B6093 - FARMACOLOGIA, TOSSICOLOGIA E ECOTOSSICOLOGIA

Learning outcomes

By the end of the course, students will have gained an understanding of the kinetics, mechanisms of action, toxicity, regulatory aspects, and pharmacological categories of veterinary drugs used in aquatic species, as well as the main contaminants in aquatic environments. Students will possess knowledge regarding various pharmaceutical formulations and different routes of administration; the kinetics, mechanisms of action, and toxicity of xenobiotics (drugs and toxins); be familiar with the different categories of drugs used in aquaculture; the kinetics, dynamics, and symptomatology of toxins of interest to the aquatic environment; and be familiar with sampling methods for toxicological diagnosis. Students will acquire knowledge regarding the effects of major contaminants in the aquatic environment on various systems, with particular regard to the immune and endocrine systems. They will also acquire knowledge of the main analytical methods applied in ecotoxicology and the types of tests used to assess the effects of xenobiotics. Students will also gain knowledge regarding the main toxicological risks posed by the presence of drug residues and substances toxic to humans. In particular, they will be able to: draft an experimental protocol for determining the withdrawal period; understand the basic principles, both theoretical and practical, of the analytical screening and confirmatory methods required by the National Residue Plan; and be familiar with the main mandatory regulations. Upon completion of the course, the student is able to conduct a toxicological risk analysis of the pollutants most commonly found in the environment, including the use of specific computer tools. The student is also able, independently, to address issues and apply the knowledge acquired regarding the main mandatory and voluntary standards related to the safety, quality, traceability, and labeling of food of animal origin.

Course contents

Specific Course Prerequisites

To better understand the course content, it is recommended that students have prior knowledge of:

• the physiology of aquatic organisms (Prerequisites for the course);
• microbiology and pathology of aquatic animals;
• principles of general chemistry and biochemistry;
• basics of aquatic ecology;
• principles of fish production hygiene.

The course is organized into five integrated teaching modules and uses four longitudinal case studies (Trota 2027, Filetto 2030, Laguna Blu, and Aquafutura) to promote integration between pharmacology, toxicology, ecotoxicology, food safety, and risk management.

MODULE 1 Fundamentals of Pharmacology

Case Study: Trout 2027

Total module hours: 8

• Veterinary pharmacology and the professional role of the graduate (1 hour)
• Pharmacokinetics in aquatic organisms (3 hours)
• Pharmacodynamics and dose-response relationship (2 hours)
• Routes of administration and treatment management (2 hours)

MODULE 2 Veterinary Pharmacology Applied to Aquaculture

Case Study: Trout 2027

Total for module: 11 hours

Antimicrobials in Aquaculture (2 hours)

PK/PD and Treatment Failure (2 hours)

Antibiotic Resistance and Stewardship (2 hours)

Antiparasitics and Sanitary Treatments (2 hours)

Anesthetics and sedatives (2 hours)

Vaccines and immunoprophylaxis (1 hour)

Integrated activities

• Progressive analysis of the Trout 2027 case
• Interpretation of antibiograms
• Discussion of treatment scenarios
• Stewardship planOutput
• Reasoned treatment plan
• Analysis of treatment failure
• Stewardship plan

MODULE 3 Veterinary Toxicology and Food Safety

Case Study: Filetto 2030

Total module hours: 12

• Principles of toxicology (2 hours)
• Toxicokinetics and toxicodynamics (2 hours)
• Heavy metals and inorganic contaminants (2 hours)
• POPs, PFAS, and emerging contaminants (2 hours)
• Marine biotoxins (2 hours)
• Pharmaceutical residues and food safety (2 hours)

Integrated activities

• Interpretation of analytical results
• Reading analytical certificates
• Analysis of the Filetto 2030 case
• Consumer risk assessmentOutput
• Technical food safety report
• Checklist for interpreting analytical data

MODULE 4 Aquatic Ecotoxicology

Case Study: Laguna Blu

Total module hours: 10

• Introduction to ecotoxicology (2 hours)
• Environmental fate of contaminants (2 hours)
• Bioaccumulation and biomagnification (2 hours)
• Ecotoxicology of veterinary drugs (2 hours)
• Environmental risk assessment, One Health, and EAS-E (2 hours)

Integrated Activities

• Analysis of the Laguna Blu case
• Construction of risk matrices
• Interpretation of EAS-E dashboards
• Application of the Environmental Risk Assessment frameworkOutput
• Environmental Risk Assessment
• One Health analysis
• Mitigation plan

MODULE 5 Regulation, Quality, and Governance

Case Study: Aquafutura

Total module hours: 8

• Regulation (EU) 2019/6 and management of veterinary medicines (2 hours)
• Residues, official controls, and non-compliance (2 hours)
• Audits, quality systems, and document management (2 hours)
• Integrated professional simulation and case study discussion (2 hours)

Integrated activities

• Audit simulation
• Non-compliance analysis
• Professional Board Meeting
• Final Aquafutura Case Study Output
• Audit Report
• Integrated Improvement Plan
• Reasoned Professional Decision

ONE HEALTH COURSE

Students will be required to complete an online course (asynchronous learning) on One Health and upload the certificate obtained to the Virtual Platform. Completion of the course is considered part of the coursework and the final exam.

Students will be required to complete a Student Workbook, which will count as bonus points toward the exam.

STUDENT WORKBOOK

Several practical activities are included as an integral part of the Workbook and will be completed progressively throughout the semester.

Part A

Trout 2027

Part B

Fillet 2030

Part C

Blue Lagoon

Part D

Aquafutura

Transversal Skills

The educational activities promote the development of:

· problem-solving skills;

· risk assessment;

· critical interpretation of scientific data;

· technical and scientific communication;

· collaborative work;

· decision-making skills in complex professional contexts.

Readings/Bibliography

Course materials are available on the Virtual Platform (https://virtuale.unibo.it/).

Required Reading

• Riviere J.E., Papich M.G., Veterinary Pharmacology and Therapeutics.
• Gupta R.C. (Ed.), Veterinary Toxicology: Basic and Clinical Principles.
• Course materials, case studies, and documentation provided by the instructor.

Further Reading

• Walker C.H., Sibly R.M., Hopkin S.P., Peakall D.B., Principles of Ecotoxicology.
• FAO, Responsible Use of Veterinary Medicines in Aquaculture.
• FAO, One Health Learning Program.
• EFSA, EMA, and WOAH documents related to aquaculture, food safety, and environmental risk assessment.

Teaching methods

The course consists of lectures and practical sessions.

The following methods will be used:

• lectures;
• guided discussion of case studies;
• problem-based learning;
• guided exercises;
• interpretation of pharmacological, toxicological, and ecotoxicological data;
• application of risk assessment frameworks;
• Student Workbook;
• Case Study Book;
• Handbook One Health + EAS-E application;
• self-assessment quizzes.

The teaching methods used promote active learning and the application of knowledge to real-world professional contexts.

With regard to safety in the learning environment, the course does not include activities in biology or chemistry laboratories. Any seminar activities held at external facilities will be conducted in accordance with the guidelines of the degree program.

Assessment methods

The assessment consists of a single written exam.

Bonus points (1 additional point each toward the final grade) will be awarded for completing the Student Book—which must be submitted at least 15 days before the exam date—and for completing the One Health Course (the certificate obtained must be uploaded to virtuale.unibo.it).

Student Books submitted less than 15 days before the exam will not be evaluated.

Written Exam

The final exam is designed to assess not only the theoretical knowledge acquired during the course, but above all the student’s ability to apply it to realistic professional contexts, integrating veterinary pharmacology, toxicology, ecotoxicology, food safety, regulations, quality, and the One Health approach.

Duration

90 minutes

Exam Structure

The exam consists of the analysis and discussion of two integrated professional case studies.

Each case presents a realistic scenario drawn from the field of aquaculture and may include:

• health issues;
• pharmacological data;
• analytical results;
• toxicological elements;
• environmental challenges;
• regulatory aspects;
• quality and governance issues.

Students must develop a structured and well-reasoned response, demonstrating their ability to integrate the various skills developed during the course.

Professional Case 1 

The first case will generally focus on aspects of:

• veterinary pharmacology;
• treatments;
• pharmacokinetics and pharmacodynamics;
• antibiotics and stewardship;
• toxicology and food safety.

The student must:

• identify the critical issues;
• interpret the available data;
• assess the possible risks;
• propose a well-reasoned management strategy.

Professional Case 2 

The second case will generally focus on aspects of:

• ecotoxicology;
• One Health;
• environmental risk assessment;
• quality;
• audits;
• governance;
• continuous improvement.

The student must:

• analyze the problem from a systemic perspective;
• identify the connections between animal health, the environment, and food safety;
• apply the principles of risk assessment;
• propose corrective and preventive actions.

Assessment Criteria

The assessment will take into account:

Data Analysis

Ability to identify relevant information and interpret it correctly.

Interdisciplinary Integration

Ability to connect pharmacology, toxicology, ecotoxicology, regulations, and quality.

Risk Assessment

Ability to recognize and discuss health, environmental, and food risks.

Quality of the Proposed Decision

Ability to formulate realistic, coherent, and technically sound strategies.

Scientific Argumentation

Ability to justify one’s conclusions using the concepts learned during the course.

Required Approach

Answers should not be limited to describing individual topics but must demonstrate the ability to address the problem in an integrated manner.

Students are encouraged to consider, where relevant:

• veterinary pharmacology;
• PK/PD;
• antimicrobial stewardship;
• vaccination;
• toxicology;
• food safety;
• residues;
• ecotoxicology;
• bioaccumulation and biomagnification;
• One Health;
• current regulations;
• audits and quality systems;
• risk management;
• corporate governance.

Additional Points

Up to 2 additional points may be earned:

Student Workbook

+1 point

awarded to students who complete and submit the Student Workbook according to the instructions provided during the course.

One Health Program

+1 point

awarded to students who complete the supplementary One Health training program.

Purpose of the Exam

The exam is designed to simulate the type of reasoning required of an aquaculture professional.

It assesses not only the ability to recall information, but above all the ability to:

• interpret data;
• manage complex situations;
• assess risks;
• make well-reasoned decisions;
• integrate animal health, food safety, the environment, and sustainability in accordance with One Health principles.

Teaching tools

· PowerPoint presentations.

· Student Workbook.

· Case Study Book.

· One Health + EAS-E Handbook.

· Formative quizzes.

· Professional case studies.

· Materials available online.

Generative AI can be used to support independent study, in-depth learning, and self-assessment, provided it is used critically and thoughtfully.

Office hours

See the website of Annalisa Zaccaroni