a.
TO
REVIEW STATE AND FEDERAL STATUTES/RULES AND LAWS REGARDING THE DISPENSING OF
PRESCRIPTION DRUGS BY A LICENSED VETERINARIAN IN THE STATE OF FLORIDA.
b.
TO
MEET THE CONTINUING EDUCATION REQUIREMENTS FOR DISPENSING PRESCRIPTION DRUGS BY
LICENSED VETERINARIANS IN THE STATE OF FLORIDA.
a.
WRITING
A PRESCRIPTION FOR YOUR CLIENTS
b.
DISPENSING
c.
NARCOTIC
CONTROL
d.
EXTRA
LABEL DRUG USE
e.
CURRENT
EVENTS
f.
PERTINIENT
STATUTES
g. INTERNET ACCESS
ADDRESSES
a.
Prerequisites
i. YOU MUST have a veterinarian/patient/client
relationship
ii. YOU MUST provide a written prescription when
requested by
iii. YOU MUST have a release from your patient to
issue a prescription to a third party
iv. YOU MAY give a prescription over the phone
v. YOU MUST speak directly to a licensed pharmacist
when telephonically issuing a prescription
vi. YOU CAN NOT give a new prescription order to a
technician
vii. YOU MAY charge a fee for writing a prescription
b.
Information
Needed
i. ANIMAL’S FIRST AND LAST NAME
ii. SPECIES
iii. FULL DRUG NAME
1. NAME OF CHEMICAL OR BRAND
2. STRENGTH TO BE DISPENSED
a. mg/ml
b. mg/ cap or tab
iv. QUANTITY TO BE DISPENSED
v. PRACTITIONER’S FULL NAME
vi. DEA NUMBER
vii. TELEPHONE NUMBER
viii.
ADDRESS
ix. NUMBER OF REFILS
a.
You
Must
i. Have sufficient documented knowledge of
the animal.
ii. Be available or provide for follow-up
care and treatment in case of adverse reactions or failure of the regimen of
therapy
iii. Maintain records which document patients
visits, diagnosis, treatment and other relevant information
b.
Information
Requirements
i. Name of drug including:
1. Brand or Generic
2. Strength
3. Dosage form
4. Complete Directions
ii. Name of Practitioner
iii. Address of Facility
iv. Telephone number of Facility
v. Date dispensed / original dispensing date
vi. Lot number / expiration date
vii. Initials of Dispensing Individual
viii.
Childproof
Container / Closure System
ix. Drug Information
1. Shake Well
2. Keep Refrigerated
3. Etc.
V.
Narcotic
Control
a.
Drug
Schedules
i. (1) Schedule I. (CI) - The drug or other
substance:
1. Has a high potential for abuse
2. Has no currently accepted medical use in
treatment in the United States, or
3. Has no accepted safe use under medical
supervision
ii. (2) Schedule II. (CII) - The drug or other
substance:
1. has a high potential for abuse
2. has a currently accepted medical use in
treatment in the United States, or
3. has a currently accepted medical use but
with severe restrictions, and
4. abuse of the drug or other substances may
lead to severe psychological or physical dependence
5. Examples: morphine, oxycodone, hydromorphone,
meperidine, codeine, anabolic steroids
iii. (3) Schedule III. (CIII) - The drug or
other substance:
1. has a potential for abuse less than the
drugs or other substances in schedules I and II
2. has a currently accepted medical use in
treatment in the United States, and
3. abuse of the drug or other substance may
lead to moderate or low physical dependence or high psychological dependence
4. Examples: hydrocodone, codeine and others
in combination with other drugs
iv. (4) Schedule IV. (CIV) - The drug or
other substance
1. has a low potential for abuse relative to
the drugs or other substances in schedule III
2. has a currently accepted medical use in
treatment in the United States, and
3. abuse of the drug or other substance may
lead to limited physical dependence or psychological dependence relative to the
drugs or other substances in schedule III
4. Examples: benzodiazepines (Valium,
Ativan, etc), propoxyphene combinations
v. (5) Schedule V. (CV) -
The drug or other substance
1. Has a low potential for abuse relative to
the drugs or other substances in schedule IV
2. Has a currently accepted medical use in
treatment in the United States, and
3. Abuse of the drug or other substance may
lead to limited physical dependence or psychological dependence relative to the
drugs or other substances in schedule IV
4. Examples: Diphenoxylate combination,
cough syrups
b.
Veterinary
Examples
i. Class I
1.
Heroin
2.
LSD
ii. Class II
1.
Meperidine
(Demerol)
2.
Oxymorphone,
3.
Morphine,
4.
Pentobarbital
5.
Droperidol/fentanyl (innovar)
iii. Class III
1.
Bethanasia
2.
Ketamine
3.
Hydrocodone,
4.
Thiamylal/Thiopental
5.
Tiletamine/Zeolazepam
( Telazol)
6.
Butorphanol
iv. Class IV
1.
Alpha
chloralose/chloral Hydrate
2.
Methohexitol
(Brevital)
3.
Midazolam
4.
Pentazocaine
v. Class V
1. Lomotil
2.
Likes
3.
Drugs
c.
Narcotic
Inventory Control
i. CHECK LIST FOR COMPLIANCE WITH NARCOTIC
RULES, REGULATIONS AND LAWS.
1.
DO YOU HAVE
AN INTIAL INVENTORY?
2.
DO YOU HAVE
A SIGNED BI-ANNUAL INVENTORY?
3.
ARE YOUR
222’S COMPLETED AND ATTACHED TO AN INVOICE?
4.
IS YOUR
INVENTORY RECORDS KEPT SEPARATELY FROM ALL OTHER RECORDS
5.
IS THERE A
RECORD OF CHECKING EXPIRATION DATES ON A REGULAR BASIS?
6.
DO YOU HAVE
LOGS FOR SCHEDULE III TO V INVENTORY AND DISPENSING HISTORY?
7.
IS YOUR
INVENTORY SECURE, DOUBLE LOCKED AND ACCESSABLE ONLY TO APPROPRIATE STAFF?
8.
DO YOU HAVE
A RECORD THAT IS EASILY RETRIEVABLE OF CLIENT’S NAME, SPECIES, DATE, QUANTITY
DISPENSED?
9.
DO YOU HAVE
A MECHANISM TO ALERT YOU OF ANY DISCREPANCIES?
10.
IF YOU HAVE
ANSWERED NO TO ANY OF THE ABOVE QUESTIONS YOU ARE AT RISK FOR CITATION FOR
VIOLATING PORTIONS OF THE PRACTICE ACT.
ii. NARCOTIC INVENTORY
CONTROL RECORD
1. A copy of this is included in the
downloaded package
2. Descriptions
a. Drug - full name, strength and
dosage form
b. Page – is drug specific
c. Disp By – the initials of the
person dispensing+ a licensed professional
d. Date - the date the drug was
dispensed
e. Patient Name - first name and last
name
f. Rx number - the prescription
identifier
g. Species - feline, canine etc
h. Amount of Rx - the amount
dispensed/ amount used
i. Inventory - the declining
inventory
j. Initials - the initials the
individual uses on the form plus a legible (printed) name of the individual
k. A notation maybe made on form for
checking expiration dates
l. A notation maybe made on form for
bi-annual (every two years) inventory, but the inventory must be reproduced on
a separate form and signed by the registrant. This becomes part of a permanent record, separate from these
forms
VI.
Extra label Drug Use (ELDU)
a.
REQUIREMENTS
FOR USE
i. ELDU is permitted only by or under the
supervision of a veterinarian
ii. ELDU is allowed only for FDA approved
animal and human drugs.
iii. A valid Veterinarian/Client/Patient
Relationship is a prerequisite for all ELDU
iv. ELDU for therapeutic purposes only
(animal’s health is suffering or threatened). Not drugs for production use
v. Rules apply to dosage form drugs and
drugs administered in water. ELDU
in feed is prohibited
vi. ELDU is not permitted if it results in
volatile food residue, or any residue which may present a risk to public
health.
vii. FDA prohibition of a specific ELDU
precludes such use
b.
LABEL
REQUIREMENTS
i. Name and address of the prescribing
veterinarian
ii. Established name of the drug
iii. Any specified directions for use
including the class/species or identification of the animal or herd, flock,
pen, lot, or other group; the dosage frequency, and route of administration;
and the duration of therapy
iv. Any cautionary statements
v. Your specified withdrawal, withholding,
or discard time for meat, milk, eggs, or any ther food
c.
RECORD
REQUIREMENTS
i. Identify the animals, either as
individuals or a group
ii. Animal species treated
iii. Numbers of animals treated
iv. Conditions being treated
v. The established name of the drug and
active ingredient
vi. Dosage prescribed or used
vii. Duration of treatment
viii.
Specified
withdrawal, withholding, or
discard time(s), if applicable, for meat, milk, eggs, or animal-derived
food
ix. Keep records for 2 years
x. FDA may have access to these records to
estimate risk to public health.
d.
Drugs
Prohibited for Extra label Use in Food Animals
i. Chloramamphenical
ii. Clenbuterol
iii. Diethylstilbestrol (DES)
iv. Dimetridazole
v. Ipronidazole
vi. Other Nitroimidazoles
vii. Furazolidone,
Nitrofurazone, Other Nitrofurans
viii.
Fluoroquinolones
ix. Glycopeptides (example:
vancomycin)
x. Phenylbutazone in female
dairy cattle 20 months of age or older
a. It’s Back Florida Senate - 2006 SB 1848 By Senator Haridopolos
A bill to be entitled An act relating to pharmacy technicians; amending s. 465.014,
F.S.; authorizing pharmacy technicians to initiate or receive requests for original prescriptions when dispensing for nonhuman use; prohibiting a licensed pharmacist
from supervising more than a certain number of pharmacy technicians in dispensing prescriptions for nonhuman use; amending s.
465.035, F.S.; providing an exception to certain requirements for dispensing medicinal drugs for nonhuman use via facsimile; providing an effective date.
Be It Enacted by the Legislature of the State of Florida:
Section 1. Section 465.014, Florida Statutes, is amended to read:
465.014 Pharmacy technician.--A person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of pharmacy, except that a licensed pharmacist may delegate to nonlicensed pharmacy technicians those duties, tasks, and functions which do not fall within the purview of s. 465.003(13). All such delegated acts must be performed under the direct supervision of a licensed pharmacist who is responsible for all such acts performed by persons under his or her supervision. A pharmacy technician, under the supervision of a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests. In addition, a pharmacy technician may initiate or receive requests for original prescriptions for nonhuman use if this is done under the supervision of a licensed pharmacist. ANolicensed pharmacist may not supervise more than one pharmacy technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one but not more than three pharmacy technicians. A licensed pharmacist may not supervise more than seven pharmacy technicians in dispensing prescriptions for nonhuman use.
Section 2. Paragraph (b) of subsection (1) of section 465.035, Florida Statutes, is amended to read: 465.035 Dispensing of medicinal drugs pursuant to facsimile of prescription.--
(1) Notwithstanding any other provision of this chapter, it is lawful for a pharmacy to
dispense medicinal drugs, including controlled substances authorized under subsection
(2), based on reception of an electronic facsimile of the original prescription if all
of the following conditions are met:
b) Except in the case of the transmission of a prescription by a person authorized
by law to prescribe medicinal drugs and except in the case of dispensing for nonhuman use:
1. The facsimile system making the transmission provides the pharmacy receiving
the transmission with audio communication via telephonic, electronic, or similar
means with the person presenting the prescription.
2. At the time of the delivery of the medicinal drugs, the pharmacy has in its
possession the original prescription for the medicinal drug involved.
3. The recipient of the prescription shall sign a log and shall indicate the name and
address of both the recipient and the patient for whom the medicinal drug was prescribed.
Section 3. This act shall take effect upon
becoming a law.
a.
For
dispensing and prescription writing. Florida Statues 465 Definitions
i. “Prescription" includes 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. The term also includes an orally transmitted order
by the lawfully designated agent of such practitioner. The term also includes
an order written or transmitted by a practitioner licensed to practice in a
jurisdiction other than this state, but only if the pharmacist called upon to
dispense such order determines, in the exercise of her or his professional
judgment, that the order is valid and necessary for the treatment of a chronic
or recurrent illness. The term "prescription" also includes a pharmacist's
order for a product selected from the formulary created pursuant to s. 465.186.
Prescriptions may be retained in written form or the pharmacist may cause them
to be recorded in a data processing system, provided that such order can be
produced in printed form upon lawful request.
ii. “Dispense" means 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. As an element of dispensing, the
pharmacist shall, prior to the actual physical transfer, interpret and assess
the prescription order for potential adverse reactions, interactions, and
dosage regimen she or he deems appropriate in the exercise of her or his
professional judgment, and the pharmacist shall certify that the medicinal drug
called for by the prescription is ready for transfer. The pharmacist shall also
provide counseling on proper drug usage, either orally or in writing, if in the
exercise of her or his professional judgment counseling is necessary. The
actual sales transaction and delivery of such drug shall not be considered
dispensing. The administration shall not be considered dispensing
b. Florida Statues
465.0255 Expiration date of medicinal drugs; display; related use and
storage instructions
i. manufacturer,
repackager, or other distributor of any medicinal drug shall display the
expiration date of each drug in a readable fashion on the container and on its
packaging. The term "readable" means conspicuous and bold
ii. Each pharmacist for a community pharmacy dispensing
medicinal drugs and each practitioner dispensing medicinal drugs on an
outpatient basis shall display on the outside of the container of each
medicinal drug dispensed, or in other written form delivered to the purchaser:
1. The expiration date when provided by the
manufacturer, repackager, or other distributor of the drug; or
2. An earlier beyond-use date for
expiration, which may be up to 1 year after the date of dispensing
iii. The dispensing pharmacist or practitioner must
provide information concerning the expiration date to the purchaser upon
request and must provide appropriate instructions regarding the proper use and
storage of the drug
iv. This section does not
impose liability on the dispensing pharmacist or practitioner for damages
related to, or caused by, a medicinal drug that loses its effectiveness prior
to the expiration date displayed by the dispensing pharmacist or practitioner
v. The provisions of this
section are intended to notify the patient receiving a medicinal drug of the
information required by this section, and the dispensing pharmacist or
practitioner shall not be liable for the patient's failure to heed such notice
or to follow the instructions for storage
&nbs