[Pharmaceutical supply of human plasminogen replacement therapy for the treatment of ligneous conjunctivitis: Logistics for a university hospital]. / Approvisionnement hospitalier en plasminogène humain substitutif pour le traitement de la conjonctivite ligneuse : comment faire en pratique ?

In order to treat a pediatric patient with ligneous conjunctivitis secondary to congenital plasminogen deficiency, a supply of topically administered replacement human plasminogen has been required. In the absence of market approval, this blood-derived drug is managed by a temporary authorisation for nominative use, allowing monthly hospital dispensations. To ensure regulatory compliance and proper use of the drug, it took two years of interactions between various hospital departments and the laboratory to define the pharmaceutical supply chain in our hospital and allow the patient to receive treatment. The main difficulties lie in respecting the cold chain of this drug stored frozen in the bottles not ready for use. Transportation from the laboratory to the patient's home via the hospital pharmacy is carried out in calibrated conditions, ensuring a temperature below -20°C for 72h. Reception and dispensing steps were combined into a single pharmaceutical service in order to optimise transport time while ensuring the safety and traceability of the drug lots. Each month, a date is scheduled between the hospital pharmacy, the laboratory and the family to ensure that delivery and dispensing take place on the same day. Appropriate use and handling are explained to the family. However, two issues remain to be addressed by the manufacturer to facilitate future use of human plasminogen: the thermostability problem, which does not allow stays away from home longer than three days, and self-administration by the child, which is unlikely to be feasible due to handling difficulties.

[Use of calcium channel blockers (CCB) for tocolysis in France and abroad]. / Utilisation des inhibiteurs des canaux calciques (ICC) en tocolyse en France et à l'étranger.

OBJECTIVES: Calcium channel blockers (CCB) are routinely off-label used for tocolysis. The purpose of this study is to establish an inventory of the use of CCB for tocolysis in France and abroad. MATERIALS AND METHODS: Four complementary approaches were performed: (i) a literature review of clinical practice and guidelines of scientific societies; (ii) a national declarative practice survey among French tertiary care centers; (iii) a regional declarative practice survey among all maternities of the Midi-Pyrénées Perinatal Network (MATERMIP); (iv) an evaluation of outpatient tocolysis prescription, analyzing the departmental database EFEMERIS in order to examine drug prescribing during pregnancy. RESULTS: CCB appear to be currently used as first-line, initial tocolysis, in the majority of French maternity hospitals (82.5% of tertiary care centers). Oral Nifedipine is the predominant regimen (86%). CCB utilization rates appear higher than those reported in 2005 in the EVAPRIMA study. Beta-agonists appear rarely prescribed in 1st line (poor maternal tolerance) and even abandoned by many institutions (75% of tertiary care centers). Using a maintenance tocolysis (usually by long-acting CCB) seems to vary depending on the hospitals. It would be prescribed in more than 50% of cases (and probably more in type 1 or 2 hospitals), despite the lack of demonstrated benefit. Furthermore, we can estimate that about 1.5 to 2% of outpatient pregnant women receive a prescription of Nifedipine LP in France. CONCLUSION: CCB (especially Nifedipine) are widely used in the treatment of threatened preterm labor in France, regardless of the type of hospital. The terms of off-label prescribing are not met.