BILL ANALYSIS Ó
AB 377
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Date of Hearing: May 4, 2011
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 377 (Solorio) - As Amended: April 14, 2011
Policy Committee: Business and
Professions Vote: 9-0
Health Vote: 19-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill provides that a hospital pharmacy license can include
a hospital pharmacy physically located outside of the hospital
within a 100-mile radius of the hospital (centralized pharmacy).
It also authorizes the centralized pharmacy to deliver
non-patient specific unit dose medications to hospitals and to
prepare both pill/capsule, as well as injectable and intravenous
medications for hospital patients.
FISCAL EFFECT
Minor, absorbable costs to the Board of Pharmacy to continue
oversight of hospital-based pharmacies.
COMMENTS
1)Rationale . This intent of this bill is to reduce medication
errors by allowing centralized hospital pharmacies to serve
multiple hospitals in order to implement bar-coding systems
for unit doses of medication. The author indicates that the
cost of technology that allows hospitals to bar-code
individual doses of medication is prohibitively expensive for
most hospitals, as current law mandates that only an on-site
hospital pharmacy can prepare drugs for patients. This bill
seeks to expand the use of bar-coding in California by making
it more economical for hospital systems to implement this
technology.
2)Regulation of Hospital Pharmacies . Hospitals are currently
licensed by the Department of Public Health, but pharmacies,
AB 377
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including those within hospitals, are licensed by the Board of
Pharmacy (BOP). Repackaging, distribution, and compounding in
advance of a patient prescription are activities currently
available only to licensed manufacturers, who are regulated by
the United States Food and Drug Administration (FDA). Recent
communication with the FDA indicates this federal regulator
may allow California to regulate this level of
"manufacturing," provided the pharmacy is only serving its own
hospitals and repackaged drugs are not commercially
distributed.
3)Related Legislation . AB 2077 (Solorio) in 2010 was virtually
identical to this bill and was vetoed. The veto message
indicated that the bill places patients at risk of medication
error or exposure to adulterated or misbranded drugs, and that
was no reason to modify existing regulatory roles for Board of
Pharmacy and DPH. As drafted, this bill does not modify
existing roles for these regulatory entities, and the intent
of the bill is to expand the implementation of bar-coding in
order to reduce medication errors.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081