84927 - Pharmaceutical Legislation and Pharmacoeconomics

Learning outcomes

At the end of the course the student possesses the specific knowledge to adapt his professional behavior, both for operation in pharmacies open to the public and in hospitals as well as in the pharmaceutical industry. In particular he knows the discipline of medicines in relation to their preparation, both galenic and industrial, in compliance with the Standards of Good Preparation of Medicines in Pharmacy (NBP) and Good Manufacturing Pratices (GMP). The student acquires the regulatory knowledge regarding sectors related to medicines such as cosmetics and nutraceuticals. He also acquires familiarity with the principles that regulate socio-political choices in health matters with particular reference to pharmaceutical expenditure.

Course contents

MEDICINAL REGULATION form
2022-2023 program
- Obligation to study the Pharmaceutical Regulations: Directive 2005/36 / EC on the recognition of professional qualifications.
-The European professional card.
- Evolution of the concept of health.
- Supranational bodies and their functions in the field of health (UN, WHO, EU).
- European Union regulatory sources (Directives, Regulations, Delegated Acts, Implementing Acts).
- Notes on the institutions of the European Union.
- The European Union Agencies: EMA, EFSA.
- The FDA.
- Definition of: jurisprudence, doctrine, jurisdiction.
- Hierarchy of Italian regulatory sources.
- Article 32 of the Italian Constitution.
- The "Pharmacy System".
- Discipline of medicinal products for human use manufactured by industry: Directive 2001/83 / EC: Code of medicinal products for human use and its implementing Legislative Decree: Legislative Decree 219/2006.
- Discipline of veterinary medicines manufactured by industry: Regulation 2019/6 / EU relating to Veterinary Medicines which repealed Directive 2001/82 / EC.
- Name of the medicinal product: invented, common, scientific.
- Definitions contained in the Legislative Decree 219/2006.
- Definition of medicinal product by presentation and function.
- EMA and AIFA.
- Authorization for the marketing of medicinal products (AIC) and procedures for obtaining it (national, mutual recognition, centralized and decentralized).
- The dossier for the AIC, the Common Technical Document and notes on clinical trials.
- The EPAR report.
- Quality, safety and efficacy of medicines manufactured by the industry: Good manufacturing practices (GMP).
- The prescription.
- The dematerialized recipe.
- The health card.
- Delivery of medicines in cases of urgency in the absence of a medical prescription: Ministry of Health Decree 31 March 2008.
- Drugs with narcotic and psychotropic action. Specific discipline: DPR 309/1990.
- Galenic medicines (magistral and officinal) their definitions and their specific discipline: Law 94/1998, so-called Bella's Law (art. 5).
- Quality, safety and efficacy of medicines prepared in Pharmacy: Standards of Good Preparation of Medicines in Pharmacy (NBP), F.U. XII.
- The current legislation and management of dangerous substances (poisons) in Pharmacy.
- Official Pharmacopoeia XII and its Tables.
- Consultation of Medicamenta and Martindale
- Homeopathic and anthroposophic medicines.
- ATC classification of medicines.
- Preparations and basis of herbal ingredients in Pharmacy (Note Prot. 600.12 / AG451 / 706, in relation to Circ. Min. Health n ° 3 of 18.7.2002.
- Disengagement of the Pharmaceutical Service: dispensing of industrial and galenic medicines in pharmacies, off-label medicines (use and prescription, art.3 law 94/1998), shipment of recipes, repeatable and to be renewed from time to time, medicines that do not require a prescription medical (SOP and OTC), generic or equivalent medicines, substitutability issues, the FDA Orange Book.
- Innovative medicines.
- Biosimilars
- The new National Medicines Tariff for magisterial preparations.
- Labeling of galenic preparations.
- Anti-doping legislation in Pharmacy.
- Day and night shifts in Pharmacies.
- The pan-European project to combat the spread of falsified medicines in Europe and timing of implementation.
- Difference between counterfeit medicine and falsified medicine.
- Regulation of the sale of medicines online in Europe by European pharmacies.
- Elements of Pharmaceutical Patenting: patentability requirements, European Patent and PCT system, the Complementary Certificate for the protection of medicines, the pediatric extension, limits of the biotechnological patent.
- Official definitions of products other than medicines dispensed / sold in pharmacies and respective legislation: medical devices, medical-surgical aids, cosmetics, foods intended for a particular diet (dietetics, supplements).
- Ownership and management of the pharmacy (historical notes).
- Eligibility for ownership of a pharmacy.
- The responsibilities of the pharmacist: civil, criminal, administrative and ethical.
- Application of art. 443 of the criminal code (broken or imperfect medicines) to expired medicines.
- Healthcare professions and arts.
- Professional Order, registration in the Register.
- Professional ethics, Code of ethics and Pharmacist's oath
- Articulation of the pharmaceutical service: from the TULS to the Law 27/2012 on liberalization.
- Territorial location of Pharmacies (organic plant of pharmaceutical offices and areas, one pharmacy for every 3300 inhabitants).
- Urban and rural pharmacies, ordinary and seasonal dispensaries, branch pharmacies.
- Evolution of the "Pharmacy system": the Pharmacy of services.

PHARMACOECONOMY module
2022-2023 program
General principles of Pharmacoeconomics
Outcome and input
Pharmacoeconomic analysis: cost-minim

Readings/Bibliography

MAURIZIO CINI - PATRIZIA RAMPINELLI: Principles of Pharmaceutical Legislation - Ed. Minerva Medica (Turin).
PAOLA MINGHETTI: Pharmaceutical Legislation - Ambrosiana Publishing House (Milan).
BRUNO RICCARDO NICOLOSO - LAURA GIORDANI - MICHELE JOMMI:
1) The responsibilities of the Pharmacist in the "Pharmacy System";
2) The territorial planning of the "Pharmacy System";
3) The organization and ethics in the "Pharmacy System"

Teaching methods

LECTURES

Assessment methods

ORAL EXAMINATION with the possibility of presentation in pptx of a topic concerning the legislation of medicines

Office hours

See the website of Patrizia Rampinelli

See the website of Leonardo Marchitto