BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 1390
S
AUTHOR: Corbett
B
AMENDED: April 5, 2010
HEARING DATE: April 14, 2010
1
REFERRAL: Business, Professions and Economic
Development 3
CONSULTANT:
9
Bain/
0
SUBJECT
Prescription drug labels.
SUMMARY
This bill would allow the California State Board of
Pharmacy to exempt from regulations requiring a
standardized, patient-centered prescription drug label,
those prescriptions dispensed to a patient in a long-term
health care facility, if the prescriptions are administered
by a licensed health care professional.
CHANGES TO EXISTING LAW
Existing law:
Existing law, the Pharmacy Law, provides for the licensure
and regulation of the practice of pharmacy by the
California State Board of Pharmacy (Pharmacy Board).
Existing law requires the Pharmacy Board to promulgate
regulations that require a standardized, patient-centered,
prescription drug label on all prescription medication
dispensed to patients in California. The Pharmacy Board
has to promulgate these regulations on or before January 1,
2011.
This bill:
Continued---
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This bill would allow the Pharmacy Board to exempt from
regulations requiring a standardized, patient-centered
prescription drug label, those prescriptions dispensed to a
patient in a long-term health care facility, if the
prescriptions are administered by a licensed health care
professional.
Under this bill, prescriptions dispensed to a patient in a
long-term health care facility that will not be
administered by a licensed health care professional, or
prescriptions that are provided to the patient upon
discharge from the facility, must still be subject to the
prescription drug labeling requirements in existing law and
its associated regulations.
This bill would define a "long-term care facility" using an
existing law definition in the Health and Safety Code that
defines such facilities as the following:
Skilled nursing facility;
Intermediate care facility;
Intermediate care facility/developmentally disabled;
Intermediate care facility/developmentally disabled
habilitative;
Intermediate care facility/developmentally
disabled-nursing;
Congregate living health facility;
Nursing facility;
Intermediate care facility/developmentally
disabled-continuous nursing; and,
A pediatric day health and respite care facility.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
This bill is a follow-up measure to the author's SB 472
(Corbett), Chapter 470, Statutes of 2007, the California
Patient Medication Safety Act. SB 472 required the
Pharmacy Board to adopt regulations to create a
patient-centered, standard format for prescription drug
labels that will take into account the needs of California
patients, including seniors and limited-English proficient
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patients.
The author indicates SB 472 was intended to address
prescription medication bottles that are provided directly
to patients. In California's long-term care facilities,
licensed personnel administer prescription medicine
directly to the patient, and patients have the option to
self-administer medications unless doing so would be
dangerous. This bill would authorize a narrow exemption
for long-term care facilities from the patient-specific
labeling requirements established by the Pharmacy Board if
the medication is administered by a health care
professional in a long-term care facility. This measure
would still require that patients have the information on
the prescription medication label required by the
regulations when the patient is discharged from a facility.
SB 472 background
SB 472 was intended to make prescription drug labels easy
to understand by standardizing the information on them so
as to facilitate patient understanding of the information
contained on these labels, thus reducing medication-related
errors, increasing prescription drug literacy, and
improving the health, safety and well-being of consumers.
SB 472 was jointly sponsored by the Latino Coalition for a
Healthy California, Gray Panthers California and
the Senior Action Network.
To ensure maximum public comment in promulgating
regulations on the prescription drug label, SB 472 required
the Pharmacy Board to hold public meetings statewide that
are separate from its normally scheduled hearings in order
to seek information from groups representing consumers,
seniors, pharmacists, other health care professionals, and
other interested parties. The Pharmacy Board was also
required, when developing the requirements for prescription
drug labels, to consider all of the following factors:
Medical literacy research that points to increased
understandability of labels;
Improved directions for use;
Improved font types and sizes;
Placement of information that is patient-centered;
The needs of patients with limited-English proficiency;
The needs of senior citizens; and,
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Technology requirements necessary to implement the
standards.
Status of regulations
The Pharmacy Board held a regulatory meeting on a proposed
regulation on January 20, 2010, and revised the
requirements related to font size and the translation
requirements contained in the original regulation proposal.
Under the proposed regulation, labels on drug containers
dispensed to patients in California must meet specified
requirements to ensure they are patient-centered. Under
the proposed regulations, 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:
Name of the patient;
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);
Directions for use; and,
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 regulations also require 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.
Comments to the Pharmacy Board on the revised regulation
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were due to the Board on March 10th, and the Pharmacy Board
is expected to adopt the patient-centered labeling
regulations in April 2010.
Application of SB 472 to health care facilities
The Pharmacy Board indicates that, in hospitals, most
medicine is administered and not dispensed directly to
patients, and that hospitals would not have to comply with
the SB 472 labeling requirements, except when patients are
discharged from a hospital to take medication home. The
Board indicates that, in a skilled nursing facility, the
medication is dispensed to the patient, although the
facility takes possession of the drugs. The Board
indicates that without an exemption, the medication
dispensed to nursing facility patients for administration
in the nursing facility would need to comply with the SB
472 labeling requirements.
Prior 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.
Arguments in support
This bill is sponsored by the California Association of
Health Facilities (CAHF), which writes that SB 472 was
intended to ensure that labels on prescription containers
were readable and understandable to the consumers who
obtained and used those medications. CAHF argues that,
while it was clear that SB 472 was intended to provide
specific labeling for consumer use, it did not foresee that
the new labeling would be required for institutional
settings, such as in long-term care facilities.
Prescriptions dispensed to patients for self-administration
have been distinguished historically from prescriptions
dispensed in institutional settings that are administered
by personnel of that facility. CAHF states these
prescriptions are, in practice, treated like those for
inpatients in hospitals, where staff are likewise
responsible for proper administration of the drugs.
CAHF states that skilled nursing facility inpatient
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medications are administered pursuant to orders in the
patient's chart and are packaged in special systems as
requested by each facility (for example, unit dose and
blister packs). These medications are not in the
possession or control of the patient and are administered
to the patient by facility personnel. CAHF states the
Pharmacy Board has expressed concerns that under SB 472, it
is not clear that the Board can exempt prescriptions
administered in long-term care facilities. SB 1390 would
provide this clear authority to the Board, thus allowing
long-term care facilities that have licensed health care
personnel administer medication to a patient to be exempt
from the labeling requirements required by SB 472.
The California Pharmacists Association (CPhA) writes in
support that SB 472 was never intended to apply to patients
in an institutional setting, such as skilled nursing
facilities (SNF). CPhA argues SNF patients' medications
are specialty packaged in bubble or blister packs in the
pharmacy, and delivered to the SNF for administration by
facility staff. CPhA argues SB 472 applies to prescription
medication dispensed to patients, which are then
self-administered by the patient, and distinguishes this
from prescriptions dispensed in institutional settings that
are administered by personnel of the facility.
Aging Services of California writes in support of the
measure, but would like to see it amended to require
(rather than permit) the Pharmacy Board to exempt
prescriptions dispensed to a patient in a long-term care
facility if the medications are administered by a licensed
health care professional.
Arguments in opposition
The California Advocates for Nursing Home Reform (CANHR)
writes in opposition that the exemption authorized by this
bill unnecessarily segregates nursing home residents by
singling them out for an exclusion from medication
information that is required for other health consumers in
this state. AARP and CANHR both argue 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. CANHR
and AARP argue that nursing home residents should not
receive less information and protection regarding their
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prescription medication than patients in other health care
settings, such as individuals in a hospital or mental
health facility, which would not be exempt from the
patient-centered labeling requirement.
POSITIONS
Support: California Association of Health Facilities
(sponsor)
Aging Services of California
California Pharmacists Association
Oppose: AARP
California Advocates for Nursing Home Reform
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