SB 204, as amended, Corbett. Prescription drugs: labeling.
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing law prohibits a pharmacist from dispensing any prescription unless it is in a specified container that is correctly labeled to include, among other information, the directions for the use of the drug.begin delete A violation of the Pharmacy Law is a crime.end deletebegin insert Existing regulations of the board provide end insertbegin insertstandardized directions for use that are required to be used on drug container labels, as specified.end insert
This bill would require the board to conduct a survey of a representative sample of licensed pharmacists to determine the usage of the directions for use described above. The bill would require this survey to address certain issues, including, but not limited to, whether and how often the pharmacist utilizes the directions for use, barriers to utilizing the directions for use, and other directions for use utilized by the pharmacist. The bill would also require the board to conduct a similar survey of vendors that provide electronic health records (EHR) to pharmacies and prescribers to determine the type of directions for use included in the vendor’s EHR programming, as specified. The bill would authorize these surveys to be conducted with other routine surveys conducted by the board during its regular course of business. The bill would require the board to report the survey findings at its July 2016 board meeting and to publish the findings on the board’s Internet Web site, as specified.
end insertThis bill would, commencing January 1, 2016, require translations of the directions for use in non-English languages published on the board’s Internet Web site to be used, as applicable, when labeling a prescription container. The bill would, notwithstanding these provisions, authorize a pharmacy to use its own translations of the board’s English language directions for use, as specified, if a trained and qualified translator or translation service, as defined, is utilized to complete the additional translations. The bill would authorize the directions for use, as specified, to be translated into additional non-English languages if a trained and qualified translator or translation service, as defined, is utilized to complete the additional translations. The bill would authorize a pharmacist to use the English language directions for use, as specified, if he or she reasonably believes a translation of the directions for use contains an error due to software or equipment malfunction. The bill would also provide that a pharmacist that reasonably uses the translations of the directions for use in non-English languages published on the board’s Internet Web site has not breached his or her legal duty if the published translations contain an error and the pharmacist did not know, or did not have reason to know, of the error. The bill would require that the board’s English language directions for use be provided in each instance in which a non-English translation of the directions for use is used. Because a violation of this requirement would be a crime, the bill would impose a state-mandated local program.
end deleteThis bill would define “translation” and “trained and qualified translator or translation service” for purposes of the provisions described above.
end deleteThe 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.
end deleteThis bill would provide that no reimbursement is required by this act for a specified reason.
end deleteVote: majority.
Appropriation: no.
Fiscal committee: yes.
State-mandated local program: begin deleteyes end deletebegin insertnoend insert.
The people of the State of California do enact as follows:
begin insertSection 4076.3 is added to the end insertbegin insertBusiness and
2Professions Codeend insertbegin insert, to read:end insert
(a) The board shall conduct a survey of a
4representative sample of licensed pharmacists to determine the
5utilization of the standardized directions for use provided in
6paragraph (4) of subdivision (a) of Section 1707.5 of Article 2 of
7Division 17 of Title 16 of the California Code of Regulations. The
8survey shall address, but not be limited to, all of the following
9issues:
10(1) Whether the pharmacist utilizes the standardized directions
11for use.
12(2) How often the pharmacist utilizes the standardized directions
13for use.
14(3) Challenges or barriers to utilizing the standardized
15directions for use.
16(4) Other directions for use utilized by the pharmacist.
17(b) The board shall conduct a survey of vendors that provide
18electronic health records (EHR) to pharmacies and prescribers
19to determine the type of directions for use included in the vendor’s
20EHR programming. The survey shall address, but not be limited
21to, all of the following issues:
22(1) Whether the standardized directions for use described in
23subdivision (a) are included in the vendor’s EHR programming.
24(2) Challenges or barriers to utilizing the standardized
25directions for use in the vendor’s EHR programming.
26(3) Other directions for use utilized by the vendor in its EHR
27programming.
28(c) The surveys required by this section may be conducted with
29other routine surveys conducted by the board during its regular
30course of business.
31(d) The board shall report the findings of the surveys required
32by this section in the aggregate at its July 2016 board meeting and
33publish these findings on its Internet Web site.
34This section shall remain in effect only until January 1, 2020,
35and as of that date is repealed, unless a later enacted statute, that
36is enacted before January 1, 2020, deletes or extends that date.
Section 4076.3 is added to the Business and
38Professions Code, to read:
(a) Translations of the directions for use in non-English
2languages published on the board’s Internet Web site shall be used,
3as applicable, when labeling a prescription container pursuant to
4Section 4076.
5(b) The English language directions for use established by
6regulation of the board may be translated into additional
7non-English languages if a trained and qualified translator or
8
translation service is utilized to complete the additional translations.
9(c) Notwithstanding subdivision (a), a pharmacy may use its
10own translations of the directions for use established by regulation
11of the board in the non-English languages published on the board’s
12Internet Web site when labeling a prescription container pursuant
13to Section 4076 if a trained and qualified translator or translation
14service is utilized.
15(d) If a pharmacist reasonably believes that a translation of the
16directions
for use contains an error due to software or equipment
17malfunction, he or she may
use the English language directions
18for use established by regulation of the board
when labeling a
19prescription container pursuant to Section 4076.
20(e) A pharmacist that reasonably uses the translations of the
21directions for use in non-English languages published on the
22board’s Internet Web site has not breached his or her legal duty if
23the published translations contain an error and the pharmacist did
24not know, or did not have reason to know, of the error.
25(f) The English language directions for use established by
26regulation of the board shall be provided in each instance in which
27a non-English translation of the directions for use is used pursuant
28to this section.
29(g) For purposes of this section, “translation” means the
30conversion of written text to the corresponding written text in a
31different language.
32(h) For purposes of this section, “trained and qualified translator
33or translation service” means any of the following:
34(1) An individual certified by the American Translators
35Association or any other nationally accredited or state-approved
36program the board deems satisfactory.
37(2) An individual
trained in translation who has been assessed
38as competent by a company specializing in translation that employs,
39or has a contractual relationship with, the individual.
P5 1(3) An individual employed by a pharmacy who meets all of
2the following requirements:
3(A) He or she has written proficiency in both English and a
4non-English language.
5(B) He or she commits to abide by the American Translators
6Association’s Code of Professional Conduct and Business
7Practices.
8(C) He or she exhibits sufficient knowledge and understanding
9of required health care vocabulary and terminology related to the
10practice of pharmacy.
11A pharmacy shall establish internal policies to determine and
12document an individual’s qualifications pursuant to subparagraphs
13(A) to (C), inclusive, of this paragraph.
14(i) This section shall become operative on January 1, 2016.
No reimbursement is required by this act pursuant to
16Section 6 of Article XIII B of the California Constitution because
17the only costs that may be incurred by a local agency or school
18district will be incurred because this act creates a new crime or
19infraction, eliminates a crime or infraction, or changes the penalty
20for a crime or infraction, within the meaning of Section 17556 of
21the Government Code, or changes the definition of a crime within
22the meaning of Section 6 of Article XIII B of the California
23Constitution.
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