Seminar 11 – Survival of hospital pharmacy preparations – standards for quality and safety, where to go? An interactive debate

Abstract:

Manufacturing and compounding of medicinal products in hospital pharmacies are performed by applying GMP guidelines and are controlled according to PIC/s. Some hospital pharmacies work according to the industry guidelines PE 009, some according to the institution guidelines PE 010. For aseptic preparation of ready-to-use parenterals, dedicated national guidelines or the EU GMP Guideline Annex 1 are followed as well. The requirements derived from either one of them are hardly applicable and practicable in a whole and have not proven so far that they are apt enough to protect hospital pharmacists from　all critical incidences.　To date, it is not evident which one of these guidelines is the most suitable for hospital pharmacies　and in which case best quality of the product can be obtained. Above all, differences between hospital and industry production in terms of dedicated or polyvalent equipment and processes respectively are not really considered.

To overcome this problem and the very different level of quality of small-scale pharmacy preparations in the member states of the Council of Europe (CE),　the EAHP was actively involved in a working party led by the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe on the standards for pharmacy prepared medicinal products. The EAHP supported the steps undertaken by the Council of Europe to enhance the quality of magistral small-scale preparations across Europe. The CE　in January 2011 adopted a resolution in form of a frame for the harmonization of quality and safety of pharmacy preparations to be implemented in the member countries.　　

The resources required to fulfill the quality standard　laid down in the resolution　are an important challenge to hospitals. It is therefore important that European hospital pharmacists know about the issues and are prepared to use the text　of the resolution in their ongoing discussion with their national authorities.　

The seminar will focus on pharmacy preparations and give points of view how to develop the quality of these products to the benefit of the patient in a way that　pharmacy preparations　will be available from Hospital Pharmacies in the future. The seminar will be performed as a debate in a focus group.

Teaching goals:

• to understand why the resolution has been developed and accepted by the national ambassadors to the Council of Europe and the Council of ministers in the Council of Europe
• to explain how the resolution should be used to keep pharmacy preparations for the future benefit of the patient
• to present the results from the working party trying to take the benefit of the resolution
• to deliver key opinion leaders’ interpretations of a selection of thesis about hospital pharmacy compounding within the cGMP frame
• to elucidate determinant weak points and risk factors for incidences existing in hospital pharmacies and to suggest approaches to overcome
• to find an agreement and a way on how to cope with the specificities of producing hospital pharmacies and on how to integrate them in further guidelines and inspection conventions

Learning objectives:

After the presentation the participant should:

• be able to outline the risks existing in their facility and assess them with regard to the requirements defined by cGMP and PIC/s.
• be able to critically analyze the musts and shoulds given by the resolution of the EC, the cGMP normes, and PIC/s guidelines and optimize the applicability and practicability in their own facility and setting.