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Questions and Answers
What type of toxicology study is conducted during the clinical development phase?
What type of toxicology study is conducted during the clinical development phase?
Which of the following substances can potentially be toxic based on the information provided?
Which of the following substances can potentially be toxic based on the information provided?
During what phase of drug development are acute toxicology studies primarily conducted?
During what phase of drug development are acute toxicology studies primarily conducted?
What does Paracelsus's statement imply about toxins?
What does Paracelsus's statement imply about toxins?
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Which study assesses the potential for a substance to cause cancer?
Which study assesses the potential for a substance to cause cancer?
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What type of toxicity is characterized by predictable effects related to the pharmacological action of a drug?
What type of toxicity is characterized by predictable effects related to the pharmacological action of a drug?
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Which type of toxicity is specifically linked to cumulative effects after prolonged usage of a medication?
Which type of toxicity is specifically linked to cumulative effects after prolonged usage of a medication?
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What is the primary focus of pharmacovigilance?
What is the primary focus of pharmacovigilance?
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An unexpected adverse event is defined as one that is inconsistent with what?
An unexpected adverse event is defined as one that is inconsistent with what?
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What kind of toxic effects can appear upon discontinuation of a drug?
What kind of toxic effects can appear upon discontinuation of a drug?
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Which of the following examples illustrate Type B toxicity?
Which of the following examples illustrate Type B toxicity?
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Cumulative toxicity is most likely associated with which type of medication usage?
Cumulative toxicity is most likely associated with which type of medication usage?
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What is one of the responsibilities associated with pharmacovigilance?
What is one of the responsibilities associated with pharmacovigilance?
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What is the potential consequence of a dog ingesting chocolate?
What is the potential consequence of a dog ingesting chocolate?
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Which of the following is a common source of poisoning in dogs?
Which of the following is a common source of poisoning in dogs?
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When should emetics be used after poisoning?
When should emetics be used after poisoning?
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Which medication is NOT a dopamine agonist used to induce vomiting in dogs?
Which medication is NOT a dopamine agonist used to induce vomiting in dogs?
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What should be avoided when inducing vomiting in case of poisoning?
What should be avoided when inducing vomiting in case of poisoning?
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What is the most effective timing for administering activated charcoal?
What is the most effective timing for administering activated charcoal?
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What is the potential outcome of a dog consuming grapes or raisins?
What is the potential outcome of a dog consuming grapes or raisins?
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Which condition is NOT typically associated with antifreeze poisoning?
Which condition is NOT typically associated with antifreeze poisoning?
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What is defined as the dose that will kill 50% of the test population?
What is defined as the dose that will kill 50% of the test population?
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Which of the following best describes a serious adverse event?
Which of the following best describes a serious adverse event?
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What differentiates acute toxicity from chronic toxicity?
What differentiates acute toxicity from chronic toxicity?
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In what situation can toxicity occur during normal use of medicines?
In what situation can toxicity occur during normal use of medicines?
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Which of the following is NOT considered an adverse event?
Which of the following is NOT considered an adverse event?
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What is a common result of chronic toxicity?
What is a common result of chronic toxicity?
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An adverse event can occur after which types of medicine usage?
An adverse event can occur after which types of medicine usage?
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Which term is used to describe diseases that occur at the same time as a serious adverse reaction?
Which term is used to describe diseases that occur at the same time as a serious adverse reaction?
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What does LD50 represent in toxicology?
What does LD50 represent in toxicology?
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Which statement accurately defines a serious adverse event?
Which statement accurately defines a serious adverse event?
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Which type of toxicity results from a single or short-term exposure to a substance?
Which type of toxicity results from a single or short-term exposure to a substance?
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What distinguishes chronic toxicity from acute toxicity?
What distinguishes chronic toxicity from acute toxicity?
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Adverse Drug Reactions (ADRs) can occur during which of the following situations?
Adverse Drug Reactions (ADRs) can occur during which of the following situations?
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Which of the following is NOT a reason why toxicity might occur during normal medication use?
Which of the following is NOT a reason why toxicity might occur during normal medication use?
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Which approach should be taken when dealing with a suspected adverse event?
Which approach should be taken when dealing with a suspected adverse event?
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What is the primary role of regulators concerning 'Adverse Event' definitions?
What is the primary role of regulators concerning 'Adverse Event' definitions?
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Study Notes
Fundamentals of Toxicology
- All substances are poisons; the right dose differentiates a poison from a remedy - Paracelsus (1493-1541)
Learning Outcomes
- Define lethal dose, adverse event, and serious adverse reaction
- Differentiate acute from chronic toxicity
- Describe situations where toxicity may occur (e.g., during medicine development, adverse events, poisoning)
- Explain why toxicity might occur during normal medicine use
- Describe how to deal with a suspected adverse event and make an official report
Pre-read - Key points
- Lethal dose (LD50): The dose that kills 50% of a test population.
- Adverse Drug Reaction/Event: Any harmful or undesirable response to a drug.
- Adverse events are any observations in animals, whether or not considered to be product related, that are unfavorable and unintended and that occur after any use of a Veterinary Medicinal Product (VMP) – off-label and on-label uses.
- A serious adverse event is any adverse event which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect.
- Acute toxicity: Results from a single dose or multiple doses in a short time period (usually within 14 days).
- Chronic toxicity: Develops from long-term exposure. Toxic effects are cumulative.
Novel Drug Development
- Discovery phase: in vitro toxicology studies (e.g., Ames).
- Pre-clinical development: Acute toxicology studies (1-4 weeks, high dose), reprotoxicology studies.
- Clinical development: Chronic toxicology studies (3-6 months, low-intermediate dose); carcinogenicity studies (2 years, low dose).
Sources of Toxins
- Plants
- Animals
- Fungi
- Inorganic material
- Drugs and medicines
- Pesticides
- Household chemicals
- Industrial chemicals
Common Sources of Poison
- Xylitol (hypoglycemia)
- Grapes and raisins (renal failure)
- Chocolate (CNS/renal failure/arrhythmias)
- Sycamore (atypical myopathy)
- Rat poison (hemorrhage)
- Mycotoxins (convulsions/coma)
- Antifreeze (ataxia/tremors/PU/PD)
- Medicines (renal/liver failure, adder bites, etc.)
Theobromine in Chocolate
- 200g chocolate bar: ~1g theobromine
- Dogs at risk: All
- Dairy milk: ~400mg theobromine
- Dogs at risk: ≤ 20kg, but err on side of caution
- Milkybar: ~2mg theobromine
- Dogs at risk: None
Veterinary Poisons Information Service
- Website: https://www.vpisglobal.com/
Emetics
- Used primarily to induce vomiting after poisoning.
- Only useful if initiated within 2-3 hours of ingestion.
- Do not induce vomiting if the poison is corrosive, causes severe CNS depression, seizures, reduced gag reflex, or bradycardia.
- Examples: apomorphine, ropinirole, xylazine, hydrogen peroxide 3%
Decontamination
- Activated charcoal: Adsorbant, most effective within 1 hour of ingestion. Only adsorbs toxins in the liquid phase.
- Gastric lavage: A method of decontamination.
Toxicity During Normal Medicine Use
- Type A: Augmented - Predictable, related to the pharmacological action (e.g., bleeding with anticoagulants). Dose-dependent, more common.
- Type B: Bizarre - Unrelated to the pharmacological action (e.g., hypersensitivity reaction).
- Type C: Chronic - Cumulative toxicity after prolonged use.
- Type D: Delayed - Teratogenic or carcinogenic effects.
- Type E: End of use - Toxic effects appear when the drug is stopped.
Hypersensitivity Reactions
- Type I: Allergic anaphylaxis and atopy
- Type II: Antibody
- Type III: Immune complex
- Type IV: Delayed
Reporting Adverse Events
- Necessary information: identified reporter, details of the affected animal or human, the product concerned, details of the suspected adverse reaction.
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Description
Explore the key principles of toxicology, including the definitions of lethal dose, adverse events, and serious adverse reactions. Understand the distinctions between acute and chronic toxicity, and learn about the circumstances surrounding toxicity during medicine use and development. This quiz will help you grasp essential concepts necessary for addressing and reporting adverse events.
