Transcript A Practical Guide to Companion Animal

A Practical Guide to
Companion Animal
Prescription Drug Labeling;
& the Role of the Center for
Veterinary Medicine (CVM)
Overall Goals
To illustrate the importance of product labeling.
To explain the process of creating a label.
To show how labeling information can be used in
the clinical setting.
To increase the understanding of CVM’s role in
new animal drug development, specifically
focusing on how the knowledge obtained from
our thorough review process is expressed in the
product labeling.
Presentation Overview
FDA/CVM Background Information
New Animal Drug Approval Process
Drugs used in Companion Animal
Medicine
Prescription Drug
Labeling
Conclusions
Case Studies
FDA
The Food and Drug Administration
(FDA) is a federal agency within
the Department of Health and
Human Services.
FDA
….is responsible for ensuring that:
foods are safe, wholesome and sanitary
human and veterinary drugs, biological
products, and medical devices are safe and
effective
cosmetics are safe
electronic products that emit radiation are
safe
products are honestly, accurately and
informatively represented to the public.
Center for Veterinary Medicine
(CVM)
CFSAN
CVM
CDER
FDA
CDRH
NCTR
ORA
CBER
Center for Veterinary Medicine
CVM is a consumer protection
organization, fostering public and
animal health.
CVM’s authority is derived from the
Federal Food, Drug, and Cosmetic Act.
Center for Veterinary Medicine
CVM is responsible for ensuring that
animal drugs and medicated feeds are
safe and effective for their intended uses
and that food from treated animals is
safe for human consumption.
CVM monitors the use of marketed
products through surveillance and
compliance programs.
New Animal Drug
Approval Process
Pharmaceutical companies (drug sponsors)
conduct the necessary research to support
drug safety and effectiveness.
Data is submitted to CVM and reviewed from
a scientific and regulatory perspective.
CVM determines if data demonstrates the
drug is safe and effective when used as
directed on the label.
Drugs Used in Companion
Animal Medicine
FDA-approved new animal drugs –
pioneer and generic
Extralabel use of approved new animal
drugs
Extralabel use of approved human
drugs
Prescription Drug Labeling
Topic Overview
Where does the information in the label
come from?
What are some limitations on label
information?
Who writes the label?
What’s in a label?
Labels as “living”
documents.
Where does the information in
the Label come from?
Animal Safety
Effectiveness
All Other
Information
Animal Safety
Target animal safety (TAS) studies – multiple
levels of exposure to mimic the potential
adverse effects in the general population
Specialized studies or tests:
- Collie safety studies
- Ocular studies
- GI endoscopy
Field safety – effectiveness studies and use
studies (open-label)
Effectiveness
Field effectiveness studies in the target
animal – adequate and well-controlled
Dose confirmation studies
Laboratory studies
- Disease models
- Target animal
Pharmacokinetic studies
All Other Information
Literature
Foreign market experience
Known drug class information
Human drug approvals
Post-approval experience
What are some Limitations on
Label Information?
Pre-approval studies for veterinary drugs include
fewer subjects than those conducted for human drug
development.
For companion animals:
Pre-approval safety studies are almost exclusively
performed in young, healthy animals.
Pre-approval effectiveness studies are generally
performed in healthy, client-owned animals.
Who Writes the Label?
Labeling language is a collaboration
between the drug sponsor and CVM to
present fair and balanced information.
What’s in a Label?
Main Labeling Components:
Package Insert
- Written for veterinarians
- Useful information for daily
practice
Client Information Sheet
- Written for owners
- Accompany certain new animal drugs
- Should be dispensed with each prescription
Bottle/Vial/Outer Box Labeling
Example Package Insert
(Suggested Major Headings)
Indications
Dosage & Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Clinical Pharmacology
Effectiveness
Animal Safety
Example Package Insert
Indications:
- Lists the specific disease(s) or condition(s)
for which the drug product is approved
Dosage & Administration:
- Recommended dose (dose studied in preapproval)
- Duration of treatment & treatment interval
- Modifications for special populations
Example Package Insert
Contraindication:
- Risk of using the drug product outweighs
any possible benefit
- Usually a proven hazard
Example Package Insert
Warnings:
- Includes user safety, human food safety,
animal safety & environmental safety
- May include warnings related to
extralabel use
- Boxed warnings –
potential risk of death
or serious injury
Example Package Insert
Precautions:
- Information that does not warrant a
warning or contraindication statement, but
needs to be communicated for the safe and
effective use of the drug
- Tests recommended prior to use
- Examples: drug interactions, statements
regarding subgroups in which the drug
has not been tested
Client Information Sheets
Written for pet owners
Contain important information
regarding what pet owners should
expect when using drugs, and what side
effects to look for
Labels as “Living” Documents
Labeling language updated based on
post-marketing experience, including
Adverse Drug Experiences (ADEs)
Sponsor-initiated updates, including
manufacturing changes, new tablet
sizes, etc.
Adverse Drug Experiences
(ADEs)
ADEs are voluntarily reported by
veterinarians, pet owners, and others to
the pharmaceutical company or CVM.
Companies are required to report all
ADEs to CVM.
Conclusions
Labels are important “living”
documents that contain useful
information for daily practice.
Read and use product labels regularly.
Report ADE’s to sponsors and/or CVM.
Case Studies
The following case studies are not intended to guide or dictate the
practice of veterinary medicine. They are simply meant as
examples of the information that can be found on the labeling of
FDA-approved animal drugs, and how that information can be
used on a daily basis.
Case Scenario #1 – Buddy
Case Scenario #1- Questions
1. Do you need any other history before deciding to
prescribe firocoxib?
2. Should you perform any other exams/evaluations
before prescribing firocoxib?
3. What toxicities are associated with NSAIDs?
4. What clinical signs warrant the discontinuation of
firocoxib?
5. Can you use this drug in pregnant horses? Foals?
6. What was the highest dose of firocoxib tested in the
studies performed to support approval?
7. At what dose is firocoxib approved?
8. What should you give to the owner in addition to the
tubes of EQUIOXX paste?
Case Scenario #2 – Shelby
Case Scenario #2 - Questions
1. What is the mechanism of action?
2. What is the dose and route?
3. What are the known side effects?
4. What are the contraindications for use? What are
the precautions for use?
5. What, if any, medications are allowed concurrently?
Not allowed concurrently?
6. What should be done if a dog vomits after
administration?
7. Is there a maximum duration of administration?
8. What should be done in an acute overdose situation?
Case Scenario #3 – Guzzles
Case Scenario #3 - Questions
1. What is the chemical name of the drug?
2. How do you know that the VETORYL you have just taken off the
clinic shelf has been FDA approved?
3. Your clinic carries two sizes of VETORYL. Which bottle will you
select?
4. Which area of the dosing table will you focus on in order to
calculate the starting dose?
5. Where will you look to check for follow-up instructions and
testing?
6. The owner is really anxious to eliminate the excessive water
drinking, urination, and food thievery. Is there a place on the
label that gives a guideline for when she can expect to see
improvement?
Case Scenario #3 –
Questions (continued)
7. The owner is very concerned about side effects on “Guzzles”
from this medication. Where would you look on the label to
give her this information?
8. The owner wants to know if there are any special storage
instructions for this medication. Where can you find this
information to let her know?
9. There are small children in the house, and Mrs. Jones is always
worried about what they will get into (boys will be boys)…She
is also excited to tell you that she is pregnant again! What can
you tell her about precautions for humans?
10. Does the medication need to be given with food? If Guzzles
decides she doesn’t want to take the pill, can Mrs. Jones mix the
powder from the capsules into the food?
11. Mrs. Jones wants to know if she can still give Heartgard Plus
and Frontline Plus.
Case Scenario #4 –
Rascal
Case Scenario #4 - Questions
1. Which antibiotic would you prescribe, and
why?
2. What dose would you choose?
3. What possible adverse effects would you
warn the owner to watch for, based on your
choice of treatment?
4. The owner is worried he’ll act “funny” again,
and asks if it’s okay for her to give him some
OTC Pepcid to prevent any upset stomach.
What is your response?
Questions?
Online Resources
Center for Veterinary Medicine (CVM):
http://www.fda.gov/AnimalVeterinary/default.htm
How to report an ADE:
http://www.fda.gov/AnimalVeterinary/SafetyHealth
/ReportaProblem/ucm055305.htm
Currently approved labels for companion
animal NSAIDs:
http://www.fda.gov/AnimalVeterinary/Products/Ap
provedAnimalDrugProducts/DrugLabels/ucm05010
5.htm