Download animal medicinal drug use clarification act

CHAPTER 1
Dr. Dipa Brahmbhatt VMD MpH, MS
[email protected]
BOOKS
WHY
‘Veterinary Technician must understand
why the diagnosis was made, why the
surgery was performed, why the prognosis
was rendered and why the treatment was
prescribed’
Medication Error
“Medication error as any
preventable event that
may cause or lead to
inappropriate medication
use or patient harm while
the medication is in the
control of the health care
professional, patient, or
consumer” June 2010
Commonly Misinterpreted Abbreviations
Abbreviation used
Intended as
Misread as
U
Units
0 (zero)
IU
International Units
IV (intravenously)
mcg or µg
Microgram
mg (milligram)
SID
Once daily
BID (twice daily) and QID
(four times daily)
TIW
Three times a week
Three times daily
Qhs
At bedtime
Every hour
Iatrogenic?
ALL DRUGS ARE POISONS
• Safety and Efficacy is dependent on DOSE, MODE OF
ADMINISTRATION and INDIVIDUAL patient
characteristics
– Tylenol (acetaminophen) safe for humans, tolerated in dogs
and DEADLY IN CATS
– Intranasal IBR given Subcutaneous
– Underweight or dehydrated patients
– Drug is a substance used to tx, prevent or dx. Dz. In
animals
Top Pet Toxin of 2008: Medications
• In 2008, human medications like
ibuprofen, acetaminophen,
decongestants, cold medicines and
anti-depressants topped the ASPCA's
list of most common pet poisons
http://www.suite101.com/content/most-common-pet-poisonsaccording-to-aspca-a87882
DEFINITION
• Veterinary Pharmacology: ‘The STUDY and USE of drugs in
animal healthcare
• Goal of veterinary clinical pharmacology is to optimize
therapy (individual, herd, flock, etc )
BRIEF HISTORY
• 5000 B.C.: India hospital for
horses and elephants
• 1700’s: Cattle epidemic in Europe
• 1760’s: France began opening
veterinary colleges
• 1860’s: First veterinary school in
Philadelphia
SOURCES OF DRUGS
Drug Source
Example
Minerals
Sulfur, iron, electrolytes
Botanicals: Plants, Molds, Bacteria
Digitalis, antibiotics
Animal
Insulin, TH, Lanolin
Synthetic (manmade/engineered)
Laboratory via chemical reaction
Greater purity
Aspirin, steroids, procaine (novocain)
PHARMACOLOGY TERMS
‘Pharmaco’
Drug / Medicine
‘Pharmacotherapeutics’
Tx of disease with
Medicine
‘Pharmacokinetics’
Study of absorption,
Blood levels, distribution,
Biotransformation,
excretion
‘Pharmacodynamics’’
MOA of drug
Effects: Biological and
physiological
PHARMACOLOGY TERMS
CHEMICAL
NAME
NONPROPRIETARY
NAME/
GENERIC NAME
Active ingredient
PROPRIETARY/
TRADE NAME
D(-)-alpha-amino-phydroxybenzyl-penicillin
trihydrate
Amoxicillin
Amoxi-Drop (Pfizer)
Biomox (Virbac)
Robamox-V (FD)
((3-phenoxyphenyl) methyl
cis-trans-3-(2,2dichloroethenyl)-2,2dimethylcyclopropanecarbox
ylate))
Permethrin insecticide
Atroban
Defend
Flysect
Dl 2-(o-chlorophenyl)-2(methylamino)
cyclohexanone
hydrochloride
Ketamine hydrochloride
Ketasat
Vetalar
PHARMACOLOGY TERMS
DOSAGE
• Amount given over time
• 10mg/kg (for 5 kg dog DOSE is 50 mg)
• Dosage regimen: 13.5mg/kg every 12 hours for 14 days
(Clavamox)
DOSE
• Amount of drug administered at one time to patient
• 1 ml 2 tablets
FDA
http://www.fda.gov/default.htm
• Pre 1906: little regulation of drugs
• 1906: Federal Pure Food and Drug Act
• The FDA (Food and Drug Administration) created to
enforce the Act
• Established standards for drug strength, purity, and
guidelines for labeling
• 1906 – 1930’s
• FDA was small and their authority was limited
• Source of drugs was botanical: ergot, quinine, digitalis
• Dosing/toxicities as proper testing was not performed
SULFANILAMIDE ELIXER
“Taste of raspberries…
taste of death” "
But to realize that six human
beings, all of them my patients, one
of them my best friend, are dead
because they took medicine that I
prescribed for them innocently, and
to realize that that medicine which I
had used for years in such cases
suddenly had become a deadly poison
in its newest and most modern
form, as recommended by a great and
reputable pharmaceutical firm in
Tennessee: well, that realization
has given me such days and nights of
mental and spiritual agony as I did not
believe a human being
could undergo and survive. I have
known hours when death for me would
be a welcome relief from this
agony." (Letter by Dr. A.S. Calhoun,
October 22, 1937)
Regulation of Drug Products
• The Food and Drug Administration (FDA) became a
government agency to enforce the federal Pure Food and
Drug Act of 1906
– The Pure Food and Drug Act established standards for drug strength,
purity, and guidelines for drug labeling
• Until the late 1930s, the FDA had little power to determine
and enforce correct drug dosage information
• In 1938, Congress passed the federal Food, Drug, and
Cosmetic Act (FDCA), which required that a drug be
adequately tested to demonstrate its safety when used as its
label directs
• In 1972, the FDCA was amended to include many more
protections
Copyright © 2011 Delmar, Cengage Learning
Regulation of Drug Products
• The FDA is headed by a commissioner and organized into a
number of different centers
• The FDA’s Center for Veterinary Medicine (CVM) ensures that
approved veterinary medicines will not harm animals
• The FDA-CVM prohibits the sale and use of a drug that would
cause animals to suffer serious health problems
• The 1968 amendments to the FDCA made drug manufacturers
specify drug withdrawal periods and detection methods for
determining drug residues in animal foodstuffs
• Details: Figure 1-1
Copyright © 2011 Delmar, Cengage Learning
FDA
http://www.fda.gov/downloads/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/UC
M236854.pdf
YES
NO
MAYBE SO
Animal Drugs
Vaccines (USDA)
Pharmacies
Banned turtles under 4
inches
Salmonella carriers
Antibodies (USDA)
Practice of Vet Med.
Extra label use
Animal Devices: if
adulterated/ misbranded
Toxoids (USDA)
Flea and Tick products
FDA/EPA
Animal Feed: safe
ingredients, human food
safety
FDA: milk, milk products
NO REGULATION
(cheese,
cat litter, pet accessories
cream, and ice cream) and
(toys, bed, crates),
“Shell eggs” (eggs
grooming aids
inside their shells)
USDA: egg products
meat, poultry, and catfish
OBTAIN DRUGS
Prescription
OTC: safe for
animal, the person
administering the
medication, people
coming into contact
with the animal, the
human food chain
and the
environment
Over the
counter
Extra - Label
Controlled
Substances
OBTAIN DRUGS
• Prescription Drugs
– Considered toxic, potentially toxic if misused or
too readily misused
– Regulated by the FDA and are limited to use under
the supervision of a veterinarian or physician
– Obtained through vet or prescription
– VETERINARIAN/CLIENT/PATIENT
RELATIONSHIP (VCPR)
– “CAUTION: Federal law restricts the use of
this drug to use by or on the order of a licensed
veterinarian”
Prescription Drug label
Vet techs cannot
write prescriptions
but can fill drug
orders and
dispense
medication as
instructed by vet
VCPR
1.
Animal has been examined by a veterinarian who assumes
responsibility for making judgments about the animal’s
health and the need for treatment
2. Client agrees to follow the given
Instructions
3. Veterinarian is available for follow-up
4. http://www.avma.org/animal_health/vcpr_poster.pdf
Jane R. Shaw, DVM, PhD
OBTAIN DRUGS
• OFF-LABEL or EXTRA-LABEL
– Vet discretion
– Not indicated by labeling by FDA
– ANIMAL MEDICINAL DRUG USE
CLARIFICATION ACT (AMDUCA) - 1994
• Extra label by OR order of licensed veterinarian
• VCPR
• NO DRUG RESIDUES IN FOOD ANIMAL
• Extra label not allowed in FEED ADDITIVES
• Code of Federal Regulations: DRUGS cannot be used
• http://cpharm.vetmed.vt.edu/vm8784/default.htm
AMDUCA
• American Medicinal Drug Use Clarification Act of 1994
• Sec. 530.41. The following drugs are prohibited for extralabel
animal and human drug uses in food-producing animals:
• (a______________________ ; (b) Clenbuterol; (c)
Diethylstilbestrol (DES); (d) Dimetridazole; (e)
Ipronidazole; (f) Other nitroimidazoles; (g) Furazolidone
(except for approved topical use); (h) Nitrofurazone (except
for approved topical use); and (i) Sulfonamide drugs in
lactating dairy cattle (except approved use of
sulfadimethoxine, sulfabromomethazine and
sulfaethoxypyridazine).
•
Dated: October 22, 1996. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 96-28662 Filed
11-6-96; 8:45 am] BILLING CODE 4160-01-F
AMDUCA
• Rimadyl in cats is used by a number of veterinarians.
– However the U.S. label states:
“WARNINGS: Keep out of reach of children. Not for human
use.
Consult a physician in cases of accidental human exposure.
For use in dogs only. Do not use in cats.”
FARAD
http://www.farad.org/
• Food Animal Residue Avoidance Databank (FARAD)
• FARAD: University based computer-based system
– Provide information on how to avoid drug, pesticide, and environmental
contaminant residue problems
– Current label information including withdrawal times of drugs, official
tolerances, scientific articles, pharmacokinetics, and the fate of chemicals in
food animals
– List of drugs prohibited for use in livestock
– Sponsored by USDA
CONTROLLED SUBSTANCES
• Drugs that are considered to be dangerous because of the
potential for human misuse or abuse
• They are regulated by the DRUG ENFORCEMENT
ADMINISTRATION (DEA) via the CONTROLLED
SUBSTANCES ACT of 1970. Before this act, drug abuse was
defined as the illicit use of an illegal drug or the improper use
of a prescription drug.
• After 1970, controlled substances were classified into 5
schedules that are based on the potential for abuse. The higher
the number (schedule), the lower the risk for abuse.
• Vet
• Details
CONTROLLED SUBSTANCES
• FDA (DHHS) regulates the development
and approval of drugs,
• DEA (Justice Dept.): regulates the laws and rules
pertaining to the purchase, storage and use of
controlled substances
• Vets need to register with the DEA annually
• Stored in locked cabinet / safe, records (file with
DEA and log every 2 years)
• Any address changes are to be reported to the DEA.
Controlled substances
• Veterinary Technician Role
– Order, keep records, maintain storage procedures
– Cannot dispense
Controlled Substance Medication
Acetominophen Toxicity
• Cat Tylenol Toxicity
• Moonface
CHAPTER REVIEW
___ drugs that can be purchased without a prescription
___ drugs considered dangerous because of their potential for
Human abuse
___ drugs that can be obtained only through a veterinarian or
Via a prescription
___ drugs used in a manner not specifically described on the
FDA- approved label
___ study of a drug’s mechanism of action and its biological
And physiological effects
___ study of the absorption, blood levels, distribution, metabolism,
And excretion of drugs
___ the treatment of disease with medicines
___ the study and use of drugs in animal health care
___ the law that allows extra-label use of a drug under certain
Conditions
___ agency that ensures that approved veterinary medicines are
Relatively safe for animals
A) pharmacodynamics
B) controlled substances
C) pharmacokinetics
D) over the counter drug
E) pharmacotherapy
F) prescription drugs
G) extra-label drugs
H) vet. pharmacology
I) FDA-CVM
J) Animal Medicinal Drug
Use Clarification Act of
1994
CHAPTER REVIEW CONT’D
1)The FDA became a government agency after the passage of
the
a) Federal Food and Drug Act of 1906
b) Controlled Substances Act of 1970
c) Food, Drug, and Cosmetic Act of 1938
2)A person studying how the body absorbs, uses, and gets rid
of codeine is engaged in the pharmacological specialty
called
a) pharmacotherapeutics
b) pharmacodynamics
c) pharmicokinetics
CHAPTER REVIEW
3) Controlled substances must
a) be kept in a locked cabinet or safe
b) have orders, receipts, uses, and thefts recorded
c) be ordered by veterinarians who register annually with
the DEA
d) All of the above
4) The higher (larger) the schedule number of a controlled
substance drug
a) the higher the risk for human abuse potential
b) the lower the risk for human abuse potential
c) the less medical value it has
CHAPTER REVIEW
TRUE OR FALSE
1) Prescription drugs are limited to use under the
supervision of a veterinarian or physician.
2) The majority of veterinary drugs in use during the early
1900s were found naturally in plants
3) The major requirement of the Food, Drug, and Cosmetic
Act of 1938 is the requirement of drug safety
4) Diazepam (Valium) is an example of a schedule I drug
5) Over the counter drugs are approved for human use only
by the FDA
THE FOLLOWING IS THE PART OF THE
PACKAGE INSERT FOR RIMADYL…..
Can you identify which section refers to
PHARMACODYNAMICS and which refers to
PHARMACOKINETICS?
CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic, non-steroidal anti-inflammatory
agent with characteristic analgesic and antipyretic activity approximately equipotent to
indomethacin in animal models. The mechanism of action of carprofen, like that of other
NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two
unique cyclooxygenases have been described in mammals. The constitutive cyclooxygenase,
COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal
function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in
inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and
renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The
specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to
species. In an in vitro study using canine cell cultures, carprofen demonstrated selective
inhibition of COX-2 versus COX-1. Clinical relevance of these data has not been shown.
Carprofen has also been shown to inhibit the release of several prostaglandins in two
inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human
rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial
cell system) inflammatory reactions. Several studies have demonstrated that carprofen
has modulatory effects on both humoral and cellular immune responses. Data also indicate
that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and
PGE2 by its inhibitory effect in prostaglandin biosynthesis.
Based upon comparison with data obtained from intravenous administration, carprofen is
rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1–3 hours after oral
administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is
approximately 8 hours (range 4.5–9.8 hours) after single oral doses varying from 1–35
mg/kg of body weight. After a 100 mg single intravenous bolus dose, the mean elimination
half-life was approximately 11.7 hours in the dog. Rimadyl is more than 99% bound to
plasma protein and exhibits a very small volume of distribution. Carprofen is eliminated in
the dog primarily by biotransformation in the liver followed by rapid excretion of the
resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2
phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70–
80%) and urine (10–20%). Some enterohepatic circulation of the drug is observed.
Medical Calculation 1
•
•
•
•
Trade name: ‘Clavamox’
Generic: Amoxicillin-Clavulanic acid
Broad spectrum bacterium
DOSAGE: 13.75 mg/ kg BID PO X 14 days
1) How many tablets for a 15.5 lbs. dog per day
• Concentration: 62.5 mg, 125 mg, 250 mg, 400 mg
tablets
2) How many total tablets dispensed to the owner
References
• Romich, J.A. Pharmacology for Veterinary
Technicians, 2nd edition. 2010.
• Bill, R.L. Clinical Pharmacology and
Therapeutics for the Veterinary Technician, 3rd
edition. 2006.
• http://cpharm.vetmed.vt.edu/vm8784/default
.htm
References
• Dave Sobecki, Allan G. Bluman, Angela
Schirck-Matthews. Math in our World.
McGraw-Hill Companies,Inc. 2010
• http://www.msnbc.msn.com/id/35286379/ns
/health-pet_health/t/when-vets-makemistakes-pets-pay-price/
• http://www.fda.gov/AnimalVeterinary/Resour
cesforYou/ucm214772.htm