BILL ANALYSIS �
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|Hearing Date:July 6, 2011 |Bill No:AB |
| |389 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: AB 389Author:Mitchell
As Amended:March 30, 2011 Fiscal:Yes
SUBJECT: Bleeding disorders.
SUMMARY: Establishes standards for the proper storage and delivery of
blood clotting factor, a prescribed biologic, and other related
equipment and supplies for home usage by people with hemophilia or
other bleeding disorders.
NOTE : This bill was heard in the Senate Committee on Health on June
22, 2011 and passed 8-0.
Existing law:
1) 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).
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) Authorizes pharmacists to administer drugs and biologics pursuant
to a prescriber's order.
4) Prohibits pharmacies from leaving, picking up from, accepting, or
delivering prescriptions to any place not licensed as a retail
pharmacy, with certain exceptions, including a patient's residence
or workplace, or a licensed health facility, as specified.
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5) Creates the Holden-Moscone-Garamendi Genetically Handicapped
Person's Program, which requires the Director of Health Services to
establish and administer a program for the medical care of persons
with genetically handicapping conditions, including hemophilia.
This bill:
1)Creates the Standards of Service for Providers of Blood Clotting
Products for Home Use Act (Act).
2) Establishes findings and declarations about bleeding disorders and
treatment for bleeding disorders.
3) Specifies that the purposes of the Act is to establish standards of
service for providers of blood clotting supplies and promoting
access to a full range of essential blood clotting products and
equipment for use at home by people with hemophilia and other
bleeding disorders.
4) Applies definitions for the purpose of this Act, specifically:
a) "Assay" as 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" as the equipment
and supplies required to infuse a blood clotting product into a
human vein, including, but not limited to, syringes, needles,
sterile gauze, field pads, gloves, alcohol swabs, numbing creams,
tourniquets, medical tape, sharps or equivalent biohazard waste
containers, and cold compression packs.
c) "Bleeding disorder" as 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 result
in uncontrollable bleeding or abnormal blood clotting without
treatment.
d) "Blood clotting product" as an intravenously administered
medicine manufactured from human plasma or recombinant
biotechnology techniques, approved for distribution by the
federal Food and Drug Administration (FDA), that is used for the
treatment and prevention of symptoms associated with bleeding
disorders.
e) "Emergency" as a situation in which a prudent layperson could
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reasonably believe that the consumer's condition requires
immediate medical attention.
f) "Hemophilia" as 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" as a facility for the treatment
of bleeding disorders, including, but not limited to, hemophilia,
that receives funding from federal government sources.
h) "Home nursing services" as specialized nursing care provided
in the home setting to assist a patient in the reconstitution and
administration of blood clotting products.
i) "Home use" as infusion or other use of a blood clotting
product in a place other than a state-recognized hemophilia
treatment center, including a home or physician's office.
j) "Patient" as a person needing a blood clotting product for
home use.
aa) "Provider of blood clotting products for home use" as
including but not limited to any hospital pharmacies, health
system pharmacies, pharmacies affiliated with hemophilia
treatment centers, specialty home care pharmacies, and retail
pharmacies that provide blood clotting products for home use.
Allows these providers to offer home nursing services for persons
with bleeding disorders. Specifies that a health care service
plan and all its affiliated providers are included as providers.
5)Provides that each provider of blood clotting products for home use
shall meet all of the following requirements:
a) Have sufficient knowledge and understanding of bleeding
disorders and the medical and psychological management thereof,
including, but not limited to, home therapy.
b) Have access to a provider with sufficient clinical experience
serving people with bleeding disorders so he or she knows when
patients have an appropriate supply of clotting factor on hand
and knows about proper 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
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emergencies, acknowledge all telephone calls within one hour or
less and have access to knowledgeable pharmacy staff on call 24
hours a day in the event of need to provide emergency clotting
factors.
d) Have the ability to obtain all brands of blood clotting
products approved by the FDA in multiple assay and vial sizes,
including products manufactured from human plasma and those
manufactured with recombinant biotechnology techniques, provided
manufacturer supply exists and payer authorization is approved.
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) When home nursing services are prescribed by the treating
physician, to offer these services either directly or through a
qualified third party with experience in infusing bleeding
disorders and coordinate pharmacy services with the third party
when one is used to provide home nursing services.
h) Upon receiving approved authorization for a non-emergency
prescription, provided manufacturer supply exists, to 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.
i) Upon receiving approved authorization to dispense a
prescription for an emergency situation, provided manufacturer
supply exists, to 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.
j) Provide patients who have ordered their products a designated
contact phone number for reporting problems with a delivery and
respond to these calls within a reasonable time period.
aa) Provide patients notification of Class 1 and Class 2 recalls
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and withdrawals of blood clotting products and ancillary infusion
equipment within 24 hours of the provider receiving notification
and requires providers to participate in the National Patient
Notification System for blood clotting product recalls.
bb) Provide language translation services, over the phone or in
person, as needed by the consumer.
cc) Have a detailed plan for meeting their requirements 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.
ee) Comply with the privacy and confidentiality requirements of
the Health Insurance Portability and Accountability Act of 1996
(HIPAA).
6)Requires the Board to enforce and administer the provisions of the
Act.
7)Clarifies that the Act does not apply to hospital pharmacies or
health system pharmacies that dispense blood clotting products for
emergency, urgent care, or inpatient encounters, or if an inpatient
is discharged with a supply of blood clotting products for home use.
FISCAL EFFECT: According to the Assembly Committee on Appropriations
analysis dated April 13, 2011, this bill will result in minor
absorbable workload to the California Board of Pharmacy to provide
oversight related to requirements the bill establishes.
COMMENTS:
1. Purpose. This bill is sponsored by the Hemophilia Council of
California (Sponsor). According to the Author and Sponsor, there
are currently no standards of service in state law governing the
proper storage and delivery of blood clotting products and this
bill will protect the health of people with coagulation disorders
who use these products at home.
2. Background. According to information provided by the Sponsors,
hemophilia is a rare, hereditary bleeding disorder affecting close
to 17,000 people in the United States, about 4,000 of which live in
California. Von Willebrand disease, another bleeding disorder,
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affects about 360,000 Californians. People born with hemophilia
have little or no clotting factor, the protein needed for normal
blood clotting. Until the 1970s, people with severe hemophilia
suffered from uncontrollable internal bleeding, orthopedic
deformities and a shortened lifespan. Recent inventions and
production of highly purified blood clotting factors have helped
give additional quality of life to those living with bleeding
diseases. Factor products on the market today are usually free
from previous risks like HIV and hepatitis as a result of
contaminated material.
Bleeding diseases are not curable but are treatable, often through
intraveneous (IV) injection or infusion of prescription blood
clotting products several times per week. A variety of blood
clotting products, produced by various pharmaceutical manufactures,
can be prescribed so as to temporarily replace the missing clotting
factors in order to prevent or correct bleeding episodes. To
properly administer blood clotting factors, patients must often use
ancillary supplies and equipment, such as syringes, tourniquets,
gauze, and alcohol swabs. Blood clotting products are generally
expensive and require special handling, including storage at
certain temperatures, and sensitivity to extreme exposure to light.
The Centers for Disease Control (CDC) recommends timely access to
hemophilia treatment and the products and services related to that
treatment.
Treatment is available to people with hemophilia and others
suffering bleeding disorders at federally funded Hemophilia
Treatment Centers (HTCs) or by prescription at pharmacies licensed
in the state. The CDC reports that patients treated at HTCs
significantly reduce their morbidity and mortality. There are over
140 HTCs in the nation which provide both diagnostic and treatment
services to people with hemophilia and other bleeding disorders,
combining the efforts of physicians, nurses, social workers,
physical therapists, orthopedists and dentists to comprehensively
serve patients.
In California, many blood clotting product providers are specialty
care pharmacies. While these pharmacies may specialize in the
provision of treatments and supplies to individuals with specific
chronic diseases, they are not licensed according to different
standards than other pharmacies. Specialty pharmacies often ship
or deliver blood clotting products to the homes of individuals with
hemophilia, and other bleeding disorders, and when necessary,
provide or arrange for nursing services to patients who may need
assistance with infusion of the blood clotting products.
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Various other states including California have attempted to
establish standards for blood clotting products, including
Massachusetts, Missouri, Pennsylvania and New Jersey. New Jersey
enacted that state's "Standards of Care in Hemophilia Homecare Law"
that was enacted in 2000. The primary issue was a requirement by
insurers that people with hemophilia worked with certain home care
companies with which they had contracts. The Hemophilia
Association of New Jersey found that often times, not all home care
companies were familiar with hemophilia care, needs, and
complications. New Jersey now requires all insurance carriers that
provide coverage for the home treatment of hemophilia to contract
with home care providers that comply with certain minimum standards
of care developed by their Department of Health & Senior Services,
in consultation with the Hemophilia Association.
Sponsors cite, as a need for a state standard, a recent situation
in which a Northern California pharmacy delivered clotting factor
product to a patient and left it on their doorstep where the
product subsequently spoiled in the heat. The Author and Sponsor
also note that pharmacies and other entities specializing in the
delivery of blood clotting products for home use form a growing
segment in California and standards will "benefit people with
hemophilia and other bleeding disorders, as well as maintain the
current cost effective model for care for future generations." The
Sponsor also states that California needs to have equal standards
for all companies distributing clotting factor in order to protect
people with bleeding disorders from companies that may not properly
store or distribute clotting factor.
3. Prior Similar Legislation. SB 971 (Pavley) of 2010, and SB 1594
(Steinberg) of 2008, were also almost identical to this bill. The
bills stemmed from conversations between the Hemophilia Council of
California and pharmacies that distribute blood clotting products
for home use. SB 971 was vetoed by the Governor and SB 1594 was
held in the Senate Committee on Appropriations.
4. Arguments in Support. Supporters like the California Medical
Association and the California Society of Health-System Pharmacists
believe that this bill will establish important standards for the
storage and delivery of highly sensitive medication while also
promoting access to cost effective, life-saving, products and
related equipment. Baxter Healthcare , a global medical products
and services company in support of universal standards for clotting
products, indicates that due to the sensitivity of the blood
clotting medication and related products, "suboptimal treatment may
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even lead to uncontrolled internal bleeding, crippling joint
malfunction, and chronic pain." Taleeris Biotherapeutics , a
producer of biological therapies from blood plasma, also support
this bill, stating that they heartily agree with the bill's
objective of standardizing the pharmacy requirement of serving both
publicly-supported and private pay individuals needing clotting
products.
SUPPORT AND OPPOSITION:
Support:
Hemophilia Council of California (Sponsor)
Baxter Healthcare
California Medical Association
California Pharmacists Association
California Society of Health-System Pharmacists
Community Healthcare Services
CSL Behring
Federal Hemophilia Treatment Centers, Region IX
Grifols
Hemophilia Foundation of Northern California
Meyer Family Cellars
National Cornerstone Healthcare Services Inc.
Pfizer
Plasma Protein Therapeutics Association
Taleeris Biotherapeutics
University of California, Davis Medical Center
Walgreens
Numerous individual pharmacies and individuals
Opposition: None received as of June 28, 2011.
Consultant:Sarah Mason