S T A T E O F N E W Y O R K
________________________________________________________________________
7342--A
2011-2012 Regular Sessions
I N A S S E M B L Y
April 29, 2011
___________
Introduced by M. of A. GOTTFRIED, ORTIZ, DINOWITZ, JACOBS, P. RIVERA,
GALEF, RODRIGUEZ, LINARES, KAVANAGH, TITONE, CASTRO, JEFFRIES, HEVESI,
ROSENTHAL, CRESPO, MENG, BARRON, MOYA, JAFFEE -- Multi-Sponsored by --
M. of A. DenDEKKER, HEASTIE, McENENY, NOLAN, STEVENSON -- read once
and referred to the Committee on Higher Education -- committee
discharged, bill amended, ordered reprinted as amended and recommitted
to said committee
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 MAY INDICATE WHETHER AN INDIVIDUAL IS LIMITED
ENGLISH PROFICIENT; AND (B) IF THE PATIENT IS LIMITED ENGLISH PROFI-
CIENT, A LINE WHERE THE PRESCRIBER MAY 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
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02457-06-1
A. 7342--A 2
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.
ALL LABELS SHALL CONFORM TO SUCH RULES AND REGULATIONS AS PROMULGATED BY
THE COMMISSIONER 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 requirements
provided in article thirty-three of the public health law. The words
"drug" and "prescription required drug" within the meaning of this arti-
cle 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. INTERPRETATION REQUIREMENTS FOR PRESCRIPTION DRUGS AND STAND-
ARDIZED MEDICATION LABELING. 1. FOR THE PURPOSES OF THIS SECTION, THE
FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS: (A) "COVERED PHARMA-
CY" MEANS ANY PHARMACY THAT IS PART OF A GROUP OF FIVE OR MORE PHARMA-
CIES OWNED BY THE SAME CORPORATE ENTITY.
(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.
(F) "MAIL ORDER PHARMACY" SHALL MEAN A PHARMACY THAT DISPENSES MOST OF
ITS PRESCRIPTIONS THROUGH THE UNITED STATES POSTAL SERVICE OR OTHER
DELIVERY SYSTEM.
2. (A) EVERY COVERED PHARMACY AND MAIL ORDER PHARMACY SHALL PROVIDE
FREE, COMPETENT ORAL INTERPRETATION SERVICES TO EACH LEP INDIVIDUAL
FILLING A PRESCRIPTION AT SUCH COVERED PHARMACY OR THROUGH SUCH MAIL
ORDER 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-
A. 7342--A 3
TION PROFILE, UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES SUCH
SERVICES.
(B) EVERY COVERED PHARMACY AND MAIL ORDER PHARMACY SHALL PROVIDE FREE,
COMPETENT ORAL INTERPRETATION OF PRESCRIPTION MEDICATION LABELS, WARNING
LABELS AND OTHER WRITTEN MATERIAL TO EACH LEP INDIVIDUAL FILLING A
PRESCRIPTION AT SUCH COVERED PHARMACY OR THROUGH SUCH MAIL ORDER PHARMA-
CY, 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
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 COVERED PHARMACY SHALL CONSPICUOUSLY POST, AT OR ADJACENT TO
EACH COUNTER OVER WHICH PRESCRIPTION DRUGS ARE SOLD, AND EVERY MAIL
ORDER PHARMACY SHALL INCLUDE IN THE PACKAGE IN WHICH PRESCRIPTION DRUGS
ARE DELIVERED 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 DETERMINED IN ACCORDANCE WITH RULES PROMULGATED BY THE
COMMISSIONER.
4. ANY PERSON AGGRIEVED BY A FAILURE TO RECEIVE SERVICES REQUIRED BY
THIS SECTION SHALL HAVE A CAUSE OF ACTION ONLY AGAINST THE COVERED PHAR-
MACY OR MAIL ORDER PHARMACY IN ANY COURT OF COMPETENT JURISDICTION FOR
DAMAGES, INCLUDING PUNITIVE DAMAGES, AND FOR INJUNCTIVE RELIEF AND SUCH
OTHER REMEDIES AS MAY BE APPROPRIATE.
5. (A) THE COMMISSIONER 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
COMMISSIONER SHALL CONSIDER FACTORS INCLUDING, BUT NOT LIMITED 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 COMMISSIONER 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 COMMISSIONER HAS ISSUED ITS
FINAL RULES AND REGULATIONS REGARDING STANDARDIZED, PATIENT-CENTERED
PRESCRIPTION MEDICATION LABELS, COVERED PHARMACIES AND MAIL ORDER PHAR-
MACIES SHALL PROVIDE FREE, COMPETENT TRANSLATED MEDICATION LABELS TO
EACH LEP INDIVIDUAL FILLING A PRESCRIPTION AT SUCH COVERED PHARMACY OR
MAIL ORDER PHARMACY WHO SPEAKS ONE OF THE PHARMACY PRIMARY LANGUAGES.
NOTHING IN THIS SECTION SHALL PROHIBIT A COVERED PHARMACY OR MAIL ORDER
PHARMACY FROM PROVIDING TRANSLATED MEDICATION LABELS IN LANGUAGES IN
ADDITION TO THE PHARMACY PRIMARY LANGUAGES. THE COVERED PHARMACY OR MAIL
ORDER PHARMACY SHALL PROVIDE FREE, COMPETENT ORAL INTERPRETATION OF
MEDICATION LABELS TO LEP INDIVIDUALS WHO DO NOT SPEAK ONE OF THE PHARMA-
CY PRIMARY LANGUAGES, UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES
SUCH SERVICES.
A. 7342--A 4
6. THIS SECTION SHALL PREEMPT ANY CONTRARY LOCAL LAW OR ORDINANCE,
EXCEPT THAT THIS SECTION SHALL NOT PREEMPT OR SUPERCEDE LOCAL LAWS OR
ORDINANCES IMPOSING ADDITIONAL OR STRICTER REQUIREMENTS RELATING TO
INTERPRETATION OR TRANSLATION SERVICES IN PHARMACIES.
S 4. Section 6509 of the education law is amended by adding a new
subdivision 15 to read as follows:
(15) A VIOLATION OF SECTION SIXTY-EIGHT HUNDRED TWENTY-NINE OF THIS
CHAPTER (INTERPRETATION REQUIREMENTS FOR PRESCRIPTION DRUGS AND STAND-
ARDIZED MEDICATION LABELING), BUT ONLY AS TO A PHARMACY AND NOT TO AN
INDIVIDUAL LICENSED PHARMACIST.
S 5. 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.