BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 931
A
AUTHOR: Fletcher
B
AMENDED: June 17, 2009
HEARING DATE: July 8, 2009
9
CONSULTANT:
3
Bain/
1
SUBJECT
Emergency drug supply container limit
SUMMARY
Increases the limit on the number of forms of drugs from 24
to 48 that can be stored in a secured emergency supplies
container (known as an "emergency kit") provided by a
pharmacy to a skilled nursing facility (SNF) or an
intermediate care facility (ICF). Caps the number of
psychotherapeutic medications in an emergency kit but
allows the number to be increased by the Department of
Public Health (DPH) through a program flexibility request
granted to a facility based on the needs of the facility's
patient population, as specified. Allows DPH to increase
the limit on the number of doses in an emergency kit from 4
to 16.
CHANGES TO EXISTING LAW
Existing law:
Requires the Department of Public Health (DPH) to license
and inspect health facilities, including SNFs and ICFs.
Authorizes, under the Pharmacy Law, a pharmacy to furnish
prescription drugs or devices to a health facility for
storage in a secure emergency pharmaceutical supplies
Continued---
STAFF ANALYSIS OF ASSEMBLY BILL 931 (Fletcher) Page
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container that is maintained within the facility under
state regulations.
Limits the number of oral dosage form or suppository form
drugs provided by a pharmacy to a SNF or ICF for storage in
a secured emergency supplies container to 24.
Permits DPH to limit the number of doses of each drug
available to not more than four doses of any separate drug
dosage form in each emergency supply.
Exempts an automated drug delivery system, when a
pharmacist controls access to the drugs, from the limit on
the number and quantity of oral dosage or suppository form
drugs provided by a pharmacy to a SNF or ICF for storage in
a secured emergency supplies container.
Defines, through regulation, a psychotherapeutic drug as a
medication to control behavior or to treat thought disorder
processes.
Defines a "special treatment program service unit distinct
part" as an identifiable and physically separate unit of a
SNF or an entire SNF that provides therapeutic programs to
an identified mentally disordered population group.
This bill:
Increases the limit on the number of oral dosage form or
suppository form drugs from 24 to 48 that can be stored in
a secured emergency supplies container provided by a
pharmacy to a SNF or an ICF.
Caps the number of psychothereapeutic drugs in an emergency
kit at 4 of the 48 oral dosage form or suppository form
drugs, but allows DPH to increase the number of
psychotherapeutic drugs in the emergency supplies container
to not more than 10 if the facility can demonstrate the
necessity for an increased number of drugs based on the
needs of the patient population at the facility. Exempts
special treatment program service units of a distinct part
of a SNF from the four psychotherapeutic drug limit.
Allows the Department of Public Health to increase from 4
to 16 the numerical limit on the number of separate drug
dosage forms of each drug available in an emergency kit,
STAFF ANALYSIS OF ASSEMBLY BILL 931 (Fletcher) Page
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but requires DPH to limit the number of doses of
psychotherapeutic drugs available to not more than 4 doses.
FISCAL IMPACT
This bill is keyed nonfiscal.
BACKGROUND AND DISCUSSION
This bill is sponsored by the California Pharmacists
Association (CPhA), which states that emergency drug supply
containers (commonly called "emergency kits") are used to
treat individuals residing in long-term care facilities who
are in need of urgent care. CPhA indicates emergency kits
generally include pain medication, antibiotics, and
anti-anxiety medications, and are used to start medication
orders for patients when drugs are not immediately
available from a pharmacy, or in a disaster situation, such
as an earthquake, fire, or flood.
CPhA argues that the current law limit on the number of
drugs means prescribed medications are frequently not
available in emergency kits, and that increasing the limit
on the number of drugs, and the number of doses, will mean
medication will be available in the event of an emergency.
CPhA states that it has been 15 years since the number of
drugs in the kits was increased. CPhA states that more
than one physician often prescribes for patients in a
single facility, and it is difficult to accommodate
prescribing physicians with different medications if only
24 medications are allowed in an emergency kit. In
addition, many new and varied medications have become
available to better treat specific ailments, and the
current law limit prevents many new drugs from being
included in the emergency kits.
CPhA states current regulations require the availability of
prescription drugs in SNFs within specified timeframes.
For example, regulations require drugs ordered "stat"
(drugs ordered immediately or without delay) during normal
business hours have to be available in one hour, drugs
ordered "stat" when a pharmacy is closed must be available
in two hours, and anti-infectives and drugs used to treat
pain, nausea, agitation, diarrhea or other severe
discomfort must be available in four hours. CPhA states
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the current emergency kit limit inhibits patient care in
urgent situations by causing patients to wait for delivery
of the medication if the order is placed after hours, or
for a patient in a rural area where a 24-hour pharmacy is
not close to a long-term care facility. CPhA states this
bill would improve the delivery of urgently needed
medications and enhance the quality of care for vulnerable
populations.
Existing law and regulation
Existing law allows a pharmacy to furnish prescription
drugs to a ICF or SNF for storage in a secured emergency
pharmaceutical supplies container. The emergency drug
supply has to be approved by the health facility's patient
care policy committee or pharmaceutical service committee,
and must be readily available to each nursing station.
Existing law limits the number of oral dosage form or
suppository form drugs in these emergency supplies to 24
(DPH indicates this is a total of all forms of drugs).
Existing regulations prohibit more than six emergency
drugs, in solid, oral dosage form or suppository dosage
form for anti-infective, anti-diarrheal, anti-nausea or
analgesic use, from being stored in sealed containers. In
addition, not more than four doses of any drug may be
stored.
Existing regulations also require the emergency drug supply
to be stored in a portable container with a seal that must
be broken to gain access to the drugs. The director of
nursing services or charge nurse is required to notify the
pharmacy when drugs have been used from the emergency kit
or when the seal has been broken. The contents of the
supply must be listed on the outside of the container, and
the supply must be checked at least monthly by the
pharmacist. Drugs used from the emergency kit must be
replaced within 72 hours and the supply must be resealed by
the pharmacist.
Arguments in support
The California Association of Health Facilities (CAHF)
states emergency kits can be used for medication orders for
patients in need or urgent care, a disaster situation, or
when drugs cannot be readily accessed from a pharmacy.
CAHF argues it has been 15 years since the last time the
number of drugs in emergency kits was increased, many new
STAFF ANALYSIS OF ASSEMBLY BILL 931 (Fletcher) Page
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and varied medications have become available to better
treat specific ailments, and that without the change in law
proposed by this bill, patients in an emergency situation
may not have access to the drugs that provide the highest
quality of care.
Prior legislation
AB 3388 (Harvey), Chapter 1060, Statutes of 1994,
established in statute the 24 drug form limit in existing
law. According to legislative analyses of that measure,
prior to the enactment of AB 3388, regulations allowed six
oral drugs to be part of each emergency drug kit, but
allowed, through the use of program flexibility, the number
of oral drugs in an emergency kit to be increased from six
to twelve.
PRIOR ACTIONS
Assembly Floor: 74-0
Assembly Health: 19-0
POSITIONS
Support: California Pharmacists Association (sponsor)
California Association of Health Facilities
Oppose: None received.
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