Postgraduate School of Clinical Pharmacology and Toxicology Reserved for Non-Doctors

Integrated training objectives (i.e. Common Trunk)
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.

The training objectives are the following:
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; skills for the identification and possible treatments 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 foods.
Acquisition of skills in statistical and epidemiological methodologies for the evaluation of drug utilization, pharmacoeconomics and pharmacovigilance.
The Specializing in Pharmacology and Clinical Toxicology must:
- obtain the basic theoretical knowledge, the technical ability and the aptitudes necessary for national and European standards, the most common 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 and pain 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 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 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 of 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 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 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 relating 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 regard to the identification of the causal link between drug intake and the onset of adverse events.
For graduates of a degree program other than Medicine and Surgery, the training objectives of the Specialization in Pharmacology and Clinical Toxicology are all activities pertinent to pharmacology and clinical toxicology, and in particular those listed below: interpretation and evaluation of the therapeutic or adverse effects of drugs; therapeutic monitoring of drugs; clinical trials of drugs; design of protocols for clinical trials of drugs.
The Specializing in Pharmacology and Clinical Toxicology must also: acquire the theoretical knowledge 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; 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 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.
Deepening 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 the professional figures of community medicine for aspects connected with 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 for achieving the educational objectives of the type:
Setting up and preparing at least 25 pharmaco-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 pharmaco-toxicological interest, also for the purposes of research and development of new drugs (50 analyses).
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 handbooks, planning of protocols for the evaluation of drug use, development of guidelines for the prevention of adverse drug effects (200 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 200 hours of activity).
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 therapeutic handbooks of hospital companies (200 hours of activity).
Participate in the rational setting of the use of medical devices in acute and chronic pathologies (100 hours of activity).
Participate in the clinical governance of the drug and the medical device at hospital and territorial level (200 hours of activity).
Participate in molecular diagnostic-therapeutic activities with receptor and pharmacogenetic analyses for the definition of therapeutic appropriateness (200 hours of activity).
Participation in refresher courses, seminars, demonstrations, conferences and congresses with topics directly relevant or in any case complementary to the training path in Pharmacology (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 pharmacoutilization, pharmacoepidemiology and pharmacoeconomics studies.
b) Participation in the preparation (or evaluation) of 5 study protocols with medical devices.
Specific activities for graduates in other degree courses other than Medicine and Surgery:
- Participation in the preparation of at least 10 pharmacological-toxicological testing protocols for the evaluation of drugs, chemotherapeutics and xenobiotic substances, also in reference to the tasks assigned to ethics committees for drug testing in humans.
- Participation in pharmacological-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 clinical pharmacology services (50 clinical cases).
- Participation in the interpretation of pharmacological-toxicological monitoring during cycles of pharmacological therapy (10 clinical cases).
For graduates in Biological Sciences, Pharmacy, Chemistry and Pharmaceutical Technology, and Veterinary Medicine, the training courses will allow them to:
- carry out evaluations of the action of drugs in various biological systems;
- implement analytical procedures (pharmacokinetics) for the determination of drugs in organic fluids or tissues;
- carry out activities in the field of pharmacovigilance and pharmacoepidemiology;
- organize and conduct pharmaco-toxicological trials in the preclinical phase;
- contribute to the compilation of the Hospital Therapeutic Formulary;
- participate in the work of the Ethics Committees;
- carry out pharmaco-economic studies in the hospital and population setting
The type of activity carried out by the trainee, based on the degree of autonomy achieved and in any case adhering to the directives given by the tutor, is divided into:
- Tutored care activity: with the presence of the structured medical director/pharmacologist who performs the service and entrusts part of it to the student;
- Protected care activity: the service, on the indication of the structured medical director/pharmacologist, can be carried out by the trainee provided that the structured medical director/pharmacologist is present in the facility and is in any case able to supervise and monitor his/her work. The performance of simple outpatient activities, instrumental diagnostics and laboratory activities, carried out by the trainee as part of his/her collaboration activity, takes place under the supervision of a structured medical director/pharmacologist. The structured medical director/pharmacologist countersigns the report of the specialist visit/instrumental service signed by the trainee who performed the service.
- Protected care activity: while the medical director/pharmacologist must always be available for consultation and any timely intervention at the discretion of the trainee, the latter carries out autonomous activities, in any case adhering to the directives given by the tutor, as defined by the individual planning carried out by the School Council.