BILL NUMBER: AB 522	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 29, 2005

INTRODUCED BY   Assembly Member Plescia

                        FEBRUARY 16, 2005

   An act to amend Section 1261.6 of the Health and Safety Code,
relating to health facilities.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 522, as amended, Plescia.  Automated drug delivery system.
   Existing law provides for skilled nursing and intermediate care
facilities to use an automated drug delivery system to store and
distribute drugs, and to track the movement of drugs into and out of
the system. Existing law regulates the manner in which a pharmacist
stocks and oversees the removal of drugs from an automated drug
delivery system.
   This bill would clarify existing law to define pharmacy services
and to require a pharmacist reviewing an order for a drug to check
for contraindications and adverse drug reactions. This bill would
further clarify existing law to prevent licensed personnel from
accessing a different drug or dose of a drug than that approved by a
pharmacist.
   Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.


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


  SECTION 1.  Section 1261.6 of the  Health and Safety Code  is
amended to read:
   1261.6.  (a) (1) For purposes of this section and Section 1261.5,
an "automated drug delivery system" means a mechanical system that
performs operations or activities, other than compounding or
administration, relative to the storage, dispensing, or distribution
of drugs. 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.
   (2) For purposes of this section, "facility" means a health
facility licensed pursuant to subdivision (c), (d), or both, of
Section 1250 that has an automated drug delivery system provided by a
pharmacy.
   (3) For purposes of this section, "pharmacy services" means the
provision of both routine and emergency drugs and biologicals to meet
the needs of the patient  as prescribed by a physician  .
   (b) Transaction information shall be made readily available in a
written format for review and inspection by individuals authorized by
law. These records shall be maintained in the facility for a minimum
of three years.
   (c) Individualized and specific access to automated drug delivery
systems shall be limited to facility and contract personnel
authorized by law to administer drugs.
   (d) (1) The facility and the pharmacy 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 stored drugs. Policies and
procedures shall define access to the automated drug delivery system
and limits to access to equipment and drugs.
   (2) All policies and procedures shall be maintained at the
pharmacy operating the automated drug delivery system and the
location where the automated drug delivery system is being used.
   (e) When used as an emergency pharmaceutical supplies container,
drugs removed from the automated drug delivery system shall be
limited to the following:
   (1) A new drug order given by a prescriber for a patient of the
facility for administration prior to the next scheduled delivery from
the pharmacy, or 72 hours, whichever is less. The drugs shall be
retrieved only upon authorization by a pharmacist and after the
pharmacist has reviewed the prescriber's order and the patient's
profile for potential contraindications and adverse drug reactions.
   (2) Drugs that a prescriber has ordered for a patient on an
as-needed basis, if the utilization and retrieval of those drugs are
subject to ongoing review by a pharmacist.
   (3) Drugs designed by the patient care policy committee or
pharmaceutical service committee of the facility as emergency drugs
or acute onset drugs. These drugs may be retrieved from an automated
drug delivery system pursuant to the order of a prescriber for
emergency or immediate administration to a patient of the facility.
Within 48 hours after retrieval under this paragraph, the case shall
be reviewed by a pharmacist.
   (f) When used to provide pharmacy services pursuant to Section
4119.1 of the Business and Professions Code, the automated drug
delivery system shall be subject to all of the following
requirements:
   (1) Drugs removed from the automated drug delivery system for
administration to a patient shall be in properly labeled units of
administration containers or packages.
   (2) A pharmacist shall review and approve all orders prior to a
drug being removed from the automated drug delivery system for
administration to a patient. The pharmacist shall review the
prescriber's order and the patient's profile for potential
contraindications and adverse drug reactions.
   (3) The pharmacy providing services to the facility pursuant to
Section 4119.1 of the Business and Professions Code shall control
access to the drugs stored in the automated drug delivery system.
   (4) Access to the automated drug delivery system shall be
controlled and tracked using an identification or password system or
biosensor.
   (5) The automated drug delivery system shall make a complete and
accurate record of all transactions which will include all users
accessing the system and all drugs added to or removed from the
system.
   (6) After the pharmacist reviews   and approves 
the prescriber's order, access by licensed personnel to the automated
drug delivery system  shall be limited only to the
prescribed drug authorized by the   shall be limited
only to the drug as ordered by the prescriber and reviewed by the
 pharmacist and  that is  specific to the patient. When
the prescriber's order requires a dosage variation of the same drug,
licensed personnel shall only have access to the drug ordered for
that scheduled time of administration.
   (g) The stocking of an automated drug delivery system shall be
performed by a pharmacist. If the automated drug delivery system
utilizes removable pockets or drawers, or similar technology, the
stocking system may be done outside of the facility and be delivered
to the facility if all of the following conditions are met:
   (1) The task of placing drugs into the removable pockets or
drawers is performed by a pharmacist or by an intern pharmacist or a
pharmacy technician working under the direct supervision of a
pharmacist.
   (2) The removable pockets or drawers are transported between the
pharmacy and the facility in a secure tamper-evident container.
   (3) The facility, in conjunction with the pharmacy, has developed
policies and procedures to ensure that the pockets or drawers are
properly placed into the automated drug delivery system.
   (h) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be done in
accordance with law and shall be the responsibility of the pharmacy.
The review shall be conducted on a monthly basis by a pharmacist 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.
   (i) Drugs dispensed from an automated drug delivery system that
meets the requirements of this section shall not be subject to the
labeling requirements of Section 4076 of the Business and Professions
Code or Section 111480 of this code if the drugs to be placed into
the automated drug delivery system are in unit dose packaging or unit
of use and if the information required by Section 4076 of the
Business and Professions Code and Section 111480 of this code is
readily available at the time of drug administration.