Use of intravenous immunoglobulins in clinical practice: data from three French university hospitals.

Since several years, the use of intravenous immunoglobulins (IVIg) has increased. This growth has encouraged some countries to publish guidelines. In parallel, some countries have conducted audits to know how IVIg are used in clinical practice in the light of the available guidelines. The objective of this study was to assess IVIg use in three French university hospitals in 2006. All IVIg administrations were evaluated during 6 months (12 September 2005-12 March 2006) in French university hospitals of Marseille. Different data were recorded for each administration: patient characteristics, indication, formulation and quantity. During the study period, 2802 administrations of IVIg (corresponding to a total quantity of 76 780 g) have been recorded. Four hundred and thirty-five patients received at least one of these administrations. The five most reported indications were multifocal motor neuropathy (11.0% of total quantity), chronic inflammatory demyelinating polyradiculoneuropathy (10.2%), corticoresistant dermatomyositis (10.2%), immune thrombocytopaenia (9.9%) and primary immune deficiency (9.1%). According to available French recommendations, 70% of the IVIg use was for 'acknowledged indications', 9% for 'indications to be assessed' and 18% for 'unwarranted indications'. The 10 most reported indications were 'acknowledged indications' according to available recommendations of the French expert group. Nevertheless, the two most reported indications were not approved by the French Health Products Agency (AFSSAPS) at the time of the study and were approved since.

Ongoing pharmaceutical reforms in France: implications for key stakeholder groups.

The rapid rise in pharmaceutical costs in France has been driven by new technologies and the growing prevalence of chronic diseases as well as considerable prescribing freedom and choice of physician among patients. This has led to the introduction of a number of reforms and initiatives in an attempt to moderate expenditure whilst ensuring universal coverage and rewarding innovation. These reforms include accelerating access to and granting average European prices for new innovative drugs, delisting drugs where there are concerns over their value and instigating rebates for excessive prescribing. Alongside this, ongoing initiatives to improve the quality and efficiency of prescribing include programmes to enhance generic prescribing and dispensing as well as to reduce antibacterial and anxiolytic/hypnotic prescribing. However, there have been few publications documenting the impact of specific reforms on the overall costs and quality of care, which have been exacerbated by compartmentalization of budgets. Estimates suggest savings of over 27 million euro/year by decreasing antibacterial prescribing, 450 million euro/year by not reimbursing ineffective drugs, 670 million euro/year from pharmaceutical company rebates and approximately 1 billion euro/year from increased prescribing and dispensing of generics (year 2003-7 values). Additional savings of at least 1.5 billion euro/year are seen as being possible from increased use of generics such as generic proton pump inhibitors, statins (HMG-CoA reductase inhibitors) and ACE inhibitors instead of current branded products such as angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]). Delisting drugs when there are concerns about their value provides an example to other countries with currently limited demand-side measures. Other possible examples include price : volume agreements and multifaceted campaigns to enhance generic prescribing and dispensing and reduce antibacterial prescribing. Possible future initiatives could include adopting more stringent criteria for categorizing new drugs as innovative as well as further reductions in the prices of generics. Other initiatives could include further enhancement of the quality and efficiency of prescribing, including formal auditing of physician prescribing, as well as increasing efforts to monitor the risk : benefit ratio of new drugs post-launch in real-world practice.

Use of various models for in vitro percutaneous absorption studies of ultraviolet filters.

BACKGROUND: The percutaneous absorption test aims to estimate the passage of a substance across the skin. The absorption process can be described in three steps: (a) penetration of a substance into the skin layer, followed by (b) penetration from one layer into another (permeation) and finally (c) resorption into the vascular system. In vivo and in vitro models are available but owing to ethical reasons as well as the latter providing greater feasibility, in vitro models are preferred. AIMS: This present study reviews the natural membranes (human skin and animal models: pig, rabbit, rat, hairless mouse, guinea-pig and mouse), artificial skin equivalents and synthetic membranes that are currently being used for in vitro percutaneous absorption studies of UV filters, in order to provide the researcher with a greater insight when selecting membrane models for given experimental conditions.

A new small volume holding chamber for asthmatic children: comparison with Babyhaler spacer.

When a new holding chamber for administrating inhaled medication is to be marketed, it needs to be compared with existing chambers with two questions in mind: is this chamber well accepted by patients and is there an in vitro equivalence? We compared the new small volume non-electrostatic valved holding chamber, usable with all pressurized metered-dose inhalers and equipped with a funny facemask, Vortex (Pari GmbH, Germany), to the most frequently prescribed holding chamber in France, Babyhaler (GlaxoSmithKline Laboratories). Preferences were studied for 75 families with a child no more than 4 yr old, using standard questionnaires. An in vitro study assessed the delivered dose and the particle size distribution of two HFA beclomethasone dipropionate pressurized metered dose inhalers (Becotide 250 microg per dose and Nexxair 100 microg per dose) by dose uniformity sample apparatus and cascade impactor according to the European Pharmacopoeia. Vortex was preferred by 95% of the families because of its small size, its duck facemask, and its robust appearance. Among children able to give their opinion, 86% preferred Vortex to Babyhaler. In vitro, both holding chambers reduced the delivered dose of beclomethasone dipropionate and increased the quantity of particles smaller than 5 microm in diameter with both medications. A higher proportion of fine particles was obtained with Nexxair than with Becotide (p < 0.05) and with Vortex than with Babyhaler (p < 0.05). As expected, throat deposition is dramatically reduced for both drugs with both holding chambers. The in vitro difference in the particle size distribution of beclomethasone dipropionate with both holding chambers probably has no clinical influence.

[Pharmaceutical development aimed at improving safety for children]. / La galénique au service de la sécurité chez l'enfant.

The safety of paediatric drugs should be improved so that the number of child deaths due to the misuse of different kinds of medication can be decreased. Formulations, excipients and containers are the major areas that should be optimised in the pharmaceutical development of a paediatric drug. Today, Afssaps (Agence française de sécurité sanitaire des produits de santé) and the European regulations play a major role in promoting paediatric medications.