B2842 - Pharmaceutical Legislation with Laboratory of Galenic Preparation (Gr. B)

Learning outcomes

At the end of the course, which includes practical activities in the laboratory, the student:

- acquires the knowledge and ability to understand the legislative and deontological aspects related to the  profession of pharmacist in Italy;

- learn to prepare officinal and magistral preparations (personalized therapies);

- applies the acquired knowledge to  prepare  the main pharmaceutical dosage forms (powders, capsules, granules, tablets, solutions, suspensions, emulsions, semi-solid preparations for skin application, suppositories).

Course contents

PHARMACEUTICAL LEGISLATION (24 hours)

• Elements of national and supranational pharmaceutical legislation.
• The Italian healthcare system (SSN). Healthcare professions.
• Organization of pharmaceutical services. Classification of community pharmacies. Territorial planning of pharmacy services.
• Practice of the pharmacy profession:

1) Community pharmacy practice;

2) The Italian Official Pharmacopoeia (with particular reference to its Tables) and other pharmacopoeias;

3) Good Preparation Practices (GPP) for medicinal products prepared in pharmacies;

4) Classification of medicinal products for human use according to origin, Anatomical Therapeutic Chemical (ATC) classification, dispensing regulations, and reimbursement/prescription within the Italian National Health Service (SSN);Prescriptions for medicinal products for human use: repeatable prescriptions (RR), non-repeatable prescriptions (RNR), prescriptions subject to restricted medical prescription (RL), and SSN prescriptions;

5) Legislation on narcotic drugs and psychotropic substances;

6) Regulations on poisonous substances;

7) Medicinal products with doping properties;

8) Veterinary medicinal products.

9) Professional ethics.

10)Legislation on medical devices and plant-based products.

11) Regulations on the "Farmacia dei servizi"

Module 2: LABORATORY OF PHARMACEUTICAL FORMULATION AND QUALITY CONTROL (60 hours)

Students are divided into two groups (Group A: Prof. Passerini and Group B: Prof. Albertini).

The laboratory program focuses on the preparation of official and magistral medicinal products, including formulations intended for personalized therapies.

The introductory lecture covers prescription processing procedures, preparation documentation requirements, and regulations concerning the pricing and labeling of compounded medicinal products.

Laboratory practical sessions include the preparation and quality control of the following pharmaceutical dosage forms:

• Solid dosage forms: oral powders, topical powders, granules, and tablets;
• Liquid preparations: solutions, medicated syrups, emulsions, and suspensions;
• Semisolid preparations for topical application: ointments, creams, gels, and pastes;
• Suppositories and vaginal pessaries.

Readings/Bibliography

1) P. Minghetti, M. Marchetti. Legislazione farmaceutica. Decima edizione. Casa Editrice Ambrosiana (2021).

2) E. Ragazzi. Galenica Pratica. Formulazione e Tecnologia. Libreria Internazionale Cortina, (2006).

3) F. Bettiol. Manuale delle preparazioni galeniche. V edizione. Tecniche Nuove (2022)

4) H.C. Ansel, S.J. Stockton. Principi di calcolo farmaceutico. 15 Ed. Edra (2017).

Teaching methods

Lectures (24 hours) and laboratory (60 hours).

As concerns the teaching methods of the laboratory unit, all students (including all the international incoming exchange students, i.e. ERASMUS) must attend Module 1, 2 online [https://www.unibo.it/it/servizi-e-opportunita/salute-e-assistenza/salute-e-sicurezza/sicurezza-e-salute-nei-luoghi-di-studio-e-tirocinio], while Module 3 on health and safety is to be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme ("studiare"--"formazione obbligatoria su sicurezza e salute").

The attendance requirement is considered fulfilled upon attendance of at least 60% of the lectures and 80% of the laboratory practical sessions. Attendance is recorded through the University's student attendance application.

Assessment methods

Learning is assessed through a single oral exam in italian language, during which students' knowledge of the topics covered in both modules will be evaluated. To pass the exam, students must obtain a minimum passing grade (18/30) in both modules.

 

Teaching tools

https://virtuale.unibo.it

Office hours

See the website of Nadia Passerini

See the website of Beatrice Albertini