Stability Study of [18F]Fludeoxyglucose and [18F]Fluorocholine in Different Medical Devices for Intravenous Administration.

OBJECTIVE: The present study had determine the impact of prolonged storage in a cartridge or syringe on the quality of the [18F]-radiopharmaceuticals used in our center [18F]fludeoxyglucose and [18F]fluorocholine). [18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multidose flasks. When the change of packaging must be made extemporaneously for the preparation of patient unit doses in a syringe or cartridge, this is under the responsibility of radiopharmacists. As drug quality in medical devices (syringe or cartridge) is not evaluated during the marketing authorization of such radiopharmaceuticals, an evaluation of drug stability in such devices seems interesting. In addition, if there are difficulties in patient care (placement of the catheter, lack of personal, etc.) or equipment problems (technical issue with the automated dispenser delaying the delivery of the prepared dose), the contact time of [18F]-radiopharmaceuticals with the medical devices (cartridge or syringe) increases. METHODS: Appearance, pH, radiochemical purity, sterility and endotoxin tests were made according the current European Pharmacopoeia. Adsorption tests were made according the literature. RESULTS: There was no drug absorption of [18F]fludeoxyglucose or [18F]fluorocholine after 1.5h, which may be related to their hydrophilic nature. No drug radiolysis was observed even after dilution of the radiopharmaceuticals (appearance, pH, and radiochemical purity were unchanged). No impurity from medical devices (cartridge or syringe) was observed, and microbiological aspects remained in specification of the current European Pharmacopoeia. CONCLUSION: These radiopharmaceuticals repackaged in plastic medical devices retained their quality after dispensing and prolonged storage.

[Retrocession, a profitable but risky activity]. / La rétrocession, une activité rentable mais à risques.

The retrocession (out-patient dispensing of hospital-reserved drugs)is a pharmaceutical critical activity requiring a care security with a territorial approach. In this drug supply chain, the pharmacist is the last step before the drug administration and the economic profitability is questionable. In this context, a risk mapping and an economic evaluation seem necessary. METHODS: The risk analysis was conducted with the adverse events collected. The economic study was realised with the point of view of the hospital and with the microcosting method. RESULTS: Six never events were observed with the risk analysis. The economic study showed that the retrocession was profitable in usual situations with a net margin from 7 to 14€. But, when an exceptional situation occurred as a troubleshooting or the creation of a public deal, the added costs became so important (76 and 85€) that the retrocession was an unbeneficial activity. CONCLUSION: The retrocession is an activity with a health, legal and economic high risk. In order to improve the healthcare quality and safety, the retrocession must be considered as a coordinated process. It means that the different health professionals must communicate with each other and that the connection between the ambulatory and the hospital care must be efficient.

Fast dissolving cyclodextrin complex of piroxicam in solid dispersion part I: influence of ß-CD and HPß-CD on the dissolution rate of piroxicam.

Sublingual drug delivery is an interesting route for drug having significant hepatic first-pass metabolism or requiring rapid pharmacological effect as for patients suffering from swallowing difficulties, nausea or vomiting. Sublingual absorption could however be limited by the kinetic of drug dissolution. This study evaluated influences of cyclodextrins (ß-CD or HP-ß-CD) and their different inclusion process (spray-drying or freeze-drying) on the drug dissolution kinetic of solid dispersions in poly(ethylene glycol) (PEG, Mw 6000Da) of piroxicam, used as poor hydrosoluble drug model. A secondary objective was to determine influences of drug dispersion process in PEG (evaporation or melting methods) on the drug dissolution kinetic of piroxicam. Piroxicam solid dispersions containing or not cyclodextrins were characterized by different scanning calorimetry (DSC), Thermogravometry analyser (TGA) and Fourier transform-infrared spectroscopy (FT-IR) spectroscopy. In vitro drug dissolution study of these solid dispersions was then performed. The results demonstrated the high potential and interest of solid dispersions of drug previously included in cyclodextrins for sublingual delivery of hydrophobic drugs. This study also showed the advantages of evaporation method on the melting ones during drug dispersion in PEG. Indeed, drug complexation with cyclodextrins as dispersion by melting prevented the presence in solid dispersions of drug in crystalline form which can represent up to 63%. Moreover, dispersion in PEG by evaporation method gave more porous drug delivery system than with melting methods. This allowed complete (limited at most at 80-90% with melting methods) and quick drug dissolution without rebound effect like with melting ones.

[The radiopharmacy end?]. / La fin de la radiopharmacie ?

In France, radiopharmaceuticals preparation and dispensation are made under the responsibility of a pharmacist. This last one made a pharmaceutical over-specialization in the field of the medical use of radioelements. However, a flaw in the French law allows nuclear medicine units to avoid the presence of the radiopharmacist decreasing so the quality and the safety of the care brought to patients. This article aims at looking for legal solutions to maintain these quality and safety by the empowerment of the radiopharmacist statute while taking into account economic aspects.

[Repackaging drugs in pill-box in France: an illegal activity for pharmacists?]. / Le déconditionnement/reconditionnement des spécialités pharmaceutiques en pharmacies : un acte illégal ?

Drug repackaging in pill-box by pharmacists is booming since few years. However, repackaging processes needed to open the industrially primary packaging will be found illegal in France. Thus, in this country drug repacking remains legal only by overwrapping medicines. Now, this solution is not applicable for example, with divisible or liquid forms. Therefore, packaging recommendations must be taken immediately in order to preserve the quality of drugs dispensed and to obtain a legalization of this activity.