Test 2- The label (Dr. K)

Question 1

What is not a veterinary drug?

Answer 1

Ectoparasiticides (fleas, ticks, lice, etc.)

– Unless combined with a drug( Revolution is a drug; frontline is NOT a drug because it’s only for ectoparasites)

Teat dips, cleaning agents, many topical hygiene products

• Vaccines
• Vitamins, herbal products, supplements, etc.

Question 2

Not drugs are regulated by:

Answer 2

These are regulated by:

U.S. Environmental Protection Agency (EPA)

U.S. Department of Agriculture (USDA)

Various state bodies

Not regulated except for manufacturing

Safety primary concern- not as much on effiacacy

Question 3

Veterinary drug

Answer 3

Definition: Products that are used to diagnose, cure, mitigate, treat or prevent diseases

• registered with US food and drug admin.
• A product is a specific formulation of an active substance(s) and has a claim for efficacy and safety at a certain dose in a particular animal- formulation has HUGE IMPACT ON EFFICACY
• The product is safe and effective for its intended use

Question 4

Can you give half of heartguard?

Answer 4

No. If IT IS NOT SCORED, THEN YOU CAN’T BREAK IT IN HALF, THEN THE MEDS COULD ALL BE IN ONE PLACE BECAUSE THE FDA HAS NOT MADE IT TO BE EQUALLY DISTRIBUTED

Question 5

Veterinary drug: requirements

Answer 5

All veterinary drugs MUST be registered with the U.S. FDA

The product is safe and effective for its intended use.

The methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.

Question 6

Veterinary drug: requirements

Dossier 5,000 to 500,000 pages

Answer 6

Public Safety

Environmental Safety

Manufacturing Chemistry

Target Animal Safety (TAS)

Effectiveness

Guidelines available to determine requirements
Meetings held with FDA to discuss studies

Question 7

Product label

Answer 7

FDA and product registration holder negotiate the wording on the label and leaflet

Indication: disease and animal class

Dose and administration

Safety (TAS)

Adverse reactions

Warnings/disposal – Human, environmental and animal

Expiry or stability; storage conditions

Other

Question 8

Product label

Label data are developed from

Answer 8

Safety studies – controlled studies

Adverse reactions that occur during efficacy and field studies

Adverse events that occur post-marketing- BY VETS

Reaction / events are not necessarily related to

the product

More data for some products

More data = better warnings

Too much data = scared of product

Question 9

Efficacy studies

Answer 9

• In vitro studies

• Bioequivalence studies

• Dose-titration/dose-determination
− Lowest dose required for the effect

• Dose-confirmation

− Efficacy for each claim in each animal species for which the product will be used OR Proof of limiting species

− Laboratory or field studies

Question 10

Efficacy definition

Definition is disease dependent

Answer 10

Pain – decreased lameness, decreased vocalization, change in facial expressions, improved mobility

Parasites – decreased worms, decreased eggs in feces

For each indication (disease, parasite), the product at the planned label dose must be shown to be effective

DIFFICULT TO COMPARE SIMLIAR PRODUCTS BECAUSE DEFINATION OF HOW THEY WORK( decreased lameness or increased motility)

Question 11

Efficacy level

Answer 11

Level of efficacy required is disease dependent

Parasiticides – ≥ 90%

All other diseases varies

Substantial evidence

Dose should be the minimum effective*

Can the product be effective for other indications?

Question 12

Efficacy

Fenbendazole Paste 10%

Answer 12

Fenbendazole Paste 10% is indicated for the control of small strongyles (cyathostomes) including encysted early 3rd stage (hypobiotic), late third stage and fourth stage mucosal cyathostome larvae.

need a 90% efficacy

Question 13

Why would a product with lower efficacy be registered?

Answer 13

Different measurements

Different mode of action

Better safety profile

Question 14

Efficacy: What is not on the label

Answer 14

• How efficacy was measured

• Level of efficacy achieved
• Resistance issues
• Other?

The label is a summary- can go to FDA website for more info

Question 15

Target Animal Safety (TAS)

Answer 15

• Tolerance Studies
• Normal, healthy laboratory beagles
• 1x, 3x and 5x dose and length of treatment

• Topical products tested topically and orally
• Maximum recommended dose/Target dose

• Animal Class Safety Study
• Youngest age group for the product

• Reproductive safety (not required
• Special Cases (specific breeds)

• Pharmacokinetics (sometimes)

Question 16

Is the product safe and efficacious when used in non-healthy animals?

Answer 16

• Thin, obese • Long-haired

Heart condition, renal impairment

Different breeds

Field study(ies) Pharmacovigilance (after market)

most studies are done in beagles, so studies are done after market to check other dogs

Question 17

Label – What can be learned?

Answer 17

• Estimate safedose/effectivedose

Estimate how close the safe dose is to the effective dose

Adverse events

Risks regarding age, weight, reproductive status

Question 18

Label – Safe/Effective dose

Answer 18

Exact dose
• one quantity of medication per kg of BW • 1 ml/kg BW
• 1 ml/kg BW = effective dose = safe dose

Dose band- this what you have to pay attention to

one quantity for a range of BW

X mg or X ml for animals X to X kg BW

1 ml for dogs 1-5 kg BW

2 ml for dogs 6-10 kg BW

Question 19

Dose band

Answer 19

Lowest weight used to estimate the maximum safe dose

Highest weight used to estimate the minimum effective dose

Must use all bands

Question 20

Label – Safe/Effective dose

Answer 20

• Do not use in sick, debilitated or underweight animals (see SAFETY).
• For cats ≥ 8 weeks of age.
• A kitten, estimated to be 5–6 weeks old (0.3 kg), died 8 1⁄2 hours after receiving a single treatment of Revolution at the recommended dosage. The kitten displayed clinical signs which included muscle spasms, salivation and neurological signs. The kitten was a stray with an unknown history and was malnourished and underweight
• 0.3 kg = 0.66 lb; 15 mg/0.66 lb = 22.7 mg/lb

Question 21

Do not use..

Answer 21

Something bad happened

Question 22

for use in…..

Answer 22

not tested