This course is aimed at acquiring the regulatory aspects that govern the activity of manufactory, distribution and dispensing of the drug. Jointly, notions, regarding pharmacy regulation and the profession of the pharmacist, are provided. The course is also aimed at the knowledge of the main methods of analisys applied to decision-making process for the economic evaluation of drug and the characteristic of the pharmaceutical products market.

PHARMACY AND MEDICINES LAW

Introduction to study of pharmaceutical regulation; general concepts of law; history of the pharmacy and the profession of pharmacist; national and supranational organizations related to drugs and health; the European union; the International pharmacopoeia; the European pharmacopoeia and the Official Italian Pharmacopoeia and other text, not official, but of relevant technical content; health and healthcare in Italy and in the European Union; National Health Service: general aspect and relationship with the pharmacies; the 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 the drugs: technical and professional aspects; direct and on-account distribution; drug legislation: general aspects, active ingredients, industrial medicines, galenic medicines, Production Authorisation, Marketing Authorisation, registration applications, Common technical document, printer matter; orphan drugs and off-label use; digital health and drug traceability; counterfeiting and falsification of medicines (hints); the Falsified Medicines Directive (2011/62 / EU); pharmaceutical patent; generic medicines; biological and biosimilar medicines; notes of vaccines and serum; pharmaceutical brand; oxygen and other therapeutics gases; medical prescription: who can precribe, what can be prescrive, how is possible to prescribe (repeateable, non-repeteable, limiting prescriptions); Sop and Otc drugs; drugs that cannot be sold to the public and the “H range”; limitative notes, treatment plans, the medical request; common dispensing errors; narcotic drugs: classification, posession, dispensig, destruction; veterinary drugs: general aspects, drugs that cannot be prescribed or used, drugs usable only by veterinary doctor, veterinary prescription (rev), prescription of narcotic drugs; the substances to be kept in a locked cabinet (“poison drugs”) and their dispensing; herbal medicines; notes of homeopathic medicines; the sale of substances as such; the parallele trade, advertising, on-line commerce, intermediate distribution, pharmacy inspection.

PHARMACOECONOMICS

Introduction of pharmacoeconomics; general aspects of pharmacoeconomics; Health technology assessment; cost and outcome; the modeling process; cost-analysis and cost-outcome analysis (cost minimization analysis, cost of illness analysis, cost-effectiveness analysis, cost-utility analysis); economic aspects of synthesis of new molecules and other aspects of pharmaceutical industry; the Italian, European and world pharmaceutical market; regional and national pharmaceutical policies; economic aspects of drug dispensing and of pharmacy.

Bridging courses are not required.

D1 - KNOWLEDGE AND UNDERSTANDING

At the end of this training activity, the student must demonstrate that he is able to:

1. know the general aspects of law;

2. know the operating bases of the National Health Service and of other institutional, national and supranational bodies related to health and pharmaceuticals;

3. know the general content of the Official Pharmacopoeia and other official texts

4. know the Italian and European authorization process for the production and marketing of the drug;

5. know the legislation relating to the preparation, management and dispensing of human and veterinary drugs in pharmacies;

6. know the rules governing the "pharmacy system";

7. know the economic aspects of drugs;

8. know some aspects of pharmaceutical marketing.

D2- ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING

At the end of this training activity, the student must demonstrate that he is able to:

1. move correctly in the sector of pharmaceutical legislation, putting the various rules in the hierarchy of sources in an appropriate manner;

2. understand the theoretical and practical importance of the various institutions related to the world of drugs;

3. identify the path that each type of medicine may have done, from its conception to its marketing;

4. know how to manage, in essential lines, the pharmacy, from a regulatory-professional point of view, with particular attention to the correct management of prescriptions of drugs for human use, veterinary drugs, narcotic drugs;

5. understand the reasons for many economic choices inherent in the world of drugs and pharmacies.

D3-AUTONOMY OF JUDGMENT

At the end of the course, the student must be able to know the main aspects of the legal system, with particular attention to the regulatory system of the drug. The student must be able to know the main regulations affecting the pharmacy, in order to be able to correctly manage, albeit in essential lines, the professional sphere. The student will also have to demonstrate knowledge and evaluation of the economic aspect of the drug market, through the main types of pharmacoeconomic analysis.

D-4 COMMUNICATION SKILLS

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

D-5 LEARNING ABILITY

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., 2021;

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

The assessment of knowledge includes an oral exam of mean duration of half an hour. The legislative knowledge concerning the industry, the drug as well as the activity of the pharmaceutical service at the community pharmacy will be investigated. The exam includes some pharmacoeconomics questions.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.