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The European Directorate for the Quality of Medicines (EDQM) released automated dose dispensing (ADD) guidelines. Their content was agreed on during an open consultation involving stakeholders, which was held this past year and concluded on February 2017. Overall, the ADD guidelines aim at harmonising the standards and approaches to ADD across Europe for the safe supply of medicines to patients.

The ADD guidelines, published this year, have been developed by a working group of experts from industry, academia, pharmacy and government from across the region of the Council of Europe. These guidelines harmonise the standards and approaches to automated dose dispensing across Europe and are intended to be used by pharmacies and manufacturers involved in automated dose dispensing, as well as by national authorities in countries where this service is provided. They include standards regarding the ADD sites and operations, as well as patient care activities associated with the ADD process.

The guidelines include detailed instructions on issues such as product liability and ADD suitability information from manufacturers, responsibility and training of personnel, traceability of medicinal products, suitable packaging materials for ADD, stability of medicinal products, automated dose dispensing process and many other aspects related to ADD. Finally, the report encourages national governments to establish legal frameworks and develop standards or guidance to support the regulation of ADD.