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Council of Europe Resolution CM/Res(2016)2: a major contribution to patient safety from reconstituted injectable medicines?
  1. Alison M Beaney1,
  2. Paul Le Brun2,
  3. Silvia Ravera3,
  4. Henk Scheepers4
  1. 1 Consultant Quality Assurance Specialist, Stockton Quality Control Laboratory, University Hospital of North Tees, Stockton-on-Tees, UK
  2. 2 Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands
  3. 3 Department of Biological Standardisation, OMCL Network & HealthCare (DBO), European Directorate for the Quality of Medicines & HealthCare (EDQM), Strasbourg, France
  4. 4 Chair of CD-P-PH/PC, Health Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, The Netherlands
  1. Correspondence to Professor Alison M Beaney, Consultant Quality Assurance Specialist, Stockton Quality Control Laboratory, University Hospital of North Tees, Stockton-on-Tees TS19 8PE, UK; alisonbeaney{at}


This article focuses on the reconstitution of parenteral medicines and the work that has been carried out at the European level to improve patient safety. Reconstitution may occur in a clinical area, for example, ward, theatre and so on, or within pharmacy. The quality of reconstituted medicines should ideally be the same, regardless of where reconstitution takes place. However, in practice, risks are greater when reconstitution is carried out in clinical areas. Although ideally all reconstitutions should be carried out within pharmacy aseptic units, capacity is generally not available to allow this, so a risk assessment approach must be taken to enable the healthcare establishment to decide which products must be reconstituted in pharmacy and which, with appropriate safeguards, can be reconstituted in clinical areas. Although guidance on reconstitution has been established in some countries, this is not the case across much of Europe. The Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (Council of Europe) (hereafter: Committee of Experts) has undertaken work to develop quality and safety standards for reconstitution in the different locations within healthcare establishments, taking a risk-based approach. In June 2016, the Committee of Ministers of the Council of Europe adopted Resolution CM/Res(2016)2 on good reconstitution practices in healthcare establishments for medicinal products for parenteral use. Drafted by the Committee of Experts, the Resolution recommends implementation measures for best practices for the reconstitution of injectable medicines for administration to patients. This article summarises the rationale behind the Resolution, its drafting process and main chapters. There is no justification for patient safety with respect to reconstituted medicines to be variable across the Member States of the Council of Europe. Implementation of Resolution CM/Res(2016)2 will enable risk reduction in healthcare establishments and is a major contribution to patient safety from injectable medicines at the international level.

  • reconstitution
  • resolution Cm/res(2016)2
  • council Of Europe
  • injectable medicine
  • parenteral
  • patient safety

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