Linked to EAHP Statements

Section 3 – Production and compounding: Statements 3.3., 3.5. and 3.6

ACPE UAN: 0475-0000-18-019-L04-P. An application based activity.

Abstract

Medication errors, including those involving the reconstitution of a medicinal product into a dosage form that is ready to be used or administered to a patient, and quality defects associated with inappropriate reconstitution, can have serious implications for patient safety, in particular in the case of parenteral administration. It is known that the standards for reconstitution of medicinal products in health care establishments is not harmonised throughout Europe. Therefore, a working party was instigated by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to advise on harmonised good reconstitution practices. The work resulted in a draft describing the responsibilities of healthcare stakeholders, the minimum requirements (standards) for reconstitution in a hospital and the handling of risks posed by reconstitution. Based on the risks, a decision can be made where reconstitution should take place: in pharmacy or in clinical areas. June, 2016, the draft was accepted as a Resolution of the Council of Europe on good reconstitution practices (GRP) and was adopted by 36 European countries. The Resolution on reconstitution is a logical follow-up to a previous Resolution on pharmacy preparation (CM/ResAP(2011)1) which was adopted by the same 36 countries in 2011. This Resolution was presented and discussed at the EAHP congress in Milan in 2012, and has now been reissued as CM/Res(2016)1.

During the workshop, the content of the new Resolution will be discussed including the probable consequences for your daily practice. We will also address the role of the hospital pharmacist in the reconstitution process, discuss the opportunities to work with clinical colleagues on the new Resolution, explain the proposed risk assessment and will encourage its implementation.

Learning objectives

After the session, the participant should be able to:

• Understand the legal status of a Resolution;
• Understand the content of the reconstitution Resolution;
• Try out risk assessment in reconstitution processes; and,
• Close possible gaps with current practice so that the participant is able to prepare for implementation in his or her hospital.

Educational need addressed

In 2012 at the EAHP Seminar 11, Congress participants learned about the "Abridged Survey report on Quality and Safety Assurance for the Preparation of Medicinal Products in Pharmacies". The idea of the Resolution CM/ResAP(2011) was to protect patient safety by ensuring they there are no gaps between medicinal products prepared in pharmacies and those prepared on an industrial scale. There is a need to know if the aim of harmonization has been obtained meanwhile or not and what is the content of the reissue.

Keywords: patient and medication safety, designated person, reconstitution of parenteral medicines, Good Reconstitution Practices, Council of Europe, risk management

Quality and Safety Standards in Pharmaceutical Practices & Pharmaceutical Care
Highlights of the Resolution on Good Reconstitution Practices in European health care establishments