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.
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.
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, ultima Ed.; N. Loliscio: "La farmacia: un campo minato. Il manuale del farmacista 2020", Editore Esculapio, ultima Ed.; "L'esame di Stato per farmacisti. Manuale di preparazione. Basi teoriche delle discipline fondamentali per l'esercizio della professione", Editore Edises, ultima Ed.; FARMACOPEA UFFICIALE ITALIANA XII ed., Istituto Poligrafico dello Stato; Farmacopea Europea.
During the lectures, the legislative aspects that identify the role and tasks of the pharmacist will be discussed, with particular attention to his administrative and criminal responsibility in dispensing medicines to citizens.
The course will be carried out in mixed mode (face-to-face and online streaming) with the support of IT tools for the projection of the teaching material that will be made available to students.
Assessment methods and criteria
The learning assessment method consists in taking two written exams during the Department's examination calendar.
The written part, relating to Pharmaceutical Legislation, consists of 8 open-ended questions.
The written part, relating to 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.
In case of the persistence of the health emergency, the written exams will be conducted remotely, through the Teams platform (guide http://selma.unipr.it/).
Students with SLD/BSE must first contact Le Eli-che: support for students with disabilities, D.S.A., B.E.S. (https://sea.unipr.it/it/servizi/le-eli-che-supporto-studenti-con-disabil...).