Unit PHARMACEUTICAL NORMATIVE AND PHARMACOECONOMICS
- Course
- Pharmacy
- Study-unit Code
- A000531
- Location
- PERUGIA
- Curriculum
- In all curricula
- Teacher
- Valeria Ambrogi
- Teachers
-
- Valeria Ambrogi
- Hours
- 94 ore - Valeria Ambrogi
- CFU
- 8
- Course Regulation
- Coorte 2019
- Offered
- 2022/23
- Learning activities
- Caratterizzante
- Area
- Discipline chimiche, farmaceutiche e tecnologiche
- Academic discipline
- CHIM/09
- Type of study-unit
- Obbligatorio (Required)
- Type of learning activities
- Attività formativa monodisciplinare
- Language of instruction
- Italian
- Contents
- Pharmacopoeias, technological tests for controlling quality according to Pharmacopoeias, Prescriptions rules. - D.L.vo 219/2006. Classification of pharmacies. Organization of NHS and pharmacist's role. Pharmacoeconomics: Principles, Methods, and Applications.
- Reference texts
- Barberini G., Cassettari L.
Legislazione farmaceutica nella pratica professionale
Piccin, 2021
Minghetti P.
Legislazione farmaceutica,
IX ed. CEA, Zanichelli 2018
Farmacopea Ufficiale Italiana edizione vigente.
Farmacopea Europea edizione vigente.
Il materiale didattico presentato a lezione non è sostitutivo dei testi di riferimento, ma integrativo di questi e costituisce una guida per la selezione e la comprensione degli argomenti da trattare. - Educational objectives
- Acquisition of theoretical knowledge about laws and their application regarding the pharmacist profession in all its aspects.
- Prerequisites
- Basic notions of pharmaceutical technologies and galenic preparations
- Teaching methods
- Face to face and practical lessons and practical lessons
- Other information
- Lessons are taught at the Department of Pharmaceutical Sciences according to the calendar published on the appropriate website.
For information on support services for students with disabilities and / or DSA visit the page http://www.unipg.it/disabilita-e-dsa - Learning verification modality
- The exam consists of a written and an oral tests which take place in the same session. The written exam consists of multiple choice quiz concerning topics discussed during course. This kind of test allows to verify the student's ability to apply theoretical knowledge by adopting a mode of examination similar to that provided in many public selections.
The oral test is taken after the written test. It consists on a discussion-interview on the topics discussed during the course. The test lasts about 30 minutes , but it depends on the performance of the test itself. The oral test aims at verifying the level of knowledge and understanding, as well as synthesis, achieved by the student. Moreover this oral test will verify if the student is able to communicate, his property of language and exposure on the topics studied.
To pass the exam it is necessary to report an evaluation of at least 18/30 for both tests. - Extended program
- Introduction to the course and importance of legislation in the pharmacy sector. Directive 2005/36 / EC relating to the recognition of professional qualifications and subsequent amendments.
Italian Pharmacopoeia and main pharmacopoeias in the world, Pharmacopoeia and quality of medicinal products, technological assays for the quality control of medicinal products (control of fundamental and derived properties of powders, technological assays for tablets, capsules, granulates (disaggregation test, dissolution test), bioavailability and bioequivalence.
Elements of supranational and national law.
Supranational health institutions (WHO, EU), European Union agencies with particular reference to the EMA. Health organization in Italy (Ministry of Health, Istituto Superiore di Sanità, Consiglio superiore di Sanità, AIFA, national health service, regional institutions, ASL).
Exercise of the profession of pharmacist and related professional orders, ethical code of the pharmacist.
Administrative classification of pharmacies and territorialisation system, organization of pharmacies open to the public, ownership, transfer, provisional management, inspections, pharmacy services, sale of non-medicinal products.
Rules relating to the production and sale of medicines for human use (D.L.vo 219/2006 and successive amendments): definition of a medicine, medicines of industrial origin and preparations prepared in a pharmacy, production authorization, marketing authorization, Dossier, equivalent medicines, presentation, scientific information, pharmacovigilance, pharmaceutical patents. Wholesale distribution, medicinal gases
Dispensing to the public of medicinal products for human use, supply regime, regulations regarding the sector of psycotropic and narcotic drugs, poisons, and doping medicines, reimbursement and price of medicines, dispensing of the service under the National Health Service.
Rules concerning veterinary medicines, homeopathic medicines.
Official definitions of products supplied / sold in pharmacies other than medicines and respective concepts / regulatory provisions with reference to cosmetics, foods intended for particular nutrition (dietetic, supplements), preparations based on herbal ingredients.
The pharmacist and the NHS.
Pharmacoeconomics, definition, costs, effects and main analysis techniques.
Pharmacoutilization, ATC classification system, therapeutic appropriateness
Exercises concerning the technological controls of industrial medicines and shipment of galenic preparations containing drugs, poisons and dopants.