Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B16 - Board of Pharmacy
Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS
Section 64B16-28.605 - Class II and Class III Institutional Pharmacies - Automated Distribution and Packaging
Universal Citation: FL Admin Code R 64B16-28.605
Current through Reg. 50, No. 187; September 24, 2024
(1) Definitions.
(a) "Automated medication system" means a
robotic, mechanical or computerized device that is not used for medication
compounding and is designed to:
1. Distribute
medications in a licensed health care facility; or
2. Package medications for final distribution
by a pharmacist.
(b)
"Centralized automated medication system" means an automated medication system
located in a pharmacy department from which medication is distributed or
packaged for final distribution by a pharmacist.
(c) "Decentralized automated medication
system" means an automated medication system that is located outside of a
pharmacy department but within the same institution.
(d) "Distribute" or "Distribution" means the
process of providing a drug to an individual authorized to administer
medications and licensed as a health care provider in the state of Florida
pursuant to an order issued by an authorized prescriber.
(e) "Medication" means a medicinal drug or
proprietary preparation.
(f)
"Override medication" means a single dose of medication that may be removed
from a decentralized automated medication system prior to pharmacist review
because a practitioner licensed pursuant to chapter 458, 459 or 466, F.S.,
determined that the clinical status of the patient would be significantly
compromised by delay.
(g) "Low risk
override medication" is a medication determined by a practitioner licensed
pursuant to chapter 458, 459 or 466, F.S., to have a low risk of drug allergy,
drug interaction, dosing error, or adverse patient outcome, and may be removed
from a decentralized automated medication system independent of a pharmacist's
review of the medication order or clinical status of the patient.
(h) "Physician controlled medication" is
medication distributed in an environment where a practitioner controls the
order, preparation and administration of the medication.
(2) General Requirements for the Use of Automated Medication Systems.
(a) The
consultant pharmacist of record shall be responsible for:
1. Maintaining a record of each transaction
or operation.
2. Controlling access
to the system.
3. Maintaining
policies and procedures for:
a. Operation of
the automated medication system.
b.
Training personnel who use the automated medication system.
c. Maintaining patient services whenever the
automated medication system is not operating; and,
d. Defining a procedure for a pharmacist to
grant or deny access to the medication in the system.
4. Security of the system.
5. Assuring that a patient receives the
pharmacy services necessary for good pharmaceutical care in a timely
manner.
6. Assuring that the system
maintains the integrity of the information in the system and protects patient
confidentiality.
7. Establishing a
comprehensive Quality Assurance program.
8. Establishing a procedure for stocking or
restocking the automated medication system; and,
9. Ensuring compliance with all requirements
for packaging and labeling.
(b) A pharmacist shall perform prospective
drug use review and approve each medication order prior to administration of a
medication except an override medication, a low risk override medication or a
physician controlled medication.
(c) A pharmacist shall perform retrospective
drug use review for an override medication.
(3) Multidisciplinary Committee for Decentralized Automated Medication Systems.
(a) The consultant pharmacist of record shall
convene or identify a multidisciplinary committee, which is charged with
oversight of the decentralized automated medication system.
(b) The Multidisciplinary Committee shall:
1. Include at least one pharmacist,
2. Establish the criteria and
process for determining which medication qualifies as an override medication or
a low risk override medication in a decentralized automated medication system,
3. Develop policies and procedures
regarding the decentralized automated medication system; and,
4. Have its decisions reviewed and approved
by the consultant pharmacist of record.
(4) Stocking or Restocking of a Decentralized Automated Medication System.
(a) Medications
in a decentralized Automated Medication System shall be stocked or restocked by
a pharmacist, registered pharmacy intern, or by a registered pharmacy
technician supervised by a pharmacist.
(b) The stocking or restocking of a
decentralized automated medication system shall follow one of the following
procedures to assure correct medication selection:
1. A pharmacist shall conduct a daily audit
of medications placed or to be placed into an automated medication system that
includes random sampling.
2. A bar
code verification, electronic verification, or similar verification process
shall be utilized to assure correct selection of medication placed or to be
placed into an automated medication system. The utilization of a bar code,
electronic, or similar verification technology shall require an initial quality
assurance validation followed by a monthly quality assurance review by a
pharmacist.
(5) Centralized Automated Medication Systems. A pharmacist utilizing a centralized medication system may distribute patient specific medications within the licensed health care facility without checking each individual medication selected or packaged by the system, if:
(a)
The initial medication order has been reviewed and approved by a pharmacist;
and,
(b) The medication is
distributed for subsequent administration by a health care professional
permitted by Florida law to administer medication; and,
(c) A bar code verification, electronic
verification, or similar verification process shall be utilized to assure
correct selection of medication placed or to be placed into an automated
medication system. The utilization of a bar code, electronic verification, or
similar verification technology shall require an initial quality assurance
validation, followed by monthly quality assurance review by a
pharmacist.
(6) Quality Assurance Program. The consultant pharmacist of record shall be responsible for establishing a quality assurance program for the automated medication system. The program shall provide for:
(a) Review of
override and low risk override medication utilization;
(b) Investigation of a medication error
related to the automated medication system;
(c) Review of a discrepancy or transaction
reports and identify patterns of inappropriate use or access;
(d) Review of the operation of the
system;
(e) Integration of the
automated medication system quality assurance program with the overall
continuous quality improvement of the pharmacy as defined in rule
64B16-27.300, F.A.C.;
and,
(f) Assurance that individuals
working with the automated medication system receive appropriate training on
the operation of the system and procedures for maintaining pharmacy services
when the system is not in operation.
(7) Record Keeping.
(a) The consultant pharmacist of record shall
maintain records related to the automated medication system in a readily
retrievable manner.
(b) The
following records shall be maintained for at least 60 days:
1. Daily audits of stocking or restocking, if
applicable;
2. Daily audits for the
output of centralized automated medication system, if applicable; and,
3. Transaction records for all
non-controlled medications or devices distributed by the automated medication
system.
(c) The following
records shall be maintained for at least four (4) years:
1. Any report or analysis generated as part
of the quality assurance program,
2. A report or database related to access to
the system or any change in the access to the system or to medication in the
system; and,
3. Transaction records
from the automated medication system for all controlled substances dispensed or
distributed.
(8) Compliance. The consultant pharmacist of record shall assure compliance with all requirements of chapter 465, F.S., and the rules of division 64B16, F.A.C.
(9) Security. A decentralized automated medication system that contains controlled substances shall prohibit simultaneous access to multiple drug entities, drug strengths, or dosage forms of controlled substances, unless otherwise contained in labeled patient-specific form.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235, 465.026 FS.
New 4-22-07, Amended 1-1-10, 7-14-14.
Disclaimer: These regulations may not be the most recent version. Florida may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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