Teaching code

4S000437

Teacher

Stefania Pretto

Credits

2

Language

Italian

Scientific Disciplinary Sector (SSD)

BIO/14 - PHARMACOLOGY

Period

LMSIO VR - 2° ANNO 1° SEM. dal Oct 8, 2020 al Feb 13, 2021.

Lessons timetable Moodle Seminars

To show the organization of the course that includes this module, follow this link:  Course organization

Learning outcomes

The safety of drug treatments is an important aspect of assistance.
- Provide useful elements to define drug safety, clinical governance and safety of care
- Provide useful elements to define strategies and pathways for managing therapies in safe conditions
- Provide useful elements to define assistance interventions characterized by various different phases that involve more professionals.
- Provide useful elements to define general indications on good practices to be implemented in the treatment process that extends from the moment the drug is prescribed to the moment it is administered.
- Provide useful elements to define their own specific tools to monitor and regulate the whole process
prescription / administration of the drug.
- Promote safety in care and develop greater awareness
- Analyze the main safety and drug issues for certain drug categories and patient classes

Program

Definition of general and special pharmacology
Definition of drug: legislation, technical data sheet, package leaflet (consolidated drug text)
Stages of drug development: clinical research, clinical trial, stages of clinical trial
Access to the drug: legislation, drug classification, reimbursement, AIFA note, therapeutic plans, centers authorized to prescribe, national and regional registers
Early access: off label use, law 648/96, compassionate use
Rare diseases: definition orphan drugs
Equivalent, biosimilar and innovative drugs
Advanced Therapy Medicines: Gene Therapies and CART Drugs
Organization of the NHS and SSR: Lea, drugs extra LEA, PSSR, clinical networks, PDTA, multidisciplinary teams, regional guidelines, recommendations for drug use, national and regional plans (example Prevention plan, chronicity - PNCAR - ICA) introduction to One Health
Definition of Appropriateness
Introduction to drug safety, clinical governance and safety of care: tasks of AIFA and tasks of the Ministry of Health
Additional monitoring: definition, operating modes
Risk Management Plan (risk management plan) definition and objectives

Ministerial recommendations:
their application throughout the entire process from prescription to drug administration

Gene therapies: focus on currently available CART drugs and their safe management (RMP risk management plan)
Operating procedures, operating instructions, check lists

Polytherapy: multipathological patient, consequences and risks of polytherapy, prescriptive appropriateness, therapeutic adherence, therapeutic persistence, interactions, adverse events
Pharmacovigilance: objectives, methodologies, PRAC, information notes

Vaccines: classification, purpose of vaccination, authorization, efficacy and safety, adverse events, mandatory vaccinations, gratuity vaccinations, vaccinations in pregnancy, evaluation of the risk and benefit of a vaccine, working group on signal analysis ( GLV), adverse event reporting
NAO: efficacy and safety, therapeutic indications, advantages and disadvantages, interactions, special populations, patient management.

Monoclonal antibodies: activity, scope of use, use of MAB drugs, common side effects, serious side effects, reporting adverse reactions.

Examination Methods

One or more open-ended questions