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 products (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) make judgements related to the Pharmacy practice based on the acquired knowledge in a context of continuous education and evolution of the regulatory framework (Making judgements);
4) 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 course is divided into two parts. In the first part of the subject, the lectures will focus on the relevant regulations for the profession of Pharmacist (Professional Associations;
Pharmacy ownership; Discipline dispensing the medicines to the public, etc.)
The second part of the subject will cover aspects related to the Pharmacy practice (pharmacy services; logistics; economic viability; information to the public, etc.).
Full programme
The course is divided into two parts. In the first part the arguments are:
- European regulations concerning medicines
- Europeen rules on the movement of pharmacists
- Professional Associations
- Organization of Italian Health
- Health Reform
- Classification of pharmacies
- Pubblic exam for the allocation of new pharmacies
- Informal and formal replacement of owner
- Temporary administration of exercise of professions and arts and health activities subject to health surveillance
- Ethics of the pharmacist
- Continuing Medical Education (CME)
- Standards for the production and trade of medicinal products for human
- Classification of medicines
- Pharmacopoeias
- Discipline dispensing the medicines to the public
- Medicinal products not subject to medical prescription
- Rules for Veterinary Medicinal Products
- Rules interesting medical devices, in vitro diagnostic, biocides and sanitary
- Definition and production of cosmetics.
In the second part of the course, the lessons concern the organization and management of the pharmacy. In particular, the topics covered are: 1) The Pharmacy Presidium of Health in the territory, the Italian market and products beyond the drug product; 2) Economic and Financial Aspects of Management of the "pharmacy" company: discounts, profit margins and economic sustainability of the system; 3) Warehouse management: distribution flow and stock management 4) computerized management of the pharmacy: practical examples of use of management softwares; the automated warehouse; 5) Complementary therapies with particular reference to homeopathic medicines; 6) professional duties of the pharmacist, the National Collective Labour Agreement for private pharmacy employees; 7) Supervisory activity required by law, relations with the NHS, Pharmacy obligations; 8) workplace safety, waste management and sensitive data; fiscal obligations; 9) The Pharmacy of services: from self-analysis to patient care; 10) culture of sell in and sell out, objectives of management choices, exposure; marketing concepts; the challenges of the Italian pharmacy in the near future.
Bibliography
P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Decima Ed. (2021)
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 (2021)
Slides presented during classes will be available every week on Elly portal.
Teaching methods
Teaching is delivered via a series of lectures 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).
All slides are made available online at the Elly website 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).
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)
