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CVM GFI #192 Anesthetics for Companion Animals

FinalCenter for Veterinary Medicine03/25/2010
Compatibility studies

Description

This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals (dogs, cats, and horses). The guidance specifically describes what should be considered while planning and executing safety and field studies for the proposed anesthetic. The guidance also includes recommendations on how to analyze and package the collected data for submission to the Center for Veterinary Medicine (CVM).

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5
Anesthetics for Companion Animals

Scope of the guidance document; Document title and scope of the guidance

general anesthetic drugs

Subject of the guidance recommendations

Injectable Anesthetics

Category of anesthetic requiring specific study designs; should be managed to prevent the risk of diversion

Inhalational Anesthetics

Category of anesthetic requiring specific study designs; Operating rooms and animal recovery areas should be provided with adequate ventilation

Anesthetics

Guidance for companion animal anesthetic drugs

Stakeholders

3
developers

Target audience for the recommendations

Controlled Substance Staff

CSS performs the scientific evaluation of the abuse potential

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

Regulatory Context

Regulatory Activities

4
NADA

New animal drug applications; New Animal Drug Application

Field Effectiveness Studies

Studies to evaluate safety and effectiveness in clinical settings

presubmission conference

Recommended meeting with CVM

Field Effectiveness Study

Evaluates if the anesthetic is safe and effective under actual conditions

Document Types

6
Case Report Forms

Used to delineate dose and timing of administration

Abuse Liability Assessment Package

identify what information should be included

Labeling

Cybersecurity information should be included in device labeling

Package Insert

Labeling information including dosage, administration, and safety sections

Final Study Report

Data presentation requirements; Comprehensive document providing evaluation of study results

Protocol

Defines the standard of veterinary practice and limits for anesthetic regimens

Attributes

3
Anesthetic dose sparing

Reduction in general anesthetic dose when used with preanesthetics

Minimal Alveolar Concentration

standard of comparison for potency of general anesthetics

Dose Sparing Effects

Effects derived from laboratory compatibility studies to be confirmed in field studies

Technical Details

Substances

10
preanesthetics

Drugs used in conjunction with general anesthetics; Drugs administered before anesthesia to prepare the patient

Alpha2-agonist

Preanesthetic drug class mentioned for dose sparing and labeling

anticholinergic medications

Drugs evaluated in compatibility studies

Preanesthetic drugs

Administered to calm, sedate, or provide analgesia before anesthesia

Phenothiazine tranquilizers

Commonly used preanesthetic drug class

Alpha₂-agonists

Commonly used preanesthetic drug class

Opioids

Commonly used preanesthetic drug class

Benzodiazepines

Commonly used preanesthetic drug class; Preanesthetic drug class compatible with proposed anesthetics

Anticholinergics

Commonly used preanesthetic drug class

NSAIDS

Nonsteroidal antiinflammatory drugs excluded from preanesthetic scope here

Testing Methods

5
Laboratory studies

Recommended over field studies for compatibility due to controlled conditions

Compatibility Study

defines safety issues including anesthetic dose sparing effects

Electrocardiogram

Used to measure cardiac rhythm

Blood Gas Analysis

Physiologic variable measuring oxygen, carbon dioxide, and pH

Crossover designs

Study design allowing animals to be used more than once

Processes

3
Exaggerated Dose/Duration Safety Studies

Study to identify adverse reactions and safe upper limits

Compatibility Studies

Studies evaluating anesthetic in conjunction with other drugs

continuous rate infusion

Method of maintaining anesthesia; Method of administering maintenance doses

Clinical Concepts

7
dogs

Target animal species

Bradycardia

Symptoms of human overexposure

Hypotension

Symptoms of human overexposure

Respiratory Depression

Symptoms of human overexposure to vapors

cats

Target animal species

horses

Target animal species

Subpopulations

Juveniles, geriatric animals, or animals with compromised organ function

Identified Hazards

Hazards

3
Arrhythmogenicity

Safety issue for volatile inhalational anesthetics

Lethal ECG Rhythm

Safety concern during anesthesia

Apnea

Adverse respiratory sign defined as >= 120 seconds

Standards & References

External Standards

1
VICH GL43

International standard for target animal safety

Specifications

2
Minimal alveolar concentration

MAC determination for inhalational anesthetics

2 ppm

limit for halogenated anesthetic agents

View on FDA.govDownload PDF

Related CFR Sections (4)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to maintain complete and accurate treatment records
4
Adulteration of an Animal Offered for Human Consumption
3
Failure to maintain treatment records
2
Failure of the study director to assure experimental data are accurately recorded and verified
1
Failure to authorize and document deviations from standard operating procedures
1
QAU failed to assure reported results accurately reflect raw data
1
Failure to assure experimental data were accurately recorded and verified
1
Study director failed to assure protocol compliance and data accuracy
1
Fabrication of animal weight data
1
Failure to maintain a Quality Assurance Unit
1

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

See Also (8)