S5000-2011 Actions

• Jan 4, 2012: REFERRED TO HEALTH
• Jun 17, 2011: PRINT NUMBER 5000A
• Jun 17, 2011: AMEND AND RECOMMIT TO HEALTH
• May 2, 2011: REFERRED TO HEALTH

S5000-2011 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.

S5000-2011 Text

 S T A T E   O F   N E W   Y O R K
 
 
                                         5000
 2011-2012 Regular Sessions
 I N  SENATE
 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.

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