Abstract

NON STERILE CLINICAL GALENIC LABORATORY: A SCIENTIFIC DISCIPLINE BETWEEN LABORATORY PRACTICE CLINICAL PHARMACY AND PERSONALIZED PHARMACOLOGICAL THERAPY. THE SEMPLIFIED NORMATIVE RULES NBP IN ITALY

*Luisetto M., Khaled Edbey, Riccardo Benzi Cipelli, Fiazza C., Mashori Gulam Rasool, Nili B. Ahmadabadi, Cabianca L. and Oleg Yurevich

ABSTRACT

Observing the today hospital practice in many countries and the international literature involved it is clear How clinical pharmacy is linked to the galenic laboratory practice. Today more then recent past due to the various kind of magistral formula request by the clinicians It is necessary that the clinical pharmacist perpesctive must to be added to the classic GALENIC laboratory competencies: this make possible to complete the profile of efficacy and safety of this fundamental Drugs. The clinical galenic activity is divided in sterile and Non sterile. (Total parenteral nutrition bags, Pain therapy, oncological parenteral drugs laboratory, radio drugs and diagnostics, non sterile galenics). Aim of this work is to deeply investigate this crucial link (CLINICAL PHARMACY with LABORATORY PRACTICE) in order to get the really best clinical results for the patiens. Clinical pharmacy principle, PHARMACEUTICAL care, managerial competencies and personalized pharmacy added to the best knowledge and competencies in galenic laboratory make the difference in order to obtain the right final clinical results. The same in this work are submitted to international pharmacy practioner, directors and researcher the Normatives rules operating in an advanced country: the semplified NBP, example that can be applied also in non advanced nations. In italy pharmacist can follow or the full NBP of the official pharmacopeia or the semplified according DM Salute 18.11.2003. (related the kind of galenic formula if sterile or not) The NBP (good manifacturing rules) introduce an QUALITY SYSTEM MANAGEMENT. The full NBP are more used in more complex laboratory in example involved in specialistic products Like oncologic or radiopharmaceutical and other. Aim of this rules is to guarantee quality, security and efficacy of a drug prepared in galenic lab. This are based on resonsability principles, plan, docuemntation of all activity.(QUALITY SYSTEM OF INSURANCE) All phases of the preparation are under the responsability of the pharmacist. The final quality depends on the correct use of API and eccipients, right calculations operation, right volume or weight operation, procedure following. Check on the final products: folowing of the procedure, aspetcs, pakaging and its closure. According NBP the laboratory must to be separated (or it must to be separable ) form the pharmacy and a second pharmacist (that is different form the pharmacist that prepare) must to check the final preparation. The locals must to be according striclty enviromental condition to make possible to prepare in safety way the drugs. And it is mandatory must to be followed written procedure. (instrument verify, training of the pharmacist Cleaning procedure, sanifications). Raw material certifications, technical sheet, safety sheet. Working sheet is mandatory. The pharmacist can follow this two option related the kind of drugs produced and the characteristic of the laboratory. It is not the main focus of this work to produce a literal translation of DM 18/11/03 only to submit its general meanings. This can be considered for the authors useful to be added also to the normative rules in force in non advanced countries.

Keywords: Galenic laboratory, magistral formula, clinical pharmacy, pharmaceutical care, personalized pharmacy, Medicine shortage,NBP, semplified rules, official pharmacopeia, control process, quality management system, Rare disease, 3d PRINTING systems.