BILL ANALYSIS �
AB 389
Page 1
Date of Hearing: March 22, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 389 (Mitchell) - As Amended: March 15, 2011
SUBJECT : Bleeding disorders.
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:
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
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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;
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;
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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
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)Defines the following terms:
a) "Assay" means the amount of a particular constituent of
a mixture or of the biological or pharmacological potency
of a drug;
b) "Ancillary infusion equipment and supplies" means the
equipment and supplies required to infuse a blood clotting
product into a human vein, including, but not limited to,
syringes, needles, sterile gauze, filled pads, gloves,
alcohol swabs, numbing creams, tourniquets, medical tape,
sharps or equivalent biohazard waste containers, and cold
compression packs;
c) "Bleeding disorder" means a medical condition
characterized by a deficiency or absence of one or more
essential blood clotting proteins in the human blood, often
called "factors" including all forms of hemophilia and
other bleeding disorders that, without treatment, result in
uncontrollable bleeding or abnormal blood clotting;
d) "Blood clotting product" means an intravenously
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administered medicine manufactured from human plasma or
recombinant biotechnology techniques, approved for
distribution by the FDA, that is used for the treatment and
prevention of symptoms associated with bleeding disorders.
Blood clotting products include, but are not limited to,
Factor VII, Factor VIIa, Factor VIII, and Factor IX
products, von Willebrand Factor products, bypass products
for patients with inhibitors, and activated prothrombin
complex concentrates;
e) "Emergency" means care as defined in current law, as
specified;
f) "Hemophilia" means a human bleeding disorder caused by a
hereditary deficiency of the Factors I, II, V, VIII, IX,
XI, XII, or XIII blood clotting protein in human blood;
g) "Hemophilia treatment center" means a facility for the
treatment of bleeding disorders, including, but not limited
to, hemophilia, that receives funding specifically for the
treatment of patients with bleeding disorders from federal
government sources, including, but not limited to, the
federal Centers for Disease Control and Prevention and the
federal Health Resources and Service Administration of the
United States Department of Health and Human Services;
h) "Home nursing services" means specialized nursing care
provided in the home setting to assist a patient in the
reconstitution and administration of blood clotting
products;
i) "Home use" means infusion or other use of blood clotting
product in a place other than a state-recognized hemophilia
treatment center or other clinical setting, including,
without limitation, a home or other nonclinical setting;
j) "Patient" means a person needing a blood clotting
product for home use; and,
aa) "Provider of blood clotting products for home use" means
all the following pharmacies, except for those exempted
from these requirements as specified:
i) Hospital pharmacies;
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ii) Health system pharmacies;
iii) Pharmacies affiliated with hemophilia treatment
centers;
iv) Specialty home care pharmacies; and,
v) Retail pharmacies.
5)Clarifies that providers may provide home nursing services for
persons with bleeding disorders.
6)Requires providers and all affiliated providers to include a
health care service plan if the health care service plan
exclusively contracts with a single medial group in a
specified geographic area to provide professional services to
its enrollees.
7)Adds a course on bleeding disorders, with particular emphasis
on von Willebrand disease, using the latest treatment
guidelines adopted by the National Heart, Lung, and Blood
Institute to the continuing education requirements under
consideration by the Division of Licensing of the Medical
Board of California.
8)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.
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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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose . 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."
Background . 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.
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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
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, the
governor 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."
Support . The sponsor of this bill, the Hemophilia Council of
California, writes in support, "Currently, pharmacies in
California wishing to provide clotting factor to patients in
Medi-Cal, California Children's Services, or the genetically
Handicapped Persons Program must sign contracts with the State
which include strict standards for the storage and delivery of
clotting factor to patients. We believe it is critical to
ensure that these standards are codified in statute for future
generations for both the public and private pay patients in
California."
Previous legislation .
SB 971 (Pavley) of 2010, establishes requirements governing
entities that provide blood clotting products for home use in
the treatment of hemophilia and other bleeding disorders and
designates the Board to administer and enforce these provisions.
This bill was vetoed.
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SB 1594 (Steinberg) of 2008, establishes standards and requires
regulations for entities that provide blood products to homes,
directs the Department of Health Care Services to establish the
necessary protocols and regulations, and directs the Board to
administer and enforce the measure. This bill was held in the
Senate Appropriations Committee.
Double referred . This bill is double-referred to the Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
Hemophilia Council of California (sponsor)
California Society of Health-System Pharmacists
Community Healthcare Services
CSL Behring
Grifols, Inc.
Federal Hemophilia Treatment Centers Region IX
Herndon Pharmacy
National Cornerstone Healthcare Services Inc.
Red Chip Enterprises
Walgreens
Opposition
None on file.
Analysis Prepared by : Rebecca May / B.,P. & C.P. / (916)
319-3301