New EU law angers Belgian hospital pharmacists

New EU law angers Belgian hospital pharmacists
The hospital pharmacy in the Imelda hospital in Bonheiden on, Thursday 17 August 2023. Credit: Belga/Dirk Waem

A new EU law limiting the shelf life of pharmaceutical medicines prepared in pharmacies to four weeks could lead to shortages of essential treatments, hospital pharmacist associations have warned.

They say healthcare is being put at risk and that thousands of patients could be affected.

The debate centres on magistral preparations, prescription medicines made in hospital pharmacies for patients who cannot be treated with standard commercial products.

The EU wants a single fixed shelf life for all such preparations, but hospital pharmacists are opposed.

Thomas De Rijdt, chair of the Belgian Association of Hospital Pharmacists, called the proposed limit "unscientific, practically unfeasible and economically irresponsible".

In practice, shelf life varies widely, with some preparations lasting months or over a year while others remain usable for only a day, he said.

A fixed limit would restrict flexibility and cost efficiency in hospital pharmacies and force operational changes, leading to higher costs, more administration and a greater risk of shortages and therapy interruptions, according to the associations.

They say the measure also undermines the ability of hospital pharmacies to respond to patient needs.

The EU is due to hold a decisive meeting on Wednesday to review pharmaceutical legislation, and hospital pharmacists are sounding the alarm.

They are calling for a flexible system in which shelf life is determined by factors such as stability, production environment, sterilisation method, type of preparation and patient circumstances.

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