PP 34/19Braille Labelling of Medicinal Gas Packages

The European Pharmaceutical Directive (2001/83EC) has been amended to include the need to label all medicinal products with the name of the product in Braille (and to supply blind or partially sighted patients with instruction leaflets in an appropriate format so that they can be read by each patient).

 The European Medicines Agency (EMEA) has issued guidance to restrict these new requirements to those medicinal products that are self administered by the patient.  This means the changes to the directive only affects those medical oxygen cylinders supplied to homecare patients. EIGA believes that fitting Braille labels to medical gas packages will not assist the safety of blind or partially sighted patients when they are prescribed medical oxygen for use at home. This Position Paper proposes that the medical gas packages, supplied to Homecare patients should be exempt from the requirement to fit Braille labels.  However, to meet the intent of the Directive and to promote patient safety for the blind or partially sighted patients EIGA proposes that:

  • An initial Homecare Risk Assessment be carried out when supplying medical oxygen to each patient at home which should consider and record whether the patient/carer is blind or partially sighted.
  • Where the patient/carer is blind or partially sighted, all information and training should be provided in a suitable format so that the patient can handle and administer the medicinal gas in a safe manner. Full details of the position and the background to it are covered in this Position Paper.

This Position Paper was revalidated in December 2019