B029427 - REGULATION OF DRUGS AND PHARMACOECONOMICS

Italian

The course will give the fundamental information for the knowledge of the legislative provisions for the profession of pharmacist, both in terms of dispensing medicines and services to citizens and regarding the production of magistral and officinal preparations, both galenic and industrial. In addition, expertise in pharmacoeconomics, the main categories of products with healthy activities and their Community and national regulations in force will be provided.

Paola Minghetti. Legislazione Farmaceutica. Ultima edizione. Casa editrice Ambrosiana

Nicoletta Loliscio. La farmacia: un campo minato. Il manuale del farmacista. Ultima Edizione. Società Editrice Esculapio.

The course is organized in theoretical lessons in which the bases for the knowledge of the main legislative provisions concerning the profession of pharmacist are provided. The objectives concern general topics of pharmaceutical legislation such as Italian and European regulations and directives concerning medicines, and health products, the Italian health organization, rules relating to the production and trade of medicines for human use, administrative classification of medicines, pharmacopoeias, discipline dispensing to the public of medicines, medicines not subject to medical prescription, veterinary medicines. In addition, topics relating to the organization and management of the pharmacy and pharmacoeconomics such as cost-effectiveness, cost-benefit and cost-utility relationships will be discussed. At the end of the course the student will have to have a global vision of the main economic-regulatory aspects of medicines, cosmetics and health products for management in the industrial and pharmacy fields.

Good knowledge of the topics covered in the course of Technology and Laboratory of Galenic Preparations.

Frontal lessons (6 ECTS)

teaching materials
Power Point lectures included on the internet site http://el.unifi.it
Lecture notes and suggested books.
Frequency of lectures: compulsory
Timetable of reception
Every day, by appointment
address
Department of Chemistry, Building ex Pharmaceutical Sciences
Via U. Schiff 6
50019 Sesto F.no - Florence
Tel. 055 4573678
e-mail: mc.bergonzi@unifi.it

The final test consists of an oral exam aimed at verifying knowledge of the subject. The interview will test the candidate's ability to organize and re-elaborate the knowledge acquired, the capacity for critical reasoning on the study carried out, the quality of the presentation and the use of appropriate vocabulary. Booking examination takes place via the booking system on-line from the website www.unifi.it

The lessons begin with an overview of the regulatory bodies in the field of medicines (FDA, EMA, AIFA) and reciprocity agreements, articulation of the pharmaceutical service, the profession of pharmacist and the production and distribution of medicines, both galenic and industrial, in compliance with Standards of Good Preparation of Pharmaceutical Medicines (NBP) and Good Manufacturing Practices (GMP). Particular emphasis will be given to the classification of medicines for human use, types of prescriptions for dispensing medicines for human and veterinary use, narcotics, preparations based on Cannabis, Galenics (doping anorectic poisons). The following topics will be addressed: administrative classification of territorial pharmacies, organic plant, hospital pharmacy, pharmacy inspections, mandatory texts in pharmacies, and exercise of the profession (achievement of ownership, replacement of the owner and provisional management, transfer of ownership, etc. .) Pharmacy supervision, code of ethics A further educational objective of the teaching is to make known the main categories of products with healthy activity sold in pharmacies, in particular cosmetics, food supplements, medical devices, and the related Community and national regulations in vigor, in relation to the production and marketing aspects. Finally, the principles and concepts of pharmacoeconomics, healthcare systems in relation to economic sustainability, characteristics of the healthcare market in Italy and in the EU countries, cost / effectiveness and cost / benefit analysis, pharmaceutical expenditure in Italy (hospital and territorial) will be addressed, pharmaceutical distribution in Italy (direct, on behalf, under agreement).

The course is aligned with the Health and Wellbeing, Quality Education objectives and Industry, innovation and infrastructure.