S T A T E O F N E W Y O R K
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11627
I N A S S E M B L Y
July 6, 2010
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Introduced by COMMITTEE ON RULES -- (at request of M. of A. Gottfried)
-- read once and referred to the Committee on Higher Education
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:
Section 1. The opening paragraph of section 21 of the public health
law is designated subdivision 1 and a new subdivision 2 is added to read
as follows:
2. THE COMMISSIONER SHALL PROMULGATE REGULATIONS REQUIRING THAT
PRESCRIPTION FORMS AND ELECTRONIC PRESCRIPTIONS INCLUDE: (A) A SECTION
WHEREIN PRESCRIBERS MUST INDICATE WHETHER AN INDIVIDUAL IS LIMITED
ENGLISH PROFICIENT; AND (B) IF THE PATIENT IS LIMITED ENGLISH PROFI-
CIENT, A LINE WHERE THE PRESCRIBER SHALL SPECIFY THE PREFERRED LANGUAGE
INDICATED BY THE PATIENT. FOR THE PURPOSES OF THIS SUBDIVISION, A
"LIMITED ENGLISH PROFICIENT INDIVIDUAL" MEANS AN INDIVIDUAL WHO IDENTI-
FIES AS BEING, OR IS EVIDENTLY, UNABLE TO SPEAK, READ OR WRITE ENGLISH
AT A LEVEL THAT PERMITS SUCH INDIVIDUAL TO UNDERSTAND HEALTH-RELATED AND
PHARMACEUTICAL INFORMATION COMMUNICATED IN ENGLISH.
S 2. Subdivision 1 of section 6810 of the education law, as amended by
chapter 905 of the laws of 1985, is amended to read as follows:
1. No drug for which a prescription is required by the provisions of
the Federal Food, Drug and Cosmetic Act or by the commissioner of health
shall be distributed or dispensed to any person except upon a
prescription written by a person legally authorized to issue such
prescription. Such drug shall be compounded or dispensed by a licensed
pharmacist, and no such drug shall be dispensed without affixing to the
immediate container in which the drug is sold or dispensed a label bear-
ing the name and address of the owner of the establishment in which it
was dispensed, the date compounded, the number of the prescription under
which it is recorded in the pharmacist's prescription files, the name of
the prescriber, the name and address of the patient, and the directions
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
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ALL LABELS SHALL CONFORM TO SUCH RULES AND REGULATIONS AS PROMULGATED BY
THE STATE BOARD OF PHARMACY PURSUANT TO SECTION SIXTY-EIGHT HUNDRED
TWENTY-NINE OF THIS ARTICLE. The prescribing and dispensing of a drug
which is a controlled substance shall be subject to additional require-
ments provided in article thirty-three of the public health law. The
words "drug" and "prescription required drug" within the meaning of this
article shall not be construed to include soft or hard contact lenses,
eyeglasses, or any other device for the aid or correction of vision.
Nothing in this subdivision shall prevent a pharmacy from furnishing a
drug to another pharmacy which does not have such drug in stock for the
purpose of filling a prescription.
S 3. The education law is amended by adding a new section 6829 to read
as follows:
S 6829. IMPROVE PATIENT SAFETY THROUGH INTERPRETATION REQUIREMENTS FOR
PRESCRIPTION DRUGS AND STANDARDIZED MEDICATION LABELING. 1. FOR THE
PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING
MEANINGS: (A) "CHAIN PHARMACY" MEANS ANY PHARMACY THAT IS PART OF A
GROUP OF FOUR OR MORE ESTABLISHMENTS THAT (I) CONDUCT BUSINESS UNDER THE
SAME BUSINESS NAME OR (II) OPERATE UNDER COMMON OWNERSHIP OR MANAGEMENT
OR PURSUANT TO A FRANCHISE AGREEMENT WITH THE SAME FRANCHISOR.
(B) "LIMITED ENGLISH PROFICIENT INDIVIDUAL" OR "LEP INDIVIDUAL" MEANS
AN INDIVIDUAL WHO IDENTIFIES AS BEING, OR IS EVIDENTLY, UNABLE TO SPEAK,
READ OR WRITE ENGLISH AT A LEVEL THAT PERMITS SUCH INDIVIDUAL TO UNDER-
STAND HEALTH-RELATED AND PHARMACEUTICAL INFORMATION COMMUNICATED IN
ENGLISH.
(C) "TRANSLATE" SHALL MEAN THE CONVERSION OF A WRITTEN TEXT FROM ONE
LANGUAGE INTO AN EQUIVALENT WRITTEN TEXT IN ANOTHER LANGUAGE BY AN INDI-
VIDUAL COMPETENT TO DO SO AND UTILIZING ALL NECESSARY PHARMACEUTICAL AND
HEALTH-RELATED TERMINOLOGY.
(D) "COMPETENT ORAL INTERPRETATION" MEANS ORAL COMMUNICATION IN WHICH
(I) A PERSON ACTING AS AN INTERPRETER COMPREHENDS A SPOKEN MESSAGE AND
RE-EXPRESSES THAT MESSAGE ACCURATELY IN ANOTHER LANGUAGE, UTILIZING ALL
NECESSARY PHARMACEUTICAL AND HEALTH-RELATED TERMINOLOGY; OR (II) A
BILINGUAL PHARMACY STAFF MEMBER COMMUNICATES PROFICIENTLY WITH AN LEP
INDIVIDUAL IN THE LEP INDIVIDUAL'S PRIMARY LANGUAGE UTILIZING ALL NECES-
SARY PHARMACEUTICAL AND HEALTH-RELATED TERMINOLOGY.
(E) "PHARMACY PRIMARY LANGUAGES" SHALL MEAN THE TOP SEVEN LANGUAGES
SPOKEN BY LEP INDIVIDUALS IN THIS STATE AS DETERMINED BIENNIALLY BY THE
STATE BOARD OF PHARMACY BASED ON DATA FROM THE MOST RECENT AMERICAN
COMMUNITY SURVEY FROM THE U.S. CENSUS BUREAU AND OTHER RELEVANT DATA
SOURCES.
2. (A) EVERY CHAIN PHARMACY SHALL PROVIDE FREE, COMPETENT ORAL INTER-
PRETATION SERVICES TO EACH LEP INDIVIDUAL FILLING A PRESCRIPTION AT SUCH
CHAIN PHARMACY IN THE LEP INDIVIDUAL'S PRIMARY LANGUAGE FOR THE PURPOSES
OF COUNSELING SUCH INDIVIDUAL ABOUT HIS OR HER PRESCRIPTION MEDICATIONS
OR WHEN SOLICITING INFORMATION NECESSARY TO MAINTAIN A PATIENT MEDICA-
TION PROFILE, UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES SUCH
SERVICES.
(B) EVERY CHAIN PHARMACY SHALL PROVIDE FREE, COMPETENT ORAL INTERPRE-
TATION OF PRESCRIPTION MEDICATION LABELS, WARNING LABELS AND OTHER WRIT-
TEN MATERIAL TO EACH LEP INDIVIDUAL FILLING A PRESCRIPTION AT SUCH CHAIN
PHARMACY, UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES SUCH SERVICES
OR THE MEDICATION LABEL, WARNING LABELS AND OTHER WRITTEN MATERIALS HAVE
ALREADY BEEN TRANSLATED INTO THE LANGUAGE SPOKEN BY THE LEP INDIVIDUAL.
(C) THE SERVICES REQUIRED BY THIS SECTION MAY BE PROVIDED BY A STAFF
MEMBER OF THE PHARMACY OR A THIRD-PARTY CONTRACTOR. SUCH SERVICES MUST
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BE PROVIDED ON AN IMMEDIATE BASIS BUT NEED NOT BE PROVIDED IN-PERSON OR
FACE-TO-FACE IN ORDER TO MEET THE REQUIREMENTS OF THIS SECTION.
3. EVERY CHAIN PHARMACY SHALL CONSPICUOUSLY POST, AT OR ADJACENT TO
EACH COUNTER OVER WHICH PRESCRIPTION DRUGS ARE SOLD, A NOTIFICATION OF
THE RIGHT TO FREE LANGUAGE ASSISTANCE SERVICES FOR LIMITED ENGLISH
PROFICIENT INDIVIDUALS AS PROVIDED FOR IN SUBDIVISION TWO OF THIS
SECTION. SUCH NOTIFICATIONS SHALL BE PROVIDED IN THE PHARMACY PRIMARY
LANGUAGES. THE SIZE, STYLE AND PLACEMENT OF SUCH NOTICE SHALL BE DETER-
MINED IN ACCORDANCE WITH RULES PROMULGATED BY THE STATE BOARD OF PHARMA-
CY.
4. (A) THE STATE BOARD OF PHARMACY SHALL DEVELOP RULES AND REGULATIONS
REQUIRING A STANDARDIZED, PATIENT-CENTERED, PRESCRIPTION DRUG LABEL TO
BE USED ON ALL PRESCRIPTION MEDICINE DISPENSED TO PATIENTS IN THIS
STATE.
(B) WHEN DEVELOPING THE REQUIREMENTS FOR PRESCRIPTION DRUG LABELS, THE
STATE BOARD OF PHARMACY SHALL CONSIDER FACTORS INCLUDING, BUT NOT LIMIT-
ED TO, THE FOLLOWING:
(I) MEDICAL LITERACY RESEARCH THAT POINTS TO INCREASED UNDERSTAND-
ABILITY OF LABELS;
(II) IMPROVED DIRECTIONS FOR USE;
(III) IMPROVED FONT TYPES AND SIZES;
(IV) PLACEMENT OF INFORMATION THAT IS PATIENT-CENTERED;
(V) THE NEEDS OF SENIOR CITIZENS.
TO ENSURE MAXIMUM PUBLIC COMMENT, THE STATE BOARD OF PHARMACY SHALL
HOLD PUBLIC MEETINGS TO SEEK INFORMATION FROM GROUPS REPRESENTING
CONSUMERS, SENIORS, PHARMACISTS OR THE PRACTICE OF PHARMACY, OTHER
HEALTH CARE PROFESSIONALS, AND OTHER INTERESTED PARTIES.
(C) TWO HUNDRED SEVENTY DAYS AFTER THE STATE BOARD OF PHARMACY HAS
ISSUED ITS FINAL RULES AND REGULATIONS REGARDING STANDARDIZED, PATIENT-
CENTERED PRESCRIPTION MEDICATION LABELS, CHAIN PHARMACIES SHALL PROVIDE
FREE, COMPETENT TRANSLATED MEDICATION LABELS TO EACH LEP INDIVIDUAL
FILLING A PRESCRIPTION AT SUCH CHAIN PHARMACY WHO SPEAKS ONE OF THE
PHARMACY PRIMARY LANGUAGES. NOTHING IN THIS SECTION SHALL PROHIBIT A
CHAIN PHARMACY FROM PROVIDING TRANSLATED MEDICATION LABELS IN LANGUAGES
IN ADDITION TO THE PHARMACY PRIMARY LANGUAGES. THE CHAIN PHARMACY SHALL
PROVIDE FREE, COMPETENT ORAL INTERPRETATION OF MEDICATION LABELS TO LEP
INDIVIDUALS WHO DO NOT SPEAK ONE OF THE PHARMACY PRIMARY LANGUAGES,
UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES SUCH SERVICES.
S 4. This act shall take effect one year after it shall become a law;
provided, however, that the commissioner of health, the commissioner of
education and the state board of pharmacy are immediately authorized and
directed to take actions necessary to implement this act when it takes
effect.