Study-unit PHARMACEUTICAL NORMATIVE AND PHARMACOECONOMICS
| Course name | Pharmacy |
|---|---|
| Study-unit Code | A000531 |
| Location | PERUGIA |
| Curriculum | Comune a tutti i curricula |
| Lecturer | Valeria Ambrogi |
| Lecturers |
|
| Hours |
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| CFU | 8 |
| Course Regulation | Coorte 2021 |
| Supplied | 2024/25 |
| Supplied other course regulation | |
| Learning activities | Caratterizzante |
| Area | Discipline chimiche, farmaceutiche e tecnologiche |
| Sector | 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, health technology assesment, classification of medicines for reimbursement purposes. |
| 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, Farmacopea Europea. The teaching material presented in class is not a substitute for the reference texts, but a supplement to them and constitutes a guide for the selection and understanding of the topics. |
| 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 an oral 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. |
| 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 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. |