Learning objectives
Upon successful completion of the module of Pharmacy Legislation the student will acquire the knowledge related to the norms regulating the Pharmacy profession.
In particular, the students will have to:
1) know and understand the legislation that regulate the Pharmacy profession and the dispensing of medicinal produts (Knowledge and understanding);
2) apply the knowledge to identify the specificities and to apply the correct procedures to fulfill the most common medical prescriptions (Applying knowledge and understanding);
3) being able to integrate new national and european legislation with the acquired knowledge (Learning skills).
Prerequisites
No preliminary knowledge is required to attend the Module of Pharmaceutical Legislation. However, a revision of what learnt by students concerning Galenic prescriptions is strongly suggested.
Course unit content
The module of Pharmaceutical Legislation has the aim to provide an overview of the regulations related to the pharmacy practice and medicinal product dispensing. The module is divided in three sections.
The first section of the subject is devoted to general presentations related to European regulations, Italian Healthcare system and Health professions registries.
The second part of the subject is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the subject is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices and for the food products sold in the pharmacy.
The second part of the subject is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the subject is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices.
Full programme
Italian Healthcare system
Classification of pharmacies and distribution on the territory
Pharmacy practice and Services in the Pharmacy, including vaccination.
Standards for the production and trade of human medicinal products (Marketing Authorization, Manufacturing Authorization)
Pharmacovigilance
Classification of medicines
Discipline dispensing the medicines to the public and dispensing of controlled substances.
Medicinal products not subject to medical prescription
Regulations for Veterinary Medicinal Products
Regulations for medical devices, in vitro diagnostics, biocides
Regulations related to cosmetics, food products and alcohols.
Bibliography
P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Nona Ed. (2018)
M. CINI, P. RAMPINELLI “Principi di Legislazione Farmaceutica”, Edizioni Minerva Medica, II Ed. (2019)
N. LOLISCIO “La Farmacia: un campo minato. Il manuale del Farmacista” Società Editrice Esculapio (2023)
Slides presented during classes will be available every week on Elly portal.
Teaching methods
Teaching is delivered via a series of lectures in presence, integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class (uploaded on the portal Elly, elly2020.saf.unipr.it).
All slides are made available online at the Elly website (elly2020.saf.unipr.it) where videorecordings of lectures will be available for a limited time (7 days).
Students will be constantly reminded the appropriate technical language, exposed to real-life profession examples, invited to understand the underlying connections between different parts of the course and other subjects and will be stimulated to actively participate to the lectures with interactive discussions.
Assessment methods and criteria
The learning assessment method consists in taking two written exams during the Department's examination calendar.
The two exams, relating to Pharmaceutical Legislation and the Role of the pharmacy in health protection, consists of 31 multiple choice questions.
The minimum threshold for passing the exam is the knowledge of the correct method of dispensing medicines, as well as the organization and management of the pharmacy.
Other information
Attendance to the lectures is compulsory (minimum 75% of the lectures). Working students are eligible for a reduction of the attendance requirements if officially registered.
Students with SLD/SEND should contact the Centro Accoglienza e Inclusione (http://cai.unipr.it) or the Department reference person (Prof.ssa Franca Zanardi
franca.zanardi@unipr.it - tel. +39 0521 905067)
