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EMA Consultation: Safety of high-strength and combination insulin products (Deadline: 2 April 2015)

The European Medicines Agency (EMA) is consulting patient organisations on questions related to insulin products.

Have your say!

If you would like to provide feedback, please send your comments to EPF by 2 April 2015.

Contact: policy@eu-patient.eu

If you have already been contacted by the EMA directly, please send your feedback directly to the Agency by 3 April.

Background to this consultation

The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has raised some concerns about medication errors following the recent approval of a number of high-strength insulins (i.e. higher than the EU-wide standard 100 units/ml concentration) either as new medicinal products or as line extension of existing medicines. A fixed combination of insulin with another non-insulin injectable blood glucose lowering agent has also been approved. Errors in using these products could lead to significant over- or under-dosing of insulin.

Objective of the consultation

The PRAC has drafted a strategy to minimise potential risk of medication errors with these types of insulin products. The PRAC is now seeking the views of healthcare professionals and patients on the content of this draft guidance and the key communication messages.

In addition, the PRAC would like to know how patients’ and professionals’ organisations could join efforts in promoting awareness and minimise the potential for medication errors with these products.

"Pre-consultation" - Full public consultation to be launched in April

Please note this is a “pre-consultation” to review the draft document before the launch of a full public consultation in April. If you cannot provide your views now, you will always have a chance to do that during the public consultation.

The document below is an internal draft for this consultation only. Please do not publish or disseminate it except via your own internal channels to collect the views of your organisation.