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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 3â 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.
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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.