Scheepers H P A, Neerup Handlos V, Walser S, Schutjens M D B, Neef C
Health Care Inspectorate, Ministry of Health, Welfare and Sport, Utrecht, The Netherlands.
CAPHRI School for Public Health and Primary Care, Maastricht University, Medical Centre, Maastricht, The Netherlands.
Eur J Hosp Pharm. 2017 Jul;24(4):218-223. doi: 10.1136/ejhpharm-2016-001017. Epub 2016 Sep 5.
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.
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.
Among the member states involved, the results of this survey show a clear commitment to implement the recommendations of the resolution.
This report presents the results of the survey with a discussion of outstanding issues.
欧洲各国对药房制剂的监管，尤其是质量保证和安全标准方面的监管并不统一，而是由各个国家自行负责。欧洲各国普遍对药房生产的药品的质量控制和安全问题表示担忧。然而，继续这种做法有充分的理由，因为它能够根据特定患者或患者群体的具体需求定制制剂，并在无法获得已获上市许可的工业生产产品或出现 licensed 药品临时短缺时提供补充供应来源。为了寻求立法指导方针并根据一个处理制药实践的专家组的建议采取行动，欧洲理事会部长委员会于 2011 年通过了一项决议。欧洲理事会决议为当局和药剂师提供了加强药房制剂安全措施以及统一质量保证和安全标准的方法。它涉及药房制剂的各个方面，如制剂和分发的质量标准、上市许可、产品档案、标签、报告和安全等。2013 年和 2014 年，专家委员会进行了一项调查，以评估该决议在部分成员国中的影响。本研究的目的既是监测这些建议在国家立法中的体现程度，也是了解成员国之间目前在立法和实践方面的差异。
在 2011 年的决议中，建议成员国根据其条款调整本国立法。2013 年和 2014 年进行的调查遵循了该决议中的建议。制作了一份问卷并发送给部分成员国。
在所涉及的成员国中，本次调查结果表明各国明确承诺实施该决议的建议。
本报告介绍了调查结果并讨论了未决问题。
