BILL ANALYSIS
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|Hearing Date:April 19, 2010 |Bill No:SB |
| |1390 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 1390Author:Corbett
As Amended:April 5, 2010 Fiscal: Yes
SUBJECT: Prescription drug labels.
SUMMARY: Exempts long-term health care facilities from certain
prescription label standards; requires that patients are provided
certain information about prescription medication upon discharge from
a long-term health care facility.
NOTE : This bill has a double-referral to Senate Health Committee and
then to this Committee.
It was heard in Senate Health Committee on April 14, 2010 and passed
out on a 9-0 vote.
Existing law:
1) The Health and Safety Code, defines long-term health care facility
as any licensed facility that is either a skilled nursing facility,
intermediate care facility, intermediate care facility for the
developmentally disabled, intermediate care facility for the
developmentally disabled-habilitative, intermediate care facility
for the developmentally disabled-nursing, congregate living health
facility, nursing facility, intermediate care facility for the
developmentally disabled-continuous nursing, pediatric day health
and respite care facility.
2) Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of Pharmacy
(Board) within the Department of Consumer Affairs (DCA).
3) Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
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prescription of a physician, dentist, podiatrist, optometrist, or
veterinarian.
4) Requires that each prescription dispensed by a pharmacist must be
in a container complying with state and federal law and correctly
labeled as specified, including:
a) Unless otherwise ordered by the prescriber, the manufacturer's
trade name of the drug or the generic name and the name of the
manufacturer, as specified.
b) The directions for the use of the drug.
c) The name of the patient or patients.
d) The name of the prescriber, as specified.
e) The date of issue.
f) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
g) The strength of the drug or drugs dispensed.
h) The quantity of the drug or drugs dispensed.
i) The expiration date of the effectiveness of the drug
dispensed.
j) The condition for which the drug was prescribed if requested
by the patient and the condition is indicated on the
prescription.
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code that
appears on the tablets or capsules.
5) Requires the Board to promulgate regulations on or before January
1, 2011, for a standardized, patient-centered, prescription drug
label on all prescription medication dispensed in the state. ( SB
472 , Corbett, Chapter 470, Statutes of 2007)
6) Requires the Board to hold public meetings statewide in order to
seek information on a standardized label from groups representing
consumers, seniors, pharmacists, the practice of pharmacy, other
health care professionals, and other interested parties.
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7) Requires the Board, when considering the requirements for
prescription labels, to consider:
a) Medical literacy research.
b) Improved directions for use.
c) Improved font types and sizes.
d) Placement of information that is patient-centered.
e) The needs of patients with limited English proficiency.
f) The needs of senior citizens.
g) Technology requirements necessary to implement the standards.
This bill:
1) Allows the Board to exempt prescriptions dispensed to patients in a
health care facility, as specified, from the requirements of a
patient-centered label, if the prescriptions are administered by a
licensed health care professional.
2) Clarifies that prescriptions dispensed to a patient in a health
care facility, as specified, by someone other than a licensed
health care professional are subject to the patient-centered label
standards.
3) Clarifies that prescriptions provided to a patient upon discharge
from a long-term health care facility are subject to the
patient-centered label standards.
4) Clarifies that existing statutory or regulatory informed consent,
patient's rights, or pharmaceutical labeling and storage
requirements still apply.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the California Association of
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Health Facilities . According to the Author, "SB 472 was intended
to address prescription medicine bottles that are provided directly
to patients. At California's long-term care facilities, licensed
personnel administer prescription medicine directly to the patient.
Patients have the option to self-administer medications unless
doing so would be dangerous." The Author and Sponsors state that
the Board has expressed concerns as to whether or not, under SB
472, they are able to exempt prescriptions administered in
long-term care facilities.
2. Background. This measure is a follow-up to the Author's SB 472
which created the patient-centered label standard. SB 472
sought to deal with the lack of uniformity in prescription drug
labels throughout the state and the resulting confusion and
medication errors that may arise. Much of the conversation
during the SB 472 debate focused on the fact that individual
pharmacies design and format their own labels, resulting in a
lack of standards across all pharmacies which adversely affects
medication users who are elderly, suffer from poor vision, have
difficulty reading and understanding instructions on labels or
have limited English proficiency.
The Board is currently in the process of approving a regulation
per the requirements set forth in SB 472. The Board conducted
outreach, hearings and information gathering sessions
throughout 2008, to collect data from the public on
prescription labels and standards for those labels. In 2009,
the Board discussed the requirements of the regulation at
regularly scheduled meetings. On January 20th of this year,
the Board held a regulation hearing to adopt the proposed
regulation, a new section at Title 16 California Code of
Regulations Section 1707.5 - "Requirements For Patient-Centered
Prescription Container Labels." At that meeting, the Board
amended the proposed regulation, specifically related to font
size and the translation requirements. Following that meeting,
the Board was advised by DCA Legal Counsel that members had not
been provided certain written comments in time for the January
20 meeting; a subsequent February 17th meeting was held to
discuss possible action on the proposed regulation. The Board
will meet on April 22, 2010 to discuss the current proposed
regulation, receive public comment on the proposed regulation
and possibly adopt or amend the proposed regulation.
Under the current proposed regulation, labels on drug
containers dispensed to patients in California must meet
specified requirements to ensure they are patient-centered.
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The regulation outlines that the following items must be
clustered into one area of the label that comprises at least 50
percent of the label, using at least 10-point font using sans
serif typeface, listing these items in the following order:
a) Name of the patient.
b) Name of the drug and strength of the drug ("name of the
drug" means either the manufacturer's trade name, or the
generic name and the name of the manufacturer.)
c) Directions for use.
d) Purpose or condition, if entered onto the prescription
by the prescriber, or otherwise known to the pharmacy, and
its inclusion on the label is requested by the patient.
The proposed regulation also requires pharmacies to have
policies and procedures in place to help patients with limited
or no English proficiency, understand the information on the
label in the patient's language. The pharmacy's policies and
procedures must be specified in writing, and must include, at
minimum, the selected means to identify the patient's language,
and to provide interpretive services in the patient's language.
Pharmacies must provide, at minimum, interpretive services in
the patient's language, if interpretive services in such
language are available, during all hours that the pharmacy is
open, either in person by pharmacy staff or by use of a
third-party interpretive service available by telephone at or
adjacent to the pharmacy counter.
1. Prescription Dispensing in Long-Term Care Facilities.
According to the Sponsor, prescriptions administered in a
skilled nursing facility or other long-term health care
facility is handled according to the following procedures:
a) A physician orders a certain medication for a long-term
care facility patient
b) That order is then transmitted to the long-term care
pharmacy that works with the long-term health care facility
or skilled nursing facility where a patient resides.
c) The pharmacy fills the prescription and dispenses the
drug in a format requested by the facility, usually either
in a bubble pack or other type of dispensing mechanism that
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works in the facility setting.
d) In most cases, the long-term health care facility
utilizes a medication cart (unless the drug needs to be
refrigerated) that is stocked by the long-term care pharmacy
and is organized by patient name and medications. Each
prescription bottle, bubble pack or other container includes
a label with the required information.
e) The authorized health care professional looks at the
prescription container then references the Medication
Administration Record (MAR) for the patient and double
checks that the drug and dosing requirements are the same as
the MAR.
f) The authorized health care professional then marks that
the drug has been dispensed to the patient and administers
the drug to the patient.
B&P Code Section 4076 (b) outlines the requirement that
specific information about medication be available in settings
like long-term health care facilities. "If a pharmacist
dispenses a prescribed drug by means of a unit dose medication
system, as defined by administrative regulation, for a patient
in a skilled nursing, intermediate care, or other health care
facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available
at the time of drug administration".
The Sponsor states that long-term health care facilities comply
with requirements that information be made readily available
through the label attached to the unit dose and information
listed in the MAR, which can be shared with the patient or
authorized representative
2. Related Legislation. SB 472 (Corbett, Chapter 470, Statutes of
2007), the California Patient Medication Safety Act, required the
Pharmacy Board to promulgate regulations that require a
standardized, patient-centered, prescription drug label on all
prescription medication dispensed to patients in California.
3. Arguments in Support. The Sponsor, California Association of
Health Facilities , writes in support of the measure, stating that
"SB 472 was intended to provide specific labeling for consumer use
and did not foresee that the new labeling would be required for
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institutional settings. Prescriptions dispensed to patients for
self-administration would have been distinguished historically from
prescriptions dispensed in institutional settings and administered
by facility nursing personnel."
4. Arguments in Opposition. According to California Advocates for
Nursing Home Reform (CANHR), "nursing home residents already suffer
from a paucity of information about their health care treatment,
particularly regarding the risks and side effects of antipsychotic
drugs". They argue that this bill allows nursing homes to disregard
drug-labeling requirements intended to convey critical information
to consumers.
In its opposition letter, AARP states that nursing home residents
should not be denied the same information provided to every other
health care consumer in the state. "Why should nursing home
residents receive fewer protections than clients in other
healthcare settings?"
SUPPORT AND OPPOSITION:
Support:
California Association of Health Facilities (Sponsor)
California Pharmacists Association
Opposition:
AARP
California Advocates for Nursing Home Reform
Consultant:Sarah Mason