Ateneo - UPO

PART 1 - The first part of the course provides the fundamentals of legislation in the field of drugs, in the distribution to the public of medicinal products for human use, veterinary and "parafarmaco". Regulatory aspects relating to the responsibility of the pharmacist in the pharmacy as well as the social function of the pharmacy on the territory are provided. Some aspects of professional ethic are given.
PARTE 2 - The course provides the theoretical and practical skills for the formulation, compounding, pricing, and packaging of magistral and officinal galenical medicinal products intended for both human and veterinary use. It covers regulatory aspects, Good Preparation Practices (NBP according to Italian and European Pharmacopoeia), and the technological specificities related to different routes of administration. Students will learn to manage compounding practices, from the selection of the excipients to quality control, ensuring the safety of the preparations and personalized dosing for each patient.

Minghetti P., Legislazione Farmaceutica, C.E.A., Milano. - Farmacopea Ufficiale Italiana in force, IPZS. - European Pharmacopoeia in force, EDQM. - Tortorella V., et al., Tirocinio professionale in farmacia, Ed. Merqurio, Napoli. - Cipollone R., Dizionario giuridico della farmacia, Editoriale Giornaleidea. - D’Agostini G., Manuale del cosmetologo, Tecniche Nuove, Milano. - Pacenti G.C., et al., La farmacia dei servizi, Tecniche nuove, Milano. - Lombardo Q., et al., La nuova farmacia del decreto Monti, Tecniche nuove, Milano. - Morel S., Grosa G., Preparazioni galeniche Esercizi di tariffazione secondo la nuova TNM, Ed. Libreria Rescalli, Novara.
Paolo Caliceti: Tecnologia Farmaceutica. CEA, Casa Editrice Ambrosiana. - Michele Amorosa (ed. a cura di F. Barbato): Principi di Tecnica Farmaceutica, Ed. Piccin. - Ansel HC et al.: Principi di calcolo farmaceutico. Ed. Edra. - Bettiol F.: Manuale delle preparazioni galeniche. Ed. Tecniche Nuove. - Bettiol F.: Manuale delle preparazioni veterinarie. Ed. tecniche Nuove.

PART 1 - The first part of the course aims to provide students the knowledge and the understanding of the basics regarding the fundamentals of the legislation in the field of drugs, the public distribution of medicinal products for human and veterinary use and some professional ethic concepts are provided.
PART 2 - The course is divided into theoretical lectures and practical laboratory sessions focusing on the compounding, pricing, labeling, and dispensing of galenical preparations for human and veterinary use.
The primary objective is to provide the theoretical knowledge and practical skills required for a correct approach to galenic medicinal preparation and dispensing. Furthermore, the course equips students with the essential pharmaceutical-technological tools to effectively manage professional pharmacy activities, enabling them to competently address challenges associated with professional practice.

A good knowledge of the courses of the previous year is recommended, in particular pharmaceutical technology.

PART 1 - The course is throughout the year with lectures lessons. The teachings will be delivered in such a way as to encourage students to take an active role, helping to stimulate a critical spirit, autonomy and involving them in learning processes.
PART 2 - Frontal lectures and practical activities in the laboratory. Attendance at both lectures and laboratory sessions is mandatory and will be certified by the professor.

External specialists can supplement lessons with seminars.
It is not allowed to record, video-record and photograph the lectures.
Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities. Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects. Then, they must contact the lecturer regarding specific exam procedures and instructional aspects, at least ten days in advance as stipulated by University regulations.

PART 1 - Oral with questions throughout the program, according to the schedule established annually. The level of difficulty of the questions corresponds to the program and the reference texts. During the oral exam the student is asked some questions on the main topics covered during the course with the dual purpose of verifying the level of knowledge and understanding of the course contents and to evaluate the autonomy of judgment, the learning ability and the communication skills. To pass the exam, the student must demonstrate knowledge and understanding at least of the fundamental concepts and the most important results relating to them. A wider knowledge and understanding of the contents of the program, which in particular allows the student to establish the connections between topics covered in different chapters of the program and greater autonomy in identifying errors and their correction, lead to an evaluation above sufficiency; to achieve a high grade, the student must be able to independently use their knowledge and understanding of the teaching contents to face an in-depth discussion on critical aspects relating to the topics covered and to be able to present their conclusions in a clear and logical. The use of appropriate language and rigorous terminology is recommended.
Part 2 - The exam will be in written form and will include the dispensing of a prescription for a galenical preparation for human and/or veterinary use. Students will be required to price the preparation, fill out the label, and demonstrate knowledge of the current regulations governing the dispensation of a galenic preparation.

PART 1 - Basic definitions: Dlvo 219/06 and glossary F.U. Italian Pharmacopoeia. European Pharmacopoeia. International Pharmacopoeia. USP-NF. Basic legislative notions. Notices about Italian, international and European legislation. Pharmacist ethics code. GMP. NBP e DM 18/11/2003. Italian health organization. L.833/78: SSN. Professional associations. Licensed to practice. Responsibility of the pharmacist. Pharmaceutical services. Classification of pharmacies. Distribution of pharmacies on the territory. Supervision of pharmaceutical services. Inspections at the pharmacy. Texts, registers and documents required. Medicinal products for human use (Dlgs 219/2006, successively modified). Procurement, storage sale/dispensing of narcotic drugs (DPR309/90 and successively modified). Pain therapy (L.12/2001 and successively modified). Storage and sell out of poisons and substances hazardous to health. Register of poisons. Expired medicines, failures, imperfect. Veterinary medicinal products. REV. Medicinal products delivery: medical prescription. SOP, OTC. Generics. Biosimilars. Anti-doping law. Homeopathic medicines. Herbal products. Orphan drugs. Drugs off label. Medical devices. Biocide. L. 69/2009. Cosmetic products (regulation 1223/2009/CE). Food in pharmacy: HACCP. Oxygen. Supervision of all products.
PARTE 2 - Galenical; officinal and magistral galenical preparations for human and veterinary use, and relevant regulatory requirements; compounding techniques; pricing according to National Price List for galenic preparations; composition of label of galenic preparations, and labelling.
Laboratory Activities: Compounding and quality control of magistral and officinal galenical preparations (powders, charts/divided powders, cachets, capsules, suppositories, pessaries, syrups, solutions, emulsions, creams, gels, ointments, pastes, palatable oral pastes, transdermal dosage forms). Pricing and labeling. Quality control of solid dosage forms (capsules and tablets) according to Pharmacopoeia specifications. Use of software for managing pharmacy professional activities.

PART 1 - To achieve the knowledge and skills corresponding to the minimum level of sufficiency, the student is asked to demonstrate knowledge of the topics presented in class. The student is asked to demonstrate that they can apply the knowledge acquired relating to the different prescriptions for human and veterinary use, understanding the importance of the different dispensing methods. The student must demonstrate that he has understood the importance of the pharmacy, services and dispensing of medicines, considering the Italian and EU legislation. The student must demonstrate mastery of appropriate language and the use of precise terminology.
PART 2 - Students must demonstrate a solid theoretical and practical knowledge of the procedures required for the correct preparation and dispensation of galenical medicines.
They are expected to independently address issues related to the compounding of galenical preparations and to possess the core skills needed to manage professional pharmacy operations. Finally, students must be able to apply pharmaceutical-technological knowledge and current regulations to handle the various situations related to the practice of the pharmacy profession professionally and competently.