Florida Regulations 64B16-28.606: Remote Medication Order Processing for Class II or Class III Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities
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(1) Definitions.
(a) “”Remote Medication Order Processing”” includes any of the following activities performed for a Class II or Class III Institutional Pharmacy or for Special Pharmacy Permits servicing Class I, Class II, Modified Class II, Class III, 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. Authorizing the release of a medication for administration.
(b) “”Medication”” means a medicinal drug or proprietary preparation.
(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. Clinical abuse or misuse of medication.
(2) General requirements.
(a) All pharmacists participating in remote medication order processing shall be Florida licensed pharmacists.
(b) A Class II or Class III Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, 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) A pharmacist shall perform the final check of a medication order.
(d) If the pharmacist performing remote medication order processing is not an employee of the pharmacy, the Class II or Class III, Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, 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. Provide that the parties have access to or share a common electronic file such that the pharmacist performing remote medication order processing has sufficient patient information necessary for prospective drug use review and approval of medication orders.
(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;
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. Reviewing the written policies and procedures and documenting the review every year.
(4) Records.
(a) A Class II or Class III Institutional Pharmacy or Special Pharmacy Permits servicing Class I, Class II, Modified Class II, Class III, 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) The record may be maintained in a common electronic file if the record is maintained in such a manner that the data processing system can produce a printout which identifies every person who performed a processing function for a medication order.
(c) The record shall be readily retrievable for at least the past four (4) years.
(d) The record shall be available for inspection by the Board or an authorized agent of the Department.
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, 7-19-17, 9-27-18.
Terms Used In Florida Regulations 64B16-28.606
- Contract: A legal written agreement that becomes binding when signed.
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. Authorizing the release of a medication for administration.
(b) “”Medication”” means a medicinal drug or proprietary preparation.
(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. Clinical abuse or misuse of medication.
(2) General requirements.
(a) All pharmacists participating in remote medication order processing shall be Florida licensed pharmacists.
(b) A Class II or Class III Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, 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) A pharmacist shall perform the final check of a medication order.
(d) If the pharmacist performing remote medication order processing is not an employee of the pharmacy, the Class II or Class III, Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, 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. Provide that the parties have access to or share a common electronic file such that the pharmacist performing remote medication order processing has sufficient patient information necessary for prospective drug use review and approval of medication orders.
(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;
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. Reviewing the written policies and procedures and documenting the review every year.
(4) Records.
(a) A Class II or Class III Institutional Pharmacy or Special Pharmacy Permits servicing Class I, Class II, Modified Class II, Class III, 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) The record may be maintained in a common electronic file if the record is maintained in such a manner that the data processing system can produce a printout which identifies every person who performed a processing function for a medication order.
(c) The record shall be readily retrievable for at least the past four (4) years.
(d) The record shall be available for inspection by the Board or an authorized agent of the Department.
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, 7-19-17, 9-27-18.