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Correspondence to HPA Scheepers, Department of Health Care Inspectorate, Ministry of Health, Welfare and Sport, Stadsplateau, Utrecht 3521 AZ, The Netherlands; [email protected]
Introduction
In many cases, parenteral medicines with a marketing authorisation cannot be administered directly to patients, that is, they are not presented in ready-to-administer form. Before administration to patients, these medicines have to be reconstituted. Hospital pharmacies can provide ready-to-administer parenteral products. The reconstitution process, which precedes administration, may vary from simple preparation to many or very complex operations.
Reconstitution relates to medicinal products with a marketing authorisation not yet ready for use by patients and may take place at different locations in healthcare establishments. There are other processes in healthcare establishments (eg, parenteral nutrition (PN)), related to the reconstitution process, where the requirements of national quality assurance standards for the safe preparation of sterile products are equally important and have to be fulfilled. Aseptic preparation of parenteral medicinal products in healthcare establishments introduces risks for patients’ safety. Adequate reconstitution of medicinal products is considered to be of crucial importance for patient safety by national authorities, healthcare establishments and hospital pharmacists.
Reconstitution is defined as the manipulation to enable the use or application of a medicinal product with a marketing authorisation in accordance with the instructions given in the summary of product characteristics (SmPC) or the patient information leaflet. This definition of reconstitution is based on consensus reached among 36 member states of the Council of Europe.1
From a regulatory point of view, reconstitution has a special position:
Reconstitution cannot be seen as a part of industrial manufacture because it is performed outside the industry. Regulation for medicinal products manufactured on an industrial scale is clear and has an international focus; the manufacture has to comply with EU GMP2 and a marketing authorisation issued by the competent regulatory authority is required for products before being placed on the market.
Reconstitution cannot be seen as a ‘regular’ pharmacy preparation because the starting material for reconstitution is a medicinal product with a marketing authorisation instead of an active pharmaceutical ingredient and also because reconstitution often occurs in clinical areas instead of pharmacies. The preparation of medicinal products in pharmacies falls under the national competencies, as far as it is not covered in international...