Course Details

PHARMACEUTICAL POLICY AND LEGISLATION

FA0063

Course
PHARMACEUTICAL POLICY AND LEGISLATION
Code
FA0063
Academic Year
2023/2024
Curriculum Year
2020/2021
Degree Programme
PHARMACY
Curriculum
000 - CORSO GENERICO
Course coordinator
-
Credits
3
Lecture Hours
24
Scientific Disciplinary Sector (SSD)
BIO/14 - Pharmacology
Course Type
Single-subject learning activity
Course Delivery
OPZ - Opzionale
Year
4
Teaching period
Secondo Semestre
Campus
NOVARA
Teaching language
Italian
Course Contents
1. The role of the pharmacist from traditional pharmacy to service pharmacy and from hospital pharmacy to clinical pharmacy 
2. Regional and local pharmaceutical governance: conditions, restrictions and limitations on pharmaceutical prescription
3. Advanced evaluation criteria for medicines and medical devices (GRADE, HTA, EtCD etc.)
4. The complex and interconnected system of therapeutic reference books and repertories of MDs
5. Off-label prescription and early access systems in public NHS facilities
6. The channelling of conventional and extra-conventional drugs
7. The therapeutic equivalence of drugs and medical devices
8. Regional and interregional health mobility; focus on the f-File
9. The procurement of medicines and medical devices by NHS structures
10. Pharmacovigilance and device-vigilance
Reference Texts
“The Medicines Utilisation Monitoring Centre. National Report on Medicines use in Italy. Year 2021. Rome: Italian Medicines Agency, 2022”
Learning Outcomes
The expected results of the training program are the knowledge of the key elements of legislation, organization, management and regulation of the pharmaceutical market in Italy, aimed to introduce undergraduates in the pharmaceutical world in general.
In particular, it aims to stimulate interest in a career within public structures of the National Health Service (hospital pharmacies and pharmaceutical services of local health organizations), of the participating pharmaceutical facilities (private pharmacies and chain pharmacies) and those called para-conventional as corner supermarket and para-pharmacies.
They will look at the specific duties and functions in the distribution area of drugs and verify the appropriateness of distribution, pharmacovigilance and that in the performance of related services.
Prerequisites
No prerequisites are required to attend the course
Teaching Methods
Traditional lectures with ppt presentations, stimuli with frequently asked questions to verify the initial knowledge and the acquisition of concepts
Additional Information
The program of study aims to lay the basis for the motivated participation in the Schools of specialization in Hospital Pharmacy (PhD) and Master's Degree, essential for entry respectively in the world of work in public office or private, with elements of competitive advantage, resulting from the acquisition of the theoretical basis, to conduct interviews / selection competitions.
Assessment Methods
Oral exams
Detailed Syllabus
1. The role of the pharmacist from traditional pharmacy to "services pharmacy” and from hospital pharmacy to clinical pharmacy is explored
2. After an overwiev on the subject of regional and local pharmaceutical governance, the conditions, restrictions and limitations on pharmaceutical prescription are explored in depth
3. Advanced evaluation criteria for medicines and medical devices are examined in detail (GRADE method, HTA method, EtCD method etc.)
4. The complex and interconnected system of therapeutic reference books and MD directories is presented
5. Early access systems in public NHS facilities and the topic of off-label prescribing are examined
6. The different channels of conventional and off-label drugs and their impact on the relative public expenditure for the NHS are illustrated
7. The issue of therapeutic equivalence of drugs and medical devices is examined in depth
8. The subject of regional and inter-regional health "mobility" is illustrated; focus on File f.
9. Notions are given on the National Procurement Code and on the subject of the procurement of medicines and medical devices by NHS structures
10. Notes are given on the subject of pharmacovigilance and device-vigilance
Expected Learning Outcomes
The expected results of the teaching program are the knowledge of the main elements of regulation, organization, management and regulation of the pharmaceutical market in Italy, aimed at introducing undergraduates in the world of pharmaceuticals more generally
Last update:09-09-2026 00:14:31