BILL ANALYSIS �
AB 389
Page 1
ASSEMBLY THIRD READING
AB 389 (Mitchell)
As Amended March 30, 2011
Majority vote
BUSINESS & PROFESSIONS 9-0 HEALTH 15-3
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|Ayes:|Hayashi, Bill Berryhill, |Ayes:|Monning, Ammiano, Atkins, |
| |Allen, Butler, Eng, | |Bonilla, Eng, Garrick, |
| |Hagman, Hill, Ma, Smyth | |Gordon, Hayashi, |
| | | |Roger Hern�ndez, Bonnie |
| | | |Lowenthal, Mansoor, |
| | | |Mitchell, Nestande, Pan, |
| | | |Williams |
| | | | |
|-----+--------------------------+-----+--------------------------|
| | |Nays:|Logue, Silva, Knight |
| | | | |
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APPROPRIATIONS 12-3
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|Ayes:|Fuentes, Blumenfield, | | |
| |Bradford, Charles | | |
| |Calderon, Campos, Davis, | | |
| |Gatto, Hall, Hill, Lara, | | |
| |Mitchell, Solorio | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Harkey, Donnelly, Nielsen | | |
| | | | |
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SUMMARY : Establishes requirements for providers of blood
clotting products for home use (providers) to treat hemophilia
and other bleeding disorders. Specifically, this bill :
1)Establishes the Standards of Service for Providers of Blood
Clotting Products for Home Use Act (Act), and designates the
California State Board of Pharmacy (Board) to enforce the Act.
2)Requires providers to meet the following requirements:
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a) Have sufficient knowledge and understanding of bleeding
disorders to accurately follow the instructions of the
prescribing physician and ensure high-quality service for
the patient and the medical and psychosocial management
thereof, including but not limited to, home therapy;
b) Have access to a provider with sufficient clinical
experience providing services to persons with bleeding
disorders that enables the provider to know when patients
have an appropriate supply of clotting factor on hand and
about proper storage and refrigeration of clotting factors;
c) Maintain 24-hour on-call service seven days a week for
every day of the year, adequately screen telephone calls
for emergencies, acknowledge all telephone calls within one
hour or less, and have access to knowledgeable pharmacy
staffing on call 24 hours a day, to initiate emergency
requests for clotting factors;
d) Have the ability to obtain all brands of blood clotting
products approved by the federal Food and Drug
Administration (FDA) in multiple assay ranges (low, medium,
and high, as applicable) and vial sizes, including products
manufactured from human plasma and those manufactured with
recombinant biotechnology techniques, provided manufacturer
supply exists and payer authorization is obtained;
e) Supply all necessary ancillary infusion equipment and
supplies with each prescription, as needed;
f) Store and ship, or otherwise deliver, all blood clotting
products in conformity with all state and federally
mandated standards including, but not limited to, the
standards set forth in the product's approved package
insert;
g) Provide home nursing services when determined to be
necessary by the treating physician, either directly or
through a qualified third party with experience in treating
bleeding disorders, and coordinate pharmacy services with
the third party when one is used to provide home nursing
services;
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h) Ship the prescribed blood clotting products and
ancillary infusion equipment and supplies to the patient
within two business days or less for established and new
patients, upon receipt of approved authorization for a
nonemergency prescription;
i) Deliver prescribed blood products, ancillary infusion
equipment and supplies, medications, and home nursing
services to the patient within 12 hours for patients living
within 100 miles of a major metropolitan airport, and
within one day for patients living more than 100 miles from
a major metropolitan airport, upon receiving approved
authorization to dispense a prescription for an emergency
situation, provided manufacturer supply exists;
j) Provide patients who have ordered their products with a
designated contact telephone number for reporting problems
with a delivery and respond to these calls within a
reasonable time period;
aa) Provide patients with notification of Class 1 and Class
2 recalls and withdrawals of blood clotting products and
ancillary infusion equipment within 24 hours of the
provider receiving notification, and participate in the
national Patient Notification System for blood clotting
product recalls;
bb) Provide language interpretive services over the phone or
in person, as needed by the patient;
cc) Have a detailed plan for meeting the requirements of
this bill in the event of a natural or manmade disaster or
other disruption of normal business operations;
dd) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and
retain copies of the patient's prescriptions; and,
ee) Comply with the privacy and confidentiality requirements
of the federal Health Insurance Portability and
Accountability Act of 1996.
3)Exempts hospital pharmacies or health system pharmacies that
dispense blood clotting products due only to emergency, urgent
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care, or inpatient encounters, or if an inpatient is
discharged with a supply of blood clotting products for home
use from the requirements of this bill.
4)Clarifies that providers may provide home nursing services for
persons with bleeding disorders.
5)Requires providers and all affiliated providers to include a
health care service plan if the health care service plan
exclusively contracts with a single medical group in a
specified geographic area to provide professional services to
its enrollees.
6)Makes legislative findings and declarations.
EXISTING LAW :
1)Establishes the Board within the Department of Consumer
Affairs to regulate the practice of pharmacy and the licensing
of pharmacies and pharmacists.
2)Specifies certain requirements regarding the proper storage,
handling, dispensing, and disposal of drugs, staff training
protocols, drug and supply inventory, labeling, and
maintenance of patient confidentiality.
3)Allows pharmacists to perform certain procedures under
specified conditions, including, among other things,
administering drugs and biologics, such as blood clotting
products, by injection, pursuant to a prescriber's order.
4)Establishes the Genetically Handicapped Persons Program,
administered by the Department of Health Care Services, to
provide for the medical care of adults with certain genetic
diseases, including hemophilia.
5)Establishes the federal FDA to regulate the manufacture of
pharmaceuticals derived from blood and blood components, such
as blood clotting products, including establishing standards
for those products for shipping, storage, and delivery,
inspecting products, approving products for use by patients,
and recalling products that may be defective or potentially
harmful.
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FISCAL EFFECT : According to the Assembly Appropriations
Committee, minor absorbable workload to the Board to provide
oversight related to requirements established by this bill.
COMMENTS : According to the author's office, "AB 389 will
establish standards of service for pharmacies that deliver blood
clotting products and related equipment, supplies, and services
for home use and would promote access to a full range of
essential, cost effective, life-saving, blood clotting products
and related equipment, supplies for home use for people who have
hemophilia, von Willebrand disease and other bleeding
disorders."
Hemophilia is a rare, hereditary bleeding disorder affecting
approximately 4,000, mostly male, Californians. It is a
chronic, lifelong, and incurable, but treatable disease marked
by the absence of clotting factors that stop bleeding. Lack of
clotting factors causes hemophiliacs to bleed for longer periods
of time and results in internal bleeding, primarily in muscles
and joints. Without treatment, hemophilia can cause pain,
severe joint damage, disability, and early death.
Hemophilia and other bleeding disorders are treated by replacing
the missing clotting factor in the blood. Clotting factors are
approved by the FDA and can only be used with a prescription.
Proper administration of blood clotting products requires the
use of ancillary supplies and equipment, including syringes,
tourniquets, gauze, and alcohol swabs. Blood clotting products
are generally expensive and require special storage and
handling.
Most blood clotting product providers in the state are specialty
care pharmacies. However, all pharmacies are permitted under
their license to supply such products. Specialty care
pharmacies specialize in providing treatments and supplies to
individuals with particular chronic diseases. Generally, they
focus their services on targeted patient populations, rather
than the needs of the general public. These types of pharmacies
usually ship or deliver blood clotting products to the homes of
individuals with hemophilia and other clotting disorders and,
when necessary, provide or arrange for nursing services to
patients who need assistance with infusing the blood factor
products.
This bill seeks to standardize the pharmacy requirements for
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both public and private pay individuals needing clotting
products. This bill is a substantially similar to SB 971
(Pavley) of 2010, which was vetoed. In his veto message,
Governor Schwarzenegger stated SB 971 "?is unnecessary and
attempts to create additional standards that are already being
adequately enforced through other regulatory and administrative
mechanisms. Since the current standards of practice for blood
clotting products and service are already being met through
state and federal pharmacy laws, voluntary compliance and
existing state contract provisions, it is unclear what problem
this bill seeks to address."
Analysis Prepared by : Rebecca May / B.,P. & C.P. / (916)
319-3301
FN: 0000305