LEGISLAZIONE ED AMMINISTRAZIONE FARMACEUTICHE E CHIMICA DEI PRODOTTI COSMETICI CON ESERCITAZIONI

With regard to the legislative part, the course aim to provide knowledge on national and supranational governing the withdrawal of the private and public pharmaceutical service.

The part of the pharmaceutical administration is intended to prepare the student to practical management (regulatory and economic) of the pharmacy.

The part of chemistry of cosmetic products aims to make students gain the basic knowledge of the physico-chemical, technological and functional properties of the main classes of cosmetic products; to provide students with the basic notions of legislation and marketing of cosmetic products.

Lectures and practical exercises in laboratory for the course of Cosmetic Products Chemistry.

PROGRAM

PHARMACEUTICAL LAW

National and International Health Organization

(O.M.S., European Union, ONU, F.I.P.).

National Health Service

Law 833/78 and and succeeding modifications. Organs of the State, the Region and responsibilities of the Local Health Units. Italian Drug Agency (AIFA). Convention for the delivery of pharmaceutical care. The pharmacist in A.S.L. and hospitals.

Practice of health professions and arts, and activities subject to health surveillance

Orders and Provincial Colleges. Requirements, registration in the professional register. Disciplinary power of the Order. Professional ethics. Regional Federations, National Federation (F.O.F.I.), National Institute of Security and Support Pharmacists (E.N.P.A.F.).

The exercise of the profession of pharmacist

Practice of pharmacy. Shipping recipes. Official Italian Pharmacopoeia XII ed. National Rates of medicines. Holding and shipping of poisonous substances. Mandatory equipment in pharmacy (substances, equipment, registers and documents).

Discipline of the inspections

Definition and general characteristics of the inspection. Types of inspections (preventive, ordinary and extraordinary). Inspection of A.S.P. Self-inspection of the pharmacy.

Professional skills and responsabilities of the pharmacist

Criminal, administrative, civil and disciplinary responsabilities. The sanzionatory system.

Regulations on the Pharmaceutical Service

Public and private pharmacies. Classification of private pharmacies (urban and rural). Territorial pharmacy regulatory (Pianta Organica). Alternative systems (branch pharmacy, interim management, dispensary).

Assignments of pharmaceutical sites that had become vacant or newly created (competitions, duties of successor pharmacist in the vacant pharmacy).

The management of the Pharmacy

Management of the private pharmacy. Corporate management. Informal and formal replacing of the owner.

Regulation on the manufacturing and trade for medicinal products for human use

Administrative classification of medicinal products for human use. Industrial medicinal products: AIC, pre-packaged drugs, industrial products other than the product. Generics. The pharmacovigilance activities. A.I.F.A. and E.M.A.

The code applies to dispense medicinal products for human use to the public

System of dispensing medicinal products to the public: repeatable prescription (RR), non-repeatable (RNR),

limitative (RL), ministerial tracing prescription (RMR). Medicines obtained without a prescription: OTC (Over the Counter) and SP.

Rules relating to the promotion and the presentation of medicines

Generality, scientific information to health professionals, publicity to the general public. The presentation of the medicinal product: package insert and label.

Regulations concerning narcotic and psychotropic substances

D.P.R. 309/90 and subsequent modifications (Testo Unico of the laws on the regulation of drugs and psychotropic substances).

Law 8 February 2001, n. 12 (Regulations to facilitate the use of analgesic opioids in pain therapy).

Law of 21 February 2006, no. 49

Medicinal products for veterinary use

Administrative classification. System of dispensation.

Rules concerning the Medical and Surgical Products, Medical devices and Sanitary Stuff

Rules concerning the field of homeopathic, dietary and herbal remedies

PHARMACEUTICAL ADMINISTRATION

Computerized management of the pharmacy

Ministerial updates. Management of the orders, storage and stocks. Statistics. Charging of the magistral preparations and prescription SSN. Websites of interest in healthcare and pharmaceuticals. Databases.

Supply of medicines

Supply of medicines from the manufacturer and the intermediate distribution (deposits and wholesalers). Sales, commercial margin and reloading.

The merchandising in pharmacy

Definition, objectives and functions.

The stock management

Stocks, turnover rate, returns to vendors, monitoring deadlines, ASSINDE expired or not.

The economic management of the pharmacy.

Private pharmacy and conventional relationship with SSN

National collective agreement for the regulation D.P.R. July 8, 1998.

CHEMISTRY OF COSMETIC PRODUCTS WITH PRACTICAL EXERCISES

Course syllabus

Marketing and legislation of cosmetic products

Definition of the cosmetic products according to the European legislation; evaluation of the safety and the effectiveness of cosmetic products; the Italian and the European cosmetic markets; cosmetic product advertisement.

The skin and its appendages

Structure and physiological functions of the skin and its appendages (sweat and sebaceous glands, hair, nails). The hydro-lipidic film. The natural moisturizing factor (NMF). Biosynthesis of melanin: mechanisms and functions. Percutaneous absorption of cosmetic ingredients.

Cosmetic raw materials

INCI and CTFA nomenclatures.

Oils, fats and waxes: characteristics and uses. Surfactants and emulsifiers: definitions, classifications, characteristics and uses. Rheological additives: characteristics and uses. Cosmetic preservatives and antioxidants. Colors and pigments. Perfumes and fragrances. Active compounds used in the cosmetic fields.

Basic cosmetic formulations

Characteristics, preparations and uses of cosmetic monophasic systems: aqueous and hydroalcoholic solutions; oil solutions; surfactant-based systems; aqueous and oil gels; powders; molded anhydrous lipids.

Characteristics, preparations and uses of cosmetic biphasic systems: O/W emulsions, W/O emulsions; anhydrous and hydrated pastes.

Characteristics, preparations and uses of cosmetic colloidal systems: liposomes, cyclodextrins, nanoparticles.

Personal care products

Skin care products; bath products; hair care products; sunscreen products; deodorants and antiperspirants; dentifrices.

Make-up products

Face and eye make-up products; lipsticks; nail preparations.

M. Marchetti, P. Minghetti - LEGISLAZIONE FARMACEUTICA - Ambrosiana 9°Ed.

R. Giampietri - Farmacia @ Marketing -Editoriale Giornalidea 1992.

C. Ludioni, P. Minghetti - Economia e normativa del farmaco - Casa Editrice Utet 1998.

F. Angeli - La domanda di salute in Italia (1989).

Massimiliano du Ban - La qualità in Farmacia - Editoriale Giornalidea 1999.

F.U.I. Edizione XII

Updates are available on the professor's site: http://www.fdf.unict.it/facoltà/docenti