Pharmaceutical Legislation and Role of the Pharmacy in the Health Protection
Learning outcomes of the course unit
The course of "Pharmaceutical Legislation and Role of Pharmacy in Health Protection" aims to allow students to know and understand the legislative elements for the profession of pharmacist, in terms of dispensing medicines, nutraceuticals and services to the citizens, about the manufacturing of dosage forms, providing information about the work and the economic management of the pharmacy and linking the academic study with the daily life of the profession. In addition, the course aims to provide students with the ability to use the acquired knowledge and understanding to provide the citizen with the information necessary for the proper use of health tools available for the protection of health.
Furthermore, the course aims to bring the student to improve communication skills in the field of pharmaceutical legislation.
Course contents summary
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
- Regional Legislation
- Classification of pharmacies
- Public 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
- 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.
The second part of the course covers:
- territorial distribution and value of the pharmacy in health protection;
- first and second level services;
- supervisory activity required by law, relations with the National Health Services, obligations of the Pharmacy;
- distribution flows, inventory management and warehouse;
- computerized and automated management; examples of use of management software;
- contribution to the economic sustainability of the National Health Service, extra-drug sector;
- duties and rights of the pharmacists, contractual rules;
- occupational safety, waste and sensitive data management;
- phytotherapy, homeopathy, self-medication;
- culture of sell-in and sell-out, objectives of management decisions, the exposure: the four P of marketing, the challenges of the Italian pharmacy in the near future.
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Ultima Ed.; VINCENZO TORTORELLA, ETTORE NOVELLINO, VINCENZO IADEVAIA “Tirocinio professionale in Farmacia-Guida all'esame di Stato. Volume 1°e 2°, Mercurio Editore; FARMACOPEA UFFICIALE ITALIANA XII ed., Istituto Poligrafico dello Stato; Farmacopea Europea.
Lectures with the aid of computer tools for the projection of lessons.
Assessment methods and criteria
The method of verifying learning consists in written exam during the Department's examination calendar. It will also be possible to carry out written tests ongoing and they will be considered valid for passing the exam if the result is positive.
The minimum threshold for overcoming the written examination is the knowledge of the correct dispensing methods of the medicines, as well as the organization and management of the pharmacy.