Senate Bill S5000A

2011-2012 Legislative Session

Relates to prescription forms and labels, interpretation services and patients with limited English proficiency

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Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 04, 2012	referred to health
Jun 17, 2011	print number 5000a
Jun 17, 2011	amend and recommit to health
May 02, 2011	referred to health

Bill Amendments

co-Sponsors

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2011-S5000 - Details

See Assembly Version of this Bill:: A7342
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Amd §21, Pub Health L; amd §§6810 & 6509, add §6829, Ed L
Versions Introduced in 2009-2010 Legislative Session:: A11627

2011-S5000 - Summary

Relates to prescription forms and labels; requires interpretation services by chain pharmacies and mail order pharmacies for patients with limited English proficiency.

2011-S5000 - Sponsor Memo

                                BILL NUMBER:S5000

TITLE OF BILL:
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

PURPOSE OF GENERAL IDEA OF BILL:
To promote safe and effective use of prescription medications by
reducing the barriers many consumers face in trying to understand
prescription drug labels, dosage instructions and other vital patient
information.

SUMMARY OF SPECIFIC PROVISIONS:
Section 1 amends § 21 of the Public Health law to require that
prescription forms and electronic prescriptions include a section
that allows prescribers to indicate whether an individual is limited
English proficient and, if so, the preferred language of the patient.

Section 2 amends § 6810 of the education law to provide that all
prescription labels must conform to the standardization and language
accessibility requirements outlined in Education Law § 6829 (see
below).

Section 3 enacts a new Education Law § 6829 to require chain
pharmacies and mail order pharmacies to provide free, competent oral
interpretation services to all limited English proficient
individuals, particularly during the process of medication counseling
and when obtaining information to establish the patient's medication
profile. This section also requires the State Board of Pharmacy to
develop standardized prescription drug labels to ensure greater
comprehension of labels by consumers, improved directions for use,
improved font types and sizes, and better placement on medication
bottles and requires that the standardized prescription drug labels
be translated into the top seven languages spoken by limited English
proficient individuals in New York State.

Section 4 adds a new subdivision (15) to Education Law § 6509 to make
a violation of § 6829 grounds for professional discipline of a
pharmacist.

Section 5 is the effective date.

JUSTIFICATION:
Misuse of prescription medications causes over one million "adverse
drug events" every year, resulting in visits to the emergency room,
hospitalization and, in some cases, even death. One of the reasons
such misuse occurs is limited English proficiency among patients.
Studies have found that less than half of patients understand the
dosage instructions currently provided on prescription medication
bottles. Pharmacists often transcribe the same medication instruction
in different ways at different times, which can cause confusion for
patients, especially those who take many medications such as the


elderly. Language barriers and the inability to read or understand
medical information in English can pose health risks to patients with
limited English proficiency.

This legislation aims to reduce the number of medication errors that
result from the challenges patients face in comprehending medication
labels. By requiring the State Board of Pharmacy to standardize and
simplify the content of medication warning and instruction labels,
the legislation will ensure that prescription drugs dispensed in New
York State are more accessible and understandable to a broad range of
consumers. By requiring interpretation services and the translation
of standardized medication labels, the legislation will ensure that
language does not pose as a barrier to safe and effective use of
prescription drugs. Standardizing drug labels will make them easier
for patients to understand, reduce errors, and make translating
labels easier.

PRIOR LEGISLATIVE HISTORY:
2010: A.11627 Referred to Higher Education/S.8365 Referred to Rules

FISCAL IMPLICATIONS:
None.

EFFECTIVE DATE:
One year after it shall become law.

2011-S5000 - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  5000

                       2011-2012 Regular Sessions

                            I N  S E N A T E

                               May 2, 2011
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

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

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD02457-05-1

S. 5000                             2

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  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.  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) "CHAIN  PHARMACY"
MEANS  ANY  PHARMACY  THAT IS PART OF A GROUP OF FOUR OR MORE ESTABLISH-
MENTS 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.
  (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 CHAIN PHARMACY AND  MAIL  ORDER  PHARMACY  SHALL  PROVIDE
FREE,  COMPETENT  ORAL  INTERPRETATION  SERVICES  TO EACH LEP INDIVIDUAL
FILLING A PRESCRIPTION AT SUCH CHAIN 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  MEDICATION
PROFILE, UNLESS THE LEP INDIVIDUAL IS OFFERED AND REFUSES SUCH SERVICES.
  (B)  EVERY  CHAIN PHARMACY AND MAIL ORDER PHARMACY SHALL PROVIDE FREE,
COMPETENT ORAL INTERPRETATION OF PRESCRIPTION MEDICATION LABELS, WARNING

S. 5000                             3

LABELS AND OTHER WRITTEN MATERIAL  TO  EACH  LEP  INDIVIDUAL  FILLING  A
PRESCRIPTION AT SUCH CHAIN PHARMACY OR THROUGH SUCH MAIL ORDER 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
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,  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
STATE BOARD OF PHARMACY.
  4. ANY PERSON AGGRIEVED BY A FAILURE TO RECEIVE SERVICES  REQUIRED  BY
THIS SECTION SHALL HAVE A CAUSE OF ACTION ONLY AGAINST THE CHAIN PHARMA-
CY  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 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 AND MAIL ORDER
PHARMACIES SHALL PROVIDE FREE, COMPETENT TRANSLATED MEDICATION LABELS TO
EACH  LEP  INDIVIDUAL  FILLING  A PRESCRIPTION AT SUCH CHAIN PHARMACY OR
MAIL ORDER PHARMACY WHO SPEAKS ONE OF THE  PHARMACY  PRIMARY  LANGUAGES.
NOTHING  IN  THIS  SECTION SHALL PROHIBIT A CHAIN PHARMACY OR MAIL ORDER
PHARMACY FROM PROVIDING TRANSLATED MEDICATION  LABELS  IN  LANGUAGES  IN
ADDITION  TO  THE PHARMACY PRIMARY LANGUAGES. THE CHAIN 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.
  S 4. Section 6509 of the education law is  amended  by  adding  a  new
subdivision 15 to read as follows:

S. 5000                             4

  (15)  A  VIOLATION  OF SECTION SIXTY-EIGHT HUNDRED TWENTY-NINE OF THIS
CHAPTER (INTERPRETATION REQUIREMENTS FOR PRESCRIPTION DRUGS  AND  STAND-
ARDIZED MEDICATION LABELING).
  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.

co-Sponsors

View additional co-sponsors

2011-S5000A (ACTIVE) - Details

See Assembly Version of this Bill:: A7342
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Amd §21, Pub Health L; amd §§6810 & 6509, add §6829, Ed L
Versions Introduced in 2009-2010 Legislative Session:: A11627

2011-S5000A (ACTIVE) - Summary

Relates to prescription forms and labels; requires interpretation services by chain pharmacies and mail order pharmacies for patients with limited English proficiency.

2011-S5000A (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S5000A

TITLE OF BILL:
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

PURPOSE OR GENERAL IDEA OF BILL:
To promote safe and effective use of
prescription medications by reducing the barriers many consumers face
in trying to understand prescription drug labels, dosage instructions
and other vital patient information

SUMMARY OF SPECIFIC PROVISIONS:
Section 1 amends § 21 of the Public
Health law to require that prescription forms and electronic
prescriptions include a section that allows prescribers to indicate
whether an individual is limited English proficient and, if so, the
preferred language of the patient.

Section 2 amends § 6810 of the education law to provide that all
prescription labels must conform to the standardization and language
accessibility requirements outlined in Education Law § 6829 (see

below).

Section 3 enacts a new Education Law § 6829 to require chain
pharmacies and mail order pharmacies to provide free, competent oral
interpretation services to all limited English proficient
individuals, particularly during the process of medication counseling
and when obtaining information to establish the patient's medication
profile. This section also requires the commissioner of health to
develop standardized prescription drug labels to ensure greater
comprehension of labels by consumers, improved directions for use,
improved font types and sizes, and better placement on medication
bottles and requires that the standardized prescription drug labels
be translated into the top seven languages spoken by limited English
proficient individuals in New York State.

Section 4 adds a new subdivision (15) to Education Law § 6509 to make
a violation of § 6829 grounds for professional discipline of only as
to a pharmacy and not to an individual pharmacist.

Section 5 is the effective date.

JUSTIFICATION:
Misuse of prescription medications causes over one
million "adverse drug events" every year, resulting in visits to the
emergency room, hospitalization and, in some cases, even death.
One of the reasons such misuse occurs is limited English proficiency
among patients, Studies have found that less than half of patients
understand the dosage instructions currently provided on
prescription medication bottles. Pharmacists often transcribe the
same medication instruction in different ways at different times,


which can cause confusion for patients, especially those who take
many medications such as the elderly. Language barriers and the
inability to read or understand medical information in English can
pose health risks to patients with limited English proficiency.

This legislation aims to reduce the number of medication errors that
result from the challenges patients face in comprehending medication
labels. By requiring the commissioner of health to standardize and
simplify the content of medication warning and instruction labels, the
legislation will ensure that
prescription drugs dispensed in New York State are more accessible and
understandable to a broad range of consumers. By requiring
interpretation services and the translation of standardized
medication labels, the legislation will ensure that language does not
pose as a barrier to safe and effective use of prescription drugs.
Standardizing drug labels will make them easier for patients to
understand, reduce errors, and make translating labels easier.

PRIOR LEGISLATIVE HISTORY:
New bill.

FISCAL IMPLICATIONS:
2010: A.11627 - Referred to Higher Education

EFFECTIVE DATE:
Shall take effect one year after enactment.

2011-S5000A (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 5000--A

                       2011-2012 Regular Sessions

                            I N  S E N A T E

                               May 2, 2011
                               ___________

Introduced by Sens. HANNON, CARLUCCI, DIAZ, DUANE, GRISANTI, MONTGOMERY,
  PARKER, RIVERA, SAVINO, VALESKY -- read twice and ordered printed, and
  when  printed  to be committed to the Committee on Health -- 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
prescription.  Such  drug shall be compounded or dispensed by a licensed
pharmacist, and no such drug shall be dispensed without affixing to  the

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD02457-07-1

S. 5000--A                          2

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-
TION  PROFILE,  UNLESS  THE  LEP  INDIVIDUAL IS OFFERED AND REFUSES SUCH
SERVICES.

S. 5000--A                          3

  (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.
  6.  THIS  SECTION  SHALL  PREEMPT ANY CONTRARY LOCAL LAW OR ORDINANCE,
EXCEPT THAT THIS SECTION SHALL NOT PREEMPT OR SUPERCEDE  LOCAL  LAWS  OR

S. 5000--A                          4

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.

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Archive: Last Bill Status - In Senate Committee Health Committee

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