Senate Bill S8365

2009-2010 Legislative Session

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

download bill text pdf

Archive: Last Bill Status - In Senate Committee Rules 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

Please enter your contact information

First Name

Last Name

Email Address

A valid email address is required.

Home address is used to determine the senate district in which you reside. Your support or opposition to this bill is then shared immediately with the senator who represents you.

Optional services from the NY State Senate:

Create an account. An account allows you to officially support or oppose key legislation, sign petitions with a single click, and follow issues, committees, and bills that matter to you. When you create an account, you agree to this platform's terms of participation.

Include a custom message for your Senator? (Optional)

Enter a message to your senator. Many New Yorkers use this to share the reasoning behind their support or opposition to the bill. Others might share a personal anecdote about how the bill would affect them or people they care about.

Actions

View Actions

Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jun 25, 2010	referred to rules

2009-S8365 (ACTIVE) - Details

See Assembly Version of this Bill:: A11627
Current Committee:: Senate Rules
Law Section:: Public Health Law
Laws Affected:: Amd §21, Pub Health L; amd §6810, add §6829, Ed L
Versions Introduced in 2011-2012 Legislative Session:: A7342

2009-S8365 (ACTIVE) - Summary

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

2009-S8365 (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S8365

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:

To ensure safe and effective use of prescription medications by
reducing the barriers many consumers face in trying to understand
prescription drug warning labels, dosage instructions and other vital
patient information

SUMMARY OF PROVISIONS:

Section 1 amends section 21 of the public health law to include
prescription forms and electronic prescriptions that allows doctors
and other prescribers to indicate whether an individual is limited
English proficient and, if so, the preferred language of the patient.

Section 2 amends section 6810 of the education law to clarify that all

prescription labels must conform to the standardization and
linguistic accessibility requirements outlined in Section 3.

Section 3 requires chain pharmacies in New York State 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 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 because of low levels of health literacy 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.

LEGISLATIVE HISTORY:

New bill.

FISCAL IMPLICATIONS:

None.

EFFECTIVE DATE:

One year after it shall become law.

2009-S8365 (ACTIVE) - Bill Text download pdf

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

                                  8365

                            I N  S E N A T E

                              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:

  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

S. 8365                             2

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

S. 8365                             3

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.

Comments

Open Legislation is a forum for New York State legislation. All comments are subject to review and community moderation is encouraged.

Comments deemed off-topic, commercial, campaign-related, self-promotional; or that contain profanity, hate or toxic speech; or that link to sites outside of the nysenate.gov domain are not permitted, and will not be published. Attempts to intimidate and silence contributors or deliberately deceive the public, including excessive or extraneous posting/posts, or coordinated activity, are prohibited and may result in the temporary or permanent banning of the user. Comment moderation is generally performed Monday through Friday. By contributing or voting you agree to the Terms of Participation and verify you are over 13.

Create an account. An account allows you to sign petitions with a single click, officially support or oppose key legislation, and follow issues, committees, and bills that matter to you. When you create an account, you agree to this platform's terms of participation.

Find your Senator and share your views on important issues.

Do you support this bill?

Senate Bill S8365

Sponsored By

Archive: Last Bill Status - In Senate Committee Rules Committee

Actions

2009-S8365 (ACTIVE) - Details

2009-S8365 (ACTIVE) - Summary

2009-S8365 (ACTIVE) - Sponsor Memo

2009-S8365 (ACTIVE) - Bill Text download pdf

Comments

Do you support this bill?

Get Status Alerts for 2009-S8365

Senate Bill S8365

Share this bill

Sponsored By

Thomas K. Duane

Archive: Last Bill Status - In Senate Committee Rules Committee

Actions

2009-S8365 (ACTIVE) - Details

2009-S8365 (ACTIVE) - Summary

2009-S8365 (ACTIVE) - Sponsor Memo

2009-S8365 (ACTIVE) - Bill Text download pdf

Comments