BILL ANALYSIS
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|Hearing Date:June 26, 2006 |Bill No:AB |
| |2408 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC
DEVELOPMENT
Senator Liz Figueroa, Chair
Bill No: AB 2408Author:Negrete McLeod
As Amended:June 1, 2006 Fiscal: Yes
SUBJECT: Pharmacies.
SUMMARY: Defines certain types of pharmacies; defines the
professional practice of pharmacy; changes requirements for
nonresident pharmacies; broadens the definition of
unprofessional conduct; and, authorizes the California
Board of Pharmacy (Board) to take additional investigative
actions.
Existing law:
1)Establishes the Board under the Department of Consumer
Affairs and charges the Board with licensing and
regulating pharmacists and pharmacies.
2)Defines a pharmacist and a pharmacy and authorizes a
licensee to engage in certain activities.
3)Sets forth activities that constitute unprofessional
conduct for a pharmacist to engage in.
4)Defines a nonresident pharmacy and requires a nonresident
pharmacy to meet certain criteria, including registration
with the Board.
5)Prohibits an unregistered nonresident pharmacy from
engaging in certain activities, including selling or
distributing dangerous drugs or dangerous devices in this
state through any person or media other than a licensed
wholesaler.
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Page 2
6)Requires a nonresident pharmacy to disclose to the board
the location, names, and titles of specified persons,
including all pharmacists dispensing controlled
substances, dangerous drugs, or dangerous devices to
residents of California.
7)Authorizes the Board to deny, revoke, or suspend a
nonresident registration for failure to comply with
specified requirements or for conduct that causes serious
bodily or psychological injury to a California resident,
in specified circumstances.
This bill:
1)Requires a pharmacist to be a natural person.
2)Entitles a licensed pharmacist to practice pharmacy
within or outside of a licensed pharmacy.
3)Modifies the definition of "pharmacy" to include the
following terms and meanings:
a) "Dispensing pharmacy" is where controlled
substances, dangerous drugs or devices are dispensed,
as specified;
b) "Prescription processing pharmacy" which is where
prescription review services (such as drug order,
utilization, and interaction reviews) are provided, as
specified; and
c) "Advice/clinical center pharmacy" which is where
cognitive pharmacy services (such as clinical advice
and medication therapy management) are provided, as
specified.
Specifies that the pharmacy types listed above are not
mutually exclusive, and a single pharmacy license issued
by the Board shall permit a pharmacy to function as one
or more type.
4)Excludes nonprofit and surgical clinics in the definition
of pharmacy.
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Page 3
5)States that pharmacy practice is continually evolving to
include more sophisticated and comprehensive patient care
activities.
6)Specifies that the scope of practice of a licensed
pharmacist includes:
a) Interpreting, verifying, and implementing drug orders
and prescriptions;
b) Dispensing pursuant to legitimate drug orders and
prescriptions;
c) Ensuring proper drug storage, documentation, inventory,
labeling, and record-keeping;
d) Maintaining accurate, complete, and confidential patient
profiles and records;
e) Supervising pharmacy technicians and other ancillary
personnel in the pharmacy;
f) Designing and implementing quality assurance procedures
and protocols;
g) Compounding drug products pursuant to prescription and
for prescriber office use;
h) Maintaining safe, secure, and sanitary conditions in
licensed premises;
i) Performing cognitive services, including drug
utilization reviews and management, medication therapy
reviews and management, and patient counseling and
consultation;
j) Collaborating with prescribers and other health care
providers regarding patient care;
aa) Implementing standardized procedures and protocols
regarding patient care;
bb) Administering or furnishing drugs or biologicals, where
permitted by law; and,
cc) Initiating, adjusting, or implementing patient drug
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regimens, as specified.
7)Allows a pharmacist to authorize the initiation or
adjustment of a prescription, or otherwise provide
cognitive services such as clinical advice or patient
consultation, if the following conditions are met:
a) The cognitive service, clinical advice, or
information or patient consultation is provided to a
health care professional or to a patient.
b) The pharmacist has access to prescription records,
patient profiles, or other relevant medical
information for purposes of cognitive services,
patient and clinical consultation, and advice, and
appropriately reviews that information before
performing any of these functions.
c) Access to the information is secure from
unauthorized access and use.
8)Requires the pharmacist to keep patient records and other
patient-specific information, including any test results
or other pertinent data, used, consulted or relied on by
the pharmacist when performing cognitive services. The
records must be maintained in a readily retrievable form,
provided to the Board upon request, and kept for a period
of at least three years.
9)Provides that unprofessional conduct for a pharmacist may
include acts or omissions that involve the failure to
exercise or implement his or her best professional
judgment and/or corresponding responsibility with
regarding the dispensing of prescription drugs and/or the
provision of cognitive services; acts or omissions that
involve the failure to consult appropriate patient,
prescription, and other records pertaining to the
performance of any pharmacy function and for pharmacists
that practice outside of a pharmacy premise; and acts or
omissions that involve, the failure to maintain and
retain appropriate patient-specific information
pertaining to the performance of any pharmacy function.
10)Clarifies that a pharmacist would be subject to
unprofessional conduct for violation of any statutes or
regulations of this state, any other state or federal
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regulatory agency.
11)Makes it unlawful for a person to perform any
prescription review, consultation, drug utilization
review, medication therapy management, or other cognitive
services for, pertaining to, or at the request of,
patients, prescribers, or other health care providers,
unless he or she is a licensed pharmacist or is a
licensed health care provider complying with a request
for consult by a licensed health care provider, as
specified.
12)Revises the definition of a nonresident pharmacy to
include a pharmacy located outside of the state that
performs prescription review, patient consultation, drug
utilization review, medication therapy management, or
other cognitive pharmacy services for patients in this
state.
13)Requires pharmacies and nonresident pharmacies to
specify their pharmacy type (e.g., dispensing pharmacy,
prescription processing pharmacy, etc.) in their initial
application, and further requires notification to the
Board within 30 days of a change in the pharmacy type
specified in the initial application.
14)Deletes the requirement that a nonresident pharmacy must
disclose the location, names, and titles of pharmacists,
and the prohibition against a nonresident pharmacy
selling or distributing dangerous drugs or devices in
California through any person or media other than a
licensed wholesaler.
15)Deletes the authorization for the board to deny, revoke,
or suspend a nonresident registration for failure to
comply with specified requirements or for conduct causing
serious bodily harm or psychological injury to a
California resident.
16)Authorizes the Board to deny, revoke, or suspend a
nonresident pharmacy registration, issue a citation or
letter of admonishment, or take any other action against
a nonresident pharmacy that it may take against a
resident pharmacy.
17)Authorizes the Board to investigate all matters related
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to the issuance of a pharmacy license including the
furnishing of dangerous drugs or dangerous devices, or to
the performance or provisions of prescription/drug order
processing or review services and/or cognitive services.
18)Authorizes the Board to report violations of laws or
regulations by a nonresident pharmacy to any appropriate
state or federal regulatory or licensing agency.
19)Recasts and revises various sections of Pharmacy Law.
FISCAL EFFECT: According to the Assembly Appropriations
Committee analysis, minor and absorbable special fund costs
(Pharmacy Board Contingent Fund) to the Board of Pharmacy.
COMMENTS:
1.Purpose. The California State Board of Pharmacy (Board)
is the source of the bill, and the Board states that this
bill is the product of a yearlong discussion by the Board
and its Licensing Committee to address inquiries that the
Board had received regarding the licensure of pharmacies
and pharmacists that perform cognitive services, such as
call centers, drug utilization review and Medication
Therapy Management, and the performance of these services
by pharmacists outside a pharmacy. The inquiries came
from chain drug stores, pharmacy benefit managers, and
individual pharmacists.
According to the Board, current pharmacy law does not
define the professional practice of pharmacy by a
pharmacist. The law states that a licensed pharmacy is
an area, place, or premise in which the profession of
pharmacy is practiced and pharmacy law restricts certain
activities to that of a licensed pharmacist. However,
the law defines "pharmacist" as a person to whom a
license has been issued by the Board, under section 4200
and does not define the functions that are inherent to
pharmacy practice and must be performed by a pharmacist.
This bill recognizes in statute that the practice of
pharmacy means far more than simply counting and
dispensing medications, that it is a professional
practice, and that licensed pharmacists can practice both
within and outside the four walls of a traditional
pharmacy.
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2.Pharmacy Functions Being Performed Outside of Traditional
Pharmacy Locations. Under current law a "pharmacy" is
defined as an area, place, or premise licensed by the
board in which the profession of pharmacy is practiced.
Only a pharmacy may possess, prepare, manufacture,
derive, compound, repackage, furnish, sell or dispense
dangerous drugs or devices. A key function to the
dispensing of a dangerous drugs is the "processing of a
prescription." (A prescription is required in order to
dispense a dangerous drug.) The activities involved in
the processing of a prescription include data entry, drug
utilization review, patient and/or prescriber contact,
patient profile review, and allergy and drug interaction
review. A pharmacist must perform some of these
activities, while ancillary personnel under the
supervision of a pharmacist may perform other
pharmacy-related functions. Pharmacy practice also
includes the provision of cognitive services by
pharmacists that include providing clinical advice or
information on prescriptions drugs, providing patient
consultation, drug utilization review, and medication
therapy management. Many of the cognitive services
encompasses a broad range of professional activities
within the pharmacist's scope of practice and may be
independent of, or can occur in conjunction with the
dispensing of a prescription drug.
According to the Board, the practice of pharmacy is unique
in that it is the only profession that is practiced in a
licensed "pharmacy" area. Over the years there has been
a change to traditional pharmacy practice where all the
activities related to the dispensing of prescription
drugs took place in one pharmacy location. While many of
the activities related to the dispensing of prescription
drugs still must be performed in a pharmacy, the actual
storage of drugs and the dispensing function may be done
at a separate location. For example, one pharmacy may
process a prescription and provide cognitive services,
while another pharmacy may actually dispense the
prescription drug to the patient. Technology such as
robotics, imaging, file-sharing and electronic records
has allowed many aspects of pharmacy practice to be
performed at different pharmacy locations and not tied to
the one traditional pharmacy location that performs the
dispensing function.
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3.Regulation of Nonresident Pharmacies Broadened. The
Board also licenses nonresident pharmacies. These are
licensed pharmacies located in another state that ship
prescription drugs to California patients in this state.
This bill amends the definition of a nonresident pharmacy
to include a pharmacy that performs prescription review,
patient consultation, drug utilization review, medication
therapy management, or other cognitive pharmacy services
for California patients. This definition is consistent
with the proposed definition for California pharmacies.
Currently, nonresident pharmacies that may not ship
prescription drugs into California but perform cognitive
pharmacy services for California patients are licensed as
nonresident pharmacies.
Consistent with current law, this bill does not require a
pharmacist residing outside of California and who is
practicing under the auspices of a nonresident pharmacy
to be licensed as a pharmacist in California. While the
Board has licensed nonresident pharmacies for over 20
years, it has never required the employee pharmacists of
these facilities to be California licensed pharmacists.
At this time, it is the Board's position that the current
licensing structure provides the necessary public
protection for California patients. The Board has
authority to take action against a nonresident pharmacy
should the action of an employee pharmacist harm a
patient. If a patient is harmed by an independent act of
non-California licensed pharmacist, then the Board will
rely on that state where the pharmacist is licensed to
take appropriate action.
4.Arguments in Support. The California Board of Pharmacy
states that this bill is a good consumer protection
proposal that recognizes the professional practice of
pharmacy outside of a traditional pharmacy practice
setting, and the provision of services to California
patients by pharmacies, pharmacists and ancillary staff
outside state lines. The Board believes this bill
acknowledges the need to balance its primary duty to
protect the public with its desire not to impede patient
access to services (especially for California patients)
and not create unnecessary barriers for pharmacists to
practice the profession of pharmacy.
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Medco Health Solutions believes that this bill updates and
clarifies the practice of pharmacy to more clearly
reflect how pharmacies and pharmacists practice today.
It can no longer be viewed as simply a matter of counting
and dispensing. It includes drug utilization review,
clinical advice, drug-interaction review, patient
consultation, and more. As such, this bill more clearly
delineates the Board's authority with regard to
regulating these new and emerging issues within the
pharmacy arena.
5.Concerns Expressed by the California Medical Association
(CMA). CMA has recently raised issues with the some of
the language contained in this bill.
The Sponsor and the CMA have agreed to continue discussions
as the bill moves through the process and hope to come to
some agreement. It is the Committee's prerogative to
bring the bill back to Committee in the event that
agreement is not reached.
SUPPORT AND OPPOSITION:
Support:
California State Board of Pharmacy (Sponsor)
California Society of Health-Systems Pharmacists
Medco Health Solutions, Inc.
Opposition:
None on file
Consultant:Robin M. Hartley