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Aseptic preparation of parenteral medicinal products in healthcare establishments in Europe
  1. HPA Scheepers1,
  2. AM Beaney2,
  3. PPH Le Brun3,
  4. V Neerup Handlos4,
  5. MDB Schutjens5,
  6. S Walser6,
  7. C Neef7,8
  1. 1Department of Health Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, The Netherlands
  2. 2Regional Quality Assurance Specialist, Royal Victoria Infirmary, Newcastle upon Tyne, UK
  3. 3Apotheek Haagse Ziekenhuizen, The Hague, The Netherlands
  4. 4Capital Region Pharmacy, Herlev, Denmark
  5. 5Department of Pharmaceutical Law, University of Utrecht, Utrecht, The Netherlands
  6. 6European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France
  7. 7Department of Clinical Pharmacy, Maastricht University Medical Centre, Maastricht, The Netherlands
  8. 8CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
  1. Correspondence to HPA Scheepers, Department of Health Care Inspectorate, Ministry of Health, Welfare and Sport, Stadsplateau, Utrecht 3521 AZ, The Netherlands; hp.scheepers{at}igz.nl

Abstract

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. Reconstitution has a special position; it can neither be seen as industrial manufacture nor as ‘regular’ pharmacy preparation. There are other processes in healthcare establishments (eg, parenteral nutrition), 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. In European healthcare establishments, aseptic preparation of parenteral medicinal products is considered to be a process of crucial importance for patient safety because errors in the preparation of these medicines may lead to a product that can cause immediate damage to patients. Aseptic preparation of medicinal products is carried out in hospital pharmacies as well as in clinical areas in healthcare establishments. The Committee of Experts on Quality and Safety Standards for Pharmaceutical Practices and Pharmaceutical Care (Council of Europe; hereafter: Committee of Experts), supported by the European Directorate for the Quality of Medicines & Healthcare, is undertaking work on the topic of aseptic preparation of medicines. The work is carried out in cooperation with the European Association of Hospital Pharmacists on the basis of a Resolution CM/Res AP(2011)1 on Quality and Safety Assurance requirements for Medicinal Products prepared in Pharmacies for the Special Needs of Patients, which was adopted by the Committee of Ministers on 19 January 2011. The Resolution includes some recommendations and an outlook to further work on reconstitution of parenteral medicines. A survey that was sent to the different European countries demonstrated that there is no or just limited regulation concerning reconstitution in Europe. This article describes the risks associated with poor reconstitution practices and the previous work as well as the ongoing activities concerning reconstitution at the European level. The article emphasises the need for regulation in this area, which is missing at present. It is expected that consensus can be reached on a guidance document for reconstitution at the European level.

  • aseptic preparation of medicinal product
  • Reconstitution
  • medication safety
  • EDQM (European Directorate for the Quality of Medicines & Healthcare)
  • regulation on reconstitution

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