BILL ANALYSIS �
AB 389
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Date of Hearing: April 13, 2011
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 389 (Mitchell) - As Amended: March 30, 2011
Policy Committee: HealthVote:15-3
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill establishes statewide standards related to the
provision, storage, and delivery of blood clotting products used
at home by patients with hemophilia and related disorders.
Specifically, this bill:
1)Establishes definitions for terms including bleeding disorder,
blood clotting product, and providers of blood clotting
product.
2)Establishes standards that apply to providers of blood
clotting product related to clinical knowledge, storage and
shipping, ability to respond to questions and problems, and
availability of diverse FDA-approved blood clotting products.
3)Requires the California Board of Pharmacy to administer and
enforce the requirements established by this bill.
FISCAL EFFECT
Minor absorbable workload to the California Board of Pharmacy to
provide oversight related to requirements established by this
bill.
COMMENTS
1)Rationale . This bill is sponsored by the Hemophilia Council of
California to establish standards in state law for the proper
provision, storage, and delivery of blood clotting products.
The author notes that pharmacies that provide clotting factor
to patients enrolled in state programs such as Medi-Cal and
GHPP are under contract to comply with standards similar to
AB 389
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those in this bill.
Blood clotting products refers to a variety of prescription
treatments approved by the FDA. Safe use of clotting products
requires the use of ancillary supplies and equipment,
including syringes, tourniquets, gauze, and alcohol swabs.
According to the author and sponsor, specialty care pharmacies
typically provide blood factor products and the ancillary
services. These specialized pharmacies have expertise to
handle the treatments and provide related clinical support.
Occasionally, less experienced pharmacies have failed to
provide safe and effective blood clotting-related treatments.
This bill establishes uniform statewide standards to ensure
minimum safety and quality levels are met in the future.
2)Blood clotting products are used by patients with hemophilia
and related diseases such as Von Willebrand disease. More than
4,000 Californians have hemophilia and more than 350,000 have
been diagnosed with Von Willebrand disease. These diseases are
inherited, chronic, lifelong, and incurable. They cause
abnormal bleeding that occurs because plasma in the blood has
too little of a protein that helps blood clot. Until recent
decades, these bleeding disorders led to uncontrolled
bleeding, orthopedic deformities, and death. More recently
blood factor products have provided effective treatment to
allow individuals with bleeding disorders to lead healthy and
stable lives.
3)Related Legislation. SB 971 (Pavley) of 2010, which was
substantially similar to this bill, was vetoed by Governor
Schwarzenegger. In his veto message, the Governor stated that
SB 971 was unnecessary 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.
AB 1183 (Committee on Budget), Chapter 758, Statutes of 2008
requires pharmacies providing blood clotting products in the
Medi-Cal Program, the California Children's Services Program,
and the Genetically Handicapped Persons Program to agree to
contracts conforming to standards similar to those outlined in
this bill.
AB 389
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Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081