Giuliani: "We focus on quality and efficacy by reducing complications and hospitalization"
Hospital pharmacists from all over Italy will meet in Catania next Tuesday and Wednesday (January 29 and 30) to discuss a highly topical issue: "Quality, safety and efficacy of medicines". Among the other representatives of the Istituto Superiore di Sanità, Italian pharmacology will be present with microbiologists, infectious disease specialists and pharmacoeconomists. "Often, in hospitals, when therapy is undertaken, we tend to forget that it is the result of a complex and articulated process, which cannot and must not be deficient at any time", explains Dr. Luigi Giuliani, head of the Pharmacy of the Major University Hospital of Charity of Novara. The appropriateness of use is fundamental: in treatments, in addition to being decisive for the choice of the best therapeutic alternative for each pathology, the quality and safety profile of a drug are always of fundamental importance. At the root of many cases of treatment failure and side effects are errors in the choice of a drug or in its administration. "It is essential to respect the conditions of dose, dosage, route of administration, type of patient, in order to be able to define a therapy as appropriate and the quality of the drug plays an important role", specifies Giuliani who will address the issue of "particle contamination" in Catania formulations that are administered directly into a vein (parenteral). The importance of quality for these medicines is even more felt because the pharmaceutical form (powder to be solubilized in an aqueous vehicle) can lead to the presence of any subvisible particles (particulate) due to chemical reactions or contaminations that may occur during production, storage or drug reconstitution. Various clinical evidences indicate that the presence of low levels of particulate matter in intravenous treatments determines a lower risk of adverse events and, for these reasons, the official Pharmacopoeia (both the US and the European one) admits very low particulate levels». Particular attention in Catania will be given to antibiotic therapy in the hospital and to the fact that often an inappropriate use of antibiotics causes the development of bacterial resistance which also represents enormous damage to the community and delays healing, resulting in an increase in hospitalization and costs hospitallers. «The patient's reactions to administration must be carefully analyzed and the quality of the drugs to be used, as indicated by the pharmacopoeia itself, is an essential element. The quality and safety of the drug - says Dr. Giuliani - are the result of rigor in terms of research, production and administration". Each new medicinal product must successfully pass the tests of preclinical experimentation (studies on in vitro biological systems, laboratory animals and tests of a chemical, physico-chemical and biochemical nature), clinical phase I (which defines a first dosage range, studies the main pharmacokinetic parameters and verifies the tolerability level in humans), phase II (to confirm the therapeutic efficacy, as well as the preliminary tolerability profile in the patient); and phase III (influence of the drug on the course of other pathologies and possible interaction with other drugs). Once marketed, the drugs are subjected to a constant monitoring system headed by the various national regulatory agencies (in Italy Aifa). The cost, in a system that intends to adopt
