Flash VIG-news : INSULINS in prefilled pens and cartridges for reusable pens: new recommendations

date: 08/02/2018

Following an alert from the United Kingdom's National Health Service (NHS ), the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) analysed reports of incidents linked to the extraction of insulin from prefilled pens and cartridges for reusable pens with the aid of a syringe. This practice can increase the risk of medication error and lead to dysglycaemia. However, until today, only the package leaflets of certain insulins mentioned the possibility of such extraction.

PRAC recommends updating the package leaflets for prefilled insulin pens and cartridges for reusable pens. The possibility of extraction using a syringe will be deleted from all patient package leaflets. A text specifying that the insulin contained in prefilled pens and cartridges for reusable pens should only be used with these pens and is only suitable for subcutaneous injection will be added to the package leaflets of all relevant products.

 It is recommended that patients talk to their doctors about whether or not an alternative insulin injection method is necessary. Patients are also encouraged:

  • to ensure that they have access to a pen, needles and/or a refill cartridge for reusable pens;
  • in the event of malfunction of the pen, to use:
    • the replacement needle and/or the cartridge for reusable pens;
    • if this fails to work, a replacement pen.


the FAMHP also encourages patients to know:

  • how to obtain a replacement pen in case of emergency;
  • when more frequent monitoring of glycaemia may be necessary;
  • when to request medical assistance;
  • that poor handling of the pen and/or the cartridge for reusable pens can result in imprecise future doses.

Furthermore, the FAMHP reminds health professionals that:

  • that ideally a replacement pen should be used if an insulin pen malfunctions;
  • extracting the insulin from pens incurs a risk of dosage error due to:
    • mixing types of insulin;
    • dose conversion errors, particularly with different concentrations of insulin;
    • a reduction in the precision of the pen;
  • the consequences of dosage errors can be fatal.
Last updated on 12/02/2018