SNP03-60 Accurate Use and Storage of Drugs in ADDS Rev 9.5

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 1 of 6
Type: Automated Drug Delivery System

Purpose: The purpose of this policy is to establish guidelines for the proper use, storage
and distribution of medications to facility residents utilizing an automated drug
dispensing system (ADDS).

1.0 Policy

1.1 It is the policy of Skilled Nursing Pharmacy to establish guidelines for medication
order review, dispensing, and authorized access to medications from automated
drug delivery systems to ensure patient safety.

1.2 Access to automated drug delivery systems is granted only to licensed facility
nursing staff and is assigned by the Director of Nursing.

1.3 Medication shall be retrieved from automated drug delivery systems only upon
authorization by a Skilled Nursing Pharmacy pharmacist.

1.4 Restocking of the automated drug delivery system.

1.5 If it is determined that a facility is not in compliance with all state and federal
regulations or the policies and procedures outlined herein, as it relates to
automated drug delivery systems, Skilled Nursing Pharmacy reserves the right to
remove the automated drug delivery system(s) from the nursing facility.

2.0 Procedure

2.1 Automated drug delivery systems shall be used for:

2.1.1 New drug orders given by prescribers for residents of the facility for
2.1.2 administration prior to the next delivery from the pharmacy, or 72 hours,
2.1.3 whichever is less.
Emergency STAT orders may be retrieved pursuant to a valid order of a
prescriber for emergency or immediate administration to a resident of the
facility. The orders should be communicated to the pharmacy
immediately and be reviewed by a pharmacist within 48 hours.
Day pass medication access is excluded.

2.2 Licensed facility nursing staff ADDS user access

2.2.1 Licensed facility nursing staff access will be determined by the facility
2.2.2 Director of Nursing, Assistant Director of Nursing or DSD.
2.2.3 Director of Nursing, Assistant Director of Nursing or DSD will routinely
update Skilled Nursing Pharmacy with an approved active user access list.
The pharmacy ADDS manager is responsible for maintaining, updating,
and managing all current ADDS users based on facility employee status
updates.

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 2 of 6
Type: Automated Drug Delivery System

2.3 Granting automated drug delivery system access

2.3.1 Authorization to remove ordered medication(s) will be given by a Skilled
Nursing Pharmacy pharmacist. Each authorization is unique per
occurrence/medication.

2.3.1.1 Before removal of medication(s) from the automated drug
delivery system(s), the medication order and the resident’s

profile must be reviewed for potential contraindications and

adverse drug reactions by a pharmacist.

2.3.2 Skilled Nursing Pharmacy pharmacist will authorize usage via telephone
or fax.

2.3.2.1 Each authorization is unique per occurrence/medication.

2.3.3 The list of medications made available in the automated drug delivery
system(s) for emergent situations will be reviewed by the pharmacy
periodically based on utilization review.

2.3.4 Drugs removed from the automated drug delivery system(s) for
administration to a resident shall be in properly labeled units of
administration.

2.3.5 Drugs dispensed from the automated drug delivery system shall be
considered to have been dispensed by the pharmacy.

2.3.6 Access to the automated drug delivery system is controlled and
tracked using bio ID fingerprint, or user identification and password system
to maintain security.

2.3.7 The automated drug delivery system keeps a complete and accurate
record of all users accessing the automated drug delivery system, all drugs
added to, or removed from, the automated drug delivery system.

2.3.7.1 Cubex C15b transaction and C2 Control discrepancies
Unresolved Reports will be generated and reviewed daily by
responsible pharmacy staff.

2.3.7.2 All data is stored for 10 years.

2.3.7.3 Cubex maintains all information in a cloud-based HIPAA
compliant software, providing on-demand access.

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 3 of 6
Type: Automated Drug Delivery System

2.4 The restocking of the automated drug delivery system(s) shall be performed by
2.5 designated facility staff. See policy SNP03-61.

2.4.1 The task of placing drugs into the removable pockets, cards, drawers,
Cubies or similar technology is performed at Skilled Nursing Pharmacy
by a licensed pharmacist, pharmacy technician or intern pharmacist
under the direct supervision of a licensed pharmacist and then delivered
to the facility in a secure tamper-evident container.

2.4.2 All products stored in an automated drug delivery system will
be transported between Skilled Nursing Pharmacy and the
facility in a secure tamper-evident container.

2.4.3 Drugs stored in the ADDS shall be considered part of the pharmacy
Inventory.

2.4.4 ADDS records for the acquisition and disposition of dangerous drugs
and dangerous devices shall be separate from other pharmacy records.

2.4.4.1 The pharmacy shall maintain separate records for acquisition and
disposition of dangerous drugs and devices for each individual
licensed ADDS.

2.4.5 Designated facility staff in conjunction with Skilled Nursing
Pharmacy will properly place removable pockets, cards,
drawers, Cubies or similar technology into the automated drug delivery
system(s) within 48 hours of receipt.

Review of the drugs within the automated drug delivery system(s) and the
operation and maintenance of the automated drug delivery system shall be done
in accordance with California State Board of Pharmacy guidelines and shall be
the responsibility of Skilled Nursing Pharmacy.

2.5.1 A review shall be conducted on a monthly basis by a Skilled
Nursing Pharmacy pharmacist. The review shall include:

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 4 of 6
Type: Automated Drug Delivery System

2.5.1.1 A physical inspection of the drugs in the automated
drug delivery system (i.e. expiration, integrity).

2.5.1.2 An inspection of the automated drug delivery
system for cleanliness.

2.5.1.3 A review of all transaction records in order to verify
the security and accountability of the system.

2.5.1.4 Location of the ADDS is secure from access and removal by
unauthorized individuals.

2.5.1.5 Cycle counts
2.5.1.5.1 Monthly for control drugs
2.5.1.5.2 Full inventory quarterly during the months of
January, April, July, and November.

2.5.1.6 Validate temperature log is in use or applicable.
2.5.1.7 Copy of documented review to be left at facility and pharmacy.

2.6 State Board of Pharmacy requirements

2.6.1 The pharmacy shall register the ADDS by providing the State Board of
Pharmacy, in writing, with the location of each device within 30 days of
installation of the device, and on an annual basis as part of the license
renewal.

2.6.2 The pharmacy shall notify the board within 30 days if the pharmacy
discontinues operating an ADDS.

2.6.3. Each ADDS installed and operated shall be individually licensed by the
board and renewed annually, corresponding with underlying pharmacy
license.

2.6.3.1 Relocation of the ADDS shall require a new application for
licensure

2.6.3.2 Replacement of an ADDS shall require notification within 30 days.
2.6.3.3 Each license, for each ADDS, shall be publicly posted at the

facility.

2.6.4 The pharmacy shall report drug losses from the ADDS to the board as
required by law.
2.6.5 The pharmacy shall own and operate the ADDS.
2.6.6 The operation of the ADDS shall be under the supervision of a licensed
pharmacist.

2.6.6.1 The supervisory ADDS pharmacist need not be physically
present at the site of the ADDS and may supervise the system
electronically.

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 5 of 6
Type: Automated Drug Delivery System

2.7 Training Requirements

2.7.1 Pharmacy shall provide annual training regarding the operation and use of
the ADDS to pharmacy personnel using the system.
2.7.1.1 Records for personnel training will be retained at the pharmacy.

2.7.2 Pharmacy shall provide annual training regarding the operation and use of
the ADDS to health facility personnel using the system.
2.7.2.1 Records for health facility personnel training will be retained at the
facility and pharmacy.

2.7.3 Written policies and procedures, reviewed annually, shall be developed
and implemented and maintained at the location of the ADDS and
pharmacy to address the following: safety, accuracy, accountability,
security, patient confidentiality, maintenance of the ADDS, as well as
quality, potency, and purity of the drugs and devices.
2.7.3.1 ADDS policy and procedure will be reviewed annually by the
Pharmacist-In-Charge and documented.

2.8 Security and Confidentiality

2.8.1 All authorized ADDS users are mandated to maintain control of any and
all access to, use of, or contact with ADDS related privileged data,
2.8.2 records, or information of any type.
All ADDS information shall only be used appropriately; that is, to access
2.8.3 information only on an “as needed” basis as necessary for those patients
2.8.4 whom you are providing care.
2.8.5 At no time is a log-in access to be shared. Each user is responsible for all
activities performed under their log-in.
All transactions conducted on the ADDS are permanently recorded with
the accessing Users ID including a date and time stamp.
If an authorized user suspects that their personal log-in has been
compromised, they should immediately notify the pharmacy ADDS
manager and the facility Director of Nursing.

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.

Policy: Accurate Use and Storage of Drugs in Policy Number:
Automated Drug Delivery System (ADDS) SNP03-60
Page 6 of 6
Type: Automated Drug Delivery System

2.9 ADDS Maintenance and Support

2.9.1 The ADDS should be installed in a secure location with minimal
temperature fluctuations.
2.9.1.1 ADDS installation location should be temperature monitored.
2.9.1.2 Recorded temperatures outside the range of 59 to 77 degrees

Fahrenheit should be reported to the Director of Nursing.
2.9.1.3 Excessive temperature shall be communicated to the

pharmacy by the Director of Nursing or designee.

2.9.2 ADDS hardware and software support
2.9.2.1 Twenty-four hour ADDS vendor support is provided by

contract, for hardware or software issues at 866-930-9251.
2.9.2.2 Twenty-four hour ADDS pharmacy support is provided by

contacting the pharmacy directly.

2.9.3 Electrical Power Outage Procedure
2.9.3.1 The ADDS should be plugged into red outlets, if available,

which indicate that they are connected to the emergency backup
generator.
2.9.3.2 During an extended power outage, if the ADDS is not
connected to an emergency power source, contact the pharmacy.
2.9.3.3 During extended or indeterminant power outages, the pharmacy
will issue standard emergency kits until power is restored.

2.9.4 Cleaning Procedures
2.9.4.1 The ADDS requires minimal facility staff maintenance.
2.9.4.2 Periodically the exterior surfaces will be gently wiped with a

mild soap solution.

Prepared by: Flynn Lew Pharm.D., Version 9.5 Effective Date: 07/01/19
Chief Compliance Officer Approved Date: 05/10/19

Approved by: Ben Mandelbaum

Manager Approved and Implemented by: Implementation Date:

Revised: (dates) Approved: (dates) Implemented: (dates)
05/10/19________________
05/10/19________ 05/10/19___________________

The information contained in this document is the Confidential and Proprietary property of Skilled Nursing Pharmacy. Do not copy
or distribute without permission from Skilled Nursing Pharmacy.