Legislation On The Preparation Of Medicinal Products In European Pharmacies And The Council Of Europe Resolution

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

Impact of the council of europe resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients

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,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 reso-lution. A questionnaire was made and sent to across section of member states.Results: Among the member states involved, the results of this survey show a clear commitment to imple-ment the recommendations of the resolution.Conclusions: This report presents the results of the survey with a discussion of outstanding issues

Aseptic preparation of parenteral medicinal products in healthcare establishments in Europe

Парентералните лекарствени продукти с разрешение за употреба не могат да се дават непосредствено на пациентите, т. е. те не са във форма, готова за употреба. Преди да се приложат на пациентите, тези лекарства трябва да се реконституират. Реконституираната форма не се счита нито за фабрично произведен, нито „стандартен` продукт приготвен в аптека. Има други процеси в здравните заведения, свързани с процеса на реконституиране (напр. парентералното хранене), за които националните изисквания на стандартите за осигуряване на качеството за безопасно приготвяне на стерилни продукти са също толкова важни и задължителни. В европейските здравни заведения асептично Преводна то приготвяне на парентерални лекарствени продукти се счита за процес с изключителна важност за безопасността на пациентите, поради това, че грешки при приготвянето на тези лекарства може да доведат до получаване на продукт, който да причини непосредствена вреда на пациента. Асептичното приготвяне на лекарствени продукти се извършва както в болничните аптеки, така и в клиничните зони в лечебните заведения. Комисията от експерти в областта на стандартите за качество и безопасност за фармацевтични практики и фармацевтични грижи (Съвета на Европа, наричана за краткост Експертна комисия), със съдействието на Европейската дирекция по качеството на лекарствата и здравеопазването извършва действия в областта на асептичното приготвяне на лекарства. Работи се съвместно с Европейската асоциация на болничните фармацевти на основание Резолюция CM/Res AP(2011)1 за изискванията за гарантиране на качество и безопасност за лекарствените продукти, приготвени в аптеки за специални нужди на пациентите, приета от Комитета на министрите на 19 януари 2011 г. Резолюцията съдържа някои препоръки и излага перспективата за по-нататъшна работа в областта на реконституирането на парентерални лекарства. Проучване, изпратено до различни европейски страни, показва, че или отсъства регламентиране на реконституирането в Европа, или ако съществува, то е много ограничено. Настоящата статия разглежда рисковете, свързани с лоши практики на реконституиране и извършените и настоящите дейности в областта на европейско ниво. Статията подчертава необходимостта от регламентиране по темата, каквото в момента липсва. Очаква се да се постигне консенсус по документ с указания за реконституиране на европейско ниво.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

Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution

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

Aseptic preparation of parenteral medicinal products in healthcare establishments in Europe

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