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 (k), 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 that will include all users
accessing the system and all drugs added to, or removed from, the
system.
(6) After the pharmacist reviews the prescriber's order, access by
licensed personnel to the automated drug delivery system shall be
limited only to drugs ordered by the prescriber and reviewed by the
pharmacist and that are specific to the patient. When the prescriber'
s order requires a dosage variation of the same drug, licensed
personnel shall have access to the drug ordered for that scheduled
time of administration.
(7) (A) Systems that allow licensed personnel to have access to
multiple drugs and are not patient specific in their design, shall be
allowed under this subdivision if those systems have electronic and
mechanical safeguards in place to ensure that the drugs delivered to
the patient are specific to that patient. Each facility using such an
automated drug system shall notify the department in writing prior
to the utilization of the system. The notification submitted to the
department pursuant to this paragraph shall include, but is not
limited to, information regarding system design, personnel with
system access, and policies and procedures covering staff training,
storage, and security, and the facility's administration of these
types of systems.
(B) As part of its routine oversight of these facilities, the
department shall review a facility's medication training, storage,
and security, and its administration procedures related to its use of
an automated drug delivery system to ensure that adequate staff
training and safeguards are in place to make sure that the drugs
delivered are appropriate for the patient. If the department
determines that a facility is not in compliance with this section,
the department may revoke its authorization to use automated drug
delivery systems granted under subparagraph (A).
(C) This paragraph shall remain in effect only until January 1,
2012, unless a later enacted statute is enacted on or before January
1, 2012, deletes or extends that date.
(g) The stocking of an automated drug delivery system shall be
performed by a pharmacist. If the automated drug delivery system
utilizes removable pockets, cards, 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, cards,
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, cards, 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, cards, 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. For purposes of
this section, unit dose packaging includes blister pack cards.