Dr. C's MPJE: Ch.4 FL Pharm Law Pt 2: Pharmacy Personnel and Pharmacy Practice

Delegation to and Supervision of Pharmacy Technicians (Rule 64B16-27.4001) Delegation:

A pharmacist shall not delegate more tasks than he or she can personally supervise and ensure compliance with this rule. A pharmacist may delegate those nondiscretionary delegable tasks in Rule 64B16- 27.420 above to registered pharmacy technicians (registered with the Board) or pharmacy technicians in training (technicians who are receiving practical training in board-approved pharmacy technician training programs who are not required to be registered with the Board). Note: This rule references non-discretionary delegable tasks in Rule 64B16-27.420, but that rule no longer lists specific tasks that pharmacy technicians may perform.

Pharmacy Technician Ratio (Rule 64B16-27.410) General Rule

A pharmacist shall not supervise > 1 registered pharmacy technician; nor shall a pharmacy allow a supervision ratio of > 1 registered pharmacy technician to one pharmacist unless specifically authorized to do so under this rule. ** This language si inexplicably still ni the rule, so ti si included ni this book, but the rule later specifically authorizes a 31., 6.1, or 81 ratio. So despite this language, ti si incorrect to state that the ratio of registered pharmacy tech- nicians to pharmacists is 1. See below,**

Pharmacy Technician Ratio (Rule 64B16-27.410) 8:1 ratio

A pharmacy may allow a supervision ratio of 8:1 if thepharmacy is a non-dispensing pharmacy or, if dispensing pharmacy, it may utilize an 8:1 ratio in any area physically separate (by a permanent wall or barrier) from the area where drugs are dispensed and there is no sterile compounding taking place.

The Florida Pharmacy Act provides for a committee to develop a formulary of medicinal drugs that a pharmacist may order (i.e., prescribe) and dispense as well as a dispensing procedure. Drugs must fall under one of the following categories:

A. Any medicinal drug of single or multiple ingredients in any strength whose active ingredients) have been approved for OTC sale. b. Any medicinal drug recommended by an FDA Advisory Panel for transfer to OTC status pending approval by FDA . C. Any medicinal drug containing an antihistamine or decongestant as a single active ingredient or in combination. d. Any medicinal drug containing fluoride in any strength. E. Any medicinal drug containing lindane in any strength. F. Any OTC proprietary drug approved for reimbursement by the Florida Medicaid program. G. Any topical anti-infectives excluding eye and ear anti-infectives.

Centralized Prescription Labeling

A. Both the central fill pharmacy and the originating pharmacy shall be identified on the label. b. The originating pharmacy must be identified on the label by name and address. c. The central fill pharmacy may be identified on the label by a code.

Pharmacies must maintain documentation that demonstrates registered pharmacy technicians have received training in their established job description, delegable tasks, task protocols, and policies and procedures in the specific pharmacy. This documentation must be 1 of the following:

A. Certification by the supervising licensee (i.e., pharmacist); b. Certification by an instructor, trainer, or other similar person; c. Training attendance logs or completion certificates accompanied by an outline of the material addresses; or D. Exam or written questionnaires

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: keratolytics

- Salicylic acid 16.7% and lactic acid 16.7% to be applied to warts except for patients under 2 and those with diabetes or impaired circulation - Vitamins with fluoride (not including vitamins with folic acid > 0.9 mg) - Medicinal drug shampoos containing lindane- not > 4oz.

Pharmacy Techs: Delegable and Non-Delegable Tasks (Rule 64B16-27.420)

- The rule now states delegable tasks are those tasks that are performed pursuant to a pharmacist's direction, without the exercise of the pharmacy technician's own judgment and discretion, and which do not require the pharmacy technician to exercise the independent professional judgment that is the foundation of the practice of the profession of pharmacy. Even though Rule 64B16-27420 no longer lists which tasks may be delegated to pharmacy technicians, you may still see a question that asks if a task can be delegated. For example, while a pharmacy technician cannot accept a new verbal prescription, they can accept a verbal authorization to refill an Rx if no changes are made.

FL allows certified pharmacists and interns to administer any CDC-recommended vaccine but only to patients ____ YO. Florida is one of only a few states that restrict pharmacists from administering vaccines to children. The only exception is for influenza vaccines, which pharmacists, but not interns, may administer to individuals ____ years of age or older if part of the protocol. Note: HHS has authorized all pharmacists and pharmacytechnicians to pro- vide immunizations to children ages 3-18 if certain conditions are met during the COVID-19 pandemic; however, it si not likely that the MPJE wil include questions on temporary rules related to the COVID-19 pandemic.

18, 7

Acertified registered intern who administers a vaccine must be supervised by a certified pharmacist at a ratio of ____ : _____

1:1 One pharmacist to one intern

A collaborative pharmacy practice agreement shall automatically terminate ___ years after execution if not renewed.

2

A pharmacy which has had passing inspections for the most current 3 years & no discipline during that time shall be inspected every __ years.

2

Laws and Rules for Al Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) To obtain certification, a pharmacist (or registered intern) must complete at least ____ hrs of CE on safe and effective administration of vaccines, including cardiopulmonary resuscitation (CPR)training.

20

Standards of Practice--Continuous Quality Improvement (CQI) Program (Rule 64B16-27.300) Each pharmacy shall establish a CQI program, which shall be described in the pharmacy's policy and procedure manual and must contain:

A CQI Committee that reviews quality-related events at least q3mo b. A planned process to record, measure, assess, and improve the quality of patient care; and c. A procedure reviewing quality-related events. At a minimum, the review shall consider the effects on quality of the pharmacy system due to staffing levels, workflow, and technological support. 5. As part of the CQI program, each pharmacy shall assure that all reasonable steps have been taken to remedy any problem for the patient. 6. Each quality-related event shall be documented.

Pharmacy Technician Ratio (Rule 64B16-27.410) 3:1 ratio

Any pharmacy or pharmacist engaged in sterile compounding shall not exceed a ratio of 3registered pharmacy technicians to one pharmacist. This ratio only applies to pharmacists and technicians engaged in sterile compounding and does not affect the technician ratios for other activities not involving sterile compounding in areas of the pharmacy separated from the sterile compounding area. In other words, a pharmacy could have 3 technicians Involved in sterile compounding supervised by a single pharmacist and 6 additional technicians in a separate area involved in other dispensing being supervised by another pharmacist.

Pharmacy Technician Ratio (Rule 64B16-27.410) 6:1 ratio

Any pharmacy or pharmacist may allow a supervision ratio of up to 6 registered pharmacy techs to 1 pharmacist as long as the pharmacist or registered pharmacy technicians are not engaged in sterile compounding.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: Topical anti-inflammatory preparations

Hydrocortisone not > 2.5%

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: anti nausea preparations

Mecizine up to 25 mg, except for patients taking a CNS depressant Scopolamine not exceeding 1.5 mg/dermal patch

The determination of the appropriate pharmacist- technician supervision ratio shall be made by the _____. No other person, permittee, or licensee shall interfere with the exercise of the _____ professional judgment in setting the pharmacist-to-technician ratio(s).

Prescription Department Manager or Consultant Pharmacist of Record. This would applyto a call center pharmacy or remote order processing pharmacy that does not dispense medication?

FL has a statewide immunization registry, the ____. It is a centralized online immunization registry that helps parents, HCP's, and schools keep track of immunization records for children. According to FL DOH,, FL pharmacists are required to report all vaccinations to the _____ program even though they can only provide immunizations to adults.

State Health Online Tracking System (SHOTS).

Standards of Practice--Continuous Quality Improvement (CQI) Program (Rule 64B16-27.300) T/F: Records maintained as a component of a pharmacy CQI program are confidential under $766.101 Florida Statutes (Medical Review Committees- immunity from liability). Records are considered peer review documents and are not subject to discovery in civil litigation or administrative actions.

T

T or F: In the event of an addendum to the material terms of an existing collaborative practice agreement, the pharmacist shall maintain a copy of the addendum and the initial agreement.

T

T/F: A community pharmacy which acts only as a central fill pharmacy and notifies the Board is exempt from requirements for a patient counseling area, signage requirements, and operating hours

T

T/F: A pharmacist who tests or screens for and treats minor, non-chronic health conditions may use any tests that may guide dx or clinical decision making in which the CMS have determined qualifies for a waiver under the federal Clinical Laboratory Improvement Amendments of 1988, or the federal rules adopted thereunder, or any established screening procedures that can safely be performed by a pharmacist

T

T/F: Aphysician may not delegate the authority to initiate or prescribe a CS as described to a pharmacist.

T

T/F: The terms and conditions of the collaborative pharmacy practice agreement must be appropriate to the pharmacist's training, and the services delegated to the pharmacist must be within the collaborating physician's scope of practice. A copy of the certification issued under this subsection must be included as an attachment to the collaborative pharmacy practice agreement.

T

Testing or screening for and treatment of minor, nonchronic health conditions

This legislation, effective July 1, 2020, allows a certified pharmacist to test or screen for and treat minor, non chronic health conditions within the framework of an established written protocol with a supervising physician (D.O. or M.D.).

Collaborative Practice

This legislation, permits a certified pharmacist to enter into a collaborative practice agreement with a physician (D.O. or M.D.) for certain chronic health conditions. Chronic health condition means: a. Arthritis; b. Asthma; c. COPD; d. T2DM; e. HIV or AIDS; f. Obesity; or g. Any other chronic condition adopted in rule by the board, in consultation with the Board of Medicine and Board of Osteopathic Medicine. In Rule 64B16-31.007, the Board adopted the following additional chronic conditions for which a pharmacist can provide services to patients under a Collaborative Pharmacy Practice Service Agreement: (1) Hyperlipidemia; (2) HTN; (3) Anti-coagulation management; (4) Nicotine dependence; and (5) Opioid use disorder.

Customized Medication Packages

packages prepared by a pharmacist for a specific patient that is a series of containers containing 2 or > solid PO dosage forms. They are used to improve patient compliance by packaging together 2 or > drugs that will be taken at the same time. They maybe used with consent of the patient or patient's agent.

Delegation to and Supervision of Pharmacy Technicians (Rule 64B16-27.4001) Readily & immediately available:

pharmacist and pharmacy technician(s) are on the same physical premises, or if not, technology is used to enable real-time, two-way communications between the pharmacist and technician.

Prior to providing or implementing patient care services under a collaborative pharmacy practice agreement or immediately after the renewal of such an agreement, the pharmacist shall submit the executed agreement to the Board's office through the ______

pharmacist's online licensure account

The pharmacist, along with the collaborating physician, must maintain on file the collaborative practice agreement at his or her ____ and must make such agreements available to the department or board upon request or inspection.

practice location,

The _____ are responsible for ensuring that a pharmacy has an operating CQI program and that all CQI activities are documented.

prescription department manager or consultant pharmacist of record

A pharmacist who practices under a collaborative pharmacy practice agreement must complete an ___ hr CE course approved by the board that addresses issues related to collaborative pharmacy practice each biennial licensure renewal, in addition to the general CE requirements. A pharmacist must submit confirmation of having completed such course when applying for licensure renewal. Apharmacist who fails to comply with this subsection shall be prohibited from practicing under a collaborative pharmacy practice agreement under this section.

8

Pharmacies must maintain documentation that is signed by the registered pharmacy technician, acknowledging the technician has reviewed the policy and procedure manual within ___ days from the date hired.

90

Laws and Rules for All Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) A pharmacist may not enter into a written protocol for administering vaccines unless he or she maintains at least _____ of professional liability insurance.

$200,000

Delegation to and Supervision of Pharmacy Technicians (Rule 64B16-27.4001) Use of technology:

(1) A pharmacist may employ technological means to communicate with or observe pharmacy technicians. (2) A pharmacist shall make certain all applicable state and federal laws, including but not limited to confidentiality, are fully observed when utilizing technological means of communication and observation. These provisions authorize remote supervision of pharmacy technicians, including technicians working at home or other locations.

A collaborative pharmacy practice agreement must include the following:

(1) Name of the collaborating physician's patient or patients for whom a pharmacist may provide services; (2) Each chronic health condition to be collaboratively managed; (3) Specific medicinal drug or drugs to be managed by the pharmacist for each patient; (4) Circumstances under which the pharmacist may order or perform and evaluate laboratory or clinical tests; (5) Conditions and events upon which the pharmacist must notify the collaborating physician and the manner and time frame in which such notification must occur; (6) Beginning and ending dates for the collaborative pharmacy practice agreement and termination procedures, including procedures for patient notification and medical records transfers; and (7) A statement that the collaborative pharmacy practice agreement may be terminated, in writing, by either party at any time.

Laws and Rules for All Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) Immunization records must be maintained for ___ years

5

Laws and Rules for Al Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) Immunizations authorized:

- Those listed in the April 30, 2021, Adult Immunization Schedule by the U.S. Centers for Disease Control and Prevention-2021, (1) Influenza: Note: Influenza vaccines may be administered by pharmacists (not interns) to individuals 7 years of age or >. All other vaccines are limited to adults. (2) Tetanus, Diphtheria, Pertussis (Td/Tap) (3) Human papillomavirus (HPV) (4) Zoster recombinant (RZV) (5) Measles, mumps, rubella (MMR) (6) Pneumococcal 13-valent conjugate (PCV13) (7) Pneumococcal polysaccharide (PPSV23) (8) Meningococcal A, C, W, Y (MenACWY) (9) Meningococcal B (MenB) (10)Hepatitis A(HepA) (11) Hepatitis B(HepB) (12) Haemophilus influenzae type b (Hib) (13)Varicella (VAR) Note: If the CDC Adult Immunization Schedule adds additional vaccines or immunizations, the Board wil need to add those by rule. - Those recommended for international travel as of April 30, 2021. Note: yellow fever vaccinations require additional qualification to administer the immunization and issuance of a stamp by the Florida Bureau of Epidemiology. - Those that have been authorized for emergency use, by FDA as of April 30, 2021. - Those approved by the Board in response to a state ofemergency declared by the Governor.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: topical antifungals/antibacterials

- lodochlorhydroxyquin with 0.59 hydrocortisone (not exceeding 20g) - Haloprogin 1% - Clotrimazole topical cream and lotion - Erythromycin topical

To test and treat for minor non chronic health conditions under this section, a pharmacist must Hold a certification issued by the board to test and screen for and treat minor, nonchronic health conditions, in accordance with requirements established by the board in rule in consultation with the Board of Medicine and Board of Osteopathic Medicine The certification must require a pharmacist to complete, on a onetime basis, a ____ hr CE course approved by the board in consultation with the Board of Medicine and the Board of Osteopathic Medicine.

20 The course, at a minimum, must address patient assessments; POC testing procedures; safe and effective treatment of minor,nonchronic health conditions; and identification of contraindications. Following additional requirements for the course content: . i Applicable laws and rules; ii. Writing and entering into a written protocol; ili. No < than 8 hours of the course shall be offered through a live webinar or video conference; Iv. A pharmacist who successfully completes a Board-approved test-and-treat certification course shall be awarded 20 hours of general continuing education credits; and V. The course may be provided by a provider who is accredited by the ACPE or a program provider approved by the American osteopathic association to offer continuing medical education credits

Laws and Rules for Al Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) To maintain immunization certification, apharmacist must complete ___ hours of CE during each 2 year renewal period.

3

Pharmacies may use an electronic imaging recordkeeping system instead of keeping original Rx's as long as the system is capable of capturing, storing, and reproducing an exact image of the Rx, including the reverse side if necessary. Such images must be retained for ___ years from the date of last filling.

4 Note: Although FL law allows this for all Rx's, DEA still requires original written CS Rx's to be maintained using the 2 or 3 file system described in Chapter 2.

Record Maintenance System for All Pharmacy Permits All original Rx's shall be retained for a period of at least __ years from the date of last filling.

4 longer than the 2-year requirement for CS Rx's required by DEA. Also note that it is 4 years from the date of last filling, not 4 years from the date the Rx was issued or first filled

The computer system record keeping rules are taken from DEA rules, but FL rules apply them to all Rx records maintained in the computer system, not just CS. Also note, if a pharmacy is not printing a daily hard copy (and most pharmacies are not), the computer must be able to produce records on demand or within ____ hours. This is slightly different than the requirement to print a "summary record' of controlled substances dispensed in the past 60 days by prescriber or patient in which must be produced within 72 hours

48

To be certified for Collaborative Practice, a pharmacist must, at minimum:

A. Hold active & unencumbered license to practice pharmacy in FL. b. earned PharmD OR have completed 5 years of experience as a licensed pharmacist. c. completed an initial 20-hr course approved by the board, in consultation with the Board of Medicine and Board of Osteopathic Medicine, that includes, at a minimum, instruction on the following: (1) Performance of patient assessments; (2) Ordering, performing, and interpreting clinical and lab tests related to collaborative pharmacy practice; 3) Evaluating & managing diseases and health conditions in collab with other HCPs 4) Any other area required by the board. In Rule 64B16-31.003, the Board adopted the following additional content areas and requirements for the initial certification course: 1. Applicable laws and rules; il. Writing and entering into a collaborative practice agreement; iii. No < than 8 hours of the course shall be offered through a live webinar or video conference; Iv: A pharmacist who successfully completes a Board-approved collaborative practice certification course shall be awarded 20 hours of general CE credits; and V. The course may be provided by a provider who is accredited by the (ACPE), a program provider accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I credit, or a program provider approved by the American Osteopathic Association to offer continuing medical education credits. D. Maintain at least $250,000 of professional liability insurance coverage. E. File an application for Pharmacist Collaborative Practice Certification available on the Board's website f. Have established a system to maintain records of all patients receiving services under a collaborative pharmacy practice agreement for a period of 5 years from each patient's most recent provision of service.

To test and treat for minor non chronic health conditions under this section, a pharmacist must:

A. Hold an active and unencumbered license to practice pharmacy in the state. B. Hold a certification issued by the board to test and screen for and treat minor, nonchronic health conditions, in accordance with requirements established by the board in rule in consultation with the Board of Med- icine and Board of Osteopathic Medicine. C. Maintain at least $250,000 of liability coverage. An application for Pharmacist Test and Treat Certification is available on the Board's website.

A minor, nonchronic health condition is typically a short- term condition that is generally managed with minimal treatment or self-care, and includes:

A. Influenza; b. Streptococcus; c. Lice; d. Skin conditions, such as ringworm and athlete's foot; and e. Minor, uncomplicated infections.

Details regarding records maintained in a data processing (computer) system include:

A. Information stored in a computer system must be backed up at least weekly. b. Computer systems must be able to produce an audit trail of drug usage for the preceding 4 years. c. Records of dispensing -Computer systems must have the capability of producing a daily hard-copy printout of all Rx filled or refilled containing the following information: (1) Prescription #; (2) Date of dispensing; (3) Patient name; (4) Prescribing practitioner's name; (5) Name and strength of product dispensed (manufac- turer if generic); (6) Quantity dispensed; (7) Initials or identification of dispensing pharmacist; and (8) If not immediately retrievable via CRT display (i.e., the monitor or computer screen), must also include patient's address, prescriber's address, prescriber's DEA # if for CS, quantity prescribed if different from quantity dispensed, date of issuance of Rx if different from date of dispensing, and total # of refills dispensed ot date. Note: Bonus points if you know what a CRT display is. This rule was written when computers only had Cathode Ray Tube (CRT) monitors. These are no longer made d. If a pharmacy chooses to print the daily hard copy, the following requirements must be met: (1) It must be produced (printed) within 72 hours of date drugs were dispensed. (2) Each individual pharmacist who dispenses or refills a Rx shall verify that the data is correct by dating and signing (no initials) the daily hard copy within 7 days. e. Instead of printing the daily hard copy, a pharmacy may maintain a logbook in which each individual pharmacist signs a statement each day attesting that the information entered into the computer is correct. Note: This is what most pharmacies do. They do not usually print out a complete daily hard copy. .f The computer system must be able to print a hard copy on demand by an authorized agent of the DOH. If no printer is on site, the hard-copy printout must be provided within 48 hours or it is considered a failure to keep and maintain records.

Rebates Prohibited (6 465.185 and Rules 64B16-27.1042 and 64B16-27.104(3))

A. It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement in any form whatsoever with any physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a pharmacy. B. Rule 64B16-27.1042 provides detailed examples of prohibited acts, such as providing supplies or equipment, including computers, fax machines, etc., to a facility. C. No pharmacist, pharmacy, employee, or agent there of shall enter into or engage in any agreement or arrangement with any physician, other practitioner, nursing home, or extended care facility for the payment or acceptance of compensation in any form or type for the recommending of the professional services of either; or enter into a rebate or percentage rental agreement of any kind, whereby in any way a patient's free choice of a pharmacist or pharmacy is or may be limited

The Florida Pharmacy Act provides for a committee to develop a formulary of medicinal drugs that a pharmacist may order (i.e., prescribe) and dispense as well as a dispensing procedure. General terms and conditions to be followed by a pharmacist when ordering and dispensing approved medicinal drugs:

A. May NOT order injectable drugs. B. May NOT order drugs for pregnant patients or nursing mothers. C. Quantity cannot exceed a 34-day supply OR standard course of treatment. D. Patients shall be advised that they should seek the advice of an appropriate healthcare provider if their present condition, symptom, or complaint does not improve upon completion of the drug regimen. E. Directions for use shall not exceed the manufacturer's recommended dosage. F. May only perform service in a Florida permitted pharmacy. G. The pharmacist must create a prescription. H. The pharmacist must maintain a patient profile, separate from the prescription order, and shall date and initial all profile entries. (1) Such profiles shall be maintained for 4 years. (2) Required information to be in patient profile includes medical history, current complaint, drug ordered, etc.

Transfer of Medicinal Drugs; Change of Ownership

A. Must provide transfer information to the Board of Pharmacy. b. Must complete an inventory of all CS c. Transfers of C2 drugs must be done with a DEA 222 form.

The Florida Pharmacy Act provides for acommittee to develop a formulary of medicinal drugs that a pharmacist may order (i.e., prescribe) and dispense as well as a dispensing procedure. Drugs provided must be labeled with the following information:

A. Name of the pharmacist ordering the medication; b. Name and address of the pharmacy dispensing the drug; c. Date of dispensing; d. Prescription # e. Name of the patient; f. Directions for use; g. Clear statement that order cannot be refilled; h. Trade name or generic name; and i. Quantity dispensed

Customized Medication Packages labeling requirements

A. Name, address, and telephone # of the pharmacy b. Date of preparation of the customized medication package c. Serial # (prescription #) of the customized medication package and a separate serial # (prescription #) for each drug dispensed d. Patient's name e. Name of each prescriber f. Directions for use and any cautionary statements required for each drug g. Storage instructions h. Name, strength, quantity, and physical description of each drug product i. A BUD that is not > 120 days from the date of the preparation of the customized medication package. If any of the drugs in the customized med- cation package have an expiration date that is < 120 days from the date prepared, that date shall be the BUD for the customized medication package. A pharmacy utilizing customized patient medication packages shall have policies and procedures that specifically address change to patient medication regimens. Be sure to know the differences ni the labeling requirements between regular prescriptions and customized medication packages. The telephone number of the pharmacy and strength and quantity of the drug seem to be more of an oversight by the Board when drafting the rule, but the BUD and the requirement for a physical description of the product are differences that are clearly intentional. Also, note that if these customized medication packages are used in nursing homes, the patient-specific information does not have to appear on each individual label.

Permits; Single Entity; Single Location (Rule 64B16-28.113)

A. Only a single entity may obtain a pharmacy permit at a single location. b. A single location is defined as a contiguous area under the control of the permit holder but cannot include an area more than 1⁄2 mile from the central location. C. A public thoroughfare (i.e., street, public walkway, etc.) does not break the area contiguity. Note: This is to allow a campus DEA registration. Pharmacists should be certain that the area covered by a permit is clear and that the pharmacy permit and DEA registration are consistent.

Pharmacy Technician Policies and Training (Rule 64B16- 27.410(2) and (3)) All pharmacies must establish and maintain a policy and procedure manual regarding the number of registered pharmacy technician positions that includes the specific scope of delegable tasks of the technicians, job descriptions, and task protocols. The manual must include the following topics:

A. Supervision by apharmacist; b. Minimum qualifications of registered pharmacy technicians; c. In-service education or ongoing training and demonstration of competency; d. General duties and responsibilities; e. All functions related to prescription processing; F. All functions related to prescription drug and CS ordering and inventory control, documentation, and recordkeeping; g. Al functions related to retrieval of prescription files, patient files, patient profile information, and other records; h. Al delegable tasks and non-delegable tasks per 64B16- 27.420 (See Pharmacy Technician section above); Note: Even though Rule 64B16-27.420 no longer lists specific delegable tasks, this rule appears to still require that the pharmacy's policy and procedure manual include a section on delegable and non-delegable tasks. i. Confidentiality and privacy laws and rules; j. Prescription refill and renewal authorizations; k. Functions related to automated pharmacy systems; and I. Continuous Quality Improvement program.

The Board shall adopt, by rule, a formulary of medicinal drugs that a pharmacist may prescribe when testing and treating the minor, non- chronic health conditions.

A. The formulary must include medicinal drugs approved by FDA which are indicated for treatment of the minor, non- chronic health condition. The formulary may not include any CS. B. Per Board Rule 64B16-31.039, the formulary of drugs a pharmacist may prescribe pursuant to a written test and treat protocol includes all medicinal drugs approved by the FDA and all compounded medicinal drugs that utilize only active pharmaceutical ingredients approved by the FDA. Medicinal drugs are prescription drugs, but not CS.

Drug Therapy Management may only be provided under the auspices of a pharmacy permit that provides:

A. Transferable patient care record, which includes a prescriber care plan that includes a section noted as "orders" from a prescriber for each patient and progress notes; b. A pharmaceutical care area that is private, distinct, and partitioned from any area in which activities other than patient care activities occur and in which the pharmacist and patient can sit down; and C. A CQI program that includes standards and procedures to identify, evaluate, and constantly improve Drug Therapy Management Services.

Delivering prescriptions from a central fill pharmacy directly to a patient

A. community central fill pharmacy may deliver non CS medications for an originating pharmacy directly to a patient if the pharmacies have a pharmacist available 40 hours a week, either in person or via two- way communication technology (telephone, etc.), and a toll-free number ot provide counseling. b. A central fill pharmacy may not deliver CS directly to a patient. This is an Important distinction. DEA only allows central fill pharmacies to send filled prescriptions to the originating pharmacy. C. When central fill pharmacy delivers a filled rx directly to patient, its not considered dispensing (treated more like its delivering Rx on behalf of originating pharmacy) D. A Class 2 Institutional central fill pharmacy may only deliver medication to the originating pharmacy.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: otic antifungal/antibacterial

Acetic acid 2% in aluminum acetate solution

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: topical antivirals

Acyclovir ointment for treatment of herpes simplex of lips Penciclovir

Outdated pharmaceuticals (Rule 64B16-28.110)

All outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs shall be removed or quarantined from active stock.

Drug Therapy Management (Rule 64B16-27.830)

Allows pharmacists to provide drug therapy management services in compliance with orders in a "Prescriber Care Plan" written by a physician, PA, dentist, or podiatrist (not APRNs) A pharmacist can provide Drug Therapy Management incidental to dispensing, as part of consulting on therapeutic values of drugs, or as part of managing and monitoring a patient's drug therapy.

Apharmacy which fails to pass an inspection, or which is disciplined during the 2 year inspection cycle, will be inspected _____ until it achieves passing inspections and no discipline for the most current three-year period.

Annually

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: otic analgesics

Antipyrene 5.49, benzocaine 1.4%, glycerin

Apharmacist testing or screening for and treating minor, nonchronic health conditions under a written protocol who diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the

DOH

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: acne product

Benzoyl peroxide

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: histamine H2 antagonists

Cimetidine Famotidine Ranitidine

A pharmacist practicing under acollaborative pharmacy practice agreement who diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the ____

DOH

Delegation to and Supervision of Pharmacy Technicians (Rule 64B16-27.4001) Supervision:

Delegated tasks must be performed under the direct supervision of a pharmacist who shall make certain al applicable state and federal laws, including but not limited to confidentiality, are fully observed. The supervising pharmacist, in consultation with the prescription department manager or consultant pharmacist of record, will determine the appropriate methods of supervision based on the following definitions and requirements. No other person, permittee, or licensee shall interfere with the exercise of the supervising pharmacist's independent professional judgment in determining the supervision of delegated tasks.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: antihistamines for pts 6 YO or +

Diphenhydramine Carbinoxamine Pyriliamine Dexchlorpheniramine Brompheniramine

Information Disclosure (5 465.0244)

Every pharmacy shall make available in its website a hyper- link to the health information that is disseminated by the Agency for Health Care Administration, which provides a consumer-friendly, internet-based platform that allows a consumer to research the cost of healthcare services and pro- cedures and alows for price comparison. This website can be found at https://pricingfloridahealthfinder.gov

Human Trafficking Sign (Florida Statute$ 546.0341)

Legislation passed in 2019 requires pharmacists to post in their place of work (i.e., in the pharmacy), in a conspicuous place accessible to employees, a sign at least 1l in. X 15 in. size, printed in a clearly legible font and in at least a 32-point type, which substantially states in English and Spanish: "If you or someone you know is beingforced to engage in an activity and cannot leave, whether it is prostitution, housework, farm work, factory work, retail work, restaurant work, or any other activity, call the National Human Trafficking Resource Center at 888-373-7888 or text INFO or HELP to 233-733 to access help and services.Victims of slavery and human trafficking are protected under United States and Florida law." This legislation also required health carepractitioners, including pharmacists, ot complete a 1 hour CE course on human trafficking. This course had to be completed by January 1, 2021.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: PO analgesics for mild to moderate pain and menstrual cramps for pts w/ no hx of PUD (limited to a 6d supply)

Magnesium salicylate/phenyltoloxamine citrate Acetylsalicylic acid (zero order release, long-acting tablets) Choline salicylate and magnesium salicylate Naproxen sodium Naproxen Ibuprofen

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: ophthalmics

Naphazoline 0.1%

Can a pharmacist Modify or discontinue medicinal drugs prescribed by a HCP with whom he or she does not have a collaborative pharmacy practice agreement? Or can a pharmacist Enter into a collaborative pharmacy practice agreement while acting as an employee without the written approval of the owner of the pharmacy?

No

Rules for pharmacy interns

No intern shall perform any acts relating to the filling, compounding, or dispensing of medicinal drugs unless done under the direct and immediate supervision of a Florida licensed pharmacist. This implies that a registered pharmacy intern can perform the same acts as a pharmacist (except making the final check of a prescription and administering influenza vaccines to patients 7 years of age or <) when under the direct and immediate supervision of a Florida licensed pharmacist. This would include those duties that a pharmacy technician cannot perform, such as counseling patients, receiving verbal prescriptions, etc. There is no maximum ratio of interns to pharmacists except when an intern is performing immunizations and for foreign pharmacy graduate interns when a 1:1 ratio applies.

Promoting sale of certain drugs prohibited (§ 465.024)

No pharmacist, owner, or employee of a retail drug establishment shall use any communication media to promote or advertise the use or sale of any CS appearing in any schedule Ch. 893. Note: This says "employees of a retail drug establishment" but it appears to apply to all pharmacists regardless of practice location, so it is included under requirements for all pharmacy permits

Does an intern need to enter into a protocol with a physi- clan to provide immunizations?

No, but must be certified to provide immunizations and be under the supervision of a pharmacist who is also certified to administer immunizations.

Pharmacist's Order for Medicinal Drugs §( 465.186)

Note: This law was an early attempt passed in the 1980s to provide limited pharmacist prescriptive authority. The law is not used in practice very often anymore, but still an active law, and you could be asked questions about it on the MPJE.

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: urinary analgesics

Phenazopyridine, not exceeding a 2d supply

Formulary of Medicinal Drugs Which May Be Ordered by Pharmacists Rule: decongestants for patients 6 YO & older

Phenylephrine Azatadine

Delegable and Non-Delegable Duties Rule (64B16-27.420)

This rule sets forth the tasks that may and may not be delegated to pharmacy technicians. The non-delegable tasks are therefore functions that only a pharmacist may perform. These include: - receiving new, non-written (i.e., verbal) prescriptions or receiving any change in the medication, strength, or directions of an existing prescription ; Note: This point is made clear again in Rule 64B16-27.103, which states that only a pharmacist or registered pharmacy intern acting under the supervision of a pharmacist may accept an oral prescription. - interpreting a prescription or medication order for therapeutic acceptability and appropriateness; - conducting the final verification of dosage and directions; - engaging in prospective drug review; - monitoring prescription usage; - overriding clinical alerts - transferring a prescription; - preparing a copy of a Rx or reading an Rx to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription is written: - engaging in patient counseling; - receiving therapy or blood product procedures in a permitted nuclear pharmacy; - engaging in any other act that requires the exercise of a pharmacist's professional judgment.

A pharmacy shall be inspected how many times during the first year of operation?

Twice

Authorized agents of the Department or other persons authorized by law may inspect ______

invoices, shipping tickets, or any other document pertaining to the transfer of drugs from or to all pharmacies.

Sink and Running Water; Sufficient Space; Refrigeration; Sanitation; Equipment; and Library Requirements The prescription department of each pharmacy must have:

a. A sink in workable condition and running water accessible tothe Rx counter; b. sufficient shelf, drawer, or cabinet space for the neat and orderly storage of pharmaceutical stock, Rx containers, Rx labels, and all required equipment; C. sufficient walking space and work counter space to allow employees to adequately, safely, and accurately fulfill their duties; D. adequate sanitation to ensure the Rx department is operating under clean, sanitary, uncrowded, & healthy conditions; and E. other equipment as is necessary to meet the needs of the professional practice of the pharmacy. 2. The prescription department of each pharmacy must have the following items: a. A current pharmacy reference compendium such as the United States Pharmacopeia/National Formulary, the U.S. Dispensatory, United States Pharmacopeia Drug Information (USP DI), Remington's Science and Practice of Pharmacy, Facts and Comparisons, or equivalent. b. A current copy of the laws and rules governing the practice of pharmacy. C. These library requirements may be maintained in a readily available electronic format.

Label Requirements for Drugs Dispensed to a Patient

a. Name and address of the pharmacy Note: Telephone number of the pharmacy is not listed in the rule. b. Date of dispensing c. Serial number (prescription number) d. Name of the patient or, if the patient is an animal, the name of the owner and species of animal e. Name of the prescriber f. Name of the drug dispensed Note: Strength and quantity is not listed in the rule. g. Directions for use h. An expiration date or BUD. The expiration date must be the date provided by the manufacturer. The beyond-use date may not exceed the expiration date and cannot be > than 1 year from the date dispensed. I. If the drug is a CS, the federal transfer warning is also required. "Discard-after date" or "Do Not Use-after date" are considered BUD's. Note that the expiration date is defined as the date from the manufacturer while the beyond-use date cannot be more than one year. Although the rules allow a pharmacy to put either on the label, most pharmacies use a beyond-use date unless the product is being dispensed in the manufacturer's original packaging.

Delegation to and Supervision of Pharmacy Technicians (Rule 64B16-27.4001) Direct supervision:

means supervision by a pharmacist who is readily and immediately available at all times the delegated tasks are being performed

Prescriber Care Plan

an individualized assessment of a patient and orders for specific drugs,laboratory tests, and other pharmaceutical services intended to be dispensed or executed by a pharmacist. It shall specify the conditions under which a pharmacist shall order lab tests, interpret lab values, execute drug therapy orders for a patient, and notify the prescriber.

The Rx department, compounding room, or any other place where prescriptions are compounded, filled, processed, accepted, dispensed, or stored in each pharmacy shall be so situated and located to allow ?

authorized agents and employees of the Department or other persons authorized by law to enter and inspect the pharmacy.

A pharmacist who enters into a collaborative pharmacy practice agreement must submit a copy of the signed agreement to the ____ before the agreement may be implemented.

board

Standards of Practice--Continuous Quality Improvement (CQI) Program (Rule 64B16-27.300) *Quality Related Event" means

inappropriate dispensing or administration of a prescribed medication, including: a variation from the prescriber's prescription order, including but not limited to: (1) incorrect drug; (2) incorrect drug strength; (3) incorrect dosageform; (4) incorrect patient; or (5) inadequate or incorrect packaging, labeling, or directions; B. or a failure to identify and manage: (1) overutilization or underutilization; (2) therapeutic duplication; (3) drug-disease contraindications; (4) drug-drug interactions; (5) incorrect drug dosage or duration of treatment; (6) drug allergy interactions; or (7) clinical abuse/misuse.

Practice of Pharmacy (Rule 64B16-27.1001)

rule sets forth the functions that only a pharmacist or registered intern acting under the direct and immediate personal supervision of a pharmacist may perform: a. Supervising and being responsible for the CS inventory; b. Receiving verbal Rx; c. Interpreting and identifying Rx contents; d. Engaging in consultation with a practitioner regarding interpretation of a Rx and data in a patient profile E. Engaging in professional communication with practitioners, nurses, or other health professionals; F. Advising or consulting with a patient, both as to Rx and the patient profile record; G. Making the final check of a completed Rx, thereby assuming the complete responsibility for its preparation and accuracy (only pharmacist can do final check, not intern) H. Being personally available to the patient or the patient's agent for consultation; and I. When preparing parenteral and bulk solutions: (1) Interpreting and identifying al incoming orders; and (2) Being physically present and giving direction to registered pharmacy technicians for the reconstitution, addition of additives, or bulk compounding.

Laws and Rules for Al Pharmacy Permits or Applicable to Pharmacists in Any Location: Administration ofVaccines and Epinephrine Auto-injection (§ 465.189) A certified pharmacist (or certified registered intern) may administer vaccines to adults under awritten protocol with a _______.

supervising physician Note: Unlike some other states, the protocol is between the supervising physician and a pharmacist, not a pharmacy.

Standards of Practice--Continuous Quality Improvement (CQI) Program (Rule 64B16-27.300) "Continuous Quality Improvement Program" means

system of standards and procedures to identify and evaluate quality-related events and improve patient care.

The Florida Pharmacy Act provides for a committee to develop a formulary of medicinal drugs that a pharmacist may order (i.e., prescribe) and dispense as well as a dispensing procedure. Drugs on formulary may only be dispensed by ___ and shall not be refilled, nor shall another drug be ordered for the same condition unless consistent with the dispensing procedures.

the pharmacist ordering the drug

A pharmacy may perform centralized prescription filling for another pharmacy if they have the same ______

they have the same owner or have a contract with the other pharmacy

The Florida Pharmacy Act provides for acommittee to develop a formulary of medicinal drugs that a pharmacist may order (i.e., prescribe) and dispense as well as a dispensing procedure. Any pharmacist providing these services shall be eligible for reimbursement by _____ when so provided by contract.

third-party plans