BILL ANALYSIS �
AB 399
Page 1
Date of Hearing: April 12, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 399 (Bonnie Lowenthal) - As Introduced: February 14, 2011
SUBJECT : Corrections: offender pharmacies.
SUMMARY : Requires the California Department of Corrections and
Rehabilitation's (CDCR) pharmacy services program to incorporate
specified features, requires CDCR's centralized pharmacy
distribution center (CPDC) and institutional pharmacies to be
licensed by the California State Board of Pharmacy (Board),
requires a system of quality control checks for the CPDC, and
requires a program for inspections of all department pharmacies,
as specified. Specifically, this bill :
1)Requires, rather than allows, CDCR's pharmacy services program
to incorporate all of the following:
a) A statewide pharmacy administration system with direct
authority and responsibility for program administration and
oversight;
b) Medically necessary pharmacy services using
professionally and legally qualified pharmacists,
consistent with the size and the scope of medical services
provided;
c) Written procedures and operational practices pertaining
to the delivery of pharmaceutical services;
d) A multidisciplinary, statewide Pharmacy and Therapeutics
Committee responsible for all of the following:
i) Developing and managing a department formulary;
ii) Standardizing the strengths and dosage forms for
medications used in department facilities;
iii) Maintaining and monitoring a system for the review
and evaluation of corrective actions related to errors in
prescribing, dispensing, and administering medications;
AB 399
Page 2
iv) Conducting regular therapeutic category reviews for
medications listed in the department formulary; and,
v) Evaluating medication therapies and providing input
to the development of disease management guidelines used
in the department.
e) A requirement for the use of generic medications, when
available, unless an exception is reviewed and approved in
accordance with an established nonformulary approval
process; and,
f) Use of an enterprise-based pharmacy operating system
that provides management with information on prescription
workloads, medication utilization, prescribing data, and
other key pharmacy information.
2)Requires, rather than expressing the intent of the
Legislature, that the CPDC and institutional pharmacies be
licensed as pharmacies by the Board and requires them to meet
all applicable regulations applying to a pharmacy.
3)Requires, rather than allows, the CPDC to maintain a system of
quality control checks on each process used to package, label,
and distribute medications, as specified.
4)Requires, rather than allows, CDCR to ensure that there is a
program providing for the regular inspection of all department
pharmacies in the state to verify compliance with applicable
laws, rules, regulations, and other standards as may be
appropriate to ensure the health, safety, and welfare of the
department's inmate patients.
EXISTING LAW :
1)Authorizes CDCR to maintain and operate a comprehensive
pharmacy services program for those facilities under the
jurisdiction of the department that is both cost effective and
efficient, and that may incorporate some or all of the
features specified above.
2)Authorizes CDCR to operate and maintain a CPDC to provide
specified cost advantages, efficiencies, and increased patient
safety.
AB 399
Page 3
3)Expresses the intent of the Legislature that the CPDC and
institutional pharmacies be licensed as pharmacies by the
Board meeting all applicable regulations applying to a
pharmacy.
4)States that the CPDC should maintain a system of quality
control checks on each process used to package, label, and
distribute medications.
5)States that CDCR should ensure that there is a program
providing for the regular inspection of all department
pharmacies in the state to verify compliance with applicable
laws, rules, regulations, and other standards as may be
appropriate to ensure the health, safety, and welfare of the
department's inmate patients.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "AB 399
strengthens the protocols in existing law and requires CDCR to
fully implement the comprehensive pharmacy services program?"
Background . California's prison health care system has been
under federal receivership since 2006, after the court found
that inadequate medical care in the state's 33 adult prisons
violated the Eighth Amendment of the United States Constitution
forbidding cruel and unusual punishment.
At the direction of the federal Receiver, Maxor National
Pharmacy Services (Maxor) in June 2006 issued a report on
California's prison pharmacy system that found CDCR pharmacy
services were costly, inefficient, and unsafe. Specifically,
pharmacy services suffered from: lack of effective central
oversight and leadership; lack of an operational infrastructure
of policies, processes, technology and human resources needed to
support an effective program; excessive costs and inefficiencies
in the purchasing processes employed; and, ineffective systems
for contracting, procurement, distribution and inventory
control. The report also estimated that prison pharmacies cost
California taxpayers $46 to $80 million more than equivalent
prison systems.
The Receiver hired Maxor to oversee an overhaul of the pharmacy
AB 399
Page 4
system, which began in January 2007 and lasted three years. AB
2747 (B. Lowenthal) of 2010, attempted to codify the plan
instituted in this overhaul to ensure it would continue to be
carried out when prison health care returns to CDCR's
jurisdiction. The Governor vetoed the bill, stating, "CDCR is
currently under federal receivership for its health care
services. The Receiver has the authority to conduct the
provisions of AB 2747 and is currently in the process of
implementing the CPDC. It would be premature for me to sign a
bill when the successfulness of the CPDC has yet to be
determined."
According to the author's office, "Although AB 2747 was vetoed
by Governor Schwarzenegger, the 2010-11 Budget trailer bill
incorporated the majority of the bill language. However, the
budget language operates more as guideline for the development
of the centralized program, instead of placing specific
requirements on the specific features of the system.
Furthermore, the budget bill, and consequently existing law, did
not require the centralized distribution center and
institutional pharmacies to be licensed by the California State
Board of Pharmacy."
Support . The American Federation of State, County and Municipal
Employees, AFL-CIO, sponsor of this bill, states, "Before a
major overhaul that took place between 2007 and 2010,
California's prison pharmacy program was not meeting minimal
standards of patient care and was wasting millions of taxpayer
dollars?After the overhaul, a framework established by the
Receiver improved pharmacy care and saved the state millions of
dollars?(This bill's) requirements are meant to reinforce the
changes made to CDCR in 2007-2010. AB 399 would ensure the
continued high quality and standards of CDCR and its vital
services."
Previous legislation .
AB 1628 (Assembly Budget Committee), Chapter 729, Statutes of
2010, is the Public Safety Budget Trailer Bill containing
provisions necessary to implement the 2010-11 Budget, including
authorization for CDCR to maintain a comprehensive pharmacy
services program and to create the CPDC.
AB 2747 (B. Lowenthal) of 2010, requires CDCR to maintain and
operate a pharmacy services program, as specified, and
AB 399
Page 5
authorizes CDCR to operate and maintain a CPDC. This bill was
vetoed.
Double referred . This bill is double-referred to Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
American Federation of State, County and Municipal Employees,
AFL-CIO (sponsor)
Opposition
None on file.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301