Learning objectives
At the end of the course, the student should have acquired knowledge and skills related to the processes of drug evaluation, choice strategies and management, in hospital and territorial settings.
In particular, the student should be able to:
1. Understand the stages of the process of creation, development, and commercialization of a new drug, including post-marketing aspects related to pharmacoepidemiology and pharmacovigilance.
2. Recognize criteria and strategies underlying the choice of drugs in the hospital setting and related acquisition policies, taking into account both therapeutic needs and economic constraints that contribute to the governance of pharmaceutical spending, at the territorial and hospital levels.
3. Know how to assess the risks associated with drug use from the perspective of preventing and reducing error in therapy.
4. Link together the different topics covered and know how to turn to the most authoritative sources of information for in-depth and up-to-date information, in accordance with the principles of evidence-based medicine.
Prerequisites
None
Course unit content
The course covers a range of relevant topics in the field of pharmacology and drug management. It begins with an analysis of the ethical and economic aspects of drugs, that is, the complex intertwining of the moral implications and financial dynamics involved in drug production and distribution.
The topic of drug origination, development and evaluation is covered, illustrating the entire process that leads to the creation of a new drug, from initial research to its release on the market, including how its efficacy and safety is evaluated.
Essential aspects regarding pharmacoepidemiology and pharmacovigilance, key disciplines for understanding the impact of drugs on the population and for monitoring any side effects or adverse reactions once drugs have been introduced to the market, will be explored.
The course also deals with drug information and documentation, with an in-depth look at Evidence-Based Medicine (EBM). This part is crucial in providing health professionals with the most up-to-date and verified information on available drugs.
Another topic addressed is hospital drug selection and acquisition policies. In this context, the criteria and strategies by which hospitals choose and acquire drugs are analyzed, taking into account both therapeutic needs and economic constraints.
An important chapter is devoted to the governance of pharmaceutical spending, both at the territorial and hospital level, where the strategies implemented to efficiently manage the economic resources allocated to drugs, avoiding waste while guaranteeing the quality of care, are illustrated.
Finally, the management of risk related to the use of drugs is discussed, with a focus on error in therapy. This aspect is essential to understanding how to prevent and manage medication errors, ensuring patient safety while using medications.
In summary, the course provides a comprehensive overview of the main aspects of medication management and use, from its creation to its distribution and monitoring, with a focus on the safety and efficiency of the health care system.
Full programme
Theoretical tools and concepts for the study and evaluation of strategies choice of drugs, pharmacovigilance and tools of government spending.
Risks associated with use of the drug with the aim of preventing and reducing the failure in therapy.
Bibliography
• C. Signorelli – Elementi di metodologia epidemiologica- Società Editrice Universo Roma
• AAVV – Governo Clinico – Il Pensiero Scientifico Editore
• Joint Commission Resources ed. italiana – Prevenire gli errori in terapia
• OsMed- L’uso dei farmaci in Italia- Ministero della Salute ( www.agenziafarmaco.it)
• PFN 2005- AIFA ( www.agenziafarmaco.it)
• Casadei-Silva – Farmacosorveglianza- Masson
• AAVV- La Medicina delle prove di efficacia- Il Pensiero Scientifico Editore
Teaching methods
Teaching activities will be conducted through frontal lectures, favoring interactive modes and thus through the involvement of students in discussions, presentations and group work.
Assessment methods and criteria
Assessment of learning will involve a written exam, including 31 multiple-choice questions (one right answer out of three options), to be taken in 30 minutes. Out of the total number of questions, 15 will be related to the topics of this specific course (drug development, pharmacoepidemiology and pharmacovigilance, EBM, drug utilization and acquisition policies, pharmaceutical expenditure governance, risks and therapeutic error, etc.), while 16 will be related to the other topics of the integrated course, thus epidemiology and hygiene.
Other information
Further information and details about the course will be provided directly in the classroom.
2030 agenda goals for sustainable development
The course in its articulation and conduct takes into account as much as possible some Agenda 2030 goals for sustainable development including health and well-being, quality education, gender equality.
