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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., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction and Objective: In the Netherlands, preparing and distributing pharmacies (PDPs) are taking over a large proportion of pharmacy preparations. PDPs prepare and distribute medicinal products to dispensing pharmacies. Many pharmacies have stopped pharmacy preparation. However, this contravenes the Dutch Medicines Act and the European Union (EU) Directive 2001/83/EC on which Dutch law is based. This is because the medicinal products of PDPs are unlicensed and PDPs do not have a manufacturing licence., Methods: To solve the conflict with the Dutch Medicines Act, PDPs have since 2007 been authorised by the Dutch Health Care Inspectorate by means of a circular letter. This circular letter describes the qualitative conditions that must be fulfilled by PDPs. The circular letter's conditions state that PDPs must perform verifiable investigations to assess the availability, or not, of licensed pharmacotherapeutic alternatives (PA investigations) and to assess the pharmacotherapeutic rationale and the needs of the patient (PT investigations)., Results: Regular visits were performed by the Dutch Health Care Inspectorate to check the compliance of PDPs with the circular letter. This article describes the results of these inspections for PA and PT investigations., Conclusions: The results of the inspections show that so far almost all PDPs inspected have complied with the PA and PT conditions of the circular level at system level. However, in a substantial proportion of cases, the rationale of the pharmacy-made products is insufficient or insufficiently documented., Competing Interests: Competing interests: None declared.

Introduction and Objective: The regulation of pharmacy preparations, especially for standards for quality assurance and safety, is not harmonised across Europe and falls under the national competencies of individual states. There are concerns about quality control and safety for the medicinal products made in pharmacies, which is widespread in European countries. There are, however, good reasons to continue this practice, which is able to tailor preparations to the specific needs of a particular patient or patient group and to provide a supplementary source of supply when an industrially manufactured product, which is authorised for marketing is not available or when there are temporary shortages of licensed medicines. In seeking to provide guidelines for legislation and acting on the advice of an expert group dealing in pharmaceutical practices, the Committee of Ministers of the Council of Europe passed a resolution in 2011. The Council of Europe Resolution provides authorities and pharmacists with the means to reinforce safety measures for medicinal products prepared in pharmacies and to harmonise quality assurance and safety standards. It dealt with aspects of pharmacy preparation such as quality standards for preparation and distribution, marketing authorisation, product dossiers, labelling, reporting, and safety. In 2013 and 2014 the Committee of Experts carried out a survey to evaluate the impact of the resolution within a cross section of member states. The objectives of this study were both to monitor the extent to which the recommendations had been enshrined in national legislation and also to understand current differences in legislation and practice between the member states., Methods: In the resolution of 2011 the member states were recommended to adapt their legislation in line with its provisions. The survey that was carried out in 2013 and 2014 followed the recommendations in the resolution. A questionnaire was made and sent to a cross section of member states., Results: Among the member states involved, the results of this survey show a clear commitment to implement the recommendations of the resolution., Conclusions: This report presents the results of the survey with a discussion of outstanding issues., Competing Interests: Competing interests: None declared.

Introduction: The rights of patients should be sufficiently protected even when an appropriate authorised medicine does not exist or is unavailable on the market. The Resolution, which was adopted by the Committee of Ministers of the Council of Europe in 2011, aims at harmonising quality and safety standards for pharmacy preparation of medicinal products in Europe., Two Pillars of Eu Regulation and the Exceptions to Them: The system of regulation of medicinal products is built upon two pillars: the marketing authorisation of the medicinal product and the licence for manufacturing and wholesale. This article provides insight into the recent interpretation of the European Court of Justice concerning the scope of European Union (EU) regulation of medicinal products and the circumstances in which the EU regulation does not apply: pharmacy preparations, specialties and the compassionate use of medicines, including manufacturing licence., Eu Regulation and the Resolution Concerning Pharmacy Preparation: Pharmacy preparations are allowed under certain strict conditions according to EU regulations. However, pharmacies specialised in preparation and distributing medicinal products to local pharmacies do not fulfil these strict conditions in EU regulation. Apart from the legal context, relevant standards for safety and quality assurance are needed in Europe in order to protect patients' rights and to avoid risks from pharmacy preparations., Discussion and Conclusions: The Council of Europe Resolution provides a means of establishing standards for safety and quality assurance for pharmacy preparations through Good Manufacturing Practice Guidelines. The Resolution is available to authorities and pharmacists in order to prevent incidents with medicines prepared in pharmacies which may threaten patients' safety. The authors conclude that pharmacy practices have changed over time in Europe and this may imply a reason for a reform of EU regulation on medicinal products., Competing Interests: Competing interests: None declared.

Introduction and Objective: The preparation of medicines in pharmacies is essential for accommodating the individual needs and medical conditions of patients in Europe and beyond. This article describes the state of pharmacy preparation in preparing and distributing pharmacies (PDPs) in the Netherlands. The Medicines Act in the Netherlands is based on the European Union Directive 2001/83/EC, which forbids a PDP from preparing and distributing unlicensed medicinal products to dispensing pharmacies. In order not to obstruct patient care, the Dutch Inspectorate has sent a Circular Letter on large-scale preparation to all Dutch pharmacists. This Circular describes the qualitative conditions that must be fulfilled by the PDPs. The aim of this study was to assess the overall compliance of Dutch PDPs with the conditions of the Circular. These conditions are: an absence of licensed pharmacotherapeutic alternatives, rational pharmacotherapy, a product dossier for all products and compliance with Good Manufacturing Practice (GMP)., Methods: PDPs are obliged to fulfil the conditions of the Circular. If PDPs do not fulfil these conditions, then they have to stop preparing and distributing medicinal products. A questionnaire was sent to all Dutch pharmacies to get information about the number of PDPs and the number of pharmacies served by each PDP. The instrument that was used in this observational study to assess the compliance of the PDPs with all conditions of the Circular is described., Results: The results of the inspections until now show that on 1 November 2014, 18 out of 21 PDPs fulfilled the four conditions of the Circular. Only minor deficiencies were found with 3 out of 21 PDPs. Twenty out of the 21 PDPs visited fulfilled the condition concerning the absence of pharmacotherapeutic alternatives and 19 out of 21 PDPs visited complied with the condition of rational pharmacotherapy. Nineteen out of the 21 PDPs visited fulfilled the Circular condition that a product dossier was available for all products. All of the 21 PDPs visited complied with GMP. Regular visits, at least every 3 years, were performed by the Inspectorate to check the compliance of the PDPs with the Circular. The publication of the inspection reports on the website of the Inspectorate allowed, probably, many PDPs to be better prepared. The inspection visits showed that the PDPs have invested in compliance with the conditions of the Circular., Conclusions: Most of the PDPs fulfilled the requirements of the Circular. The Inspectorate is in consultation with the Ministry of Health, Welfare and Sport about how to proceed with the question of PDPs and the conditions they have to fulfil. Recent European case law will have to be taken into account., Competing Interests: Competing interests: None declared.

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., Competing Interests: Competing interests: None declared.