Florida Regulations 64B16-26.301: Subject Matter for Consultant Pharmacist Course
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(1) Jurisprudence.
(a) Laws and regulations, state and federal, pertaining to institutional pharmacy and health care facilities.
(b) Laws and regulations, state and federal, pertaining to the safe and controlled storage of alcohol and other related substances, and relating to fire and health-hazard control.
(c) Laws and regulations, state and federal, pertaining to collabborative practice agreements.
(2) Policy and Procedures.
(a) Written procedures for outlining the medication system in effect.
1. Traditional systems.
2. Unit-dose systems.
a. Centralized.
b. Decentralized.
c. Automated medication systems.
3. Routine and emergency use of drugs.
4. After hours procedure for medication dispensing.
5. Managing drug shortages.
(b) Record keeping and reports.
1. Controlled substance control and record-of-usage.
2. Alcohol inventory and record-of-usage.
3. Patient drug use control and records.
a. Recalls.
b. Medication use evaluation.
c. Medication errors.
4. Drug charges, methods, accountability, and reports.
5. Statistical reports of usage, volume, etc.
6. Written collaborative practice agreement records.
(c) Regimen review, documentation and communication.
1. Performing drug regimen review.
2. Documentation of drug regiment review.
3. Communication of findings to appropriate individuals or groups.
(3) Administrative Responsibilities.
(a) Fiscal Control.
1. Perpetual and traditional inventory systems.
2. Application of EDP techniques.
(b) Personnel Management, orientation and training.
(c) Intra-professional relations pertaining to medication use.
(d) Inter-professional relations with other members of the institutional health care team.
1. Pharmacy & Therapeutic Committee.
a. Rational drug therapy; review of medication use and prescribing.
b. Formulary development – evaluation, appraisal, selection, procurement, storage, distribution, medication safety, criteria for use development and safety.
c. Automatic stop orders on potent and dangerous drugs.
d. Controls on storage and use of investigational drugs.
2. In-service education of nurses and other health-related personnel.
3. Infectious Disease Committee.
(e) Facility Review
1. Areas appropraite for evaluation
2. Documentation of evaluations
3. Reporting of evaluations
(4) Professional Responsibilities.
(a) Drug information retrieval and methods of dispersal.
(b) Development of pharmacy practice.
(c) Development of an IV Admixture service.
(d) Procedures to enhance medication safety.
1. Availability of equipment, technique, etc., to prepare special dosage forms for pediatric and geriatric patients.
2. Preparation of sterile dosage forms.
3. Proper writing, transcribing and initiating and/or transferring patient medication orders; development of physician’s chart order copy system.
4. Safety of patient self-medication and control of drugs at bedside.
5. Reporting and trending adverse drug reactions.
6. Screening for potential drug interactions.
7. Development and maintenance of up-to-date emergency kits.
(e) Maintain drug quality and safe storage.
1. Procedures for eliminating out-dated drugs.
2. Requirements for safe and appropriate storage conditions.
(f) Maintain drug identity.
1. Procedures for labeling, transferring of bulk medications, etc.
2. Manufacturing and packaging procedures.
3. Pre-packaging control and supervision.
(g) Conducting patient assesments.
(h) Ordering and evaluating laboratory or clinical tests.
(i) Administration of medicinal drugs.
(5) The Institutional Environment.
(a) The institution’s pharmacy function and purpose.
(b) Interdepartmental relationships important to the institutional pharmacy.
(c) Understanding of scope of service and in-patient care mission of the institution.
(d) Special training with respect to the operation of nursing homes and Extended Care Facilities (ECF)/pharmacy relationship and special procurement procedures.
(6) Nuclear pharmacy.
(a) Procurement.
(b) Compounding.
(c) Quality control procedures.
(d) Dispensing.
(e) Distribution.
(f) Basic radiation protection and practices.
(g) Consultation and education to the nuclear medicine community; including patients, pharmacists, other health professionals, and the general public.
(h) Research and development of new formulations.
(i) Record keeping.
(j) Reporting adverse drug reactions and medication errors.
(k) Screening for potential drug interaction.
Rulemaking Authority 465.005, 465.0125 FS. Law Implemented Florida Statutes § 465.0125. History-New 5-19-72, Amended 12-18-74, 10-17-79, Formerly 21S-1.27, 21S-1.027, Amended 7-31-91, Formerly 21S-26.301, 61F10-26.301, 59X-26.301, Amended 5-5-05, 12-20-20.
Terms Used In Florida Regulations 64B16-26.301
- Appraisal: A determination of property value.
- Jurisprudence: The study of law and the structure of the legal system.
(b) Laws and regulations, state and federal, pertaining to the safe and controlled storage of alcohol and other related substances, and relating to fire and health-hazard control.
(c) Laws and regulations, state and federal, pertaining to collabborative practice agreements.
(2) Policy and Procedures.
(a) Written procedures for outlining the medication system in effect.
1. Traditional systems.
2. Unit-dose systems.
a. Centralized.
b. Decentralized.
c. Automated medication systems.
3. Routine and emergency use of drugs.
4. After hours procedure for medication dispensing.
5. Managing drug shortages.
(b) Record keeping and reports.
1. Controlled substance control and record-of-usage.
2. Alcohol inventory and record-of-usage.
3. Patient drug use control and records.
a. Recalls.
b. Medication use evaluation.
c. Medication errors.
4. Drug charges, methods, accountability, and reports.
5. Statistical reports of usage, volume, etc.
6. Written collaborative practice agreement records.
(c) Regimen review, documentation and communication.
1. Performing drug regimen review.
2. Documentation of drug regiment review.
3. Communication of findings to appropriate individuals or groups.
(3) Administrative Responsibilities.
(a) Fiscal Control.
1. Perpetual and traditional inventory systems.
2. Application of EDP techniques.
(b) Personnel Management, orientation and training.
(c) Intra-professional relations pertaining to medication use.
(d) Inter-professional relations with other members of the institutional health care team.
1. Pharmacy & Therapeutic Committee.
a. Rational drug therapy; review of medication use and prescribing.
b. Formulary development – evaluation, appraisal, selection, procurement, storage, distribution, medication safety, criteria for use development and safety.
c. Automatic stop orders on potent and dangerous drugs.
d. Controls on storage and use of investigational drugs.
2. In-service education of nurses and other health-related personnel.
3. Infectious Disease Committee.
(e) Facility Review
1. Areas appropraite for evaluation
2. Documentation of evaluations
3. Reporting of evaluations
(4) Professional Responsibilities.
(a) Drug information retrieval and methods of dispersal.
(b) Development of pharmacy practice.
(c) Development of an IV Admixture service.
(d) Procedures to enhance medication safety.
1. Availability of equipment, technique, etc., to prepare special dosage forms for pediatric and geriatric patients.
2. Preparation of sterile dosage forms.
3. Proper writing, transcribing and initiating and/or transferring patient medication orders; development of physician’s chart order copy system.
4. Safety of patient self-medication and control of drugs at bedside.
5. Reporting and trending adverse drug reactions.
6. Screening for potential drug interactions.
7. Development and maintenance of up-to-date emergency kits.
(e) Maintain drug quality and safe storage.
1. Procedures for eliminating out-dated drugs.
2. Requirements for safe and appropriate storage conditions.
(f) Maintain drug identity.
1. Procedures for labeling, transferring of bulk medications, etc.
2. Manufacturing and packaging procedures.
3. Pre-packaging control and supervision.
(g) Conducting patient assesments.
(h) Ordering and evaluating laboratory or clinical tests.
(i) Administration of medicinal drugs.
(5) The Institutional Environment.
(a) The institution’s pharmacy function and purpose.
(b) Interdepartmental relationships important to the institutional pharmacy.
(c) Understanding of scope of service and in-patient care mission of the institution.
(d) Special training with respect to the operation of nursing homes and Extended Care Facilities (ECF)/pharmacy relationship and special procurement procedures.
(6) Nuclear pharmacy.
(a) Procurement.
(b) Compounding.
(c) Quality control procedures.
(d) Dispensing.
(e) Distribution.
(f) Basic radiation protection and practices.
(g) Consultation and education to the nuclear medicine community; including patients, pharmacists, other health professionals, and the general public.
(h) Research and development of new formulations.
(i) Record keeping.
(j) Reporting adverse drug reactions and medication errors.
(k) Screening for potential drug interaction.
Rulemaking Authority 465.005, 465.0125 FS. Law Implemented Florida Statutes § 465.0125. History-New 5-19-72, Amended 12-18-74, 10-17-79, Formerly 21S-1.27, 21S-1.027, Amended 7-31-91, Formerly 21S-26.301, 61F10-26.301, 59X-26.301, Amended 5-5-05, 12-20-20.