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Hazardous Medicinal Products: the European classification landscape

Room:

Room -2.31

Facilitator:

Valladolid Walsh, Ana

Speakers:

Abstract:

Linked to EAHP Statements

Section 3 – Production and Compounding: Statements 3.3, 3.4, 3.5 and 3.6
Section 5 – Patient Safety and Quality Assurance: Statement 5.6 and 5.9

ACPE UAN: 0475-0000-22-020-L03-P. A knowledge-based activity.

Abstract

Hospital pharmacists and members of the multidisciplinary team – such as nurses, pharmacy technicians and others – are dealing with hazardous medicinal products in their daily work. Their safe handling is of uttermost importance for the safety of healthcare professionals and patients treated with these medicines. Their classification plays an essential role in determining suitable handling procedures. However, unlike the United States, Europe does not have one single body similar to the National Institute for Occupational Safety and Health (NIOSH) that addresses all questions linked to the classification of hazardous medicinal products.

To better understand the classification landscape for hazardous medicinal products in Europe, the European Association of Hospital Pharmacists (EAHP) has established a Special Interest Group (SIG). EAHP’s SIG on Hazardous Medicinal Products discussed and gathered information on the current status of hazardous medicinal product classification in European countries as well as their similarities and differences, put together a definition of the term ‘hazardous medicinal product’ for Europe and reflected on the protection of healthcare professionals and patients from exposure to hazardous medicinal products. Specific focus was put on the NIOSH model which is used by many European countries and the Dutch model (Risico instrument Farmaceutische Stoffen (RiFaS) – Pharmaceutical Substances Risk Assessment).

‘Hazardous medicinal products’ were addressed in a wide sense including but not limited to carcinogenic, mutagenic or toxic to reproduction (CMR) drugs, some of the immunomodulators and biological substances. Based on their findings and discussion outcomes the SIG developed recommendations and guidance to support hospital pharmacists and their advocacy work linked to protocols around classification, storage, and handling of potentially hazardous medicinal products. This session will be dedicated to sharing the results of the work carried out by EAHP’s SIG on Hazardous Medicinal Products throughout 2021, including the European-developed classification model recommended by the SIG.

Learning objectives

After the session, participants should be able to:

  • Recognise different classification models for hazardous medicinal products identified by the SIG (e.g. NIOSH, the Dutch model), including their strengths and weaknesses
  • Identify hazardous medicinal products with the help of a proposed European definition and the European-developed classification model recommended by the SIG
  • Discuss protocols around the classification, storage, and handling of potentially hazardous medicinal products

Educational need addressed
The classification of hazardous medicinal products is largely influenced by NIOSH. EAHP’s SIG has closed gaps by identifying classification systems around Europe and creating a European model  a definition of the term ‘hazardous medicinal products’ applicable to the European treatment landscape.

Keywords: Hazardous medicinal products; occupational exposure; personnel; pharmaceutical preparations

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