Chapter 3 fl Flashcards
Practitioners with Independent/Prescriptive Authority in Florida
Allopathic physicians (MD)
Osteopathic physicians (DO)
Podiatrists
Certified optometrists
Veterinarians
In the state of Florida, PAs may not prescribe:
- psychiatric mental health controlled substances for children younger than 18yo
- general, spinal, or epidural anesthetics
- radiographic contrast materials
In the state of Florida, what are the controlled substance restrictions on PAs?
- CII are limited to a 7 day supply
- CS may not be prescribed in a pain management clinic
- other restrictions on prescribing CII opioids for pain are also applicable (chapter 2)
In which setting practice do PAs have the ability to write orders for any medication?
hospital practice
T or F
APRNs may prescribe any drug based on a written protocol from a supervising physician
True
What restrictions do APRNs have when prescribing CS?
- CII are limited to a 7 day supply (DOES NOT APPLY to CS that are psych meds prescribed by psychiatric nurses)
- may not prescribe CS in a pain management clinic
- except for psych nurses, may not prescribe psych mental health CS for children younger than 18yo
- other restrictions on prescribing CII opioids for pain are also applicable
Psych APRNs may prescribe…
NOT SUBJECT TO THE 7 DAY LIMITATION for CII psych meds
may prescribe psych CS to children younger than 18
T or F
Certified optometrists have independent authority but limited formulary
They may administer and prescribe ocular pharmaceutical agents from an approved formulary for dx and tx of ocular conditions of the human eye and its appendages without the use of surgery or other invasive techniques
true
Certified optometrists can also prescribe certain oral drugs after completing addition training; which analgesics (or their generic therapeutic equivalents) can they prescribe?
(may not administer or prescribe for more than 72 hours)
tramadol hcl
acetaminophen 300mg with No. 3 codeine phosphate 30mg
may not be administered or prescribed for more than 72 hours without consultation with a physician who is skilled in diseases of the eye
Certified optometrists can also prescribe certain oral drugs after completing addition training;
Which antibiotics or their generic therapeutic equivalents can be prescribed?
amoxicillin with or without clavulanic acid
azithromycin
erythromycin
dicloxacllin
doxycycline/tetracycline
keflex
minocycline
Certified optometrists can also prescribe certain oral drugs after completing addition training;
Which antivirals or their generic therapeutic equivalents can be prescribed?
acyclovir
famciclovir
valacyclovir
Certified optometrists can also prescribe certain oral drugs after completing addition training;
Which oral anti-glaucoma or their generic therapeutic equivalents can be prescribed? (may not administer or prescribe for more than 72 hours)
acetazolamide
methazolamide
Prescriptions from telehealth providers are valid assuming they are based on a valid practitioner-patient relationship. However, telehealth providers may not prescribe CS unless the CS is prescribed for the following:
(4)
1) tx of a psychiatric disorder
2) inpatient tx at a hospital
3) tx of a pt receiving hospice services
4) tx of a resident of a nursing home facility
The FL board of Medicine has a rule that requires rx or orders for any drug, synthetic compound, nutritional supplement, or herbal tx for the purpose of assisting in weight loss be
1)
2)
in writing
signed by the prescribing physician
the initial rx or order of this type shall NOT be called into a pharmacy by the physician or by an agent of the physician.
FL requires all prescriptions be transmitted electronically, unless certain exceptions are met
(8)
1) the practitioner and the dispenser are the same entity
2) the rx cannot be transmitted electronically under the most recently implemented version of National Council for Rx Drug Programs SCRIPT Standard
3) The practitioner has been issued a waiver by the department, not to exceed 1 yr, due to demonstrated economic hardship, technology limitations that are not reasonably within the control of the practitioner, or another exceptional circumstance demonstrated by the practitioner
4) the practitioner reasonably determines that it would be impractical for the pt to obtain a medicinal drug prescribed by electronic rx in a timely manner and such delay would adversely impact pt’s medical condition
5) research protocol
6) rx is for a drug for which the FDA requires the rx to contain elements that may not be included in electronic prescribing
7) hospice care or nursing home facility
8)to compare rx drug price among area pharmacies (must be documented)
T or 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
True
These drugs must be dispensed by the pharmacist who ordered the drug. Pharmacists CANNOT issue an rx to be filled by another pharmacist or at another pharmacy **
__________ may legally prescribe a drug to treat any disease or illness. Although a pharmacist should exercise caution, it is legal to fill an rx written outside of this prescriber’s specialty.
A physician (DO or MD)
ex: HTN med written by an orthopedic surgeon or an oncologist
________, _______, _________ may only prescribe drugs used within their scope of practice.
Dentists, Podiatrists, veterinarians
Per the Florida Board of Medicine, self-prescribing of controlled substances is allowed/prohibited?
prohibited
T or F
Per the Florida Board of Medicine, self-prescribing of controlled substances is prohibited BUT there is no specific law or rule that strictly forbids self-prescribing or prescribing for family members for NON-CS.
True
BUT in order to be a legal rx, there must be a valid practitioner-patient relationship and the rx must be issued in the usual course of professional practice.
^if not, considered grounds for discipline of the dr and rph if the rph is aware.
If a practitioner retires or dies, what does FL recommend about filling an rx?
FL does not appear to address this topic, but may be an opportunity to use emergency fill rules.
NOTE:
DEA registration terminates when a practitioner dies. From a strict legal POV, it makes sense that any REFILLS remaining on an rx are NO LONGER VALID once a practitioner is deceased or retired.
T or F
There is no law that prohibits a practitioner from prescribing, or an rph from dispensing, an approved drug for use that is not approved in the drug’s labeling.
true
A prescription written for “_________ ________” can NOT be filled.
Office Use
- a pharmacist can sell an original manufacturer’s bottle of an rd drug to a practitioner for use in his or her office, but cannot dispense drugs pursuant to a rx for office use.
What is the purpose of the FL Board of PHarmacy?
to protect the public health, safety, and welfare.
licensure, monitoring, and education to assure competency and safety.
The Florida BOP is composed of __ members.
9 members
___ members of the BOP must be licensed pharmacist
7
must be residents of FL and have been engaged in practice for at least FOUR YEARS
2 of the 9 BOP members are
consumer members/public (one has to be 60yo or older)
The pharmacist members must include
__ practicing in a community pharmacy
__ practicing in an institutional pharmacy (class II, modified class II, or class III)
__ pharmacist practicing in any pharmacy setting
2
2
3
BOP members are appointed by the _________ and confirmed by the ____________
appointed by the governor
confirmed by the Florida senate
Board members are appointed for ___ year terms and may not serve more than __ full terms
4 years; two full terms
// until a new board member has been appointed
The BOP is run by an __________ __________, who is an employee of the DOH. They are NOT one of the BOP members and does not have to be an rph
Executive Director
The pharmacy department of any permittee shall be considered closed whenever a FL licensed pharmacist is not:
present and on duty.
FL Licenses renew every
2 years (biennially) on Sept 30th of odd-number years
Person licensed for __ years or more is expect from payment of renewal or delinquent fee and is given a lifetime license
50 years
To renew a pharmacist license, an rph must obtain __ hours of CE in courses approved by the board during the 24 months prior to expiration of the license.
30 hours
Pharmacists must complete __ hours of a board approved course on medication errors
2 hours
Pharmacists must complete __ hours of board approved CE on Validation of Prescriptions for Controlled Substances
2 hours
At least ___ hours must be LIVE seminars, video teleconferences, or interactive computer based applications
10 hours
A pharmacist certified to administer vaccines or epinephrine auto injectors must complete a __ hour CE course on the safe and effective administration of vaccines and epinephrine
3 hours
For initial license renewal,
1 hour __________ CE course is required (one time only)
HIV/AIDS
If you are renewing your license for the first time and your initial renewal occurs 12 months or more after initial licensure, you are required to complete ___ hours (__hour live), including 2 hours med errors, 2 hrs of CS, and 1 hour HIV/AIDS.
15 hours (5 live)
If you are renewing your license for the first time and your initial renewal occurs 12 months or less after initial licensure, you are required to complete:
1 hour HIV/AIDS
2 hr med errors
2 hrs CS
How many hrs are required for Instruction on Human Trafficking CE?
1 hr
*one time requirement
**requires posting a sign regarding human trafficking (Board has not adopted any rules on this tho)
How many CEUs are in 1 hr of CE?
0.1 CEU
How many hours can a licensee obtain by attending one full day of a board meeting at which disciplinary hearings are conducted?
5 hours
How many hours of CE credit may be obtained by performing volunteer services to the indigent or to underserved populations or in areas of critical need WITHIN the state?
5 hours
1 hour is awarded for every two hours of volunteer work
____
live seminar presenter - 1 credit CE
All healthcare providers licensed by the Florida DOH must use an electronic system called _______________ for taking their CE
CE Broker
To become a consultant pharmacist, the pharmacist must successfully complete a consultant pharmacist course of no fewer than __ hours sponsored by an accredited college of pharmacy and approved by the Tripartite Committee
20 hours
How many CE hours do consultant pharmacists need in order to order and evaluate laboratory tests?
3 hour initial certification course; 1 hr thereafter
A consultant pharmacist must complete ____ hours of consultant pharmacist CE, which includes:
drug therapy
administrative responsibilities
consultant pharmacist facility requirements
compounding sterile or non sterile drugs
24 hours
The 24 hours of CE required for consultant pharmacists recertification may / may not be used toward the general 30 hr CE requirements for an rph license
MAY NOT
Pharmacy technicians must complete no less than ___ hours of Board-approved CE in order to renew registration
20 hours
PHarmacy technicians must complete a __ hour Board approved course on med errors; counts toward the full 20 hours
2 hours
At least __ hours of the 20 hours must be obtained at a live seminar, live video teleconference or through an interactive computer based application for pharmacy technicians.
4 hours
Upon first renewal, pharm techs must complete __ contact hour of board approved course on HIV/AIDS and __ hour of human trafficking
1 hour; 1 hour
Pharm techs may obtain __ hours of CE in subject matter of risk management by attending one full day of board meeting at which disciplinary hearings are conducted. The max CE allowable by this is 10 hours.
5 hours
A delinquent license may only be reactivated within __ years, after that it is void.
2 years (must have CE and reactivation fee)
T or F
A pharmacy may display the license of each pharmacy employee or alternatively may display a notice that licenses are available for viewing upon request
True
Passing an on-site inspection is required before
the issuance of a new pharmacy permit
a change of ownership
change of address
change of location
Institutional pharmacies may not dispense drugs to outpatient unless they obtain what kind of permit?
community pharmacy permit
NOTE: Class II and Class III institutional pharmacies may do limited outpatient dispensing with a Special-Limited Community Pharmacy Permit (exception, emergency rooms)
No medicinal drugs may be dispensed in a class __ institutional pharmacy
class I (nursing home)
still requires a Class I Institutional Pharmacy Permit (Florida is weird in that it still requires this bc no drugs are being dispensed as they’ve already been dispensed)
Class II Institutional Pharmacy permits are generally for
hospitals
Modified Class II Institutional Pharmacy permits are for
Urgent care, ER stand alone, prisons
Which Pharmacy permit does not require to have a full-time pharmacist on duty (drugs are administered to patients on the premise, and no outpatient dispensing is permitted)
Modified Class II
All Modified class II institutional pharmacies must have a consultant pharmacist who provides on-site consultation at least _____ per month.
once
Modified class II pharmacies must have a Pharmacy Services Committee that at least meets __________
annually
An example of Modified Class II Type A Permit is:
alcoholism treatment center
-formulary of no more than 15 medicinal drugs, stored in bulk, CS may not exceed 100 dosage units
An example of Modified Class II Type B Permit is:
urgent care centers, outpatient surgery centers, correctional institutions
-has expanded formulary, medicinal drugs stored in bulk and in patient specific form
An example of Modified Class II Type C Permit is:
Jail with small inmate population
-expanded formulary and medicinal drugs are stored in patient specific form. NO BULK DRUGS ALLOWED.
Class III Institutional PHarmacy permits are:
LARGE hospitals
allows the pharmacy to:
dispense, distribute, compound, fill
prepare prepackaged drug products
conduct other pharmaceutical services
Which Permit is required for any location where medicinal drugs are compounded, dispensed, stored, or sold but is not a community pharmacy, institutional pharmacy, nuclear pharmacy, or internet pharmacy?
Special Pharmacy Permit
provide misc specialized pharmacy services
____________________ Permit
- required for any institutional Class II (hospital) pharmacy that dispenses to employees, medical staff, and their dependents; patients of the ER; and discharged patients of the hospital
NOT TO EXCEED 3 DAY SUPPLY (exception: inhalers, ocular products, otic products, insulin vials or pens, bulk antibiotic suspensions, topical agents, methylprednisolone dose packages)
Special Limited Community Permit
_____________ Permit
- required for any pharmacy that provides parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients
Special Sterile Products and Special PArenteral/Enteral Compounding
- required to have a PDM, maintain a patient profile, policy and procedure and quality assurance program, space and compounding requirements
________________ Permit
- required for pharmacies to compound and dispense patient-specific paraental/enteral drugs in conjunction with an institutional permit
Special Parental/Enteral Extended Scope Permit Rule
**allows a pharmacy to prepare patient specific sterile products for pts in a hospital or other institutional facility
_______________ Permit
- required for any pharmacy or outsourcing facility compounding sterile products
- required for ALL outsourcing facilities
Special Sterile Compounding Permit
*not required for a modified type B class II institituinal pharmacy if the pharmacy only compounds low risk level sterile products for immediate use
_____________________ Permit
- required for any pharmacy that dispenses to facilities where res are individually prepared for the ultimate user, including nursing homes, jails, adult congregate living facilities, intermediate care facilities for individuals with intellectual disabiltiies
Special closed system pharmacy permit
- must have 24 hr on call service
_____________ PErmit
-provide dialysis products and supplies to persons with CKD for self administration at the persons home or specified address
special ESRD
__________ permit
– an option licensed for assisted living facilities using drugs in unit dose packaging, drugs may not be dispensed on the premises.
Special ALF permit
drugs can be returned to dispensing pharmacy (NOT CS)
_____________ Permit
- required for any location not otherwise issued a permit, within or outside the state, that uses the internet to communicate with or obtain info from sonumsers and uses info to fill or refill rx or to dispense, distribute, or otherwise engage in practice of pharmacy in FL
Special internet pharmacy permit rule
_______________ Permit
- required for pharmacies located outside of FL that ship, mail, or deliver in any manner, a dispensed medication drug into FL
- does not allow shipping, mailing, delivering, or dispensing a compounded sterile product into FL
Nonresident Pharmacy PErmit
if only dispensing one time per year, not required
________________ Permit
- require for pharmacies located outside of FL that ship, mail, deliver or dispense in any manner a patient specific compounded sterile product into FL
Nonresident Sterile Compounding Permit
MUST. have a current and satisfactory inspection report
_____________ Permit
- required for outsourcing facilities located outside of FL to ship, mail, or deliver a sterile compounded product into FL for OFFICE USE
-may also ship, mail, deliver, or dispense a pt-specific compounded sterile product into FL
Nonresident Sterile Compounding Outsourcing Facility Permit
Pending federal approval, FL will establish two programs to safely import FDA-approved rx drugs into Florida:
1) canadian drug importation program
2) international drug importation program
The Florida Food Drug and Cosmetic Act is enforced by who?
Florida Department of Business and Professional Regulation (DBPR)
goal: to administer and enforce the FFDCA to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacturer, repackaging, or distribution of drugs, devices, and, cosmetics
Who does the FFDCA primary apply to?
drug manufacturers
drug repackagers
drug wholesalers
medical gas/oxygen manufacturers and distributors
__________________ Permit
- required for retail pharmacy that engages in wholesale distribution of rx drugs
- wholesale distribution activity does not exceed 30% of total annual purchases of rx drugs (if it does will need to obtain rx drug wholesale distributor permit)
Retail Pharmacy Wholesale Distributor Permit
The transfer/distribution must be between a retail pharmacy and another retail pharmacy, or a modified class II institutional pharmacy, or a healthcare practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs
___________________ Permit
- required for any person that engages in the distribution of a complimentary drug (rx drug samples)
Complimentary Drug Distributor
The FFDCA requirements for rx drug samples are similar to the federal requirements under the PDMA
All expired rx drug samples must be returned to the manufacturer or distributor who provided the sample
__________________ Permit
- required for an entity that is located in FL. that sells or delivers medical oxygen directly to patients in FL
- the sale and delivery must be based on an rx or an order from a practitioner authorized by law to prescribe
Medical Oxygen Retailer PErmit
______________ Permit
- required for any person that sells veterinary rx drugs to the public but does not include a pharmacy
Veterinary Prescription Drug Retailer Permit
an order may not be valid for more than 1 year
What two establishments may dispense drugs but are not a pharmacy?
Veterinary
Medical Oxygen Retailer
________________ Permit
- required for the purchase of a prescription drug by a place of business at one general physical location that provides healthcare or veterinary services, which is owned and operated by a business entity that has been issued a federal employer tax ID#
Healthcare Clinic establishment Registration Permit
- allows a clinic to purchase rx drugs that may be used by multiple providers at the clinic
-must have a qualifying practitioner to do al of the legal items
The refusal or constructive refusal to allow the ________ to enter or inspect an establishment which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held is a violation of the FFDCA
DBPR - they are allowed to come and inspect!
they can also enter and inspect any vehicle that is being used to transport drugs, devices, or cosmetics and take samples
Selling a product containing dextromethorphan to an individual less than ___ yo is a violation of the FFDCA
18yo
The Cancer Drug Donation Program is ran by the ____________ and was established to facilitate the donation of cancer drugs and supplies to eligible patients
DBPR
Who Can a donor be of the Cancer Drug Donation Program?
- patient or patient representative who donates cancer drugs or supplies needed to administer cancer drugs that have been maintained within a closed drug delivery system
- healthcare facilities, nursing homes, hospices, or hospitals with closed drug delivery systems
-pharmacies, drug manufacturers, medical device manufacturers or supplies, or wholesalers of drugs or supplies
- a physician who receives cancer drugs or supplies directly from a drug manufacturer, wholesale distributor or pharmacy
Cancer Drug Donation Program-
Institutional Class II (Hospital) pharmacies can elect to participate int he program as a “______________” and accept donated cancer drugs and supplies under the rules adopted by the department for the program.
participant facility
Cancer Drug Donation Program-
A cancer drug may not be accepted or dispensed under the program if the drug bears and expiration date that is less than ___ months after the date the drug was donated or if the drug appears to have been tampered with or mislabeled
6 months
Cancer Drug Donation Program – T or F
A participant facility that voluntarily takes part in the program may charge a handling fee sufficient to cover the cost of preparation and dispensing of cancer drugs or supplies under the program.
True
