STATE OF NEW YORK
________________________________________________________________________
8365
IN SENATE
June 25, 2010
___________
Introduced by Sen. DUANE -- read twice and ordered printed, and when
printed to be committed to the Committee on Rules
AN ACT to amend the public health law and the education law, in relation
to prescription forms and labels, interpretation services and patients
with limited English proficiency
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The opening paragraph of section 21 of the public health
2 law is designated subdivision 1 and a new subdivision 2 is added to read
3 as follows:
4 2. The commissioner shall promulgate regulations requiring that
5 prescription forms and electronic prescriptions include: (a) a section
6 wherein prescribers must indicate whether an individual is limited
7 English proficient; and (b) if the patient is limited English profi-
8 cient, a line where the prescriber shall specify the preferred language
9 indicated by the patient. For the purposes of this subdivision, a
10 "limited English proficient individual" means an individual who identi-
11 fies as being, or is evidently, unable to speak, read or write English
12 at a level that permits such individual to understand health-related and
13 pharmaceutical information communicated in English.
14 § 2. Subdivision 1 of section 6810 of the education law, as amended by
15 chapter 905 of the laws of 1985, is amended to read as follows:
16 1. No drug for which a prescription is required by the provisions of
17 the Federal Food, Drug and Cosmetic Act or by the commissioner of health
18 shall be distributed or dispensed to any person except upon a
19 prescription written by a person legally authorized to issue such
20 prescription. Such drug shall be compounded or dispensed by a licensed
21 pharmacist, and no such drug shall be dispensed without affixing to the
22 immediate container in which the drug is sold or dispensed a label bear-
23 ing the name and address of the owner of the establishment in which it
24 was dispensed, the date compounded, the number of the prescription under
25 which it is recorded in the pharmacist's prescription files, the name of
26 the prescriber, the name and address of the patient, and the directions
27 for the use of the drug by the patient as given upon the prescription.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD17857-01-0
S. 8365 2
1 All labels shall conform to such rules and regulations as promulgated by
2 the state board of pharmacy pursuant to section sixty-eight hundred
3 twenty-nine of this article. The prescribing and dispensing of a drug
4 which is a controlled substance shall be subject to additional require-
5 ments provided in article thirty-three of the public health law. The
6 words "drug" and "prescription required drug" within the meaning of this
7 article shall not be construed to include soft or hard contact lenses,
8 eyeglasses, or any other device for the aid or correction of vision.
9 Nothing in this subdivision shall prevent a pharmacy from furnishing a
10 drug to another pharmacy which does not have such drug in stock for the
11 purpose of filling a prescription.
12 § 3. The education law is amended by adding a new section 6829 to read
13 as follows:
14 § 6829. Improve patient safety through interpretation requirements for
15 prescription drugs and standardized medication labeling. 1. For the
16 purposes of this section, the following terms shall have the following
17 meanings: (a) "Chain pharmacy" means any pharmacy that is part of a
18 group of four or more establishments that (i) conduct business under the
19 same business name or (ii) operate under common ownership or management
20 or pursuant to a franchise agreement with the same franchisor.
21 (b) "Limited English proficient individual" or "LEP individual" means
22 an individual who identifies as being, or is evidently, unable to speak,
23 read or write English at a level that permits such individual to under-
24 stand health-related and pharmaceutical information communicated in
25 English.
26 (c) "Translate" shall mean the conversion of a written text from one
27 language into an equivalent written text in another language by an indi-
28 vidual competent to do so and utilizing all necessary pharmaceutical and
29 health-related terminology.
30 (d) "Competent oral interpretation" means oral communication in which
31 (i) a person acting as an interpreter comprehends a spoken message and
32 re-expresses that message accurately in another language, utilizing all
33 necessary pharmaceutical and health-related terminology; or (ii) a
34 bilingual pharmacy staff member communicates proficiently with an LEP
35 individual in the LEP individual's primary language utilizing all neces-
36 sary pharmaceutical and health-related terminology.
37 (e) "Pharmacy primary languages" shall mean the top seven languages
38 spoken by LEP individuals in this state as determined biennially by the
39 state board of pharmacy based on data from the most recent American
40 Community Survey from the U.S. Census Bureau and other relevant data
41 sources.
42 2. (a) Every chain pharmacy shall provide free, competent oral inter-
43 pretation services to each LEP individual filling a prescription at such
44 chain pharmacy in the LEP individual's primary language for the purposes
45 of counseling such individual about his or her prescription medications
46 or when soliciting information necessary to maintain a patient medica-
47 tion profile, unless the LEP individual is offered and refuses such
48 services.
49 (b) Every chain pharmacy shall provide free, competent oral interpre-
50 tation of prescription medication labels, warning labels and other writ-
51 ten material to each LEP individual filling a prescription at such chain
52 pharmacy, unless the LEP individual is offered and refuses such services
53 or the medication label, warning labels and other written materials have
54 already been translated into the language spoken by the LEP individual.
55 (c) The services required by this section may be provided by a staff
56 member of the pharmacy or a third-party contractor. Such services must
S. 8365 3
1 be provided on an immediate basis but need not be provided in-person or
2 face-to-face in order to meet the requirements of this section.
3 3. Every chain pharmacy shall conspicuously post, at or adjacent to
4 each counter over which prescription drugs are sold, a notification of
5 the right to free language assistance services for limited English
6 proficient individuals as provided for in subdivision two of this
7 section. Such notifications shall be provided in the pharmacy primary
8 languages. The size, style and placement of such notice shall be deter-
9 mined in accordance with rules promulgated by the state board of pharma-
10 cy.
11 4. (a) The state board of pharmacy shall develop rules and regulations
12 requiring a standardized, patient-centered, prescription drug label to
13 be used on all prescription medicine dispensed to patients in this
14 state.
15 (b) When developing the requirements for prescription drug labels, the
16 state board of pharmacy shall consider factors including, but not limit-
17 ed to, the following:
18 (i) medical literacy research that points to increased understand-
19 ability of labels;
20 (ii) improved directions for use;
21 (iii) improved font types and sizes;
22 (iv) placement of information that is patient-centered;
23 (v) the needs of senior citizens.
24 To ensure maximum public comment, the state board of pharmacy shall
25 hold public meetings to seek information from groups representing
26 consumers, seniors, pharmacists or the practice of pharmacy, other
27 health care professionals, and other interested parties.
28 (c) Two hundred seventy days after the state board of pharmacy has
29 issued its final rules and regulations regarding standardized, patient-
30 centered prescription medication labels, chain pharmacies shall provide
31 free, competent translated medication labels to each LEP individual
32 filling a prescription at such chain pharmacy who speaks one of the
33 pharmacy primary languages. Nothing in this section shall prohibit a
34 chain pharmacy from providing translated medication labels in languages
35 in addition to the pharmacy primary languages. The chain pharmacy shall
36 provide free, competent oral interpretation of medication labels to LEP
37 individuals who do not speak one of the pharmacy primary languages,
38 unless the LEP individual is offered and refuses such services.
39 § 4. This act shall take effect one year after it shall become a law;
40 provided, however, that the commissioner of health, the commissioner of
41 education and the state board of pharmacy are immediately authorized and
42 directed to take actions necessary to implement this act when it takes
43 effect.
