The Board proposes the rule amendments to update, revise and streamline board rules relating to pharmacies serving assisted living/long term care facilities.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-28.301Destruction of Controlled Substances - Institutional Class I Pharmacies (Nursing Homes)

64B16-28.501Institutional Permit - Consultant Pharmacist of Record

64B16-28.503Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities

64B16-28.606Remote Medication Order Processing for Class II Institutional Pharmacies

64B16-28.870Special-ALF

PURPOSE AND EFFECT: The Board proposes the rule amendments to update, revise and streamline board rules relating to pharmacies serving assisted living/long term care facilities.

SUMMARY: The rules relating to pharmacies serving assisted living/long term care facilities will be updated, revised and streamlined.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.022, 465.0125 FS.

LAW IMPLEMENTED: 465.019, 465.0196, 465.0125, 465.022, 465.026 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.301 Destruction of Controlled Substances – Institutional Class I Pharmacies (Nursing Homes).

(1) No change.

(2) For each controlled substance destroyed, documentation A document must be completed showing the name and quantity of the drug, strength and dosage form, patient’s name, prescription number and name of the institution. Destruction of the controlled substance shall be witnessed, and documentation thereof shall be This documentation, at the time of destruction, shall be witnessed and signed by at least two (2) of the following individuals:

a. the consultant pharmacist;

b. director of nursing;

c. and the facility administrator; or his/her designee which may include

d. a licensed physician, mid-level practitioner, nurse, or another pharmacist employed by or associated with the facility; or

e. a sworn law enforcement officer.

(3) The consultant pharmacist shall be responsible for the creation and implementation of policies and procedures to ensure that controlled substances are disposed of in accordance with applicable state and federal laws and rules. Furthermore, the consultant pharmacist shall review all controlled substance destruction documentation monthly to ensure compliance with this rule and federal and state law.

(4) The consultant pharmacist shall ensure that non-controlled substances are returned to the provider pharmacy in compliance with Rule 64B16–28.118, F.A.C.

Rulemaking Authority 465.005, 465.022(12), FS. Law Implemented 465.022(12), 465.019, 893.07(1), (3), (5), FS. History–New 4-21-87, Formerly 21S-19.001, Amended 7-31-91, Formerly 21S-28.301, 61F10-28.301, Amended 1-30-96, Formerly 59X-28.301, Amended 7-21-09, 2-10-14,         .

 

64B16-28.501 Institutional Permit - Consultant Pharmacist of Record.

(1) Each facility holding a Class I, a Class II, or a Modified Class II Institutional permit shall designate a consultant pharmacist of record to ensure compliance with the laws and rules governing the permit. The Board office shall be notified in writing within ten (10) days of any change in the consultant pharmacist of record.

(2) The consultant pharmacist of record for a Class I, Class II, or Modified Class II, or a Special ALF permit shall conduct Drug Regimen Reviews as required by Federal or State law, inspect the facility and prepare a written report to be filed at the permitted facility at least monthly. In addition, the consultant pharmacist of record must monitor monthly the facility system for providing medication administration records and physician order sheets to ensure that the most current record of medications is available for the monthly drug regimen review. The consultant pharmacist of record may utilize additional consultant pharmacists to assist in this review and or in the monthly facility inspection.

(3) A consultant pharmacist licensed in Florida may remotely access a facility or pharmacy’s electronic database from outside the facility or pharmacy to conduct supplemental drug regimen review services, subject to the pharmacy or facility establishing policies and procedures to ensure the security and privacy of confidential patient records, including compliance with applicable Federal HIPAA regulations.

Rulemaking Specific Authority 465.005, 465.0125, 465.022 FS. Law Implemented 465.0125, 465.019, 465.022, 465.0266, FS. History–New 7-18-94, Formerly 61F10-28.501, 59X-28.501, Amended 1-2-02, 12-30-07,_________.

 

64B16-28.503 Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Institutional Facilities.

(1) Definitions. 

(a) No change.

(b) “Starter dose pharmacy” means a pharmacy that dispenses a medicinal drug pursuant to a starter dose prescription for to a patient in a facility served by the vendor pharmacy.

(c) “Starter dose prescription” means a prescription transmitted by a vendor pharmacy to a starter dose pharmacy for the purpose of initiating drug therapy for a patient in a facility served by the vendor pharmacy. The term “starter dose prescription” does not include prescriptions for controlled substances,

(2) A vendor pharmacy may transmit a starter dose prescription, excluding a prescription for a controlled substance, to a starter dose pharmacy if the vendor pharmacy:

(a) No change.

(b) Has a written contract with the starter dose pharmacy.

(b)(c) Has written authorization from a prescribing practitioner, directly or via facility agreement, to act as the practitioner’s agent for the purpose of transmitting a starter dose prescription.

(d) through (f) re-designated (c) through (e) No change.

(3) A starter dose pharmacy may dispense a medicinal drug, excluding a controlled substance, pursuant to a starter dose prescription for a patient in a facility that holds a Class I Institutional Permit or Modified II B Permit if the starter dose pharmacy:

(a) Has a written contract with the vendor pharmacy.

(b) mMaintains a record of each starter dose prescription and.

(c) mMaintains a policy and procedure manual that references starter dose prescriptions.

(4) The contract between a vendor pharmacy and a prescribing practitioner shall:

(a) Be in writing.

(b) Identify each facility served by the vendor pharmacy for which the authorization is valid.

(c) Authorize the vendor pharmacy to transmit, as an agent of the practitioner, a starter dose prescription to a starter dose pharmacy.

(d) Be on file at the vendor pharmacy, at the facility served by the vendor pharmacy, and with the prescribing practitioner.

(e) Be available for inspection by agents of the Department of Health or the Board of Pharmacy.

(5) The contract between the vendor pharmacy and the starter dose pharmacy shall:

(a) Be in writing.

(b) Identify each facility served by the vendor pharmacy.

(c) Assign the responsibility for prospective drug use review required by Rule 64B16-27.810, F.A.C., to the vendor pharmacy.

(d) Assign the responsibility for patient counseling required by Rule 64B16-27.820, F.A.C., to the vendor pharmacy.

(e) Be referenced in the Policy and Procedure Manual of the vendor pharmacy and of the starter dose pharmacy.

(f) Be updated as necessary to identify facilities or practitioners.

(g) Be on file at the vendor pharmacy, at the starter dose pharmacy, and at the facility.

(h) Be available for inspection by authorized agents of the Department of Health and the Board of Pharmacy.

(4)(6) A record of each starter dose prescription shall be:

(a) rReadily retrievable and

(b) mMaintained for four (4) years.

Rulemaking Authority 465.005, 465.019(4), 465.022 FS. Law Implemented 465.018, 465.019, 465.022(12), FS. History–New 11-29-04, Amended 7-14-14,_________.

 

64B16-28.606 Remote Medication Order Processing for Class II Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, and Special ALF Permitted Facilities.

(1) Definitions.

(a) “Remote Medication Order Processing” includes any of the following activities performed for a Class II Institutional Pharmacy or for Special Pharmacy Permits servicing Class I, Class II, Modified Class II, and Special ALF permitted facilities from a remote location:

1. Receiving, interpreting, or clarifying medication orders;.

2. Entering or transferring medication order data;.

3. Performing prospective drug use review;.

4. Obtaining substitution authorizations;.

5. Interpreting and acting on clinical data;.

6. Performing therapeutic interventions;.

7. Providing drug information;.

8. No change.

(b) No change.

(c) “Prospective drug use review” means an evaluation of medication orders and patient medication records for:

1. Over-utilization or under-utilization of medication;.

2. Therapeutic duplication of medication;.

3. Drug-disease contraindications;.

4. Drug interactions;.

5. Incorrect drug dosage or duration of drug treatment;.

6. No change.

(2) General requirements.

(a) No change.

(b) A Class II Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, and Special ALF permitted facilities may utilize remote medication order processing if the pharmacist performing the remote medication order processing has access to sufficient patient information necessary for prospective drug use review and approval of medication orders.

(c) No change.

(d) If the pharmacist performing remote medication order processing is not an employee of the Class II Institutional pharmacy, the Class II Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, and Special ALF permitted facilities must have a written agreement or contract with the pharmacist or entity employing the pharmacist. The written agreement or contract shall:

1. Outline the services to be provided;.

2. Delineate the responsibilities of each party including compliance with federal and state laws and regulations governing the practice of pharmacy as well as state and federal medical privacy requirements including compliance with applicable Federal HIPAA regulations;.

3. Require that the parties adopt a policies and procedures manual;.

4. No change.

(3) Policy and Procedures. A policy and procedures manual shall:

(a) Be accessible to each party involved in remote medication order processing;.

(b) Be available for inspection by the Board or an authorized agent of the Department;.

(c) Outline the responsibilities of each party involved in remote medication order processing;.

(d) Include a current list of the name, address, telephone number, and license number of each pharmacist involved in remote medication order processing;.

(e) Include policies and procedures for:

1. Ensuring the security and privacy of confidential patient records, including compliance with applicable Federal HIPAA regulations Protecting the confidentiality and integrity of patient information.

2. Ensuring that a pharmacist performing prospective drug use review has access to appropriate drug information resources;.

3. Ensuring that medical and nursing staff understand how to contact a pharmacist;.

4. Maintaining records to identify the name, initials, or identification code of each person who performs a processing function for a medication order;.

5. Complying with federal and state laws and regulations;.

6. Operating or participating in a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;.

7. No change.

(4) Records.

(a) A Class II Institutional Pharmacy or Special Pharmacy Permits servicing Class I, Class II, Modified Class II, and Special ALF permitted facilities involved in remote medication order processing shall maintain a record that identifies the name, initials, or identification code of each person who performed a processing function for every medication order. The record shall be available by medication order or by patient name.

(b) through (d) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.026, 465.0266, FS. History–New 11-29-04, Amended 7-14-14,                               .

 

64B16-28.870 Special-ALF.

(1) The Special-ALF permit is an optional facility license for those Assisted Living Facilities providing a drug delivery system utilizing medicinal drugs provided in unit dose packaging.

(2) Medicinal Drugs. 

(a) Medicinal drugs may not be dispensed on the premises.

(b) All medicinal drugs must be maintained in individual prescription containers for the individual patient. Medicinal drugs may not be dispensed on the premises.

(c) Medicinal drugs dispensed to the residents of a Special-ALF permit shall meet the labeling requirements of Rules 64B16-28.502 and 64B16-28.108, F.A.C.

(d) Medicinal drugs dispensed to patients of Special-ALF permits may be returned to the dispensing pharmacy’s stock under the provisions of Rule 64B16-28.118, F.A.C.  Dispensed controlled substances that have been discontinued shall be disposed of under the provisions of Rule 64B16-28.301, F.A.C. Medicinal drugs dispensed to the residents of a Special-ALF permit shall meet the labeling requirements of Rule 64B16-28.502 and paragraph 64B16-28.402(1)(h), F.A.C.

(3) Consultant Pharmacist of Record.

(a) Each facility holding a Special-ALF permit shall designate a consultant pharmacist of record to ensure compliance with the laws and rules governing the permit. The Board office shall be notified in writing within ten (10) days of any change in the consultant pharmacist of record.

(b) The consultant pharmacist of record shall be responsible for the preparation of the Policy and Procedure Manual required by subsection 64B16-28.800(2), F.A.C. Policy and Procedure Manuals must provide for the appropriate storage conditions and security of the medicinal drugs stored at the facility.

(c) The consultant pharmacist of record shall inspect the facility and prepare a written report to be filed at the permitted facility at least monthly.

(d) The consultant pharmacist of record shall conduct Drug Regimen Reviews as required by Federal or State law, inspect the facility, and prepare a written report to be filed at the permitted facility at least monthly. In addition, the consultant pharmacist of record must monitor the facility’s system for maintaining medication administration records and physician order sheets to ensure that the most current record of medications is available for the monthly drug regimen review. The consultant pharmacist of record may utilize additional consultant pharmacists to assist in this review and or in the monthly facility inspection.

(e) A consultant pharmacist licensed in Florida may remotely access a facility or pharmacy’s electronic database from outside the facility or pharmacy to conduct supplemental drug regimen review services, subject to the pharmacy or facility establishing policies and procedures to ensure the security and privacy of confidential patient records, including compliance with applicable Federal HIPAA regulations.

Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.003(11)(a), 465.016(1)(l), 465.0196 FS. History–New 2-23-98,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 4, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 5, 2017