Atelier 5 : Are syringes as primary containers for ready-to-administer compounded preparations (un)safe ?

5 octobre 2016

Moderators : I. Krämer1, P. Le Brun2 1 Department of Pharmacy, University Medical Center, Johannes Gutenberg-University,
Langenbeckstraße 1, 55131 Mainz, Germany
2 The Hague, Holland

Injectables are categorised as high risk medicines. Over the years many cases have been published about incorrectly prepared injectables causing harm to patients. Most medicinal products need manipulation steps before administration, such as reconstitution and/or transfer into empty syringes as primary containers. Ready to administer (RTA) injectable dosage forms are a useful option to improve patient safety. So far only a minority of licensed injectable products are marketed in prefilled syringes. Therefore, hospital pharmacists are challenged to prepare ready to administer RTAs in the pharmacy departments or on the wards. Aseptic preparation of these RTAs is covered by different guidelines dealing with the preparation areas, the equipment, the preparation process, and the quality assurance system. Major issues of pharmacy prepared RTAs are the quality (identity, content, purity) and the stability. Numerous valid publications about the stability of RTA products are available. Only few publications deal with the incompatibility of the content and the single-use plastic syringes used as packaging material. It got obvious that e.g. lubricants, antislip additives, antioxidants, stabilizers, and monomers can be leached from the packaging material into the injection product especially during prolonged storage periods. Leaching from the plastic containers is product and time dependent. The influence of the leached compounds on the safety and efficacy of the injection products remains unclear. Nevertheless, alternative packaging materials like syringes made of cyclic olefin copolymer, empty bags, and sterile tubes are developed.

In this workshop the legal background and definitions of RTA’s will be presented. Next the preparation of RTA’s will be discussed with a focus on prefilled syringes. Both the product and the process will be interactively presented. The long-term compatibility of the injectable products and the single-use-syringes used as primary and the risk of leaching and leachables from the container material will be emphasized. Alternative packaging material for RTAs and processing will be discussed.

The learning objective is the preparation of safe RTA products in the form of prefilled syringes.

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