Postgraduate School of Clinical Pharmacology and Toxicology

Integrated training objectives (i.e. common core)
The trainee must have acquired knowledge of physiopathology, functional and instrumental semiotics and therapeutic monitoring in the field of internal medicine, neurological and psychiatric, pediatric, obstetric-gynecological and medical specialist diseases essential for the preparatory training of the specialists of the class for the diagnostic and therapeutic objectives of the pathological conditions of interest of the individual types of specialization, through the use of teachings pertaining to the relevant scientific-disciplinary sectors

Basic training objectives
Acquisition of essential knowledge and methodologies for the interpretation and evaluation of responses to pharmacotherapeutic treatments based on the pharmacodynamic, pharmacokinetic and pharmaceutical characteristics of the drugs used.
Acquisition of skills on the cellular, biochemical and molecular bases of the action of drugs and toxicants and their interactions within the human body, as well as the interactions of drugs and toxicants with food.
Acquisition of skills in statistical and epidemiological methodologies for the evaluation of drug utilization, pharmacoeconomics and pharmacovigilance.
Knowledge of the clinical pharmacology of the most commonly used drugs, their interactions, adverse effects and cost/benefit ratio; competence for the diagnosis and treatment of the most common poisonings and overdose of psychotropic drugs and substances of abuse.
Acquisition of essential knowledge and methodologies for the interpretation and evaluation of responses to pharmacotherapeutic treatments on the basis of the pharmacodynamic, pharmacokinetic and pharmaceutical characteristics of drugs and other active ingredients.
Acquisition of skills on the cellular, biochemical and molecular bases of the action of the various classes of active ingredients and their interactions within the human organism and in particular at the level of organs and districts and at the cellular and sub-cellular level, as well as the interactions of the various classes of active ingredients with food.
Acquisition of skills in statistical and epidemiological methodologies for drug utilization, pharmacoeconomics and pharmacovigilance evaluations.

The Specializing in Pharmacology and Clinical Toxicology must:
- Acquire the basic theoretical knowledge, technical ability and aptitudes necessary to appropriately address, according to national and European standards, the general clinical situations that are reflected in human pathologies of toxic origin;
- Know the monitoring methods and the functioning of the related instruments;
- Learn the scientific bases and the physiopathological correlates of the states that concern general intensive care medicine, pain therapy and hyperbaric therapy;
- Acquire the theoretical bases and techniques necessary to evaluate toxic damage, not only in adults, but also at maternal-fetal and pediatric levels and in elderly subjects;
- Acquire knowledge of the biochemical, pharmacological, physiopathological and psychological and medico-legal correlates of addictions to substances of abuse, including alcohol-related syndromes of toxicological relevance;
- Acquire the fundamental notions to be able to participate in controlled clinical studies according to the rules of good clinical practice, in epidemiological investigations, in chemical risk assessment studies and in toxicological consultations conducted in poison control centers;
- Learn the regulatory aspects and the legal and juridical correlates inherent to the professional activity of the medical specialist in Pharmacology and Clinical Toxicology.
The basic training objectives also include learning the fundamental sciences for the definition and evaluation of the processes of acute and chronic toxicity of chemical substances and acquiring knowledge on the etiopathogenetic and physiopathological mechanisms of human diseases of toxic origin.
The Specializing in Pharmacology and Clinical Toxicology must also acquire in-depth knowledge of the general mechanisms of intoxication and detoxification, as well as acquire knowledge of biochemistry, physiology, pathology, microbiology and statistics fundamental for the definition of toxicity processes.

Educational objectives of the School typology
- Acquisition of advanced knowledge on the pharmacodynamic, pharmacokinetic and toxicological characteristics of active ingredients, also aimed at their therapeutic use, research and development of new drugs.
- Acquisition of specific biomedical skills that allow to interpret, predict and evaluate the effects of active ingredients in the main pathological conditions.
- Acquisition of knowledge of cellular and molecular pharmacology and toxicology related to individual organs and systems and related pathologies; acquisition of biomedical and pharmacological and toxicological skills for the setting up of treatment protocols for the most common acute and chronic pathologies as well as for the interpretation and treatment of adverse effects.
- Acquisition of toxicodynamic and toxicokinetic knowledge for the interpretation of the toxicological effects of classes of active ingredients and to appropriately address for national and European standards the clinical situations connected with acute and chronic intoxications in drug addictions and in pharmacotoxicological emergencies.
- Acquisition of basic, physiopathological and clinical knowledge aimed at optimizing therapeutic regimens.
- Acquisition of skills in pharmacokinetics, pharmacodynamics and pharmacogenetics aimed at therapeutic monitoring in function of the individualization of therapeutic regimens.
- Acquisition of basic knowledge on the methodologies of regulatory disciplines at national and international level and on the functioning of ethics committees, for drug testing.
- Acquisition of knowledge related to the methodologies of epidemiological and economic analysis necessary for the organization and control of pharmacological therapies.
- Acquisition of skills for comparative analysis, in terms of efficacy, tolerability and cost, of alternative pharmacological treatments.
- Acquisition of knowledge for the analysis and interpretation of pharmacovigilance data, with particular attention to the identification of the causal link between drug intake and the onset of adverse events

For the graduate in Medicine and Surgery, the educational objectives of the Specialization in Pharmacology and Clinical Toxicology are all the activities pertinent to clinical pharmacology and clinical toxicology, and in particular those listed below: interpretation and evaluation of the therapeutic or adverse effects of drugs in the main pathological conditions; setting up therapeutic interventions in intoxications, drug addictions and pharmacotoxicological emergencies; therapeutic monitoring of drugs;
- Optimization and individualization of therapeutic regimens;
- Evaluation of protocols for drug testing in humans;
- Clinical drug testing; design of protocols for clinical drug testing

The Specializing in Pharmacology and Clinical Toxicology must also
- Acquire the theoretical knowledge and clinical practice required for the correct use of antidotal therapy, biomedical technologies that allow for the acceleration of detoxification (hemodialysis, blood transfusion, etc.) and fundamental support techniques for the critical patient;
- Be able to deal with the main situations of intra and extra-hospital health emergencies;
- Also be able to diagnose and treat diseases associated with drug, alcohol and pharmaceutical addiction, including neurological and psychiatric complications and organ damage caused by substances of abuse with a prevalent toxicological clinical expression;
- Acquire in-depth knowledge on the directions of clinical management and care of the drug addict and the technical skills necessary to treat crisis situations and withdrawal syndromes;
- Know the legislative provisions that regulate diagnostic, therapeutic and rehabilitative intervention in addictions to substances of abuse

They are similar or complementary objectives
- Acquisition of skills related to the development and enhancement of the tools of the pharmaco-toxicokinetic and pharmaco-toxicogenetic analysis laboratory, as well as the management of the Pharmacology and Clinical Toxicology laboratory and its connection to clinical medicine care facilities and to the individual medical specialties for the therapeutic optimization of the related pathologies; through the acquisition of biomedical and pharmacological and toxicological skills for the setting up of treatment protocols for the most common acute and chronic pathologies.
- In-depth study of the methodologies for the design and analysis of pharmacovigilance activities and of the telematic connection programs with national and international networks for the surveillance of the adverse effects of active ingredients.
- Acquisition of skills in the field of public health, health legislation, biostatistics, pharmacoepidemiology, bioethics.

For the purposes of the final exam, the Specialist must carry out all the appropriate activities in the clinical and laboratory setting for the preparation of a diploma thesis of pharmaco-toxicological interest.

The trainee must also acquire the linguistic and IT skills for management and organization to carry out specialist activities in the pharmaco-toxicological field and in the field of research, characterization and development of innovative drugs.

The trainee must also demonstrate the ability to interact with community medicine professionals for aspects related to the health management of chemical risks and intoxications and epidemics.

The trainee must also demonstrate the knowledge that allows him to interact positively with other specialists for the appropriate clinical management of multi-pathological and complex states, for the prevention of toxic and unwanted effects of therapy in critical patients and for the use of drugs intended to correct disorders that may influence anesthesiological conduct and the perioperative period

These are mandatory professionalizing activities to achieve the educational objectives of the type
- Setting up and preparing at least 25 pharmacological-toxicological, preclinical testing projects for the evaluation of drugs, chemotherapeutics and xenobiotic substances.
- Participation in procedures for evaluating the efficacy and tolerability of substances of pharmacological-toxicological interest, also for the purposes of research and development of new drugs (50 analyses).
- Carrying out at least 50 clinical interventions in cases of acute intoxication and 30 clinical interventions in cases of chronic intoxication, also with regard to laboratory diagnostics. The aforementioned interventions must have been conducted with full professional autonomy.
- Participation in the activities of the Clinical Pharmacology Services laboratories: monitoring of pharmacological treatments (100 determinations of drug concentrations in biological fluids), monitoring of substances of abuse and pharmacogenetic analyses (10 clinical cases).
- Collaboration in the preparation of Therapeutic Formularies, planning of protocols for the evaluation of drug use, and the development of guidelines for the prevention of adverse drug effects (100 hours of activity).
- Participation in the activity of finding information on pharmacological treatments also through the creation and use of databases and other documentary resources by means of IT tools (at least 100 hours of activity).
- Conducting the diagnostic-therapeutic itinerary of at least 50 clinical cases of patients affected by addiction to the main substances of abuse, with particular attention to the application of integrated protocols and psychiatric comorbidity in facilities dedicated to the treatment of such patients, including the Territorial Services for Drug Addiction (SerT).
- Participation in at least 30 clinical-toxicological interventions at Intensive Care Services or in other facilities dedicated to the management of urgency-emergency, including Poison Control Centers (CAV).
- Participation in the development and management of therapeutic protocols for the treatment of drug abuse and/or misuse.
- Continuous training period at Emergency Services or in Territorial Services of ?118? and activities at a Poison Control Center, within which he/she must have independently carried out at least 50 clinical toxicology consultation interventions.
- Execution of emergency room and cardiopulmonary resuscitation simulation tests on dummies and participation in extra-hospital rescue activities and intra- and inter-hospital transfer of critical patients.
- Participation in Pharmacovigilance activities, also in the context of Phase IV trials (10 cases).
- Participation in the preparation of at least 20 Phase 1, 2 and 3 clinical trial protocols, also in reference to the tasks and activities assigned to the Ethics Committees for drug testing.
- Collaboration in updating the Therapeutic Handbooks of Hospital Companies (100 hours of activity).
- Discussion with medical specialists from other disciplines of the integrated therapeutic conduct in at least 10 complex toxicological cases.
- Management and resolution in full autonomy of 50 cases of patients in outpatient treatment for complex toxicological pathologies.
- Execution of at least 10 telephone consultations and any visits for Perinatal Toxicology problems.
- Participation in the rational setting of the use of medical devices in acute and chronic pathologies (100 hours of activity).
- Participation in the clinical governance of the drug and the medical device at hospital and territorial level (100 hours of activity).
- Participation in biomolecular, receptor and pharmacogenetic diagnostic-therapeutic activities, for the definition of therapeutic appropriateness (100 hours of activity).
- Participation in refresher courses, seminars, demonstrations, conferences and congresses with topics directly relevant or in any case complementary to the training course in Clinical Pharmacology and Toxicology (at least 200 hours of activity).
- Participation in the design and execution of comparative evaluations of efficacy, tolerability and costs of alternative pharmacological treatments. For example: a) Participation in the preparation (or evaluation) of 5 protocols of drug-utilization, pharmacoepidemiology and pharmacoeconomics studies. b) Participation in the preparation (or evaluation) of 5 protocols of studies with medical devices.
Specific activities for graduates in Medicine and Surgery:
- Participation in diagnostic and therapeutic activities in general medicine departments, specialist medicine (cardiology, endocrinology, geriatrics, gynecology, internal medicine, infectious diseases, emergency medicine, pediatrics, medical oncology, pulmonology, nephrology, neurology, pneumology, psychiatry and rheumatology, intensive care and medical toxicology for at least 100 hours)
- Collection and interpretation of anamnestic data and functional and instrumental diagnostic data for the purposes of diagnostic orientation and therapeutic decisions relating to the pharmacological treatment of pathologies in the internal medicine and specialist fields (cardiology, endocrinology, gastroenterology, geriatrics, infectious diseases, internal medicine, nephrology, neuro-psychiatry, pneumology, psychiatry, oncology, rheumatology (50 clinical cases).
- Participation in diagnostic and therapeutic activities in prevention, assessment and monitoring in drug addiction services (100 hours of activity).
- Participation in the preparation of at least 10 pharmaco-toxicological and clinical trial protocols for the evaluation of drugs, chemotherapeutics and xenobiotic substances, also in reference to the tasks assigned to the Ethics Committees for drug testing in humans.
- Participation in pharmaco-toxicological consultancy activities (100 hours of activity).
- Evaluation of reports of adverse reactions to drugs, also in the context of phase IV trials (10 cases).
- Participation in the activities of evaluation of pharmacological treatments, therapeutic monitoring, pharmacogenetic analysis, control and individualization of therapies in hospital wards and/or pharmacology and/or clinical toxicology services (50 clinical cases).
- Participation in diagnostic and therapeutic activities in general medicine and specialist medicine departments in order to follow the diagnostic and therapeutic itinerary of patients undergoing pharmacological treatment (20 clinical cases).
- Participation in the interpretation of pharmacological-toxicological monitoring during cycles of pharmacological therapy (10 clinical cases).
The training courses for graduates in Medicine and Surgery will be structured to train specialists capable of:
- Participating in the healthcare activities of the Health Services through the monitoring and evaluation of drug responses in humans (identification of non-responders).
- Participating in the identification of unfavorable and adverse therapeutic effects of drugs.
- Participating in the rational setting of pharmacological-therapeutic interventions in both acute and chronic pathological conditions.
- Take an active part in the characterization and evaluation of the effects of new drugs, especially in the initial phases of their clinical trials.
- Participate in the activities of the CAV and the Perinatal Toxicology Services.
- Work as consultants in the Emergency-Urgency Departments.
- Work in the Territorial Services for drug-drug addiction (SerT).
Other student activities are those useful for acquiring specific and advanced knowledge related to the risk assessment of chemical agents, biological monitoring of drugs and toxicants, health management of major emergencies and medicine of chemical catastrophes. The related knowledge is acquired with activities conducted in chemical-pharmaco-toxicological analysis services and laboratory medicine, in pharmacology, pharmacogenetics and clinical and environmental toxicology centers, drug-drug-addiction centers, pharmacoepidemiology, pharmacoeconomics and in the territorial services of "118".
The specialist will be able to compete for the diploma after completing the professionalizing activities.
The trainee, as part of the training course, will have to learn the scientific bases of the School typology in order to reach full maturity and professional competence that includes an adequate capacity to interpret scientific innovations and a critical knowledge that allows him to consciously manage both assistance and his own updating; in this context, participation in meetings, conferences and the production of scientific publications and periods of attendance in qualified Italian and foreign institutions useful for his training may be foreseen.