[Postmarketing surveillance in patients with cardiac pace-makers or automatic implantable defibrillators]. / Aspects généraux et réglementaires de la matériovigilance des stimulateurs et des défibrillateurs cardiaques.

This article includes an overview of the actual French control and regulation system of the safety alerts involving pacemakers and implantable cardioverter-defibrillator and an evaluation of the general information and trends about the characteristics of the reported incidents obtained in the last years in that field. The national security agencies have the mission to collect the data on safety and efficacy of medical devices but manufacturers, physicians and patients also have a role to play. The technical appreciation of the necessity of a notification is not easy in some cases but the lack of notification of a severe incident may lead to heavy penal consequences. If doubtful cases, one should keep in mind the spirit of these safety systems: a collective insurance against the risks related to the use of medical devices. In the 10 last years, the annual advisory rate was increased. The pacemakers were recalled more frequently than implantable cardioverter-defibrillators in absolute value but less frequently in relative value (advisories per 100 person-years). This increase may be related to the growing number of device implants and expanding indications for device therapy, to the increasing sophistication of the devices and to the modifications in the regulation aspects of these problems with a closer attention of users and physicians to the several types of malfunctions.

[Centralized preparation in the pharmacy of dilute solutions of ganciclovir: (Cymevan): work load change and economic potential]. / Préparation centralisée en pharmacie des solutions diluées de ganciclovir (Cymévan): prévision de la charge de travail et de l'économie potentielle.

The production of ganciclovir doses by a hospital pharmacy having the necessary facilities to reconstitute anticancer drugs would be of the utmost relevance regarding both protection of the nursing staff and therapeutic safety. As this activity is also economically worthwhile a large number of our colleagues would like to implement it. The aim of this work has was to take advantage of a 40 weeks production of ganciclovir dose by the pharmacy at Rangueil hospital in Toulouse so as to answer some of the questions raised by such a project. The savings achieved by the team at Brabois hospital in Vandoeuvre les Nancy could therefore be validated. They are expressed in fraction of flask per dose produced (0,265). Applied to the number of doses that we delivered over a 40 week period, this coefficient enabled us to estimate from the only datum which is initially available to us, namely the number of flasks used, the extra work load and the savings that could be made: given steady activity, the number of doses the pharmacy will have to prepare is equal to the number of flasks multiplied by 1.418 and, provided one opts for a production process mostly in batches, the savings will be equivalent to 37.5% of the flasks.

Differential regulation of serum growth hormone (GH)-binding protein during continuous infusion versus daily injection of recombinant human GH in GH-deficient children.

Serum GH-binding protein (GHBP) was evaluated in 2 randomly divided groups of prepubertal children presenting with idiopathic GH deficiency and receiving recombinant human GH, either continuously by sc infusion (group 1) or as 1 daily sc injection (group 2). After the first 6 months, group 1 switched from continuous infusion to daily injections for the following 6 months. There was no significant difference in clinical data, GH values, or GHBP levels between the 2 groups before treatment. During the first 6 months, GHBP levels increased in all except 1 of the 8 children in group 1 from 8.6% to 16.9% after 3 months and 22.5% after 6 months. The increment factor ranged from 1.1-7.9, with wide individual variations. In group 2, the mean variation in GHBP was from 8.3-8.2% after 3 months and 10.7% after 6 months. Only 2 of the 10 children in this group showed a significant increase in GHBP levels. During the second period, group 1 maintained their GHBP levels, whereas the 2 children in group 2 tended to a continued increase in their GHBP levels. There was no correlation with the increase in growth velocity, as children in both groups grew equally well, but higher insulin-like growth factor-I levels were found in group 1, although the difference between the two groups was not significant. These data show that GH can increase GHBP levels and that there is a differential effect depending on the mode of GH administration, although the reason for and the role of such regulation remains to be explained.