This course is finalized to acquisition of law’s aspects that govern the activity of manufactory, distribution and dispensing of drug. Jointly, are provided notion that concern the regulations of pharmacy and inherent the profession of phamacist. The course, also, is finalized to the knowledge of the main methods of analisys applicate to decisional process for the economic evaluation of drug and the features of market of pharmaceutical drugs.

PHARMACY AND MEDICINES LAW

Introduction to study of pharmaceutical regulation; general aspects of law; history of the pharmacy and of pharmacist’s profession; national and supranational bodys that are connect to the drug and to the health; European union; International pharmacopoeia; European pharmacopoeia and the Official Italian Pharmacopoeia and other book, not official, but of relevant technical content; health and health support in Italy and in the Union; National Health Service: general aspect and relationship with the pharmacy;  pharmacy and the pharmacist: technical, legal and professional aspects; organization of pharmaceutical service and administrative classification of the pharmacies; the hospital pharmacy; health professions and professional; Order of pharmacists; dispensing of drugs: technical and professional aspects; direct and be half distribution; the rule of drug: general aspects, active principles, industrial drugs, galenic drugs, Manufacturing authorisation, Marketing authorisation, applications for registration, Common technical document, the prints of drugs; orphan drugs and off-label use; digital healt and the traceability of drugs; pharmaceutical patent; generic drugs; biological and biosimilar drugs; note of vaccines and sera; pharmaceutical brand; oxigen and other therapeutics gas; medical prescription: who can precribe, what is possible to prescrive, how is possible to prescribe (repeat prescription, not-repeat prescription, restrictive prescription); Sop and Otc drugs; not saleble drugs to the public and “H type” drugs; the medical request; common dispensing errors; psychotropic drugs: classification, detention, dispensig, destruction; veterinary drugs: general aspects, rules aspects, drug that aren’t prescribable and usable, drugs usable only by veterinary doctor, veterinary’s prescription (rev), prescription of psychotropic drugs; substances to be kept in a locked cabinet (“poison drugs”) and their dispensing; herbal medicines; nods of homeopathic drugs; sale of substances as such; parallele trade, advertising, on-line commerce, intermediary distribution, pharmacy’s inspection.

PHARMACOECONOMICS

Introduction of pharmacoeconomics; general aspects of pharmacoeconomics; Health technology assessment; cost and outcome; modeling process; cost analisys and cost-result analysis (cost minimization analisys, cost of illness analisys, cost-efficacy analysis, cost-utility analysis); economic aspects of synthesis of new molecules and other aspects of drug industry; the italian, european and world pharmaceutical market; regional and national pharmaceutical policy; economic aspects of drug dispensing and of pharmacy.

D1-At the term of this formative activity, the student will must be able to:

1.  to know the general aspects of law;

2.  to know the basics of operating of National Health Service and other national or supranationals institutional organizations,  connect to health and to drug;

3.  to know the content, in general, of the Official Pharmacopoeia and other official books;

4.  to know the authorization path, italians or community, of production and marketing authorisation of the drug;

D2-At the end of this formative activity, the student must be able to:

1.  to move properly in the sector of drug’s law, putting, in appropriate way, the various rules in hierarchy’s source;

2.  to understand theoric and practice relevance of the various institution that are related to the drug’s world;

3.  to identify the path that everyone drug type may have done, from the ideation to commercialization;

4.  to manage, in the essential lines, the pharmacy, from a law-professional point of view with particular attention to manage of prescription drugs, of human’s drugs, veterinary drugs, narcotics drugs or medical devices;

5.  to understand why of a lot of economics choices that are related to the drugs or to the pharmacy.

5.  to know the regulations relative to preparation, management and dispensation of human drug and veterinary drug in pharmacy;

6.  to know the law that regulation the “pharmacy system”;

7.  to know the economics aspects of  drugs;

8.  to know some aspects of pharmaceutical marketing.

D-3

The student, at the end of course, must be able to know the main regulations of legal system, with special attention to regulation system of the drug. The student must be able to know the main regulations that interest the pharmacy, in order to know how to manage, althought in the essentials lines, the professional sector. The student, also, should be able to know and to value the economics aspect of drug’s throught the mains types of pharmacoeconomics analysis.

D-4

The student, at the end of course, must be able to descript the notions imparted and to espress with appropriate terminology.

D-5

At the term of training activity, the student must be able to find, to evaluate and place correctly the new regulations or notions.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

The lessons may be support by professionals of law or professional sector.

Teaching

Frontal teaching.

Course books

Study books:

Casettari-Barberini: Legislazione farmaceutica nella pratica professionale. Piccin ed., 2020 (testo in stampa):

Frongia-Casettari: Il galenista ed il laboratorio. Edra ed., 2019;

Fabrizio Gianfrate: Farmacoeconomia-La valutazione economica dei farmaci. Edra, 2015.

Reference books:

Paola Minghetti: Legislazione farmaceutica. Cea, 2018;

Nicoletta Lo Liscio: La farmacia. Un campo minato. Il manuale del farmacista, Soc. ed. Esculapio, 2020.

Giuseppe F. Ferrari, Fausto Massimino: Diritto del farmaco. Cacucci ed., 2015;

Tony Ellery, Neal Hansen: Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. John Wiley & Sons, 2012.

Assessment

Oral exam.

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.