BILL ANALYSIS
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|Hearing Date:June 14, 2004 |Bill No:AB |
| |2660 |
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SENATE COMMITTEE ON BUSINESS AND PROFESSIONS
Senator Liz Figueroa, Chair
Bill No: AB 2660Author:Leno
As Amended:April 12, 2004 Fiscal:Yes
SUBJECT: Prescriptions: issuance by a pharmacist.
SUMMARY: Amends existing law to reinstate pharmacists'
authority to register with the U.S. Drug Enforcement Agency
(DEA) and therefore initiate or adjust controlled substance
drug therapy under specified conditions.
Existing law:
1)Provides for the licensure and regulation by the State
Board of Pharmacy (Board) of pharmacies, pharmacists, and
pharmacy practices.
2)Defines "prescription," in part, as being issued by
designated healing arts practitioners, not including a
pharmacist.
3)Makes specific requirements for issuing prescriptions for
a controlled substance, and requires a copy of the
prescription to be submitted to the Department of Justice
at the end of the month in which the prescription was
filled.
4)Authorizes pharmacists to furnish, transmit, and
administer prescription medication. Authorizes them to
perform routine drug therapy-related patient assessment
procedures, including temperature, pulse and respiration,
ordering drug therapy-related lab tests, administering
drugs and biologicals by injection, and initiating or
adjusting the drug regimen of a patient pursuant to an
order or authorization made by the patient's prescriber
in accordance with policies, procedures and protocols.
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Allows pharmacists to furnish emergency contraception
drug therapy as long as the pharmacist completes a
training program on emergency contraception drug therapy.
5)Allows certified nurse-midwives, nurse practitioners, and
physician assistants to order or furnish drugs or devices
under the supervision of a physician and surgeon.
6)Allows a pharmacist, under physician supervision, who is
functioning as part of a multidisciplinary group in a
clinical setting, to initiate or adjust a drug therapy.
7)Precludes any person from possessing a controlled
substance, unless a person has a valid prescription for
that drug.
8)Prohibits the Board from issuing a pharmacy license to,
or renewing a pharmacy license of, specified persons,
including those who are authorized to write a
prescription,
This bill:
1)Revises the definition of "prescription" to include a
drug order issued by a pharmacist under conditions
specified where the pharmacist is authorized to initiate
or adjust the drug regimen of a patient.
2)Requires a pharmacist who is authorized to issue an order
to initiate or adjust a controlled substance therapy to
personally register with the DEA.
3)Authorizes a person to possess a controlled substance
furnished under a drug order by a pharmacist under
specified conditions.
4)Authorizes the Board to issue or renew a license for a
pharmacy that is owned and operated by a pharmacist who
is authorized to issue a drug order under specified
conditions.
5)Makes other nonsubstantive technical changes.
FISCAL EFFECT: According to the Assembly Appropriations
Committee, minor if any costs to the Board of Pharmacy.
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COMMENTS:
1.Purpose. According to the Author, until recently the
DEA issued registration numbers to qualified California
pharmacists. However, based on legislation unrelated to
pharmacists that specifically authorized other mid-level
practitioners to furnish drugs under physician protocols
(but unintentionally excluded pharmacists), the DEA
believes that California law no longer allows them to do
so. The Author states that this bill continues
pharmacists' ability to help physicians manage
prescription drug therapies by restoring their ability to
initiate or adjust drug therapies under physician
protocols.
2.Background. The California Pharmacist Practice Act allows
specifically authorized and specially qualified
pharmacists to initiate and adjust prescription drug
therapy under protocols jointly developed by physicians
and pharmacists. This authority applies to both
controlled and non-controlled substances. Controlled
substances are also regulated by federal law, which
requires anyone handling controlled substances to have a
DEA registration number. DEA issues registration numbers
to mid-level practitioners, in accordance with state law.
The DEA used to issue registration numbers to qualified
California pharmacists because they were considered
mid-level practitioners. In 1999, the Legislature passed
SB 816 (Escutia), Chapter 749, Statutes of 1999, which
specifically designated certified nurse-midwives, nurse
practitioners and physician assistants as mid-level
practitioners, so that they could continue to exercise
there authority to furnish drugs under physician
protocols.
However, SB 816 did not include pharmacists in its
provisions. This legislation was unrelated to pharmacists
and no one thought to include pharmacists or knew that
this would prevent pharmacists from assisting physicians
with drug therapy involving controlled substances. As a
result, pharmacists have been denied DEA registration
numbers and have been unable to assist physicians in
managing controlled substance drug therapies, though
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state law still permits them to do so. This bill simply
rectifies the oversight of not including pharmacists as
mid-level practitioners in SB 816 and re-establishes the
ability of qualified pharmacists to work under a
physician in adjusting controlled substance drug therapy.
The inability of pharmacists to continue to assist
physicians in managing controlled substance drug
therapies unnecessarily burdens physicians, who are
required to personally approve even the slightest
adjustment to any controlled substance therapy.
According to the Author's office, this is particularly
problematic in managing pain therapy, which a qualified
pharmacist could assist with under this bill.
3.Arguments in Support. According to Kaiser Permanente
(Kaiser), the sponsor of this bill, the bill will allow
pharmacists to continue to help physicians manage
prescription drug therapies by restoring their ability to
initiate or adjust controlled substance drug therapies
under physician protocols. Kaiser's support notes that
the bill will rectify the oversight that left pharmacists
out of state law designation as mid-level practitioners
that the DEA requires as a prerequisite to issuing its
registration number.
The California Association of Physician Groups (CAPG)
supports the bill because it encourages the managed care
delegated model of health care. CAPG states that by
allowing pharmacists to initiate or adjust controlled
drug therapies, healthcare resources and physician time
are maximized, resulting in controlled health care costs.
The bill is also supported by others including the
California Medical Association (CMA), the California
State Board of Pharmacy, and the California Retailers
Association for the same reasons as stated by Kaiser and
CAPG
SUPPORT AND OPPOSITION:
Support:
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Kaiser Permanente (Sponsor)
California Association of Nurse Practitioners (CANP)
California Association of Physician Groups (CAPG)
California Medical Association (CMA)
California Pharmacists Association (CPhA)
California Retailers Association (CRA)
California Society of Health-System Pharmacists
(CSHP)
California State Board of Pharmacy
Opposition: None on file.
Consultant:Jay J. DeFuria