Bill Text: CA SB306 | 2013-2014 | Regular Session | Amended

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Bill Title: Nursing: licensing criteria.

Sponsorship: Partisan Bill (Democrat 1)

Status: (Engrossed - Dead) 2014-01-13 - From committee with author's amendments. Read second time and amended. Re-referred to Com. on B.,P. & C.P. [SB306 Detail]

Download: California-2013-SB306-Amended.html

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BILL NUMBER: SB 306	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JANUARY 13, 2014
	AMENDED IN ASSEMBLY  JUNE 20, 2013
	AMENDED IN SENATE  MAY 7, 2013
	AMENDED IN SENATE  APRIL 18, 2013

INTRODUCED BY   Senator Torres
    (   Principal coauthor: 
 Assembly Member   Cooley  
) 

                        FEBRUARY 15, 2013

   An act to amend  Sections 4170, 4180, and 4186 
 Section 2732  of the Business and Professions Code,
relating to  pharmacy   nursing  .


	LEGISLATIVE COUNSEL'S DIGEST


   SB 306, as amended, Torres.  Pharmacy: dangerous drugs and
dangerous devices: automated drug delivery systems.  
Nursing: licensing criteria.  
   Existing law, the Nursing Practice Act, until January 1, 2016,
provides for the licensure and regulation of registered nurses by the
Board of Registered Nursing. Existing law prohibits a person from
engaging in the practice of nursing, as defined, without holding a
license which is in an active status issued under the act, except as
specified. Existing law authorizes every licensee to be known as a
registered nurse and to place the letters "R.N." after his or her
name.  
   This bill would make technical, nonsubstantive changes to these
provisions.  
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacies in this state by the California State Board
of Pharmacy. A violation of the Pharmacy Law is a crime. 

   Among other provisions, the Pharmacy Law prohibits a prescriber
from dispensing dangerous drugs or dangerous devices, as defined, to
patients in his or her office unless specified conditions are met.
Existing law defines a prescriber for purposes of this provision to
mean a person who holds a physician's and surgeon's certificate, or
one of other specified health care licenses or certificates, and who
is registered to engage in that practice with the appropriate board
of this state. Existing law authorizes certain health care
professionals, including a certified nurse-midwife or a nurse
practitioner, as specified, to hand to a patient of the supervising
physician and surgeon a properly labeled prescription drug
prepackaged by a physician and surgeon, a manufacturer, as defined,
or a pharmacist.  
   This bill would revise the conditions under which a prescriber may
dispense dangerous drugs and dangerous devices. The bill would
require a health care professional who is licensed as specified, or
his or her designee, to physically furnish the dangerous drug or
device to the patient, to be identified, except as specified, by the
drug or device manufacturer or wholesaler supplying the drug or
device as the recipient of the drug or device, and as the recipient
in all invoices, bills of lading, state or federal order forms, and
other documentation, and to provide the patient with an oral
consultation, as specified. The bill would revise the definition of a
prescriber to apply to a person who is licensed to prescribe and
dispense dangerous drugs, including, but not limited to, the licensed
health care professionals authorized pursuant to existing law. The
bill would also authorize a registered nurse who functions within a
licensed primary care clinic, federal or state government operated
clinic, community or free clinic to hand to a patient of the
supervising physician and surgeon a properly labeled prescription
drug prepackaged by a physician and surgeon, a manufacturer, as
defined, or a pharmacist.  
   Existing law authorizes clinics to purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, to patients registered for care at the clinic. Existing law
also authorizes an automated drug delivery system, as defined, to be
located in any clinic licensed by the board, as specified. Existing
law requires an automated drug delivery system to collect, control,
and maintain all transaction information to accurately track the
movement of drugs into and out of the system for security, accuracy,
and accountability.  
   This bill would authorize an automated drug delivery to be located
in a group practice, as specified. The bill would authorize
specified entities, including a group practice, that uses an
automated drug delivery system, as described, to purchase drugs at
wholesale for administration or dispensing, under the direction of a
physician and surgeon or other prescriber when permitted by law, and
would make conforming and related changes.  
   The bill would also impose new conditions on an automated drug
delivery system. Among other requirements, the bill would require
that an automated drug delivery system be located within the clinic
or office of the group practice, that its contents be secure from
access or removal by unauthorized individuals, and that it maintain a
readily retrievable electronic record to identify all pharmacists,
registered pharmacy technicians, prescribers, and all other personnel
involved in the dispensing of a drug. The bill would also require
that the record of transactions conducted through the automated drug
delivery system be made available to authorized agents of the board.
The bill would authorize the board to adopt regulations permitting
the use of an automated drug delivery system that delivers dispensed
medications directly to a patient.  
   Because of violation of the bill's requirements would be a crime,
the bill would impose a state-mandated local program. 

   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason. 
   Vote: majority. Appropriation: no. Fiscal committee:  yes
  no  . State-mandated local program:  yes
  no  .


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 2732 of the   Business
and Professions Code  is amended to read: 
   2732.   No   (a)     A
 person shall  not  engage in the practice of nursing,
as defined in Section 2725, without holding  a license which
is in  an active status  license  issued 
under   pursuant to  this chapter except as
otherwise provided in this act.
    Every licensee   (b)     A
person licensed pursuant to this chapter  may be known as a
registered nurse and may place the letter "R. N." after his  or
her  name. 
  SECTION 1.    Section 4170 of the Business and
Professions Code is amended to read:
   4170.  (a) No prescriber shall dispense dangerous drugs or
dangerous devices to patients in his or her office or place of
practice unless all of the following conditions are met:
   (1) The dangerous drugs or dangerous devices are dispensed to the
prescriber's own patient. A health care professional who is licensed
as described in this section, or his or her designee, shall
physically furnish the dangerous drug or device to the patient.
   (2) The dangerous drugs or dangerous devices are necessary in the
treatment of the condition for which the prescriber is attending the
patient.
   (3) The prescriber does not keep a pharmacy, open shop, or
drugstore, advertised or otherwise, for the retailing of dangerous
drugs, dangerous devices, or poisons.
   (4) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists by Section 4076, all of the recordkeeping
requirements of this chapter, and all of the packaging requirements
of good pharmaceutical practice, including the use of childproof
containers.
   (5) Unless the prescriber is employed by or under contract to a
clinic or group practice that is licensed by the board pursuant to
Section 4180, the prescriber is identified by the drug manufacturer
or wholesaler supplying the drugs as the recipient of the drugs and
identified by name and registration number as the recipient in all
invoices, bills of lading, state or federal order forms, and other
documentation. As the recipient of the drugs, the prescriber is
responsible for ensuring that the drugs are securely and safely
stored prior to dispensing and is responsible for maintaining all
required records regarding the receipt, storage, and dispensing or
other disposition of all drugs and devices.
   (6) The prescriber, prior to dispensing, offers to give a written
prescription to the patient that the patient may elect to have filled
by the prescriber or by any pharmacy.
   (7) The prescriber provides the patient with written disclosure
that the patient has a choice between obtaining the prescription from
the dispensing prescriber or obtaining the prescription at a
pharmacy of the patient's choice.
   (8) The prescriber provides the patient with an oral consultation
regarding issues that the prescriber, in his or her professional
judgment, deems necessary to ensure the safe and effective use of the
prescribed drug or device. The oral consultation shall include all
subjects that pharmacists are required to discuss pursuant to
regulations adopted by the board pursuant to Section 4005.
   (9) A certified nurse-midwife who functions pursuant to a
standardized procedure or protocol described in Section 2746.51, a
nurse practitioner who functions pursuant to a standardized procedure
described in Section 2836.1, or protocol, a physician assistant who
functions pursuant to Section 3502.1, a registered nurse who
functions pursuant to Section 2725.1, or a naturopathic doctor who
functions pursuant to Section 3640.5, may hand to a patient of the
supervising physician and surgeon a properly labeled prescription
drug prepackaged by a physician and surgeon, a manufacturer as
defined in this chapter, or a pharmacist. Nothing in this section
shall preclude the use of an automated drug delivery system described
in Section 4186.
   (b) The Medical Board of California, the State Board of Optometry,
the Bureau of Naturopathic Medicine, the Dental Board of California,
the Osteopathic Medical Board of California, the Board of Registered
Nursing, the Veterinary Medical Board, and the Physician Assistant
Committee shall have authority with the California State Board of
Pharmacy to ensure compliance with this section, and those boards are
specifically charged with the enforcement of this chapter with
respect to their respective licensees.
   (c) "Prescriber," as used in this section, means a person who is
licensed to prescribe and dispense dangerous drugs and devices,
including, but not limited to, a person who holds a physician's and
surgeon's certificate, a license to practice optometry, a license to
practice naturopathic medicine, a license to practice dentistry, a
license to practice veterinary medicine, or a certificate to practice
podiatry, and who is duly registered by the Medical Board of
California, the State Board of Optometry, the Bureau of Naturopathic
Medicine, the Dental Board of California, the Veterinary Medical
Board, or the Board of Osteopathic Examiners of this state.
   (d) This section shall not prevent a group practice, licensed
pursuant to Section 4180, from owning an inventory of dangerous drugs
and devices and dispensing the drugs and devices from the inventory
owned by the group practice provided that the following conditions
are met:
   (1) Each prescriber dispenses dangerous drugs or devices only to
the patients seen or treated by that prescriber, and not to the
patient of any other prescriber in the group practice, and the drugs
or devices are packaged, labeled, and recorded in accordance with
paragraph (4) of subdivision (a).
   (2) The group practice identifies a responsible prescriber within
the group practice who shall be named by the drug manufacturer or
wholesaler supplying the drugs as the recipient of the drugs on all
invoices, bills of lading, state or federal order forms, and other
documentation, and who shall be responsible for the record-keeping
and storage of the drug inventory.
   (3) Records are maintained by each prescriber to identify the
identity of the patient and the name, strength, quantity, and
directions for use for each dangerous drug dispensed by the
prescriber to his or her patient.
   (4) A daily dispensing log or some other paper or electronic
record is created each day, and maintained by the group practice, to
identify both of the following:
   (A) A daily starting inventory of all dangerous drugs that are
jointly owned by the prescribers who comprise the group practice.
   (B) The name, strength, and quantity of all dangerous drugs
dispensed by each prescriber.
   (e) A prescriber employed by, or under contract to, a clinic or
group practice licensed under Section 4180 may dispense drugs that
are owned by the clinic or group practice.
   (f) (1) For purposes of this section, a dangerous drug is owned if
it is delivered to the possession of a prescriber, clinic, or group
practice, and each prescriber, clinic, or group practice has
responsibility for the security and recordkeeping associated with
possession of the dangerous drugs, regardless of the person or entity
responsible for payment for the dangerous drug inventory.
   (2) For the purposes of this section, "group practice" means more
than one prescriber practicing under a single professional
corporation or license, including a medical group or risk-bearing
organization as defined in the Knox-Keene Health Care Service Plan
Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2
of the Health and Safety Code).  
  SEC. 2.    Section 4180 of the Business and
Professions Code is amended to read:
   4180.  (a) (1) Notwithstanding any provision of this chapter, any
of the following entities may purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, or other prescriber when permitted by law, to patients
registered for care at the clinic:
   (A) A licensed nonprofit community clinic or free clinic as
defined in paragraph (1) of subdivision (a) of Section 1204 of the
Health and Safety Code.
   (B) A primary care clinic owned or operated by a county as
referred to in subdivision (b) of Section 1206 of the Health and
Safety Code.
   (C) A clinic operated by a federally recognized Indian tribe or
tribal organization as referred to in subdivision (c) of Section 1206
of the Health and Safety Code.
   (D) A clinic operated by a primary care community or free clinic,
operated on separate premises from a licensed clinic, and that is
open no more than 20 hours per week as referred to in subdivision (h)
of Section 1206 of the Health and Safety Code.
   (E) A student health center clinic operated by a public
institution of higher education as referred to in subdivision (j) of
Section 1206 of the Health and Safety Code.
   (F) A nonprofit multispecialty clinic as referred to in
subdivision (  l  ) of Section 1206 of the Health
and Safety Code.
   (G) A group practice, as defined in Section 4170, that uses an
automated drug delivery system, as described in Section 4186.
   (2) The clinic or group practice shall keep records of the kind
and amounts of drugs purchased, administered, and dispensed, and the
records shall be available and maintained for a minimum of three
years for inspection by all properly authorized personnel.
   (b) No clinic or group practice shall be entitled to the benefits
of this section until it has obtained a license from the board. A
separate license shall be required for each clinic location. A clinic
or group practice shall notify the board of any change in the
address of the clinic or group practice on a form furnished by the
board. 
  SEC. 3.    Section 4186 of the Business and
Professions Code is amended to read:
   4186.  (a) An automated drug delivery system, as defined in
subdivision (i), may be located in any clinic or group practice
licensed by the board as described in Section 4180.
   (b) (1) If an automated drug delivery system is located in a
clinic, the clinic shall develop and implement written policies and
procedures to ensure safety, accuracy, accountability, security,
patient confidentiality, and maintenance of the quality, potency, and
purity of drugs. All policies and procedures shall be maintained at
the location where the automated drug system is being used.
   (2) If an automated drug delivery system is located in a group
practice, the group practice shall develop and implement written
policies and procedures to ensure safety, accuracy, accountability,
security, patient confidentiality, and maintenance of the quality,
potency, and purity of drugs. All prescribers who will be dispensing
drugs from the automated drug delivery system and all health care
professionals and delegated personnel authorized to stock, refill, or
retrieve the drugs inventory from the automated drug delivery system
shall be required to comply with the policies and procedures
developed by the group practice. All policies and procedures shall be
maintained at the location where the automated drug system is being
used.
   (c) Drugs shall be removed from the automated drug delivery system
only upon authorization by a pharmacist or prescriber after the
pharmacist or prescriber has reviewed the prescription and the
patient's profile for potential contraindications and adverse drug
reactions. Drugs removed from the automated drug delivery system
shall be provided to the patient by a health professional licensed
pursuant to this division or an individual operating under the
supervision of the prescriber.
   (d) The stocking of an automated drug delivery system shall be
performed by a pharmacist or, in a clinic or group practice, by a
prescriber or a designee of the prescriber.
   (e) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be the
responsibility of the clinic in a clinic setting or by the
responsible prescriber in a group practice. The review shall be
conducted on a monthly basis by a pharmacist or responsible
prescriber and shall include a physical inspection of the drugs in
the automated drug delivery system, an inspection of the automated
drug delivery system machine for cleanliness, and a review of all
transaction records in order to verify the security and
accountability of the system.
   (f) The automated drug delivery system used at the clinic or group
practice shall provide for patient consultation pursuant to Section
1707.2 of Title 16 of the California Code of Regulations with a
pharmacist via a telecommunications link that has two-way audio and
video, unless a consultation is provided by the prescriber pursuant
to paragraph (8) of subdivision (a) of Section 4170.
   (g) A pharmacist operating the automated drug delivery system
shall be licensed in California.
   (h) Drugs dispensed from the automated drug delivery system shall
comply with the labeling requirements in Section 4076.
   (i) For purposes of this section, an "automated drug delivery
system" means a mechanical system controlled remotely by a
pharmacist, or, if used to facilitate prescriber dispensing by a
prescriber, that performs operations or activities, other than
compounding or administration, relative to the storage, dispensing,
or distribution of prepackaged dangerous drugs or dangerous devices.
An automated drug delivery system shall collect, control, and
maintain all transaction information to accurately track the movement
of drugs into and out of the system for security, accuracy, and
accountability and shall meet all of the following requirements:
   (1) The system shall be located within the clinic or office of the
group practice, and its contents shall be secure from access or
removal by unauthorized individuals.
   (2) A policy and procedure manual shall be developed and
maintained and shall include the type or name of the system including
a serial number or other identifying nomenclature and a description
of the security provisions, stocking processes, and other
documentation practices of the clinic or group practice.
   (3) The system shall have a method to ensure security of the
system to prevent unauthorized access to dangerous drugs or devices
contained within the system. The method may include the use of
electronic passwords, biometric identification, including optic
scanning or fingerprint, or other coded identification.
   (4) The clinic or group practice shall employ a process of filling
and stocking the system with drugs. The stocking or restocking of a
drug shall only be completed by a pharmacist, prescriber, or
personnel designated by the pharmacist or prescriber and all of the
following shall apply:
   (A) The cartridges or containers to be stocked or restocked shall
be provided by a licensed wholesale drug distributor or repackaged by
the pharmacy or prescriber in compliance with state and federal law.
The licensed wholesale drug distributor shall have a method of
receiving and disposing of rejected, expired, or unused medications
consistent with state or federal law.
   (B) The individual cartridge or container shall be transported to
the dispensing site in a secure, tamper-evident package.
   (C) The system shall use a bar code verification, electronic
verification, weight verification, radio frequency identification, or
similar process to ensure that the cartridge or container is
accurately stocked or restocked into the automated system. The system
shall provide for alerts to the responsible pharmacist or prescriber
if a cartridge or container is not recorded in the automated system.

   (D) The pharmacist or prescriber responsible for the dispensed
drug shall be responsible if the cartridge or container is stocked or
restocked incorrectly by the personnel designated to load the
cartridges or containers.
   (5) The system shall maintain an electronic or hard copy record of
medication filled into the system, including the product
identification, lot number, and expiration date.
   (6) The system shall maintain a readily retrievable electronic
record to identify all pharmacists, registered pharmacy technicians,
prescribers, and all other personnel involved in the dispensing of a
drug.
   (7) The system shall be able to comply with product recalls
generated by any manufacturer or distributor and shall have a process
in place to isolate affected lot numbers.
   (8) The record of transactions conducted through the automated
drug delivery system shall be available to authorized agents of the
board. The record of transactions shall, only to the extent
authorized or permitted by state or federal law, include the
following:
   (A) Name of the patient.
   (B) Name, strength, and dosage form of the drug product dispensed.

   (C) Quantity of drug dispensed.
   (D) Date and time of dispensing.
   (E) Prescription number or other unique serial number assigned to
the transaction.
   (F) Name of prescriber.
   (G) Identity of the pharmacist who approved the prescription, or
of the prescriber.
   (H) Identity of the person to whom the drug was released.
   (9) Unless the prescriber provides consultation pursuant to
regulations adopted by the board pursuant to Section 4005, the system
shall provide patients with telephonic access to consultation by a
California-licensed pharmacist.
   (10) In the case of dangerous drugs that require reconstitution,
the prescriber or his or her designee shall reconstitute the
medication for the patient.
   (j) The board is authorized to adopt regulations authorizing the
use of an automated drug delivery system that delivers dispensed
medications directly to a patient. The regulations shall be based, in
part, upon the board's assessment of the safety of the systems.
 
  SEC. 4.    No reimbursement is required by this
act pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.