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Objective: Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [Tc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [Ga]Ga-DOTA-TOC (Somakit-TOC)., Methods: Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (<25 ml). Sorption tests were performed according to the literature., Results: After 2 h storage in a syringe, drug sorption of Tektrotyd and Somakit-TOC was of less than 2.5% and similar to other Tc-radiopharmaceuticals (range: from 1.1 ± 0.5% to 4.2 ± 0.6%). For Tektrotyd, this sorption phenomenon was positively influenced by the drug concentration and a short contact with the medical device (4.8 ± 0.2% up to 5 s vs. 2.3 ± 0.2%, n = 4; P < 0.001). For Somakit-TOC, the duration of contact with syringe had no impact (1.6 ± 0.2% up to 5 s vs. 1.7 ± 0.6%; P = 1.000). No drug radiolysis or alteration of microbiological aspects were observed. No impurity from a 3-piece-syringe was observed according to drug aspect, pH, and subvisible and visible particles, which remained within specification of the current European Pharmacopoeia., Conclusion: This study found that drug sorption to packaging was compatible with clinical use and absence of drug alteration of Tektrotyd and Somakit-TOC after repackaging in a syringe in polypropylene and prolonged storage during 2 h.

Objectives: Failure mode effect analysis (FMEA) improves safety in the drug life cycle. As the drug dispensation by hospital's pharmacy can be at risk, the FMEA tool has been used to evaluate and enhance the process., Methods: After detailing the process, a first FMEA has been run in 2015. Corrective actions were implemented every time criticality indexes (CI) were above 15. One year later, we have evaluated potential impacts of these actions by running a new FMEA., Results: In 2015, 11 failure modes were prioritized (CI>15) and the total CI for the overall process was 397. Corrective actions were implemented and one year later this amount has decreased by 14% (340) with 6 failure modes still prioritized. Thus, thanks to the FMEA, risks could be identified in year "y", they were taken into account and corrected and then effectively reassessed in year "y+1"., Conclusion: This study showed us the interest of performing FMEA analysis in the drug dispensation process by hospital. The renewal of this risk analysis after a year helped us to monitor corrective actions, to evaluate their effectiveness and to improve safety. Finally, FMEA seems to be an effective way to steer the drug dispensation process., (Copyright © 2019 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Valpromide and sodium divalproate are indicated in the treatment of maniac episodes of bipolar disorder. These drugs are metabolized into valproic acid. The occurrence of peripheral edema has been described as a very rare adverse reaction of those drugs., Case Report: We report the case of a patient treated with valpromide who presented edema of the lower limbs. The increase in furosemide dose allowed regression of edema, and valpromide discontinuation resulted in rapid normalization. Recurrence of mood disorders led to the reintroduction of valpromide, which was associated with recurrence of edema. The definitive withdrawal of valpromide resulted in resolution of edema., Conclusion: Edema of the lower limbs can be induced by valproate. The mechanism of this reaction is unknown. These edema appear to be reversible upon discontinuation of the drug. Clinicians should be aware of a possible relationship between valproate-derived drugs and peripheral edema., (Copyright © 2014 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.)