Canine NSAIDs and Client Education An FDA Perspective Dr

1
Canine NSAIDs and Client Education

• An FDA Perspective
• Dr. Amy Omer, Dr. Barbara Leotta, and Dr. Michele
  Sharkey
• Center for Veterinary Medicine

2
The Food and Drug Administration

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

3
FDA

• 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.

4
Who are we?
5
CVM

• FDAs Center for Veterinary Medicine (CVM) is a
  consumer protection organization.
• We foster public and animal health by approving
  safe and effective products for animals and by
  enforcing other applicable provisions of the
  Federal Food, Drug, and Cosmetic Act and other
  authorities.

6
What We Do

• The Center for Veterinary Medicine is responsible
  for animal drug approval as well as post-approval
  monitoring of marketed animal drugs to assure
  continuing safety and effectiveness.

7
How are veterinary drugs approved?

• Pharmaceutical companies decide, based on
  marketability, need, economics, etc., to pursue
  development of a drug.
• CVM does not propose products or label
  indications.

8
How are veterinary drugs approved?

• Pharmaceutical companies conduct the necessary
  research to support drug safety and
  effectiveness.
• Data is submitted to CVM and scientifically
  reviewed.
• CVM determines if data demonstrates the drug is
  safe and effective when used as directed on the
  label.

9
How are veterinary drugs approved?

• Pre-approval studies for veterinary drugs
  generally include fewer subjects than those
  conducted for human drug development.

10
How are veterinary drugs approved?

• For companion animals
• Pre-approval safety studies are almost
  exclusively performed in young, healthy animals
  (generally 32 animals).
• Pre-approval effectiveness studies are generally
  performed in healthy, client-owned animals.

11
How are veterinary drugs approved?

• Pre-testing by the manufacturer and review of
  the data by the government does not guarantee
  absolute safety and effectiveness of approved
  veterinary drugs due to the inherent limitations
  imposed by testing the product on a limited
  population of animals.
• -CVMs Adverse Drug Experience Reporting
  Webpage

12
What are NSAIDs?

• Nonsteroidal anti-inflammatory drugs (NSAIDs)
  reduce prostaglandins throughout the body by
  inhibiting the enzyme cyclooxygenase (COX).
• Cyclooxygenase catalyzes the formation of
  prostaglandins from arachidonic acid.

13
Kurie, J. M. et al. Clin Cancer Res 200172608-26
14
How NSAIDs Work

• Prostaglandins have several important functions
• promote inflammation, pain, and fever
• support the function of platelets
• protect the lining of the stomach from the
  damaging effects of acid
• play a role in renal homeostasis

15
What NSAIDs Do

• As a consequence, ongoing inflammation, pain,
  and fever are reduced.

• BUT ..
• There is a risk of gastrointestinal bleeding,
  ulcers, perforations, and in rare cases kidney
  damage and liver problems.

16
Why talk about NSAIDs?

• NSAIDs
• are the most commonly prescribed veterinary
  analgesics.
• account for the largest amount of Adverse Drug
  Events (ADEs) reported to CVM.
• Newer human NSAIDs (COX-2 selective) have been
  shown to be safer on the GI system NOT the case
  in veterinary medicine.
• Based on CVM ADE database.

17
Approved NSAIDs

• To date, NSAIDs for use in dogs have been
  approved for two indications
• Osteoarthritis
• Postoperative pain (ortho /or soft tissue)

18
Approved NSAIDs

• Consider the risk factors commonly associated
  with these two populations of patients
• Osteoarthritis? geriatric population ? underlying
  concomitant diseases (hepatic/renal disease)
• Postoperative ? hydration status ? potential for
  compromised renal function

19
Approved NSAIDs

• Veterinary NSAIDs approved for use in dogs
• ETOGESIC (etodolac)
• RIMADYL (carprofen)
• METACAM (meloxicam)
• DERAMAXX (deracoxib)
• PREVICOX (firocoxib)
• ZUBRIN (tepoxalin)
• NOVOX (carprofen)
• VETPROFEN (carprofen)

20
Recently Approved Veterinary NSAIDs

21
Approved NSAIDs

• In the United States, there are no veterinary
  NSAIDs approved for oral use in cats.
• Cats have a reduced ability to metabolize NSAIDs
  compared to other species.

22
NSAIDs Benefits

• The approved NSAIDs provide a tremendous amount
  of good to our canine patients.
• NSAIDs offer pain relief and improved quality of
  life to many dogs.
• NSAIDs contribute to the effective management of
  postoperative pain.

23
NSAIDs Risks

• Risks are associated with the use of any drug.
• All veterinary NSAIDs have inherent risks.
• CVM strives to promote the safe and effective use
  of NSAIDs by painstakingly crafting drug labels,
  including Client Information Sheets (CISs).
• CISs are intended to be dispensed to clients with
  each NSAID prescription.

24
NSAIDs Signs of Toxicity

• As a class, NSAIDs are associated with
  gastrointestinal, renal and hepatic toxicity.
• The four most commonly reported adverse events
  are vomiting, anorexia, depression, and diarrhea.
  
• Others include gastric ulceration, intestinal
  ulceration, renal failure, hepatic failure, and
  death.

25
Adverse Drug Events (ADEs)

• Adverse drug experience is any adverse event
  associated with the use of a new animal drug,
  whether or not considered to be drug related, and
  whether or not the new animal drug was used in
  accordance with the approved labeling. -21 CFR
  514.3

26
Adverse Drug Events (ADEs)

• ADEs are voluntarily reported by veterinarians,
  pet owners, and others to the drug company and/or
  CVM.
• Companies are required to report all ADEs to CVM.
  
• ADEs are stored in CVM's database and analyzed by
  clinical veterinarians.

27
Why You?

• Technicians often prepare drug prescriptions.
• Even when clients have heard the benefits and
  risks of NSAIDs from the veterinarian, hearing it
  again from you will increase their understanding.

28
What You Can Do

• Technicians can ensure that the Client
  Information Sheets are included with each NSAID
  prescription.
• Technicians are often in charge of ordering.
  Technicians can request CISs from the drug
  representative or distributor.

29
What You Need To Know

• Many ADEs may be prevented or treated
  successfully through better understanding of
  these drugs and good client communication.
• Educate Yourselfon the safe use of NSAIDs, the
  benefits/risks, and the potential ADEs.
• Educate Your Clientsso they can recognize
  potential ADEs, stop using the drug, and seek
  immediate veterinary care.
• Report ADEs associated with any drug.

30
Educate Yourself

• Labels Package Inserts contain important
  information, including
• Indications Usage
• Dosage Administration
• Contraindications
• Warnings
• Precautions
• Adverse Reactions
• Post Approval Experience

31
Educate Yourself

• Extralabel Use (ELU) veterinarians may prescribe
  certain approved animal drugs, including NSAIDs,
  for use in animals that is not in accordance with
  the approved label directions, in the context of
  a veterinarian-client-patient relationship. -The
  Animal Medicinal Drug Use Clarification Act of
  1994 (AMDUCA)
• ELU has not been tested and clients should be
  informed of ELU.

32
Educate Your Clients Communication is Key!

• Written Communication
• Labels Client Information Sheets
• are part of labeling for FDA-approved oral
  NSAIDs.
• provide information written specifically for pet
  owners.
• should be provided by pharmaceutical companies
  with your drug order.
• should be sent home with each NSAID prescription
  to provide an easy reference for clients after
  they leave your clinic.

33
Educate Your Clients Communication is Key!

• Verbal Communication
• Face-to-Face conversations with your clients can
  reinforce the information provided to them by the
  veterinarian, and included in the Client
  Information Sheet.
• Explain the potential benefits and risks.
• Describe the signs of possible adverse reactions
  to the drug.
• Tell your clients what to do if they notice any
  of these signs STOP THE DRUG and CONTACT THEIR
  VETERINARIAN.

34
REPORT

• Options
• Report any ADEs to the pharmaceutical company.
• Toll-free number on the label.
• Report any ADEs directly to the Center for
  Veterinary Medicine if necessary.
• 1-888-FDA-VETS

35
(No Transcript)
36
5 Take Home Points

• Benefits/Risks are associated with any drug.
• Know the signs of NSAID toxicity so you can
  educate your clients. Client communication is
  key.
• Provide CIS with each NSAID prescription.
• Problems Stop the drug Call your Veterinarian.
• Report ADEs.

37
Further Information

• Center for Veterinary Medicine (CVM) Website
• http//www.fda.gov/cvm/default.html
• Veterinary NSAID specific information
• http//www.fda.gov/cvm/nsaids.htm
• Free NSAIDs Brochure www.pueblo.gsa.gov
• 503R Keeping Your Best Friend Active, Safe,
  and Pain Free http//www.pueblo.gsa.gov/cic_text/m
  isc/dog/treatdog.htm
• Current Labels
• http//www.fda.gov/cvm/currentlabels.html
• May 2008