Dr. C's MPJE: Chapter 3

What is Chapter 456?

Health Professions and Occupations

What is Chapter 465?

Florida Pharmacy Act (FPA)

What is Chapter 893?

Florida Controlled Substances Act (FLCSA)

What is Chapter 499?

Florida Food, Drug, and Cosmetics Act (FLFDCA)

Which rule applies to pharmacists licensure?

64B16-26

Which rule applies to pharmacy practice?

64B16-27

Which rule applies to permits?

64B16-28

Which rule applies to animal control shelter permits?

64B16-29

Which rule applies to disciplinary guidelines?

64B16-30

Which rule applies to collaborative practice and test and treat certifications?

64B16-31

Which rule applies to nonresident pharmacies?

64B16-32

Which practitioners have independent prescriptive authority?

Allopathic physicians (MD)

Osteopathic physicians (DO)

Dentists

Podiatrists

Certified optometrists

Veterinarians

Physician assistants have dependent prescriptive authority. What does this mean?

A supervising physician may delegate to a prescribing PA only such authorized medicinal drugs as are used in the supervising physician's practice.

What are the limitations on the prescribing authority of non-controlled substances of PAs?

They may not prescribe:

Psychiatric mental health controlled substances for children younger than 18

General, spinal, or epidural anesthetics

Radiographic contrast materials

What are the limitations on the prescribing authority of controlled substances of PAs?

CIIs are limited to a 7 day supply

Controlled substances may not be prescribed in a pain management clinic

Other restrictions on prescribing CII opioids for pain are also applicable

t/f: In a hospital practice, a PA may write orders for any medication.

True

APRNs have dependent prescribing authority. What does this mean?

They may prescribe any drug based on a written protocol from a supervising physician.

What are the limitations on the prescribing authority of controlled substances of APRNs?

CIIs are limited to a 7 day supply. This limitation does not apply to controlled substances that are psychiatric medication prescribed by psychiatric nurses.

May not prescribe controlled substances in a pain management clinic.

Except for psychiatric nurses, may not prescribe psychiatric mental health controlled substances for children younger than 18

Other restrictions on prescribing CII opioids for pain are also applicable

What is a psychiatric nurse?

An APRN who has a master's or doctoral degree in psychiatric nursing, holds a national advanced practice certification as a psychiatric mental health advanced practice nurse, and has 2 years of post-master's clinical experience under the supervision of a physician.

Who has dependent prescriptive authority but is not subject to the 7 day limitation for CIIs if they are psychiatric medications? They may also prescribe psychiatric controlled substances to children younger than 18.

Psychiatric nurses

___ have independent prescribing authority but a limited formulary.

Certified optometrists

What can optometrists prescribe?

Ocular pharmaceutical agents from an approved formulary for the diagnosis and treatment of ocular conditions of the human eye and its appendages without the use of surgery or other invasive techniques

What is on the topical formulary for certified optometrists?

Cyclopegic and mydriatics: atropine sulfate, phenylephrine HCl, cyclopentolate HCl, scopolamine HBr, homatropine HBr, tropicamide, hydroxyamphetaminee HBr/tropicamide

Local Anesthetics: tetracaine, proparacaine HCl, benoxinate HCl

Diagnostic products: fluorescein paper strips

Antibacterial: erythromycin, bacitracin, polymyxin, neomycin, gentamicin, tobramycin, gramcidin, ciprofloxacin HCl, trimethoprim, ofloxacin, levofloxacin, gatifloxacin, moxifloxacin, sodium sulfacetamide, azithromycin, besifloxacin

Anti-inflammatory agents: medrysone, prednisolone acetate, prednisolone sodium phosphate, flurometholone, dexamethasone, dexamethasone sodium phosphate, fluorometholone acetate, rimexolone, loteprednol etabonate, diclofenac sodium, ketorlac tromethamine, hydrocortisone, bromfenac, nepafenac, difluprednate

Anti-histamines/Anti-allergy: cromolyn sodium, lodoxamide tromethamine, olopatadine, nedocromil sodium, azelastine HCl, pemirolast potassium, epinastine HCl, bepotastine besilate, alcaftadine

Anti-virals: trifluridine, ganciclovir, povidone-iodine

Anti-glaucoma: betaxolol HCl, levobunolol HCl, metipranolol HCl, timolol maleate or hemihydrate, carteolol, carbachol, pilocarpine HCl, pilocarpine, latanoprost, bimatoprost, travoprost, tafluprost, unoprostone isoprophyl, latanoprostene bunod, brimonidine tartrate, apraclonidine HCl, brinzolamide, dorzolamide, netarsudil

Miscellaneous: hydroxypropyl cellulose ophthalmic insert, dapiprazole, cyclosporine emulsion, polyvinyl pyrrolidone, bimatoprost, natamycin, lifitegrast, cyclosporine

Certified optometrists can also prescribe certain oral drugs after completing additional training. List them.

The following analgesics (3-day supply max): tramadol, acetaminophen and codeine (Tylenol 3)

Antibiotics: amoxicillin with or without clavulanic acid, azithromycin, erythromycin, dicloxacillin, doxycycline/tetracycline, keflex, minocycline

Antivirals: acyclovir, famciclovir, valacyclovir

Anti-glaucoma: acetazolamide, methazolamide

Assuming a valid practitioner-patient relationship, when is it acceptable for a telehealth provider to prescribe controlled substanced?

The treatment of a psychiatric disorder

Inpatient treatment at a hospital

The treatment of a patient receiving hospice services

The treatment of a resident of a nursing home facility

t/f: Initial prescriptions or orders for any drug that assists in weight loss must be written and signed by the prescribing physician. They shall not be called into a pharmacy by the physician or agent of the physician.

True

Florida now requires all prescriptions be transmitted electronically unless:

The practitioner and dispenser are the same entity

The prescription cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard

The practitioner has been issues a waiver by the department due to demonstrated economic hardship, technology limitations, or another exceptional circumstance

The practitioner determines that it would be impractical for the patient to obtain the drug prescribed by electronic prescription in a timely manner and such delay would adversely impact their medical condition

The practitioner is prescribing a drug under a research protocol

The prescription is for a drug for which the FDA requires the prescription to contain certain elements not included in the e-script

The prescription is issued to an individual in hospice or nursing home facility

The practitioner determines that it is in the best interest of the patient, or the patient determines that it is in his own best interest, to compare prescription drug prices among area pharmacies

t/f: Pharmacists are not recognized as healthcare practitioners with prescriptive authority, but they do have limited authority to independently order and dispense certain medicinal drugs to patients. These drugs must be dispensed by the pharmacist who ordered the drug. Pharmacists cannot issue a prescription to be filled by another pharmacist or at another pharmacy.

True

What can physicians prescribe?

Legally, they may prescribe a drug to treat any disease or illness even if it is outside the physician's specialty

Who must prescribe within their scope of practice?

Dentists

Podiatrists

Veterinarians

Can a provider self-prescribe controlled substances?

No.

Can a provider prescribe controlled substances to family members?

Yes

Note: Pharmacists should still exercise caution and only fill such prescriptions if they can validate that there is a valid practitioner-patient relationship and that the prescription was issued in the usual course of practice.

Can the pharmacist be disciplined for dispensing drugs when the pharmacist knows or has reason to believe a purported prescription is not based on a valid provider-patient relationship?

Yes

What happens to a DEA registration number when a practitioner dies?

It terminates.

How should you handle prescriptions if the prescriber retires/dies?

Legally, it makes sense that any refills remaining on a prescription are no longer valid once a practitioner is deceased or retired.

However, in the absence of specific guidance, this may be an opportunity to use the emergency refill rules.

Can you fill a prescription written for office use?

No. A pharmacist can sell an original manufacturer's bottle of a prescription drug to a practitioner for use in his or her office, but cannot dispense drugs pursuant to a prescription for office use.

What is the purpose of the FL BOP?

Established by the legislature to ensure that every pharmacist practicing in this state and every pharmacy meet the minimum requirements for safe practice

Who is responsible for the licensure, monitoring, and education of pharmacy professionals to assure competency and safety to practice in their service to the people of Florida?

FL BOP

How many members comprise the FL BOP? Who are they?

9 members

7 of which are licensed pharmacists who are residents of FL and who have been engaged in the practice of pharmacy in FL for at least 4 years, the other two are consumer members

2 of the 7 pharmacists must practice in the community setting, 2 must practice in an institutional pharmacy, the remaining 3 can practice in any setting

The consumers must be residents of FL, may not have ever been licensed as a pharmacist, may not be connected with the pharmacy profession in any manner, and may not be connected in any manner with a drug manufacturer or wholesaler

At least one member of the BOP must be 60 years or older

Who appoints members of the BOP?

Governor and confirmed by the FL senate

How long is a term in the BOP?

4 years

Note: If a Board member's term ends, they may continue to service until a new Board member has been appointed.

How many terms can a member serve in the BOP?

A Board member may not serve more than 2 full terms; however, if a member's term expires, they may remain on the Board until a new appointment is made by the governor

Who runs the BOP?

An executive director (employee of the DOH)

Define consultant pharmacist.

A pharmacist licensed by the department and certified as a consultant pharmacist pursuant to chapter 465

Note: FL law requires all institutional pharmacies to be under the direction of a consultant pharmacist, and a consultant pharmacist license is a separate additional license from a pharmacist license with additional requirements.

Define dispense.

The transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. This includes the acts of assessing a prescription for adverse reactions, interactions, and dosage regimen as well as patient counseling if necessary.

Define drugs.

Substances or preparations commonly known as prescription or legend drugs, which are required by federal or state law to be dispensed only on a prescription but shall not include patents or proprietary preparations as hereafter defined

Define patent or proprietary preparation (OTC drugs).

A medicine in its unbroken, original package which is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof and which is not misbranded under the provisions of the FL FDCA

Define community pharmacy.

Includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis

Define institutional pharmacy.

Includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as healthcare institutions, where medicinal drugs are compounded, dispensed, stored or sold

Define nuclear pharmacy.

Includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. It does not include hospitals or the nuclear medicine facilities of such hospitals.

Define special pharmacy.

Includes every location where medicinal drugs are compounded, dispensed, stored, or sold it such locations are not otherwise defined in this subsection

Define internet pharmacy.

Locations not otherwise licensed or issued a permit under this chapter, which use the internet to communicate with or obtain information from consumers in the state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this site

t/f: The pharmacy department of any permittee shall be considered closed whenever a FL licensed pharmacist is not present and on duty.

True

Define the practice of the profession of pharmacy.

Includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and conducting other pharmacy services (e.g. monitoring drug therapy, reviewing and making recommendations regarding their therapy and healthcare status in communication with their provider)

Includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients

Includes administration of vaccines to adults, the testing or screening for and treatment of minor non-chronic health conditions, and the preparation of pre-packaged drug products in Class III institutional pharmacies

Also includes the ordering and evaluating of any lab or clinical test, conducting patient assessments, and modifying, discontinuing, or administering medicinal drugs

Define prescription.

Any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist.

Also includes out of state practitioners who prescribe medications for chronic or recurrent illness and verbal orders

Who is eligible for pharmacist licensure by examination?

Complete application form and pay examination fee

Must be at least 18

Must be a recipient of a degree from an accredited school or college of pharmacy; or have graduation from a school or college of pharmacy outside the US and passes the TOEFL, TSE, and FPGEE and have 500 hours of supervised work activity program

Must submit proof of completion of internship program approved by the Board that shall not exceed 2,080 hours

t/f: All requirements for licensure by examination (including passing scores) must be met within one year of receipt of application or else have to be reapplied.

True

How long are examination scores good for?

3 years if you need to reapply

Who is eligible for licensure by endorsement?

Must meet age, internship, and education requirements

Must have obtained a passing score on the NAPLEX

Must submit evidence of being licensed and actively practicing pharmacy in another jurisdiction for at least 2 of the immediately preceding 5 years or submit evidence of successful completion of Board approved post-graduate training or Board-approved clinical competency examination within the year preceding application, or have completed internship requirements in the preceding 2 years

Must obtain a passing score on the MPJE-FL version

If licensed in another state for more than 2 years, must submit proof of 30 hours of CE for the 2 years preceding application

May not be under investigation in any jurisdiction

May not have has a license suspended or revoked in another state or currently be subject to discipline in another state

When do licenses renew?

Every 2 years on September 30 of odd numbered years

Who is given a lifetime license?

Persons licensed for 50 or more years

What are the CE requirements for pharmacists?

A pharmacist must obtain 30 hours of CE during the 24 months prior to expiration of the license

2 hours of these hours must be on medication errors

2 hours must be on Validation of Prescriptions for CS

To administer vaccines or epi auto-injectors: a 3 hour CE course on the safe and effective administration of vaccines and epi auto-injection

What is required for the initial license renewal?

A 1 hour HIV/AIDS CE course

If it occurs more than 12 months after your initial licensure date: you are required to complete 15 hours of CE (5 live), including 2 hours of medication errors, 2 hours of controlled substances, and 1 hour in HIV/AIDS

If it occurs less than 12 months from initial licensure date: you are required to complete 1 hour in HIV/AIDS, 2 hours of medication errors, and 2 hours of controlled substances

What CE is required by most healthcare professions as a one-time requirement?

Human Trafficking CE

How can you obtain CE?

All programs approved by the ACPE

5 hours of CE (Risk management) by attending one full day at a Board meeting at which disciplinary hearings are conducted (max 10 hours of this)

5 hours of CE by performing volunteer services to the indigent or underserved populations or in areas of critical need within the state (max 5 hours)

Completion of a post-professional degree program from accredited colleges or schools of pharmacy

5 hours of CE (Risk management) by being a volunteer expert witness providing expert witness opinions for cases being reviewed by the DOH ( max 10 hours)

The presenter of a live seminar, live video teleconference, or interactive computer based application

A pharmacist who earns general CE in another state that is not ACPE approved, but is approved by the BOP in another state

Who has the ability to approve CE providers and courses?

Tripartite CE Committee

Note: They are comprised of equal representation from the Board of Pharmacy, each College and School of pharmacy in the state, and practicing pharmacists.

CE courses on laws and rules shall be at least ___ in length and must cover specific topics as outlined in the rule.

12 hours

CE courses on quality related events shall be at least ___ in length and cover specific topics as outlines in the rule.

8 hours

Note: This is often required after a dispensing error.

How is CE tracked?

CE broker

Note: FL approved CE providers will automatically report your hours to CE broker, but you may have to manually report hours from national providers.

What is CPE monitor?

NABP's online CE tracking service

Note: All ACPE approved providers report CE hours to CPE.

t/f: The FL DOH will not allow you to renew your license if you do not have the required CE hours reported in CE broker.

True

What are the requirements to be eligible to get a consultant pharmacist license?

Must hold a license as a pharmacist which is active and in good standing

Must successfully complete a consultant pharmacist course of no fewer than 20 hours sponsored by a college of pharmacy and approved by the Tripartite Committee

The consultant pharmacist course must include a cognitive test that the applicant must pass

Successfully completing a period of assessment and evaluation under the supervision of a preceptor within one year of completion of the course (3 consecutive months, at leas 40 hours of training)

What are the requirements to be able to serve as a consultant pharmacist preceptor?

A person must be a consultant pharmacist of record at an institutional pharmacy, have at least one year of experience as a consultant pharmacist of record, and not serve as a preceptor to more than 2 applicants at one time

A consultant pharmacist may provide medication management services in a healthcare facility within the framework of a written ____ between the pharmacist and a healthcare facility medical director or a physician, a podiatric physician, or a dentist.

collaborative practice agreement

Note: The pharmacist can only provide care for the physician's patients with whom they entered the contract with.

What must a collaborative practice agreement contain?

It must outline the circumstances under which the consultant pharmacist may:

Order and evaluate any laboratory or clinical tests to promote and evaluate patient health and wellness and monitor drug therapy and treatment outcomes

Conduct patient assessments as appropriate to evaluate and monitor drug therapy

Modify or discontinue medicinal drugs as outlined in the patient-specific order or pre-approved treatment protocol under the direction of a physician

Administer medicinal drugs

How can a consultant pharmacist become eligible to order and evaluate lab tests?

They must complete a 3 hour initial certification course and then a one hour CE on ordering and evaluating lab tests in order to renew their license

How many hours of CE are required to renew a consultant pharmacist license?

24 hours

t/f: The 24 hours of CE required for consultant pharmacist recertification may not be used toward the general 30 hour CE requirements for a pharmacist license.

True

Who is eligible to be a pharmacist intern?

Those enrolled in an internship program at an accredited college or school of pharmacy or have graduated from one and not yet licensed in the state

t/f: An intern may not perform any acts relating to filling, compounding, or dispensing of medicinal drugs unless it is under the direct and immediate personal supervision of a licensed pharmacist.

True

When should a termination of enrollment in an intern program be reported to Board?

Within 30 days

What is the ratio of pharmacists to foreign pharmacy graduate interns?

1:1

Who is eligible to serve as preceptors to pharmacist interns?

Pharmacists who hold current licensure in the state in which pharmacy is practiced

May not have a license revoked, suspended, on probation, or subject to payment of an unpaid fine, or be subject of ongoing disciplinary proceedings

Must agree to assist the school of pharmacy in achievement of the educational objectives and provide documentation of the pharmacist's continued professional education and of active involvement in a patient-centered practice

Shall accept responsibility for professional guidance and training of the intern and be able to devote time to preceptor training sessions and instruction of the intern

How many internship hours are required to be licensed as a pharmacist?

2080

Note: All internship hours may be obtained prior to the applicant's graduation. Hours worked in excess of 50 hours per week prior to an applicant's graduation or in excess of 60 hours per week after an applicant's graduation will not be credited.

Who is eligible to be a pharmacy technician?

Any person wishing to work as a pharmacy tech in FL must register with the Board by filing an application and paying a registration fee.

The applicant must be at least 17 and have completed a pharmacy technician training program approved by the board (e.g. preapproved pharmacy technician training programs, federal armed services programs, other non-employer based programs, employer-sponsored training programs)

Note: A person whose license to practice pharmacy has been denied, suspended, or restricted for disciplinary reasons may not register as a pharmacy technician

t/f: A pharmacy technician student who is enrolled in a pharmacy technician training program that is approved by the BOP may be in a pharmacy to obtain practical training.

True

t/f: A pharmacy intern may be employed as a pharmacy technician without paying a registration fee or filing an application as a pharmacy technician.

True

How many hours of CE must pharmacy technicians complete to renew their license?

20 hours

2 of which must be on medication errors

4 of which have to be live hours

1 of which has to be on HIV/AIDS if initial renewal

What happens to a license that is not renewed in time?

Reverts to delinquent status

A license may be reinstated if all CE requirements are met and a reactivation fee is paid, but it must be done prior to the next renewal

Note: Notice a delinquent license may only be reactivated within 2 years; after that, the license is void.

How can an inactivated license become active?

They can be reactivated by meeting required CE hours and paying a reactivation fee

Note: Unlike a delinquent license, you can keep a license inactive for more than 2 years as long as you continue to pay the renewal fee.

How can you retire a pharmacist license?

A licensee may elect to place their license on retired status by making a request to the Board and paying a retired status fee and an unlicensed activity fee

How can you reactivate a retired license?

Meet all CE requirements for all 2 year periods when the license was inactive

If retired for 5 or more years: they must pass the MPJE +/- NAPLEX

Who is exempt from license renewal provisions (renewing license or registrations, CE requirements, paying renewal fees)?

Any pharmacist or pharmacy tech on active duty with the Armed Forces of the US who at the time of becoming a member of the Armed Forces was in good standing with the Board is exempt while on active duty and for 6 months after discharge

A pharmacist or pharmacy tech who is a spouse of a member of the Armed Forces of the US and was caused to be absent from the state of FL because of the spouse's duties

t/f: A pharmacy may displace the license of each pharmacy employee or alternatively may display a notice that licenses are available for viewing upon request. In addition, every pharmacist, pharmacy intern, or registered tech must be identified by an ID badge.

True

Note: Every pharmacist, pharmacy intern, and registered pharmacy technicians must maintain proof of current licensure that is readily retrievable upon request by any representative of the DOH or BOP or any member of the public.

What is required to get a pharmacy permit?

A person must file a sworn application, which may include a set of fingerprints from each person having an ownership interest of 5% or greater and any person who directly or indirectly manages, oversees, or controls the operation of the applicant

For corporates having more than $100 million of business taxable assets in the state, only the PDM or consultant pharmacist of record is required to submit fingerprints

An application for a pharmacy permit must include written policies and procedures for preventing controlled substance dispensing based on fraudulent prescriptions or invalid prescriber-patient relationships

Passing an on-site inspection

When must a pharmacy have an on-site inspection?

Before the issuance of a new pharmacy permit, for a change of ownership, a change of address, or a change of location

Can a pharmacy permit be transferred upon the sale of a pharmacy?

No. It is non-transferable. Upon the sale, a new application must be filed and a new permit obtained.

What is required to attain a community pharmacy permit?

A community pharmacy permit is required for every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled and dispensed on an outpatient basis. A community pharmacy permit may not be issued unless a licensed pharmacist is designated as a PDM.

What is a PDM?

In FL, the term PDM is used in community pharmacies to identify the pharmacist who is responsible for the legal operation of the pharmacy.

An institutional pharmacy permit is required for any location in any healthcare institution where medicinal drugs are compounded, dispensed, stored, or sold. An institutional pharmacy permit may not be issued unless a licensed pharmacist is designated as the ____.

consultant pharmacist of record