A Practical Guide to Companion Animal Prescription Drug Labeling

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A Practical Guide to Companion Animal
Prescription Drug Labeling

• the Role of the Center for Veterinary Medicine
  (CVM)

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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 CVMs role in
  new animal drug development, specifically
  focusing on how the knowledge obtained from our
  thorough review process is expressed in the
  product labeling.

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Presentation Overview

• FDA/CVM Background Information
• New Animal Drug Approval Process
• Drugs used in Companion Animal Medicine
• Prescription Drug
• Labeling
• Conclusions
• Case Studies

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FDA

• The Food and Drug Administration (FDA) is a
  federal agency within the Department of Health
  and Human Services.

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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.

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Center for Veterinary Medicine (CVM)
CFSAN
CVM
CDER
FDA
NCTR
CDRH
ORA
CBER
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Center for Veterinary Medicine

• CVM is a consumer protection organization,
  fostering public and animal health.
• CVMs authority is derived from the Federal Food,
  Drug, and Cosmetic Act.

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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.

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New Animal DrugApproval 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.

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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

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Prescription Drug LabelingTopic Overview

• Where does the information in the label come
  from?
• What are some limitations on label information?
• Who writes the label?
• Whats in a label?
• Labels as living
• documents.

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Where does the information in the Label come from?

• Animal Safety
• Effectiveness
• All Other
• Information

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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)

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Effectiveness

• Field effectiveness studies in the target animal
  adequate and well-controlled
• Dose confirmation studies
• Laboratory studies
• - Disease models
• - Target animal
• Pharmacokinetic studies

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All Other Information

• Literature
• Foreign market experience
• Known drug class information
• Human drug approvals
• Post-approval experience

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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.

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Who Writes the Label?

• Labeling language is a collaboration between the
  drug sponsor and CVM to present fair and balanced
  information.

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Whats 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

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Example Package Insert (Suggested Major Headings)

• Indications
• Dosage Administration
• Contraindications
• Warnings
• Precautions
• Adverse Reactions
• Clinical Pharmacology
• Effectiveness
• Animal Safety

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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 pre-approval)
• Duration of treatment treatment interval
• Modifications for special populations

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Example Package Insert

• Contraindication
• Risk of using the drug product outweighs any
  possible benefit
• Usually a proven hazard

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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

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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

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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

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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.

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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.

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Conclusions

• Labels are important living documents that
  contain useful information for daily practice.
• Read and use product labels regularly.
• Report ADEs to sponsors and/or CVM.

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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.

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Case Scenario 1 Buddy
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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?

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Case Scenario 2 Shelby
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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?

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Case Scenario 3 Guzzles

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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?

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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 doesnt 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.

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Case Scenario 4 Rascal
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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 hell act funny again,
  and asks if its okay for her to give him some
  OTC Pepcid to prevent any upset stomach. What is
  your response?

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Questions?
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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/Appr
  ovedAnimalDrugProducts/DrugLabels/ucm050105.htm