dangerous drugs dispensed to patients in this state, when applicable and in the professional judgment of the dispenser, a dispenser shall use a standardized direction for use on the label of the prescription container from the list in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(b)The board shall make available translations, in a minimum of five languages other than English, of the standardized directions for use that are listed in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. These translations shall be approved by qualified translators, as determined by the board. The board shall post these translated standardized directions for use on its Internet Web site. The board shall allow a dispenser a period of 180 days from the date of adoption by the board of any change to the translated standardized directions for use to implement that change.
(c)Upon the request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those established in accordance with subdivision (b), if available, and append it to the label on the patients prescription container or provide it on a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the label. container. The translated direction for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. The English version may appear in an area of the label outside the patient-centered area.
(d)A dispenser may provide his or her own translated directions, in any language other than English, as an alternative to the translations made available by the board and the procedure established in subdivisions (a) to (c), inclusive. The translated directions for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations or a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the container. The English version may appear in other areas of the label outside the patient-centered area.
SEC. 2.Section 1714.20 is added to the Civil Code, immediately following Section 1714.2, to read:1714.20.(a)A dispenser who complies with subdivision (c) of Section 4076.6 of the Business and Professions Code shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
(b)This section does not affect existing liability under this division for translated directions not approved by the California State Board of Pharmacy.
SEC. 3.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.
(a)For all dangerous drugs dispensed to patients in this state, when applicable, applicable and in the professional judgment of the dispenser, a dispenser shall use a standardized direction for use on the label of the prescription container from the list in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(b)The board shall make available translations, in a minimum of five languages other than English, of the standardized directions for use that are listed in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. These translations shall be approved by qualified translators, as determined by the board. The board shall post these translated standardized directions for use on its Internet Web site.
(c)Upon the request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those established in accordance with subdivision (b), if available, and append it to the label on the patients prescription container or provide it on a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the label. The translated direction for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. The English version may appear in an area of the label outside the patient-centered area.
(d)A dispenser may provide his or her own translated directions as an alternative to the procedure established in subdivisions (a) to (c), inclusive. The translated directions for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations or a supplemental document. The English version may appear in other areas of the label outside the patient-centered area.
SEC. 2.Section 1714.20 is added to the Civil Code, immediately following Section 1714.2, to read:1714.20.A dispenser who complies with subdivision (c) of Section 4076.6 of the Business and Professions Code shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
SEC. 3.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.
(a)For all dangerous drugs dispensed to patients in this state, when applicable, a dispenser shall use a standardized direction for use on the label of the prescription container from the list in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(b)The board shall make available translations, in a minimum of five languages other than English, of the standardized directions for use that are listed in subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. These translations shall be approved by qualified translators, as determined by the board. The board shall post these translated standardized directions for use on its Internet Web site.
(c)Upon the request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those established in accordance with subdivision (b), if available, and append it to the label on the patients prescription container or provide it on a supplemental document. If a translated direction for use appears on a prescription container label, the English version of the direction shall also appear on the label. The translated direction for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations. The English version may appear in an area of the label outside the patient-centered area.
(d)A dispenser may provide his or her own translated directions as an alternative to the procedure established in subdivisions (a) to (c), inclusive. The translated directions for use shall appear in the patient-centered area of the label in accordance with subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations or a supplemental document. The English version may appear in other areas of the label outside the patient-centered area.
SEC. 2.Section 1714.20 is added to the Civil Code, immediately following Section 1714.2, to read:1714.20.A dispenser who complies with subdivision (c) of Section 4076.6 of the Business and Professions Code shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
SEC. 3.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.
SECTION 1.Section 4076.5 of the Business and Professions Code is amended to read:4076.5.(a)The board shall promulgate regulations that require 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)The board may exempt from the regulations promulgated pursuant to subdivision (a) prescriptions dispensed to a patient in a health facility, as defined in Section 1250 of the Health and Safety Code, if the prescriptions are administered by a licensed health care professional. Prescriptions dispensed to a patient in a health facility that will not be administered by a licensed health care professional or that are provided to the patient upon discharge from the facility shall be subject to this section and the regulations promulgated pursuant to subdivision (a). Nothing in this subdivision shall alter or diminish existing statutory and regulatory informed consent, patients rights, or pharmaceutical labeling and storage requirements, including, but not limited to, Section 1418.9 of the Health and Safety Code or Section 72357, 72527, or 72528 of Title 22 of the California Code of Regulations.
(e)(1)The board may exempt from the regulations promulgated pursuant to subdivision (a) a prescription dispensed to a patient if all of the following apply:
(A)The drugs are dispensed by a JCAHO-accredited home infusion or specialty pharmacy.
(B)The patient receives health-professional-directed education before the beginning of therapy by a nurse or pharmacist.
(C)The patient receives weekly or more frequent followup contacts by a nurse or pharmacist.
(D)Care is provided under a formal plan of care based upon a physician and surgeons orders.
(2)For purposes of paragraph (1), home infusion and specialty therapies include parenteral therapy or other forms of administration that require regular laboratory and patient monitoring.
(a)The board shall promulgate regulations that require, on or before January 1, 2011, require 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)The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) prescriptions dispensed to a patient in a health facility, as defined in Section 1250 of the Health and Safety Code, if the prescriptions are administered by a licensed health care professional. Prescriptions dispensed to a patient in a health facility that will not be administered by a licensed health care professional or that are provided to the patient upon discharge from the facility shall be subject to the requirements of this section and the regulations promulgated pursuant to subdivision (a). Nothing in this subdivision shall alter or diminish existing statutory and regulatory informed consent, patients rights, or pharmaceutical labeling and storage requirements, including, but not limited to, the requirements of Section 1418.9 of the Health and Safety Code or Section 72357, 72527, or 72528 of Title 22 of the California Code of Regulations.
(e)(1)The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) a prescription dispensed to a patient if all of the following apply:
(A)The drugs are dispensed by a JCAHO-accredited home infusion or specialty pharmacy.
(B)The patient receives health-professional-directed education prior to before the beginning of therapy by a nurse or pharmacist.
(C)The patient receives weekly or more frequent followup contacts by a nurse or pharmacist.
(D)Care is provided under a formal plan of care based upon a physician and surgeons orders.
(2)For purposes of paragraph (1), home infusion and specialty therapies include parenteral therapy or other forms of administration that require regular laboratory and patient monitoring.
|
Date
|
Status
|
|---|---|
| Sep 9, 2015 | In Assembly. Concurrence in Senate amendments pending. |
| Jul 8, 2015 | Read second time and amended. Re-referred to Com. on JUD. |
| Jul 9, 2015 | Re-referred to Com. on APPR. |
| Jul 9, 2015 | Withdrawn from committee. |
| Aug 17, 2015 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8. |
| Aug 18, 2015 | Read second time. Ordered to third reading. |
| Sep 1, 2015 | Read third time and amended. Ordered to second reading. |
| Sep 2, 2015 | Read second time. Ordered to third reading. |
| Sep 4, 2015 | Read third time and amended. Ordered to second reading. |
| Sep 8, 2015 | Read second time. Ordered to third reading. |
| Jul 7, 2015 | From committee: Amend, and do pass as amended and re-refer to Com. on JUD. (Ayes 7. Noes 0.) (July 6). |
| Sep 9, 2015 | Read third time. Passed. Ordered to the Assembly. |
| Sep 9, 2015 | Read third time. Passed. Ordered to the Assembly. (Ayes 40. Noes 0. Page 2636.). |
| Sep 10, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Sep 10, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0. Page 3066.). |
| Sep 10, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0.). |
| Sep 18, 2015 | Enrolled and presented to the Governor at 4 p.m. |
| Oct 11, 2015 | Approved by the Governor. |
| Oct 11, 2015 | Chaptered by Secretary of State - Chapter 784, Statutes of 2015. |
| May 6, 2015 | From committee: Do pass. (Ayes 16. Noes 0.) (May 6). |
| Mar 1, 2015 | From printer. May be heard in committee March 31. |
| Mar 2, 2015 | Read first time. |
| Mar 19, 2015 | Referred to Com. on B. & P. |
| Apr 6, 2015 | From committee chair, with author's amendments: Amend, and re-refer to Com. on B. & P. Read second time and amended. |
| Apr 7, 2015 | Re-referred to Com. on B. & P. |
| Apr 9, 2015 | In committee: Hearing postponed by committee. |
| Apr 27, 2015 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (April 21). |
| Apr 28, 2015 | Read second time and amended. |
| Apr 29, 2015 | Re-referred to Com. on APPR. |
| Feb 27, 2015 | Introduced. To print. |
| May 7, 2015 | Read second time. Ordered to third reading. |
| May 14, 2015 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 14, 2015 | Read third time. Passed. Ordered to the Senate. |
| May 14, 2015 | Read third time. Passed. Ordered to the Senate. (Ayes 76. Noes 0. Page 1438.) |
| May 28, 2015 | Referred to Coms. on B., P. & E.D. and JUD. |
| Jun 9, 2015 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Jun 11, 2015 | In committee: Hearing postponed by committee. |
| Jun 17, 2015 | In committee: Set, first hearing. Hearing canceled at the request of author. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 10, 2015 | AB 1073 TING Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Sep 9, 2015 | Assembly 3rd Reading AB1073 Ting By Hernandez | Senate Floor |
Passed |
|
| Jul 6, 2015 | Do pass as amended, but first amend, and re-refer to the Committee on [Judiciary] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| May 14, 2015 | AB 1073 TING Assembly Third Reading | Assembly Floor |
Passed |
|
| May 6, 2015 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 21, 2015 | Do pass as amended and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| American Federation of State, County and Municipal Employees | ** Support | Sep 9, 2015 |
| Asian Americans Advancing Justice-Los Angeles | ** Support | Sep 9, 2015 |
| Board of Pharmacy | ** Support | Sep 9, 2015 |
| California Board of Pharmacy | * Support | Jul 6, 2015 |
| California Healthy Nail Salon Collaborative | ** Support | Sep 9, 2015 |
| California Immigrant Policy Center | ** Support | Sep 9, 2015 |
| California Pan-Ethnic Health Network | ** Support | Sep 9, 2015 |
| California Pharmacist Association | * Neutral | Jul 6, 2015 |
| California Retailers Association | ** Support | Sep 9, 2015 |
| California State Board of Pharmacy | ** Support | Jul 6, 2015 |
| California Veterinary Medical Association | * Neutral | Jul 6, 2015 |
| Health Access California | ** Support | Sep 9, 2015 |
| Justice in Aging, Asian Health Services | ** Support | Sep 9, 2015 |
| Latina Coalition for Healthy California | * Support | Jul 6, 2015 |
| Latino Coalition for a Health California | ** Support | Sep 9, 2015 |
| National Association Of Chain Drug Stores | * Indeterminate | Apr 21, 2015 |
| Occupational Therapy Association Of California | * Neutral | Jul 6, 2015 |
| Rite Aid Pharmacy | ** Support | Sep 9, 2015 |
| Southeast Asia Resource Action Center | ** Support | Sep 9, 2015 |
| The City Project | ** Support | Sep 9, 2015 |
| Touro University of California | ** Support | Sep 9, 2015 |
| Walgreen Co. | * Support | Jul 6, 2015 |
AB 1073
Page 3
CONCURRENCE IN SENATE AMENDMENTS
AB 1073
(Ting)
As Amended September 4, 2015
Majority vote
ASSEMBLY: |
76-0 |
(May 14, 2015) |
SENATE: |
40-0 |
(September 9, 2015) |
Original Committee Reference: B. & P.
SUMMARY: Requires dispensers, upon request of a patient or patient's representative, to provide translated directions, provided by the Board of Pharmacy (BOP), for use on prescription containers. Specifies that a dispenser is responsible for the accuracy of the English-language directions provided to the patient.
The Senate amendments:
Specify that, upon the request of a patient or patient's representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
Permit a dispenser to use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations.
Specify that a dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the BOP has made available in translated form.
Indicate that nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
Specify that a dispenser shall be responsible for the accuracy of the English-language
directions for use provided to the patient. This section shall not affect a dispenser's existing responsibility to correctly label a prescription pursuant to Section 4076.
Clarify that for purposes of this section, a dispenser does not include a veterinarian.
Specifies that a dispenser shall use professional judgment to provide a patient with directions for use that enhance the patient's understanding of those directions, consistent with the prescriber's instructions.
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by the BOP. According to the author, "Access to healthcare is undermined if patients and medical professionals cannot communicate effectively. AB 1073 would help limited-English proficient (LEP) patients across California access healthcare in their primary language by helping them understand prescription drug information in their primary language, a need that can literally be a matter of life and death. This bill would require pharmacists to provide LEP patients with translated directions for use on prescription drug labels, by ensuring that all LEP patients understand how to take their medication safely and without error. "
Background. Business and Professions Code Section 4076.5, requires the BOP to develop standardized, patient-centered prescription labels. In 2010, the BOP adopted regulations to require directions for use and improved font types and sizes on the labels of prescription drug containers.
In order to address the needs of patients with LEP, the BOP regulations also require pharmacies to provide oral translation services in at least 12 languages via on-site or telephone – based interpretive services. The BOP is also required to publish on its Web site standardized and translated directions for use in at least five languages other than English including, 1) Chinese, 2) Korean, 3) Russian, 4) Spanish and 5) Vietnamese. However, these translations have not been widely adopted by pharmacies due to concerns about liability in the event that there are errors in the translated materials that pharmacy staff may be unable to detect.
Patients with Limited English Proficiency (LEP). A report from the Institute of Medicine estimates that at least 1.5 million Americans are sickened, injured or killed each year because of medication errors. This is particularly troubling when one examines the growing and diverse population of California. According to data from the 2010 United States Census, of the more than 6.5 million residents of California, one out of every five speak English "less than very well." Additionally, over 44% of Californians speak a language other than English at home and almost half of Medi-Cal enrollees have LEP.
It can be difficult for even the most educated patient to understand complicated medication regimens. According to an article in the Journal of the American Medical Association, 46% of adults cannot understand the information listed on their prescription drug labels. When factoring in a patient who has LEP, this problem is exacerbated as there are communication barriers that may result in a lack of understanding and a lack of adherence to a prescribed medication regimen. For example, a study in the Journal of the American Medical Association revealed that patients who have LEP, who do not receive adequate interpreter services when needed, are unlikely to understand their diagnosis and treatment provided by their physician. Additionally, a study in the Journal of General Internal Medicine found that patients who have LEP, who received translated standardized directions for use, were more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen and simplify medication use by consolidating when pills should be taken.
Other States. In 2007, a study in the Journal of the American Medical Association found that of 200 pharmacists in New York City, 88% reported serving patients with LEP. The pharmacists reported that 78% of the patients spoke Spanish and 16% spoke Chinese.
In 2012, New York enacted the first state law that requires all chain and mail order pharmacies to provide comprehensive translation and interpretation services for patients who have LEP, including written translations of all prescription drug labels and directions for use.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0002355
AB 1073
Page 7
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 1073
Amended: 9/4/15 in Senate
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson, Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 76-0, 5/14/15 - See last page for vote
SUBJECT: Pharmacy: prescription drug labels
DIGEST: This bill requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use, authorizes a dispenser to use translations made available by the Board of Pharmacy (Board), and requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient and clarifies that veterinarians are not subject to these provisions.
Senate Floor Amendments of 9/4/15 clarify that a pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescriber’s instructions.
Senate Floor Amendments of 9/1/15 make technical changes and require English-language versions of directions for use to be provided when translated directions for use are provided.
Existing law:
Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified. (Business and Professions Code (BPC) § 4076)
Requires the Board to promulgate regulations for a standardized, patient-centered, prescription drug label on all prescription medication dispensed in the state. (BPC § 4076.5 (a))
Requires the Board, when considering the requirements for prescription labels, to consider:
Medical literacy research.
Improved directions for use.
Improved font types and sizes.
Placement of information that is patient-centered.
The needs of patients with limited English proficiency.
The needs of senior citizens.
Technology requirements necessary to implement the standards. (BPC § 4076.5 (c))
Establishes the Dymally-Alatorre Bilingual Services Act (Act) which requires each state agency to conduct a survey, related to its bilingual services, of each of its statewide offices which render services to the public every two years to determine specified information, and to report results and any additional information requested to the California Department of Human Resources (CalHR). Requires the survey to contain a detailed description of complaints regarding language access received by the agency. The Act also requires each agency that serves a substantial number of non-English-speaking people who comprise five percent or more of the people served to develop an implementation plan, as specified, in every odd-numbered year, and to submit the implementation plan to the department for its review. Additionally, the Act requires CalHR, if it determines that a state agency has not made reasonable progress toward complying with the Act, to issue orders that it deems appropriate to effectuate the purposes of the Act. (Government Code (GC) § 7290 et seq.)
Stipulates that, by July 1, 2015, a state agency subject to the Act must translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Also, requires that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. In addition, requires that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. (GC § 7299.3)
This bill:
Requires a pharmacist to use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescriber’s instructions.
Requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use printed on the prescription container, label, or on a supplemental document. Requires the English version of the direction for use to appear on the container or label whenever possible when a translated direction for use appears on the container. Requires the English version to appear on a supplemental document when it is not possible for it to appear on the container.
Authorizes a dispenser to use translations made available by the Board but does not require a dispenser to provide translated directions for use beyond the language that the Board has made available or beyond the directions that the Board has made available in translated form. Authorizes a dispenser to provide his or her own translations.
Requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient.
Clarifies that dispenser does not include a veterinarian, for purposes of these requirements.
Background
State government agency efforts to serve California’s limited English proficient (LEP) population. The Dymally-Alatorre Bilingual Services Act ensures that all residents, including those who are LEP, have equal access to public services. The Act requires every state and local agency to have a sufficient number of qualified bilingual staff and translated written materials so that the LEP population they serve are able to effectively access and communicate with government. The Act became law in 1973 with the legislative intent of ensuring people are not precluded from accessing public services because of language barriers. It requires agencies to provide the same information that is available in English in other languages if the agency services a “substantial number” of non-English speakers.
Medication errors and legislative response. According to the Journal of the American Medical Association, 46 percent of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies indicates that medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90 percent of Medicare patients take medications for chronic conditions with nearly half of them taking five or more medications a day. Given the large numbers of prescriptions that may be prescribed, it is not easily discernable what the purpose for each of these medications is. This increases the chances that a patient may take the wrong medication increasing the likelihood of serious injury or death. SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) established the Medication Errors Panel (Panel) which published a report in March 2007 entitled, “Prescription for Improving Patient Safety: Addressing Medication Errors.” One bill was pursued in response to the Panel report, SB 472 (Corbett, Chapter 470, Statutes of 2007), the California Patient Medication Safety Act, which sought to deal with the lack of uniformity in prescription drug labels throughout the state and the resulting confusion and medication errors that may arise.
Implementation of a standardized prescription drug label and translation efforts by the Board of Pharmacy. California is the first state to require redesigned prescription container labels to emphasize information most important to consumers offering an element of safety and consistency since prescription labels are the key source of patients’ reference for information when taking medications in their homes. Part of this current requirement also ensures that oral interpreter services are available to limited English speaking patients in pharmacies, to insure such patients have access to information about how to take their medications. The Board’s regulation, contained in Title 16 California Code of Regulations Section 1707.5 – “Requirements For Patient-Centered Prescription Container Labels” outlines that the following items must be clustered into one area of the label that comprises at least 50 percent of the label, using at least 10-point font using sans serif typeface, listing these items in the following order: name of the patient; name of the drug and strength of the drug; directions for use and; purpose or condition, if entered onto the prescription by the prescriber, or otherwise known to the pharmacy, and its inclusion on the label is requested by the patient.
The regulation also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency and understand the information on the label in the patient’s language. The pharmacy’s policies and procedures must be specified in writing, and must include, at minimum, the selected means to identify the patient’s language, and to provide interpretive services in the patient’s language. Pharmacies must provide, at minimum, interpretive services in the patient’s language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.
The Board also promulgated a regulation to amend its Notice to Consumers poster which has also been printed in six additional languages: Chinese, Korean, Russian, Spanish, Tagalog, and Vietnamese, and which is available upon request from the Board or available for download from the Board’s website. Pharmacies are also authorized to request Board approval of another format or display methodology. The Board also developed a “Point to Your Language” poster, which is required to be posted in pharmacies at or adjacent to the pharmacy counter so that consumers can point to a language to receive interpreter services. The “Point to Your Language” text is printed in 12 languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese. A Board project supported by The California Endowment, in an effort to support quality labels for those who do not read English, relied on national patient literacy researchers to develop and vet translations of the Board’s standardized directions for use as outlined in the patient-centered label regulation. Those translations are available on the Board’s website.
The author and supporters of this bill believe that LEP individuals who receive translated standardized directions for use are more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen, and simplify medication use by consolidating when pills should be taken but they are concerned that there is no existing law that requires dispensers to provide patients with translated directions for use and that although translations have been posted in Chinese, Korean, Russian, Spanish, and Vietnamese, they have not been widely adopted by pharmacies.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes
Board of Pharmacy (source)
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice—Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California Retailers Association
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
The City Project
Touro University of California
None received
ARGUMENTS IN SUPPORT: Supporters cite studies that show that a large percentage of patients misunderstand dosage instructions on their labels and estimate that at least 1.5 million Americans are sickened, injured, or killed each year because of medication errors, which are only exacerbated for California’s LEP patients. Supporters believe that this lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens and support this bill as a means to reduce medical errors, increase patient compliance, and meet the needs of LEP patients.
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Perea, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Beth Gaines, Roger Hernández, Patterson, Rendon
Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104
9/8/15 20:56:23
**** END ****
AB 1073
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 1073
Amended: 9/1/15 in Senate
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson, Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 76-0, 5/14/15 - See last page for vote
SUBJECT: Pharmacy: prescription drug labels
DIGEST: This bill requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use, authorizes a dispenser to use translations made available by the Board of Pharmacy (Board), and requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient and clarifies that veterinarians are not subject to these provisions.
Senate Floor Amendments of 9/1/15 make technical changes and require English-language versions of directions for use to be provided when translated directions for use are provided.
Existing law:
Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified. (Business and Professions Code (BPC) § 4076)
Requires the Board to promulgate regulations for a standardized, patient-centered, prescription drug label on all prescription medication dispensed in the state. (BPC § 4076.5 (a))
Requires the Board, when considering the requirements for prescription labels, to consider:
Medical literacy research.
Improved directions for use.
Improved font types and sizes.
Placement of information that is patient-centered.
The needs of patients with limited English proficiency.
The needs of senior citizens.
Technology requirements necessary to implement the standards. (BPC § 4076.5 (c))
Establishes the Dymally-Alatorre Bilingual Services Act (Act) which requires each state agency to conduct a survey, related to its bilingual services, of each of its statewide offices which render services to the public every two years to determine specified information, and to report results and any additional information requested to the California Department of Human Resources (CalHR). Requires the survey to contain a detailed description of complaints regarding language access received by the agency. The Act also requires each agency that serves a substantial number of non-English-speaking people who comprise 5 percent or more of the people served to develop an implementation plan, as specified, in every odd-numbered year, and to submit the implementation plan to the department for its review. Additionally, the Act requires CalHR, if it determines that a state agency has not made reasonable progress toward complying with the Act, to issue orders that it deems appropriate to effectuate the purposes of the Act. (Government Code (GC) § 7290 et seq.)
Stipulates that, by July 1, 2015, a state agency subject to the Act must translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Also, requires that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. In addition, requires that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. (GC § 7299.3)
This bill:
Requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use printed on the prescription container, label, or on a supplemental document. Requires the English version of the direction for use to appear on the container or label whenever possible when a translated direction for use appears on the container. Requires the English version to appear on a supplemental document when it is not possible for it to appear on the container.
Authorizes a dispenser to use translations made available by the Board but does not require a dispenser to provide translated directions for use beyond the language that the Board has made available or beyond the directions that the Board has made available in translated form. Authorizes a dispenser to provide his or her own translations.
Requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient.
Clarifies that dispenser does not include a veterinarian, for purposes of these requirements.
Background
State government agency efforts to serve California’s limited English proficient (LEP) population. The Dymally-Alatorre Bilingual Services Act ensures that all residents, including those who are LEP, have equal access to public services. The Act requires every state and local agency to have a sufficient number of qualified bilingual staff and translated written materials so that the LEP population they serve are able to effectively access and communicate with government. The Act became law in 1973 with the legislative intent of ensuring people are not precluded from accessing public services because of language barriers. It requires agencies to provide the same information that is available in English in other languages if the agency services a “substantial number” of non-English speakers.
Medication errors and legislative response. According to the Journal of the American Medical Association, 46 percent of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies indicates that medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90 percent of Medicare patients take medications for chronic conditions with nearly half of them taking five or more medications a day. Given the large numbers of prescriptions that may be prescribed, it is not easily discernable what the purpose for each of these medications is. This increases the chances that a patient may take the wrong medication increasing the likelihood of serious injury or death. SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) established the Medication Errors Panel (Panel) which published a report in March 2007 entitled, “Prescription for Improving Patient Safety: Addressing Medication Errors.” One bill was pursued in response to the Panel report, SB 472 (Corbett, Chapter 470, Statutes of 2007), The California Patient Medication Safety Act, which sought to deal with the lack of uniformity in prescription drug labels throughout the state and the resulting confusion and medication errors that may arise.
Implementation of a standardized prescription drug label and translation efforts by the Board of Pharmacy. California is the first state to require redesigned prescription container labels to emphasize information most important to consumers offering an element of safety and consistency since prescription labels are the key source of patients’ reference for information when taking medications in their homes. Part of this current requirement also ensures that oral interpreter services are available to limited English speaking patients in pharmacies, to insure such patients have access to information about how to take their medications. The Board’s regulation, contained in Title 16 California Code of Regulations Section 1707.5 – “Requirements For Patient-Centered Prescription Container Labels” outlines that the following items must be clustered into one area of the label that comprises at least 50 percent of the label, using at least 10-point font using sans serif typeface, listing these items in the following order: name of the patient; name of the drug and strength of the drug; directions for use and; purpose or condition, if entered onto the prescription by the prescriber, or otherwise known to the pharmacy, and its inclusion on the label is requested by the patient.
The regulation also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency and understand the information on the label in the patient’s language. The pharmacy’s policies and procedures must be specified in writing, and must include, at minimum, the selected means to identify the patient’s language, and to provide interpretive services in the patient’s language. Pharmacies must provide, at minimum, interpretive services in the patient’s language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.
The Board also promulgated a regulation to amend its Notice to Consumers poster which has also been printed in six additional languages: Chinese, Korean, Russian, Spanish, Tagalog, and Vietnamese, and which is available upon request from the Board or available for download from the Board’s website. Pharmacies are also authorized to request Board approval of another format or display methodology. The Board also developed a “Point to Your Language” poster, which is required to be posted in pharmacies at or adjacent to the pharmacy counter so that consumers can point to a language to receive interpreter services. The “Point to Your Language” text is printed in 12 languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese. A Board project supported by The California Endowment, in an effort to support quality labels for those who do not read English, relied on national patient literacy researchers to develop and vet translations of the Board’s standardized directions for use as outlined in the patient-centered label regulation. Those translations are available on the Board’s website.
The author and supporters of this bill believe that LEP individuals who receive translated standardized directions for use are more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen, and simplify medication use by consolidating when pills should be taken but they are concerned that there is no existing law that requires dispensers to provide patients with translated directions for use and that although translations have been posted in Chinese, Korean, Russian, Spanish, and Vietnamese, they have not been widely adopted by pharmacies.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes
Board of Pharmacy (source)
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice—Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California Retailers Association
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
The City Project
Touro University of California
None received
ARGUMENTS IN SUPPORT: Supporters cite studies that show that a large percentage of patients misunderstand dosage instructions on their labels and estimate that at least 1.5 million Americans are sickened, injured, or killed each year because of medication errors, which are only exacerbated for California’s LEP patients. Supporters believe that this lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens and support this bill as a means to reduce medical errors, increase patient compliance, and meet the needs of LEP patients.
ASSEMBLY FLOOR: 76-0, 5/14/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Perea, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Beth Gaines, Roger Hernández, Patterson, Rendon
Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104
9/2/15 14:24:59
AB 1073
Page 7
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 1073
Amended: 7/8/15 in Senate
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson, Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 76-0, 5/14/15 - See last page for vote
SUBJECT: Pharmacy: prescription drug labels
DIGEST: This bill requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use, authorizes a dispenser to use translations made available by the Board of Pharmacy (Board), and requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient and clarifies that veterinarians are not subject to these provisions.
Existing law:
Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified, including:
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.
The directions for the use of the drug.
The name of the patient or patients.
The name of the prescriber, as specified.
The date of issue.
The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
The strength of the drug or drugs dispensed.
The quantity of the drug or drugs dispensed.
The expiration date of the effectiveness of the drug dispensed.
The condition for which the drug was prescribed if requested by the patient and the condition is indicated on the prescription.
The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. (Business and Professions Code (BPC) § 4076)
Requires the Board to promulgate regulations for a standardized, patient-centered, prescription drug label on all prescription medication dispensed in the state. (BPC § 4076.5 (a))
Requires the Board, when considering the requirements for prescription labels, to consider:
Medical literacy research.
Improved directions for use.
Improved font types and sizes.
Placement of information that is patient-centered.
The needs of patients with limited English proficiency.
The needs of senior citizens.
Technology requirements necessary to implement the standards. (BPC § 4076.5 (c))
Establishes the Dymally-Alatorre Bilingual Services Act (Act) which requires each state agency to conduct a survey, related to its bilingual services, of each of its statewide offices which render services to the public every two years to determine specified information, and to report results and any additional information requested to the California Department of Human Resources (CalHR). Requires the survey to contain a detailed description of complaints regarding language access received by the agency. The Act also requires each agency that serves a substantial number of non-English-speaking people who comprise 5% or more of the people served to develop an implementation plan, as specified, in every odd-numbered year, and to submit the implementation plan to the department for its review. Additionally, the Act requires CalHR, if it determines that a state agency has not made reasonable progress toward complying with the Act, to issue orders that it deems appropriate to effectuate the purposes of the Act. (Government Code (GC) § 7290 et seq.)
Stipulates that, by July 1, 2015, a state agency subject to the Act must translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Also, requires that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. In addition, requires that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. (GC § 7299.3)
This bill:
Requires a dispenser, upon the request of a patient or patient’s representative, to provide translated directions for use printed on the prescription container, label, or on a supplemental document.
Authorizes a dispenser to use translations made available by the Board but does not require a dispenser to provide translated directions for use beyond the language that the Board has made available or beyond the directions that the Board has made available in translated form.
Requires a dispenser to be responsible for the accuracy of the English-language directions for use provided to a patient.
Clarifies that dispenser does not include a veterinarian, for purposes of these requirements.
Background
State government agency efforts to serve California’s limited English proficient (LEP) population. The Dymally-Alatorre Bilingual Services Act ensures that all residents, including those who are LEP, have equal access to public services. The Act requires every state and local agency to have a sufficient number of qualified bilingual staff and translated written materials so that the LEP population they serve are able to effectively access and communicate with government. The Act became law in 1973 with the legislative intent of ensuring people are not precluded from accessing public services because of language barriers. It requires agencies to provide the same information that is available in English in other languages if the agency services a “substantial number” of non-English speakers.
Medication errors and legislative response. According to the Journal of the American Medical Association, 46 percent of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies indicates that medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90 percent of Medicare patients take medications for chronic conditions with nearly half of them taking five or more medications a day. Given the large numbers of prescriptions that may be prescribed, it is not easily discernable what the purpose for each of these medications is. This increases the chances that a patient may take the wrong medication increasing the likelihood of serious injury or death. SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) established the Medication Errors Panel (Panel) which published a report in March 2007 entitled, “Prescription for Improving Patient Safety: Addressing Medication Errors.” One bill was pursued in response to the Panel report, SB 472 (Corbett, Chapter 470, Statutes of 2007), The California Patient Medication Safety Act, which sought to deal with the lack of uniformity in prescription drug labels throughout the state and the resulting confusion and medication errors that may arise.
Implementation of a standardized prescription drug label and translation efforts by the Board of Pharmacy. California is the first state to require redesigned prescription container labels to emphasize information most important to consumers offering an element of safety and consistency since prescription labels are the key source of patients’ reference for information when taking medications in their homes. Part of this current requirement also ensures that oral interpreter services are available to limited English speaking patients in pharmacies, to insure such patients have access to information about how to take their medications. The Board’s regulation, contained in Title 16 California Code of Regulations Section 1707.5 – “Requirements For Patient-Centered Prescription Container Labels” outlines that the following items must be clustered into one area of the label that comprises at least 50 percent of the label, using at least 10-point font using sans serif typeface, listing these items in the following order: name of the patient; name of the drug and strength of the drug; directions for use and; purpose or condition, if entered onto the prescription by the prescriber, or otherwise known to the pharmacy, and its inclusion on the label is requested by the patient.
The regulation also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency and understand the information on the label in the patient’s language. The pharmacy’s policies and procedures must be specified in writing, and must include, at minimum, the selected means to identify the patient’s language, and to provide interpretive services in the patient’s language. Pharmacies must provide, at minimum, interpretive services in the patient’s language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.
The Board also promulgated a regulation to amend its Notice to Consumers poster which has also been printed in six additional languages: Chinese, Korean, Russian, Spanish, Tagalog, and Vietnamese, and which is available upon request from the Board or available for download from the Board’s website. Pharmacies are also authorized to request Board approval of another format or display methodology. The Board also developed a “Point to Your Language” poster, which is required to be posted in pharmacies at or adjacent to the pharmacy counter so that consumers can point to a language to receive interpreter services. The “Point to Your Language” text is printed in 12 languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese. A Board project supported by The California Endowment, in an effort to support quality labels for those who do not read English, relied on national patient literacy researchers to develop and vet translations of the Board’s standardized directions for use as outlined in the patient-centered label regulation. Those translations are available on the Board’s website.
The author and supporters of this bill believe that LEP individuals who receive translated standardized directions for use are more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen, and simplify medication use by consolidating when pills should be taken but they are concerned that there is no existing law that requires dispensers to provide patients with translated directions for use and that although translations have been posted in Chinese, Korean, Russian, Spanish, and Vietnamese, they have not been widely adopted by pharmacies.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes
Board of Pharmacy (source)
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice—Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California Retailers Association
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
The City Project
Touro University of California
OPPOSITION: (Verified 8/18/15)
None received
ARGUMENTS IN SUPPORT: Supporters cite studies that show that a large percentage of patients misunderstand dosage instructions on their labels and estimate that at least 1.5 million Americans are sickened, injured, or killed each year because of medication errors, which are only exacerbated for California’s LEP patients. Supporters believe that this lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens and support this bill as a means to reduce medical errors, increase patient compliance, and meet the needs of LEP patients.
ASSEMBLY FLOOR: 76-0, 5/14/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Perea, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Beth Gaines, Roger Hernández, Patterson, Rendon
Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104
8/19/15 20:42:56
**** END ****
AB 1073 (Ting) Page 14 of 14
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1073 Hearing Date: July 6, 2015
Author: |
Ting |
||
Version: |
June 9, 2015 |
||
Urgency: |
No |
Fiscal: |
Yes |
Consultant: |
Sarah Mason |
||
Subject: Pharmacy: prescription drug labels.
SUMMARY:
Requires a dispenser to use a standardized direction for use on the label of a prescription container for limited English proficient patients in five languages, according to translations provided by the Board of Pharmacy on its website. Authorizes a dispenser to provide his or her own translated directions in any language other than English as an alternative to the translations made available by the Board. Specifies that a dispenser who provides the Board’s translated directions for use shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
Existing law:
Under the Pharmacy Law, provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 4000 et seq.)
Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian or naturopathic doctor. (BPC § 4059)
Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified, including:
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.
The directions for the use of the drug.
The name of the patient or patients.
The name of the prescriber, as specified.
The date of issue.
The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
The strength of the drug or drugs dispensed.
The quantity of the drug or drugs dispensed.
The expiration date of the effectiveness of the drug dispensed.
The condition for which the drug was prescribed if requested by the patient and the condition is indicated on the prescription.
The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules. (BPC § 4076)
Requires the Board to promulgate regulations on or before January 1, 2011, for a standardized, patient-centered, prescription drug label on all prescription medication dispensed in the state. (BPC § 4076.5 (a))
Requires the Board to hold public meetings statewide in order to seek information on a standardized label from groups representing consumers, seniors, pharmacists, the practice of pharmacy, other health care professionals, and other interested parties. (BPC § 4076.5 (b))
Requires the Board, when considering the requirements for prescription labels, to consider: (BPC § 4076.5 (c))
Medical literacy research.
Improved directions for use.
Improved font types and sizes.
Placement of information that is patient-centered.
The needs of patients with limited English proficiency.
The needs of senior citizens.
Technology requirements necessary to implement the standards.
Establishes the Dymally-Alatorre Bilingual Services Act (Act) which requires each state agency to conduct a survey, related to its bilingual services, of each of its statewide offices which render services to the public every two years to determine specified information, and to report results and any additional information requested to the California Department of Human Resources (CalHR). Requires the survey to contain a detailed description of complaints regarding language access received by the agency. The Act also requires each agency that serves a substantial number of non-English-speaking people who comprise 5% or more of the people served to develop an implementation plan, as specified, in every odd-numbered year, and to submit the implementation plan to the department for its review. Additionally, the Act requires CalHR, if it determines that a state agency has not made reasonable progress toward complying with the Act, to issue orders that it deems appropriate to effectuate the purposes of the Act. (Government Code Section 7290 et seq.)
Stipulates that, by July 1, 2015, a state agency subject to the Act must translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Also, requires that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. In addition, requires that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. (GC § 7299.3)
This
bill:
Requires a dispenser to use a standardized direction for use on the label of a prescription container from the list provided in the Board’s regulations establishing the patient centered label.
Requires the Board to make available translations, in a minimum of five languages other than English of the standardized directions for use. Specifies that the translations must be approved by qualified translators, as determined by the Board and that the Board must post these standardized directions for use on its Internet Web site. Provides the dispenser a period of 180 days from the date of adoption of the Board of any change to the translated standardized directions for use to implement that change.
Provides that, upon request of a patient for a translated direction for use, a dispenser shall select the appropriate translated standardized direction for use from those made available by the Board pursuant to the provisions in 2) above, if available, and append the direction for use to the label on the patient’s prescription container or provide it on a supplemental document.
Provides that if a translated direction for use appears on a container, the English version of the direction for use shall also appear on the label. Requires the translated direction for use to appear in the patient-centered area of the label in accordance with Board regulations. Authorizes the English version to appear in an area of the label outside the patient-centered area.
Authorizes a dispenser to provide his or her own translated directions in any language other than English as an alternative to the translations made available by the Board and procedures outlined above. Requires the translated direction for use to appear in the patient-centered area of the label in accordance with Board regulations. Requires the English version of the direction to appear on the prescription container if a translated direction for use appears on a container. Authorizes the English version to appear in an area of the label outside the patient-centered area.
Provides that a dispenser who provides the Board’s translated directions for use shall not be liable for civil damages for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English. States that this section does not affect existing liability under this division for translated directions not approved by the Board.
FISCAL EFFECT: This bill is keyed “fiscal” by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated May 6, 2015, this bill will result in minor and absorbable costs to the Board.
COMMENTS:
Purpose. The Board of Pharmacy is the Sponsor of this measure. According to the Author, as healthcare for California’s diverse population becomes increasingly accessible through Covered California, it is more critical than ever to ensure that all patients receive culturally-competent care. The Author cites the 2010 U.S. Census which found that more than 6.5 million residents of California, one out of every five, speak English “less than very well.” Over 44% of Californians speak a language other than English at home. Furthermore, almost half of Medi-Cal enrollees are limited English proficient (LEP), with 3 million more enrollees expected to need language assistance over the next five years as the program expands. According to the Author, research has found that difficulty in understanding instructions results in lack of adherence to a prescribed medication regimen, as well as dangerous and sometimes fatal medical reactions that could have been easily avoided. The Author states that this problem rings true for all patients, as prescription medication information is complex and cannot be easily imparted during brief consultations with a pharmacist. The risk of falling victim to the problem is particularly high for LEP patients who face communication barriers with health care providers and pharmacists.
According to the Author, research published in the Journal of General Internal Medicine found that LEP individuals who received translated standardized directions for use were more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen, and simplify medication use by consolidating when pills should be taken.
According to the Author, there is no existing law that requires dispensers to provide patients with translated directions for use. According to the Author, in attempt to address the needs of Limited English Proficient (LEP) patients, Board regulations require pharmacies to provide oral translation services in at least 12 languages via on-site or telephone-based interpretive services, and require the Board to publish on its website standardized and translated directions for use in at least five languages other than English. The Author notes that although translations have been posted in Chinese, Korean, Russian, Spanish, and Vietnamese, they have not been widely adopted by pharmacies. According to the Author, the broad utilization of these translated materials by pharmacies has been impeded by concerns over liability in the event that there are inadvertent errors in materials which pharmacy staff cannot detect. The Author states that this bill would require pharmacists to provide LEP patients with a translated standardized direction for use, and remove barriers for utilization of these translations, bringing the state one big step closer to making patient-centered prescription labels available.
Government Agency Efforts to Serve California’s LEP Population. The Dymally-Alatorre Bilingual Services Act ensures that all residents, including those who are LEP, have equal access to public services. The Act requires every state and local agency to have a sufficient number of qualified bilingual staff and translated written materials so that the LEP population they serve are able to effectively access and communicate with government. The Act became law in 1973 with the Legislative intent of ensuring people are not precluded from accessing public services because of language barriers. It requires agencies to provide the same information that is available in English in other languages if the agency services a "substantial number" of non-English speakers. To determine which languages must be included under the defined threshold, agencies are required to conduct surveys every other year to assess their contact with non-English speakers. Then, they must create or update implementation plans to ensure compliance and submit them to CalHR.
Medication Errors and Legislative Response. According to the Journal of the American Medical Association, 46 percent of adults cannot understand the information listed on their prescription drug labels. Furthermore, the Institute of Medicine of the National Academies indicates that medication errors are among the most common medical errors, harming at least 1.5 million people annually. Families USA reports that 90 percent of Medicare patients take medications for chronic conditions with nearly half of them taking five or more medications a day. Given the large numbers of prescriptions that may be prescribed, it is not easily discernable what the purpose for each of these medications is. This increases the chances that a patient may take the wrong medication increasing the likelihood of serious injury or death.
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) established the Medication Errors Panel (Panel) which published a report in March 2007 entitled, "Prescription for Improving Patient Safety: Addressing Medication Errors." The report listed six general goals to reduce medication errors. Under each goal were recommendations (12 in all) and methods to accomplish each recommendation. The Panel report states that "the information that consumers need to know about regarding their medication is often complex and may include unfamiliar language or concepts. Expecting a consumer to retain all the pertinent knowledge from a brief verbal encounter may not be reasonable in many instances." Although the Panel did not come to consensus on the most important subset of consumers that are at “high risk” for medication errors, it did acknowledge that there are a variety of factors which may increase an individual’s risk for experiencing a medication error. These include: i) low health literacy; ii) limited English proficiency; iii) cultural incongruence with healthcare providers; iv) physical, cognitive and/or other impairments that make understanding and/or complying with medication instructions difficult; v) age at either end of the age spectrum (the variability of a medication’s response, metabolism and dose increases in children and seniors); vi) multiple medications; vii) multiple prescribers; viii) non-prescription medication use (including herbals, dietary supplements, alcohol, and tobacco); and, ix) medication procurement from more than one pharmacy including mail-order. The Panel did state that these factors must be taken into consideration in the development of any consumer education efforts.
One bill was pursued in response to the Panel report. SB 472, The California Patient Medication Safety Act, (Corbett, Chapter 470, Statutes 2007) sought to deal with the lack of uniformity in prescription drug labels throughout the state and the resulting confusion and medication errors that may arise. Much of the conversation during the SB 472 debate focused on the fact that individual pharmacies design and format their own labels, resulting in a lack of standards across all pharmacies which adversely affects medication users who are elderly, suffer from poor vision, have difficulty reading and understanding instructions on labels or have limited English proficiency.
The bill required the Board to promulgate regulations on or before January 1, 2011, that require a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients. Additionally, the Board was required to report to the Legislature by January 1, 2010, on its progress in implementing these regulations.
Implementation of a Standardized Prescription Drug Label by the Board of Pharmacy. California is the first state to require redesigned prescription container labels to emphasize information most important to consumers offering an element of safety and consistency since prescription labels are the key source of patients’ reference for information when taking medications in their homes. Part of this current requirement also ensures that oral interpreter services are available to limited English speaking patients in pharmacies, to insure such patients have access to information about how to take their medications.
The Board was charged with promulgating regulations that require a standardized, patient-centered prescription drug container label for all prescription drugs dispensed to patients in California. The Board reported on its efforts in a January 2010 report to the Legislature. The Board established a “SB 472 Medication Label Subcommittee” in January of 2008, to conduct public forums and to work with organizations and individuals to develop recommendations to implement the provisions of the law to establish a patient-centered prescription drug label. In May 2008, the Board developed an open-ended prescription label survey for distribution at public outreach events. A total of 606 consumers completed the surveys.
When asked what to change on the prescription label, the top
responses were:
Print should be larger or darker = 30.1%
Nothing needs to be changed on the label =24.6%
Include purpose of drug = 12%
The Board concluded that most consumers participating in the survey requested larger and bolder type font on prescription labels to increase readability. Many participants suggested that if a generic drug is provided, the prescription label should state the name of the generic drug name and the brand-name it is generic for. They also noted that color printing and highlighting on labels brings attention to important information. Some participants suggested that the labels themselves be color-coded to help differentiate between multiple medications and family members. Many consumers responded that they want to know “what the drug is for” and suggested that “the purpose of drug” be printed directly on prescription labels.
The Board approved a regulation per the requirements set forth in SB 472 after engaging in a lengthy process. The Board conducted outreach, hearings and information gathering sessions throughout 2008, to collect data from the public on prescription labels and standards for those labels. The Board considered testimony and information provided from the public, the pharmaceutical industry, pharmacy professionals and literacy subject matter experts on medical literacy research, improved directions for use, improved font types and sizes, the placement of information that is patient-centered, the needs of patients with limited English proficiency, the needs of senior citizens, and technology requirements necessary to implement the standards developed. Board members were also provided with research articles on designing patient-centered labels. In 2009, the Board discussed the requirements of the regulation at regularly scheduled meetings.
Throughout early 2010, the Board held regulation hearings to adopt the proposed regulation, a new section at Title 16 California Code of Regulations Section 1707.5 – “Requirements For Patient-Centered Prescription Container Labels.” The regulation outlines that the following items must be clustered into one area of the label that comprises at least 50 percent of the label, using at least 10-point font using sans serif typeface, listing these items in the following order:
Name of the patient.
Name of the drug and strength of the drug. (“Name of the drug” means either the manufacturer’s trade name, or the generic name and the name of the manufacturer.)
Directions for use.
Purpose or condition, if entered onto the prescription by the prescriber, or otherwise known to the pharmacy, and its inclusion on the label is requested by the patient.
Since the adoption of the regulation, the Board has continued to evaluate the implementation of the requirements provided under SB 472. When the Board initially promulgated the regulation, a requirement was included for the Board to reevaluate the regulation by December 2013. In April 2013, the Board’s Public Education subcommittee began its review of the regulation. As a result of discussions at these subcommittee meetings (which are presented to the full Board for further discussion at Board meetings), in April 2014 the Board initiated a new rulemaking request to change the font size to a minimum of 12-point, rather than the current 10-point. Additionally, the new rulemaking request requires that only four items be clustered into one area of the label that comprises at least 50 percent of the label. The Board continues to discuss the directions for use component of the standardized label at its Public Education subcommittee meetings.
Translation Efforts by the Board. The regulation outlining requirements for a patient-centered label also requires pharmacies to have policies and procedures in place to help patients with limited or no English proficiency and understand the information on the label in the patient’s language. The pharmacy’s policies and procedures must be specified in writing, and must include, at minimum, the selected means to identify the patient’s language, and to provide interpretive services in the patient’s language. Pharmacies must provide, at minimum, interpretive services in the patient’s language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.
Following the implementation of the patient-centered prescription label requirements, the Board also promulgated a regulation to amend its Notice to Consumers poster which has also been printed in six additional languages: Chinese, Korean, Russian, Spanish, Tagalog, and Vietnamese, and which is available upon request from the Board or available for download from the Board’s website. Pharmacies are also authorized to request Board approval of another format or display methodology. The Board also developed a “Point to Your Language” poster, which is required to be posted in pharmacies at or adjacent to the pharmacy counter so that consumers can point to a language to receive interpreter services. The “Point to Your Language” text is printed in 12 languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese.
According to the Board, The California Endowment, in an effort to support quality labels for those who do not read English, funded a project with national patient literacy researchers to develop and vet translations of the Board’s standardized directions for use as outlined in the patient-centered label regulation. According to information provided to the Board by one of the project leaders, the effort is a very intensive process and, while he would like to include more languages, based on the timeline provided in the regulation, translation of the standard directions for use in five languages is reasonable. The Board determined then that it will not require a pharmacy or pharmacist to provide patients with written translated prescription drug labels but specified that the adopted regulation does not prohibit a pharmacy from providing translated prescription drug labels to patients. The Board determined at the time it provided a final statement of reasons for its proposed regulation that providing fully vetted translations into five languages other than English of the standard directions for use, as well as the oral language interpretive services available, serve the needs of LEP patients.
The Board’s website provides the following disclosure related to
the translated directions for use stemming from the California
Endowment project: “While every effort was made to ensure accuracy
and reliability of these translations, the Board cannot ensure that a
particular translation is appropriate for a particular patient. The
Board recommends that each pharmacy and pharmacist confirm the
validity and the medical appropriateness of any given translation for
a particular patient before using it for the patient’s drug label.
Prior Related Legislation. AB 2253 (Ting, Chapter 469, Statutes of 2014) updated the Dymally-Alatorre Bilingual Services Act to require, by July 1, 2015, a state agency subject to the Act to translate and make accessible on the homepage of its Internet Web site, forms and processes for submitting complaints of alleged violations of the Act. Required that the forms and processes be translated into all languages spoken by a substantial number of non-English speaking people served by the state agency. Required that translated copies of the forms must be printed and made available in the statewide office and any local office of the state agency. Required CalHR to issue orders that it deems appropriate to effectuate the purposes of the Act if a state agency has not made reasonable progress toward reaching compliance.
SB 204 (Corbett) of 2013-14 originally would have required pharmacists to use the translated standard directions for use from the Board’s website when providing patients with translated directions in Spanish, Chinese, Vietnamese, Korean, and Russian on their prescription medication labels and would have required pharmacists to use certified translation services if they choose to provide translations in languages other than the five provided on the Board’s website. The bill was amended to require the Board to conduct a survey of pharmacists and vendors of electronic health records to gather information about the utilization of, and the obstacles to, the use the Board’s standardized directions for use on prescription drug labels. (Status: The measure was vetoed by Governor Brown who indicated in his veto message that “the Board currently does not have the resources to conduct these surveys.”)
SB 205 (Corbett) of 2013 would have required the information on the prescription label to be printed in at least a 12-point sans serif typeface. (Status: The bill was vetoed by Governor Brown who indicated in his veto message that “the Board of Pharmacy is required to provide an update of its 2010 labeling guidelines to the Legislature next month. I prefer to wait for their findings before mandating such a change.”)
AB 396 (Fox) of 2013 would have required every prescription to include a legible, clear notice of the condition or purpose for which the drug is prescribed, unless the patient or prescriber requests that this information be omitted. Also, would have required that every prescription container be correctly labeled to include that information, if indicated on the prescription, unless the patient or prescriber requests that this information be omitted. (Status: The bill was never heard in a policy committee.)
AB 1136 (Levine, Chapter 304, Statutes of 2013) required a pharmacist to include a written label on the drug container indicating that the drug may impair a person's ability to operate a vehicle or vessel.
SB 1390 (Corbett) of 2010 would have repealed the requirement that the Board promulgate regulations requiring a standardized, patient-centered, prescription drug label on all prescription medications dispensed to patients in California on or before January 1, 2011, and instead established statutory requirements for standardized, patient centered prescription drug labels. (Status: The bill failed passage in the Assembly Committee on Business, Professions and Consumer Protection.)
SB 470 (Corbett, Chapter 590, Statutes of 2009) permitted, if requested by patients, the purpose of the prescribed medication to be listed on prescription drug labels.
SB 472 (Corbett, Chapter 470, Statutes of 2007), the California Patient Medication Safety Act, required the Pharmacy Board to promulgate regulations that require a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. Additionally, the Board was required to report to the Legislature by January 1, 2010, on its progress in implementing these regulations.
AB 1276 (Karnette, 2007) would have required medication prescribers to ask a patient if they wanted the intended use on the prescription label. (Status: The measure failed passage in the Assembly Committee on Business and Professions.)
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005) created a panel to study the causes of medication errors and recommend changes in the health care system that reduces errors associated with the delivery of prescription and over the counter medication to consumers. This resolution required the panel to convene by October 1, 2005, and to submit to the Assembly Committee on Health and the Senate Committee on Health, a report on its finding by June 1, 2006.
AB 657 (Karnette, 2005) would have required prescription drug labels to include the intended purpose of the drug, if indicated on the prescription, and required prescribers to ask the patient or the patient's authorized representative, if the patient is either incapacitated or a minor who cannot provide informed consent, whether to indicate the intended purpose of the prescription on the label. (Status: The bill was held in this Committee at the request of the Author.)
AB 288 (Mountjoy, 2005) would have amended
the prescription labeling requirement to include the condition for
which the drug is prescribed unless the patient, physician or legal
guardian requested that the information be omitted. (Status:
The measure was held in the Assembly Committee on Business and
Professions at the request of the Author.)
AB 2125 (Levine, 2004) would have required a physician and surgeon to indicate the patient’s diagnosis on each prescription written, unless directed otherwise by the patient and amended the prescription labeling requirement to require that the condition be included on the label unless otherwise directed by the patient. (Status: The bill was held in the Assembly Committee on Business and Professions at the request of the Author.)
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.
AB 2099 (Epple, Chapter 397, Statutes of 1993) required that the condition for which the drug is being prescribed must be included on the label if the patient requests that information on the label.
Arguments in Support. Writing in support of the bill, a coalition of groups including the California Pan-Ethnic Health Network, Asian Americans Advancing Justice—Los Angeles, California Immigrant Policy Center , Latino Coalition for a Health California, and Southeast Asia Resource Action Center, states that studies show that a large percentage of patients misunderstand dosage instructions on their labels. The coalition cites The Institute of Medicine estimate that at least 1.5 million Americans are sickened, injured, or killed each year because of medication errors, which are only exacerbated for California’s LEP patients. The coalition states that this lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens. These groups support this bills effort to reduce medical errors, increase patient compliance, and meet the needs of LEP patients.
Justice in Aging, Asian Health Services, Touro University of California, Greenlining Institute, The City Project, and the California Healthy Nail Salon Collaborative all write in support of the bill, stating that AB 1073 will improve patient access to prescription drug information in their primary languages. According to these organizations, California is the most linguistically diverse state in the nation. The 2010 U.S. Census found over 6.5 million Californians speak English less than “very well,” and 44% of Californians speak a language other than English at home. The organizations state that this bill will ensure all Californians, regardless of the language they speak, understand how to safely and correctly take their medication by requiring a dispenser to use a standardized direction for use on the label of the prescription container.
According to the American Federation of State, County and Municipal Employees, AB 1073 would help LEP patients across California by helping them understand prescription drug information in their primary language. The organization states that it can be difficult for proficient English patients to understand complicated medication regimens and cites an article in the Journal of the American Medical Association showing that 46% of adults do not understand the information listed on their prescription drug labels and when factoring in a patient who has LEP, this problem is exacerbated.
The California State Board of Pharmacy states that AB 1073 contains important provisions to aid patients in understanding how to take their prescription medications accurately. According to the Board, enactment of this bill will encourage pharmacists to use the translations available from the Board’s Web site, when the pharmacist deems it appropriate. The Board states that pharmacists have advised the Board that they are reluctant to use the online translations because they cannot read the language themselves and the waiver of liability for an inadvertent transcription mistake contained in this bill resolves this issue.
Health Access California and Rite Aid Pharmacy state that prescription medications are an important element of health care, and AB 1073 recognizes the reality that many Californians need prescription drug labels in languages other than English in order for patient to adhere to medication regimens.
Arguments in Opposition. The National Association of Chain Drug Stores (NACDS), the California Retailers Association, and the California Pharmacists’ Association take an oppose unless amended position and state that the bill would impose new translation requirements on pharmacies without providing proper liability protections. According to the organizations, community pharmacies are required, by law, to develop prescription labels that provide information in a manner that is most useful and helpful to patients in addition to providing oral interpreter services to patients. A patient can request these interpreter services and the pharmacy will bring in an interpreter by phone to help in translating all information necessary for patients to properly comply with their medications. The groups note that in 2012, the Board finalized the patient centered labeling requirements but did not require translated labels due to strong concerns raised by pharmacists about their compromised ability to guarantee accurate information to a patient if a label was in a language they could not read. According to the organizations, AB 1073, while mandating translated labels, does authorize pharmacies to develop and implement their own translation services including translations on the label or on an insert, however it does not provide any liability protection for those pharmacists who work in pharmacies that choose to provide translation services through a different means than the Board’s five translations provided on their website. The groups state that in many cases, pharmacies can develop a more sophisticated and comprehensive translation program for their patients without utilizing the more limited Board translations and that these programs should be covered for liability purposes.
Proposed Author’s Amendments. In response to concerns raised by stakeholders as outlined above, the Author proposes restructuring the bill according to the following:
Strike the current provisions of the bill and replace with:
(a) Upon the request of a patient or patient’s representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document.
(b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with the requirements of this section.
(c) A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d) Nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e) A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient.
(f) For purposes of this section, a dispenser does not include a veterinarian.
NOTE:
Double-referral to Senate Judiciary Committee
SUPPORT AND OPPOSITION:
Support:
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice—Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California State Board of Pharmacy (Sponsor)
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
Touro University of California
The City Project
Opposition:
California Pharmacists’ Association
California Retailers Association
National Association of Chain Drug Stores
-- END --
AB 1073
Page 3
ASSEMBLY THIRD READING
AB 1073
(Ting)
As Amended April 28, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Business & Professions |
14-0 |
Bonilla, Jones, Baker, Bloom, Campos, Chang, Dodd, Eggman, Gatto, Holden, Mullin, Ting, Wilk, Wood |
|
Appropriations |
16-0 |
Gomez, Bigelow, Bloom, Bonta, Calderon, Chang, Daly, Eggman, Eduardo Garcia, Holden, Jones, Quirk, Rendon, Wagner, Weber, Wood |
|
SUMMARY: Requires the Board of Pharmacy (BOP) to post translated standardized directions for use in at least five languages other than English on its Web site. This bill requires pharmacists to provide these directions to patients with limited English proficiency, and limits the liability against pharmacies if the inaccurate standardized translations are provided to a patient. Specifically, this bill:
Requires a dispenser, in his or her professional judgment, to use a standardized direction for use on the label of the prescription container from a list in existing regulations.
Requires the BOP to make available translations of the standardized directions for use, in a minimum of five languages other than English,
Requires the BOP to post the standardized directions for use on its Web site.
Requires a dispenser, upon request of a patient, to provide the appropriate translated standardized direction for use, and append it to the label on a patient’s prescription container or provide it on a supplemental document.
Authorizes a dispenser to provide his or her own translated directions as an alternative.
Exempts a dispenser who complies with the requirement to select the translated standardized direction for use from civil liability if there is an error in appending the direction for use to the medication container or on a supplemental document.
FISCAL EFFECT: According to the Assembly Committee on Appropriations, the bill will result in minor and absorbable costs to the BOP.
COMMENTS:
Purpose. This bill is sponsored by the BOP. According to the author, "Access to healthcare is undermined if patients and medical professionals cannot communicate effectively. AB 1073 would help limited-English proficient (LEP) patients across California access healthcare in their primary language by helping them understand prescription drug information in their primary language, a need that can literally be a matter of life and death. This bill would require pharmacists to provide LEP patients with translated directions for use on prescription drug labels, by ensuring that all LEP patients understand how to take their medication safely and without error. "
Background. Business and Professions Code Section 4076.5, requires the BOP to develop standardized, patient-centered prescription labels. In 2010, the BOP adopted regulations to require directions for use and improved font types and sizes on the labels of prescription drug containers.
In order to address the needs of patients with LEP, the BOP regulations also require pharmacies to provide oral translation services in at least 12 languages via on-site or telephone – based interpretive services. The BOP is also required to publish on its Web site standardized and translated directions for use in at least five languages other than English including, 1) Chinese, 2) Korean, 3) Russian, 4) Spanish and 5) Vietnamese. However, these translations have not been widely adopted by pharmacies due to concerns about liability in the event that there are errors in the translated materials that pharmacy staff may be unable to detect.
Patients with Limited English Proficiency (LEP). A report from the Institute of Medicine estimates that at least 1.5 million Americans are sickened, injured or killed each year because of medication errors. This is particularly troubling when one examines the growing and diverse population of California. According to data from the 2010 United States Census, of the more than 6.5 million residents of California, one out of every five speak English "less than very well." Additionally, over 44% of Californians speak a language other than English at home and almost half of Medi-Cal enrollees have LEP.
It can be difficult for even the most educated patient to understand complicated medication regimens. According to an article in the Journal of the American Medical Association, 46% of adults cannot understand the information listed on their prescription drug labels. When factoring in a patient who has LEP, this problem is exacerbated as there are communication barriers that may result in a lack of understanding and a lack of adherence to a prescribed medication regimen. For example, a study in the Journal of the American Medical Association revealed that patients who have LEP, who do not receive adequate interpreter services when needed, are unlikely to understand their diagnosis and treatment provided by their physician. Additionally, a study in the Journal of General Internal Medicine found that patients who have LEP, who received translated standardized directions for use, were more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen and simplify medication use by consolidating when pills should be taken.
Other States. In 2007, a study in the Journal of the American Medical Association found that of 200 pharmacists in New York City, 88% reported serving patients with LEP. The pharmacists reported that 78% of the patients spoke Spanish and 16% spoke Chinese.
In 2012, New York enacted the first state law that requires all chain and mail order pharmacies to provide comprehensive translation and interpretation services for patients who have LEP, including written translations of all prescription drug labels and directions for use.
Arguments in Support:
The Board of Pharmacy (sponsor) writes in support, "The board believes that AB 1073 contains important provisions to aid patients in understanding how to take their prescription medications accurately. Moreover, AB 1073 represents another important milestone in the development of patient-centered labels in California. Enactment of this bill will encourage pharmacists to cut and paste the translations available from the board's Web site, when applicable, who currently state they are reluctant to use them because they cannot read the language themselves – the waiver of liability for an inadvertent mistake resolves this issue."
The California Healthy Nail Salon Collaborative writes in their letter of support, "The Collaborative comprises over 40 public health and environmental advocates, nail salon workers and owners, and allies in government agencies. The Collaborative focuses on language access for members of the nail salon community, 59%-80 % are Vietnamese. Many of those individuals are Limited English Proficient… We think that AB 1073 is a good idea and it’s about time, especially given the diversity of language in California."
The California Pan-Ethnic Health Network states in their letter of support, "A patient's first and best source of information about their medication is the prescription label… LEP patients are more than twice as likely as English speaking patients to have difficulty understanding their medications. This lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens."
Arguments in Opposition:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0000311
AB 1073
Page 1
Date of Hearing: May 6, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB 1073
(Ting) – As Amended April 28, 2015
Policy Committee: |
Business and Professions |
Vote: |
14 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill requires the Board of Pharmacy (BOP) to post translated standardized directions for use in at least five languages, other than English, on its website, requires pharmacists to provide these directions to patients with limited English proficiency, and limits the liability against pharmacies if the inaccurate standardized translations are provided to a patient.
FISCAL EFFECT:
Minor and absorbable costs to the BOP.
COMMENTS:
Purpose. The purpose of this bill is to mandate pharmacists provide translated directions on prescription bottles.
Background. Current law requires the BOP to develop standardized, patient-centered prescription labels. In 2010, the BOP adopted regulations to require directions for use and standard font types and sizes on the labels of prescription drug containers. The regulations also require pharmacies to provide oral translation services.
The BOP also publishes on its website standardized and translated directions for use in at least five languages other than English including, Chinese, Korean, Russian, Spanish and Vietnamese. But these translations have not been widely adopted by pharmacies due to concerns about liability, in the event that there are errors in the translated materials that pharmacy staff may be unable to detect. This bill allows immunity from liability for pharmacies that use the translated standardized directions provided by the BOP.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
AB 1073
Page 4
Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 1073
(Ting) – As Amended April 6, 2015
SUBJECT: Pharmacy: prescription drug labels.
SUMMARY: Requires the Board of Pharmacy (BOP) to post translated standardized directions for use in at least five languages other than English on its website. The bill requires pharmacists to provide these directions to patients with limited English proficiency, and limits the liability against pharmacies if the inaccurate standardized translations are provided to a patient.
EXISTING LAW:
Provides for the licensure and regulation of pharmacists by the BOP within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 4101 et seq.)
Requires that each prescription dispensed by a pharmacist must be in a container complying with state and federal law and correctly labeled as specified, including: (BPC § 4076)
Unless otherwise ordered by the prescriber, the manufacturer’s trade name of the drug or the generic name and the name of the manufacturer;
The directions for the use of the drug;
The name of the patient or patients;
The name of the prescriber;
The date of issue;
The name and address of the pharmacy, and prescription number or other means of identifying the prescription;
The strength of the drug or drugs dispensed;
The quantity of the drug or drugs dispensed;
The expiration date of the effectiveness of the drug dispensed;
The condition for which the drug was prescribed and the condition is indicated on the prescription; and,
The physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules.
Requires the BOP to 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. (BPC § 4076.5)
THIS BILL:
Requires a dispenser to use a standardized direction for use on the label of the prescription container from a list in existing regulations.
Requires the BOP to make available translations of the standardized directions for use, in a minimum of five (5) languages other than English,
Requires the BOP to post the standardized directions for use on its website.
Requires a dispenser, upon request of a patient, to provide the appropriate translated standardized direction for use, and append it to the label on a patient’s prescription container or provide it on a supplemental document.
Authorizes a dispenser to provide his or her own translated directions as an alternative.
Exempts a dispenser who complies with the requirement to select the translated standardized direction for use from civil liability if there is an error in appending the direction for use to the medication container or on a supplemental document.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, “Access to healthcare is undermined if patients and medical professionals cannot communicate effectively. AB 1073 would help limited-English proficient (LEP) patients across California access healthcare in their primary language by helping them understand prescription drug information in their primary language, a need that can literally be a matter of life and death. This bill would require pharmacists to provide LEP patients with translated directions for use on prescription drug labels, by ensuring that all LEP patients understand how to take their medication safely and without error.”
Background. Business and Professions Code section 4076.5, requires the BOP to develop standardized, patient-centered prescription labels. In 2010, the BOP adopted regulations to require directions for use and improved font types and sizes on the labels of prescription drug containers.
In order to address the needs of patients with LEP, the BOP regulations also require pharmacies to provide oral translation services in at least 12 languages via on-site or telephone – based interpretive services. The BOP is also required to publish on its website standardized and translated directions for use in at least five languages other than English including, 1) Chinese, 2) Korean, 3) Russian, 4) Spanish and 5) Vietnamese. However, these translations have not been widely adopted by pharmacies due to concerns about liability in the event that there are errors in the translated materials that pharmacy staff may be unable to detect.
Patients with Limited English Proficiency (LEP). A report from the Institute of Medicine estimates that at least 1.5 million Americans are sickened, injured or killed each year because of medication errors. This is particularly troubling when one examines the growing and diverse population of California. According to data from the 2010 U.S. Census, of the more than 6.5 million residents of California, one out of every five speak English “less than very well.” Additionally, over 44% of Californians speak a language other than English at home and almost half of Medi-Cal enrollees have LEP.
It can be difficult for even the most educated patient to understand complicated medication regimens. According to an article in the Journal of the American Medical Association, 46% of adults cannot understand the information listed on their prescription drug labels. When factoring in a patient who has LEP, this problem is exacerbated as there are communication barriers that may result in a lack of understanding and a lack of adherence to a prescribed medication regimen. For example, a study in the Journal of the American Medical Association revealed that patients who have LEP, who do not receive adequate interpreter services when needed, are unlikely to understand their diagnosis and treatment provided by their physician. Additionally, a study in the Journal of General Internal Medicine found that patients who have LEP, who received translated standardized directions for use, were more likely to take a single prescription medication appropriately, dose more medications correctly in a multi-drug regimen and simplify medication use by consolidating when pills should be taken.
Other States. In 2007, a study in the Journal of the American Medical Association found that of 200 pharmacists in New York City, 88% reported serving patients with LEP. The pharmacists reported that 78% of the patients spoke Spanish and 16% spoke Chinese.
In 2012, New York enacted the first state law that requires all chain and mail order pharmacies to provide comprehensive translation and interpretation services for patients who have LEP, including written translations of all prescription drug labels and directions for use.
Prior Related Legislation. SB 204 (Corbett) of 2013, originally required translations of the direction for use in non-English languages published on the BOP’s website to be used on labeling prescription containers, but was later amended to require the BOP to survey pharmacists’ compliance with using standardized directions. NOTE: This bill was vetoed by Governor Brown because he indicated that the BOP did not have the resources to conduct the surveys.
ARGUMENTS IN SUPPORT:
The Board of Pharmacy (sponsor) writes in support, “The board believes that AB 1073 contains important provisions to aid patients in understanding how to take their prescription medications accurately. Moreover, AB 1073 represents another important milestone in the development of patient-centered labels in California. Enactment of this bill will encourage pharmacists to cut and paste the translations available from the board’s Web site, when applicable, who currently state they are reluctant to use them because they cannot read the language themselves – the waiver of liability for an inadvertent mistake resolves this issue.”
The California Healthy Nail Salon Collaborative writes in their letter of support, “The Collaborative comprises over 40 public health and environmental advocates, nail salon workers and owners, and allies in government agencies. The Collaborative focuses on language access for members of the nail salon community, 59-80 % are Vietnamese. Many of those individuals are Limited English Proficient…We think that AB 1073 is a good idea and it’s about time, especially given the diversity of language in California.”
The California Pan-Ethnic Health Network states in their letter of support, “A patient’s first and best source of information about their medication is the prescription label…LEP patients are more than twice as likely as English speaking patients to have difficulty understanding their medications. This lack of understanding results in an increased risk of adverse drug reactions and non-compliance with drug regimens.”
AMENDMENT:
In order to clarify that it is the professional judgment of a dispenser to decide when a standardized direction or use on the label of a prescription is applicable, the following amendment should be made:
On page 2, in line 4, after “when applicable” please add: and in the professional judgment of a dispenser
ARGUMENTS IN OPPOSITION:
None on file.
REGISTERED SUPPORT:
Board of Pharmacy (sponsor)
California Healthy Nail Salon Collaborative
California Pan-Ethnic Health Network
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301
Discussed in Hearing
1MIN
Assembly Floor
2MIN
Senate Floor
8MIN
Senate Standing Committee on Business, Professions and Economic Development
49SEC
Assembly Floor
2MIN
Assembly Standing Committee on Appropriations
11MIN
Assembly Standing Committee on Business and Professions
Bill Author
Bill Co-Author(s):