64B16-28.605. Class II Institutional Pharmacies – Automated Distribution and Packaging

(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 Chapter 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. History–New 4-22-07, Amended 1-1-10, 7-14-14.